id
int64 0
35.8k
| prompt
listlengths 2
2
| completion
listlengths 1
1
| Label
stringclasses 3
values |
|---|---|---|---|
700
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRAAS Optimization for Acute CHF Patients\n\n**Clinical Trial Summary:**\n\nHolding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure\r may help preserve renal function with a lesser decline in GFR. This treatment modification\r will also allow the option of aggressive diuresis in volume overloaded CHF patients which\r should result in a lesser decline of AKI, length of stay, readmission rates, and cost\r associated with CHF treatment.\n\n**Clinical Trial Detailed Description:**\n\nThe investigators hypothesize that worsening renal function can be mitigated by withholding\r ACEI/ARB during the initial phase of in-patient treatment with aggressive diuresis. This\r hypothesis will be tested by randomly allocating 360 admitted patients with ADHF on two\r treatment paths: 1) no ACEI/ARB administered for initial 72 hours of treatment during\r aggressive diuresis versus 2) full dose ACEI/ARB administered concurrently with aggressive\r diuresis in naïve patients/home dose, who are already on such therapy. The study team hopes\r to find that holding ACEI/ARBs during the initial 72 hours of admission with acute\r decompensated systolic heart failure will help preserve renal function, as demonstrated by a\r lesser decline in GFR. In addition, this treatment would allow the option of aggressive\r diuresis in volume overloaded CHF patients, resulting in a lesser decline of AKI, length of\r stay, readmission rates, and costs associated with CHF treatment. By understanding the\r complex interaction between holding ACEIs/ARBs and continued aggressive diuresis, the\r investigators intend to develop optimal dosing strategies for acute, decompensated CHF\r patients, further minimizing adverse events such as electrolyte issues and declining GFR/AKI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Patients are eligible for enrollment if within the previous 24 hours they were treated with\r acute decompensated heart failure or diagnosed on the basis of the investigator's clinical\r diagnosis of heart failure, which needs to be supported by at least 2 the following\r criteria:\r\n\r - Elevated concentration of B-type natriuretic peptide (BNP) or N-terminal pro-BNP.\r (Elevated BNP\" defined as >300 for sinus rhythm, >500 for patients will atrial\r fibrillation and elevated pro BNP defined as >1000 for sinus rhythm, >1600 for atrial\r fibrillation.)\r\n\r - Pulmonary edema on physical examination.\r\n\r - Radiologic pulmonary congestion or edema.\r\n\r - History of Chronic Heart Failure. Anticipated need for IV loop diuretics for at least\r 48 hours\r\n\r - Willingness to provide informed consent\r\n\r Exclusion Criteria:\r\n\r - Previously diagnosed end-stage renal disease; Serum Potassium >5.5 mmol/L\r\n\r - Cardiogenic Shock within 48 hours, ST-segment elevation myocardial infarction, ongoing\r ischemia.\r\n\r - Need for renal replacement therapy through dialysis or ultrafiltration\r\n\r - Myocardial infarction within 30 days of screening.\r\n\r - Patients with systolic blood pressure of less than 90 mm Hg.\r\n\r - Patients requiring Intravenous Vasodilators or inotropic agents (other than Digoxin)\r for heart failure\r\n\r - BNP less than 250 ng/ml and/or proBNP less than 1000 mg/ml\r\n\r - Pregnant women, prisoners, and institutionalized individuals\r\n\r - Severe stenotic valvular disease\r\n\r - Complex congenital heart disease\r\n\r - Need for mechanical hemodynamic support\r\n\r - Sepsis\r\n\r - Terminal illness (other than HF) with expected survival of less than one year\r\n\r - Previous adverse reaction to the study drugs\r\n\r - Use of IV iodinated radiocontrast material in last 72 hours or planned during\r hospitalization\r\n\r - Enrollment or planned enrollment in another randomized clinical trial during this\r hospitalization\r\n\r - Inability to comply with planned study procedures\r\n\r - Primary admission diagnosis other than acute heart failure\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
701
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery\n\n**Clinical Trial Summary:**\n\nIncreased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive\r mechanism to help limit systolic wall stress and preserve ejection fraction (EF). This study\r Aim to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV\r function in patients undergoing aortic valve replacement (AVR) alone or in addition to\r coronary artery bypass graft (CABG). It Designs as A prospective randomized controlled\r comparative study in which eighty patients received either general anesthesia ( control group\r n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to\r normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition\r to (CABG).\n\n**Clinical Trial Detailed Description:**\n\nBackground: Increased left ventricular mass index (LVMI) results from aortic valve lesions as\r an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF).\r\n\r Aim: to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV\r function in patients undergoing aortic valve replacement (AVR) alone or in addition to\r coronary artery bypass graft (CABG).\r\n\r Design: A prospective randomized controlled comparative study. Methods: Eighty patients\r received either general anesthesia ( control group n=40) or with high thoracic epidural\r analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM)\r group(n=20), all submitted to (AVR) alone or in addition to (CABG).Perioperative heart rate\r (HR), mean arterial blood pressure (MAP), incidence of ischemic ECG, LV systolic and\r diastolic function changes were measured till 48 h, postoperatively.\r\n\r Patients were subjected to ambulatory Holter monitoring, Hemodynamic measures, intraoperative\r transesophageal echocardiography (iTEE) and postoperative Trans Thoracic Echocardiography\r (TTE) to assess myocardial ischemia and Left ventricular systolic/diastolic function.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients between 65 and 75 years with:\r\n\r - physical status of ASA II and IV\r\n\r - who underwent aortic valve replacement (for isolated or mixed aortic valve lesions)\r alone or in addition to-coronary artery bypass grafting. in the Cardio-thoracic\r Surgery Department of Tanta University Hospital during a two year period were enrolled\r in this study.\r\n\r - Before inclusion in the study, all patients were evaluated with extended\r echocardiographic imaging, full history including cardiac symptoms (dyspnea,\r orthopnea, paroxysmal nocturnal dyspnea, chest pain, and low cardiac output symptoms)\r was taken from all patients. General (including body weight and height) and systematic\r (including cardiac examination) examinations were done to all patients.\r\n\r Exclusion Criteria:\r\n\r - Patients with an ejection fraction of 0.3, myocardial infarction within the last 4\r weeks\r\n\r - diabetes\r\n\r - severe pulmonary or arterial hypertension.\r\n\r - a contraindication for HTEA.\r\n\r - patients without preoperative optimal echocardiographic imaging were excluded.\r\n\r - Among the exclusion criteria were the administration of ticlopidine within 15 days\r before surgery and the administration of platelet glycoprotein IIb/IIIa inhibitors. In\r common with previous investigators, we did not consider treatment with\r low-molecular-weight heparin and aspirin below the dosage of 160 mg/day to be\r contraindications to the procedure.\r\n\r - Patients with significant aortic insufficiency were also excluded from the study in\r order to avoid introducing further variables that could influence hemodynamic response\r to the procedure.\r\n\r - Patients were excluded if they underwent an AVR on an emergency basis, had poor\r acoustic windows for adequate echocardiographic assessment, and/or did not undergo an\r echocardiogram before the operation.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
702
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nOutcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy\n\n**Clinical Trial Summary:**\n\nThis is a prospective, single-center study to assess clinical phenotype and prognosis of\r different pathogenic mutations in Chinese patients with hypertrophic cardiomyopathy. Patients\r with hypertrophic cardiomyopathy were consecutively recruited, and then DNA samples were\r extracted from peripheral blood. Targeted sequencing of 142 genes was performed to obtain\r variants associated with hypertrophic cardiomyopathy. Patients will undergo face-to-face\r interviews, phone calls, or/and chart reviews at 6 months, 12 months, 24 months, 36 months,\r 48 months and 60 months for data collection of clinical outcomes.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 1. Adults: a wall thickness ≥15 mm in one or more LV myocardial segments-as measured\r by any imaging technique (echocardiography, cardiac magnetic resonance imaging (CMR)\r or computed tomography (CT))-that is not explained solely by loading conditions;\r\n\r - 2. Children: an LV wall thickness more than two standard deviations greater than the\r predicted mean (z-scored>2, where a z-score is defined as the number of standard\r deviations from the population mean);\r\n\r - 3. Relatives: the first-degree relatives of patients with unequivocal disease (LVH ≥15\r mm) is based on the presence of otherwise unexplained increased LV wall thickness ≥13\r mm in one or more LV myocardial segments, as measured using any cardiac imaging\r technique [echocardiography, cardiac magnetic resonance (CMR) or CT].\r\n\r Exclusion Criteria:\r\n\r - 1. Patients with severe valvular disease, aortic stenosis, congenital heart disease,\r hypertensive heart disease, diabetic cardiomyopathy, or other cardiovascular or\r systemic diseases that may cause ventricular hypertrophy;\r\n\r - 2. Patients who had participated in any clinical trial during the first 3 months;\r\n\r - 3. Previous history of cancer or tumor, or pathological examination confirmed\r precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia\r of the cervix);\r\n\r - 4. Patients refused to comply with the requirements of this study to complete the\r research work.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
703
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nmHealth Lifestyle Intervention on CHD Primary Prevention\n\n**Clinical Trial Summary:**\n\nBackground: Coronary heart disease (CHD), the most prevalent type of cardiovascular disease\r among adults, has been identified as one of the chronic diseases which are epidemic in the\r world. Teaching and encouraging the working population to adopt a healthier lifestyle could\r favor in preventing and/or decreasing the incidence of CHD among this population. The use of\r mobile application (app) is the next logical wave of healthcare support tools to prevent and\r manage chronic diseases like CHD.\r\n\r Aims: The aims of the study are to develop a mHealth programme, entitled \"Care4Heart\" for the\r working population in Singapore, and thereafter examine its feasibility and effectiveness in\r increasing the awareness and knowledge of coronary heart disease (CHD) as well as improving\r their heart-related lifestyle.\r\n\r Methods: A two-phase study design will be adopted. Phase 1 is a pilot, two-arm randomized\r controlled trial (RCT) study and phase 2 is a single group pretest and repeated posttest\r longitudinal study. The study will be conducted in National University of Singapore. A\r convenience sampling will be used, and a total of 240 healthy working adults will be\r recruited via posters advertising in campus canteens, which comprising 80 participants in\r Phase 1 and 160 participants in Phase 2 study. The first recruited 80 participants will be\r randomly allocated to an intervention group and a control group, and only those in the\r intervention group will receive 4-week \"Care4Heart\" programme. For the participants recruited\r in phase 2 (n = 160), the newly developed mobile app will be installed onto their'\r smartphones, and a well-trained research assistant will brief the participants about the\r utilization of the app.\r\n\r The main outcomes will be measured using the survey questionnaires: Awareness of CHD, Heart\r Disease Fact Questionnaire-2, Behavioral Risk Factor Surveillance System and Perceived Stress\r Scale. Data will be collected at baseline, and at the 4th week for phase 1 study while a\r third data collection at the 6th month thereafter will be conducted for phase 2 participants.\r Data will be analyzed using IBM SPSS 22.0.\r\n\r Applications: If this project is proved to be feasible and effective, \"Care4Heart\" app, a\r novel CHD prevention programme will be popularized nationwide to promote knowledge and elicit\r positive heart-related behavioral changes for the working population in Singapore\n\n**Clinical Trial Detailed Description:**\n\nThe study aims to develop a mHealth programme, entitled \"Care4Heart\" for the working\r population in Singapore and examine its feasibility and effectiveness in increasing the\r awareness and knowledge of coronary heart disease (CHD) as well as improving their\r heart-related lifestyle.\r\n\r The objectives are:\r\n\r 1. To develop a mHealth programme using the smartphone app, entitled \"Care4Heart\" for the\r working population in Singapore to assist them in establishing a healthy lifestyle.\r\n\r 2. To test the effectiveness of the \"Care4Heart\" app in increasing the awareness and\r knowledge of CHD among the working population in Singapore.\r\n\r 3. To test the effectiveness of the \"Care4Heart\" app in eliciting a positive heart-related\r lifestyle modification, including stress reduction among the working population in\r Singapore.\r\n\r Background Deaths caused by CHD are often preventable. Deranged serum lipid profile,\r hypertension, obesity, physical inactivity and excess working stress are the well-known\r preventable risk factors of CHD, and the reduction of these risk factors will improve\r physical and psychological health and prevent future adverse and fatal cardiac events.\r Sedentary lifestyles and unhealthy diets are common reasons that may predispose Singaporeans\r to the risk of developing CHD, especially the majority of the workforce working in offices\r who engage in little or no physical activity. It was reported that about 40% of the working\r population (i.e. 21 to 65 years old) in Singapore do not engage in regular physical exercise.\r The increasing popularity of high fat diet and eating out and the high levels of stress\r experienced by the working population may further increase their risk of developing CHD.\r\n\r Many of risk factors of CHD are modifiable and can be greatly reduced by adopting a healthy\r lifestyle. Exercising regularly and following a healthy diet plan are effective strategies in\r lowering cardiovascular risk factors. Obviously there is a need for an updated educational\r programme aimed at teaching and encouraging people in the working population to adopt a\r healthier lifestyle, which would result in them changing their behaviours and sustaining a\r healthy lifestyle to reach optimal health. Even though, health promotion programmes including\r the traditional face-to-face cardiac education sessions have been developed to be accessed by\r the general population, a known barrier for not reaching the working population is the lack\r of time as a result of long work hours. With a substantial increase in the number of people\r owning smartphones and a sharp increase in the usage of smartphones in recent years, the\r smartphone is a device most people in Singapore own. Recently the Infocomm Development\r Authority of Singapore (2013) announced plans for a well-connected mobile network to support\r major industries including healthcare. Hence the promotion of mobile health (mHealth) is the\r next logical wave of healthcare support tools to prevent and manage chronic diseases like\r CHD. A recent whitepaper based on market research conducted in Singapore reported that about\r 92% of Singaporeans aged between 25 to 39 years owned smartphones. While 83% of the older\r population aged from 55 years onwards owned smartphones as well. Based on this report, it is\r widely expected that mHealth will reach many Singaporeans as tools to maintain and improve\r their health.\r\n\r Over the past few decades, more innovative ways for the design and delivery of\r primary/secondary prevention programme have been developed due to the rapid evolution of\r technology. One such programme used increasingly in the prevention and management of chronic\r diseases is mHealth which includes web-based programmes and smartphone applications (apps).\r Several studies conducted in Western countries reported on the effectiveness of mHealth in\r improving self-management skills and increasing healthy behaviours of individuals with\r chronic disease, such as diabetes, hypertensionand CHD. More importantly, apps are more\r accessible and convenient, enabling the information to reach more people by overcoming\r obstacles such as physical distance to attend a face-to face education session. However,\r these apps that have been developed are not completely relevant and suitable for Singaporeans\r because of significant cultural and economic differences that influence cardiac risk factors.\r For example the diet in Singapore and the culture of longer working hours are significantly\r different from Western countries.\r\n\r Design/Methodology This study was funded by a grant from Singapore Heart Foundation (Grant\r Number: RG2013/02). A two-phase study design will be adopted. Phase 1 is a pilot, two-arm RCT\r study and phase 2 is a single group repeated test longitudinal study. The data of Phase1\r study will be collected at the baseline and 4th week. The Phase 2 data will be collected at\r the baseline, 4th week and 6th months from the baseline.\r\n\r Participants\r\n\r The target population for this study is the working population in Singapore. The study will\r be conducted in National University of Singapore. A total of 240 convenient samples will be\r recruited via posters advertising in campus canteens, comprising 80 subjects in Phase 1 and\r 160 subjects in Phase 2 study. The first recruited 80 participants will be randomly allocated\r to an intervention group or a control group.\r\n\r Phase 1 Randomization All eligible participants will be assigned a unique case number\r according to the sequence in which participants are recruited, for example, the first\r eligible participant will be assigned the number of one, and the second eligible assigned the\r number of two and so on. A total of 40 numbers without any duplicates will be randomly\r generated, from 1 to 80, using SPSS. Participants whose assigned numbers matched the numbers\r generated by the software will be allocated into the intervention group; otherwise, the\r participant will be assigned to the control group.\r\n\r Theoretical rationale for intervention According to the Health Belief Model, there are\r several factors which influence health outcomes of an individual. These factors are: (1) the\r individual's belief that there is a threat to his/her health because of the illness, (2) the\r level of motivation of the individual to take action to improve his/her health and (3) the\r individual's belief that the intervention recommended will decrease the threat to his/her\r health. These factors will be addressed in our proposed \"Care4Heart\" mHealth programme which\r will cover the CHD risk factors, the possible health-threatening outcomes and strategies to\r decrease these risk factors are provided.\r\n\r Intervention A 4-week mHealth programme in the form of a smartphone app, named \"Care4Heart\",\r has been developed. The content and scope of the design are developed by a thorough\r literature review and an extensive analysis of existing education leaflets and brochures used\r to prevent CHD. The contents are specified and tailored to the working population.\r\n\r The app is developed by a team of software engineers from Computing School of NUS. Several\r functions include: (1) app using instructional video; (2) easy-to-read information on healthy\r lifestyle toward heart health, including information about the disease, CHD risk factors\r (e.g. diet, smoking cessation), stress, physical exercises and relaxation techniques; and (3)\r scheduled reminders for doing exercise and relaxation.\r\n\r A website (www.care4heart.sg) has been created as well. Participants are allowed to visit the\r website for the details about this project and research team members.\r\n\r Study procedure\r\n\r Phase 1: Pilot RCT One face-to-face briefing session will be offered for the 40 participants\r allocated to the intervention group after the consent is obtained. The smartphone app will be\r installed to the participant's own smartphone, and one of the research team members will\r brief the participant on the utilization of app. This session will take about 20 to 30\r minutes. After participants are familiar with the setup and the structure of the app, the\r participants will be expected to spend 15-20 minutes every day to go through all the\r educational content in 4 weeks' time. The participants will also be encouraged to change\r their lifestyle to modify their cardiac risk factors according to the information given in\r the app, for example engaging in regular exercise, and practicing relaxation.\r\n\r No intervention will be provided to the participants in the control group. Data will be\r collected online. Participants can complete the questionnaires on the website\r (www.care4heart.sg). All data will be electronically stored in an encrypted and password\r accessed-only computer database, in accordance to the University's Research Data Management\r Policy.\r\n\r The above questionnaires will be completed at two time points; (1) upon giving consent to\r participate in the study (baseline), and (2) at the 4th week.\r\n\r Phase 2: single group pretest and repeated posttest longitudinal study A total of 160\r participants will be recruited for phase 2 study. The same as phase 1 study, One face-to-face\r briefing session will be offered for all participants after the consent is obtained. The\r smartphone app will be installed to the participant's own smartphone, and one of the research\r team members will brief the participant on the utilization of app. This session will take\r about 20 to 30 minutes. . After participants are familiar with the setup and the structure of\r the app, the participants will be expected to spend 15-20 minutes every day to go through all\r the educational content in 4 weeks' time. The participants will also be encouraged to change\r the lifestyle to modify their cardiac risk factors according to the information given in the\r app, for example engaging in regular exercise, and practicing relaxation.\r\n\r Data will be collected online. Participants can complete the questionnaires on the website\r (www.care4heart.sg). All data will be electronically stored in an encrypted and password\r accessed-only computer database, in accordance to the University's Research Data Management\r Policy.\r\n\r The above questionnaires will be completed at three time points; (1) upon giving consent to\r participate in the study (baseline); (2) at the 4th week from the baseline; and. (3) at the\r 6th month follow-up period.\r\n\r Data analysis All data obtained will be analyzed using IBM SPSS 22.0 (Armonk, NY, USA).\r Descriptive statistics, including the frequency distribution, mean and standard deviation\r will be used to describe the social-demographic and anthropometric data, HDFQ-2, BRFSS and\r PSS-10 of all participants. In Phase 1 study, significant differences in the change scores of\r HDFQ-2, BRFSS and PSS-10 will be examined via paired samples t-test and between-group changes\r will be examined via independent t-test. In Phase 2 study, significant differences in the\r change scores of HDFQ-2, BRFSS and PSS-10 will be examined via paired samples t-test. The\r level of significance selected for this study is set at p = 0.05, indicating a 5% of\r committing a Type I error. The Bonferroni posthoc test will be run to reduce the likelihood\r of identifying the difference by chance.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. working full-time;\r\n\r 2. aged between 21-65 years;\r\n\r 3. use a smartphone (e.g. Samsung, iPhone) in their daily lives frequently; and\r\n\r 4. able to read, speak and understand English.\r\n\r Exclusion Criteria\r\n\r 1. have a clinical diagnosis of CHD or other heart diseases (e.g. congestive heart\r failure);\r\n\r 2. work in a health-relevant school/department/environment (e.g. school of medicine,\r school of public health, department of dentistry, school of pharmacy; university\r health centre); and\r\n\r 3. have reading difficulties.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
704
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effects of Abdominal Massage on Functional (Primary) Chronic Constipation\n\n**Clinical Trial Summary:**\n\nThe aim of the present study is to investigate the efficacy of abdominal massage in patients\r with functional (primary) chronic constipation. The present study is designed as a randomized\r placebo controlled. Since the placebo group is included in the research design, if there is a\r greater improvement of symptoms of constipation and quality of life in the massage group when\r compared to the control group, it will be determined that this effect is not related to a\r placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled\r design, the therapist effect will be eliminated and further evidence on a well-known massage\r technique in functional (primary) chronic constipation, a common gastrointestinal problem,\r will be provided. The results of the present placebo controlled randomized trial will\r indicate that the need for pharmacological agents and the side effects associated with these\r agents will be reduced. According to the literature, there are studies that investigate the\r effects of abdominal massage on symptoms of constipation and quality of life. However, it has\r generally been used for secondary constipation or two applications have been compared. In\r addition, there is no randomized placebo-controlled study investigating the effect of\r abdominal massage on severity of chronic constipation and quality of life.\n\n**Clinical Trial Detailed Description:**\n\nConstipation is a subjective symptom that defines as inadequate defecation including several\r symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and\r difficulty in defecation. The general prevalence of constipation in adults is 16%. The\r pre-defined risk factors are women gender, advanced age, non-white ethnicity, low\r socio-economic level, decreased physical activity underlying diseases, and medications.\r Chronic constipation affects quality of life and causes problems such as anxiety, depression,\r somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following\r periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux,\r hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.\r\n\r In the treatment of chronic constipation, conservative approaches (lifestyle change and\r physiotherapy applications) are used at the first phase. If conservative approaches are not\r helpful for patients pharmacological and surgical treatment can be performed based on the\r characteristics of patients, respectively. Pharmacological treatments aim to increase the\r frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to\r improve stool consistency. However, side effects such as abdominal bloating, abdominal\r cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by\r patients in the following period. Furthermore, medications for constipation management are\r not cost-effective. Therefore, the level of evidence on conservative approaches with low\r cost, non-invasive and no-side effects in constipation treatment should be increased.\r\n\r Physiotherapy approaches to alleviate chronic constipation symptoms include such as\r defecation training, abdominal massage, connective tissue massage, electrical stimulation,\r Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application\r in constipation is used in constipation management since the early 1870s and it is popular in\r recent years. The benefits of abdominal massage are known as follows: reduction in the\r abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic\r movements. The technique of abdominal massage consists of 5 stages as follows: abdominal\r muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle\r stroking.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age between 18 and 65 years.\r\n\r - Diagnosed with chronic constipation according to Rome IV criteria\r\n\r Exclusion Criteria:\r\n\r - A recent history of abdominal surgery\r\n\r - Intestinal obstruction, ileus, colon cancer\r\n\r - Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease,\r Megacolon, Megarectum\r\n\r - Umbilical hernia\r\n\r - Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease,\r Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm\r\n\r - Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis,\r Cerebro-vascular event,\r\n\r - Paraplegia Mental problem to prevent co-operative treatment\r\n\r - Pregnancy and lactation\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
705
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nValvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nThis is a prospective, controlled, single-arm clinical investigation for the treatment of\r subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational\r Ultrasound Therapy (PCUT) - First-In-man\n\n**Clinical Trial Detailed Description:**\n\nCARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to\r treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a\r new ultrasound therapy based on a disruptive technology involving delivering an extremely\r precise and focused ultrasound beam to perform a reparative effect on the aortic valve\r leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving\r the overall clinical status related to the aortic valve stenosis. This is a FIM study\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects\r with a bicuspid valve).\r\n\r 2. Patient is not eligible for TAVR/SAVR .\r\n\r 3. Age ≥18 years.\r\n\r 4. Subjects who are willing to provide a written informed consent prior to participating\r in the study.\r\n\r 5. Subjects who can comply with the study follow up or other study requirements.\r\n\r 6. Subject eligible according to Clinical Review Committee\r\n\r -\r\n\r Exclusion Criteria:\r\n\r 1. Subjects with any electrical device implanted.\r\n\r 2. Subjects with unstable arrhythmia not controlled by medical treatment.\r\n\r 3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in\r aortic position.\r\n\r 4. Subjects with complex congenital heart disease.\r\n\r 5. Chest deformity.\r\n\r 6. Cardiogenic shock.\r\n\r 7. History of heart transplant.\r\n\r 8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral\r valve procedure, tricuspid valve procedure) within one month after treatment.\r\n\r 9. Thrombus in heart.\r\n\r 10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one\r month prior to enrolment*.\r\n\r 11. Subjects who are pregnant or nursing.\r\n\r 12. Subjects who are participating in another research study for which the primary\r endpoint has not been reached.\r\n\r -\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
706
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to demonstrate that transcatheter artificial aortic valve and\r transcatheter artificial heart values delivery system is associated with a reduction of\r all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or\r ineligible for aortic valve replacement.\n\n**Clinical Trial Detailed Description:**\n\nAortic valve diseases is usually caused by rheumatic fever, congenital aortic valve\r structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve\r implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR)\r with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis,\r who were considered to be at very high or prohibitive operative risk.\r\n\r This project take the incidence of all-cause mortality at 12 months since TAVI as the primary\r endpoint to evaluate the safety and efficacy, then take the procedure success rate, device\r success rate, incidence of severe adverse events, device operative performance, prosthetic\r valve performance and quality of life to evaluate transcatheter artificial aortic valve and\r transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co.,\r Ltd. in clinical application.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects ≥ 65 years of age;\r\n\r - Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s,\r or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of\r <1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or\r regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or\r LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular\r systolic dysfunction (LVEF<50%);\r\n\r - Symptoms suggestive of aortic stenosis, NYHA class III or IV;\r\n\r - Patients who are considered unsuitable for surgery are considered by two or more than\r two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system\r estimation; or there is a severe and irreversible organ damage to the patient, such as\r lung disease, liver disease, kidney disease and so on; or the patient's physical\r weakness can not be tolerated by surgery; or have other factors affecting surgery,\r such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe\r calcification of the aorta, etc);\r\n\r - A life expectancy of > 1 year;\r\n\r - Voluntarily participate in and sign the informed consent form and willing to undergo\r the related examination and clinical follow-up.\r\n\r Exclusion Criteria:\r\n\r - Untreated severe coronary stenosis and needs revascularization; or acute myocardial\r infarction occurred within 1 months, or coronary stent implantation in 1 month;\r\n\r - Artificial heart valve and artificial valve ring have been implanted；\r\n\r - Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area<1.5\r cm2)；\r\n\r - left ventricular or atrial thrombus;\r\n\r - Aortic annulus diameter <17mm or >27 mm;\r\n\r - Severe left ventricular dysfunction, ejection fraction <20%；\r\n\r - Severe pulmonary hypertension or severe right ventricular dysfunction；\r\n\r - The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm;\r\n\r - Cerebrovascular event in last 3 months；\r\n\r - Active endocarditis or other active infection;\r\n\r - Severe renal failure and requires long-term dialysis treatment；\r\n\r - Severe liver dysfunction；\r\n\r - Active peptic ulcer；\r\n\r - Severe coagulation dysfunction; it is known that all anticoagulant schemes are taboo\r or allergic, or anticoagulants can not be used in the process of testing；\r\n\r - Severe respiratory failure；\r\n\r - Severe Alzheimer's disease；\r\n\r - Patients who were enrolled in any other study in one month;\r\n\r - Other cases which the researchers believe that it is not suitable to participate in.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
707
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHLT Meridian Valve CE Mark Trial\n\n**Clinical Trial Summary:**\n\nTo evaluate the safety and performance of the HLT System in patients with symptomatic heart\r disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate\r or High Risk for aortic valve replacement surgery.\n\n**Clinical Trial Detailed Description:**\n\nProspective, non-randomized, single arm, multi-center CE Mark trial.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of\r the following:\r\n\r 1. Aortic valve area ≤ 1.0 cm^2 or 0.6 cm^2/m^2\r\n\r 2. Mean aortic valve gradient ≥ 40 mmHg\r\n\r 3. Peak aortic valve velocity ≥ 4 m/sec\r\n\r - Symptoms due to severe aortic stenosis resulting in one of the following:\r\n\r 1. NYHA Functional Classification of II or greater\r\n\r 2. Presence of angina\r\n\r 3. Presence of syncope\r\n\r - Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range\r is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of\r pre-procedure imaging.\r\n\r - Patient is considered intermediate or high risk to undergo surgical aortic valve\r replacement with one of the following:\r\n\r 1. Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%\r\n\r 2. High Surgical Risk: STS-PROM score of ≥ 8%\r\n\r 3. Documented heart team agreement of risk for surgical aortic valve replacement\r (SAVR) due to other factors not captured by risk-scores (i.e. frailty or\r comorbidities)\r\n\r - Geographically available, willing to comply with follow up and able to provide written\r informed consent\r\n\r Exclusion Criteria:\r\n\r - Patients with a coronary height of <10mm, or otherwise determined to be at high risk\r for coronary obstruction\r\n\r - Patients with low flow/low gradient aortic stenosis\r\n\r - Patients with significant annular or LVOT calcification that could compromise\r procedural success\r\n\r - Pre-existing prosthetic heart valve in any position, or prosthetic ring\r\n\r - Severe aortic, mitral or tricuspid valve regurgitation\r\n\r - Untreated clinically significant coronary artery disease requiring revascularization\r\n\r - Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive\r calcification or severe tortuosity) that would preclude passage of 18 Fr catheters\r from the femoral arterial access to the aorta as evidenced by peripheral MSCT\r\n\r - Need for emergent surgery or intervention other than the investigational procedure\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
708
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry\n\n**Clinical Trial Summary:**\n\nThe objective of this study is to evaluate the procedural and clinical outcomes of patients\r with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age≥18 years.\r\n\r 2. Severe aortic stenosis with bicuspid anatomy.\r\n\r 3. NYHA≥2 and/or syncope and/or angina.\r\n\r 4. Patient judged by the Heart Team as indicated for TAVR.\r\n\r Exclusion Criteria:\r\n\r 1. Age <18 years\r\n\r 2. Asymptomatic patients\r\n\r 3. Pure aortic regurgitation.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
709
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEffect of Migalastat on Cardiac Involvement in Fabry Disease\n\n**Clinical Trial Summary:**\n\nAnderson-Fabry Disease (AFD) is one of the rare lysosomal storage disorders for which a cause\r - specific therapy is available. Recently, a new specific drug has been marketed, namely\r Migalastat, a small-molecule pharmacological chaperone. The effect of Migalastat on cardiac\r involvement has been assessed so far by 2D echocardiography, demonstrating a significant\r reduction in left ventricular (LV) mass after 18 months of therapy. Calculation of LV mass by\r 2D echocardiography is limited by geometrical assumptions and quality of echocardiographic\r window, with a strong impact on accuracy. Cardiac Magnetic Resonance (CMR) overcomes these\r limitations, thus representing the gold standard technique for ventricular mass, volumes and\r function estimation. Moreover, CMR offers the unique possibility to perform a non-invasive\r tissue characterization, including the detection of both myocardial fibrosis by Late\r Gadolinium Enhancement and sphingolipid storage by T1 mapping. Beyond an accurate\r morphological description and a detailed tissue characterization, a complete cardiological\r assessment should also integrate functional data and bio-humoral profile.\r\n\r This study is designed to provide a comprehensive evaluation of the therapeutic effect of\r Migalastat (123 mg every other day) on cardiac involvement after 18 months of therapy,\r integrating a morphological, functional and bio-humoral assessment.\n\n**Clinical Trial Detailed Description:**\n\nAnderson-Fabry disease is a rare X-linked lysosomal disorder, mainly affecting\r cardiovascular, renal and nervous systems. Cardiac injury is the leading cause of death in\r these patients. Heart involvement is characterized by left ventricular hypertrophy (LVH),\r myocardial scarring and/or inflammation, Bradyarrhythmias or tachyarrhythmias, heart failure\r and represents the main cause of death in these patients. Since 2001, specific therapies\r (enzyme replacement therapy (ERT) first and pharmacological chaperone migalastat more\r recently) are available to treat these patients.\r\n\r Migalastat is a small-molecule pharmacological chaperone stabilizing specific mutant forms of\r the enzyme (α-Gal ) and promoting its catabolic function. These mutant forms of α-Gal are\r defined as amenable to Migalastat. In patients with amenable mutations, orally administered\r Migalastat is a potential alternative treatment to intravenous ERT. Because of its chemical\r nature (small molecule) and route of administration (orally), Migalastat would avoid\r ERT-associated immunogenicity and infusion-associated reactions. Additionally, the higher\r volume of distribution of migalastat relative to ERT suggests enhanced penetration of organs\r and tissues. Theoretically, the chaperoning of α-Gal by Migalastat to lysosomes may better\r mimic natural enzyme trafficking and result in more constant α-Gal activity than biweekly ERT\r infusions.\r\n\r Two main clinical studies have been published so far about safety and efficacy of Migalastat\r in AFD, demonstrating good safety, tolerability and comparable efficacy to ERT. These studies\r reported a significant decrease in LV mass index assessed by 2D echocardiography (-6,6 g/m2\r in 33 patients after 18 months of therapy), mostly in patients with overt cardiac involvement\r and greater than the changes observed with ERT (-2 g/m2 in 16 patients after 18 months of\r therapy).\r\n\r Calculation of LV mass by 2D echocardiography is based on the \"Devereux formula\", assuming\r that the LV is a prolate ellipsoid with a 2:1 long/short axis ratio and symmetric\r distribution of hypertrophy. This is not always the case in AFD Cardiomyopathy, showing a\r wide variety of hypertrophy patterns. Moreover, since linear measurements of LV wall\r thickness and diameters are cubed in this formula, even small measurement errors in\r dimensions or thickness have a strong impact on accuracy.\r\n\r Cardiac magnetic resonance (CMR) represents the gold standard technique for ventricular mass,\r volumes and function estimation because of the possibility to directly measure these\r parameters without geometrical assumption. Therefore, CMR has an excellent inter-study\r reproducibility both in normal and in pathologic hearts, overcoming 2D echocardiography.\r Beyond its high reproducibility in LV mass measurement, CMR offers the unique possibility of\r non-invasive tissue characterization. This concept includes both detection and quantification\r of myocardial fibrosis by Late Gadolinium Enhancement images and application of new\r techniques, namely T1 mapping, detecting myocardial sphingolipid storage even before LVH\r occurs. Also, CMR allows a detailed characterization of myocardial deformation by feature\r tracking. Feature tracking CMR (FT-CMR) approximately applies the same principles of speckle\r tracking echocardiography (even though with differences methods of image acquisition and\r reconstruction) in order to measure global and segmental myocardial deformation. The strength\r of FT-CMR consists of its relatively unrestricted access to large fields of view, its high\r spatial resolution and its relatively high signal to noise and contrast to noise ratios.\r\n\r MicroRNAs (miRNAs) are small noncoding RNAs that regulate gene expression at the\r post-transcriptional level. MiRNAs have emerged as key regulators of several physiological\r and pathophysiological processes. Besides their intracellular function, recent studies\r demonstrated that miRNAs can be exported or released by cells and circulate in blood in a\r remarkably stable form. The discovery of circulating miRNAs opens the possibilities to use\r circulating miRNA patterns as biomarkers for several pathologies also for cardiovascular\r diseases. In a recent study, a common microRNA signature in AFD patients regardless of gender\r and age has been identified.15 miRNAs differentially expressed between 10 AFD subjects and 10\r normal controls (NC) have been found. The levels of these 15 miRNAs in plasma sample of 10\r subjects with LVH and no mutation in the Galactosidase Alpha (GLA) gene have also been\r studied. Among these 15 miRNAs, 3 discriminated AFD patients from subjects with LVH. In\r particular, 2 microRNAs (mir-199a-5p and mir126a-3p) were up-regulated and 1 miRNA\r (mir-423-5p) was down-expressed in AFD patients. Interestingly, in a recent study increased\r plasmatic levels of miR-126 and miR-199a were significantly associated with a lower major\r adverse Cardiovascular (CV) event rate in patients with coronary artery disease. Instead,\r elevated plasmatic levels of mir-423-5p is strongly related to the clinical diagnosis of\r Heart Failure. Several evidences indicate that the aberrantly expressed plasmatic miRNAs in\r AFD are linked to microvascular or macrovascular damage involved in the typical AFD\r vasculopathy and could be attractive as diagnostic markers as well as for the monitoring of\r the pharmacological treatment.\r\n\r Integration of all these aspects allows a complete morpho-functional evaluation of cardiac\r involvement in AFD and a detailed monitoring of the effects of specific drugs.\r\n\r This study is designed to provide a comprehensive evaluation of the therapeutic effect of\r Migalastat on cardiac involvement, integrating a morphological, functional and bio-humoral\r assessment of heart involvement. 15 patients with amenable mutation, clinical indication to\r Migalastat and signs of early or overt cardiac involvement with will undergo a complete\r cardiological evaluation before and 18 months after therapy with Migalastat. The\r cardiological assessment will include ECG, 2D echocardiography, CMR, cardio-pulmonary test,\r dosage of peripheral biomarkers (TnT High Sensitive; NT-proBNP, mir-199a-5p and mir126a-3p,\r mir-423-5p).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Genetic diagnosis of Fabry Disease and amenable mutation\r\n\r - Clinical indication to Migalastat\r\n\r - Signs of clinical or preclinical cardiac involvement (low T1 values with or without\r left ventricular hypertrophy)\r\n\r - Age >16\r\n\r - Ability to give a complete informed consent (for minor patients informed consent will\r be given by parents)\r\n\r Exclusion Criteria:\r\n\r - Contraindication to Migalastat (pregnancy, age <16, Glomerular Filtration Rate <30\r ml/min, hypersensitivity to the active ingredient)\r\n\r - Contraindication to CMR study (metallic fragment or foreign body, known\r claustrophobia, PaceMaker/Implantable Cardioverter Defibrillator not CMR conditional,\r electronic implant or device, eg, insulin pump or other infusion pump)\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
710
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\naccuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nAim of this study is to evaluate whether microsurgical repair or replacement of the aortic\r valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.\n\n**Clinical Trial Detailed Description:**\n\nStenosis of the aortic valve leads to a narrowing of the valve, consequently to low blood\r flow from the heart into the Aorta, and is associated with symptoms like fatigue,\r breathlessness, dizziness, fainting, and chest pain. For many of the patients suffering from\r severe aortic stenosis surgical or catheter-assisted repair or replacement of the damaged\r aortic valve has been proven to be a safe and effective treatment option.\r\n\r Probably about 20-30% of patients suffering from severe aortic stenosis display a deviation\r from the usually observed disease pattern: These patients do not show the typical high\r pressure difference between the left ventricle (heart chamber) and the aorta (transvalvular\r gradient; \"paradoxical\" low flow/low gradient aortic stenosis). For these patients it is not\r yet clear, if microsurgical repair of the aortic valve (transcatheter aortic valve repair -\r TAVR) should be a treatment option as well.\r\n\r REBOOT-PARADOX evaluates whether TAVR is advantageous compared to optimal medical Treatment\r alone for patients suffering from paradoxical aortic stenosis. Two thirds of the\r participating patients will be treated by TAVR, one third will receive medical Treatment\r alone.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years\r\n\r - I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient\r < 40 mmHg and stroke volume index (SVI) < 35ml/m2\r\n\r - I3. Left ventricular ejection fraction ≥ 50%\r\n\r - I4. MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood\r criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age <\r 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV\r longitudinal function without other reason)\r\n\r - I5. Heart team agrees on eligibility for TAVR\r\n\r - I6. Written informed consent\r\n\r - I7. Negative pregnancy test in women with childbearing potential\r\n\r Exclusion Criteria:\r\n\r - E1. Hemodynamic instability\r\n\r - E2. Cardiogenic shock\r\n\r - E3. Pre-existing mechanical or bio-prosthetic valve in any position\r\n\r - E4. Concomitant severe valvular heart disease\r\n\r - E5. Pre-existing or active endocarditis\r\n\r - E6. Need for heart surgery due to other conditions\r\n\r - E7. Aortic valve is congenital unicuspid or congenital bicuspid\r\n\r - E8. Hypertrophic cardiomyopathy with or without obstruction\r\n\r - E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\r\n\r - E10. Acute myocardial infarction within 1 month before intended AS-treatment\r\n\r - E11. Renal replacement therapy\r\n\r - E12. Estimated life expectancy < 24 months (730 days) due to carcinomas end stage\r liver disease or renal disease\r\n\r - E13. Currently participating in an investigational drug or another device study. Note:\r Trials requiring extended follow-up for products that were investigational, but have\r since become commercially available, are not considered investigational trials.\r\n\r - E14. Patient refuses aortic valve repair\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
711
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRole of Elastin Metabolites in Aortic Remodelling in AS\n\n**Clinical Trial Summary:**\n\nAround 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of\r the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve\r (narrowing or leakage) at a much earlier age. It is also more common for them to develop\r enlargement of the main blood vessel coming out of the heart, the aorta, and some studies\r suggest that they are also at higher risk of life-threatening tears in the aortic wall.\r Current guidelines recommend surgical replacement of the aorta at an earlier stage in these\r patients. The exact mechanism for the dilatation is not clear, and some studies have\r suggested greater 'stiffness' in the wall of the aorta. In this study, the investigators\r propose to 1.) study aortic size, stiffness and flow patterns using MRI in patients with\r bicuspid and tricuspid valves with a narrowing (aortic stenosis, 2.) measure markers in\r patients' blood that may be important in the process of expansion, 3.) compare the change in\r MRI and blood markers at before and 12 months after surgery, in patients who are due to have\r aortic valve replacement surgery.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participant is willing and able to give informed consent for participation in the\r study.\r\n\r - Age 18 years or above.\r\n\r - Planned surgical AVR (+/- CABG or aortic root surgery) for severe AS.\r\n\r - Ability to understand the written information in English.\r\n\r Exclusion Criteria:\r\n\r The participant may not enter the study if ANY of the following apply:\r\n\r - Contraindication to MRI (e.g., non-compatible pacemaker or other device).\r\n\r - Severe claustrophobia (unable to have MRI scan).\r\n\r - eGFR<30ml/min (contra-indication to have contrast agent during MRI).\r\n\r - Contraindication to Adenosine (severe asthma).\r\n\r - Significant arrhythmia.\r\n\r - Other valve disease > moderate in severity.\r\n\r - Female participants who are pregnant or lactating.\r\n\r - Previous aortic valve or aorta surgery, previous CABG or other surgery involving\r aortic cross clamping.\r\n\r - Participant in an interventional cardiovascular clinical trial.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
712
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBranched-chain Amino Acid Supplementation for Hepatocellular Carcinoma\n\n**Clinical Trial Summary:**\n\nHepatocellular carcinoma (HCC) is the fifth most common cause of cancer death among men.\r While several new treatment options have recently become available, they are costly and have\r a potential for significant, adverse side effects. Many patients diagnosed with HCC also\r suffer from underlying liver disease, including cirrhosis. As many as 80-90% of patients\r diagnosed with HCC also have cirrhosis. Protein-energy malnutrition (PEM) in cirrhosis is as\r high as 65-90% and significantly increases the risk of morbidity and mortality as well as\r decreased quality of life.\r\n\r Branched-chain amino acid (BCAA) supplementation has been extensively studied for usefulness\r in liver disease, specifically to treat hepatic encephalopathy to and preserve and restore\r muscle mass. Maintenance of liver function and prevention of PEM are essential for improving\r outcomes in patients with HCC. Branched-chain amino acid supplementation in HCC has been\r studied extensively in China & Japan with multiple studies showing improvements in liver\r function, progression-free survival, and overall survival. Additionally, patients in\r treatment groups have shown improvement in quality of life indicators. However, these results\r have yet to be replicated in the United States. Branched-chain amino acid supplementation may\r be a safe, low-cost approach to improve survival, liver function indicators, and quality of\r life for patients diagnosed with HCC.\r\n\r In this study, patients with primary HCC will be randomized to either a treatment group,\r which will receive standard of care and BCAA supplement or to a control group which will\r receive standard of care and a maltodextrin placebo. Both groups will receive liver-directed\r therapy including transarterial chemoembolization (TACE) and thermal ablation. All patients\r will complete a quality of life survey (FACT-Hep) at each visit.\n\n**Clinical Trial Detailed Description:**\n\nProducts or Devices to be Studied:\r\n\r Branched Chain Amino Acid anhydrous blend (1250mg valine, 2500mg leucine, 1250mg isoleucine)\r Pre-assigned IND number: 140871 Holder of the IND (Richard Marshall, MD)\r\n\r Purpose of the Study:\r\n\r Aim: To evaluate the effect of branched-chain amino acid (BCAA) supplementation on\r progression-free survival and overall survival in patients diagnosed with hepatocellular\r carcinoma (HCC).\r\n\r Rationale:\r\n\r Hepatocellular carcinoma (HCC) is the most common adenocarcinoma affecting the liver.\r Approximately 14 million people are affected globally and the number of cases is expected to\r increase to 22 million by 2032. In the United States, HCC accounts for 5% of all\r cancer-related deaths and has a 1-year survival rate of 41.5% and a 5-year survival rate of\r 16.5%. Although several new treatment options have recently become available, they are\r expensive and show a strong potential for adverse side effects. Regardless of treatment\r modality, liver function maintenance is an essential component for improving outcomes in\r patients with HCC.\r\n\r The liver functions as a primary site for macronutrient, enzyme, vitamin, bile acid, and heme\r metabolism as well as the breakdown and excretion of toxic waste products of metabolism.\r Among the liver's many roles is the production of albumin, a serum protein responsible for\r maintaining oncotic pressure and the transportation of nutrients throughout the body. Low\r levels of albumin (hypoalbuminemia) are associated with severe malnutrition and can lead\r edema due to decreased oncotic pressure. Hepatic tissue damage, tumor formation, and tumor\r proliferation decreases the liver's functional capacity for executing these processes.\r\n\r Chronic injury to the hepatocytes can lead to the development of hepatocellular carcinoma.\r Once developed, tumor cells and stromal cells form a network called the tumor\r microenvironment which further contributes to tumor proliferation. Treatments to disrupt the\r microenvironment (e.g. sorafenib) may be successful in reducing fibrosis, liver damage,\r inflammation, and angiogenesis. These treatments are not without serious side effects\r including: myocardial infarction, bleeding problems, bowel perforation, and hypertension to\r name a few.\r\n\r Therapeutic approaches to manage symptoms associated with HCC include late evening snacks and\r protein supplementation. The rationale purports that improvements in nutritional quality will\r alleviate catabolic stress, thereby reducing risks of associated complications of\r malnutrition including: protein energy malnutrition, hypoalbuminemia, and hepatic\r encephalopathy. Further, the branched-chain amino acids (BCAA) valine, leucine, and\r isoleucine may act on the same signaling pathways of chemotherapeutic pharmaceuticals in\r addition to improving nutritional status in patients with HCC.\r\n\r Recently, BCAA supplementation has been explored as a possible treatment for hepatocellular\r carcinoma in conjunction with standard of care in Japan and China. A recent meta-analysis of\r clinical studies from China and Japan supports the safety of BCAA supplementation and the\r possible benefit of improving liver functional reserves and quality of life. However,\r significant differences in study designs and BCAA doses make inferring conclusions from these\r studies difficult. Moreover, studies don't adequately control for differences in dietary\r intake between treatment groups which may skew results. To date, no clinical trials have been\r conducted in the United States that examine the effects of BCAA supplementation in patients\r with HCC. The purpose of this study is to examine the safety, efficacy, and feasibility of\r BCAA supplementation in patients with HCC who undergo locoregional therapies.\r\n\r Study Procedures:\r\n\r Current standard of care for hepatocellular carcinoma consists of physician monitoring\r following liver directed therapy and does not include any nutrition or dietary intervention\r beyond meeting basic nutritional needs. The study procedures differ from standard of care\r only by the addition of either a BCAA supplement or maltodextrin placebo, administration of a\r quality of life survey (FACT-Hep), and a personalized diet prescription.\r\n\r To ensure protein and energy intake is equivalent between groups, individualized diets will\r be calculated by the dietitian based on current height, weight, and stress factors for those\r in both arms of the study. The corresponding meal plan will be administered by the research\r pharmacist. The intervention group receiving 10g of BCAA daily will receive a meal plan that\r reflects a protein deficit of 10g below estimated needs (which will be covered by the BCAA\r supplement).\r\n\r Subjects:\r\n\r Forty subjects will be enrolled. Patients who are seeking treatment in the interventional\r radiology department at University Medical Center (UMC) will comprise the sample.\r\n\r Duration of the Study:\r\n\r Enrollment of the full sample will take approximately 36 months and each participant will be\r followed for 12 months after enrollment and initiation of the treatment. This study would\r conclude approximately 48 months following first enrollment. Each individual's participation\r in the study will be 12-14 months following their enrollment.\r\n\r Implementation Summary:\r\n\r Patients will be educated about the study by an interventional radiologist and oncology\r dietitian during their first visit to the interventional radiology clinic at UMC. After\r providing informed consent to participate in the study, patients will be immediately started\r on their dietary supplement (BCAA or placebo) for two weeks. BCAA supplements will be\r dispensed a UMC pharmacist. Patients will then have a brief hospital stay at UMC (typically\r ranging 6-24 hours) to receive their TACE and/or ablation procedure. All patients will be\r assessed by an interventional radiologist or nurse practitioner prior to discharge, and those\r undergoing a TACE procedure will also have a comprehensive metabolic panel (CMP) drawn. After\r discharge patients will have a one month, three month, 6 month, 9 month, and 12 month follow\r up in the interventional radiology clinic where they will meet with the physician and\r dietitian. A detailed list of procedures is provided below. Patients may require additional\r visits if it is determined that they need additional local therapies (repeat TACE and/or\r Ablation).\r\n\r Risks of Interventions:\r\n\r Branched-chain amino acid supplementation. Risks: Based on data from prior studies,\r participants receiving BCAA supplementation protocol may experience nausea, vomiting,\r abdominal pain, diarrhea or hypertension.\r\n\r Maltodextrin supplementation. Risks: Maltodextrin is a sugar. Consuming maltodextrin may\r cause a temporary rise in blood sugar. However the amounts consumed for this study will be\r very small. There are no known risks associated with its use. Maltodextrin is affirmed by the\r FDA as GRAS per Title 21 of the Code of Federal Regulations Section 184.1444.\r\n\r Fact-Hep questionnaire. Risks: there are no known risks to questioning about health-related\r quality of life.\r\n\r Data Safety Monitoring:\r\n\r Definition:\r\n\r Serious adverse event (SAE): events including death, a life-threatening adverse experience,\r inpatient hospitalization, prolongation of existing hospitalization, and persistent or\r significant disability or incapacity.\r\n\r Adverse event (AE): any health-related, unfavorable or unintended medical occurrence that\r happens throughout study participation. Examples of adverse events include but are not\r limited to the following:\r\n\r A clinically significant laboratory or clinical test result. An event that results in missing\r a study visit. An event that requires a visit to a physician. An event that occurs as a\r result of a study procedure. Unanticipated or untoward medical events that may be study\r related.\r\n\r Monitoring Plan:\r\n\r Adverse events will be reported to the principal investigator as they are collected from the\r participant. Adverse event data will be analyzed quarterly, whereas serious or\r life-threatening adverse events will necessitate immediate reporting and follow-up. It is\r anticipated that most adverse events will be mild and the participant will be able to resume\r activities within one to two days of reporting the event.\r\n\r SAEs that are unanticipated, serious, and possibly related to the study intervention will be\r reported to the IRB and FDA. Unexpected problems involving risks to participants or others\r include incidents only if the incident is unexpected, related or possibly related to\r participation in the research, and indicated that subjects or others are at a greater risk of\r harm than was previously known or recognized. A SAE will result in the unblinding of the\r participant and will be reported to the IRB and FDA per CFR § 312.32(c)(5). Any action\r resulting in unblinding, and/or a temporary or permanent suspension of this study (e.g., IRB\r actions, or actions by the PI and/or co-investigators) will be reported to the appropriate\r officials.\r\n\r Aggregate comparisons of AE and SAE between study arms will occur after 50% of the\r participants are enrolled. If there is evidence of a significant, clinically relevant\r difference in SAE between groups, the study will be unblinded; and in the event the BCAA\r group experiences significantly fewer SAEs, the placebo group will be offered the BCAA\r supplement. Conversely, if the BCAA group experiences significantly more SAEs, the\r supplementation will be terminated and follow-up will continue as planned.\r\n\r Statistical Analysis:\r\n\r A total of 40 subjects will be recruited (20 in each intervention and control group). Sample\r size was determined to achieve a power of 0.8 for a two-sided test (α = 0.05) for a balanced\r study design. The results of the power analysis indicate that this can be achieved with a\r sample ranging from 13-21 patients in each arm with the assumption that 1 year mortality will\r be 41.5% in the control group (mortality rate derived from epidemiological data) and a\r mortality rate ranging from 85 - 95% in the intervention group. Progression-free survival and\r overall survival will be examined using survival regression analyses while controlling for\r relevant covariates (age, demographics, etc.). Quality of life, Child Pugh score, and\r biomarkers of liver function will be examined using repeated measures ANOVA with contrasts\r between the treatment groups. Tolerability of the BCAA supplement will be assessed by\r examining the number of adverse effects reported by participants. The severity of the adverse\r events will be assessed by the physician and frequency differences between groups will be\r compared using Χ² test statistic.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Have been diagnosed with HCC and deemed a candidate for nonsurgical local therapy\r (TACE and/or percutaneous ablation)\r\n\r - Have a Child-Pugh score < 6\r\n\r - Are at least 18 years of age or older\r\n\r - Otherwise healthy adults\r\n\r - Provide written consent to participate\r\n\r Exclusion Criteria:\r\n\r - Have a diagnosis of renal failure\r\n\r - Have a Child-Pugh score > 6\r\n\r - Consume > 60g alcohol intake per day\r\n\r - Have been diagnosed with branched-chain ketoaciduria (maple syrup urine disease)\r\n\r - Have hepatic encephalopathy\r\n\r - Have been diagnosed with a medical condition that warrants a low-protein diet\r\n\r - Are currently taking insulin or metformin\r\n\r - Pregnant women\r\n\r - Younger than 18 years of age\r\n\r - Are unable to provide consent\r\n\r - Are incarcerated\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
713
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia\n\n**Clinical Trial Summary:**\n\nThis phase III trial studies how well blinatumomab works in combination with chemotherapy in\r treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or\r B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as\r blinatumomab, may induce changes in the body's immune system and may interfere with the\r ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine,\r dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine,\r mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to\r stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,\r or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate.\r Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving\r blinatumomab and combination chemotherapy may work better than combination chemotherapy alone\r in treating patients with B-ALL. This trial also assigns patients into different chemotherapy\r treatment regimens based on risk (the chance of cancer returning after treatment). Treating\r patients with chemotherapy based on risk may help doctors decide which patients can best\r benefit from which chemotherapy treatment regimens.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine in a randomized manner if the addition of 2 cycles of blinatumomab to\r standard therapy improves disease-free survival (DFS) in patients with standard risk (SR)\r B-ALL and higher risk features (SR-High), and patients with standard-risk average (SR-Avg)\r B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have\r detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of\r induction (EOI).\r\n\r II. To confirm that boys in the standard-risk favorable (SR-Fav) subset of B-ALL, with or\r without Down syndrome (DS), will maintain a 5-year DFS of greater than 93% when treated with\r a standard chemotherapy regimen with a treatment duration of 2 years from the start of\r interim maintenance I (IM1).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To describe the DFS for patients with SR-Avg B-ALL who are negative for MRD measured by\r flow cytometry and HTS at EOI when treated with standard chemotherapy with a treatment\r duration of 2 years from the start of IM1, regardless of sex.\r\n\r II. To describe the DFS for patients with standard-risk favorable (SR-Fav) B-ALL when treated\r with a standard chemotherapy regimen.\r\n\r III. To determine if patients with DS-High achieve a reduction of treatment-related mortality\r (TRM) after replacement of intensive elements of standard chemotherapy (omission of\r anthracyclines in induction, omission of the second month of delayed intensification [DI])\r with 3 cycles of blinatumomab.\r\n\r IV. To describe the DFS characterized by the replacement of intensive elements of standard\r chemotherapy with 3 cycles of blinatumomab in patients with DS-High B ALL.\r\n\r V. To describe the DFS for patients with localized (Murphy stage I and II) B lymphoblastic\r lymphoma (B-LLy) receiving standard risk B-ALL therapy.\r\n\r VI. To compare the change in neurocognitive functioning, as measured by the CogState\r Cognitive Composite, from baseline to end-of-therapy among patients with ALL ages 4- < 10\r years at the time of diagnosis between children from poor families (defined as presence of\r household material hardship [HMH], including either food, housing or energy insecurity) and\r non-poor families (absence of HMH).\r\n\r VII. To describe the impact of blinatumomab on caregiver burden and patient/proxy-reported\r symptoms among a subset of children enrolled in the HMH and neurocognitive outcome study.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To explore adaptive and innate immune functions and host genetic factors associated with\r severe infectious complications in children with DS B-ALL.\r\n\r II. To explore the impact of acute lymphoblastic leukemia (ALL) and its therapy on\r neurocognitive, functional, and quality of life outcomes in patients with DS and ALL, as\r measured by caregiver (parent/legal guardian) questionnaires.\r\n\r III. To define the prevalence of minimal marrow disease (MMD) in B-LLy and to correlate MMD\r at diagnosis with outcome in patients with B-LLy.\r\n\r OUTLINE: All patients are assigned to, and complete an INDUCTION treatment regimen. Patients\r are then assigned to a CONSOLIDATION treatment regimen. Finally, following CONSOLIDATION,\r patients are either assigned or randomized to 1 of 7 arms.\r\n\r NON-DS SR B-ALL INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1,\r vincristine intravenous (IV) push over 1 minute on days 1, 8, 15, and 22, dexamethasone\r orally (PO) or IV twice daily (BID) on days 1-28, pegaspargase IV over 1-2 hours or\r intramuscularly (IM) on day 4, and methotrexate IT on days 8 and 29. CNS2 patients also\r receive cytarabine IT twice weekly except during weeks when days 8 and 29 methotrexate is\r administered. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r * After Non-DS SR B-ALL INDUCTION, SR-Fav and SR-Avg patients complete SR CONSOLIDATION,\r while patients with SR-High complete high-risk (HR) CONSOLIDATION.\r\n\r DS B-ALL INDUCTION: Patients receive cytarabine IT on day 1, vincristine IV push over 1\r minute on days 1, 8, 15, and 22, pegaspargase IV over 1-2 hours or IM on day 4, methotrexate\r IT on days 8 and 29, and leucovorin PO or IV every 6 hours for 2 doses on days 9 and 30.\r Additionally, patients under 10 years of age receive dexamethasone PO or IV BID on days 1-28,\r and patients 10 years of age or older receive prednisone or prednisolone PO or IV BID on days\r 1-28. CNS2 patients also receive cytarabine IT twice weekly except during weeks when days 8\r and 29 IT methotrexate is administered. CNS3 patients also receive methotrexate IT on days 15\r and 22, and leucovorin PO or IV every 6 hours for 2 doses on days 16 and 23. Treatment\r continues for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r * After DS B-ALL INDUCTION, patients without high risk features and MRD < 0.01 % complete SR\r CONSOLIDATION. Patients without high risk features and MRD >= 0.01%, OR with high risk\r features and any MRD complete HR CONSOLIDATION.\r\n\r NON-DS B-LLy INDUCTION: Patients receive cytarabine IT on day 1 and twice weekly if CNS2,\r vincristine IV push over 1 minute on days 1, 8, 15, and 22, dexamethasone PO or IV BID on\r days 1-28, pegaspargase IV over 1-2 hours or IM on day 4, and methotrexate IT on days 8 and\r 29. Treatment continues for 35 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r * After NON-DS B-LLy INDUCTION, all B-LLy patients then complete SR CONSOLIDATION.\r\n\r DS B-LLY INDUCTION: Patients receive cytarabine IT on day 1, vincristine IV push over 1\r minute on days 1, 8, 15, and 22, pegaspargase IV over 1-2 hours or IM on day 4, methotrexate\r IT on days 8 and 29, and leucovorin PO or IV every 6 hours for 2 doses on days 9 and 30.\r Additionally, patients under 10 years of age receive dexamethasone PO or IV BID on days 1-28,\r and patients 10 years of age or older receive PO or IV prednisone or methylprednisolone on\r days 1-28. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r * After DS B-LLy INDUCTION, patients then complete SR CONSOLIDATION.\r\n\r SR CONSOLIDATION: Patients receive vincristine IV push over 1 minute on day 1, mercaptopurine\r PO on days 1-28, and methotrexate IT on days 1, 8, and 15. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on days 2, 9, and 16. Treatment continues for\r 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r * After SR CONSOLIDATION, patients with MRD undetectable are assigned to ARM A, and patients\r with MRD detectable/indeterminate/unavailable are randomized to ARM A or B. Patients with\r SR-Fav and all B-LLy patients are assigned to treatments identical to that in ARM A.\r\n\r HR CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, vincristine IV\r push over 1 minute on days 15, 22, 43, and 50, mercaptopurine PO on days 1-14 and 29-42,\r methotrexate IT on days 1, 8, 15, and 22 , and pegaspargase IV over 1-2 hours or IM on days\r 15 and 43. DS patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2,\r 9, 16, and 23 (on days 2 and 9 only for DS CNS3 patients). Treatment continues for 56 days in\r the absence of disease progression or unacceptable toxicity. Patients with continued clinical\r evidence of DS or testicular leukemia (from diagnosis through the end of Induction) undergo\r testicular radiation therapy over 12 fractions once daily (QD).\r\n\r * After HR CONSOLIDATION, patients are randomized to ARM C or D. DS B-ALL patients with MRD <\r 1% are assigned to an arm including three blocks of blinatumomab.\r\n\r ARM A:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted)\r on days 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1 and 29, dexamethasone\r PO BID or IV on days 1-7 and 15-21, vincristine IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV push/infusion over 1-15 minutes on days 1, 8, and 15, pegaspargase IV\r over 1-2 hours or IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29,\r thioguanine PO on days 29-42, and cytarabine IV over 1-30 minutes or subcutaneously (SC)\r on days 29-32 and 36-39. DS patients receive leucovorin PO or IV every 6 hours for 2\r doses on days 2 and 30. Treatment continues for 56 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes undiluted or 10-15 minutes diluted\r on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS patients receive\r leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32. Treatment continues for\r 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Non-DS patients receive methotrexate IT on day 1, vincristine IV push over\r 1 minute on day 1, dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84, and\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. DS patients\r receive vincristine IV push over 1 minute on day 1, methotrexate IT on day 1,\r dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84, and methotrexate PO on\r days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78, and leucovorin IV or PO on day 2 if\r DS. Treatment repeats every 84 days until a total duration of therapy of 2 years from\r start of INTERIM MAINTENANCE I is reached in the absence of disease progression or\r unacceptable toxicity.\r\n\r ARM B:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone IV or PO on day 1, methotrexate IT\r on day 1, and blinatumomab IV continuously on days 1-28. DS patients also receive\r leucovorin IV or PO every 6 hours for 2 doses on day 2. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted)\r on days 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive methotrexate IT on day 1, and blinatumomab IV\r continuously on days 1-28. DS patients also receive leucovorin PO or IV every 6 hours\r for 2 doses on day 2. Treatment continues for 35 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1 and 29, dexamethasone\r PO or IV on days 1-7 and 15-21, vincristine IV push over 1 minute on days 1, 8, and 15,\r doxorubicin IV push/infusion over 1-15 minutes on days 1, 8, and 15, pegaspargase IV\r over 1-2 hours or IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29,\r thioguanine PO on days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32\r and 36-39. DS patients receive leucovorin PO or IV every 6 hours for 2 doses on days 2\r and 30. Treatment continues for 56 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes\r (diluted) on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS\r patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - MAINTENANCE: Non-DS patients receive methotrexate IT on day 1 (omit on final 2 cycles),\r vincristine IV push over 1 minute on day 1, dexamethasone PO on days 1-5, mercaptopurine\r PO on days 1-84, and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71,\r and 78 (omit day 1 on final 2 cycles). DS patients receive methotrexate IT on day 1\r (omit on final 2 cycles), dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84,\r and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (omit day 1\r except for final 2 cycles), for DS patients and leucovorin IV or PO every 6 hours for 2\r doses on day 2 (omit on final 2 cycles). Treatment repeats every 84 days until a total\r duration of therapy of 2 years from start of INTERIM MAINTENANCE I is reached in the\r absence of disease progression or unacceptable toxicity.\r\n\r ARM C:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 15,\r 29, and 43, high dose methotrexate IV on days 1, 15, 29, and 43, mercaptopurine PO on\r days 1-14, 15-28, 29-42, and 43-56, methotrexate IT on day 1 and 29, and leucovorin PO\r or IV on days 3-4, 17-18, 31-32, and 45-46. Treatment continues for 56 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1, dexamethasone PO BID\r or IV on days 1-7 and 15-21, vincristine IV over 1 minute on days 1, 8, 15, 43, and 50,\r doxorubicin IV over 1-15 minutes on days 1, 8, and 15, pegaspargase IV over 1-2 hours or\r IM on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on\r days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV over 1 minute on days 1, 11, 21,\r 31, and 41, Capizzi style methotrexate IV over 2-5 minutes (undiluted) or over 10-15\r minutes (diluted) on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and\r pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV over 1 minute on day 1, prednisone or\r prednisolone or methylprednisolone PO or IV on days 1-5, mercaptopurine PO on days 1-84,\r methotrexate IT on days 1 and 29 of cycles 1-2 and on day 1 of subsequent cycles,\r methotrexate PO on days 8, 15, 22, 29 (for cycle 3 and later only), 36, 43, 50, 57, 64,\r 71, and 78. Treatment repeats every 84 days until a total duration of therapy of 2 years\r from start of interim maintenance I is reached in the absence of disease progression or\r unacceptable toxicity.\r\n\r ARM D:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, methotrexate IT\r on day 1, and blinatumomab IV continuously on days 1-28. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV over 1 minute on days 1, 15, 29,\r and 43, high dose methotrexate IV on days 1, 15, 29, and 43, mercaptopurine PO on days\r 1-14, 15-28, 29-42, and 43-56, methotrexate IT on days 1 and 29, and leucovorin PO or IV\r on days 3-4, 17-18, 31-32, and 45-46. Treatment continues for 56 days in the absence of\r disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive blinatumomab IV on days 1-28 and methotrexate IT\r on day 1. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1, dexamethasone PO or\r IV on days 1-7 and 15-21, vincristine IV over 1 minute on days 1, 8, 15, 43, and 50,\r doxorubicin IV over 1-15 minutes on days 1, 8, and 15, pegaspargase IV over 1-2 hours or\r IM on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on\r days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV over 1 minute on days 1, 11, 21,\r 31, and 41, Capizzi style methotrexate IV over 2-5 minutes (undiluted) or over 10-15\r minutes (diluted) on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and\r pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive methotrexate IT on day 1, vincristine IV over 1 minute on\r day 1, prednisone, prednisolone or methylprednisolone PO or IV on days 1-5,\r mercaptopurine PO on days 1-84, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50,\r 57, 64, 71, and 78. Treatment repeats every 84 days until a total duration of therapy of\r 2 years from start of interim maintenance I is reached in the absence of disease\r progression or unacceptable toxicity.\r\n\r DS-HIGH B-ALL:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV\r continuously on days 1-28, methotrexate IT on day 1 (or on day 56 of Consolidation), and\r leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE: Patients receive vincristine IV push over 1 minute on days 1, 15,\r 29, and 43, intermediate dose methotrexate IV over 24 hours on days 1, 15, 29, and 43,\r mercaptopurine PO on days 1-14, 15-28, 29-42, and 43-46, methotrexate IT on days 1 and\r 29, and leucovorin PO or IV every 6 hours for 2 doses on days 2-4, 16-18, 30-32, and\r 44-46. Treatment continues for 63 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive blinatumomab IV on days 1-28, methotrexate IT on\r day 1, and leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment continues\r for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive vincristine IV over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes on days 1, 8, and 15, dexamethasone PO or IV on\r days 1-7 and 15-21, methotrexate IT on day 1, leucovorin PO or IV every 6 hours for 2\r doses on day 2, and pegaspargase IV over 1-2 hours or IM on day 4. Treatment continues\r for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, methotrexate IT\r on day 1, and leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment\r continues for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV push over 1 minute on day 1, prednisone,\r prednisolone or methylprednisolone PO or IV BID on days 1-5, mercaptopurine PO on days\r 1-84, methotrexate IT on day 1, methotrexate PO on days 8, 15, 22, 29 (omit day 29 for\r first 3 cycles for patients who do not receive cranial radiotherapy), 36, 43, 50, 57,\r 64, 71, and 78, and leucovorin PO on days 2 and 30 (day 30 dose is for cycles 1-3 and\r for patients who do not receive cranial radiotherapy). CNS3 patients receive cranial\r radiotherapy during first 4 weeks of cycle 1. Treatment repeats every 84 days until a\r total duration of therapy of 2 years from start of interim maintenance I is reached in\r the absence of disease progression or unacceptable toxicity.\r\n\r All B-LLy patients:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 (diluted) on days\r 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive vincristine IV push over 1 minute on days 1, 8\r and 15, doxorubicin IV over 1-15 minutes on days 1, 8, and 15, dexamethasone PO or IV on\r days 1-7 and 15-21, methotrexate IT on days 1 and 29, pegaspargase IV over 1-2 hours or\r IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days\r 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. DS patients\r additionally receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 30.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes\r (diluted) on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS\r patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV push over 1 minute on day 1, dexamethasone\r PO on days 1-5, mercaptopurine PO on days 1-84, methotrexate IT on day 1, and\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. DS patients also\r receive leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment repeats every\r 84 days until a total duration of therapy of 2 years from start of interim maintenance I\r is reached in the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up every 4 weeks until complete\r blood count(CBC)/differential/platelet count recovery, then every 3 months for the first 2\r years, then every 4-6 months for the 3rd year, and every 6-12 months for the 4th and 5th\r years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening\r (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement\r for B-LLy patients. B-LLy patients may directly enroll on AALL1731.\r\n\r - Age at diagnosis:\r\n\r - Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS).\r\n\r - Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS).\r\n\r - Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or\r without DS).\r\n\r - B-ALL patients without DS must have an initial white blood cell count < 50,000/uL\r (performed within 7 days prior to enrollment).\r\n\r - B-ALL patients with DS are eligible regardless of the presenting white blood cell\r count (WBC) (performed within 7 days prior to enrollment).\r\n\r - Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on\r a bone marrow (BM) aspirate;\r\n\r - OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis\r can be established by a pathologic diagnosis of B-ALL on a BM biopsy;\r\n\r - OR a complete blood count (CBC) documenting the presence of at least 1,000/uL\r circulating leukemic cells;\r\n\r - OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without\r Down syndrome.\r\n\r - Note: For B-LLy patients with tissue available for flow cytometry, the criterion\r for diagnosis should be analogous to B-ALL. For tissue processed by other means\r (i.e., paraffin blocks), the methodology and criteria for immunophenotypic\r analysis to establish the diagnosis of B-LLy defined by the submitting\r institution will be accepted (diagnostic biopsy for B-LLy must be performed\r within 14 days prior to enrollment).\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent.\r\n\r Exclusion Criteria:\r\n\r - Patient must not have secondary ALL that developed after treatment of a prior\r malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior\r history of transient myeloproliferative disease (TMD) are not considered to have had a\r prior malignancy. They would therefore be eligible whether or not the TMD was treated\r with cytarabine.\r\n\r - With the exception of steroid pretreatment or the administration of intrathecal\r cytarabine, patients must not have received any prior cytotoxic chemotherapy for\r either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to\r initiation of protocol therapy on AALL1731.\r\n\r - For patients receiving steroid pretreatment, the following additional exclusion\r criteria apply:\r\n\r - Non-DS B-ALL patients must not have received steroids for more than 24 hours in\r the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to\r initiation of the steroids.\r\n\r - DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV\r steroids within 4 weeks of diagnosis.\r\n\r - Patients who have received > 72 hours of hydroxyurea.\r\n\r - B-ALL patients who do not have sufficient diagnostic bone marrow submitted for\r APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted\r containing > 1,000/uL circulating leukemia cells.\r\n\r - Patient must not have acute undifferentiated leukemia (AUL).\r\n\r - Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be\r known prior to enrollment).\r\n\r - Note: DS patients with CNS3 disease are eligible but will be assigned to the\r DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior\r to administration of any systemic or intrathecal chemotherapy, except for steroid\r pretreatment.\r\n\r - Non-DS B-ALL patients with testicular leukemia. (Note: DS patients with testicular\r disease are eligible but will be assigned to the DS-High B-ALL arm).\r\n\r - For LLy patients, the following additional exclusion criteria apply:\r\n\r - T-Lymphoblastic Lymphoma.\r\n\r - Morphologically unclassifiable lymphoma.\r\n\r - Absence of both B-cell and T-cell phenotype markers in a case submitted as\r lymphoblastic lymphoma.\r\n\r - CNS positive disease or testicular involvement.\r\n\r - M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow.\r\n\r - Patients with known Charcot-Marie-Tooth disease.\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype.\r\n\r - Patients requiring radiation at diagnosis.\r\n\r - Female patients who are pregnant since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential.\r\n\r - Lactating females who plan to breastfeed their infants.\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of their study participation.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
714
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nLCZ696 in Advanced LV Hypertrophy and HFpEF\n\n**Clinical Trial Summary:**\n\nPatients with advanced LVH and HFpEF will be randomly assigned in open-label fashion to\r receive LCZ696 titrated to 200 mg twice daily or valsartan titrated to 160 mg twice daily,\r and will be treated for 24 weeks.\n\n**Clinical Trial Detailed Description:**\n\nHeart failure with preserved ejection fraction (HFpEF) has a significant morbidity and\r mortality, and therapies that have proven effective in HF with reduced EF have not been shown\r to improve long-term prognosis in HFpEF. Inhibition of circulating neprilysin could augment\r deficient NP-receptor GC signaling and therefore be beneficial in HFpEF, as suggested by the\r decrease in NP following administration of valsartan/sacubitril in the phase 2 (PARAMOUNT\r study). Use of valsartan/sacubitril is currently being tested in the multicenter PARAGON-HF\r trial with HFpEF patients. The investigators suppose the best candidates for LCZ696 therapy\r will be patients with HFpEF and advanced concentric LV hypertrophy and obesity, i.e. having\r the lowest BNP bioavailability.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Moderate/severe hypertensive left ventricular (LV) hypertrophy (LVMi ≥109 g/m² in\r women and ≥132 g/m² in men);\r\n\r 2. New York Heart Association (NYHA) class II-III heart failure;\r\n\r 3. Left ventricular ejection fraction > 50%;\r\n\r 4. Increased LV filling pressures assessed at rest or at peak exercise by\r echocardiography\r\n\r 5. Body mass index (BMI) > 30 kg/m²\r\n\r 6. Signed and data informed consent\r\n\r Exclusion Criteria:\r\n\r 1. Age ≤ 18 years;\r\n\r 2. Evidence of myocardial ischemia during stress echocardiography;\r\n\r 3. Chronic atrial flutter or atrial fibrillation;\r\n\r 4. Alternative cause of left ventricular hypertrophy and impaired diastolic function\r (hypertrophic/restictive cardiomyopathy, aortic stenosis, constrictive pericarditis\r and etc.);\r\n\r 5. NYHA classification I or decompensated heart failure at screening;\r\n\r 6. Systolic blood pressure < 110 mmHg or > 180 mmHg;\r\n\r 7. Diastolic blood pressure < 40 mmHg or > 100 mmHg;\r\n\r 8. Anemia (Hb < 100 g/l);\r\n\r 9. Significant left sided structural valve disease;\r\n\r 10. Secondary hypertension;\r\n\r 11. Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity,\r primary valvular, or myocardial diseases;\r\n\r 12. Myocardial infarction or myocardial revascularization within the last 3 months of\r screening;\r\n\r 13. Stroke or TIA within the last 3 months of screening;\r\n\r 14. Autoimmunic and oncological diseases;\r\n\r 15. Impaired renal function, defined as eGFR < 30 ml/min/1.73 m²;\r\n\r 16. Impaired liver function;\r\n\r 17. Potassium concentration >5.2 mmol/L.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
715
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities\n\n**Clinical Trial Summary:**\n\nThe primary purpose of this study is to evaluate the diagnostic performance of three methods\r for measuring right ventricular size and function including the Philips Novel RV\r quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and\r the Upper Valley Right Ventricle Algorithm (UVRV) algorithm as compared to the gold standard\r of volumetric analysis via cardiac magnetic resonance imaging (CMR) in a broad patient\r population.\n\n**Clinical Trial Detailed Description:**\n\nThis is a single-center, blinded, randomized control trial of patients 18-years or older that\r are undergoing CMR as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon,\r NH. After informed consent is obtained, subjects undergo a study-specific external,\r non-invasive echocardiogram utilizing a special RV focused protocol on the same day of their\r CMR as close to their scheduled CMR as possible to minimize wait time for consented patients.\r The echocardiogram takes approximately an additional 30 minutes of the subject's time.\r\n\r De-identified echocardiogram images from each subject will be evaluated by experienced\r echocardiographers using three different methodologies (standard method, Phillips Novel\r technology and the newly developed UVRV algorithm). The methodologies will be compared with\r each other to determine sensitivity, specificity and accuracy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient age is over 18 years\r\n\r - Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric\r analysis\r\n\r - Patient is capable of giving informed consent\r\n\r - The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes\r\n\r Exclusion Criteria:\r\n\r - Patient unable to under echocardiogram\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
716
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSurgery in Secondary Tricuspid Regurgitation\n\n**Clinical Trial Summary:**\n\nCurrently, in cardiology/cardiosurgery the indicators for the surgical correction of\r secondary tricuspid regurgitationare unclear. AIM: To compare right ventricle structural and\r functional changes after operation in patients with secondary tricuspid regurgitation with\r severe mitral /aortic valve pathology, requiring surgical intervention; define the factors\r influencing major adverse cardiac events depending on the operation/non-operation due to\r moderate tricuspid regurgitation. This study intends to include 200-300 people and will occur\r over 5 years with an additional 3-year follow-up.\n\n**Clinical Trial Detailed Description:**\n\nBackground It has been demonstrated in recent large patient monitoring registers that the\r presence of even mild secondary tricuspid regurgitation (TR) has a significant effect on life\r expectancy. Currently, in cardiology/cardiosurgery the indicators for the surgical correction\r of secondary TR are unclear. In this area, international guidelines lack randomized studies\r and are based on a C level of evidence. C level evidence is based solely on the opinion of\r experts, retrospective, and/or observational studies. The first indicator for tricuspid valve\r (TV) surgery is considered to be a combination of TR with severe aortic or mitral valve\r lesions that require surgical treatment. However, the level of indicators for moderate\r corrections in such situations is typically II A-B. At the C level of evidence there is no\r consensus for surgical treatment of such a defect in the international community. Severe TR\r indicators are Class I while the evidence remains C level because it is not well established\r that surgical treatment improves the prognosis of these patients. There is a lack of\r information about the structural and functional changes of the right ventricle after surgery\r depending on the degree of TR.\r\n\r Aims and objectives of studying AIM: To compare right ventricle structural and functional\r changes after operation in patients with secondary tricuspid regurgitation with severe mitral\r /aortic valve pathology, requiring surgical intervention; define the factors influencing\r major adverse cardiac events depending on the operation/non-operation due to moderate\r tricuspid regurgitation.\r\n\r OBJECTIVES:\r\n\r 1. To study tricuspid regurgitation parameters affecting the long-term prognosis for the\r surgical correction of severe secondary tricuspid regurgitationof patients with severe\r aortic/mitral valve pathology requiring surgical treatment.\r\n\r 2. To define hemodynamic parameters of patients with moderate tricuspid regurgitation, when\r surgical treatment of this defect gives an additional improvement in the short-term and\r long-term prognosis following surgical treatment of severe aortic/mitral valve diseases.\r\n\r 3. To study changes in contractility parameters in the right ventricle and tricuspid valve\r function after reconstructive surgery over a period of 3 years.\r\n\r Methods and study plans This study intends to include 200-300 people and will occur over 5\r years with an additional 3-year follow-up.\r\n\r Inclusion criterion: 1) Signed informed consent form, 2) Previously diagnosed aortic or\r mitral heart diseases requiring surgical treatment, 3) Over 18 years of age 4) The presence\r of moderate or severe secondary tricuspid insufficiency.\r\n\r Exclusion criterion: 1) Significant oncology diseases with a known prognosis of a less than 1\r year life expectancy.\r\n\r Cardiologist examination and survey. Echocardiography All patients will undergo standard\r echocardiography, including a detailed study of the function and sizes of the right ventricle\r and right atrium, and measurement of global longitudinal left ventricular deformations using\r the Speckle Tracking method, peak systolic and diastolic blood flow velocity in TV,\r fractional changes in area, and tricuspid annulus systolic excursion. Tricuspid regurgitation\r will be measured according to the standards of EAE/ASE, and will also use the recent 3-tiered\r classification system of severe insufficiency.\r\n\r Laboratory techniques Standard for surgical treatment of aortic/mitral valve Coronary\r catheterization Standard for surgical treatment of aortic/mitral valve, Plan I. Initial visit\r - cardiologist/cardiosurgeon clinical evaluation - survey and examination II.\r Echocardiography study - screening - defining degree of tricuspid regurgitation III. Common\r tests for surgical treatment of aortic/mitral valve IV. Patient randomization with only a\r moderate degree of TR V. Surgical treatment VI. 30-40 days after surgery - cardiologist\r examination VII. 90 days after surgery ¬ - cardiologist examination + echocardiography VIII.\r 1 year after surgery - cardiologist examination + echocardiography IX. 3 years after surgery\r - cardiologist examination + echocardiography Expected benefits for patients All patients\r will receive advanced tests using the latest safe ultrasound methods. Frequent\r echocardiography and patient observations can reveal possible complications after cardiac\r surgery for aortic/mitral diseases; This study will allow for the correction of drug therapy\r due to extended diagnosis.\r\n\r Severe lesions of the tricuspid valve and aortic / mitral heart defects will be corrected in\r all patients.\r\n\r New and / or untested methods of treatment will not be used in this study. All surgical\r procedures will already have undergone testing and been proven effective for the treatment of\r heart diseases.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age > 18 years\r\n\r 2. Indication left-side valve surgery\r\n\r Exclusion Criteria:\r\n\r 1. Unwillingness to give informed consent and to enter a regular follow-up program.\r\n\r 2. Prior surgical or percutaneous mitral valve intervention\r\n\r 3. Contraindication to cardiopulmonary bypass (CPB)\r\n\r 4. Clinical signs of cardiogenic shock at the time of randomization\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
717
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nInotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy\n\n**Clinical Trial Summary:**\n\nThis phase III trial studies whether inotuzumab ozogamicin added to post-induction\r chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves\r outcomes. This trial also studies the outcomes of patients with mixed phenotype acute\r leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without\r inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab,\r linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in\r a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy\r regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin,\r methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and\r pegaspargase work in different ways to stop the growth of cancer cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. This trial will\r also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and\r disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.\r\n\r The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard\r of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic\r Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy:\r Induction and Consolidation. This part will collect information on the leukemia, as well as\r the effects of the initial treatment, in order to classify patients into post-consolidation\r treatment groups. On the second part of this study, patients will receive the remainder of\r the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance\r II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this\r study include investigating whether treating both males and females with the same duration of\r chemotherapy maintains outcomes for males who have previously been treated for an additional\r year compared to girls, as well as to evaluate the best ways to help patients adhere to oral\r chemotherapy regimens. Finally, this study will be the first to track the outcomes of\r subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute\r Leukemia (MPAL) when treated with B-ALL chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To determine in a randomized manner if the addition of 2 blocks of inotuzumab ozogamicin\r to modified Berlin-Frankfurt-Munster (mBFM) chemotherapy will improve 5-year disease-free\r survival (DFS) in children and young adults with high-risk B-cell acute lymphoblastic\r leukemia (HR B-ALL).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To describe the 5-year DFS for a favorable risk subset of National Cancer Institute (NCI)\r HR B-ALL (HR-Fav) when treated with mBFM chemotherapy with a single high-dose methotrexate\r (HD-MTX) interim maintenance (IM) phase and treatment duration of 2 years from the start of\r IM regardless of sex.\r\n\r II. To determine the toxicity and tolerability of inotuzumab ozogamicin integrated into the\r mBFM chemotherapy backbone in HR B-ALL.\r\n\r III. To describe the 5-year event-free survival (EFS) for patients with mixed phenotype acute\r leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi\r escalating intravenous (IV) methotrexate (MTX) without leucovorin rescue plus pegaspargase\r (C-MTX).\r\n\r IV. To describe the 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell\r lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM\r phase with C-MTX.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To describe the therapy administered, disease response, and survival outcomes of patients\r with MPAL who come off protocol therapy due to poor disease response to ALL therapy either\r during Induction, at end of induction (EOI), or at end of consolidation (EOC).\r\n\r II. To define the prevalence and significance of minimal marrow disease (MMD) at diagnosis\r and bone marrow minimal residual disease (MRD) at EOI in disseminated B-LLy.\r\n\r III. To determine the impact of proposed adherence-enhancing interventions on adherence to\r oral 6-mercaptopurine in patients with ALL.\r\n\r OUTLINE: All patients receive the same Induction and Consolidation chemotherapy. Patients\r with HR-Fav B-ALL are assigned to Arm I. Patients with HR B-ALL are randomized to Arm II or\r III. Patients with MPAL are assigned to Arm IV, and patients with B-LLy are assigned to Arm\r V.\r\n\r All patients with B-ALL receive Induction and Consolidation therapy:\r\n\r INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1 and central nervous system\r (CNS)2 patients also receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also\r receive vincristine intravenously (IV) or IV push over 1 minute on days 1, 8, 15, and 22,\r daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargase intramuscularly (IM) or\r IV over 1-2 hours on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for\r CNS3 patients). Patients < 10 years old receive dexamethasone orally (PO) twice daily (BID)\r or IV on days 1-14; patients >= 10 years old receive prednis(ol)one PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39,\r mercaptopurine PO once daily (QD) on days 1-14 and 29-42, and methotrexate IT on days 1, 8,\r 15, and 22 (CNS3 patients receive methotrexate IT on days 1 and 8). Patients also receive\r vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and pegaspargase IV over\r 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in the absence of disease\r progression or unacceptable toxicity. Additionally, patients with testicular disease at\r diagnosis that does not resolve by the end of induction will undergo radiation therapy over\r 12 once daily fractions.\r\n\r POST-CONSOLIDATION THERAPY: After Consolidation, based on clinical features and response,\r patients with B-ALL are designated as HR-Fav or HR B-ALL. Patients with HR-Fav B-ALL are\r assigned to Arm I. Patients with HR B-ALL are randomized to Arm II or III. Patients with MPAL\r and B-LLy are assigned to therapy arms (Arms IV and V) that are identical to Arm II. Patients\r that are < 10 years, have CNS1, no testicular leukemia, with favorable cytogenetics (ETV6\r RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours of steroids in the two weeks prior\r to diagnosis, and EOI MRD < 0.01% are assigned to Arm I. Patients with HR B-ALL who are\r surface CD22 positive at diagnosis and have MRD < 0.01% by the end of Consolidation, are\r randomized to either Arm II or III.\r\n\r ARM I: HR-FAV B-ALL (Patients that are < 10 years, have CNS1 status, no testicular leukemia,\r with favorable cytogenetics (ETV6 RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours\r of steroids in the two weeks prior to diagnosis, and EOI MRD < 0.01%)\r\n\r INTERIM MAINTENANCE: Patients receive vincristine IV or IV push over 1 minute on days 1, 15,\r 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO\r or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO QD on days 1-14, 15-28, 29-42,\r and 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the\r absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINTENANCE: Patients receive methotrexate IT on days 1 and 29 for cycles 1-4, and day 1 for\r subsequent cycles. Patients also receive vincristine IV or IV push over 1 minute on day 1,\r prednisolone PO BID or IV on days 1-5, mercaptopurine PO QD on days 1-84, and methotrexate PO\r on days 8, 15, 22, (29 excluded in cycles 1-4), 36, 43, 50, 57, 64, 71, and 78. Cycles repeat\r every 12 weeks for up to 2 years in the absence of disease progression or unacceptable\r toxicity.\r\n\r Patients with HR B-ALL who have MRD < 0.01% by the end of Consolidation, and leukemic blasts\r positive for surface CD22 at diagnosis are randomized to Arm II or Arm III.\r\n\r ARM II: HR B-ALL (CONTROL) INTERIM MAINTENANCE I: Patients receive vincristine IV or IV push\r over 1 minute on days 1, 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1,\r 15, 29 and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, 45-46, mercaptopurine PO QD on\r days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29. Treatment continues\r for 9 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31 and 41, methotrexate IV over 2-15 minutes or 10-15 minutes on days 1, 11, 21, 31,\r and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2 hours or IM on days 2\r and 22. Treatment continues for 8 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r ARM III: HR B-ALL (EXPERIMENTAL) INOTUZUMAB OZOGAMICIN (InO) BLOCK 1: Patients receive\r inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 and methotrexate IT on day 1.\r Treatment continues for 4 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r INTERIM MAINTENANCE I: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin\r PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-14, 15-28, 29-42,\r and 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the\r absence of disease progression or unacceptable toxicity.\r\n\r InO BLOCK 2: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15.\r Treatment continues for 4 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV on days 1, 11, 21, 31, and 41, methotrexate IT on days 1\r and 31, and pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 8\r weeks in the absence of disease progression or unacceptable toxicity.\r\n\r ARMS II AND III: HR B-ALL MAINTENANCE: Patients receive vincristine IV or IV push over 1\r minute on day 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO on days 1-84,\r methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71\r and 78, and methotrexate IT on days 1 (and 29 of cycles 1-2 for patients who do not receive\r cranial radiation). Cycles repeat every 12 weeks for up to 2 years in the absence of disease\r progression or unacceptable toxicity. Patients with CNS3 disease undergo cranial radiation\r therapy over 10 fractions during the first 4 weeks.\r\n\r ARM IV: MPAL INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also\r receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV or\r IV push over 1 minute on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8,\r 15, and 22, pegaspargase IM or IV over 1-2 hours on day 4, and methotrexate IT on days 8 and\r 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone\r PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO\r on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22\r for CNS3 patients), vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and\r pegaspargase IV over 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in\r the absence of disease progression or unacceptable toxicity. Patients with testicular disease\r at diagnosis that does not resolve by the end of induction will and continued evidence of\r testicular disease at end of induction undergo testicular radiation over 12 once-daily\r fractions.\r\n\r ARM V: B-LLY INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also\r receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV or\r IV push over 1 minute on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8,\r 15, and 22, pegaspargase IM or IV over 1-2 hours on day 4, and methotrexate IT on days 8 and\r 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone\r PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO\r on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22\r CNS3 patients), vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and\r pegaspargase IV over 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in\r the absence of disease progression or unacceptable toxicity. Patients with testicular disease\r at diagnosis that does not resolve by the end of induction will and continued evidence of\r testicular disease at end of induction undergo testicular radiation therapy over 12\r once-daily fractions.\r\n\r ARM IV AND V: MPAL AND B-LLY (Post-Consolidation Therapy) INTERIM MAINTENANCE I: Patients\r receive vincristine IV or IV push over 1 minute on days 1, 15, 29, and 43, high dose\r methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4,\r 17-18, 31-32, and 45-46, methotrexate IT on days 1 and 29 and mercaptopurine PO QD on days\r 1-14, 15-28, 29-42, and 43-56. Treatment continues for 9 weeks in the absence of disease\r progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV or infusion over 2-15 minutes or 10-15 minutes on days 1,\r 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2 hours or\r IM on days 2 and 22. Treatment continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINTENANCE: Patients receive vincristine IV or IV push over 1 minute on days 1, prednisolone\r PO BID or IV on days 1-5, mercaptopurine PO on days 1-84, methotrexate PO on days 8, 15, 22,\r 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71, and 78, and methotrexate IT on days\r 1 (and 29 of cycles 1-2 for patients who do not receive cranial radiation). Cycles repeat\r every 12 weeks for up to 2 years in the absence of disease progression or unacceptable\r toxicity. Patients with CNS3 disease at diagnosis undergo cranial radiation therapy for 10\r fractions over 4 weeks.\r\n\r After completion of study treatment, patients are followed up at 4 weeks, then every 3 months\r for 2 years, every 4-6 months for the third year, then every 6-12 months for years 4-5.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility\r studies (Part A) prior to treatment and enrollment on AALL1732. Note that central\r confirmation of MPAL diagnosis must occur within 7 business days after enrollment for\r MPAL patients. If not performed within this time frame, patients will be taken off\r protocol.\r\n\r - APEC14B1 is not a requirement for B-LLy patients but for institutional compliance\r every patient should be offered participation in APEC14B1. B-LLy patients may directly\r enroll on AALL1732.\r\n\r - White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to\r the start of protocol-directed systemic therapy):\r\n\r - Age 1-9.99 years: WBC >= 50,000/uL\r\n\r - Age 10-24.99 years: Any WBC\r\n\r - Age 1-9.99 years: WBC < 50,000/uL with:\r\n\r - Testicular leukemia\r\n\r - CNS leukemia (CNS3)\r\n\r - Steroid pretreatment.\r\n\r - White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to\r the start of protocol-directed systemic therapy):\r\n\r - Age 1-24.99 years: any WBC.\r\n\r - Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016\r criteria) with > 25% blasts on a bone marrow (BM) aspirate;\r\n\r - OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the\r diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM\r biopsy;\r\n\r - OR A complete blood count (CBC) documenting the presence of at least 1,000/uL\r circulating leukemic cells if a bone marrow aspirate or biopsy cannot be\r performed.\r\n\r - Patient has newly diagnosed B-LLy Murphy stages III or IV.\r\n\r - Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\r\n\r - Note: For B-LLy patients with tissue available for flow cytometry, the criterion for\r diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e.,\r paraffin blocks), the methodology and criteria for immunophenotypic analysis to\r establish the diagnosis of B-LLy defined by the submitting institution will be\r accepted.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent.\r\n\r - All institutional, Food and Drug Administration (FDA), and NCI requirements for human\r studies must be met.\r\n\r Exclusion Criteria:\r\n\r - Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL\r are eligible for AALL1731, regardless of NCI risk group).\r\n\r - With the exception of steroid pretreatment or the administration of intrathecal\r cytarabine, patients must not have received any prior cytotoxic chemotherapy for the\r current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to\r initiation of protocol therapy on AALL1732.\r\n\r - Patients who have received > 72 hours of hydroxyurea within one week prior to start of\r systemic protocol therapy.\r\n\r - Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow\r submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted\r containing > 1,000/uL circulating leukemia cells.\r\n\r - Patients with acute undifferentiated leukemia (AUL) are not eligible.\r\n\r - For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid\r pretreatment, the following additional exclusion criteria apply:\r\n\r - T-lymphoblastic lymphoma.\r\n\r - Morphologically unclassifiable lymphoma.\r\n\r - Absence of both B-cell and T-cell phenotype markers in a case submitted as\r lymphoblastic lymphoma.\r\n\r - Patients with known Charcot-Marie-Tooth disease.\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype.\r\n\r - Patients requiring radiation at diagnosis.\r\n\r - Female patients who are pregnant, since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential.\r\n\r - Lactating women who plan to breastfeed their infants while on study and for 2 months\r after the last dose of inotuzumab ozogamicin.\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of study participation. For those\r patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the\r last dose of inotuzumab ozogamicin for females and 5 months after the last dose of\r inotuzumab ozogamicin for males.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
718
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTreatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.\n\n**Clinical Trial Summary:**\n\nTo evaluate whether patients after successful transfemoral transcatheter aortic valve\r implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR)\r benefit from an additional treatment of this valve disease as well.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria\r\n\r - Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or\r subsequent models)\r\n\r - Moderate to severe mitral regurgitation\r\n\r - Symptom status NYHA II-III\r\n\r - Treatment and compliance with optimal, individually-tailored guideline directed\r medical therapy for heart failure for at least 30 days before inclusion\r\n\r - Age ≥ 18 and < 90 years\r\n\r - Written informed consent\r\n\r Exclusion criteria\r\n\r - MR mechanism/anatomy precluding MitraClip therapy\r\n\r - Groin blood vessels are not eligible for TAVI procedure\r\n\r - Massive or torrential tricuspid regurgitation\r\n\r - Patients who cannot tolerate procedural anticoagulation or post procedural\r anti-platelet regimen.\r\n\r - Life expectancy < 1 year due to non-cardiac conditions\r\n\r - LVEF ≤ 25%\r\n\r - Hypotension (systolic pressure < 90 mmHg) or requirement of inotropic support or\r mechanical hemodynamic support\r\n\r - Cardiomyopathy other than dilated cardiomyopathy\r\n\r - Fixed pulmonary artery systolic pressure > 70 mm Hg\r\n\r - Any prior mitral valve surgery or transcatheter mitral valve procedure\r\n\r - Stroke or transient ischemic event within 6 months prior to randomization\r\n\r - Severe symptomatic carotid stenosis\r\n\r - Implant or revision of any rhythm management device (CRT or CRT-D) or implantable\r cardioverter defibrillator within 90 days prior to randomization\r\n\r - Untreated clinically significant coronary artery disease requiring revascularization\r\n\r - Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to\r randomization, or any cardiac surgery within six months prior to randomization.\r\n\r - Need for any other cardiovascular surgery (other than MV or AV disease)\r\n\r - Echocardiographic evidence of intracardiac mass, thrombus, or vegetation\r\n\r - Active endocarditis or active infections requiring current antibiotic treatment\r\n\r - Any condition making it unlikely that the patient will be able to complete all\r protocol procedures\r\n\r - Patient unable to provide written informed consent prior to study enrolment\r\n\r - Pregnant or nursing women\r\n\r - Women of child bearing potential\r\n\r - Current participation in any other interventional clinical trial\r\n\r - Patients under legal supervision or guardianship Patients placed in an institution by\r official or court order\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
719
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nReobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)\n\n**Clinical Trial Summary:**\n\nWith the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to\r younger patients, the feasibility of coronary ostia cannulation beyond different\r bioprosthesis stent is currently a matter of debate. Purpose of this study is: 1) to assess\r the feasibility to re-engage coronary ostia after TAVR; 2) to discover potential native\r anatomical or prosthesis-related features that may preclude proper coronary cannulation after\r TAVR.\n\n**Clinical Trial Detailed Description:**\n\nSingle-center, prospective, pilot study. Aim of this study is to assess the feasibility of\r coronary ostia re-engagement beyond transcatheter aortic valve (TAV) stent through a\r transfemoral access in 300 consecutive patients undergoing transfemoral TAVR with\r pre-procedural computed tomography assessment available.\r\n\r The possibility to selectively cannulate each coronary, the amount of time and contrast will\r be evaluated in each patient before and after implantation of either balloon-(SAPIEN 3) or\r self-expanding (Evolut R/PRO, Acurate Neo or Portico) TAVs, thus generating an internal\r comparator.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially\r available devices\r\n\r - Availability of preprocedural aortic root evaluation by computed tomography\r angiography scans\r\n\r Exclusion Criteria:\r\n\r - TAVR in degenerated bioprostheses\r\n\r - Known ostial chronic total occlusion\r\n\r - Transcatheter valve not deployed in its anatomical position\r\n\r - Patients with hemodynamic instability during the procedure\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
720
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nLeft Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve\n\n**Clinical Trial Summary:**\n\nAortic stenosis is a commonly found heart disease, which often leads to mortality and\r morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost\r especially in the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia.\r In addition to the expensive cost, patients who have mechanical prosthetic valve have an\r increased risk of infection of the prosthetic valve and developing thrombo-embolism thus have\r to consume a lifelong anticoagulant therapy that increase risk of bleeding. A surgical\r technique using autologous pericardium is an alternative to prosthetic valve replacement, one\r of which is a single pericardium strip technique that uses modified autologous pericardium\r technique from Ozaki et al and Duran et al.\r\n\r The objective of this study is to investigate the outcome of aortic valve replacement with a\r single pericardium strip of autologous pericardium in patients with aortic stenosis.\r\n\r This study will be conducted at the Integrated Heart Center of Cipto Mangunkusumo Hospital,\r Jakarta, Indonesia, by using quasi experimental type time series design. Subjects are\r patients with aortic stenosis who are candidates for valve replacement. Inclusion criteria is\r having low to moderate surgical risk (EuroScore II <5). The sampling method used in this\r study is non-probability consecutive sampling. This study will assess the outcome of the\r aortic valve replacement (valve hemodynamic, left ventricular reverse remodelling, sST2,\r 6MWT) at 3 months and 6 months post-aortic valve replacement.\r\n\r It is expected that aortic valve replacement using a single strip of autologous pericardium\r will have good valve hemodynamic outcome, yield left ventricular reverse remodelling,\r decrease sST2 level, show upgrade in 6MWT, and have shorter aortic cross clamp time so that\r it can be an alternative to aortic valve replacement using mechanical prosthetic valve that\r is less expensive and have good outcomes in patient with aortic stenosis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients aged more than 10 years old\r\n\r - Patients with aortic valve stenosis with an indication of aortic valve replacement\r having low to moderate surgical risk (EuroScore II <5)\r\n\r - The patient or guardian (the research subject's parent) agrees to follow the study\r\n\r Exclusion Criteria:\r\n\r - Patients who have previously underwent aortic valve replacement\r\n\r - Patients with aortic stenosis due to bicuspid aortic valve\r\n\r - Patients with autoimmune disease\r\n\r - Patients with mixed connective tissue disease\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
721
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nATTR Amyloidosis in Elderly Patients With Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nSevere aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg\r and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients\r do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface\r area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF > 50%). This entity\r is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with\r a worse prognosis.\r\n\r ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic\r stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis\r could be frequent but underdiagnosed in patients with aortic stenosis. There is significant\r overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing\r prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle\r (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all\r features, which lead to a reduction in stroke volume, the underlying mechanism of the low\r flow condition as observed in PLFLG AS patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Symptomatic, severe aortic stenosis\r\n\r Exclusion Criteria:\r\n\r - More than mild valvular disease of any other valve\r\n\r - Other severe disease with a life expectancy < 1 year\r\n\r - Participating in trial interfering with routine clinical practice or use of a non-CE\r marked device\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
722
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAcute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia\n\n**Clinical Trial Summary:**\n\nThis study will evaluate the acute effect of one single bout of high intensity exercise on\r the tendency for ventricular arrhythmia.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a substudy of a planned study involving participants with an implantable\r cardioverter defibrillator (ICD), who will be randomly assigned to either take part in a\r exercise program for 12 weeks or serve as control and live as usual (Clinical Trials Unique\r Protocol ID: 2018/1592). In that study all participants will complete an exercise treadmill\r test to determine maximum oxygen uptake (VO2 peak).\r\n\r In this study we wish to examine the acute effect of one single bout of high intensity\r exercise (i.e the VO2 peak test) on the tendency for ventricular arrhythmia. The study will\r evaluate changes in ICD-parameters and the number of premature ventricular contractions the\r first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to\r the test.\r\n\r The study will also examine if the acute effect after VO2 peak testing alters after\r completing 12 weeks of aerobic interval training or control respectively.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for\r implantation\r\n\r - ICD implanted at St Olavs hospital, Trondheim\r\n\r In case of difficulties with patient inclusion for the study, the criteria might be\r broadened to include patients with idiopathic ventricular arrhythmia as cause for\r implantation.\r\n\r Exclusion Criteria:\r\n\r - inability to accomplish the exercise program due to serious comorbidity or to\r participate in regular training within the next 3 months due to other reasons\r\n\r - signs of severe cardiac ischemia or persistent ventricular tachycardia during\r individualized treadmill O2 peak test, which after individual assessment is to be\r found at risk\r\n\r - comorbidity where endurance training at more than moderate intensity is discouraged\r\n\r - severe cardiac valve disease\r\n\r - planned surgery within the next 3 months\r\n\r - inability to give informed consent\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
723
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAssessment of Risk in Thoracic Aortopathy Using 18F-Sodium Fluoride\n\n**Clinical Trial Summary:**\n\nPatients with bicuspid aortic valve-related aortopathy are at increased risk of aortic\r dilatation, dissection and rupture. Currently, risk stratification is largely based on aortic\r diameter measurements, with those deemed high risk referred for aortic replacement surgery.\r This approach is imperfect, and potentially exposes many patients to unnecessary high-risk\r aortic surgery, or fails to identify those at risk of dissection or rupture with smaller\r diameters. In patients with abdominal aortic aneurysms, the investigators recently\r demonstrated that uptake of 18F-sodium fluoride predicts disease progression and clinical\r events independent of aneurysm diameter and standard clinical risk factors. Based on the\r investigators preliminary data, a study was proposed to look at 18F-sodium fluoride uptake in\r patients with bicuspid aortic valve-related aortopathy. The proposed study will shed light on\r the underlying pathological processes involved in aortic complications of this disease as\r well as potentially providing an important risk marker to predict disease progression and\r guide the need for major aortic surgery.\n\n**Clinical Trial Detailed Description:**\n\nBicuspid aortic valve, along with other congenital conditions affecting the aortic wall, has\r been associated with elastic fibre loss, decrease in size of elastic lamellae, increased\r collagen deposition and smooth muscle loss compared to healthy controls on both light\r microscopy and electron microscopy. Further, analysis of site specific regions of the\r ascending aorta using biopsy specimens demonstrated significant differences in the apoptosis\r rate and survival of smooth muscle cells favouring the lesser curvature over the greater\r curvature of the aorta (the area of greater wall shear stress).\r\n\r Studies to date suggest vessel wall microcalcification (lesions<50μm) is a dynamic marker of\r this vessel wall pathology: the end-product of a pathological process involving vessel wall\r inflammation, apoptosis and necrosis of medial smooth muscle cells and subsequent elastic\r fibre degradation. Granular medial calcinosis, the deposition of microcalcification in the\r medial layer of resected aortic tissue, has been recognised as a significant feature of\r bicuspid aortic valve-related aortopathy when compared to aortic samples taken from patients\r with tricuspid valves.\r\n\r Recent histological analysis of human and murine Marfan aortas demonstrated elastin breaks\r co- localising with areas of microcalcification in aortic media. Further, the areas of\r elastin break were significantly correlated to decreased distensibility and increased aortic\r diameter. Finally, the group demonstrated an elastin receptor complex-ERK1/2-ALP-mediated\r mechanism for increased microcalcification deposition. Although focused on Marfan syndrome,\r these results are relevant to bicuspid aortic valve-related aortopathy as they suggest\r microcalcification is associated with elastic fibre breakdown, a proposed mechanism of\r bicuspid aortic valve aneurysm formation at areas of high wall shear stress. The ability to\r demonstrate and quantify aortic microcalcification, both ex vivo and non-invasively in vivo\r in patients with bicuspid aortic valve-related aortopathy would be important step in\r improving our knowledge of the pathological process underpinning this condition.\r\n\r Positron emission tomography (PET) utilises a radiotracer which provides functional\r information on tissues at the cellular or molecular level. Because of its limited spatial\r resolution, PET images are combined with computed tomography (CT) or magnetic resonance\r imaging (MRI) so that the functional PET images can be co-registered with the detailed\r anatomical and structural images afforded by CT or MRI. While CT or MRI alone has been\r utilised in a wide range of cardiovascular diseases and can identify larger areas of\r macrocalcification (>200 μm), PET/CT using 18F-sodium fluoride has been used to identify\r vessel wall microcalcification (calcific lesions <50 μm) that is not detectable on CT or MRI.\r 18F-Sodium fluoride has been extensively validated as a radiotracer of microcalcification\r utilising electron microscopy, immunohistochemical analysis, pharmacodynamic\r concentration-response curves, and ex vivo and in vivo micro-PET/CT on vessel wall sections.\r 18F-Sodium fluoride uptake is mediated through exchange of fluoride ions with hydroxyl groups\r of hydroxyapatite, the major constituent of vessel wall calcification. Positron emission\r tomography using 18F-sodium fluoride has demonstrated significant promise as identifying\r active vessel wall pathology in a number of cardiovascular diseases including carotid,\r coronary, aortic valve, and abdominal aortic aneurysm disease. The use of 18F-sodium fluoride\r PET imaging in thoracic aortic aneurysms is novel.\r\n\r There is a correlation between areas of high wall stress and intimal tear location location.\r Further, aneurysmal aortic tissue has been demonstrated to have reduced delamination strength\r in both longitudinal and circumferential dimensions: evidence for an involvement of\r haemodynamic effects on precipitating dissection. Time resolved 3D blood flow captured on\r MRI, also known as 4D-flow MRI, is an evolving research tool which non-invasively captures\r patient-specific regionalised blood flow and velocity, allowing calculation of aortic wall\r sheer stress, and has been used to study bicuspid aortic valve-related aortopathy. A study\r pairing pre-operative 4D-flow MRI and post-operative biopsies of aortic tissue have\r demonstrated a decrease in elastin at sites of high aortic wall stress, suggesting a\r relationship between haemodynamics and the structural composition of the aneurysmal aortic\r wall. The ability to demonstrate a pathological process associated with aneurysmal weakness\r could be an important step to better identifying high risk lesions.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Bicuspid aortic Valve or Age-sex matched healthy volunteer\r\n\r Exclusion Criteria:\r\n\r - Pregnancy\r\n\r - eGFR < 30\r\n\r - previous aortic replacement surgery\r\n\r - previous aortic valve surgery\r\n\r - contrast allergy\r\n\r - other reason unable to undergo MRI\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
724
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPersistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy\n\n**Clinical Trial Summary:**\n\nTo identify clinical, echocardiographic, and hemodynamic parameters which can predict\r persistent PH after PMC, and also to determine the impact of persistent PH on the clinical\r outcomes.\n\n**Clinical Trial Detailed Description:**\n\nPure mitral Stenosis develops in approximately 40% of all patients with rheumatic heart\r disease, and is frequently complicated by Pulmonary hypertension (PH). Pulmonary hypertension\r influences symptomatology and long-term prognosis. Percutaneous Mitral Commissurotomy (PMC),\r was first described in 1984, has good results and is performed by antegrade access to the\r mitral valve through trans-septal puncture by one of various techniques (e.g. Inuoe, and\r multitrack system). Pulmonary artery pressures (PAP) decrease following PMC. The improvement\r in pulmonary hypertension after PMC is explained by the improvement in the mitral valve area\r and subsequent decompression of left atrium (LA) and pulmonary venous beds. Even though there\r have been studies showing excellent results following PMC in all grades of PH, nonregression\r of PH following PMC is not uncommon. The component of PAP contributed by the passive\r transmission of the elevated LA pressure regresses immediately after a successful PMC\r proportional to the reduction in transmitral gradient. The PH contributed by pulmonary\r arteriolar constriction slowly comes down over weeks or a few months, But a \"fixed\" component\r due to pulmonary vascular disease usually persists.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Severe mitral stenosis (mitral valve area ≤1.5cm).\r\n\r - Significant dyspnea.\r\n\r - Favorable anatomical characteristics for PMC as assessed by transthoracic\r echocardiography\r\n\r Exclusion Criteria:\r\n\r - Significant mitral regurgitation (≥ grade II/IV). Bilateral commissural calcification.\r\n\r - Presence of other lesions which need open heart surgery.\r\n\r - Wilkins' score > 12.\r\n\r - Persistent LA thrombus despite adequate anticoagulation.\r\n\r - End stage renal or liver disease.\r\n\r - Patients with severe COPD and other chest problems that might be complicated by\r pulmonary hypertension per se.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
725
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEarly Insertion of Axillary Impella® With VA ECMO\n\n**Clinical Trial Summary:**\n\nVeno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is used as a rescue strategy for\r patients in acute hemodynamic deterioration such as cardiogenic shock and cardiopulmonary\r arrest with severe pulmonary congestion. VA ECMO is the fastest way to stabilize a patient\r with cardiogenic shock and improve end-organ perfusion. However, one of the major\r disadvantages of peripheral VA-ECMO is that it provides no left ventricular unloading and\r increases left ventricular (LV) afterload secondary to the retrograde blood flow. Therefore,\r LV wall tension and myocardial oxygen demand may actually increase in the setting of VA ECMO.\r\n\r The Impella® device is a miniature rotary blood pump which can be inserted retrograde across\r the aortic valve. In this configuration, it withdraws blood from the LV and ejects it into\r the ascending aorta. It unloads the left ventricle, reducing LV wall tension and myocardial\r oxygen demand and increasing myocardial blood flow. The Impella® 5.0 is an FDA approved pump\r designed for intermediate support in patients with severe, cardiogenic shock. The axillary\r positioning allows for early extubation and ambulation and is more stable than groin\r placement.\r\n\r In present practice, the decision to place an Impella® pump in VA-ECMO patients is based on\r the perceived need for direct LV unloading or when a bridge device is required to transition\r off ECMO support. Patients with peripheral VA ECMO are managed with inotropic agents at the\r beginning and once patients develop pulmonary edema mechanical LV unloading is considered\r electively. The advantage of LV unloading with Impella® has been demonstrated in recent\r studies. We also reported that concomitant implantation of Impella® with VA ECMO for LV\r unloading resulted in improved survival and recovery of ventricular performance in patients\r with cardiogenic shock. Compared to delayed elective LV unloading, early LV unloading could\r lead to decreased pulmonary edema, improved oxygenation delivery to the myocardium, increased\r chance of LV recovery and improved survival.\r\n\r The objective of this prospective study is to assess whether the early direct ventricular\r unloading using axillary Impella® leads to higher rates of cardiac recovery, defined as\r survival free from mechanical circulatory support, heart transplantation or inotropic support\r at thirty days, compared with the conventional, elective placement of Impella® after\r developing significant pulmonary congestion.\n\n**Clinical Trial Detailed Description:**\n\nThis prospective, single-arm trial will include all consecutive patients undergoing\r cannulation of peripheral VA ECMO at the Massachusetts General Hospital (MGH) from April 2019\r to March 2020. All enrolled patients will undergo surgical placement of Impella® via axillary\r artery within 48 hours after peripheral VA ECMO initiation and be managed with early\r extubation and ambulation strategy.\r\n\r After Impella® placement, there will be no research procedures performed. Subjects will\r receive standard of care and the subject's progress will be documented throughout the 30 days\r study follow-up. The data obtained from the electronic medical record in Epic health record\r system at MGH will be reviewed throughout the study.\r\n\r The primary outcome of this study will be survival at 30 days. Prespecified secondary end\r points will include the rate of death from cardiovascular causes, New York Heart Association\r (NYHA) functional class, LV function (assessed by echocardiography), and the rate of stroke,\r neurological functional status, acute kidney injury, vascular complications, and bleeding.\r\n\r The enrolled subjects (early Impella®) would be compared with patients who underwent current\r elective placement of Impella® after cannulation of VA ECMO (elective Impella®) in the past\r two years. Student's t-test (for continuous variables) or Fisher exact test (for categorical\r variables) will be used for between-group comparisons. The primary endpoint in the data\r analysis is binary: 30-day survival. The null hypothesis of no difference between early\r Impella® and elective Impella® will be tested using logistic regression. The secondary\r endpoint, the rate of death from cardiovascular causes, NYHA functional class, LV function,\r and the rate of stroke, neurological functional status, acute kidney injury, vascular\r complications, and bleeding, will be addressed using competing risks hazard regression\r models. This is a pilot study for the future multicenter study. If this study demonstrates no\r inferiority or any significant superiority, we will proceed to do multicenter prospective\r study. Power analysis will be assessed based on the result of this preliminary study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥18\r\n\r - Impaired LV systolic function with ≤35% of left ventricular ejection fraction (LVEF)\r\n\r - Enlarged LV with ≥50mm of left ventricular diastolic diameter (LVEDD) on\r echocardiogram\r\n\r Exclusion Criteria:\r\n\r - Non-cardiac etiology\r\n\r - Surgically correctable cardiac abnormality\r\n\r - Recent significant pulmonary embolism\r\n\r - Severe pulmonary hypertension\r\n\r - Acute aortic dissection\r\n\r - Presence of mechanical aortic valve prosthesis\r\n\r - Presence of left ventricle thrombus\r\n\r - Pre-existing Impella® 5.0\r\n\r - Critical aortic stenosis\r\n\r - Uncorrectable system malperfusion under ECMO support\r\n\r - Significant cerebrovascular accident\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
726
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComparative Imaging Assessment of Valvular Heart Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to compare the various 2D and 3D methods of valvular heart\r disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac\r magnetic resonance (CMR) measurements of left and right ventricular systolic function strain\r and myocardial fibrosis assessment.\n\n**Clinical Trial Detailed Description:**\n\nThe objective of this study is to compare the accuracy of 3D TTE to 2D TTE in assessing the\r severity of valvular heart disease in patients with aortic stenosis, aortic regurgitation,\r and mitral valve regurgitation by comparing this to the reference standard of cardiac\r magnetic resonance (CMR) in subjects with different etiologies and mechanisms of valvular\r lesions and to the integrative method of valvular lesion grading as recommended by\r inter-societal guidelines. Another objective is to assess prevalence of focal and diffuse\r myocardial fibrosis as assessed by CMR in patients with aortic stenosis, aortic regurgitation\r and mitral regurgitation. In addition, the investigators aim to determine whether severity of\r myocardial fibrosis predicts onset of symptoms, referral for valve surgery and adverse\r ventricular remodeling. The investigators also aim to look at patients who will be undergoing\r CRT implant to predict their response to therapy.\r\n\r At baseline, the Rapid Assessment of Physical Activity questionnaire and the Kansas City\r Cardiomyopathy Questionnaire will be completed. A 6 month follow-up is required and will\r include an abbreviated non-contrast research cardiac MRI and subject questionnaires. At 1\r year, subject questionnaires will again be required.\r\n\r Other follow-up will include using electronic medical records and the Social Security Death\r Index database for outcomes such as death, hospitalization for heart failure, mitral or\r aortic valve interventions and cardiovascular death.\r\n\r Select patients will be asked to undergo a supine bicycle exercise stress MRI at enrollment.\r Approximately 40 subjects will be included in this substudy.\r\n\r Additional exclusion criteria for this substudy:\r\n\r - Unable to pedal a supine bicycle\r\n\r - Require supplemental oxygen\r\n\r During the exercise stress MRI, patients will be asked to cycle on a supine bike that will be\r mounted on the MRI platform. During this test, a caregiver will be present. An\r electrocardiogram (ECG) will be used to obtain tracings of cardiac activity. Respirations,\r blood pressure, and heart rate are also monitored during exercise. The test is continued\r until peak exercise level or target heart rate is achieved. As soon as the exercise portion\r is complete, MRI images will be acquired. When the test is complete, patients will be\r monitored until ECG, heart rate, and breathing have returned to baseline. Patients will be\r assessed for symptoms such as chest pain, dyspnea, leg pain, dizziness, or fatigue and may be\r given medications or instructed to stop the test early as necessary.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18-90 years of age\r\n\r - Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history\r or clinical exam.\r\n\r - Suspected CRT \"non-responder\" with an implanted MRI compatible CRT device and reduced\r ejection fraction\r\n\r Exclusion Criteria:\r\n\r - Acute traumatic cardiac injury\r\n\r - Aortic dissection or aortic root rupture\r\n\r - Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD\r and VSD\r\n\r - Presence of A-V fistula or intracardiac shunts\r\n\r - Any contraindications to CMR\r\n\r - Moderate or severe dysfunction in multiple valves\r\n\r - Patients with significant claustrophobia\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
727
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRuling Out Coronary Artery Disease and Myocardial Injury by Biomarkers\n\n**Clinical Trial Summary:**\n\nA considerable proportion of patients with clinically suspected coronary artery disease (CAD)\r do not have angiographic signs of luminal narrowing caused by coronary atherosclerosis. In\r patients with suspected CAD, we will assess the ability of cardiovascular biomarkers to\r identify patients with (a) angiographically normal epicardial coronary vessels (b) absence of\r significant epicardial coronary stenosis, as assessed by coronary computed tomography\r angiography (CCTA). Patients will be stratified according to the presence or absence of\r dynamic changes of high sensitivity cardiac troponin T levels above the 99th percentile.\n\n**Clinical Trial Detailed Description:**\n\nThis is an observational study of patients with suspected coronary artery disease referred to\r coronary computed tomography angiography (CCTA). The plan is to include 1000 patients prior\r to CCTA at two centers.\r\n\r Blood samples for biomarker measurement will be obtained prior to the procedures. The\r diagnostic results of the imaging tests will be compared to the levels of circulating\r troponins. Patient will be followed for a minimum of 12 months and the incidence of\r cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart\r failure, stroke and cardiac arrhythmias requiring rehospitalization. Symptoms of angina\r pectoris according to the Canadian Cardiovascular Society grading of angina pectoris and\r symptoms of chronic heart failure according to the New York Heart Association classification\r of chronic heart failure will be recorded.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Consenting patient over the age of 18 referred to CCTA for suspected coronary artery\r disease\r\n\r Exclusion Criteria:\r\n\r - Inability to provide informed consent.\r\n\r - Short life expectancy (<12 months) due to non-cardiovascular disease\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
728
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement\n\n**Clinical Trial Summary:**\n\nTo demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the\r risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement\r (TAVR).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject has documented aortic valve stenosis and is treated with an approved TAVR\r device via transfemoral access\r\n\r - Subject has the recommended artery diameter at the site of filter placement per the\r Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the\r brachiocephalic artery and 6.5-10 mm in the left common carotid artery.\r\n\r - Subject (or legal representative) provides written informed consent.\r\n\r Exclusion Criteria:\r\n\r - Subject has arterial stenosis >70% in either the left common carotid artery or the\r brachiocephalic artery.\r\n\r - Subject's brachiocephalic or left carotid artery reveals significant stenosis,\r ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic\r ostium.\r\n\r - Subject has compromised blood flow to the right upper extremity.\r\n\r - Subject has access vessels with excessive tortuosity.\r\n\r - Subject has uncorrected bleeding disorders.\r\n\r - Subject is contraindicated for anticoagulant and antiplatelet therapy.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
729
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIdentification of Genetic Causes of Calcific Aortic Valve Disease\n\n**Clinical Trial Summary:**\n\nThis study aims to identify the molecular genetic causes of the variability in development of\r calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated\r aortic dilation.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with a plan to undergo elective aortic valve replacement and/or ascending\r aortic surgery\r\n\r Exclusion Criteria:\r\n\r - Age < 20 years\r\n\r - Unable/unwilling to consent\r\n\r - History of aortic valve replacement or transcatheter aortic valve replacement (TAVR)\r\n\r - History of endocarditis\r\n\r - History of rheumatic fever\r\n\r - History of chest radiotherapy\r\n\r - History of organ transplant\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
730
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nArterial Composition and Cardiovascular Outcome in DIabeteS\n\n**Clinical Trial Summary:**\n\n1. People living with type 2 diabetes are told that they have a significantly higher risk of\r developing a disease related to the heart or blood vessels. These diseases can play a major\r role for the overall health of the patient and can even cause death due to a blood clot in\r the heart, brain or other parts of the body. Understandibly, this information can cause a\r great deal of stress and anxiety for the patient.\r\n\r As of today a doctor can not determine which patient has a higher risk of disease in the\r Heart and blood vessels. Therefore, we see a great need for further exploration of the\r mechanisms that could help identify diabetic patients with a particularly high risk of\r developing these diseases.\r\n\r In this PhD project we aim at identifying diabetic patients with a specific pattern in the\r amount of proteins in the blood, tissue and genetic material who are at high risk of death or\r disease related to the heart and blood vessels. We explore this problem from two angles.\r\n\r In the first part of the PhD study, we identify and measure proteins, which are related to\r high risk of disease in the heart and blood vessels. These proteins come from the blood\r vessels (a specific part called the basement membrane) and are believed to be present in a\r higher concentration, when people have diabetes. At the same time, we measure the same\r proteins in a blood sample from the patients, and we also examine their genetic properties\r with a focus on specific genetic areas.\r\n\r All the tissue and blood samples have already been collected from patients, who have\r undergone a by-pass operation in the Heart at Odense University Hospital since 2008. All of\r the material is stored in a biobank (Odense Artery Biobank).\r\n\r We also collect data from Statictics Denmark about each individual. These data are used to\r categorize people into risk categories.\r\n\r We then hope to see a pattern in the measurements from the laboratory that match the risk\r profile of the patient.\r\n\r In the second part of the study we use a different approach. Data from a large study done on\r the population of Malmö, Sweden, can be used to examine the Development of blood vessels in\r diabetic patients.\r\n\r In this study healthy people from Malmö have undergone a number of examinations in the early\r 1990'ies and again 15 years later. One of the tests was an ultrasound of the large blood\r vessel on the neck, the carotid artery. With this ultrasound we are able to measure the\r thickness of the wall of the blood vessel and the diameter in which the blood can pass\r through.\r\n\r We think that there is a connection between diabetes and the diameter of the blood vessel and\r that, over time, diabetes can cause the blood vessel to become narrower. This idea links the\r two studies because the same proteins that can be found in the first study are important in\r determining the risk of having a narrow blood Vessel when the patient has diabetes.\r\n\r 2.\r\n\r This project can contribute with a deeper knowledge about the linking mechanisms between\r diabetes and disease in the heart and blood vessels: which proteins are present in higher\r concentration? How does this relate to a higher risk? How do diabetic blood vessels change\r over time? We will aim at answering these questions.\r\n\r With regards to clinical practice, we see several perspectives:\r\n\r - deeper knowledge and understanding of the mechanisms behind the diasease in the heart\r and blood vessels that follows diabetes\r\n\r - development of a new blood test. Over time, the proteins measured in this study could be\r developed to a new blood test that gives information about a patients risk of developing\r a diasease in the heart or blood vessels\r\n\r - better treatment for patients with diabetes because aptient with high risk can be\r treated more intensely\r\n\r In order to achieve the goals of this project there are several overall tasks:\r\n\r - select patients form the biobank, that are suitable for the project (the correct type of\r tissue and blood sample available)\r\n\r - do work in the laboratory. This includes cutting and preparing tissue, analyzing the\r tissue and blood samples, implementing new methods for analysis etc.\r\n\r - collect clinical data form Statistics Denmark. This process can be quite detailed and\r time consuming.\r\n\r - obtain data from 'The Diet and Cancer Study' in Sweden, Malmö\r\n\r - analyze data from study 1\r\n\r - analyze data from study 2\r\n\r - write articles\r\n\r - collect all parts of the projects in the final thesis\n\n**Clinical Trial Detailed Description:**\n\nPhD project description\r\n\r The arterial wall in patients with diabetes: Do changes in arterial basement membrane\r proteins predict future arterial disease? Are remodeling processes altered?\r\n\r Applicant: Anne-Sofie Faarvang Thorsen1, MD\r\n\r Main supervisor: Professor Lars Melholt Rasmussen1\r\n\r Co-supervisors: Assoc. Professor Michael Hecht Olsen2\r\n\r Assoc. Professor Martin Overgaard1\r\n\r Collaborators: Director Morten Karsdal, Nordic Bioscience3\r\n\r Consultant Lars Peter Riber4\r\n\r Professor Peter Nilsson5\r\n\r 1: Department of Clinical Biochemistry and Pharmacology, Odense University Hospital. 2:\r Department of Internal Medicine, Holbaek Hospital, University of Southern Denmark. 3: Nordic\r Biosciences 4: Department of Heart, Vascular and Thoracic Surgery, Odense University Hospital\r 5: Malmö Diet and Cancer Study, Malmö, Sweden\r\n\r Project description Cardiovascular diseases (CVDs) occur frequently among individuals with\r type 2 diabetes mellitus (T2DM), and the mortality after cardiac interventions and\r cardiovascular events is significantly increased in T2DM. We have recently identified a\r series of distinct molecular alterations in non-atherosclerotic parts of the arterial tree in\r diabetes, which represent elements of the generalized diabetic vascular pathology. Whether\r these generalized diabetic alterations are related to the development of clinical\r cardiovascular diseases is not known.\r\n\r Overall hypothesis Our overall hypothesis is that specific arterial protein alterations,\r particularly related to basement membrane molecules as seen in T2DM, are followed by\r dysfunctional vessel remodeling (inward instead of outward). Such changes may provide the\r background for lumen reduction in relation to atherosclerosis build-up in diabetes and\r explain the high incidence of CVDs among these patients.\r\n\r Aims and study designs\r\n\r In this ph.d.-project, we will test two aspects of this hypothesis with the following aims:\r\n\r 1. We will determine if the presence of a diabetic arterial protein pattern predicts future\r incidence of cardiovascular events and occurrence of lumen reduction and ultimately\r occlusion in the repair vessel (left internal mammary artery (LIMA)) after by-pass\r operations.\r\n\r We will quantitate specific arterial basement membrane proteins by targeted proteome\r analysis in non-atherosclerotic human arterial tissue (the repair artery from coronary\r by-pass operations) and in plasma by immunoassays from a large group of coronary by-pass\r patients with or without T2DM. We will determine if the concentration of these\r components in a follow-up study predicts occlusion (clinical proxy for lumen reduction)\r of the repair vessel itself, the incidence of cardiovascular events and/or the\r development of diabetic small- and large vessel disease.\r\n\r 2. We will determine if dysfunctional arterial remodeling occurs in T2DM or subjects with\r impaired fasting glucose in relation to plaque build-up in the carotid artery We will\r therefore identify the influence of T2DM on the relationship between the amounts of\r atherosclerosis, remodeling (luminal size and wall thickness) and blood pressure in\r previously scanned individuals from the Malmö Diet and Cancer Study.\r\n\r Perspective The results will provide important information about whether arterial matrix\r changes in diabetes are involved in the development of cardiovascular symptoms and, moreover,\r determine if dysfunctional remodeling occurs in diabetes.\r\n\r Such pathophysiological insight is a prerequisite for:\r\n\r - better biomarkers for diagnosing and stratifying T2DM patients with risk of arterial\r disease\r\n\r - development of new targets for treatment of large-vessel complications in diabetes\r\n\r Background T2DM is a severe illness that results in affection of various organ systems,\r including the cardiovascular system (1). Diabetes is a global threat that affects every part\r of the world. The number of people suffering from T2DM is increasing and is expected to rise\r to more than 350 million people worldwide in the year 2030 (2). Patients with T2DM have\r increased risk of morbidity and mortality of CVDs such as stroke and acute myocardial\r infarction (AMI) and have a shorter life expectancy (3, 4). Diabetes also increases the risk\r of microvascular complications such as diabetic retinopathy (5).\r\n\r Arterial tissue is affected by diabetes. The arterial pathology includes changes in the\r extracellular matrix, increased arterial stiffness, dysfunctional remodeling (6) ,\r endothelial dysfunction and accelerated atherosclerosis. It is hypothesized that arterial\r stiffness in diabetic patients with hypertension correlates to endothelial dysfunction (7).\r Patients with T2DM that undergo coronary artery bypass graft surgery (CABG) have an increased\r risk of death compared to non-diabetic patients, as shown in the Swedish SWEDEHEART study\r (8). Diabetes affects long-term survival after CABG, and if the patient has diabetic kidney\r disease or other diabetic vascular complications the difference is even more profound (9).\r The exact mechanisms that link T2DM to CVDs are not fully understood. During recent years, we\r have identified molecular changes in the arterial wall in humans with T2DM. Using microarray\r techniques for RNA-analysis, we found that specific molecular pathways were altered in\r arterial tissue in diabetes. These dysregulated pathways included insulin signaling and\r matrix biosynthesis (10). We also observed that a basement membrane and elastin-related\r molecule called fibulin-1 is present in increased amounts in diabetes (11-13). Afterwards, we\r have been able to show that increased amounts of fibulin-1 in plasma correlates to\r cardiovascular morbidities and predict mortality (11, 13, 14). Recently, we have used\r proteome analysis of human arteries to find arterial proteins with different concentrations\r in diabetic arteries (15).\r\n\r We observed that most basement membrane proteins, and certain proteins related to smooth\r muscle phenotypic states, in combination with other peptides are present in altered\r concentrations in diabetes.\r\n\r As previously mentioned, we only understand some of the processes that link diabetes to the\r development of CVDs. We have yet to determine whether the above mentioned findings are indeed\r involved in the development of clinical CVDs.\r\n\r The overall hypothesis of this PhD-project is depicted in the above figure 1: Metabolic and\r hormonal factors lead to arterial basement membrane changes diffusely in the arterial tree.\r This leads to altered ability of the arterial wall to adapt by outward remodeling as the\r normal consequence to atherosclerosis. On the contrary, inward shrinkage, leading to lumen\r obstructions, occurs. Thus, generalized diabetic arterial matrix changes may ultimately lead\r to arterial lumen obstructions and clinical symptoms coupling molecular changes to\r development of CVDs.\r\n\r Patients with T2DM have elevated serum levels of fibulin-1, elevated expression of elements\r from lamina basalis in the left internal mammary artery, and increased glycation of collagen\r in the arterial wall due to hyperglycemia (13). This may all contribute to the increased\r central arterial stiffness observed in T2DM, which can be assessed by carotid femoral pulse\r wave velocity (cfPWV). Normal aging as well as hypertension is, in the carotid arteries,\r associated with hypertrophic remodeling with increase of both lumen diameter and wall\r thickness, assessed by intima-media thickness (IMT). We have recently demonstrated that\r progression of IMT is associated with the sum of cardiovascular risk factors but with\r different contributions of the individual risk factors in the common carotid artery (CCA) and\r the bifurcation, respectively. However, IMT alone might not fully reflect the remodeling of\r the carotid artery, because lumen may change differently compared to IMT in response to\r certain cardiovascular risk factors. IMT progression is positively associated with most of\r the cardiovascular risk factors, whereas increased lumen is primarily associated with aging\r and hypertension (16). Furthermore, coronary atherosclerosis has been demonstrated to lead to\r inward instead of outward remodeling in T2DM, which might be secondary to the stiffer\r arteries and explain the reverse outcome after percutane coronary intervention (PCI) in T2DM.\r\n\r The PhD-study will consist of two independent substudies, as described below.\r\n\r Study 1\r\n\r Hypothesis We hypothesize that the amount of basement membrane proteins in arterial tissue\r and plasma from patients with T2DM can predict long-term clinical outcome.\r\n\r Patients and methods From most coronary by-pass operations done at OUH for the last 8 years,\r we have secured immediate handling and storing of the repair artery (internal mammary\r artery). The mid-portion of each artery is freed from surrounding tissue, cut, short-time\r formalin fixed and embedded in paraffin. The rest of the tissue is frozen. The tissue is\r stored in \"Odense Artery Biobank\" where tissue and blood samples from patients undergoing\r CABG have been collected continuously since 2008. We will include all patients with available\r tissue in our biobank, which will be approximately 180 patients with T2DM and 420 patients\r without diabetes.\r\n\r Ethical considerations All participants gave written informed consent, and the study was\r approved by the local ethics committees (S-20100044). The clinical studies will be approved\r by the Regional Scientific Ethical Committee for Southern Denmark and all projects will be\r reported to the Danish Data Protection Agency.\r\n\r Targeted proteome analysis on arterial tissue Quantitative targeted proteome analysis based\r on mass spectrometry will be performed on small amounts of arterial tissue using\r modifications of our recently developed protocols. Four sections of paraffin-embedded tissue\r from each patient will be used and targeted proteome analysis will be performed based on the\r methods based both on proteome analysis of the arterial wall (15, 17, 18) and multiplex,\r targeted LC-MS analysis of different proteins in other studies (19, 20).Our proteome analysis\r is based on material from slices of the same formalin-fixed paraffin-embedded (FFPE) tissue\r as used for histology. We will quantitate peptides derived from abundant proteins, where we\r previously found changes in diabetes, i.e. type IV collagen alpha 1 and alpha 2 chain,\r nidogen, biglycan, laminin, and desmin and will furthermore use the amount of alpha-smooth\r muscle actin and vimentin as controls, since no alterations were previously observed in\r patients with T2DM.\r\n\r From these results we will calculate a composite \"Basement membrane risk score\". This score\r is based on that each basement membrane proteins couints for 0, if the concentration is below\r the median and 1 if the concentration is above. The combined basement membrane score is\r calculated as the sum of each of the five proteins, i.e. it can have values between 0 and 5.\r\n\r Quantitative histomorphometric calculations We will quantitate the tissue volume of fibrosis,\r elastin content, smooth cell content and number as previously described Preil et al (15).\r\n\r Plasma measurements of basement membrane proteins We plan to measure the amounts of\r circulating fragments of several of the same proteins as mentioned above, i.e. type IV\r collagen (C4M3a, C4M), biglycan (BGN) and laminin as well as fibulin-1. These assays have\r been developed by Nordic Biosciences. Pilot data on a small group of our combined diabetic\r and non-diabetic patients (n=36) show that the plasma level of these components correlate\r well to HbA1c (C4M3a: r=0.39, p<0.05, C4M2: r=0.36, p<0.05, BGN: r=0.45, p<0.01, Signe Holm\r Nielsen et al, Nordic Bioscience, unpublished).\r\n\r Outcome measurements\r\n\r We will investigate possible associations between plasma and tissue concentrations of the\r specific proteins and several clinical parameters as registered in a 2-8 year follow up\r period after the harvest of arterial tissue. Follow-up parameters will include the following\r three types:\r\n\r 1. Parameters related to the repair vessel, i.e. LIMA lumen size in the latest coronary\r arteriography performed after the operation compared to LIMA lumen size at the operation\r\n\r 2. Parameters related to the heart, i.e. MI, angina, re-CAD, heart failure\r\n\r 3. Parameters related to occurrence of generalized cardiovascular events and diabetic\r complications in the diabetic group.\r\n\r We have available a subfraction of the operated patients with renewed coronary arteriography\r (approximately 35 %). We are aware that this subgroup is biased due to clinical indications\r for renewed arteriography giving competing reasons for a smaller LIMA lumen at the renewed\r arteriography. We will measure lumen size of this internal mammary artery from the coronary\r arteriography and compare it to the size of the vessel at the time of harvest at the\r operation, where it can be measured by histology. Although the two methods may not be equally\r calibrated, we assume that the bias is approximately the same in all patients. In this\r subgroup we will measure correlations between lumen diameter change (or occlusion) and plasma\r and arterial measures of the selected proteins.\r\n\r The following clinical follow-up parameters are registered: all-cause mortality, non-fatal\r myocardial infarction, coronary revascularization, cardiac arrest with resuscitation,\r hospitalization for heart failure or unstable angina pectoris, non-fatal stroke, progression\r of nephropathy or retinopathy. Progression of nephropathy is defined as renal failure\r (defined by the need for chronic dialysis), development of macroalbuminuria or doubling of\r s-creatinine (only above 200uM). Development of retinopathy is defined as proliferative\r retinopathy or macular edema that requires laser therapy, vitrectomy or diabetes related\r blindness (Snellen visual acuity below 0.1). Death is obtained from the Civil Registration\r System. The individual diagnoses, operations and procedure codes are obtained from The Danish\r National Patient Register. P-creatinine and U-albumin-creatinine-ratio is obtained through\r laboratory result database. Our primary end point is defined as a composite of cardiac events\r (MI, coronary revascularization, sudden death, hospitalization for heart failure or angina\r pectors). Event rate are expected to be 2 % yearly (ref), i.e. approximately 60 events out of\r all our 600 patients after the average follow-up time of 5 years.\r\n\r Moreover, we will investigate the associations between plasma and arterial tissue levels of\r the measured components. We will also judge if specific proteins are related to the\r prevalence and incidence of diabetic microvascular disease as defined above (i.e.\r albuminuria, renal insufficiency, retinopathy).\r\n\r Clinical data concerning diabetes debut, medication, biochemical data from time of operation\r and co-morbidities is stored in our database at the time of the operation.\r\n\r Plan for analyses\r\n\r 1. Test whether the \"Basement Membrane Protein Risk Score\" is negatively associated with\r\n\r 1. Lumen size from the coronary arteriography performed in relation to the operation\r\n\r 2. The ratio between lumen size from the renewed coronary arteriography and the one\r performed in relation to the operation using univariate and multivariate regression\r analyses\r\n\r 2. Test whether the \"Basement Membrane Proteins Risk Score\" predicts the composite cardiac\r endpoint (MI, coronary revascularization, sudden death, hospitalization for heart\r failure or angina pectors) using univariate and multivariate Cox-regression analyses\r (primary end point).\r\n\r 3. Test whether the \"Basement Membrane Proteins Risk Score\" predicts the broad composite\r endpoint of all-cause mortality, major cardiovascular events, progression of nephropathy\r or retinopathy using univariate and multivariate Cox-regression analyses\r\n\r Statistical analysis, bioinformatics, estimation of power and sample size considerations Data\r will be analysed using both simple correlation analysis, but also proportional hazard models\r with adjustments for follow-up time and relevant clinical parameters. Fisher's Exact test and\r Chi-square tests will be used to evaluate event rates in groups of patients with high or low\r amounts of specific proteins. The Benjamini-Hochberg method will be used to correct for\r multiple testing, where suitable. Analyses will be done primarily in the total group of\r individuals (n=600) testing for interactions by presence of T2DM, but subgroup analysis in\r diabetic and non-diabetic patients will also be done.\r\n\r Sample size calculation for the primary end point (composite of cardiac events) is calculated\r as follows: We assume that the number and proportion of events will be: BM-score 0: n=50,\r events: 2 %, BM-score 1: n=100, events: 6 %, BM-score 2: n=150, events: 8 %, BM-score 3:\r n=150, events: 10 %, BM-score : n=100, events: 15 %, BM-score 5: n=50, events: 22 %.\r Calculation of the necessary number of individuals needs to find a statistical difference\r between the score 0 group and the score 5 group is 50 in each group.\r\n\r Feasibility and project organization The project is done at the Center for Individualized\r Medicine in Arterial Diseases (CIMA), Center for Clinical Proteomics, and the Department of\r Clinical Biochemistry and Pharmacology at Odense University Hospital. All instruments and\r expertise are available. Methods for proteome analysis of arterial tissue have been\r developed.\r\n\r Anticipated impact of results and perspective Less than ten previous papers, worldwide, have\r reported on the use of proteome analysis on human arterial tissue, most of them with the use\r of material from less than 10 individuals. Previous studies have shown that histological\r signs of dysfunctional remodeling (hypertrophy) in small vessels predict cardiovascular\r events very well (21). However, nothing is known about structural and molecular aspects in\r larger arteries.\r\n\r Results from the proposed study may point out whether the amounts of arterial proteins, known\r to be altered in T2DM, are associated with the development of cardiovascular events.\r Therefore, we will generate new knowledge concerning important molecular pathways, which may\r be causally involved in the development of arterial diseases. The identification of such\r proteins is important for finding new treatment modalities and biomarkers for the development\r of cardiovascular diseases.\r\n\r We expect to be able to show that quantitative alterations of specific proteins and groups of\r proteins in the vasculature and in plasma predict the development of different CVD-outcomes.\r Such findings will strongly support the overall hypothesis that general arterial alterations\r in diabetes are important for the development of cardiovascular diseases.\r\n\r Study 2\r\n\r Hypothesis We hypothesize that patients with T2DM have dysfunctional carotid remodeling with\r more inward remodeling and decrease of lumen diameter. The overall aim is to investigate the\r relative importance of different cardiovascular risk factors for carotid artery remodeling\r assessed by carotid lumen, IMT and cross-sectional area (CA) in CCA and the bifurcation,\r respectively.\r\n\r The specific hypotheses are:\r\n\r 1. The bifurcation vs. CCA will present more inward remodeling as it is more prone to\r atherosclerosis\r\n\r 2. Glucose intolerance and to a higher degree T2DM are associated with a higher degree of\r inward remodeling\r\n\r 3. This higher degree of inward remodeling is associated with increased arterial stiffness\r assessed by cfPWV and changes in lamina basalis assessed by selected markers\r\n\r Patients and methods This study is a substudy to the large Malmö Diet and Cancer Study in\r which carotid artery ultrasound was performed in 3426 middle-aged Swedish men and women in\r 1991-94 (baseline) and again in 2007-12 (re-examination).\r\n\r Statistical analysis, bioinformatics, estimation of power and sample size considerations In\r multiple regression analyses we will test the association between\r\n\r 1. CV risk factors and IMT, lumen, CA and distensibility in CCA and the bifurcation at\r baseline\r\n\r 2. CV risk factors and IMT, lumen, CA and distensibility in CCA and the bifurcation at\r re-examination\r\n\r 3. Changes in CV risk factors and changes in IMT, lumen, CA and distensibility in CCA and\r the bifurcation between baseline and re-examination\r\n\r 4. Serum levels of selected markers of changes in lamina basalis and CV risk factors, cfPWV\r as well as IMT, lumen, CA and distensibility in CCA and the bifurcation at\r re-examination\r\n\r 5. Test for gender, fasting glucose, T2DM, CCA distensibility, cfPWV and selected markers\r of changes in lamina basalis interaction on the above associations.\r\n\r Feasibility and project organization This project will be performed at the Center for\r Individualized Medicine in Arterial Diseases (CIMA), Center for Clinical Proteomics, and the\r Department of Clinical Biochemistry and Pharmacology at Odense University Hospital, Odense,\r Denmark. All instruments are available and expertise is accessible.\r\n\r Anticipated impact of results and perspective The results from study 2 may generate new\r knowledge and a deeper understanding of how T2DM affects the carotid artery, the degree of\r inward remodeling and lumen reduction. This could change the way we treat diabetic patients\r with carotid atherosclerosis, as these patients are at high risk of developing total stenosis\r of the carotid artery. Knowledge of the pathogenesis behind is the key to earlier\r intervention and reduction of risk for the patient.\r\n\r Regarding both studies 1 and 2\r\n\r Practical performance of study 1 and 2 The applicant will take part in proteome analysis and\r histomorphometric analysis of the tissue. All expertise and equipment are available at the\r Department of Clinical Biochemistry and Pharmacology, Odense University Hospital. Data\r analysis will be performed by the applicant and publications will primarily be written by the\r applicant as first author. The applicant will measure lumen of the common carotid arteries\r and of the carotid bulb using stored cine-loop recordings.\r\n\r Expected publications in study 1 and 2\r\n\r 1. Changes in arterial and plasma matrix proteins in relation to the development of\r LIMA-diameters after CABG (Authors: Thorsen, AF, Overgaard, M, Nordic Bioscience, Olsen,\r MH, Rasmussen, LM)\r\n\r 2. Changes in arterial and plasma matrix proteins in relation to cardiovascular mortality,\r Proteome analysis in relation to outcome after CABG (Authors: Thorsen, AF, Nordic\r Bioscience, Olsen, MH, Overgaard, M, Rasmussen, LM)\r\n\r 3. The impact of glucose intolerance and overt diabetes on arterial stiffening,\r atherosclerotic plaques and carotid artery remodelling (Authors: Thorsen, AF,\r Malmø-researchers, Rasmussen, LM, Olsen, MH) These suggestions may be subject to change\r depending on the development of the investigations.\r\n\r Time schedule\r\n\r June 2018 Start proteome analysis in study 1 November 2018 Start data analysis in study 2\r June 2019 Complete study 2 December 2019 Complete proteome analysis in study 1 December 2019\r Begin data analysis in study 1 December 2020 Complete study 1 January-June 2021 Complete\r PhD-study\r\n\r References\r\n\r 1. Gu K, Cowie CC, Harris MI. Mortality in adults with and without diabetes in a national\r cohort of the U.S. population, 1971-1993. Diabetes Care. 1998;21(7):1138-45.\r\n\r 2. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates\r for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5):1047-53.\r\n\r 3. Ergul A, Kelly-Cobbs A, Abdalla M, Fagan SC. Cerebrovascular complications of diabetes:\r focus on stroke. Endocrine, metabolic & immune disorders drug targets.\r 2012;12(2):148-58.\r\n\r 4. Franco OH, Steyerberg EW, Hu FB, Mackenbach J, Nusselder W. Associations of diabetes\r mellitus with total life expectancy and life expectancy with and without cardiovascular\r disease. Arch Intern Med. 2007;167(11):1145-51.\r\n\r 5. Ellis TP, Choudhury RH, Kaul K, Chopra M, Kohner EM, Tarr JM, et al. Diabetic\r retinopathy and atherosclerosis: is there a link? Current diabetes reviews.\r 2013;9(2):146-60.\r\n\r 6. Jensen LO, Thayssen P, Mintz GS, Maeng M, Junker A, Galloe A, et al. Intravascular\r ultrasound assessment of remodelling and reference segment plaque burden in type-2\r diabetic patients. European heart journal. 2007;28(14):1759-64.\r\n\r 7. Bruno RM, Penno G, Daniele G, Pucci L, Lucchesi D, Stea F, et al. Type 2 diabetes\r mellitus worsens arterial stiffness in hypertensive patients through endothelial\r dysfunction. Diabetologia. 2012;55(6):1847-55.\r\n\r 8. Holzmann MJ, Rathsman B, Eliasson B, Kuhl J, Svensson AM, Nystrom T, et al. Long-term\r prognosis in patients with type 1 and 2 diabetes mellitus after coronary artery bypass\r grafting. Journal of the American College of Cardiology. 2015;65(16):1644-52.\r\n\r 9. Leavitt BJ, Sheppard L, Maloney C, Clough RA, Braxton JH, Charlesworth DC, et al. Effect\r of diabetes and associated conditions on long-term survival after coronary artery bypass\r graft surgery. Circulation. 2004;110(11 Suppl 1):II41-4.\r\n\r 10. Skov V, Knudsen S, Olesen M, Hansen ML, Rasmussen LM. Global gene expression profiling\r displays a network of dysregulated genes in non-atherosclerotic arterial tissue from\r patients with type 2 diabetes. Cardiovascular diabetology. 2012;11:15.\r\n\r 11. Cangemi C, Skov V, Poulsen MK, Funder J, Twal WO, Gall MA, et al. Fibulin-1 is a marker\r for arterial extracellular matrix alterations in type 2 diabetes. Clinical chemistry.\r 2011;57(11):1556-65.\r\n\r 12. Cangemi C, Hansen ML, Argraves WS, Rasmussen LM. Fibulins and their role in\r cardiovascular biology and disease. Advances in clinical chemistry. 2014;67:245-65.\r\n\r 13. Hansen ML, Rasmussen LM. Associations between plasma fibulin-1, pulse wave velocity and\r diabetes in patients with coronary heart disease. Journal of diabetes and its\r complications. 2015;29(3):362-6.\r\n\r 14. Skov V, Cangemi C, Gram J, Christensen MM, Grodum E, Sorensen D, et al. Metformin, but\r not rosiglitazone, attenuates the increasing plasma levels of a new cardiovascular\r marker, fibulin-1, in patients with type 2 diabetes. Diabetes Care. 2014;37(3):760-6.\r\n\r 15. Preil SA, Kristensen LP, Beck HC, Jensen PS, Nielsen PS, Steiniche T, et al.\r Quantitative Proteome Analysis Reveals Increased Content of Basement Membrane Proteins\r in Arteries from Patients with Type 2 Diabetes and Lower Levels among Metformin Users.\r Circulation Cardiovascular genetics. 2015.\r\n\r 16. Rosvall M, Persson M, Ostling G, Nilsson PM, Melander O, Hedblad B, et al. Risk factors\r for the progression of carotid intima-media thickness over a 16-year follow-up period:\r the Malmo Diet and Cancer Study. Atherosclerosis. 2015;239(2):615-21.\r\n\r 17. Lyck Hansen M, Beck HC, Irmukhamedov A, Jensen PS, Olsen MH, Rasmussen LM. Proteome\r Analysis of Human Arterial Tissue Discloses Associations Between the Vascular Content of\r Small Leucine-Rich Repeat Proteoglycans and Pulse Wave Velocity. Arteriosclerosis,\r thrombosis, and vascular biology. 2015;35(8):1896-903.\r\n\r 18. Faarvang AS, Rordam Preil SA, Nielsen PS, Beck HC, Kristensen LP, Rasmussen LM. Smoking\r is associated with lower amounts of arterial type I collagen and decorin.\r Atherosclerosis. 2016;247:201-6.\r\n\r 19. Kristensen LP, Larsen MR, Mickley H, Saaby L, Diederichsen AC, Lambrechtsen J, et al.\r Plasma proteome profiling of atherosclerotic disease manifestations reveals elevated\r levels of the cytoskeletal protein vinculin. Journal of proteomics. 2014;101:141-53.\r\n\r 20. Ravnsborg T, Andersen LL, Trabjerg ND, Rasmussen LM, Jensen DM, Overgaard M.\r First-trimester multimarker prediction of gestational diabetes mellitus using targeted\r mass spectrometry. Diabetologia. 2016.\r\n\r 21. Mathiassen ON, Buus NH, Sihm I, Thybo NK, Morn B, Schroeder AP, et al. Small artery\r structure is an independent predictor of cardiovascular events in essential\r hypertension. Journal of hypertension. 2007;25(5):1021-6.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Coronary artery bypass surgery performed at Odense University Hospital\r\n\r - Useful sample of internal mammary artery\r\n\r - Willingness to participate\r\n\r Exclusion Criteria:\r\n\r - Other cardiac surgery performed\r\n\r - Withdrawal of consent\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
731
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems\n\n**Clinical Trial Summary:**\n\nA Multicenter, prospective, non-randomized, non-inferiority trial evaluating the safety and\r clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF\r Transcatheter Heart Valves, implanted in patients with severe aortic stenosis. A comparison\r with the Medtronic EVOLUT R/EVOLUT PRO systems from DIRECT trial.\n\n**Clinical Trial Detailed Description:**\n\nThe aim of this study is to evaluate the 30 day clinical and echo outcomes of Boston\r Scientific ACURATE NEO/TF TAVR and to compare them with outcomes in patients from the DIRECT\r trial treated with the Evolut TAVR system (Evolut R and Evolut PRO), aiming in showing\r non-inferiority of the ACURATE NEO/TF device. Primary endpoint will be device success rate as\r defined by the VARC-2 criteria. Secondary endpoints involve the composite endpoint of early\r safety at 30 days, according to the VARC-2 definitions, specifically all cause mortality,\r cardiovascular mortality, stroke-TIA, acute kidney injury, conduction\r disturbances-arrhythmias, life-threatening or disabling bleeding, myocardial infarction,\r major vascular complication, valve related dysfunction requiring repeat procedure\r (BAV,TAVR,SAVR) as well as the echocardiographic outcomes and valve performance as designated\r by the VARC-2 definitions at 30 days.\r\n\r Study type: Observational, non-inferiority trial\r\n\r Estimated Enrollment: 80 patients\r\n\r Allocation: Non - randomized, all comers\r\n\r Primary Purpose: Treatment\r\n\r Observational Model: Case-Control\r\n\r Condition or disease: Aortic valve stenosis\r\n\r Intervention/Treatment: Device: Boston Scientific ACURATE neoTM transfemoral TAVI system\r\n\r Time Perspective: Prospective\r\n\r Participating centers: Henry Dunant Hospital (Athens, Greece), Hippokration Hospital (Athens,\r Greece), Silesian Center for Heart Diseases (Zabrze, Poland), Athens Naval Hospital (Athens,\r Greece). It is possible that the number of the participating center may change.\r\n\r Methods: Based on an anticipated incidence proportion of 90% for the primary composite\r endpoint of device success at 30 days, the total required sample size amounts to 80 patients.\r Patients treated with the Boston Scientific ACURATE NEO/TF system will be prospectively. All\r patients will be followed for at least 30 days. Event rates will be presented by Kaplan-Meier\r curves. On the basis of previous observations regarding TAVR success rate by VARC 2\r definitions (DIRECT study), the study design uses a predefined non-inferiority margin of Δ =\r 15% for the primary endpoint of device success rate at 30 days. The primary hypothesis is\r non-inferiority of ACURATE NEO/TF TAVR versus Evolut R and Evolut-Pro TAVR (based on the\r results of the DIRECT trial) for the primary endpoint at 30 days. The non-inferiority\r assumption will be tested at a one-sided significance level with a type I error rate\r (a=0.05). Non-inferiority will be met if the lower bound of the one-sided 95% confidence\r interval (CI) of the primary weighted difference of proportions endpoint (weighted average\r test-control) is over -15%. Pre-specified subgroup analyses will be conducted by using the\r appropriate interaction tests contrasting categories of mean gradient, aortic valve area\r (AVA) and left ventricular ejection fraction (>50% vs 50%).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient with severe symptomatic aortic stenosis defined by a mean aortic gradient > 40\r mmHg or peak jet velocity > 4.0 m/s or an aortic valve area (AVA) < 1cm2 or AVA\r indexed to body surface area (BSA) of <0.6 cm2/m2\r\n\r - Patient is symptomatic (heart failure with New York Heart Association (NYHA)\r Functional Class > I, angina or syncope)\r\n\r - Patients are considered at high risk for mortality with conventional surgical aortic\r valve replacement as assessed by a Heart Team consisting of a cardiologist and surgeon\r or as confirmed by a logistic EuroSCORE I > 20% and / or STS score > 8% OR\r\n\r - Over 80 years old OR\r\n\r - Over 65 years old with 1 or 2 (but not more than two) from the following criteria:\r\n\r Liver cirrhosis (Class A or B). Pulmonary insufficiency: VMS<1 liter. Previous heart\r surgery (CABG, vascular surgery). Porcelain aorta. Pulmonary artery systolic pressure >60\r mmHg and high risk for heart surgery. Relapsing pulmonary embolism. Right ventricular\r insufficiency. Thoracic wall injuries that contraindicate an open heart surgery. History of\r radiation therapy of the mediastinum. Connective tissue disease that contraindicates an\r open heart surgery. Frailty/cachexia.\r\n\r - Aortic valve diameter of ≥20mm and ≤2 9mm as measured by echo.\r\n\r - Ascending aorta diameter ≤ 43 mm at the sinotubular junction.\r\n\r - Arterial aorto-iliac-femoral axis suitable for transfemoral access as assessed by\r conventional angiography and/or multi-detector computed tomographic angiography\r (access vessel diameter ≥ 6mm)\r\n\r - Patient understands the purpose, the potential risks as well as benefits of the trial\r and is willing to participate in all parts of the follow-up\r\n\r - Patient has given written consent to participate in the trial\r\n\r Exclusion Criteria:\r\n\r - A known hypersensitivity or contraindication to any of the following which cannot be\r adequately pre-medicated: aspirin or heparin and bivalirudin, ticlodipine and\r clopidogrel, nitinol (titanium or nickel), contrast media\r\n\r - Ongoing sepsis, including active endocarditis.\r\n\r - Any percutaneous coronary or peripheral interventional procedure with a bare metal or\r drug eluting stent performed within 30 days prior to Heart Team assessment.\r\n\r - Echocardiographic evidence of LV or LA thrombus.\r\n\r - Mitral or tricuspid valve insufficiency (> grade II).\r\n\r - Previous aortic valve replacement (mechanical or bioprosthetic).\r\n\r - Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or\r transient ischemic attack (TIA).\r\n\r - Patients with:\r\n\r Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a\r transcatheter sheath.\r\n\r OR Symptomatic carotid or vertebral artery disease (> 70% stenosis).\r\n\r - The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.\r\n\r - Estimated life expectancy of less than 12 months due to associated non-cardiac\r co-morbid conditions.\r\n\r - Creatinine clearance < 20 ml/min.\r\n\r - Active gastritis or gastrointestinal ulcer.\r\n\r - Pregnancy.\r\n\r - Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <\r 20%.\r\n\r - Unicuspid or bicuspid aortic valve.\r\n\r - Mixed aortic valve disease (aortic stenosis and aortic regurgitation> 2+).\r\n\r - Liver failure (Child-Pugh class C).\r\n\r - Severe dementia (resulting in either inability to provide informed consent for the\r study/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits).\r\n\r - Extreme aortic valve calcification and calcific asymmetry (if semiquantively measured:\r grade 4, Agatston score: grade 4 AgS>5000 AU).\r\n\r - Aortic valve area of < 0.4 cm2.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
732
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)\n\n**Clinical Trial Summary:**\n\nPurpose of this prospective, randomized, controlled, multi-center study is to evaluate the\r safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical\r aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis.\r Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For\r TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3\r Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery\r systems will be sued, for SAVR any commercially available surgical bioprosthetic valve.\r Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge,\r 30 day, 6 months (telephone contact) and 1 year.\n\n**Clinical Trial Detailed Description:**\n\nRecent large meta-analyses and a large retrospective study from the STS/ACC TVT Registry\r demonstrated improved survival in female versus male aortic sclerosis patients undergoing\r TAVI despite their advanced age and increased rates of major peri-procedural vascular\r complications, bleeding events and strokes. These gender-related patient profile differences\r have also been present in multicentre cohorts across the world. A recent meta-analysis by\r Siontis et al. showed that TAVI, when compared with SAVR, was associated with a significant\r 13% relative risk reduction in 2-year mortality, a benefit more pronounced amongst females\r and patients undergoing transfemoral TAVI.\r\n\r In a recent meta-analysis, the female-specific survival advantage from TAVI over SAVR was\r explored. Amongst females, TAVI recipients had a significantly lower mortality than SAVR\r recipients, at 1 year (OR 0.68; 95%CI 0.50 to 0.94). Amongst males there was no difference in\r mortality between TAVI and SAVR at 1 year (OR 1.09; 95%CI 0.86 to 1.39). There was\r statistically significant evidence of a difference in treatment effect between genders at 1\r year (p interaction = 0.02). In an attempt to explore the mechanisms for an increased\r mortality rate in women undergoing SAVR, different endpoints were explored in female patients\r exclusively. It was shown that women, undergoing SAVR, having both a higher periprocedural\r mortality, higher rates of bleeding and acute kidney injury, worse patient prosthesis match\r and worse long term recovery of left ventricular function.In the recent PARTNER 3 the\r composite of death from any cause, stroke, or rehospitalization had occurred in 42 patients\r (8.5%) in the TAVI group as compared with 68 patients (15.1%) in the surgery group at 1 year.\r The difference was 6.6% (95%CI -10.8% to -2.3%) and thus exceeded the pre-defined\r non-inferiority margin of 6%.\r\n\r Subgroup analyses of the primary end point at 1 year showed no heterogeneity of treatment\r effect in any of the subgroups that were examined including gender (p=0.27). There were 292\r women included with an endpoint rate of 18.5% for SAVR (men 13.8%) and 8.1% for TAVI (men\r 8.7%), showing a clear trend for an increased benefit of women undergoing TAVI instead of\r SAVR (rate difference -10.4%; 95%CI -18.3% to -2.5%). Nonetheless, the benefits of TAVI were\r preserved in both men and women.Earlier observational and clinical studies indicated an\r increased risk for women undergoing SAVR compared to men while being at a comparable risk for\r TAVI. In a recent meta-analysis of TAVI vs. SAVR in men and women the risk of dying from the\r intervention was reduced by a relative 32% in women (OR 0.38; 95%CI 0.50-0.94) while there\r was no such difference in men (OR 1.09; 95%CI 0.86-1.39). This was mostly documented as being\r the effect of a reduced periprocedural mortality with TAVI (-54%; OR 0.46; 95%CI 0.22-0.96)\r and major bleeding (-57%; OR 0.43; 95%CI 0.25-0.73) while the difference in strokes and acute\r kidney injury did not reach statistical significance. Taken all available scientific data on\r the comparison of TAVI versus open surgery in patients with indication for AVR together it\r remains probable, that independently of the individual surgical risk female patients in\r particular seem to benefit from a non-surgical aortic valve replacement strategy.\r\n\r As the indirect comparisons of the intermediate to low risk outcomes in PARTNER 2/3 suggest a\r favorable risk reduction in women compared to men as described, the investigators believe it\r is timely for a dedicated trial to demonstrate the non-inferiority of TAVI in women compared\r to SAVR and, in case of this being true, whether TAVI is actually superior to performing\r SAVR.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Female patients with severe aortic stenosis as follows:\r\n\r • High gradient severe AS (Class I Indication for aortic valve replacement [AVR]): Jet\r velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg with Aortic Valve Area (AVA) ≤ 1.0 cm^2\r or AVA index ≤ 0.6 cm^2/m^2 OR\r\n\r • Low gradient severe aortic stenosis (Class I/IIa indication of AVR) Jet velocity <\r 4.0 m/s and mean gradient < 40 mmHg and AVA ≤ 1.0 cm^2 and AVA index ≤ 0.6 cm^2/m^2\r with confirmation of severe AS by: mean gradient ≥40 mmHg on dobutamine stress\r echocardiography and/or aortic valve calcium score ≥ 1200 AU on non-contrast CT.\r\n\r AND\r\n\r - NYHA Functional Class ≥ II OR\r\n\r - Exercise test that demonstrates a limited exercise capacity, abnormal BP\r response, or arrhythmia\r\n\r 2. Age ≥ 18 years\r\n\r 3. The study patient has been informed of the nature of the study, agrees to its\r provisions and has provided written informed consent as approved by the Institutional\r Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.\r\n\r Exclusion Criteria:\r\n\r 1. Patient is not a candidate for both surgical and transcatheter aortic valve\r replacement.\r\n\r 2. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV based on 3D\r imaging analysis\r\n\r 3. Iliofemoral vessel characteristics that would preclude safe placement of the\r introducer sheath.\r\n\r 4. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization\r\n\r 5. Aortic valve is unicuspid, bicuspid, or is non-calcified\r\n\r 6. Severe aortic regurgitation (>3+)\r\n\r 7. Any concomitant valve disease that requires an intervention\r\n\r 8. Pre-existing mechanical or bioprosthetic valve in any position (mitral ring is not an\r exclusion).\r\n\r 9. Complex coronary artery disease:\r\n\r - Unprotected left main coronary artery stenosis\r\n\r - Syntax score > 32 (in the absence of prior revascularization)\r\n\r - Heart Team assessment that optimal revascularization cannot be performed.\r\n\r 10. Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within 30 days before randomization\r\n\r 11. Leukopenia (WBC < 3000 cell/mcL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt <\r 50,000 cell/mcL), history of bleeding diathesis or coagulopathy, or hypercoagulable\r states\r\n\r 12. Hemodynamic or respiratory instability requiring inotropic support, mechanical\r ventilation or mechanical heart assistance within 30 days before randomization\r\n\r 13. Hypertrophic cardiomyopathy with obstruction\r\n\r 14. Ventricular dysfunction with lleft ventricular ejection fraction < 30%\r\n\r 15. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or\r vegetation\r\n\r 16. Inability to tolerate or condition precluding treatment with anti-\r thrombotic/anticoagulation therapy during or after the valve implant procedure\r\n\r 17. Stroke or transient ischemic attack within 90 days before randomization\r\n\r 18. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal\r replacement therapy\r\n\r 19. Active bacterial endocarditis within 180 days of randomization\r\n\r 20. Severe lung disease (FEV1 < 50%) or currently on home oxygen\r\n\r 21. Severe pulmonary hypertension (e.g., pulmonary arterial systolic pressure ≥ 2/3\r systemic pressure)\r\n\r 22. History of cirrhosis or any active liver disease\r\n\r 23. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm,\r severe calcification, aortic coarctation, etc.) that would preclude safe passage of\r the delivery system or cannulation and aortotomy for surgical AVR.\r\n\r 24. Hostile chest or conditions or complications from prior surgery that preclude safe\r reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of\r aorta or internal mammary artery to sternum, etc.)\r\n\r 25. Patient refuses blood products\r\n\r 26. BMI > 50 kg/m^2\r\n\r 27. Estimated life expectancy < 24 months\r\n\r 28. Absolute contraindications or allergy to iodinated contrast agent that cannot be\r adequately treated with pre-medication\r\n\r 29. Immobility that would prevent completion of study procedures\r\n\r 30. Currently participating in an investigational drug or another device study.\r\n\r 31. Pregnancy or lactation\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
733
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComparison Different Method Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal\n\n**Clinical Trial Summary:**\n\nFracture of the base of the fifth metatarsal is one of the most common injuries in ankle\r trauma. There are many conservative treatment protocols for fifth metatarsal base fractures\r which have up to 99% success. Short leg cast and walking boot are conservative treatment\r methods that aim to prevent weight-bearing. There are many different conservative treatment\r methods that allow weight-bearing such as an elastic bandage. There was no significant\r difference between cast and symptomatic treatment in the previous studies. Muscle atrophy\r developing after immobilization with cast may adversely affect the daily activities of the\r patient in the first few months. However, there was no study comparing the effect of these\r two treatment methods on ankle muscle strength.\r\n\r In this study, the investigators compared the strength of the ınjured and healthy ankle\r muscle when symptomatic and cast treatment methods are applied to patients with tuberosity\r fractures of proximal fifty metatars. In addition, patients' functional, clinic and\r radiological outcomes were also compared.\n\n**Clinical Trial Detailed Description:**\n\nWe prospectively treated 73 patients with 5th metatarsal base fractures (Zone 1) who came to\r the emergency department. Patients were allocated to a treatment group using an electronic\r random number generator. The generation of an even number randomized the participant to a\r below-knee cast, and an odd number to a double-layered elasticated bandage. In all, patients\r were allocated to wear a double layered elasticated bandage (group 1) applied by S.B and\r patients were given a below-knee cast (group 2) applied by D.K. Duration of both treatments\r were for four weeks and the cast removed in that time in our clinic. This reference form of\r treatment was the same as in previous reports.\r\n\r The non-injured extremity was measured with isokinetic test at initial injury time for\r evaluation of side effect of immobilization after treatment. At that time, patients were\r asked for height, weight and pain scores. Body muscle index was calculated for all patients.\r Tobacco using was also asked.To measure clinical outcomes, using the validated Visual\r Analogue Scale Foot and Ankle (VAS-FA) score [7] and The EuroQol-5D visual analogue scale\r (EQ-5D VAS) score were used [8]. The VAS-FA score ranges from 0 to 100 points: higher scores\r indicate a better functional outcome. EQ-5D VAS score was used as a secondary outcome\r measure: this ranges from 0 to 100. Baseline functional scores were collected at the time of\r consult in the clinic.\r\n\r Both ankle plantar-dorsiflexors and inversion-eversion'strength (peak torque %BW (Body\r Weight)) were measured with an isokinetic dynamometer (Cybex Humac Norm, CA, USA) at\r Isokinetic Test Laboratory of Sports Medicine in the Istanbul Medical Faculty. Test procedure\r was performed by the same investigator (T.Ş) in all cases for ensuring standardization. The\r muscle strength can be defined as the capacity of a muscle to withstand great force.\r\n\r Injured extremity values were compared with non-injured extremity. The non-injured extremity\r was measured at initial injury time for evaluation of side effect of both treatment methods.\r The tests were started with non-injured sides of the patients and measurements at low angular\r velocity. The dynamometer was calibrated at the beginning of each testing session. Subjects\r were tested in prone position and stabilized in the exercise chair as per the manufacturer's\r recommendation. The anatomical axis of the ankle was aligned with the axis of the dynamometer\r while the foot was secured to the foot plate with velcros. Proximal stabilization was\r achieved with the straps at the thigh and calf. In the test, dorsiflexion-plantarflexion and\r inversion-eversion peak torque force (strength) measurements were performed in 3 trials and 3\r tests repetitions at 30 degrees/sec angular speed for both side of the patient.\r\n\r All of the patients were given follow-up appointments at 2, 4, 8, 12 and 24 week interval at\r our clinic. Radiographs were similarly scheduled for 4, 8, and 12 week intervals to assess\r bony healing. However, functional outcomes and isokinetic test was applied also at 24 week\r control. At second visit, isokinetic test was not applied. These studies were started on\r fixed ground and then continued on moving boards. Standard rehabilitation program was given\r for all patients each group included joint mobilizations, passive stretching,\r electrotherapy-ice compression for pain relieving and ankle proprioceptive exercises, as\r considered necessary by same author (T.Ş).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Aged over 18 years\r\n\r - Acute (presented within one week of injury) Zone 1 fractures of fifth metatarsi\r\n\r Exclusion Criteria:\r\n\r - Zone 2-3 fractures\r\n\r - Diabetes mellitus\r\n\r - Osteoporotic bone (T score<-2.5),\r\n\r - History of osteoporotic drug therapy,\r\n\r - Other lower extremity any fracture,\r\n\r - Previous foot surgery or fracture in both lower extremity,\r\n\r - Chronic fracture, pathological fracture,\r\n\r - Aged over 65 years (congruity of muscle strength test)\r\n\r - Open fracture\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
734
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation\n\n**Clinical Trial Summary:**\n\nA single-center, investigator-initiated, single arm interventional study in patients\r undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical\r Center in Rotterdam (NL). Study population will be patients undergoing TAVR with no formal\r indication for oral anticoagulant (OAC) and no dual antiplatelet therapy (DAPT) requirement\r for coronary stents. Primary endpoint is the incidence of leaflet thickening on MSCT after\r three months of edoxaban treatment.\n\n**Clinical Trial Detailed Description:**\n\nRationale: Thromboembolic- and bleeding events can occur after TAVI and can have great\r consequences. There is currently no evidence-based guideline on prevention of thromboembolic\r events after TAVI and the current standard of care with DAPT 3-6 months is based on expert\r opinion. Recently multislice computed tomography (MSCT) studies identified bioprosthesis\r leaflet thickening and impaired leaflet motion after TAVI. The goal of this study is to\r investigate whether in TAVI patients, treatment with edoxaban leads to a reduction in leaflet\r thickening incidence after 3 months and whether it is safe and clinically efficient.\r\n\r Objective: To investigate whether treatment with edoxaban leads to a decrease in incidence of\r leaflet thickening and is clinical efficient and safe.\r\n\r Study design: A single-center, investigator-initiated, open-label, observational study.\r\n\r Study population: Patients undergoing transfemoral transcatheter aortic valve replacement in\r the Erasmus University Medical Center with no formal novel oral\r anticoagulants/vitamin-K-antagonist (NOAC/VKA) indication.\r\n\r Intervention (if applicable): Patients will be treated with edoxaban for a period of 3 months\r following TAVI. Afterwards they will switch to acetylsalicylic acid.\r\n\r Main study parameters/endpoints: The incidence of leaflet thickening on MSCT 3 months after\r TAVI and edoxaban treatment.\r\n\r Nature and extent of the burden and risks associated with participation, benefit and group\r relatedness: Thus far edoxaban has proven to be safe and non-inferior to treatment with\r warfarin in several indications. The role of anticoagulant agents in TAVI still has to be\r unravelled. Subjects participating in this trial are possibly at higher risk for bleeding\r complications than patients being treated with dual antiplatelet therapy after TAVI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Completed successful elective TAVI for severe native aortic valve stenosis with any\r commercially-available transcatheter heart valve (THV).\r\n\r - Correct positioning of a single prosthetic heart valve\r\n\r - Device success, defined by:\r\n\r - Mean aortic valve gradient < 20 mmHg\r\n\r - Peak transvalvular velocity < 3.0 m/s\r\n\r - Aortic valve regurgitation of 2 or less\r\n\r - No periprocedural complications.\r\n\r - No overt stroke\r\n\r - No uncontrolled bleeding\r\n\r - No major vascular complication defined by the Valve academic research committee 2\r (VARC-2) consensus\r\n\r - No formal indication for oral anticoagulation\r\n\r - Prevention of thromboembolic complications in patients with atrial fibrillation\r\n\r - Prevention for recurrent venous thromboembolism\r\n\r - Prevention for recurrent pulmonary embolism\r\n\r Exclusion Criteria:\r\n\r - History of life-threatening or major bleeding event ≥ Bleeding academic research\r committee (BARC) 3b definitions within the last year.\r\n\r - Conditions with a high risk of bleeding\r\n\r - Active peptic ulcer or upper gastrointestinal bleeding (< 3 months)\r\n\r - Malignancy with high risk of bleeding\r\n\r - Recent unresolved brain of spinal injury\r\n\r - Spinal or ophthalmic surgery within last 3 months prior to enrolment\r\n\r - Intracranial haemorrhage\r\n\r - Esophagal varices\r\n\r - Arteriovenous malformations with high risk of bleeding\r\n\r - Vascular aneurysms\r\n\r - Major intraspinal or intracerebral vascular abnormalities\r\n\r - Hypersensitivity or contraindications to edoxaban\r\n\r - No percutaneous coronary intervention within 6 months prior to randomization\r (requiring DAPT after TAVR)\r\n\r - Dialysis-dependency or glomerular filtration rate < 30 mL/min at time of enrollment\r\n\r - Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <\r 50.000 cells/UL), thromboasthenia, haemophilia or von Willebrand disease\r\n\r - Patients unable to adhere to or complete the investigational protocol for any reason\r including but not limited to geographical residence, psychiatric condition or\r life-threatening disease\r\n\r - Pregnant or breast-feeding subjects\r\n\r - Current participation in clinical trials that potentially interfere with the current\r study\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
735
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRight Ventricular Pacing in Pulmonary Arterial Hypertension\n\n**Clinical Trial Summary:**\n\nIn pulmonary arterial hypertension (PAH), progressive pulmonary vascular remodeling leads to\r supraphysiologic right ventricular (RV) afterload. Pharmacologic trials have shown that\r aggressive upfront treatment reversing pulmonary vascular remodeling successfully increases\r RV function and improves survival. To date, however, there are no proven treatments that\r target RV contractile function.\r\n\r Echocardiographic studies of RV dysfunction in the setting of pressure overload have\r demonstrated intra and interventricular dyssynchrony even in the absence of overt right\r bundle branch block (RBBB).\r\n\r Electrophysiologic studies of patients with chronic thromboembolic disease (CTEPH) at the\r time of pulmonary endarterectomy have shown prolongation of action potential and slowed\r conduction in the right ventricle which has correlated with echocardiographic measures of\r dyssynchrony.\r\n\r Cardiac MRI measures of RV strain in patients with PAH demonstrated simultaneous initiation\r of RV and left ventricular (LV) contraction, but delayed peak RV strain suggesting that\r interventricular dyssynchrony is a mechanical rather than electrical phenomenon.\r\n\r Prior studies of RV dysfunction in an animal model, computer model, congenital heart disease,\r and CTEPH have suggested acute hemodynamic benefits of RV pacing. However, RV pacing has not\r been studied in patients with PAH. Furthermore, it remains unclear if pacing particular\r regions of the RV can achieve a hemodynamic benefit and what cost this hemodynamic\r improvement may incur with regards to myocardial energetics and wall stress.\r\n\r Therefore, the investigators propose to examine RV electrical activation in PAH, map the area\r of latest activation, and then evaluate the hemodynamic and energetic effects of RV pacing in\r these patients.\n\n**Clinical Trial Detailed Description:**\n\nResearch procedures in chronological order:\r\n\r 1. Baseline clinical variables will be prospectively determined and then obtained\r retrospectively from the clinical assessment of individual pulmonary hypertension team\r physicians via chart review. The most recent transthoracic echocardiogram will also be\r evaluated and routine clinical variables including tricuspid annular plane systolic\r excursion (TAPSE), RV fractional area change (FAC), RV outflow tract (OT) and LVOT\r velocity time integral (VTI), and ejection fraction (EF) will be extracted.\r\n\r 2. All patients will have cardiac MRI performed prior to the procedure to allow precise\r measurement of right ventricular volumes as well as LV volumes, RVEF, and LVEF.\r Gadolinium enhancement using gadolinium contrast will be measured.\r\n\r 3. Standard of care right heart catheterization (RHC) will be performed on the day of the\r research procedure.\r\n\r 4. Radial arterial pressure will be used for periprocedural monitoring as well as for\r sampling of arterial oxygen content and arterial oxygen lactate.\r\n\r 5. Myocardial energetics will be assessed via sampling of coronary sinus venous blood with\r measurement of oxygen saturation and lactate.\r\n\r 6. Following the standard of care RHC, endocardial mapping will be performed. After\r pressure-volume measurements are obtained (step 7), pacing will be performed from the\r right atrium (RA), His bundle, and RV at the site of the latest activation with repeat\r measurements of pressure-volume relationships.\r\n\r 7. Once endocardial mapping is complete, a 7-French Millar conductance catheter will be\r placed into the RV and used to obtain pressure-volume data for the RV using the INCA PV\r signal processor. The Valsalva maneuver will be used to generate a series of PV-loops\r reflecting preload reduction subsequently allowing for the calculation of a load\r independent measure of contractility, the end systolic pressure volume relationship\r (Ees). RV afterload will be measured as effective arterial elastance (Ea) and V-A\r coupling will be assessed by the ratio of Ees/Ea. Myocardial energetics will be assessed\r via PV area (PVA) and calculation of the transmyocardial arteriovenous oxygen\r extraction.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients referred for a clinically indicated right heart catheterization to either\r diagnose pulmonary arterial hypertension prior to initiating therapies or monitor\r response to ongoing therapies in patients with diagnosed pulmonary arterial\r hypertension.\r\n\r - Patients with pulmonary arterial hypertension with or without significant right\r ventricular dysfunction as assessed by baseline echocardiography and standard of care\r right heart catheterization\r\n\r - Functional class 2 or 3 symptoms\r\n\r - Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements\r\n\r - English speaking\r\n\r - All patients will be required to have evidence of right ventricular hypertrophy or\r conduction delay (QRS > 130ms) on surface ECG\r\n\r Exclusion Criteria:\r\n\r - Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/\r defibrillators\r\n\r - Functional class 4 symptoms\r\n\r - Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension\r\n\r - Contraindication to right heart catheterization including significant thrombocytopenia\r (platelets < 50,000), coagulopathy (INR > 1.8), or pregnancy as determined by routine\r screening laboratory work\r\n\r - Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart\r catheterization on the day of the study procedure\r\n\r - Pulmonary capillary wedge pressure greater than or equal to 15 mmHg as determined by\r the right heart catheterization on the day of the study procedure\r\n\r - Severe tricuspid regurgitation as determined by baseline transthoracic echocardiogram.\r\n\r - Left ventricular dysfunction (EF < 50%) as determined by baseline transthoracic\r echocardiogram.\r\n\r - Inability to complete cardiac MRI or transthoracic echocardiography\r\n\r - Patients with confounding systemic disease specifically portopulmonary hypertension\r and scleroderma associated pulmonary hypertension\r\n\r - Patients otherwise deemed not appropriate for the study as determined by the study\r investigators\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
736
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery\n\n**Clinical Trial Summary:**\n\nAortic valve sparing operations are applied in patients with a non-calcified tricuspid or\r bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and\r avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis.\r\n\r This results in a normal functioning aortic valve, with a low forward gradient across the\r left ventricular outflow tract.\r\n\r Little is known about how the repaired aortic valve behaves in conditions of controlled\r exercise, and how the gradients across the valve change during exercise.\n\n**Clinical Trial Detailed Description:**\n\nIn a cohort of patients operated on since 2000 with a valve sparing operation for aortic root\r aneurysm in the Department of Cardiac surgery of the University Hospital Ghent, Belgium, and\r with gradients at rest across the aortic valve of <20mmHg, a graded exercise test on a\r bicycle (stepwise increase of afterload) will be performed, and the gradient across the\r aortic valve will be monitored by transthoracic echocardiography at each exercise level.\r Patients with tricuspid and bicuspid valves will be compared. An age matched, unoperated, and\r asymptomatic control group with normal functioning tricuspid and bicuspid valves will be\r examined with the same exercise protocol.\r\n\r The purpose of the study is the description of the gradients across the aortic valve during\r exercise, and the discrimination of risk factors that may induce increased gradients.\r\n\r The hypothesis is that patients with bicuspid valves will demonstrate higher gradients than\r patients with tricuspid valves, in operated and unoperated individuals.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - been operated with a valve sparing root procedure in the University Hospital Ghent,\r Belgium, since 2000\r\n\r - being able to perform an exercise test on a reclining bicycle\r\n\r - normal left ventricular function\r\n\r Exclusion Criteria:\r\n\r - <18 years or >60 years of age\r\n\r - peak gradient across the aortic valve at rest of >20mmHg\r\n\r - decreased left ventricular function\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
737
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Prognostic Impact of Using High-dose Hydralazine in Severe Systolic Heart Failure With Hemodynamically Significant Mitral Regurgitation\n\n**Clinical Trial Summary:**\n\nBackground: Severe systolic heart failure would be complicated with low cardiac output and\r high left ventricular filling pressure and the clinical presentations would be low blood\r pressure, poor peripheral perfusion, and pulmonary edema. Severe systolic heart failure with\r hemodynamically significant mitral regurgitation brings even more challenged since the\r obvious elevation of left atrial pressure induces more pulmonary congestion and backward flow\r of regurgitation in cases with already low cardiac output and poor peripheral perfusion\r complicates more severe of low cardiac output. Surgical interventions in those cases aren't\r strongly recommended due to very high operation risk. In the era of lack of nitroprusside in\r Taiwan (more than 7 years), hydralazine, a direct vasodilator, is a potential substitute for\r treatment of those cases. The advantages of hydralazine include 1) different dosage forms are\r available (10 mg, 25 mg, and 50 mg); 2) short half-life makes it reaching steady blood\r concentration in short period and allow to up- titrate rapidly and also recover fast while\r adverse reaction occurs; 3) it is much cheaper than other evidence-based medications. In this\r study, the investigators try to use rapid up-titration of hydralazine to maximal tolerable\r dose, almost up to 300-400 mg per day, combined with other evidence-based medications in\r cases with left ventricular ejection fraction less than 35% and mitral regurgitation severity\r more than moderate degree and assess the prognostic impact.\r\n\r Objective: Four hundred of patients with severe systolic dysfunction and hemodynamically\r significant mitral regurgitation, who were admitted for intensive care unit for acute\r decompensated heart failure, will be enrolled and the participants will be divided into two\r groups according 1 to 1 randomization process. Control group will receive conventional\r treatment with tolerable maximal dose of evidence-based medications and study group will use\r hydralazine with rapid up-titration, if no clinical adverse responses were noted, following\r by or simultaneously using evidence-based medications. The end-points include in- hospital\r mortality, 3-year all-cause mortality and heart failure rehospitalization.\r\n\r During follow-up period, any adverse response of high-dose hydralazine including lupus-like\r syndrome and arthritis will be monitored.\n\n**Clinical Trial Detailed Description:**\n\nBackground:\r\n\r The investigator team had focused on heart failure (HF) treatment for many years and tried to\r develop non-invasive guide for HF treatment. Initially, the investigators had dedicated to\r use echocardiography to simulate Swan-Ganz and performed validation for non-invasive\r Swan-Ganz (echo Swan-Ganz). Although this method wasn't successful in assessing the full\r spectrum of Swan-Ganz data, the estimates of stroke volume and left ventricular filling\r pressure (LVFP) were reliable and well-validated by comparing with invasive measurements.\r Based on those two data, the investigators could control severe HF patients better and\r conducted a HF special outpatient clinic. Guiding HF treatment by this model was on-going.\r Due to lack of nitroprusside in Taiwan for more than 8 years, some cases with terminal HF\r combined with severe mitral regurgitation or aortic regurgitation were more complicated and\r troubled for management since it might present as even more reduction of forward flow with\r more low cardiac output and high LVFP. High-dose of hydralazine, a direct vasodilator, was\r the solution of our team and it was used to a substitute of nitroprusside. According to the\r preliminary results of previous studies, rapid up-titration of hydralazine to maximal\r tolerable dose, then combined with evidence-based medications, was very effective in patients\r with severe systolic HF and hemodynamically significant mitral regurgitation, especially in\r acute pulmonary edema with critical and unstable conditions. This method is useful for\r reducing regurgitation volume and promoting forward flow after afterload reduction and the\r counterbalance between increasing forward flow and pressure-lowing effect of vasodilator\r brings stable blood pressure without obvious hypotension or poor peripheral perfusion.\r Therefore, it increases the possibility of extubation and reduces the in-hospital mortality\r in those cases. Additionally, the risk of lupus-like syndrome, arthritis, and positive result\r of ANA are relatively lower than those in The East population. However, the exact short-term\r and long-term benefits of high-dose hydralazine in Taiwanese with severe systolic HF and\r significant mitral regurgitation are unknown. The investigators conduct this study to confirm\r our previous observation.\r\n\r Introduction Heart failure, either acute or chronic, is a clinical syndrome caused by a\r structural and/or functional cardiac abnormality, resulting in a reduced cardiac output\r and/or elevated intracardiac pressures at rest or during stress. This means two major\r components associated with HF symptoms are inadequate cardiac output and high filling\r pressure. Although many categories of medications have been approved as therapeutic\r interventions for HF, including beta-blockers, angiotensin converting enzyme inhibitors\r (ACEI), angiotensin receptor antagonists (ARB), mineralocorticoid receptor antagonists (MRA),\r ivabradine, and entresto, the prognosis of HF remains poor, even worse than that of most\r cancers. Up-titration of evidence-based medications to maximal tolerable dosages has been\r recommended, but loop diuretics remain the main stream of HF treatment despite lack of\r evidence of prognostic benefit. In daily practice, diuretics resolve respiratory distress\r with reduction preload and LVFP, but overdiuresis with postural hypotension, renal function\r decline and worsening low cardiac output is not uncommon. Decompensated HF with low blood\r pressure is always difficult to manage, and most evidence-based medications have\r blood-pressure-lowing effect at initiation of treatment. Many physicians do not up-titrate\r those medications to maximal dosages for fear of more reduction of blood pressure, which\r potentially induces adverse events or complications. Therefore, many eligible patients don't\r reach suggested dosage according to guidelines, which may adversely affect prognosis. It\r points out a blind spot of HF treatment that relatively low blood pressure would avoid\r up-titration of evidence-based medications in daily practice of the majority of\r cardiologists. Regarding severe systolic HF with hemodynamically significant mitral\r regurgitation (MR), it is an even more complicated situation because regurgitation will bring\r much lower stroke volume and higher LVFP, which blood pressure becomes low enough to let\r physicians withdrawing any medications with blood-pressure-lowering effect, including\r evidence-based medications. The nitroprusside with powerful vasodilating and short-active\r (rapid conversion after stopping infusion) effects are the solution of this critical\r situation. Unfortunately, this medication was unavailable for more than 8 years in Taiwan.\r\n\r Many short-active medications with vasodilator effect such as captopril and hydralazine have\r potential to be a substitute of nitroprusside in this situation and are suitable for rapid\r up-titration because short half-life brings to achieve steady blood concentration soon.\r Compared to hydralazine, captopril decreases the mortality of advanced HF, mainly sudden\r death, in line with enalpril. But only the form of captopril 25 mg per tab is available in\r Taiwan and one fourth tab three times per day is the common initial regimen.\r\n\r Although ACEIs offer strong prognostic benefit in HF and favorable hemodynamic change, it is\r not so convenient to use in study cohort. Regarding hydralazine, three forms including 10,\r 25, and 50 mg are available. Animal study reveals that it is effective for treatment of\r mitral regurgitation with reduction of peripheral vascular resistance and LVFP, and increase\r of stroke volume and cardiac output. The effect of hydralazine is comparable to nitroprusside\r with a similar reduction in systemic vascular resistance but a slightly greater increase in\r cardiac index, with a lesser fall in mean arterial pressure, mean pulmonary arterial\r pressure, and pulmonary wedge pressure. Hydralazine combined with nitrate had been documented\r useful in chronic heart failure, especially in African or black population, according to many\r publications. Based on the hypothesis that initial low-dose hydralazine with rapid\r up-titration to maximal tolerable dose, following by or simultaneously using other\r evidence-based medications, in acute HF patients with low-cardiac-output and\r low-blood-pressure patients due to severe left ventricular systolic dysfunction and\r hemodynamically significant mitral regurgitation, would bring better outcome compared to\r conventional treatment, the investigators conduct this study to assess short-term and\r long-term prognostic change.\r\n\r Methods Study population: This prospective study will recruit 400 patients aged 18 years or\r older, and hospitalization to E-Da Hospital for acute decompensated heart failure due to\r severe left ventricular systolic dysfunction combined with hemodynamically significant mitral\r regurgitation. Severe systolic dysfunction and hemodynamically significant mitral\r regurgitation are defined as left ventricular ejection fraction less than 35% and mitral\r regurgitant volume more than 45 ml (more than moderate degree), respectively. All\r participants will be randomly divided into two groups according to 1 to 1 fashion. One group\r will receive conventional evidence-based medication with up-titration to maximal tolerable\r dose and another group will receive low-dose hydralazine initially with rapid up-titration,\r if no adverse effect including hypotension with worsening low cardiac output sign, skin rash\r and joint pain occurred. Since the half-life of hydralazine is around 4-6 hours and 3-5\r half-life achieves the steady blood concentration, up-titration of hydralazine will be done\r per 1-2 days. For example, initial dose of hydralazine would be 25 mg tid and the dose would\r be 50 mg bid next day if no adverse effect occurred. Following this rule, one week is enough\r to reach high-dose hydralazine with daily dose of 300-400 mg. According to our prior\r experience of acute HF control, the most patients could tolerate this dose well with\r acceptable peripheral perfusion and blood pressure. This process will follow by or\r simultaneously use evidence-based medications including ACEI/ARB, beta-blocker, and MRA.\r Exclusion criteria include any history of the following: 1) cancer or other significant\r co-morbid diseases with expected life span less than 3 years, 2) any sign of inadequate\r preload such as poor skin turgor, severe thirsty feeling, evidence of gastrointestinal tract\r bleeding or sepsis, 3) adverse effects of hydralazine, 4) surgical interventions of mitral\r regurgitation will be done in follow-up period which change the course of native condition,\r 5) other valvular conditions other than mitral regurgitation with severity more than or equal\r to moderate degree, particularly mitral stenosis, and aortic regurgitation/stenosis, or 6)\r lack of written informed consent. Signs of inadequate peripheral perfusion including downhill\r consciousness level, decreased urine output, and prerenal azotemia will be assessed\r routinely. Histories of hyperlipidemia, hypertension, diabetes and smoking are recorded. The\r endpoints for the current study are in-hospital mortality, 3-year HF rehospitalization and\r 3-year all-cause mortality. All participants will give written informed consent to\r participate in the study, and the study had been approved by the institutional review board.\r\n\r Measurement of hemodynamic change after high-dose hydralazine: Thirty patients in each group\r will be arranged for admission to intensive care unit for severe HF control, and they will\r receive invasive hemodynamic monitor by Swan-Ganz catheter routinely for 1 week. Hydralazine\r will be up-titrated to maximal tolerable dose in hydralazine group at first 7 days and the\r target dose will be 300-400 mg per day. Echocardiographic measurements including stroke\r volume, left ventricular ejection fraction, left atrial size, mitral regurgitation severity,\r mitral regurgitant volume, pulmonary artery systolic pressure, tissue Doppler parameters, and\r left ventricular filling pressure estimated by left atrial expansion index, will be done at\r day 1 and day 7.\r\n\r Maintenance of high-dose hydralazine: After discharge, high-dose hydralazine is maintained\r except any adverse effect and up-titration of other evidence-based medications to maximal\r tolerable dose will be done. The dose of medications is adjusted by clinical signs,\r especially peripheral perfusion, not only simply by blood pressure. If participant had low\r blood pressure (for example, systolic blood pressure less than 90 mmHg) but no sign of\r postural hypotension, or low cardiac output (cold limbs, decreased urine output, dizzy), the\r investigators will keep up-titration of medications. Regarding the initial negative inotropic\r effect of beta blockers, it will be titrated slowly. While any reasons induce postural\r hypotension, the investigator will reduce the dose of hydralazine first and try to keep the\r ordinary dose of other evidence-based medications as possible. If participants would admit\r for recurrent heart failure or other non-cardiovascular problems, ordinary regimen of\r high-dose hydralazine will be maintained unless low blood pressure combined with low cardiac\r output occurs.\r\n\r Monitor adverse effect of high-dose hydralazine: Antinuclear antibody, hematogram and CXR\r will be checked per 6 months. Signs of lupus-like syndrome, serositis, joint pain, skin rash,\r liver biochemical and hematological studies will be monitored regularly. For patients with\r coronary artery disease and ischemic HF, the investigators will take care of any signs of\r worsening myocardial ischemia if chest pain occurs or HF worsens.\r\n\r High-dose captopril will replace hydralazine if any adverse effects of high-dose hydralazine\r are suspected. Echocardiographic measurements: Basic echocardiographic measurements including\r left ventricular ejection fraction, pulmonary artery systolic pressure, left atrial size, and\r tissue Doppler imaging will be done. Echocardiography is performed in all patients. The\r severity of mitral regurgitation will be evaluated quantitatively by regurgitant volume.\r Heart failure patients are admitted with left ventricular ejection fraction less than 35% and\r mitral regurgitant volume more than 45 ml will be enrolled if they are willing to participate\r in. Left atrial volume measurements were calculated using the biplane area-length method\r immediately before mitral valve opening. In all participants, the left atrial volumes were\r indexed to the body surface area. The mitral regurgitation volume is calculated as follows:\r regurgitation volume = (stroke volume of mitral annulus) - (stroke volume of left ventricular\r outflow tract), where the stroke volumes of the mitral annulus and left ventricular outflow\r tract were obtained by multiplying the cross-sectional area by the respective time-velocity\r integral. The mitral regurgitant volumes will be assessed at enrollment, at discharge, and at\r least once per year during follow-up period. Based on our prior studies, the change of LVFP\r assessed by left atrial expansion index will be examined during the course of admission.\r\n\r Biochemical studies and biomarker measurements: Blood samples will be obtained during index\r hospitalization and per 3 months after discharge. The measurements of B-type natriuretic\r peptide, anti-nuclear antibodies, renal function, liver function and hematogram will be done\r regularly.\r\n\r Follow up: The median follow-up will be 3 years and the end-points will be in-hospital\r mortality, 3-year HF rehospitalization and 3-year all-cause mortality. Hospitalization for HF\r is defined as a hospital stay of at least 1 night for treatment of a clinical syndrome with\r at least two of the following symptoms: paroxysmal nocturnal dyspnea, orthopnea, elevated\r jugular venous pressure, pulmonary rales, a third heart sound, cardiomegaly on chest\r radiography, or pulmonary edema on chest radiography. These clinical signs and symptoms might\r have represented a clear change from the normal clinical state of the patient and might have\r been accompanied by either failing cardiac output, as determines by peripheral hypoperfusion,\r or peripheral or pulmonary edema requiring treatment with intravenous diuretics, inotropes,\r or vasodilators. Supportive documentation of a decreased cardiac index, an increased\r pulmonary capillary wedge pressure, decreasing oxygen saturation, and end organ\r hypoperfusion, if available, are included in the adjudication. Follow-up includes medical\r record reviews and patient interviews. Medical assistants will check medical records once per\r 3 months. The certification of death is based on death records, death certificates, and\r hospital medical records.\r\n\r Statistical analysis: The SPSS software will be used for all statistical analyses. All\r continuous variables are presented as means ± standard deviation. A p value of < 0.05 is\r considered statistically significant. Comparisons of clinical characteristics are performed\r by chi-square analysis for categorical variables. Acute hemodynamic changes after high-dose\r hydralazine will be assessed and comparisons of Swan-Ganz and echocardiographic data before\r and after high-dose hydralazine will be performed. Otherwise, comparisons of hemodynamic\r changes between conventional treatment group and hydralazine will also be done. Kaplan-Meier\r curve will be performed to assess the cumulative event-free rate according to different\r treatment strategies. Cox proportional regression analysis of hazard ratio after adjusting\r significant covariates in univariate analyses will be done. Otherwise, multivariate analysis\r will be done to identify the independent prognostic indicators of in-hospital, 3-year HF\r rehospitalization, and 3-year all-cause mortality. ROC curve analysis is also performed to\r assess the sensitivity and specificity of the cut-off points of covariates for predicting\r those events. The frequency of adverse effects of high-dose hydralazine, including positive\r antinuclear antibody, lupus-like syndrome, serositis, arthritis, hematogram change, and\r worsening myocardial ischemia will be assessed. If the strategy of high-dose hydralazine\r combined with conventional evidence-based medications was proved to have prognostically\r beneficial effect, the prognostic impact according to maximal tolerable dose of hydralazine\r will be analyzed. Additionally, high dose of hydralazine will compress the use of other\r evidence-based medications and it is assumed that, compared to conventional treatment group,\r up-titration of those medications becomes difficult in high-dose hydralazine group. The\r effect of counter-balance between high-dose hydralazine and relatively low doses of ACEI,\r ARB, beta blocker and MRA will be assessed by multivariate analysis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - aged 18 years or older\r\n\r - acute decompensated heart failure due to severe left ventricular systolic dysfunction\r combined with hemodynamically significant mitral regurgitation. Severe systolic\r dysfunction and hemodynamically significant mitral regurgitation are defined as left\r ventricular ejection fraction less than 35% and mitral regurgitant volume more than 45\r ml (more than moderate degree), respectively\r\n\r Exclusion Criteria:\r\n\r - cancer or other significant co-morbid diseases with expected life span less than 3\r years\r\n\r - adverse effects of hydralazine\r\n\r - surgical interventions of mitral regurgitation will be done in follow-up period which\r change the course of native condition\r\n\r - other valvular conditions other than mitral regurgitation with severity more than or\r equal to moderate degree, particularly mitral stenosis, and aortic\r regurgitation/stenosis\r\n\r - lack of written informed consent.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
738
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nQuality of Life After Cardiac Surgery\n\n**Clinical Trial Summary:**\n\nDuring the last twenty years heart surgery has become safer and the number of patients having\r heart surgery has increased with more frail patients being offered increasingly complex\r surgery. Heart operations often improve survival and quality of life (QoL), but that is not\r true for all patients. Regarding survival, clinicians can measure the risk to life from\r having a heart operation and the risk to life from not quite precisely, but clinicians have\r little idea about the impact of heart operations on QoL, which is the outcome that patients\r care about most. Clinicians are unable to provide patients with robust information on how an\r operation will affect their QoL. This study will provide this information by analysing the\r data from patient questionnaires immediately before and after the procedure and monthly\r thereafter for 12 months.\n\n**Clinical Trial Detailed Description:**\n\nThe Sponsor shall use existing questionnaires to measure QoL in patients having major heart\r surgery. QoL will be measured before the operation and monthly afterwards for 12 months in\r order to answer the following questions:\r\n\r 1. How does having heart surgery affect the QoL immediately after the operation?\r\n\r 2. How long does it take patients to return to the same quality of life they had before the\r surgery?\r\n\r 3. How long does it take patients to regain any loss of quality of life due to the\r operation? Does quality of life improve thereafter?\r\n\r 4. What proportion of patients will achieve a net benefit in QoL?\r\n\r 5. Are there features that can predict who will benefit in terms of QoL and who will not?\r The Sponsor will use the data to develop an electronic calculator to enable quick and\r robust evaluation of the impact of heart surgery on the QoL of individuals. Patients\r will then be able to give truly informed consent and to decide if they wish have surgery\r based on a full knowledge of both surgical risk and the potential impact on QoL.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6%\r\n\r - Patients undergoing routine/ urgent cardiac surgery\r\n\r - Patients must have the ability to provide informed consent\r\n\r Exclusion Criteria:\r\n\r - Patients undergoing salvage or emergency operations\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
739
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAccuracy of Using 2D Transesophageal Echocardiography Compared to Balloon Sizing in Determining Valve Size During Transcatheter Aortic Valve Implantation\n\n**Clinical Trial Summary:**\n\nThe method of transcatheter aortic valve implantation (TAVI) introduced in 2002 by Alain\r Cribier et al. has offered new prospects for patients with severe aortic stenosis and\r multiple comorbidities, who are at high operative risk(1).\r\n\r The PARTNER series of randomized controlled trials has firmly established the role of TAVI\r with the balloon-expandable Edwards Sapien valve in patients with severe symptomatic aortic\r stenosis (AS) at prohibitive risk of surgery (PARTNER IA), high risk for surgery (PARTNER\r IB), and intermediate risk for surgery (PARTNER 2).(2)\r\n\r Also PARTNER 3 and Evolut Low Risk trial strongly suggest that TAVI is not only a suitable\r alternative and may be superior to surgical aortic valve replacement ( SAVR) in low-risk\r patients.(2)\r\n\r The accurate determination of the size of the implant is dependent on pre-procedural imaging.\r Annular measurements are important in the TAVI as inaccurate estimation can lead to\r complications e.g paravalvular leakage .(3) Transthoracic echocardiography (TTE),\r transoesophageal echocardiography (TOE), multidetector computed tomography (MDCT) and\r magnetic resonance imaging (MRI) have been extensively studied with respect to pre-procedural\r aortic annular sizing.(3).\r\n\r However, even with some of the evidence returning a discrepancy in annular measurements\r between techniques, the literature to date does not clarify whether TOE undersizes\r inappropriately or appropriately with respect to MDCT.(3) In a recent study, 29.5% of\r patients would have been deemed ineligible for TAVI because of overestimation of annular\r measurements by MDCT, a figure reduced to 1.3% with the use of TOE (4)\r\n\r In a recent small retrospective study, TOE, MDCT and MRI all performed comparatively well\r with device sizing. (5)\r\n\r Balloon aortic valvuloplasty (BAV) dilatation before TAVI is considered a mandatory\r procedural step in the early years of TAVR. BAV is used to confirm annular sizing and to\r enhance trans-catheter heart valve (THV) deliverability.(6) However till now there is no\r comparison of annular measurement by 2D transesophgeal echocardiography with balloon sizing.\n\n**Clinical Trial Detailed Description:**\n\nAim of work To compare accuracy of 2D transesophageal echocardiography versus balloon sizing\r in determining size of device during transcatheter aortic valve implantation and inhospital\r outcomes of this approach using 2D TEE and balloon sizing only during TAVI .\r\n\r Patients and methods. The study will include (100) patients, prospective observational study\r\n\r All patient will undergo :\r\n\r 1-Written consent. 2-Detailed history including symptoms (NYHA class) ,co morbidities\r 3-Clinical examination 4-Electrocardiogram (detection of conduction disturbance , ischemic\r changes). 5-Laboratory investigation (hemoglobin level, creatinine, glomerular filteration\r rate(GFR)) 6-Risk stratification: using STS score 6- Transthoracic Echocardiography: (7)\r\n\r 1-Assesment of aortic valve by\r\n\r 1. Mean and maximum pressure gradiant (severe AS if mean pressure >40mmhg and maximum\r pressure >64mmhg) in presence of normal ejection fraction (EF).\r\n\r 2. Aortic valve area by continuity equation (severe AS if < 1cm2).\r\n\r 3. Measurement of aortic valve annulus (in parasternal long axis view) .\r\n\r 4. Assesment of associated aortic regurge (8) :\r\n\r -Regurge jet width/LVOT width (mild <25%,moderate 25-65%, severe >65%)\r\n\r - Vena contracta (VC) (mild <0.3cm, moderate 0.3-0.6cm, severe >0.6cm)\r\n\r - Regurge volume (RV) (mild <30ml, moderate 30-60ml, severe >60ml).\r\n\r - Regurge fraction (RF) (mild <30%, moderate 30-50% and severe > 50%).\r\n\r - Effective regurgitant orifice area (EROA) (mild <0.1 cm, moderate 0.1-0.29cm and\r severe ≥0.3cm) 2- Assesment of EF (by M-mode and simpsons method). 3-Assesment of\r other valves .\r\n\r 7-Transesophegeal Echocardiography.(9):\r\n\r 1. Morphology of valve (tricuspid, bicuspid , unicuspid).\r\n\r 2. Measurement of aortic valve area (AVA) by planimetry.\r\n\r 3. Extent, distribution and location of Calcification. (annular calcification\r symmetrical or asymmetrical, sinuotubular junction , subvalvular\r calcification)\r\n\r 4. Measurement of aortic annulus dimension, LVOT, sinus of valsalva, sinotubular\r junction and ascending aorta dimensions.\r\n\r Determinations of 2D TEE aortic annular and LVOT diameters were performed in the\r 3-chamber long-axis view at approximately the 120◦ angle during early systole . The\r aortic annular diameter was measured from the junction of the aortic leaflet with the\r septal endocardium to the junction of the leaflet with the mitral valve posteriorly,\r using the inner edge to inner edge. The LVOT diameter was obtained 5 mm into the LVOT\r from the level of the annulus.(10) Calculation of a cover index: defined as a 100 x\r (prosthesis diameter - transoesophageal echocardiography annulus diameter)/prosthesis\r diameter. (11).\r\n\r 6- Aortic atheroma: The Katz classification for grading aortic atheromas is as follows:\r Grade 1, normal-appearing intima of the aorta; Grade 2, extensive intimal thickening;\r Grade 3, sessile atheroma protruding <5 mm into the aorta; Grade 4, sessile atheroma\r protruding >5 mm; and Grade 5, mobile atheroma.(12) 7-Associated basal septal\r hypertrophy . 8-Assesment of associated aortic regurge. 8-Pre-TAVI workup in cardiac\r catheterization laboratory:\r\n\r 1. Access route evaluation: assess peripheral vasculature for size, tortuosity,\r calcification -Iliofemoral angiography: A 5F metric (graded) pigtail is used for\r calibration and accurate determination of vessel calibre and minimal lumen\r diameter. The pigtail is placed at the lumber 4/5 level, which approximates a\r position just proximal to the common iliac bifurcation with injection of 15-20mls\r contrast at 20mls/sec.\r\n\r -Iliofemoral diameter: determined by Sheath-to-iliofemoral artery ratio (SIFAR) was\r defined as sheath outer diameter divided by access-side vasculature diameter.\r\n\r -Iliofemoral calcification: Calcification can be evaluated on fluoroscopy and\r graded as: none, mild (spotty), moderate (coalescing), severe (bulky, protruding,\r horse-shoe, circumferential ). Iliofemoral tortuosity : determined by tortuosity\r score which is defined as follows: 0 = no tortuosity; 1 = mild tortuosity (30° to\r 60°); 2 = moderate tortuosity (60° to 90°); and 3 = marked tortuosity (>90°).(13)\r\n\r -Subclavian or axillary angiography if femoral axis is unsuitable.\r\n\r 2. Diagnostic coronary angiography: for assessment of presence and severity of\r coronary artery disease.\r\n\r 3. Aortogram: is done to asses for angle between LVOT and ascending aorta , distance\r of coronary vessels from annulus and presence of aortic regurge.\r\n\r - 5F graded pigtail is placed into the non-coronary cusp (NCC) and an aortogram\r performed (20mls contrast at 20mls/sec). Fluoroscopic projection of RAO 30◦\r and LAO 30◦.\r\n\r 4. Aortic valve cross over: to demonstrate feasibility of crossing valve.\r\n\r 5. Hemodynamic assessment: assess invasive transaortic gradiant with simultaneous\r pressure transduction.\r\n\r - Pigtail will be crossed into the LV cavity, simultaneous measurement of\r pressures from the LV and femoral artery can be obtained. Use of a 5F pigtail\r enables simultaneous pressures to be transduced from the 6F femoral artery\r sheath without the need for a second arterial sheath.\r\n\r 6. Left ventriculogram: assess EF by eyeballing (mild 40-50%,moderate 30-40% and\r severe <30%) and presence of MR according to seller criteria described later on.\r\n\r Left ventriculography is done using 25ml contrast at rate 10ml/second in both RAO\r 30◦ and LAO 60◦\r\n\r 7. Right heart catheterization: assess pulmonary artery (PA) pressure, Pulmonary\r capillary wedge pressure (PCWP).\r\n\r TAVI procedure:\r\n\r The detailed steps of procedure are reported by Nijhoff F,etal. TAVI is performed\r through transfemoral or transapical approach, based on the feasibility of the\r iliofemoral anatomy and suitable access sites. All procedures are performed in a fully\r equipped hybrid cardiac catheterization laboratory. Surgical cutdown is used to close\r the vascular access site at the femoral arteries.\r\n\r Fluoroscopy is used to guide the deployment of the valves and prosthesis positioning.\r Both predilatation of the native valve and prosthetic valve implantation are performed\r during rapid right ventricular pacing (160 to 200 beats/min). Prosthesis position,\r function, and coronary ostia patency are assessed with fluoroscopy and aortography .\r\n\r -Balloon sizing: An appropriately sized valvuloplasty balloon is choiced .The initial\r volume of inflation is set to obtain a balloon size of 1 mm less than the TEE\r measurement. The balloon is positioned across the aortic valve through femoral sheath\r and inflated with the same volume during rapid ventricular pacing, using a 30 cc\r inflation syringe.\r\n\r At full inflation, an aortography is performed. The following parameters are recorded:\r (I) presence of a waist on the balloon at the level of the annulus, (II) intra-balloon\r pressure, (III) patency of the coronary artery ostia and their relations with the\r displaced aortic valve cusps, (IV) presence and entity of aortic regurgitation on\r aortography at full balloon inflation (\"para-balloon leak\"). In the absence of a waist\r on the balloon and/or in case of major para-balloon leak, the procedure is repeated with\r a larger diameter balloon (larger balloon or same balloon inflated with a larger volume\r of contrast media).\r\n\r Assesment of inhospital outcomes after TAVI procedure:\r\n\r 1- paravalvular leakage : Assessment of paravalvular leakage\r\n\r 1-Angiographic evaluation of paravalvular leakage :\r\n\r Ten minutes after the deployment of the prosthetic valve, angiography of the aortic root\r is performed to assess the severity of aortic regurgitation according to Sellers\r criteria (14):\r\n\r (0) no regurgitation.\r\n\r 1. only trace of contrast could be seen in the left ventricle, and it is cleared in\r each systole.\r\n\r 2. contrast filling the entire LV in diastole with less density compared with\r opacification of the ascending aorta.\r\n\r 3. contrast filling the entire LV in diastole equal in density to the contrast\r opacification of the ascending aorta.\r\n\r 4. contrast filling of the entire LV in diastole on the first beat with greater\r density compared with the contrast opacification of the ascending aorta.\r\n\r Two observers independently score the images. In case of discrepancy the images will be\r re-evaluated and consensus will be reached by a third observer. .\r\n\r 2-Transthoracic Echocardiographic study:\r\n\r All patients will be evaluated after TAVI by pre-discharge transthoracic\r echocardiography. The extent of PVL is assessed according to the main VARC criteria\r (15):\r\n\r 1. Semiquantitative parameters\r\n\r 1. Diastolic flow reversal in the descending aorta-pulsed wave : mild (Absent or\r brief) ,moderate ( early diastolic Intermediate), severe (Prominent holodiastolic)\r\n\r 2. Circumferential extent of prosthetic valve paravalvular regurgitation:\r\n\r (0) no regurgitation; (1) mild PVL is defined as<10 % circumferential extent; (2)\r moderate PVL was defined as [>10 % but<30 % of PVL and (3) severe PVL is defined as >30\r % according to the updated VARC guideline , that is the circumferential extent of PVL in\r a parasternal short-axis view (19).\r\n\r 2. Quantitative parameters:\r\n\r 1. Regurgitant volume (ml/beat) mild (<30) , moderate (30-59) ,severe (>60).\r\n\r 2. Regurgitant fraction (%) mild (< 30), moderate (30-49 ) ,severe (>50).\r\n\r 3. Effective regurgitant orifice area (cm2) mild (<0.10) ,moderate (0.10-0.29) ,\r severe (>0.30).\r\n\r 2-Other complication results from inaccurate annular sizing : prosthesis embolization,\r annular rupture, aortic dissection, coronary artery occlusion , conduction defects.\r\n\r 3-Assesment of other complication ,vascular site complication, bleeding, stroke and\r mortality.\r\n\r Statistical analysis:\r\n\r The collected data will be tabulated and statistically analyzed and will be shown in\r tables and figures.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 1-Patients must have severe degenerative high flow AS (echocardiographic criteria:\r aortic valve (AV) effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40\r mmHg, or AV peak systolic velocity of > 4.0 m/s) in presence of normal ejection\r fraction (EF).\r\n\r 2- Patients must be symptomatic from the AS (dyspnea in NYHA-class II or greater,\r angina pectoris, or syncope), or asymptomatic but with decreased left ventricular\r ejection fraction, positive stress test , Pulmonary hypertension (systolic pulmonary\r artery pressure >60 mmHg).\r\n\r 4-Symptomatic patients with severe low-flow, low-gradient (<40 mmHg) aortic stenosis\r with reduced ejection fraction and evidence of flow (contractile) reserve.\r\n\r 3- Patients surviveal time more than one year . 4- Patients have contraindications for\r open chest surgery, such as :\r\n\r 1. Presence of comorbidities not adequately reflected by risk scores.\r\n\r 2. Procelain aorta\r\n\r 3. Squelae of chest radiation.\r\n\r 4. Severe chest deformation or scoliosis.\r\n\r 5. Previous cardiac surgery\r\n\r Exclusion Criteria:\r\n\r 1. Evidence of an acute myocardial infarction 30 days before the intended\r treatment.\r\n\r 2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is\r noncalcified.\r\n\r 3. Mixed aortic stenosis and aortic regurgitation with predominant aortic\r regurgitation > 3+).\r\n\r 4. Hemodynamic or respiratory instability within 30 days of screening\r evaluation.\r\n\r 5. Need for emergency surgery for any reason.\r\n\r 6. Hypertrophic cardiomyopathy with or without obstruction.\r\n\r 7. Severe left ventricular dysfunction with LVEF <20%.\r\n\r 8. Severe pulmonary hypertension and RV dysfunction.\r\n\r 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. .\r 10-A known contraindication to all anticoagulation regimens, or inability to\r be anticoagulated for the study procedure.\r\n\r 11-MRI confirmed stroke or transient ischemic attack within 6 months (180 days)\r of the procedure.\r\n\r 12-Renal insufficiency (creatinine >3mg) and / or end stage renal insufficiency\r requiring chronic dialysis at the time of screening.\r\n\r 13-Estimated life expectancy<12 month.\r\n\r . 14-Severe incapacitating dementia 15-Significant aortic disease, including\r abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or\r greater; marked tortuosity (hyperacute bend), aortic arch atheroma [especially if\r thick (>5 mm), protruding or ulcerated] or narrowing of the abdominal or thoracic\r aorta, severe tortuosity of the thoracic aorta.\r\n\r Also a minimum iliac or femoral artery diameter of less than 6 mm may be deemed\r unsuitable for femoral approach.\r\n\r 16-Severe mitral regurgitation. 17-Annulus size out of range of available\r prosthese (<18mm and >29mm). 18-Untreated coronary artery disease requiring\r revascularization. 19- Elevated risk of coronary ostium obstruction (asymmetric\r valve calcification, short distance between annulus and coronary ostium less than\r 10mm.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
740
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImpact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair\n\n**Clinical Trial Summary:**\n\nIn the present study, the investigators aim to use the in-vivo Transcatheter Mitral Valve\r Repair (TMVR) model to determine how Mitral Regurgitation (MR) affects coronary hemodynamics\r in patients affected with severe MR and concomittant angiographically-documented coronary\r artery disease. The investigators will also provide unique physiologic data on the acute\r effect of TMVR using the MitraClip system on coronary microcirculation in patients with\r severe MR.\n\n**Clinical Trial Detailed Description:**\n\nConsecutive patients with significant degenerative or functional MR planned for TMVR using\r the percutaneous edge-to-edge MitraClip system will be assessed for study eligibility.\r Patients with documented concomitant coronary artery disease, defined as coronary artery\r stenosis of 50% diameter or more in at least 1 epicardial coronary artery, will be informed\r about the study. Written informed consent will be obtained from all patients before enrolment\r in the study.\r\n\r The TMVR procedure will be performed under general anesthesia with fluoroscopy and\r transesophageal echocardiographic guidance using the MitraClip device via a femoral venous\r approach. Cardiac catheterisation and coronary angiography will be undertaken via the\r transradial route, using standard equipment. The hemodynamic data listed below will be\r acquired immediately before and after TMVR.\r\n\r For all lesions, intracoronary blood flow and pressure measurements will be used to generate\r the following intracoronary physiological parameters:\r\n\r - Fractional Flow Reserve, FFR.\r\n\r - Absolute coronary Blood Flow, ABF.\r\n\r - Coronary Flow Reserve, CFR.\r\n\r - Index for Microvascular Resistance, IMR.\r\n\r - Baseline Resistance Index, BRI.\r\n\r - Resistance Reserve Ratio, RRR.\r\n\r - Instantaneous wave-free ratio, iFR\r\n\r Post-procedural evaluation: Patients will be followed up according to local standard clinical\r practice.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age ≥18 years;\r\n\r 2. Patients with significant degenerative or functional MR planned for TMVR with the\r percutaneous edge-to-edge mitral valve repair MitraClip system;\r\n\r 3. Patients with ≥ 1 coronary artery lesion with angiographically-documented ≥50%\r diameter stenosis,\r\n\r 4. Patient willing and able to provide written informed consent.\r\n\r Exclusion Criteria:\r\n\r 1. Previous coronary artery bypass surgery;\r\n\r 2. Presence of ≥1 coronary total occlusion(s);\r\n\r 3. Documented non-viable myocardium in the area of the corresponding coronary artery\r being studied;\r\n\r 4. Severe left ventricular systolic dysfunction (<30%);\r\n\r 5. Cardiogenic shock/hemodynamic instability at the time of intervention (heart rate<50\r beats per minute, systolic blood pressure <90mmHg) and/or need for\r mechanical/pharmacologic hemodynamic support;\r\n\r 6. Systolic pulmonary artery pressure > 70 mmHg on baseline echocardiography;\r\n\r 7. Significant contraindication to adenosine administration (e.g. heart block, severe\r asthma);\r\n\r 8. Extremely calcified or tortuous vessels precluding invasive coronary physiology\r measurement;\r\n\r 9. Acute coronary syndrome with recent ST-elevation myocardial infarction <5 days prior\r to randomization, or ongoing non-ST elevation acute coronary syndrome with biomarkers\r (cardiac troponin) still rising;\r\n\r 10. Hypertrophic cardiomyopathy, restrictive pericarditis, constrictive pericarditis,\r infiltrative cardiomyopathy;\r\n\r 11. Participation or planned participation in another clinical trial, except for\r observational registries;\r\n\r 12. Patients unable or unwilling to provide written informed consent\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
741
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUltra-high-resolution CT vs. Conventional Angiography for Detecting Coronary Heart Disease\n\n**Clinical Trial Summary:**\n\nCardiac catheterization with invasive coronary angiography is the gold standard for\r determining the presence or absence of significant coronary heart disease (CHD). However,\r cardiac catheterization is costly and, as an invasive procedure, it is associated with some\r risk of adverse events, rarely even stroke, myocardial infarction, or death. Recent advances\r in multi-detector computed tomography angiography (CTA) have allowed rapid, noninvasive\r coronary artery imaging in patients with suspected CHD. CTA generally yields high accuracy\r for identifying patients with CHD when compared to cardiac catheterization. However,\r diagnostic accuracy is reduced in the setting of severe coronary artery calcification and\r coronary stents due to its inferior spatial resolution compared to cardiac catheterization.\r Because high-risk patients often have severe coronary calcification or stents, the\r application of CTA has been particularly limited in this important patient group. Recently,\r an ultrahigh-resolution CT scanner was released which has shown promise to overcome the\r limitation of conventional CTA in the setting of severe coronary artery calcification or\r stents. This ultrahigh-resolution \"precision\" CT scanner (UHR-CT) contains detector rows with\r half the width than currently available systems (0.25 mm vs. 0.5 mm) resulting in\r approximately twice the spatial resolution.\r\n\r The purpose of this investigation is to test the hypothesis that high-resolution CTA is not\r inferior to the current standard of cardiac catheterization for identifying significant CHD\r in patients with high-risk characteristics, including severe coronary artery calcification\r and coronary stents.\r\n\r The investigators propose to enroll 43 patients over 24 months in this pilot investigation.\r Patients referred for cardiac catheterization with known CHD and suspected obstructive\r coronary artery stenosis will be included. All patients will undergo both cardiac\r catheterization and UHR-CT for determining significant CHD as defined by coronary functional\r assessment. The primary end point will be the diagnostic accuracy by area-under-curve (AUC)\r method for identifying patients with hemodynamically significant CHD.\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objective The primary objective of this study is to generate preliminary data in\r support of the hypothesis that noninvasive UHR-CT is not inferior to invasive coronary\r angiography by cardiac catheterization for identifying patients with hemodynamically\r significant CHD.\r\n\r Secondary Objectives Secondary objectives include testing the diagnostic accuracy of UHR-CT\r vs. cardiac catheterization on a vessel and segment based analysis, comparison of UHR-CT\r Fractional Flow Reserve (FFR) to conventional angiography, and comparison of adverse events\r and radiation doses between the CT and conventional angiography groups.\r\n\r Patient-Based Hypotheses\r\n\r 1. Diagnostic accuracy of UHR-CT using visual assessment of coronary artery disease is\r non-inferior to invasive, conventional coronary angiography for identifying patients\r with hemodynamically significant CHD defined by an FFR or QFR-value of <0.8 in at least\r one vessel of 2.0 mm or larger in diameter.\r\n\r 2. Diagnostic accuracy of UHR-CT using quantitative assessment of coronary artery disease\r is non-inferior to invasive, conventional coronary angiography for identifying patients\r with hemodynamically significant CHD defined by an FFR-value of <0.8 in at least one\r vessel of 2.0 mm or larger in diameter.\r\n\r 3. Diagnostic accuracy of UHR-CT using CT-FFR is non-inferior to invasive, conventional\r coronary angiography for identifying patients with hemodynamically significant CHD\r defined by an FFR-value of <0.8 in at least one vessel of 2.0 mm or larger in diameter.\r\n\r 4. UHR-CT coronary angiography is associated with lower radiation dose than conventional,\r invasive coronary angiography.\r\n\r 5. UHR-CT coronary angiography is associated with lower adverse effects than conventional,\r invasive coronary angiography.\r\n\r Vessel Based Hypotheses\r\n\r 1. Diagnostic accuracy of UHR-CT using visual assessment of coronary artery disease is\r non-inferior to invasive, conventional coronary angiography for identifying vessels with\r hemodynamically significant CHD defined by an FFR or QFR-value of <0.8 in a vessel of\r 2.0 mm or larger in diameter.\r\n\r 2. Diagnostic accuracy of UHR-CT using quantitative assessment of coronary artery disease\r is non-inferior to invasive, conventional coronary angiography for identifying vessels\r with hemodynamically significant CHD defined by an FFR-value of <0.8 in a vessel of 2.0\r mm or larger in diameter.\r\n\r 3. Diagnostic accuracy of UHR-CT using CT-FFR is non-inferior to invasive, conventional\r coronary angiography for identifying vessels with hemodynamically significant CHD\r defined by an FFR-value of <0.8 in a vessel of 2.0 mm or larger in diameter.\r\n\r Segment-Based Hypotheses\r\n\r 4. Diagnostic accuracy of UHR-CT using visual assessment of coronary artery disease is\r non-inferior to invasive, conventional coronary angiography for identifying arterial\r segments with hemodynamically significant CHD defined by an FFR-value of <0.8 in a\r vessel of 2.0 mm or larger in diameter.\r\n\r 5. Diagnostic accuracy of UHR-CT using quantitative assessment of coronary artery disease\r is non-inferior to invasive, conventional coronary angiography for identifying arterial\r segments with hemodynamically significant CHD defined by an FFR-value of <0.8 in a\r vessel of 2.0 mm or larger in diameter.\r\n\r 3. Background Cardiac catheterization with invasive coronary angiography has remained the\r gold standard for determining the presence or absence of significant coronary luminal\r stenosis despite its limited accuracy compared to the standard of intravascular ultrasound.\r Because of the inherent risks involved with this invasive procedure (e.g., stroke, myocardial\r infarction, death or need for emergency surgical intervention) with a major complication rate\r of 1-2%), and considerable costs, non-invasive assessment of coronary artery disease would be\r preferred. Advances in multi-detector computed tomography angiography (CTA) have made the\r non-invasive imaging of the coronary arterial lumen and wall feasible. Numerous studies have\r since demonstrated good accuracy of CTA to identify patients with obstructive coronary artery\r disease. However, studies also demonstrated that CTA's diagnostic accuracy is only modest in\r patients with severe coronary artery calcification or stents, representing a major limitation\r of the technology. This limitation is due to fair spatial resolution and associated image\r artifacts in the setting of an attenuation-based image reconstruction algorithm. In this\r situation, high density structures, such as calcium or metal, will disproportionally dominate\r information derived from an affected image voxel leading overrepresentation of these\r structures on image display (partial volume effect).\r\n\r Recently, an ultrahigh-resolution CT scanner has been released which has shown promise to\r overcome the limitation of conventional CTA in the setting of severe coronary artery\r calcification or stents. This ultrahigh-resolution \"precision\" CT scanner (UHR-CT) contains\r detector rows with half the width than currently available systems (0.25 mm vs. 0.5 mm)\r resulting in approximately twice the spatial resolution. It is likely that this improvement\r will lead to improved diagnostic accuracy in high-risk patients. To conclusively test this\r hypothesis, a larger, multi-center study is required. The purpose of this investigation is to\r test the feasibility of such study and to generate initial data on the hypothesis that\r high-resolution CTA is not inferior to the current standard of cardiac catheterization for\r identifying significant CHD in patients with high-risk characteristics.\r\n\r 4. Study Procedures\r\n\r a) Study design The CORE (CORonaryEvaluation)-PRECISION Pilot study is a prospective single\r center study of comparing the diagnostic accuracy of UHR-CT to conventional, invasive\r coronary angiography by cardiac catheterization for the presence of hemodynamically\r significant CHD in 43 patients with CHD. For each participant, the screening evaluation\r periods will last less than 60 days and will be followed by the imaging period (less than 60\r days). All patients will be followed by additional 30 days after cardiac catheterization for\r occurrence of adverse events.\r\n\r Screening-Evaluation Period: The screening period will begin when a patient is scheduled for\r a clinically indicated coronary angiogram. The protocol inclusion and exclusion criteria will\r be reviewed for each potential participant. If the patient appears to be eligible for the\r study based on the initial evaluation, informed consent will be obtained. Baseline\r information and medical history will be collected. Blood will be obtained at the time of CTA\r (during intravenous cannula [IV] placement) for laboratory testing of cholesterol profile and\r serum biomarkers. No genetic testing will be performed.\r\n\r The clinically indicated coronary angiogram will not be delayed to complete the research\r protocol. If the CTA scan cannot be scheduled prior to the clinically indicated coronary\r angiogram the patient will not be enrolled in the trial. Consented patients will continue to\r be evaluated for participation in the trial through the imaging period.\r\n\r Imaging Period The imaging period will consist of two tests: 1) ultra-high resolution CT\r (UHR-CT) angiography; 2) conventional coronary angiography (CTA). All enrolled patients\r referred for a clinically indicated catheterization will first a UHR-CT angiogram.\r\n\r UHR-CT Imaging Patients will have one 18-20 gauge intravenous lines placed, preferably in an\r antecubital vein for contrast administration. The patient will be hydrated with normal saline\r intravenously (250 - 500 ml) prior to UHR-CT scanning. The patient will lie supine on the\r scanner table and be attached to a 12 lead electrocardiographic monitor and an automated\r blood pressure monitor. Baseline electrocardiogram (ECG), heart rate, and blood pressure will\r be recorded and reviewed by one of the study investigators. Due to resultant artifacts from\r precordial leads, the 12 ECG leads and electrodes will be removed and rhythm monitoring will\r continue using the 3-lead system attached to the scanners monitoring system during scanning.\r Patients may receive oral metoprolol and/or oral ivabradine 1-2 hours prior to the CT\r according to a hospital approved heart rate control algorithm. Specifically, if the heart\r rate (HR) is >70 beats per minute, 50 mg of oral metoprolol will be given along with 15 mg of\r oral ivabradine. If the heart rate is >65 but lower than 70 beats per minute, 25 mg of oral\r metoprolol will be given along with 15 mg of oral ivabradine. If the heart rate is >60 beats\r per minute but lower than 65 beats, only 15 mg of ivabradine is given. If HR remains >60\r beats per minute after 60 minutes post initial dosing of metoprolol and ivabradine, a second\r doses of 25-50 mg oral metoprolol is given. Scout images for determining scanning range will\r be obtained in the anterior-posterior and lateral views. Patients with systolic blood\r pressure ≥110 will receive 0.8 mg sublingual nitroglycerin for vasodilation. The adequate\r calcium score scan protocol will be confirmed on the scanner for each participant prior to\r the initiation of the calcium score scan. Patients will then be asked to hold patients'\r breath (approximately 10-15 seconds) and non-contrast CT imaging will be performed starting\r just cranial to the coronary ostia and extending just caudal to the apex of the heart in\r order to obtain a coronary calcium score. To limit radiation exposure, a coronary calcium\r score will only be generated for patients who have not previously been stented as the\r presence of stents affects the accuracy of the calcium score. CT angiogram will then be\r performed to evaluate the coronaries using iodine contrast.\r\n\r UHR-CT Protocol for Coronary Angiography\r\n\r 1. If no previous stents, coronary calcium scan will be performed using the following\r protocol:\r\n\r - No contrast.\r\n\r - CT Imaging: tube voltage = 120 kilovolt (kV), tube current = 140 milliAmpere (mA),\r gantry rotation speed = 0.275 seconds, slice thickness = 0.25 mm, rows = 100, range\r = 40 mm. Estimated radiation dose = 1.0-2.5 milli-Sievert (mSv).\r\n\r 2. Coronary arterial imaging Coronary arterial imaging will be performed during a 4-6\r ml/sec intravenous iodinated contrast iohexol (Omnipaque-350) infusion for a total\r volume of 60-100 ml. The automated bolus tracking feature will be used to judge contrast\r bolus arrival and optimize image quality. Bolus tracking will result in approximately\r 0.7-1.2 mSv radiation dose to the patient (weight dependent).\r\n\r Images will be prospectively triggered using ECG gating which reduces radiation exposure to\r the patient compared to retrospective gating. The estimated range of radiation dose for CT\r coronary angiography will be 3.2-8.0 mSv depending on patient size and weight.\r\n\r Total estimated radiation dose, including calcium scoring, bolus tracking, and CT coronary\r angiography, will therefore range between 4.9-11.7 mSv. For comparison, a standard nuclear\r stress test typically results in a radiation dose of 10-12 mSv to the patient. Diagnostic\r cardiac catheterization for conventional coronary angiography typically averages 12 mSv\r radiation dose.\r\n\r CT raw data and reconstructed data will be saved by the site for at least 2 years after\r completion of the study. Within 3 weeks of the CTA, the CTA will be reviewed for non-cardiac\r findings by a locally qualified, institutionally approved radiologist, and reported. The\r investigator will report these findings to the patient's clinical physician and patient in a\r timely fashion preferably prior to or during the 30-day follow-up.\r\n\r A pre-catheterization serum creatinine should be obtained post CTA (per local standard, or\r preferably > 3 days post CTA).\r\n\r Conventional Coronary Angiography Patients will undergo patients' clinically indicated\r cardiac catheterization/coronary angiography, within 60 days of CT imaging with a recommended\r goal of completing all imaging within 30 days. A time window of ≥ 48 hours is recommended\r between CT imaging and conventional coronary angiography to minimize cumulative risk of\r contrast exposure from these two tests. Coronary angiography guidelines to obtain optimum\r angles and images for comparison will be enforced. Isocenter calibration will be performed\r for all studies to enable quantitative flow reserve (QFR) assessment. Intracoronary\r nitroglycerine will be administered (150-200 mcg) prior to first image of the left coronary\r artery system and right coronary artery. This is to standardize the vasomotor state of the\r coronary artery and eliminate any potential for catheter-induced changes (i.e., catheter\r induced spasm).\r\n\r Fractional-flow-reserve (FFR) assessment will be performed as clinically indicated but not\r solely for research purposes. Coronary angiographic images will be saved in the universal\r DICOM format and forwarded to the Angiographic Core Laboratory for Quantitative Coronary\r Angiographic Analysis. Quantitative coronary analysis (QCA) will be performed using standard,\r validated analysis software from Pie Medical Systems. QFR will be performed using a dedicated\r software (QFR, Medis Medical Imaging Systems).\r\n\r A post-catheterization serum creatinine should be obtained per local standard, or preferably\r within 48-72h post invasive coronary angiogram. Primary Objective The primary objective of\r this study is to generate preliminary data in support of the hypothesis that noninvasive\r UHR-CT is not inferior to invasive coronary angiography by cardiac catheterization for\r identifying patients with hemodynamically significant CHD.\r\n\r Secondary Objectives Secondary objectives include testing the diagnostic accuracy of UHR-CT\r vs. cardiac catheterization on a vessel and segment based analysis, comparison of UHR-CT\r Fractional Flow Reserve (FFR) to conventional angiography, and comparison of adverse events\r and radiation doses between the CT and conventional angiography groups.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients aged 45-85 years with history of CHD will be asked to participate. History of\r CHD is defined as prior documentation of a coronary artery stenosis of 50% or greater\r by coronary angiography or by prior documentation of coronary artery revascularization\r by percutaneous coronary intervention (PCI). Women of child bearing potential must\r demonstrate a negative pregnancy test within 24 hours of the study CTA.\r\n\r - Suspected obstructive coronary artery stenosis based on clinical history and/or\r noninvasive testing, prompting a clinical referral for invasive coronary angiography;\r and/or planned PCI within the next 60 days.\r\n\r - Ability to understand and willingness to sign the Informed Consent Form.\r\n\r Exclusion Criteria:\r\n\r - Known allergy to iodinated contrast media\r\n\r - History of multiple myeloma or previous organ transplantation\r\n\r - Elevated serum creatinine (> 1.5mg/dl) or calculated creatinine clearance of < 60\r ml/min (using the Cockcroft-Gault formula\r\n\r - Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular\r block (second or third degree heart block)\r\n\r - Evidence of severe symptomatic heart failure (NYHA Class III or IV);\r\n\r - Known or suspected moderate or severe aortic stenosis\r\n\r - Previous coronary artery bypass or other cardiac surgery\r\n\r - Suspected acute coronary syndrome\r\n\r - Presence of any other history or condition that the investigator feels would be\r problematic\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
742
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nOutcomes of Surgery of Aortic Valve\n\n**Clinical Trial Summary:**\n\nOverall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different\r approaches such as standard aortic valve replacement, aortic valve repair, novel techniques\r as Ozaki's procedure and their subsequent results and complications.\r\n\r - Objective 1: Identify predictors of complications following different types of aortic\r valve surgery accordingly.\r\n\r - Objective 2: Determine the value of each type in terms of advantages and disadvantages.\r\n\r - Objective3: Assess outcomes such as postoperative life expectancy, hospital stay,\r prognosis and quality of life.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with severe symptomatic aortic valve lesion.\r\n\r 2. Asymptomatic aortic insufficiency patients with left ventricular dysfunction or\r significant left ventricular dilatation (LV end diastolic diameter>70 mm or LV end\r systolic diameter>50 mm.\r\n\r 3. Patients with aortic regurgitation caused by:\r\n\r - a dilated aortic annulus\r\n\r - conjoined cusp prolapse in bicuspid aortic valves (BAV)\r\n\r - single cusp prolapse in tricuspid aortic valves\r\n\r - aortic valve cusp perforation from endocarditis\r\n\r Exclusion Criteria:\r\n\r - Patients with previous aortic root or valve surgery.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
743
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAssessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI\n\n**Clinical Trial Summary:**\n\nRationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for\r elderly patients with high surgical risks. Paravalvular leakage after TAVI is relatively\r common and there is conflicting evidence regarding the clinical impact of mild paravalvular\r leakage in self-expanding devices. Prospective data for self-expanding devices are required\r to compare the extent of paravalvular leakage as a result of device design. Grading\r paravalvular leakage after TAVI is difficult. Echocardiography and angiography systematically\r underestimate paravalvular leakage (PVL) as compared to cardiac MRI. Hemodynamic measurements\r are used to aid decision making directly after TAVI implantation. Prospective data comparing\r hemodynamic measurements with cardiac MRI are needed to design an optimal strategy to grade\r paravalvular leakage peri-operatively in order to optimize TAVI outcomes.\r\n\r Objective: To assess procedural hemodynamic measurements in patients with paravalvular\r regurgitation quantified by means of cardiac MRI (CMR) and to analyse its association with\r impaired clinical outcome during 5-year follow-up.\r\n\r Study design: This is a prospective, single center clinical trial. Patients will receive a\r TAVI. After implantation different hemodynamic indices of paravalvular leakage will be\r assessed. At 1 month a cardiac MRI will be performed to quantify the amount of paravalvular\r leakage. Standardized clinical follow-up will take place at discharge, 30 days, 3 months and\r yearly up to 5 years.\r\n\r Study population: Approximately 80 patients with severe symptomatic aortic valve stenosis\r with an indication for TAVI will be included.\r\n\r Intervention: Patients will undergo cardiac MRI on top of standard clinical care within 30\r days after TAVI.\r\n\r Main study parameters/endpoints: The primary endpoint is defined as paravalvular leakage\r regurgitation fraction as measured by cardiac MRI. The secondary endpoint will comprise a\r composite of device success, early safety and clinical efficacy as defined by the Valve\r Academic Research Consortium-2 (VARC-2)(1) and will comprise death, vascular complications,\r stroke/ Transient Ischemic Attack (TIA), life threatening bleeding requiring transfusion, and\r acute kidney injury requiring dialysis.\n\n**Clinical Trial Detailed Description:**\n\n1. INTRODUCTION AND RATIONALE Transcatheter aortic valve implantation (TAVI) has become the\r standard of care in elderly patients with severe symptomatic aortic valve stenosis and\r increased surgical risks due to advanced age and multiple comorbidity(2-4). However, in\r contrast to surgical aortic valve replacement (SAVR), paravalvular leakage after TAVI is\r fairly common. More than moderate paravalvular leakage is associated with intermediate\r and long-term morbidity and mortality(5).\r\n\r Since the introduction of TAVI, implantation- and device technology have improved\r significantly. Nevertheless, mild paravalvular leakage remains a common finding after\r implantation of new generation devices. Conflicting evidence exists regarding the impact\r of mild versus none to trivial paravalvular leakage on mortality and morbidity. Several\r factors might be of influence on these conflicting results. Patients with left\r ventricular hypertrophy and no previous aortic regurgitation might experience rapidly\r rising end-diastolic pressures resulting in heart failure even at small regurgitant\r volumes as seen with mild paravalvular leakage (6-9). Moreover, paravalvular leakage\r might have greater impact on survival in patients with impaired left ventricular\r function as compared to patients with preserved left ventricular ejection fraction(10).\r\n\r Furthermore, studies have used different definitions of paravalvular leakage, assessed\r paravalvular leakage at different time intervals and used different prostheses. Since\r paravalvular leakage might decrease over time in self- expandable TAVI devices, this\r potentially influenced outcomes(11). The widely used VARC-2 criteria for paravalvular\r leakage grading comprise echocardiographic measurements only(1). Especially quantitative\r assessment of paravalvular leakage in the intermediate strata (mild-moderate) using\r echocardiography (TTE) remains difficult. TAVI under conscious sedation or local\r anesthesia more or less preclude the use of peri-operative trans esophageal\r echocardiography (TEE). TTE analysis and grading of paravalvular leakage is limited by\r patient factors such as pulmonary disease, patient habitus and prior cardio-thoracic\r surgery. Moreover, TTE has been shown to underestimate paravalvular leakage as compared\r to cardiac MRI(12-14). However,the presence of clinical relevant paravalvular leakage\r necessitates post-dilatation; therefore grading of paravalvular leakage preferably\r should be done intra-operatively.\r\n\r Hemodynamic parameters have been shown to be of great value in grading paravalvular\r leakage post implantation(15-18). These objective parameters are easily obtained during\r TAVI and have been shown to have prognostic relevance. All of these parameters are a\r function of left ventricular end-diastolic pressure (LVEDP). For instance, diastolic\r delta (DD), defined as the gradient between diastolic aortic pressure and LVEDP, ≤18\r millimetres of mercury (mmHg) was associated with adverse prognosis(15). Heart rate\r adjusted diastolic delta (HR-DD) (HR-DD= [DD/heartrate] *80) <25 mmHg/beats per minute\r (BPM) was associated with mortality at 1 year in a retrospective study(16). Combined\r with angiography and (transesophageal) echocardiography, it was associated with impaired\r clinical outcome in balloon-expandable bioprostheses (16, 17). Furthermore, the aortic\r regurgitation index (ARI), defined as the ratio of the diastolic delta to systolic\r aortic pressure (Aortic regurgitation index = (DD/Aortic pressure systolic)*100) >25\r combined with angiographic or echocardiographic assessment of paravalvular leakage had a\r negative predictive value of 95%-100% for the occurrence of more than mild paravalvular\r leakage. ARI <25 was associated with 1 year mortality, even after adjustment for\r paravalvular leakage severity(18-20). However, interpretation of ARI is challenging;\r bradycardia might lead to an ARI <25 without the presence of relevant paravalvular\r leakage. Determination of ARI should therefore be performed at a heart rate between\r 60-80 BPM and preferably over several cycles, especially when measured during atrial\r fibrillation or extrasystoles.\r\n\r Both echocardiographic and hemodynamic measures provide an estimation of the amount of\r paravalvular leak. In contrast to echocardiography, MRI provides accurate quantification\r of paravalvular leakage volume. In this study the investigators want to assess the\r contributive value of hemodynamic indices of paravalvular leakage based on paravalvular\r leakage volume measured by means of cardiac MRI and to assess its association with\r impaired clinical outcomes during 5 year follow-up.\r\n\r 2. OBJECTIVES 2.1 Primary Objective To assess per-procedural hemodynamic indices of\r paravalvular leakage and to relate these to paravalvular leakage as quantified by\r cardiac MRI.\r\n\r 2.2 Secondary Objectives To exploratory assess short- and long-term outcomes in patients\r with different severity of paravalvular leakage\r\n\r 3. STUDY DESIGN The study is designed as a single center, investigator-initiated, clinical\r trial.\r\n\r In case patients want to participate there is no change of standard clinical care. After\r TAVI, study participants will receive additional cardiac MRI within 1 month. Subsequent\r 3-month and 1-year out-patient clinical follow-up will be performed. Telephone follow-up\r will be performed after 2,3,4 and 5 years. The end of the study is defined as the day\r when the last patient completes her/his last visit planned in the protocol.\r\n\r 4. STUDY POPULATION 4.1 Population (base) Patients with severe symptomatic aortic valve\r stenosis allocated to TAVI by a dedicated heart team will be screened for potential\r participation. The definition of severe symptomatic aortic valve stenosis is defined in\r the inclusion criteria.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients must be >18 years old.\r\n\r 2. Written informed consent is obtained from all patients.\r\n\r 3. Severe aortic valve stenosis is defined as: jet velocity greater than 4.0m/s or\r Doppler Velocity index <0.25 or an initial aortic valve area (AVA) of ≤ 1.0cm²\r (indexed EOA≤06 cm²/m²) as measured by trans thoracic echocardiography <6months prior\r to inclusion.\r\n\r 4. Patients have symptomatic aortic stenosis, as demonstrated by New York Heart\r Association (NYHA) functional class 2 or greater or other symptoms of aortic stenosis\r (e.g. syncope or angina in the absence of coronary artery disease).\r\n\r 5. Surgical risk is deemed high or intermediate by Society of Thoracic Surgery (STS) risk\r score or by documented Heart-team agreement due to frailty or co-morbidities.\r\n\r 6. The aortic annulus diameter as measured by ECG-triggered CT-scanning < 6months prior\r to inclusion meets the ranges indicated in the instructions for use.\r\n\r 7. The access artery diameters (femoral or subclavian) as measured by CT-scanning < 6\r months prior to inclusion meet the ranges indicated in the instruction for use.\r\n\r 8. There are no contra-indications (e.g.: severe claustrophobia, metal implants, severe\r renal failure) for and patient is willing to undergo cardiac MRI at discharge to 30\r days after TAVI.\r\n\r Exclusion Criteria:\r\n\r 1. Patient is unwilling or unable to comply with study-required follow-up evaluations.\r\n\r 2. There is evidence of a myocardial infarction within 30 days to index procedure.\r\n\r 3. The presence of severe mitral regurgitation or stenosis.\r\n\r 4. The presence of pre-existing prosthetic cardiac device, valve or prosthetic ring in\r any position.\r\n\r 5. Left ventricular ejection fraction (LVEF) less than 30%.\r\n\r 6. Untreated significant coronary artery disease requiring revascularization.\r\n\r 7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation suggesting\r active endocarditis.\r\n\r 8. The patient is hemodynamically unstable, requiring inotropic or vasopressive and / or\r mechanical support.\r\n\r 9. The presence of pulmonary edema or intra venous diuretics to stabilize heart failure\r at index procedure.\r\n\r 10. Renal insufficiency, defined as a serum creatinin greater than 250umol/l or end-stage\r renal disease requiring dialysis.\r\n\r 11. Morbid obesity, defined as a BMI ≥40.\r\n\r 12. A life expectancy of less than one year.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
744
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations\n\n**Clinical Trial Summary:**\n\nThis phase III trial compares standard chemotherapy to therapy with CPX-351 and/or\r gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3\r mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab\r ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up\r of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone\r marrow longer and could be less likely to cause heart problems than traditional anthracycline\r drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an\r abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that\r carry instructions for development, functioning, growth and reproduction) inside each cell\r that tell the cell what to do and when to grow and divide. FLT3 plays an important role in\r the normal making of blood cells. This gene can have permanent changes that cause it to\r function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function\r of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to\r compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people\r with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or\r bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or\r other FLT3 mutations and 3) to study changes in heart function during and after treatment for\r AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in\r treating patients with acute myeloid leukemia compared to standard chemotherapy alone.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To compare event-free survival (EFS) in children with de novo acute myeloid leukemia (AML)\r without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A with\r daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) (DA-GO) versus Arm B with\r liposome-encapsulated daunorubicin-cytarabine (CPX-351) and GO.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To compare overall survival (OS) and rates of end of Induction 1 (EOI1) minimal residual\r disease (MRD) in children with de novo AML without FLT3 mutations who are randomly assigned\r to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).\r\n\r II. To estimate the EFS and rate of EOI1 MRD in FLT3 internal tandem duplication mutation\r positive patients (FLT3/ITD+; as defined by allelic ratio > 0.1) without favorable\r cytomolecular characteristics (NPM1 and/or CEBPA) receiving gilteritinib fumarate\r (gilteritinib) in combination with DA-GO (Arm AC).\r\n\r III. To estimate the EFS and rate of EOI1 MRD in patients with non-ITD FLT3 activating\r mutations who receive backbone therapy (DA-GO or CPX-351 and GO) with gilteritinib (Arms AD\r and BD).\r\n\r IV. To determine the feasibility of combining gilteritinib and DA-GO or CPX-351 and GO in\r patients with FLT3/ITD mutations (Arm AC/Arm BC/Arm AD/Arm BD).\r\n\r V. To compare EOI1 MRD and EFS in patients with FLT3/ITD AML+ (allelic ratio [AR] > 0.1)\r without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib\r versus (vs) CPX-GO-gilteritinib (Arm AC vs Arm BC).\r\n\r VI. To compare the incidence of significant left ventricular systolic dysfunction (LVSD) in\r children with de novo AML without FLT3 mutations who are randomly assigned to standard\r induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).\r\n\r VII. To compare the changes in echocardiography-derived measures of cardiac function,\r including left ventricular ejection fraction (EF) and global longitudinal strain (GLS),\r throughout AML therapy in patients with low and high risk AML without FLT3 mutations\r receiving Arm A vs Arm B.\r\n\r VIII. Determine if early changes in sensitive echocardiographic measures of cardiac function\r (i.e., post-Induction 1 decline in GLS) and elevations in circulating cardiac biomarkers\r (i.e., cardiac troponin T and N-terminal pro b-type natriuretic peptide) are associated with\r subsequent declines in left ventricular ejection fraction in patients with non-FLT3 mutant\r AML receiving therapy on Arms A or B.\r\n\r IX. To compare longitudinal acute changes in neuropsychological functioning and\r neurocognitive late effects between those with central nervous system (CNS) disease and those\r without CNS disease and between those treated with hematopoietic stem cell transplant (HSCT)\r and those treated with chemotherapy only for patients on Arms A and B.\r\n\r X. To compare cardiotoxicity measures (EF, GLS, and cardiac biomarkers) in patients receiving\r standard induction with dexrazoxane hydrochloride (dexrazoxane) vs. CPX-351 in the context of\r gilteritinib therapy and explore whether the differential cardiotoxicity across arms varies\r from that observed in non-FLT3 mutant AML without gilteritinib exposure.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To estimate the EFS and rate of EOI1 MRD in patients with high allelic ratio (HAR)\r FLT3/ITD+ patients, as historically defined by an AR > 0.4, receiving gilteritinib in\r combination with DA-GO (Arm AC with AR > 0.4).\r\n\r II. To estimate the EFS and rate of EOI1 MRD in FLT3/ITD+ patients (as defined by allelic\r ratio > 0.1) with NPM1 and/or bZIP CEBPA mutations receiving gilteritinib in combination with\r DA-GO (Arm AC).\r\n\r III. Compare the changes in high sensitivity troponin and natriuretic peptide elevations\r throughout AML therapy, as measured at the end of each chemotherapy course, in patients with\r low and high risk AML without FLT3 mutations receiving Arm A vs Arm B.\r\n\r IV. Quantify the association of host factors (age, sex, body mass index [BMI], race),\r treatment exposures (cumulative anthracycline dose, anthracycline arm, hematopoietic stem\r cell transplant vs. chemotherapy alone), early declines in GLS, and elevations in cardiac\r biomarkers (cTnT and NT-proBNP) with subsequent LVSD.\r\n\r V. Develop a multi-marker risk prediction model incorporating significant host factors,\r treatment exposures, and echocardiographic predictors for the development of LVSD within 1\r year of completing therapy.\r\n\r VI. To describe the rates of CNS disease utilizing an updated strategy for diagnosing and\r defining CNS disease in pediatric AML.\r\n\r VII. To describe the rates of CNS relapse (both isolated CNS and combined bone marrow/CNS)\r when utilizing this updated strategy as well as changing CNS prophylaxis and treatment to\r include triple intrathecal chemotherapy.\r\n\r VIII. To describe disease-free survival (DFS) and overall survival (OS) in high risk patients\r based on multi-dimensional flow cytometry detection of measurable residual disease prior to\r hematopoietic stem cell transplant (HSCT).\r\n\r IX. To describe plasma metabolomics that may impact efficacy, toxicity, and/or\r pharmacokinetics of allogeneic HSCT.\r\n\r X. To estimate the prevalence of non-risk stratifying cytogenetic/molecular variants and\r assess their impact on outcome in childhood AML.\r\n\r OUTLINE: Patients are randomized to either Arm A or B and assigned to Arm C or D based on\r FLT3 testing results.\r\n\r TREATMENT FOR PATIENTS WITHOUT FLT3 MUTATIONS:\r\n\r ARM A LOW RISK GROUP 1:\r\n\r INDUCTION 1: Patients receive cytarabine intravenously (IV) over 1-30 minutes every 12 hours\r (Q12H) on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes\r on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1\r receive methotrexate intrathecally (IT), therapeutic hydrocortisone (hydrocortisone) IT, and\r cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT once weekly (QW) starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the cerebral spinal fluid (CSF) is clear of blasts (CNS1\r status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 1 for 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi intramuscularly (IM) or IV\r over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM B LOW RISK GROUP 1:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM A LOW RISK GROUP 2:\r\n\r INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane\r IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and\r gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and\r dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15\r minutes on days 3-6.\r\n\r INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM B LOW RISK GROUP 2:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and\r dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15\r minutes on days 3-6.\r\n\r INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM A HIGH RISK GROUP:\r\n\r INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane\r IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and\r gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r ARM B HIGH RISK GROUP:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r TREATMENT FOR PATIENTS WITH FLT3/ITD MUTATIONS (ITD AR > 0.1):\r\n\r ARM AC LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via\r nasogastric (NG) or gastronomy (G) tube daily on days 1-365.\r\n\r ARM BC LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM AC HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r ARM BC HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r TREATMENT FOR NON-ITD FLT3 ACTIVATING MUTATIONS:\r\n\r ARM AD LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM BD LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM AD HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r ARM BD HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r NOTE: During Induction 2 or Intensification 2, patients in Arms A and B with left ventricular\r systolic dysfunction receive a replacement course of high-dose cytarabine IV over 3 hours on\r days 1, 2, 8, and 9, and asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9. Patients in Arms AC, BC, AD, and BD\r receive treatment as in Arms A and B and also receive gilteritinib PO QD on days 10-37\r (Induction 2) or days 10-37 (Intensification 2).\r\n\r All treatment continues in the absence of disease progression or unacceptable toxicity.\r\n\r OPTIONAL NEUROCOGNITIVE STUDY:\r\n\r Patients may complete the Cogstate assessment battery at the end of Induction 1, at the end\r of therapy, and at 9 and 60 months post-enrollment.\r\n\r After completion of study treatment, patients are followed up monthly for 6 months and then\r every other month for 6 months (year 1), every 4 months during year 2, every 6 months during\r year 3, then yearly for years 4-10. Patients who undergo HSCT are also followed up at 30,\r 100, and 180 days, 9 months, and 1 year post-HSCT.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part\r A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens\r must be done according to the Manual of Procedures). Risk stratification will not be\r possible without the submission of viable samples. Given there are multiple required\r samples, bone marrow acquisition techniques such as frequent repositioning or\r performing bilateral bone marrow testing should be considered to avoid insufficient\r material for required studies. Consider a repeat marrow prior to starting treatment if\r there is insufficient diagnostic material for the required studies\r\n\r - Patients must be less than 22 years of age at the time of study enrollment\r\n\r - Patient must be newly diagnosed with de novo AML according to the 2016 World Health\r Organization (WHO) classification with or without extramedullary disease\r\n\r - Patient must have 1 of the following:\r\n\r - >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)\r\n\r - In cases where extensive fibrosis may result in a dry tap, blast count\r can be obtained from touch imprints or estimated from an adequate bone\r marrow core biopsy\r\n\r - < 20% bone marrow blasts with one or more of the genetic abnormalities\r (sample obtained within 14 days prior to enrollment)\r\n\r - A complete blood count (CBC) documenting the presence of at least 1,000/uL\r (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a\r WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells\r (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed\r within 7 days prior to enrollment)\r\n\r - ARM C: Patient must be >= 2 years of age at the time of Late Callback\r\n\r - ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular\r Oncology\r\n\r - ARM C: Patient does not have any congenital long QT syndrome or congenital heart block\r\n\r - ARM C: Females of reproductive potential must agree to use effective contraception\r during treatment and for at least 6 months after the last dose of gilteritinib\r\n\r - ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib\r and for 2 months after the last dose of gilteritinib\r\n\r - ARM C: Males of reproductive potential must agree to use effective contraception\r during treatment and for at least 4 months after the last dose of gilteritinib\r\n\r - ARM D: Patient must be >= 2 years of age at the time of Late Callback\r\n\r - ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating\r mutations as reported by Foundation Medicine\r\n\r - ARM D: Females of reproductive potential must agree to use effective contraception\r during treatment and for at least 6 months after the last dose of gilteritinib\r\n\r - ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib\r and for 2 months after the last dose of gilteritinib\r\n\r - ARM D: Males of reproductive potential must agree to use effective contraception\r during treatment and for at least 4 months after the last dose of gilteritinib\r\n\r - NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who\r transfer to Arm C or Arm D are not eligible\r\n\r - NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment\r\n\r - NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking\r\n\r - NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to\r diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental\r retardation)\r\n\r - NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would\r prevent computer use or recognition of visual test stimuli\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met.\r\n\r Exclusion Criteria:\r\n\r - Patients with myeloid neoplasms with germline predisposition are not eligible\r\n\r - Fanconi anemia\r\n\r - Shwachman Diamond syndrome\r\n\r - Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21\r\n\r - Any other known bone marrow failure syndrome\r\n\r - Any concurrent malignancy\r\n\r - Juvenile myelomonocytic leukemia (JMML)\r\n\r - Philadelphia chromosome positive AML\r\n\r - Mixed phenotype acute leukemia\r\n\r - Acute promyelocytic leukemia\r\n\r - Acute myeloid leukemia arising from myelodysplasia\r\n\r - Therapy-related myeloid neoplasms\r\n\r - Administration of prior anti-cancer therapy except as outlined below:\r\n\r - Hydroxyurea\r\n\r - All-trans retinoic acid (ATRA)\r\n\r - Corticosteroids (any route)\r\n\r - Intrathecal therapy given at diagnosis\r\n\r - In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be\r avoided from the time of enrollment until it is determined whether the patient\r will receive gilteritinib. Patients receiving gilteritinib will be required to\r avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the\r study treatment\r\n\r - Female patients who are pregnant since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential\r\n\r - Lactating females who plan to breastfeed their infants\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of their study participation\r\n\r - ARM D: Patients with congenital long QT syndrome or congenital heart block are not\r eligible for this treatment arm\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
745
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTowards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches\n\n**Clinical Trial Summary:**\n\nChronic Kidney Disease (CKD) is a worldwide major public health problem that is associated\r with an increased incidence of kidney failure and cardiovascular events, that lead a high\r burden for affected patients and high costs for society. Symptoms of CKD occur late, when\r kidney function drops to below 30%. At that time preventive measures will have only limited\r efficacy. Protein excretion in urine has increasingly been recognized as early marker of CKD,\r and is often associated with high blood pressure, diabetes, and/or high cholesterol levels.\r These are all important risk factors for progression of kidney and cardiovascular disease.\r Population screening for urinary protein loss could detect a considerable number of subjects\r with yet unknown risk factors for progressive kidney and cardiovascular disease who can\r benefit of early intervention. However, there is no validated method for population screening\r yet. We aim to develop a home based population screening for elevated urinary protein loss.\r We will investigate two screening methods, and evaluate their yield and cost-effectiveness.\n\n**Clinical Trial Detailed Description:**\n\nChronic kidney disease (CKD) is a worldwide major public health problem that is associated\r with an increased incidence of kidney failure and cardiovascular disease (CVD). To tackle\r this burden, screening for CKD among the general population could be beneficial to allow\r early detection and treatment. In the last decades, elevated albuminuria has increasingly\r been recognized as an early marker of generalized vascular endothelial damage, that predicts\r CKD and CVD progression.\r\n\r It has been estimated that approximately 6% of the general population has elevated\r albuminuria, and that the majority of these subjects are not known yet with this abnormality.\r Among these subjects, many have hypertension, hyperlipidemia, diabetes and/or impaired kidney\r function, that often is also not known yet. Early detection of elevated albuminuria may be\r important because it gives the opportunity to invite subjects that test positive for further\r screening for CKD and CVD risk factors. Thus these risk factors for CKD and CVD progression\r could be treated in an early stage.\r\n\r Population screening for albuminuria could be justified according to the WHO criteria of\r Wilson and Jungner , because CKD has important consequences for subjects, the course of the\r disease is initially symptomless, and there are treatment methods available. However,\r implementation research to validate screening the general population for albuminuria and\r related health consequences is lacking, as are cost-effectiveness studies.\r\n\r In the current study we aim to develop a home-based screening technique for detecting\r elevated albuminuria. We will investigate two screening methods, and evaluate their yield and\r cost-effectiveness.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 45 to 80 years.\r\n\r - Living in the municipality of Breda, The Netherlands.\r\n\r - Not institutionalised.\r\n\r Exclusion Criteria:\r\n\r - Younger than 45 years or older than 80 years.\r\n\r - Not living in the municipality of Breda, The Netherlands.\r\n\r - Institutionalised.\r\n\r A random sample of 15.032 subjects will be drawn from the population aged 45-80 years from\r the municipality of Breda by the Dutch Central Bureau for Statistics (CBS).\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
746
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients\n\n**Clinical Trial Summary:**\n\nTakayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective\r well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels,\r including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in\r mild and moderate patients, to observe the relatively better treatment strategy, facilitating\r better intervention strategy in TAK patients.\n\n**Clinical Trial Detailed Description:**\n\nThe Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks effective\r well-accepted intervention strategy. Previous studies have revealed that methoxamine,\r tofacitinib, adalimumab, and tocilizumab were effective in controlling disease activity and\r preventing disease relapse in some TAK patients. However, we believed that different patients\r should be prescribed different drug combinations, i.e. personalized medicine, to obtain the\r optimal intervention effect.\r\n\r So, here we tried to classify the TAK patients into three levels, and prescribe different\r drug interventions to discover the relatively better treatment strategy.\r\n\r 1. Patients were classified as mild, moderate and severe group according to the disease\r severity of TAK patients.\r\n\r 1.1 Severe\r\n\r 1. Severe hypertension\r\n\r 1. Continuously upper limb systolic blood pressure ≥180mmHg or diastolic blood\r pressure ≥110mmHg;\r\n\r 2. OR upper limb blood pressure cannot be measured if lower limb systolic blood\r pressure ≥200mmHg or diastolic blood pressure ≥120mmHg;\r\n\r 3. With target organ damage due to hypertension;\r\n\r 2. Aortic arch and its branches involved\r\n\r a. Multiple branches involved (two or more) and severe stenosis (stenosis rate ≥70%); b.\r stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and / or signs; c.\r stenosis rate ≥50%, accompanied by recent history of cerebrovascular events;\r\n\r 3. Carotid artery and its branches involved\r\n\r 1. Multiple branches (two or more) involved and severe stenosis (stenosis rate ≥70%);\r\n\r 2. stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and / or signs;\r\n\r 3. stenosis rate ≥50%, accompanied by recent history of cerebrovascular events;\r\n\r 4. Pulmonary artery involvement\r\n\r a. Chest tightness, hemoptysis, dyspnea, radionuclide pulmonary ventilation / blood\r perfusion imaging or CTA suggesting pulmonary artery thrombosis with respiratory failure\r (type I); b. Chest tightness, shortness of breath, and cardiac ultrasound suggesting\r severe pulmonary artery hypertension with cardiac function abnormality (NYHA class III\r and above);\r\n\r 5. Coronary artery involved\r\n\r 1. Onset of unstable angina pectoris or myocardial infarction;\r\n\r 2. Cardiac ultrasound indicating ischemic cardiomyopathy, NYHA class III and above;\r\n\r 6. Aortic valve and aortic root involved\r\n\r 1. Severe reflux of the aortic valve;\r\n\r 2. OR aortic valve leakage, annulus tearing;\r\n\r 3. OR aneurysm in aortic root and / or ascending aortic (≥2 times in diameter);\r\n\r 4. OR dilation of the aortic root and / or ascending aorta (≥5cm in diameter);\r\n\r 5. OR dissection of the aortic root and / or ascending aorta; Any item of the above a\r - e is accompanied by abnormal cardiac function (NYHA III and above);\r\n\r 7. Renal artery involved a. Severe stenosis of renal artery secondary to malignant\r hypertension (blood pressure is still 180 / 120mmHg after treatment with three or more\r antihypertensive drugs) b. Severe renal artery stenosis accompanied by a progressive\r increase in serum creatinine or a reduction in glomerular filtration rate (GFR) of ≥25%;\r\n\r 8. Glucocorticoids, and the traditional synthetic chemical immunosuppressants were of no\r use. And the disease is not well controlled with severe injury of the organs.\r\n\r 1.2 Moderate\r\n\r 1. Hypertension\r\n\r a. Upper limb systolic blood pressure ≥160-180mmHg or / and diastolic blood pressure\r ≥100-110mmHg; b. OR upper limb blood pressure is unmeasurable or lower limb systolic\r blood pressure is ≥180mmHg or diastolic blood pressure is ≥100-110mmHg;\r\n\r 2. Aortic arch and its branches involved\r\n\r a. 1-2 vessels are involved with moderate stenosis (stenosis rate ≥50%-<70%); b.\r Dizziness occurs during physical activity, and symptoms disappear in the resting state;\r\n\r 3. Carotid artery and its branches involved\r\n\r a. Unilateral or bilateral vascular stenosis rate ≥50% -70%, with dizziness during light\r physical activity;\r\n\r 4. Pulmonary artery involved\r\n\r a. Radionuclide pulmonary ventilation / blood perfusion imaging or CTA indicates\r pulmonary vascular disease; chest tightness after activity; Cardiac ultrasound indicates\r moderate pulmonary artery hypertension (pressure> 40-60mmHg), with abnormal cardiac\r function (NYHA class Ⅱ);\r\n\r 5. Coronary artery involvement a. Chest tightness and chest pain after moderate activities,\r CTA showed 50% or more in coronary artery stenosis, abnormal cardiac function (NYHA\r class Ⅱ);\r\n\r 6. Aortic valve and aortic root involved\r\n\r 1. Moderate aortic regurgitation;\r\n\r 2. Aortic root and / or ascending aortic aneurysm (diameter <2 times);\r\n\r 3. Dilation of the aortic root and / or ascending aorta (diameter <5cm); Each item of\r a - c is accompanied by abnormal cardiac function (NYHA Class II);\r\n\r 7. Renal artery involvement a. Renal artery stenosis rate ≥50%, and blood pressure 160-180\r / 110-120 (excluding 120) mmHg after treatment, or with left ventricular myocardial\r hypertrophy, hypertension and heart disease, CKD-II;\r\n\r 1.3 Mild\r\n\r 1. Hypertension\r\n\r 1. Upper limb systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg;\r\n\r 2. OR upper limb blood pressure is unmeasurable or lower limb systolic blood pressure\r is ≥140mmHg or diastolic blood pressure is ≥90mmHg;\r\n\r 2. Aortic arch and its branches involved\r\n\r a. Single or multiple lesions with mild stenosis (stenosis rate <50%), and without\r neurological ischemic symptoms and / or signs in daily activities;\r\n\r 3. Carotid artery and its branches involved\r\n\r a. Single or multiple lesions with mild stenosis (stenosis rate <50%) and no\r neurological ischemic symptoms and / or signs during daily activities;\r\n\r 4. Pulmonary artery involved\r\n\r a. Cardiac ultrasound indicates mild or normal pulmonary artery pressure (pressure\r 30-40mmHg); b. Imaging shows pulmonary arteritis or pulmonary artery stenosis, occlusion\r a and b, with chest tightness, shortness of breath, and hemoptysis without activity;\r cardiac function (NYHA I), normal blood gas analysis;\r\n\r 5. Coronary artery involved\r\n\r a. Chest tightness, shortness of breath, chest pain after inactivity; cardiac function\r (NYHA I);\r\n\r 6. Aortic valve and aortic root involved\r\n\r 1. Mild aortic regurgitation;\r\n\r 2. Aortic root and / or ascending aortic aneurysm-like expansion (diameter <1.5\r times); a and b, each with cardiac function (NYHA I);\r\n\r 7. Renal artery involved a. Renal artery stenosis rate <50%, without/with mild hypertension\r (see 1), or normal serum creatinine, normal or slightly impaired glomerular filtration\r rate (GFR);\r\n\r 2. Based on the TAK patients in the ECTA cohort (Clinical trials. No: NCT03893136), we tried\r to compare the treatment efficacy between Tofacitinib (TOF) and methotrexate (MTX) in mild\r and moderate patients, with a randomized open-label study.\r\n\r Other important detailed description of the study are listed as follows:\r\n\r 1. Basic treatment of prednisone: The initial prednisone dose is 40mg.qd.po, and maintained\r for 1 month. After 1 month's treatment, the dose is gradually tapered to 15mg by 5mg per\r 2 weeks. Subsequently, the dose is decreased to 5mg by 2.5mg per 3 months. The 5mg is\r the final target maintained dose. In the treatment, if the relapse occurs, the dose of\r prednisone returned to the last dosage. For example, if the patient gets a relapse at\r the dose of 15mg of prednisone, then the dose of prednisone returned to 20mg.\r\n\r The relapse of TAK is defined according to the \"2018 Update of the EULAR recommendations\r for the management of large vessel vasculitis\". Relapse includes major relapse or minor\r relapse. Major relapse: Recurrence of active disease with either of the following: a.\r Clinical features of ischemia* (including jaw claudication, visual symptoms, the visual\r loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of\r active aortic inflammation resulting in progressive aortic or large vessel dilatation,\r stenosis or dissection. Minor relapse Recurrence of active disease, not fulfilling the\r criteria for a major relapse.\r\n\r 2. TOF: 5mg bid p.o.\r\n\r 3. MTX: 15mg qw p.o.\r\n\r 4. Treatment shift: if the TAK patients in the TOF group failed to reach clinical remission\r at the end of the 24th week, they would be shifted to MTX group starting a new round of\r induction and complete the rest 24-week follow-up; and vice versa.\r\n\r In the follow-up, the disease remission and related markers are monitored.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. age≥14 years;\r\n\r 2. active status: Kerr score≥ 2;\r\n\r 3. mild and moderate:\r\n\r 1. Blood pressure (maximum) < 180/110mmHg;\r\n\r 2. 1-2 branches with the stenotic rate < 70% involved;\r\n\r 3. mildly ischemic manifestation relative to activity but relieve after rest;\r\n\r 4. no or low degree of organ insufficiency: NYHF I~II; eGFR (MRDR) ≥ 60ml/min;\r\n\r Exclusion Criteria:\r\n\r 1. Severe organ insufficiency;\r\n\r 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;\r\n\r 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4\r relative disease;\r\n\r 4. malignant tumors;\r\n\r 5. history of severe drug allergy;\r\n\r 6. successive twice relapse occurs even after the intervention adjustment ( for the\r benefits of patients)\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
747
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Pilot Study in Severe Patients With Takayasu Arteritis.\n\n**Clinical Trial Summary:**\n\nTakayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective\r well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild,\r moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly\r prescribed in severe patients, to find out the relatively better treatment strategy,\r facilitating better intervention strategy in severe TAK patients.\n\n**Clinical Trial Detailed Description:**\n\nThe Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an\r effective well-accepted intervention strategy. Previous studies have revealed that\r methotrexate, tofacitinib, adalimumab, and tocilizumab were effective in controlling disease\r activity and preventing disease relapse in some TAK patients, especially the latter two\r biological agents. However, we believed that different patients should be prescribed\r different drug combinations, i.e. personalized medicine, to obtain the optimal intervention\r effect.\r\n\r Here we tried to classify the TAK patients into three levels including mild, moderate, and\r severe, and prescribe different drug interventions to discover which biological agent is\r better in severe TAK patients.\r\n\r 1. Patients were classified as mild, moderate, and severe groups according to the disease\r severity of TAK patients.\r\n\r 1.1 Severe\r\n\r 1. Severe hypertension\r\n\r 1. Continuously upper limb systolic blood pressure ≥180mmHg or diastolic blood\r pressure ≥110mmHg;\r\n\r 2. OR upper limb blood pressure cannot be measured if lower limb systolic blood\r pressure ≥200mmHg or diastolic blood pressure ≥120mmHg;\r\n\r 3. With target organ damage due to hypertension;\r\n\r 2. Aortic arch and its branches involved\r\n\r a. Multiple branches involved (two or more) and severe stenosis (stenosis rate ≥70%); b.\r stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and/or signs; c.\r stenosis rate ≥50%, accompanied by a recent history of cerebrovascular events;\r\n\r 3. The carotid artery and its branches involved\r\n\r 1. Multiple branches (two or more) involved and severe stenosis (stenosis rate ≥70%);\r\n\r 2. stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and/or signs;\r\n\r 3. stenosis rate ≥50%, accompanied by the recent history of cerebrovascular events;\r\n\r 4. Pulmonary artery involvement\r\n\r a. Chest tightness, hemoptysis, dyspnea, radionuclide pulmonary ventilation/blood\r perfusion imaging or CTA suggesting pulmonary artery thrombosis with respiratory failure\r (type I); b. Chest tightness, shortness of breath, and cardiac ultrasound suggesting\r severe pulmonary artery hypertension with cardiac function abnormality (NYHA class III\r and above);\r\n\r 5. The coronary artery involved\r\n\r 1. The onset of unstable angina pectoris or myocardial infarction;\r\n\r 2. Cardiac ultrasound indicating ischemic cardiomyopathy, NYHA class III and above;\r\n\r 6. The aortic valve and aortic root involved\r\n\r 1. Severe reflux of the aortic valve;\r\n\r 2. OR aortic valve leakage, annulus tearing;\r\n\r 3. OR aneurysm in the aortic root and/or ascending aortic (≥2 times in diameter);\r\n\r 4. OR dilation of the aortic root and/or ascending aorta (≥5cm in diameter);\r\n\r 5. OR dissection of the aortic root and/or ascending aorta; Any item of the above a -\r e is accompanied by abnormal cardiac function (NYHA III and above);\r\n\r 7. Renal artery involved a. Severe stenosis of renal artery secondary to malignant\r hypertension (blood pressure is still 180 / 120mmHg after treatment with three or more\r antihypertensive drugs) b. Severe renal artery stenosis accompanied by a progressive\r increase in serum creatinine or a reduction in glomerular filtration rate (GFR) of ≥25%;\r\n\r 8. Glucocorticoids and the traditional synthetic chemical immunosuppressants were of no\r use. And the disease is not well controlled with the severe injury of the organs.\r\n\r 1.2 Moderate\r\n\r 1. Hypertension\r\n\r a. Upper limb systolic blood pressure ≥160-180mmHg or / and diastolic blood pressure\r ≥100-110mmHg; b. OR upper limb blood pressure is unmeasurable or lower limb systolic\r blood pressure is ≥180mmHg or diastolic blood pressure is ≥100-110mmHg;\r\n\r 2. Aortic arch and its branches involved\r\n\r a. 1-2 vessels are involved with moderate stenosis (stenosis rate ≥50%-<70%); b.\r Dizziness occurs during physical activity, and symptoms disappear in the resting state;\r\n\r 3. The carotid artery and its branches involved\r\n\r a. Unilateral or bilateral vascular stenosis rate ≥50% -70%, with dizziness during light\r physical activity;\r\n\r 4. Pulmonary artery involved\r\n\r a. Radionuclide pulmonary ventilation/blood perfusion imaging or CTA indicates pulmonary\r vascular disease; chest tightness after activity; Cardiac ultrasound indicates moderate\r pulmonary artery hypertension (pressure> 40-60mmHg), with abnormal cardiac function\r (NYHA class Ⅱ);\r\n\r 5. Coronary artery involvement\r\n\r a. Chest tightness and chest pain after moderate activities, CTA showed 50% or more in\r coronary artery stenosis, abnormal cardiac function (NYHA class Ⅱ);\r\n\r 6. The aortic valve and aortic root involved\r\n\r 1. Moderate aortic regurgitation;\r\n\r 2. Aortic root and/or ascending aortic aneurysm (diameter <2 times);\r\n\r 3. Dilation of the aortic root and/or ascending aorta (diameter <5cm); Each item of a\r - c is accompanied by abnormal cardiac function (NYHA Class II);\r\n\r 7. Renal artery involvement a. Renal artery stenosis rate ≥50%, and blood pressure 160-180\r / 110-120 (excluding 120) mmHg after treatment, or with left ventricular myocardial\r hypertrophy, hypertension and heart disease, CKD-II;\r\n\r 1.3 Mild\r\n\r 1. Hypertension\r\n\r 1. Upper limb systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg;\r\n\r 2. OR upper limb blood pressure is unmeasurable or lower limb systolic blood pressure\r is ≥140mmHg or diastolic blood pressure is ≥90mmHg;\r\n\r 2. Aortic arch and its branches involved a. Single or multiple lesions with mild stenosis\r (stenosis rate <50%), and without neurological ischemic symptoms and/or signs in daily\r activities;\r\n\r 3. The carotid artery and its branches involved\r\n\r a. Single or multiple lesions with mild stenosis (stenosis rate <50%) and no\r neurological ischemic symptoms and/or signs during daily activities;\r\n\r 4. The pulmonary artery involved\r\n\r 1. Cardiac ultrasound indicates mild or normal pulmonary artery pressure (pressure\r 30-40mmHg);\r\n\r 2. Imaging shows pulmonary arteritis or pulmonary artery stenosis, occlusion a and b,\r with chest tightness, shortness of breath, and hemoptysis without activity; cardiac\r function (NYHA I), normal blood gas analysis;\r\n\r 5. The coronary artery involved\r\n\r a. Chest tightness, shortness of breath, chest pain after inactivity; cardiac function\r (NYHA I);\r\n\r 6. The aortic valve and aortic root involved\r\n\r 1. Mild aortic regurgitation;\r\n\r 2. Aortic root and / or ascending aortic aneurysm-like expansion (diameter <1.5\r times); a and b, each with cardiac function (NYHA I);\r\n\r 7. Renal artery involved a. Renal artery stenosis rate <50%, without/with mild hypertension\r (see 1), or normal serum creatinine, normal or slightly impaired glomerular filtration\r rate (GFR);\r\n\r 1.2. Based on the TAK patients in the ECTA cohort (Clinical trials. No: NCT03893136), we\r tried to compare the treatment efficacy of biological agents between tocilizumab (TCZ) and\r adalimumab (ADA) in severe TAK patients, with a pilot study.\r\n\r Other important detailed description of the study are listed as follows:\r\n\r 1. Basic treatment of prednisone:\r\n\r The initial prednisone dose is 40mg.qd.po, and maintained for 1 month. After 1 month's\r treatment, the dose is gradually tapered to 15mg by 5mg per 2 weeks. Subsequently, the\r dose is decreased to 5mg by 2.5mg per 3 months. The 5mg is the final target maintained\r dose. In the treatment, if the relapse occurs, the dose of prednisone returned to the\r last dosage. For example, if the patient gets a relapse at the dose of 15mg of\r prednisone, then the dose of prednisone returned to 20mg.\r\n\r The relapse of TAK is defined according to the \"2018 Update of the EULAR recommendations\r for the management of large vessel vasculitis\". Relapse includes major relapse or minor\r relapse. Major relapse: Recurrence of active disease with either of the following: a.\r Clinical features of ischemia* (including jaw claudication, visual symptoms, the visual\r loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of\r active aortic inflammation resulting in progressive aortic or large vessel dilatation,\r stenosis or dissection. Minor relapse Recurrence of active disease, not fulfilling the\r criteria for the major relapse.\r\n\r 2. ADA: 40mg bim IH.\r\n\r 3. TCZ: 8mg/kg qm ivgtt.\r\n\r 4. Treatment shift: if the TAK patients in ADA group failed to reach clinical remission at\r the end of 24th week, they would be shifted to TCZ group starting a new round of\r induction and complete the rest 24-week follow-up; and vice versa;\r\n\r In the follow-up, the disease remission and related markers are monitored.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. age≥14 years old;\r\n\r 2. active: Kerr score≥ 2;\r\n\r 3. severe:\r\n\r 1. Blood pressure > 180/110mmHg;\r\n\r 2. ≥ 3 branches with the stenotic rate > 70% involved;\r\n\r 3. high degree of organ insufficiency: NYHF III~IV; eGFR (MRDR) 15~ 60ml/min;\r\n\r Exclusion Criteria:\r\n\r 1. Severe organ insufficiency;\r\n\r 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;\r\n\r 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4\r relative disease;\r\n\r 4. malignant tumors;\r\n\r 5. history of severe drug allergy;\r\n\r 6. successive twice relapse occurs even after the intervention adjustment ( for the\r benefits of patients)\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
748
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effect of Zoledronic Acid on Patients With Osteoarthritis of the Hip\n\n**Clinical Trial Summary:**\n\nHip Osteoarthritis (OA) is one of the most common diseases affecting the ageing population.\r No specific and safe treatment slowing the development of hip OA as reflected in reduced\r joint space narrowing has been developed so far. Implantation of hip prosthesis has been a\r great success, but is expensive and puts a great financial pressure on hospitals and national\r healthcare programs. It also poses risks of serious complications. Current non-surgical\r treatment options focus on pain management and physiotherapy.\r\n\r Bisphosphonates have been shown to exert multiple beneficial effects in OA. Animal studies\r have demonstrated that bisphosphonates protect against subchondral bone degradation and\r preserve articular cartilage in mice and rats with OA.\r\n\r In this study 70 participants will be treated with either Zoledronic Acid (a potent\r Bisphosphonate) or Placebo (Saltwater). Allocation will be random and both parties are\r blinded. The investigators hypothesis is that participants treated with Zoledronic acid will\r have less pain, and better function after 12 months. The results will be tested with\r functional and pain scores, and functional tests. The study team will also measure the\r effects on disease related quality of life, bone quality measurements and the effect on bone\r marrow lesions on MRI (magnetic resonance imaging) and histological examination\n\n**Clinical Trial Detailed Description:**\n\nBackground Hip Osteoarthritis (OA) is one of the most common diseases affecting the ageing\r population. No specific and safe treatment slowing the development of hip OA as reflected in\r reduced joint space narrowing has been developed so far. Implantation of hip prosthesis has\r been a great success, but is expensive and puts a great financial pressure on hospitals and\r national healthcare programs. It also poses risks of serious complications. Current\r non-surgical treatment options focus on pain management and physiotherapy.\r\n\r Bisphosphonates have been shown to exert multiple beneficial effects in OA, not only through\r effects on subchondral bone, but also through chondroprotection and possibly by inhibiting\r synovitis. Animal studies have demonstrated that bisphosphonates protect against subchondral\r bone degradation and preserve articular cartilage in mice and rats with OA. Efforts to\r further improve subchondral bone using a combination of zoledronic acid (ZA) and parathyroid\r hormone (PTH), was, however, shown to be ineffective.\r\n\r Rationale for study Effects of bisphosphonates in OA\r\n\r Bisphosphonates may target Pain and OA development by several different mechanisms:\r\n\r Anti-osteoclastic action:\r\n\r Increased bone turnover in OA causes bone loss and osteoporosis of subchondral bone beneath\r the thickened subchondral plate, which alters flexibility, and increases the risk of\r microfracture, which may cause of bone marrow lesions (BMLs) in OA. Bisphosphonates may also\r increase the strength of subchondral bone by reducing turnover and improve bone material\r properties.\r\n\r Osteoclasts mediate the extension of channels from marrow spaces into the non-calcified\r articular cartilage. This leads to loss of integrity at the osteochondral junction exposing\r subchondral nerves to proinflammatory and pain inducing factors from the synovial fluid. This\r action has also been shown to induce sensory nerve growth into the non-calcified articular\r cartilage.\r\n\r Osteoclasts may also reduce pH at the osteochondral junction, thereby sensitizing and\r activating sensory nerves through actions on ion channels on their peripheral terminals.\r\n\r Effects on synovitis Synovitis is an integral part of OA pathogenesis. Multinucleated giant\r cells have been reported in synovitis, these cells are targets for bisphosphonates as are\r osteoclasts, and may be responsible for the positive effects noted in synovitis. Indeed\r bisphosphonates have been shown to inhibit macrophage activation in the synovium and reduce\r synovitis Effects on Bone marrow lesions The formation of bone marrow edema (BME, Bone marrow\r lesions) is part of OA pathogenesis, and is associated with progressive disease and\r disability. Several studies have demonstrated that increased remodeling activity in the\r subchondral region is associated with increased cartilage lesions and the investigators own\r studies supported by a grant from HSØ (South-East Health Region of Norway), have demonstrated\r that the presence of increased remodeling activity and vascularization of bone marrow lesions\r also show association with cartilage degradation. Bisphosphonates may target both the\r turnover increase, but also angiogenesis as bisphosphonates, and ZA in particular; exert\r pronounced anti-angiogenic effects.\r\n\r Direct effects on chondrocytes Chondroprotection with less fibrillation and ulceration has\r been demonstrated for ZA in an OA models in rabbits and dogs and it has been hypothesized\r that bisphosphonates may exert an anabolic effect on chondrocytes. In humans, several\r bisphosphonates have been shown to reduce cartilage degradation as reflected in the biomarker\r CTXII (C-terminal telopeptides of type 2 collagen).\r\n\r Clinical trials testing bisphosphonates in OA Bisphosphonates have been tested prospectively\r as treatment modalities in previous human clinical trials with equivocal results. One trial\r tested the effects of a less potent bisphosphonate (risedronate) with 4 different doses (5\r and 15 mg daily, 35 and 50 mg/week) in knee OA. Joint space width in the placebo group\r decreased non-significantly by 8 mm vs. 4 and 1mm in the 5 and 15 mg groups, respectively and\r pain scores did not show significant reductions. Furthermore, serendipitously, the placebo\r group in the Risedronate trial was very healthy, as it did not exhibit worsening of symptoms\r over the trial period. This may further have jeopardized the trial outcome. Markers of\r cartilage degradation, however, revealed significant reductions. In a Japanese study looking\r at the effects of another oral bisphosphonate, Alendronate, however, Nishii et al.\r demonstrated significant reductions in VAS and WOMAC pain scores for up to 24 months.\r\n\r The lack of efficacy of oral bisphosphonates in OA have been primarily ascribed to their poor\r absorption resulting in lower Cmax after administration (24). Therefore, more recent trials\r have focused on iv administration, where Cmax will be much higher. Varenna et al randomized\r 64 patients with OA and demonstrable BML's on MRI to receive either 4 iv. doses (100 mg per\r infusion of the bisphosphonate Neridronate or placebo. They demonstrated significant\r reductions in pain, reduced use of analgesics and improved QoL after 50 days. Similar\r improvements have been reported 5 weeks after intraarticular administration of the\r bisphosphonate clodronate. Data from the Osteoarthritis initiative demonstrated that patients\r treated with the iv bisphosphonate zoledronic acid for osteoporosis revealed significant\r reduction in OA pain scores for up to 3 years. In a later study, Laslett et al demonstrated\r significant effects on bone marrow edema size and pain in OA over a 1 year period. The doses\r given in the intravenous trials have been much higher than in the trials using oral\r administration.\r\n\r Rationale for dosage and placebo It seems that the dose required for effect on OA should be\r higher than that which is used for treatment of osteoporosis shown by Varenna et al.\r Therefore, in this study the investigators choose to treat with two doses of ZA.\r\n\r As there is no curable treatment for OA, best standard of care is alleviation through\r paracetamol, NSAIDs or in some cases opioids. Many patients already use one or more of these\r when they are referred to surgical evaluation. One of the endpoints of this study is to\r register use of these medications before and after treatment. Using paracetamol instead of\r placebo could potentially lead to overuse as it can be bought over the counter.\r Contraindication to NSAID's is common in the elderly population and could exclude many\r participants.\r\n\r Simulating the active phase reaction commonly seen with ZA infusion with an active placebo is\r difficult. However, administration of prednisolone and NSAID's should minimize symptoms.\r\n\r The investigators experience Based on the published experience with zoledronic acid in OA,\r the investigators administered two doses of IV. Zoledronic acid (5 mg) with a 3 month\r interval to patients with osteoporosis and OA of the hip and knee and demonstrable BML on\r MRI. The dosing regimen was based on previous studies reporting effects of zoledronic acid on\r bone marrow edema in transient osteoporosis. The patients achieved significant pain reduction\r as assessed by VAS within a period of 3 and 6 months. VAS decreased 85% from 6,8 (SD 1,8) at\r baseline to 1,0(0,9) at month 3 and 0,9(0,9) at month 6 (ANOVA p > 0,001). Among these were 3\r patients scheduled for surgery. 80% of the patients have been followed for more than 1 year\r and still exhibit the same degree of pain reduction and increased mobility.\r\n\r Risk versus benefits The risks of implant surgery are numerous, including infection,\r thrombosis, dislocation, fracture and in rare instances death. Therefore, a safe and\r effective conservative management can save the patient from unnecessary complications. The\r survivorship of hip implants has improved considerably over the last decades, but younger\r patients are at risk of needing one or more revisions during their lifetime. Revision\r surgeries are more prone to complications.\r\n\r The goal of this treatment is to delay or prevent the need for implant surgery. To\r participate, patients will delay a possible operation for 12 months. Those that are included\r in the placebo group will not receive any active treatment and cannot expect any better\r function other than placebo effect. Patients can withdraw from the study at any time.\r\n\r Although ZA is not approved for treatment of OA, it is regarded as safe for use in adults.\r The side effects of ZA are rarely serious. Known side effects such as atypical femur fracture\r and osteonecrosis of the jawbone is extremely rare (1/10.000-1/100.000). Acute phase\r reactions are common (30%), but usually mild to moderate and lasts 1-3 days. The symptoms can\r be alleviated with paracetamol, NSAID's or prednisolone.\r\n\r Microindentation includes injection of local anesthetics and a needle puncture on the tibial\r bone. No serious adverse events have been recorded.\r\n\r Magnetic resonance imaging poses no risks given that the participant has no contraindications\r to imaging such as metal or electronic implants sensitive to magnetic forces.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 50-80\r\n\r - Continuous worsening of hip pain with an onset of minimum 3 months\r\n\r - Hip Pain intensity >40mm on a visual analogue scale (VAS) ranging from 0 (no pain) to\r 100mm (maximal pain) during weight bearing for the last 7 days\r\n\r - HHS < 65 (Harris Hip Score)\r\n\r - Hip OA fulfilling the ACR (American College of Rheumatology) criteria [33]\r\n\r - Hip MRI scan showing large (>1 cm diameter) Bone Marrow lesions (BMLs)\r\n\r - Willing and able to consent and comply with the study protocol\r\n\r Exclusion Criteria:\r\n\r - eGFR (estimated glomerular filtration rate) < 35 ml/min or hypocalcemia\r\n\r - Exposure to any treatment affecting bone other than Ca+D ( bisphosphonates, Denosumab\r teriparatide or continuous treatment of prednisolone)\r\n\r - Diseases affecting bone and joints (i.e inflammatory joint diseases, osteonecrosis\r with segmental collapse and deformation, primary bone cancer or known skeletal\r metastases)\r\n\r - Severe vitamin D deficiency (S-25(OH)D < 25 nmol/l) has to be supplemented with Ca+D\r before zoledronic acid infusion\r\n\r - Ipsilateral knee prosthesis\r\n\r - Contralateral hip prosthesis\r\n\r - Women of child bearing potential (WOCBP). Female participants must be in a\r postmenopausal state or permanent sterile.\r\n\r - Hypersensitivity or previous allergic reaction to ZA or other bisphosphonates.\r\n\r - Hypersensitivity or previous allergic reaction to Calcigran Forte (a calcium and\r vitamine D supplement) or Prednisolone\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
749
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nOptimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial\n\n**Clinical Trial Summary:**\n\nThe primary objective of this study is to compare, in patients with severe aortic stenosis\r and concomitant coronary artery disease accepted for transcatheter aortic valve implantation\r (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the\r safety and efficacy of fractional flow reserve (FFR)-guided complete revascularization\r performed after (within 1-40 days) with FFR-guided complete revascularization performed\r before (within 1-40 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.\n\n**Clinical Trial Detailed Description:**\n\nThe prevalence of coronary artery disease in patients with severe aortic stenosis is high.\r About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal\r timing of coronary revascularization in patients with severe aortic stenosis and concomitant\r coronary artery disease undergoing TAVI is uncertain.\r\n\r The goal of this investigator-initiated, randomized, multicenter, two-arm, open-label,\r non-inferiority trial is to compare two treatment strategies that are currently performed in\r clinical practice: PCI before TAVI versus PCI after TAVI in patients with severe aortic\r stenosis and concomitant coronary artery disease.\r\n\r In this trial, consecutive patients with severe aortic stenosis and concomitant coronary\r artery disease accepted for TAVI and PCI by the Heart Team will be randomized in a 1:1 ratio\r to either FFR-guided complete coronary revascularization before (within 1-40 days) or after\r (within 1-40 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.\r\n\r For both treatment groups, suitable lesions with FFR≤0.80 or >90% diameter stenosis on\r coronary angiography in a coronary artery ≥2.5 mm in diameter are considered significant.\r\n\r TAVI and PCI will be performed according to current guidelines.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥18 years\r\n\r - Patients with severe aortic stenosis and concomitant coronary artery disease accepted\r for TAVI and PCI by a multidisciplinary Heart Team\r\n\r - Severe symptomatic aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or\r ≥40 mmHg (echocardiography) and at least one of the following:\r\n\r 1. Dyspnea\r\n\r 2. Angina symptoms\r\n\r 3. Syncope\r\n\r 4. Decline in left ventricular ejection fraction <50%, symptoms or fall in blood\r pressure on exercise testing, or presence of high-risk criteria (peak transaortic\r velocity >5.5 m/s, severe valve calcification, peak transaortic velocity\r progression ≥0.3 m/s per year, and severe pulmonary hypertension with systolic\r pulmonary artery pressure >60 mmHg) according to current guidelines\r\n\r Exclusion Criteria:\r\n\r - Inability to give informed consent\r\n\r - No PCI-eligible coronary artery stenosis\r\n\r - Admission with acute coronary syndromes within 30 days before randomization\r\n\r - Previous coronary artery bypass grafting (CABG)\r\n\r - Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12\r inhibitors (clopidogrel, ticagrelor, prasugrel)\r\n\r - Planned cardiac or major surgery\r\n\r - Known pregnancy at the time of inclusion\r\n\r - Participation in another clinical study with an investigational product\r\n\r - Life expectancy <1 year due to other severe non-cardiac disease\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
750
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSerum Biomarkers for Aortic Valve Stenosis\n\n**Clinical Trial Summary:**\n\nAthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the\r assessment of severity and prognosis of progression of aortic valve stenosis (AS, a\r devastating disease without early diagnosis and medical treatment). Two independent clinical\r cohorts of patients will provide serum samples, along with tissue and serum of a validated\r animal model of the disease for evaluation of the early stages, in order to develop and\r validate a multiplexed Enzyme-linked Immunosorbent Assay kit (multiplex ELISA). Advanced\r bioinformatics analysis will facilitate the selection of most promising molecules from\r integrated proteomics-transcriptomics-metabolomics data. The novel biomarkers will help\r clinicians to early diagnose patients at high risk and will pave the way for the experimental\r implementation of promising pharmaceutical therapies.\n\n**Clinical Trial Detailed Description:**\n\nThe deposition of calcium salts in the arterial wall and the heart valves is a commonly\r occurring phenomenon associated with increasing age and various pathological factors. A\r particular case is the calcification of the aortic valve, which is accompanied by gradual\r stenosis leading to heart failure. As a result, causes significant morbidity and a dramatic\r increase in mortality if not treated surgically or via transcatheter intervention. It affects\r approximately 2% of the population over the age of 65, being the third cause of death in this\r population. It numbers about 100 surgeries per 100,000 person-years in the decade and 180000\r patients each year are candidates for percutaneous aortic valve implantation (TAVI) in the\r US, Canada, and European Union.\r\n\r Characteristic of the disease is that it remains even today without a diagnosis at the\r critical early stages and all existing therapies have failed to slow or reverse the damage\r when applied in the final stages. Previous experimental studies suggested that existing drugs\r may be more effective if given early in the disease course. At the time when the aortic\r stenosis becomes evident on echocardiography or Computerized Tomography (CT), underlying\r biochemical and molecular lesions have already developed. Moreover, among the aortic valve\r stenosis patients, it is unknown who will rapidly evolve to a dynamic narrowing of the valve\r and previous research studies report significantly diverse progression rates among patients,\r with approximately 20-25% demonstrating more than double rates. Thus, the Achilles heel of\r the therapeutic management of patients is the lack of early diagnosis and disease progression\r prognosis.\r\n\r Under a combination of pathological effects by factors such as hypertension, diabetes\r mellitus and dyslipidemia in patients with a possible genetic predisposition, impairment of\r the normal structure and function of endothelium occurs, which progressively leads to the\r disease of the underlying valve tissue. Local acidosis and accumulation of oxidative oxygen\r radicals cause damage to membrane phospholipids, oxidation of cholesterol and proteins, which\r lose their normal quaternary structure and degrade. The gradual deposition of phosphate and\r calcium carbonate salts over the pathological proteins leads to calcification of the valve\r tissue. Intense inflammatory reaction with activation of bone marrow and infiltration of\r tissue with immunocompetent cells accompanies the damage: macrophages, B and T lymphocytes,\r mast cells infiltrate and actively contribute to the disease. Within this environment,\r inflammatory cytokines secreted from the inflammatory cells lead to activation of embryonic\r cell pathways that help to further enhance the calcification through the conversion of\r resident fibroblasts to active osteoblasts, which actively deposit calcium salts through\r extracellular vesicles.\r\n\r In the disease, multiple cell types and distant organs are involved (liver - cholesterol\r metabolism, spleen and bone marrow - immune response activation) and the damage is expected\r to release fragments of biological and biochemical substances in the blood circulation.\r Hence, the disease is expected to be reflected in changes in serum protein and. It is\r possible to detect proteins and metabolites in the blood serum in appropriately selected\r patients, prospectively enrolled and monitored through the course of aortic valve stenosis.\r An optimal subgroup description of patients with rapid or slow disease progression can reveal\r important information for future clinical diagnostic and prognostic use.\r\n\r The purposes of Athena Valve are:\r\n\r (A) Collection of data on the progression of calcification and aortic valve stenosis,\r description of subpopulations with rapid and slow progression and record of clinical events.\r\n\r (B) The bioinformatics analysis of data from combined transcriptomics-metabolomics-proteomics\r of diseased animal model aortic valve tissue in the early, intermediate and final stages, in\r comparison with existing patient multi-omics databases, in order to investigate candidate\r molecules - \"drivers\" of the damage with a causal relationship.\r\n\r (C) The differential proteomic analysis of patient sera samples with severe aortic valve\r stenosis, retrospectively defined as rapid versus slow disease progressors and control group\r of individuals without aortic valve stenosis and severe calcification.\r\n\r (D) The differential metabolomic analysis of patient sera samples with severe aortic valve\r stenosis, retrospectively defined as rapid versus slow disease progressors and control group\r of individuals without aortic valve stenosis and severe calcification.\r\n\r (E) The integrated bioinformatics data analysis of differential patient serum proteome and\r metabolome enriched with the results of the animal model and existing databases from other\r patients, to determine the most probable - causally related molecules with disease\r progression in a molecular network.\r\n\r (F) Utilization of the more important protein targets for the development of a novel\r detection assay for multiple protein targets in blood serum by multiplex ELISA based on the\r results of the bioinformatics analysis.\r\n\r (G) Application of the new assay multiplex ELISA in paired serum samples of patients with\r moderate to severe aortic stenosis and control group of individuals without aortic valve\r stenosis and severe calcification, prospectively enrolled and monitored, initial validation\r of the assay and review of its diagnostic performance.\r\n\r Brief Methodology:\r\n\r Two independent clinical cohorts will provide necessary data and serum samples. The first, a\r retrospective cohort of patients with severe aortic valve stenosis will define serum,\r echocardiographic and clinical differences among subgroups with different progression rates.\r The second cohort, prospectively developed, will confirm the retrospectively obtained\r clinical and echocardiographic data and provide baseline and follow-up measurements of aortic\r valve calcification (CT calcium score). Paired baseline and follow-up serum samples will\r validate serum targets from the retrospective cohort. Patients will be assessed with\r echocardiography annually and with follow-up CT at 2 and 5 years from enrollment.\r\n\r Retrospective proteomics will be done with untargeted Liquid Chromatography/Mass Spectrometry\r (LC/MS) and metabolomics with untargeted Liquid Chromatography-tandem Mass Spectrometry\r (LC-MS/MS) in Serial Reaction Monitoring (SRM) mode. Prospective proteomics and metabolomics\r will be quantitative and targeted. Blood samples will be immediately frozen and stored to -80\r C.\r\n\r For pathophysiological enrichment, a modified New Zealand rabbit model for aortic stenosis\r will be used in a longitudinal protocol of tissue harvesting in the early, intermediate and\r late-stage disease (corresponding to inflammation - calcification and subsequent valve\r stenosis).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Retrospective cohort: patients with severe aortic valve stenosis in echocardiography:\r\n\r • Vmax > 4 m/sec and mean Gradient >40 mmHg and/or Aortic Valve Area indexed (AVAi) <\r 0.6 cm2/m2 and/or Velocity index <0.25 whichever worse, with available complete past\r echocardiographic follow-up (>2 past studies) indicating disease progression, by the\r same performing physician.\r\n\r - Prospective cohort: patients with moderate aortic valve stenosis in echocardiography:\r\n\r - Vmax 3-4 m/sec and mean Gradient 25-40 mmHg and/or AVAi 0.6-0.9 cm2/m2,\r\n\r - Where inconsistent: Velocity index = 0.25-0.50.\r\n\r - Technical details: Optimal doppler measurements obtained by the best feasible\r echocardiographic window (demonstrating at least 2 windows, where possible\r including right parasternal with or without pencil probe).\r\n\r - Prospective Control group: patients at intermediate to high risk for CVD according to\r atherosclerotic risk factors assessment - Heart Score\r\n\r Exclusion Criteria:\r\n\r - Echocardiographic Stroke Volume indexed (SVi) <35 ml/m2\r\n\r - Bicuspid aortic valve\r\n\r - Stenosis of rheumatic etiology\r\n\r - More than mild aortic valve regurgitation\r\n\r - More than mild mitral valve regurgitation\r\n\r - More than mild mitral stenosis\r\n\r - Severe pulmonary hypertension\r\n\r - Chronic ischemic heart failure with Ejection Fraction < 45%\r\n\r - Right heart failure (based on the echocardiographic assessment of Right Ventricle\r Dimension, Tricuspid Annular Plane Systolic Excursion, tricuspid annular velocity, and\r clinical syndrome)\r\n\r - Acutely decompensated Heart Failure with preserved Ejection Fraction <4 weeks\r\n\r - N-terminal-pro hormone Brain Natriuretic Peptide (NT-proBNP)> 900 pg/ml for ages\r 60-75, NT-pro-BNP > 1800 pg/ml for ages >75 years\r\n\r - Presence of chronic systematic inflammatory disease\r\n\r - Presence of autoimmune disease\r\n\r - Active malignancy\r\n\r - History of chemotherapy past 3 years\r\n\r - Any history of thoracic radiotherapy\r\n\r - Active treatment with monoclonal antibodies\r\n\r - Under-treated hypertension\r\n\r - Under-treated metabolic or endocrine disease\r\n\r - Acute infection (<4 weeks)\r\n\r - Any acute inflammation (<4 weeks)\r\n\r - Unstable angina - myocardial infarction past 3 moths\r\n\r - Stage 4 or 5 Chronic Kidney Disease (as defined by CKD-EPI derived estimated\r Glomerular Filtration Rate or 24hr urine measurement)\r\n\r - Any acute renal failure <4 weeks\r\n\r - Stroke past 3 months\r\n\r - Any disabling stroke\r\n\r - Surgery except for minor procedures past 3 months\r\n\r - Poor mobility/immobilization\r\n\r - Life expectancy < 3 years for any reason\r\n\r - Difficulty in following follow-up protocol for any reason\r\n\r For the control group:\r\n\r - Known coronary artery disease\r\n\r - Any heart valve disease, excluding minor valve regurgitation\r\n\r - Any heart failure\r\n\r - Pulmonary Hypertension\r\n\r - Peripheral artery disease\r\n\r - Presence of chronic systematic inflammatory disease\r\n\r - Presence of autoimmune disease\r\n\r - Active malignancy\r\n\r - History of chemotherapy past 3 years\r\n\r - Any history of thoracic radiotherapy\r\n\r - Active treatment with monoclonal antibodies\r\n\r - Under-treated hypertension\r\n\r - Under-treated metabolic or endocrine disease\r\n\r - Acute infection (<4 weeks)\r\n\r - Any acute inflammation (<4 weeks)\r\n\r - Stage 4 or 5 Chronic Kidney Disease, as defined by the Chronic Kidney Disease -\r Epidemiology Collaboration (CKD-EPI) derived estimated Glomerular Filtration Rate or\r 24hr urine measurement\r\n\r - Any acute renal failure <4 weeks\r\n\r - Any stroke\r\n\r - Surgery except for minor procedures past 3 months\r\n\r - Poor mobility/immobilization\r\n\r - Life expectancy < 3 years for any reason\r\n\r - Difficulty in following follow-up protocol for any reason\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
751
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMorbidity and Mortality Due to Deferral of Aortic Valve Replacement in Patients With Severe Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nBackground and Project Rationale:\r\n\r Degenerative aortic valve stenosis affects 2% of the elderly population aged 70 years or\r older and progresses insidiously with advancing age [1] before manifesting with symptoms such\r as decreased exercise tolerance, shortness of breath, chest pain and syncope on exertion.\r Without aortic valve replacement, the survival prognosis of patients with symptomatic aortic\r stenosis is poor. In the PARTNER 1B trial, all-cause mortality among 179 inoperable patients\r with severe symptomatic aortic stenosis allocated to conservative management amounted to 51%\r at one year [2]. Consistently, prospective registry data reported a mortality rate of 55% at\r 1 year in 78 patients with severe aortic stenosis undergoing conservative management [3].\r\n\r The rapid spread of the SARS-CoV-2 pandemic represents an unprecedented challenge for\r healthcare systems. A limited number of ventilators and ICU beds call for a careful\r allocation of healthcare resources. On March 20 2020, the Federal Council prohibited elective\r interventions in all hospitals in Switzerland. Patients with untreated severe aortic stenosis\r are particularly vulnerable to SARS-CoV-2 infection [4] and face the dual risk of cardiac\r death from aortic stenosis on one side, and death from acute respiratory distress syndrome\r secondary to SARS-CoV-2 infection on the other. While the balance between the two risks is a\r matter of clinical judgement, the investigators established an algorithm for the management\r of patients with severe aortic stenosis during the SARS-CoV-2 pandemic. Patients with aortic\r stenosis deemed critical will undergo valvular replacement in spite of the ongoing pandemic\r while patients with severe but not critical aortic stenosis will undergo deferred\r intervention once the number of new SARS-CoV-2 infections flattens.\r\n\r In the current situation, aortic valve replacement in patients with severe, non-critical\r aortic stenosis will be deferred in order to give priority to SARS-CoV-2 patients. This\r unique situation allows the investigators to study the effect of deferral of aortic valve\r replacement in patients with severe aortic stenosis.\r\n\r The study is an amendment to the Swiss-TAVI registry. In contrast to the Swiss-TAVI registry,\r patients are not enrolled at the time of aortic valve replacement, but already at the time of\r referral for aortic valve replacement.\r\n\r Primary Objective:\r\n\r The aim of the present observational study is to explore the effect of deferral of valvular\r replacement in patients with severe but not critical aortic stenosis on morbidity and\r mortality. The primary objective is to describe rates of morbidity and mortality among\r patients with severe but not critical aortic stenosis in the interval from\r referral/indication for valvular replacement to intervention.\r\n\r Project Design:\r\n\r The study is a prospective cohort study of patients with severe aortic stenosis referred for\r aortic valve replacement. All referrals for aortic valve replacement will be allocated to\r either \"transcatheter aortic valve replacement (TAVR)/ surgical aortic valve replacement\r (SAVR) (standard of care)\" or \"deferred intervention\" based on prespecified criteria.\r Patients with critical aortic stenosis as defined by an aortic valve area (AVA) <0.6 cm2 or a\r transvalvular mean gradient of >60 mmHg or a history of cardiac decompensation during the\r previous 3 months or clinical symptoms on minimal exertion (NYHA III) will be allocated to\r TAVR or SAVR. All other patients with severe aortic stenosis defined by an AVA <1.0 cm2 will\r be scheduled for a deferred intervention.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 18 years\r\n\r - Patients with severe AS defined by an AVA <1cm2 or AVA indexed to BSA of <0.6 cm2/m2,\r including low-flow severe aortic stenosis defined by SVI <35ml/m2.\r\n\r Exclusion Criteria:\r\n\r - Life expectancy <1 year irrespective of severe AS.\r\n\r - Severe dementia defined as MMS-Test <16 points.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
752
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAnalysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nThis study evaluates and compares aortic calcium by computed tomography and histopathology in\r patients with aortic stenosis.\n\n**Clinical Trial Detailed Description:**\n\n1. Title\r\n\r Analysis and comparative evaluation of aortic calcium by computed tomography and\r histopathology in patients with aortic stenosis.\r\n\r 2. Background.\r\n\r Calcified aortic valve disease (CAVD) was initially considered to be a passive\r degeneration of the extracellular matrix (EM). Recent studies have shown that within the\r development of the damage mechanism there is complexity and it is an active (1) and\r degenerative process where genetic, environmental and epigenetic phases overlap and\r interact leading to hemodynamic changes in blood flow, endothelial dysfunction and\r metabolic disorders that lead to low-density lipoprotein cholesterol deposits in the ME\r where at the same time there is an underlying infiltration of macrophages, oxidative\r stress, and release of pro-inflammatory cytokines. (2) However, although there are\r several theories of damage, and some of them are attributed to a diversity of origin\r such as genetic, congenital, infectious, and degenerative. Finally, the dynamic and\r functional impact of the heart affects equally. It leads to organic deterioration when\r the AD reaches clinical and echocardiographic criteria of severity, and the only\r therapeutic option is the change or replacement of the aortic valve.\r\n\r The participation of imaging methods such as computerized tomography about to the\r concerning the aortic valve through the measurement of the aortic calcium score (AVC-CT)\r as a method to determine the severity of aortic stenosis (AS) in those cases where\r echocardiographic measurements are conflicting, allows us to see the interest in\r defining this problem through different angles of investigation (7). In AD, progressive\r calcification is the trigger factor that also predominantly leads to aortic valve\r obstruction. (3) Currently, such calcification can be easily quantified using the same\r acquisition protocol and Agatston Scoring Method as used for a coronary artery calcium\r scan and is particularly attractive because it provides an assessment of the severity of\r AD, which is independent of the geometry and ventricular ejection fraction. Advances in\r the field of CT CVA measurement have been demonstrated in the last decade and are\r closely associated with hemodynamic measurements of moderate to severe AD in Doppler\r echocardiography, however, until recently, significant over-positioning of calcium from\r the aortic valve area among patients with hemodynamically severe AD and those with\r non-severe AD made it challenging to implement in clinical practice.\r\n\r This development has generated significant interest in the use of CT-CVA as an\r alternative and complementary assessment of the severity of AD, especially in patients\r with discordant echocardiographic findings. (11) In fact: 1) CVA is strongly but\r non-linearly associated with hemodynamic measures of severity in moderate to severe AD\r (12). Thus, the determination of CVA may help discriminate severe AD from non-severe AD\r in patients with discordant findings measured by echocardiography, and 3) in patients\r with moderate to severe AD, CVA is also likely associated with faster progression of AD\r and with survival. However, it should be mentioned that the analysis of that series did\r not make adjustments to the calcium measured in the patients' coronary artery. Although\r the CVA score has been recommended in the European Society of Cardiology Guidelines to\r confirm the severity of AD in the following conditions 1) patients with low left\r ventricular ejection fraction (LVEF), gradient and low flow, in which dobutamine stress\r echocardiography is inconclusive and 2) patients with low gradient AD and preserved\r LVEF, and this is not yet part of the American Heart Association (AHA) and American\r College of Cardiology (ACC) guidelines (13).\r\n\r So it has been suggested that clinical applicability should be established, so what are\r the next steps? While the reproducibility of coronary calcium quantification by\r multidetector CT has been tested for various workstation platforms before, (14,15) the\r same has not been done so far for CVA quantification through variability with standard\r Gold through the histopathological study and determine the variability of the CVA score\r measured by CT by determining its relationship through the flow and gradient status of\r patients with AD and define what implications can be suggested for the patient's\r treatment(13,16)\r\n\r 3. Problem statement.\r\n\r There is a high prevalence of aortic valve calcification in patients who are subjected\r to valve change regardless of the cause (genetic, congenital, or degenerative structural\r malformation). Early identification of calcification in these patients is critical since\r they will receive a valve change that is likely to return to dysfunction if there is no\r history of the type of damage with or without preceding valve calcification. Currently,\r there is controversy about the ideal time to initiate valve therapy, as it has not been\r possible to identify those patients who will develop significant valve calcification.\r However, little is known about the relationship between the new imaging methods that are\r promising for measuring it and its correlation with standard gold, that is, what is\r quantified at the histopathological level.\r\n\r 3.1. Justification.\r\n\r Magnitude: The global prevalence of aortic stenosis is 0.3-0.5% and 2-7% in >65 years\r and of valvular calcification. According to its definition and criteria to classify\r valve stenosis, up to 30% will require aortic valve change due to valve insufficiency.\r\n\r Significance: In the last two decades, the incidence of aortic valve insufficiency has\r increased exponentially and has been associated with unfavorable outcomes.\r\n\r Vulnerability: Currently, the cornerstone of aortic stenosis management includes\r prevention and early support management. The identification of calcification has not\r been entirely clear either through laboratory parameters or about to with concerning\r risk factors, which are inadequate and late. Early detection and intervention of\r calcification during the disease can improve the prognosis if it is recognized early.\r\n\r Feasibility: The study will be carried out in the two departments of Immunology through\r Dr. Soto who will coordinate the research) (Cardiovascular Medicine through Dr. Israel\r Pérez Torres who will evaluate calcification and histological changes in the valve\r tissue) (Pathology through Dr. Aranda who will manage and treat the valve samples) and\r the Image Department coordinated by Dr. Sergio Críales Vera who will quantify the valve\r calcium). All departments are recognized for their extensive participation in research.\r\n\r The study of the pathogenesis of persistent inflammatory damage in aortic stenosis in\r relation to the type of prosthesis will lead in the future to evaluate if it is a factor\r involved in the recurrent damage in stenosis, calcification, and deterioration. In the\r last decades in Mexico, the demographic transition increased the number of people over\r 65 years old, the population in which the most significant complication of valve\r dysfunction has been seen. However, regardless of age and etiology, this is currently a\r population group with significant expansion and is expected to triple by 2030. This\r inflammatory damage will increase the prevalence of aortic stenosis, and therefore more\r patients will require valve replacement surgery.\r\n\r Our Institute is a national reference hospital that attends a significant number of\r patients with aortic stenosis, among others. Of the valves that are implanted, a quarter\r is manufactured at the Institute. Therefore, evaluating processes highly related to\r valve dysfunction such as calcification is a priority and is considered a health problem\r that requires prevention.\r\n\r 3.2. Research question.\r\n\r In patients who have undergone aortic valve surgery, will the quantification of calcium\r using the 4D computerized tomography method have a reasonable correlation with that\r measured by histopathology, and will it also allow it to be proposed as an early\r predictor of dysfunction?\r\n\r 4. Hypothesis.\r\n\r Working hypothesis (H1): The quantifiable assessment of valve calcium by CT is similar\r to that measured by histopathology and predicts early valve dysfunction.\r\n\r Null hypothesis (H0): The quantifiable assessment of calcium by CT scan is different\r from that measured by histopathology and does not predict early valve dysfunction.\r\n\r 5. Methodology.\r\n\r 5.1. Study design.\r\n\r Cohort, observational, comparative, and prospective study.\r\n\r 5.2.5. Elimination criteria.\r\n\r a) Not having an adequate sample or staining of the valve tissue.\r\n\r 5.3. Sample size.\r\n\r For the calculation of the sample size, a determination of the sample size (two tails)\r shall be made, taking into account the means and standard deviation (SD) of the items\r corresponding to each one. All patients who meet the inclusion criteria described above\r shall be considered for evaluation during the period 2017-2020.\r\n\r 5.4. Data collection technique\r\n\r Data collection will be divided into three stages:\r\n\r Pre-surgical:\r\n\r Once the study population has been identified, a personal interview will be conducted,\r the objective of the study will be explained to the patient, and informed consent will\r be obtained. Various echocardiographic parameters will be collected for each patient\r (pre-surgical echocardiogram). The study of the valve, which is requested before\r surgery, will be analyzed in a tomography scan, and this is the one that will be used to\r measure the calcium.\r\n\r Post-surgery\r\n\r Employing the sample of the valve tissue obtained from the surgery, the appropriate cuts\r and stains for the measurement of the calcium will be requested.\r\n\r Echocardiographic study.\r\n\r The echocardiographic study performed will be re-evaluated by two expert\r echocardiographers following current recommendations.16 The Philips iE33 xMATRIX\r (Philips, Andover Massachusetts) ultrasound system with X5-1 transducer. The dimensions\r of the left ventricle will be quantified in the long parasternal axis; the volumes of\r the left atrium and left ventricle will be calculated with the Simpson method. The\r aortic valve area will be estimated with the continuity equation. The mass of the LV was\r estimated with the Devereaux method.17 The mean and maximum transvalvular aortic\r gradients will be acquired in the apical projection of three or five chambers, where a\r suitable continuous Doppler spectrum and the highest transaortic velocity were obtained.\r The pulmonary artery systolic pressure will be estimated by adding the right atrial\r pressure to the tricuspid insufficiency gradient.\r\n\r Computed tomography evaluation.\r\n\r The study was performed with a multidetector with double energy source of 256 cuts\r definition Flash Medical Systems Forcheim Germany (128 x 2), performing prospective\r additive in the best diastolic phase (65-70 %), with 3 mm thick reconstructions and 3mm\r spacing with Kernel B 35f filter and visual field adjusted only to the heart. The images\r were processed on a workstation (SmartScore by Syngo via, Waukeesha WI Electronics for\r Medicine. The results were expressed in Agatston units. The study was carried out\r without a contrast medium and with a radiation equivalent to 1.0 mSv.\r\n\r Tissue evaluation\r\n\r Histological technique.\r\n\r A 5-micron segment of the aortic valve, obtained by cardiothoracic surgery, was washed\r in 0.9% NaCl for 30 seconds immediately after the tissues were fixed by immersion in\r phosphate buffer with 10% formalin (pH 7.4) for 24 hours. Histological sections of the\r aortic valve were processed according to conventional histological procedures using Von\r Kossa staining. The technique is based on the reaction of silver nitrate in the presence\r of a reducing agent, usually, hydroquinone, resulting in insoluble silver phosphate that\r can be seen under the microscope in black. Histological sections were analyzed using a\r Carl Zeiss light microscope (Carl Zeiss, West Germany, Germany) (model 63,300) equipped\r with a Tucsen digital camera (9 megapixels) with TSview 7.1 software (Tucsen Imaging\r Technology Co., Ltd. Chuo, Japan, at 25x magnification. The photomicrographs were\r analyzed by densitometry using Sigma Scan Pro 5 Systat Software Inc. San Jose,\r California, CA, USA. Density values are expressed as pixel units.\r\n\r 6. Statistical analysis plan.\r\n\r Categorical variables were expressed as proportions, continuous variables as means with\r standard deviation or median with interquartile range according to the distribution.\r Comparisons will be made for categorical variables with Chi-square or Fisher exact test and\r dimensional variables with Student t or Mann-Whitney U. Correlations with Pearson's r for\r quantitative variables or Spearman's rho for qualitative variables. Related samples were\r analyzed with ANOVA for repeated measurements and Friedman's test according to distribution\r with post-hoc analysis to identify differences between groups. The diagnostic test study will\r include the ROC curve to analyze cut-off points. The p-value of statistical significance was\r established to be less than 0.05 at two-tailed. Statistical analysis was performed with SPSS\r version 22 software (SPSS Inc. Chicago, Illinois).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients who are candidates for aortic valve replacement.\r\n\r 2. Age greater than or equal to 18 years of age.\r\n\r 3. Both genders.\r\n\r 4. With any associated comorbidity\r\n\r 5. Any etiology\r\n\r 6. Hospitalized and with an echocardiographic study showing the variables to be studied\r\n\r 7. Informed Consent.\r\n\r Exclusion Criteria:\r\n\r 1. Patients who have previously undergone other aortic valve surgery\r\n\r 2. Patients who have received contrast medium ≤24 hours.\r\n\r 3. Patients on hemodialysis.\r\n\r 4. Patients with infection.\r\n\r 5. Patients with cancer.\r\n\r 6. Patients with autoimmune diseases.\r\n\r 7. Pregnant women.\r\n\r 8. Patients who refuse to be included.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
753
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStudy of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.\n\n**Clinical Trial Summary:**\n\nClarification of indications for surgical correction in patients with borderline expansion of\r the ascending aorta\n\n**Clinical Trial Detailed Description:**\n\nExpanding indications for surgical treatment of patients with borderline values of the\r ascending aorta\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Extension of the ascending aorta less than 55 mm\r\n\r 2. Tricuspid Aortic Valves.\r\n\r 3. Extension of the ascending aorta more than 45 mm\r\n\r Exclusion Criteria:\r\n\r 1. Age less 45 years\r\n\r 2. Age more 75 years\r\n\r 3. Multiple organ failure\r\n\r 4. oncological disease\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
754
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSevere Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI\n\n**Clinical Trial Summary:**\n\nPatients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery\r disease (CAD) are known to have higher mortality rates compared to patients without CAD. This\r same phenomenom has not been clearly mapped in patients with CAD that goes through a\r transcatheter aortic valve implantation procedure.\n\n**Clinical Trial Detailed Description:**\n\nA narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the\r elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and\r fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic\r valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large\r setback of this method is that a third of these patients could not undergo the treatment due\r to too high surgical risk.\r\n\r Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment\r of severe aortic valve stenosis during the last decade. The procedure, which is a minimal\r invasive type of surgery, introduces a new aortic valve through a catheter, usually\r transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is\r known to have higher mortality rates postoperatively. However, it is not clearly known how an\r underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal\r to contribute with the mapping of how a CAD affects the long term results for patients with a\r severe aortic valve stenosis that undergoes TAVI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients that underwent a TAVI procedure at Örebro University Hospital between\r 2009 till 1st december 2019.\r\n\r Exclusion Criteria:\r\n\r - Patients with procedural-related coronary artery injury and patients with solitary\r stenosis in a diagonal branch were excluded from the study.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
755
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAerosol Combination Therapy of All-trans Retinoic Acid and Isotretinoin as A Novel Treatment for Inducing Neutralizing Antibodies in COVID -19 Infected Patients Better Than Vaccine : An Innovative Treatment\n\n**Clinical Trial Summary:**\n\nAerosol Combination therapy of All-trans retinoic acid and Isotretinoin as A novel Treatment\r for Inducing Neutralizing Antibodies in COVID -19 Infected Patients better than vaccine : An\r innovative Treatment\r\n\r Mahmoud ELkazzaz(1),Tamer Haydara(2), Mohamed Abdelaal(3), Ahmed M. Kabel(4), Abedelaziz\r Elsayed(5) ,Yousry Abo-amer(6) ,Hesham Attia(7)\r\n\r 1. Department of chemistry and biochemistry, Faculty of Science, Damietta University,Egypt.\r\n\r 2. Department of Internal Medicine,Faculty of Medicine, Kafrelsheikh University, Egypt\r\n\r 3. Department of Cardiothoracic Surgery,Faculty of Medicine, Kafrelsheikh University, Egypt\r\n\r 4. Department of Clinical Pharmacy, Faculty of Medicine , Tanta University,Egypt.\r\n\r 5. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy,Tanta University,Egypt.\r\n\r 6. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology\r Teaching Hospital,Egypt\r\n\r 7. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt.\r\n\r - Study Chair ((( Dr.Tamer Hydara))), Department of Internal Medicine,Faculty of\r Medicine, Kafrelsheikh University, Egypt Contact: Dr.Tamer Hydara-Tel:\r 00201142233340 Mail: [email protected]\r\n\r - Principal Investigator ((( Mahmoud Elkazzaz))), Faculty of Science, Damietta\r University,GOEIC,Egypt Contact:Tel: 00201090302015 Mail:\r [email protected]\r\n\r - Study coordinator ((Prof/Dr Mohamed Abdelaal)), Department of Cardiothoracic\r Surgery,Faculty of Medicine, Kafrelsheikh University, Egypt Contact:Tel:\r 00201001422577 Mail: [email protected]\r\n\r Abstract\r\n\r The pandemic of COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2\r (SARS-COV-2) has infected over 20,000,000 people causing over 700,000 deaths .It has no\r currently approved treatments. In this clinical study we confirm that combination of\r isotretinoin and All trans retinoic acid can be used in the treatment of SARS-COV-2 better\r than vaccine according to the findings of previous studies and researches. Retenoic acid can\r induce neutralizing antibodies in case of corona virus (COVID-19) by restoring inhebited and\r exhausted T cells via inhebiting both CD13 and Angiotensin-converting enzyme-2 (ACE2). CD13\r amyloid receptor which abundantly overexpressed on cell surface of lymphocyte, Dentritic\r cell, Macrophage, granulocytes and monocytes and is ubiquitous in respiratory tract\r epithelial cells, smooth muscle cells, fibroblasts, epithelial cells in the kidneys and small\r intestine, activated endothelial cells, and platelets In addition inhibing of\r Angiotensin-converting enzyme-2 (ACE2) , Angiotensin T1 protein and Angiotensin II-mediated\r intracellular calcium release pathway which is responsible for COVID-19 cell fusion and\r entry.ACE2-expressing cells are prone to SARS-CoV-2 infection as ACE2 receptor facilitates\r cellular viral entry and replication. A study demonestrated that patients with hypertension\r and diabetes mellitus may be at higher risk of SARS-CoV-2 infection, as these patients are\r often treated with ACE inhibitors (ACEIs) or angiotensin II type-I receptor blockers (ARBs),\r which have been previously suggested to increase ACE2 expression.Butisotretinoin was found to\r be the strongest down-regulator of ACE 2 receptors.and this will give hope for diabetic\r patients or patients with hypertension infected with COVID-19.Therefore we suggest that\r Retinoic Acid will help in inhabiting factors which may enhance antibody dependent\r enhancement (ADE), A phenomenon caused by covid-19 which expected to lead to failure of\r vaccination specially in case of corona virus (covid-19) as a hyper mutatated COVID-19\r antigens can lead to (ADE) phenomenon in which IgG antibodies facilitate viral entry and\r fusion with infected cell through uptake of the virus-IgG complex via the Fc receptors and\r later viral fusion with antigen presenting cells like Dentric cells, macrophages and B cells\r via FcR , through the neonatal FcR instead of antibodies induced viral agglutination and this\r is known as antibody dependent enhancement (ADE)(2) ADE can hamper vaccine development, as a\r vaccine may cause the production of antibodies which, via ADE, worsen the disease the vaccine\r is designed to protect against. ADE in COVID-19 infection can be caused by high mutation rate\r of the gene that encodes spike (S) protein. In this clinical study we suggest that Hyper\r mutated spike protein ,lymphopenia, and impaired dentreic cells all these factors can help in\r and lead to delayed antibodies response and appearing after a period of covid -19 symptoms\r onset and this may be responsible for antibody dependent enhancement (ADE)\r\n\r Keywords: COVID 2019 , Retinoic acid, Lymphopenia ,T Cells, Dentric cells , ADE, Vaccine\n\n**Clinical Trial Detailed Description:**\n\nThis is a Phase 2, , randomized (1:1:1), placebo-controlled, 2-weeks, proof-of-concept study\r to evaluate the safety and tolerability as well as the mechanistic effect of oral\r administration of potent inhibitor of neutrophil elastase(Inhaled All trans retinoic acid and\r inhaled isotretinoin in subjects infected with COVID -19\r\n\r Unfortunately, all of the vaccinated monkeys treated with the Oxford vaccine known as ChAdOx1\r nCoV-19, is undergoing human trials in Britain.became infected when challenged as judged by\r recovery of virus genomic RNA from nasal secretions,\" said Dr William Haseltine, a former\r Harvard Medical School professor who had a pivotal role in the development of early HIV/Aids\r treatments. and in general future COVID-19 vaccination which depends on inactivated viral\r vaccine will be restricted to healthy people with strong immunity and It will not be given to\r patients with History of contact with a SARS-CoV-2 infection (positive in nucleic acid test).\r In addition to the COVID-19 viral antigens lead to stimulate antibodies formation of IgM in\r acute phase and IgG type in chronic phase which is facilitate viral entry and fusion with\r infected cell through uptake of the virus-IgG complex via the Fc family of receptors and\r later viral fusion with antigen presenting cells like macrophages, B cells, monocytes via FcR\r family, and vascular endothelium through the neonatal Fc receptor (nFcR) instead of\r antibodies induced viral agglutination and this is known as antibody dependent enhancement\r (ADE)(2).\r\n\r There are various hypotheses on how ADE happens and there is a likelihood that more than one\r mechanism exists. In one such pathway, some cells of the immune system lack the usual\r receptors on their surfaces that the virus uses to gain entry, but they have Fc receptors\r that bind to one end of antibodies. The virus binds to the antigen-binding site at the other\r end, and in this way gains entry to and infects the immune cell. Dengue virus can use this\r mechanism to infect human macrophages, if there was a preceding infection with a different\r strain of the virus, causing a normally mild viral infection to become life-threatening.(3)\r An ongoing question in the COVID-19 pandemic is whether-and if so, to what extent-COVID-19\r receives ADE from prior infection with other coronaviruses.\r\n\r ADE can hamper vaccine development: ADE can hamper vaccine development, as a vaccine may\r cause the production of antibodies which, via ADE, worsen the disease the vaccine is designed\r to protect against. Vaccine candidates for Dengue virus and feline infectious peritonitis\r virus (a cat coronavirus) had to be stopped because they elicited ADE.(4)\r\n\r ADE in coronavirus infection can be caused by high mutation rate of the gene that encodes\r spike (S) protein. A thorough analysis of amino acid variability in SARS-CoV-2 virus\r proteins, that included the S-protein, revealed that least conservative amino acids are in\r most exposed fragments of S-protein including receptor binding domain (RBD).(5) Delayed\r antibodies response and secretion after covid -19 symptoms onset is responsible for antibody\r dependent enhancement (ADE)\r\n\r A study shows the first seroconversion day of IgA was 2 days after onset of initial symptoms,\r and the first seroconversion day of IgM and IgG was 5 days after onset. The positive rate of\r antibodies in the 183 samples was 98.9%, 93.4% and 95.1%, for IgA, IgM and IgG, respectively.\r The seroconversion rate for IgA, IgM or IgG was 100% 32 days after symptom onset. According\r to the cumulative seroconversion curve, the median conversion time for IgA, IgM and IgG was\r 13, 14 and 14 days, respectively. (6)\r\n\r Because this immune response takes a while to show up, antibody tests will be negative for\r those newly infected with COVID-19, which is why they're not used for diagnosis.\r\n\r \"If it's the beginning of the infection, you don't pick it up, it's something that only\r develops later,\" Dr. Melanie Ott, a virologist and immunologist at the Gladstone Institutes\r and a professor at the University of California, San Francisco.(7)\r\n\r So, the principal investigator expects that delayed antibody response and delayed\r immunoglobulin class switching are the main reason for antibodies infectivity and\r non-specificity in the highly mutated covid-19 infection\r\n\r High-affinity IgG antibodies may efficiently resolve Covid -19 infection\r\n\r The more than 100 COVID-19 vaccines in development mainly focus on another immune response:\r antibodies. These proteins are made by B cells and ideally latch onto SARS-CoV-2 and prevent\r it from entering cells. T cells, in contrast, thwart infections in two different ways. Helper\r T cells spur B cells and other immune defenders into action, whereas killer T cells target\r and destroy infected cells. The severity of disease can depend on the strength of these T\r cell responses(1).\r\n\r Studies on humoral responses to infections have been mainly geared toward the production of\r high-affinity IgG antibodies that efficiently resolve an infection. It has been well\r recognised, however, that humoral immune response to infection can be a double-edged sword\r that either serves as a protective mechanism to resolve the infection or aggravates the\r tissue injury, e.g. IgG response causes fatal acute lung injury by skewing\r inflammation-resolving response in SARS .(8)\r\n\r In the case of respiratory infection, while IgM and IgG isotypes have been the primary\r emphasis in characterising immunity, mucosal and systemic IgA responses that may play a\r critical role in the disease pathogenesis, have received much less attention.(9),(11)\r\n\r High neutrophils in covid-19 infection may be the reason of delayed antibody response and\r severe complications\r\n\r Humoral immune response, especially production of neutralizing antibody, plays a protective\r role by limiting infection at later phase and prevents reinfection in the future. In\r SARS-CoV, both T and B cell epitopes were extensively mapped for the structural proteins, S,\r N, M and E protein.(12) A limited serology details of SARS-CoV-2 was reported. In a\r preliminary study, one patient showed peak specific IgM at day 9 after disease onset and the\r switching to IgG by week 2.25 Interestingly, sera from 5 patients of confirmed COVID-19 show\r some cross-reactivity with SARS-CoV, but not other coronavirus. Furthermore, all sera from\r patients were able to neutralize SARS-CoV-2 in an in vitro plaque assay, suggesting a\r possible successful mounting of the humoral responses.(13) Whether the kinetic/titer of\r specific antibody correlates with disease severity remains to be investigated.(14)\r\n\r In severe cases of coronavirus disease 2019 (COVID-19), viral pneumonia progresses to\r respiratory failure. Neutrophil extracellular traps (NETs) are extracellular webs of\r chromatin, microbicidal proteins, and oxidant enzymes that are released by neutrophils to\r contain infections. However, when not properly regulated, NETs have potential to propagate\r inflammation and microvascular thrombosis - including in the lungs of patients with acute\r respiratory distress syndrome. While elevated levels of blood neutrophils predict worse\r outcomes in COVID-19, the role of NETs has not been investigated. We now report that sera\r from patients with COVID-19 (n = 50 patients, n = 84 samples) have elevated levels of\r cell-free DNA, myeloperoxidase(MPO)-DNA, and citrullinated histone H3 (Cit-H3); the latter\r two are highly specific markers of NETs.(15)\r\n\r Neutrophils Are Sophisticated Cells Able to Adapt to Changing Inflammation\r\n\r Neutrophils are not simple bags of enzymes sent to kill pathogens before the adaptive immune\r cells move in. In fact, they are able to respond to altered inflammatory status; neutrophils\r can produce cytokines , alter their gene expression during inflammation and throughout\r \"aging\" and survive for significantly longer than traditionally thought, with one study\r placing lifespan from bone marrow at 5.4 days . As a consequence, neutrophils are able to\r adapt to changing conditions and direct other cells' behaviour-a task which they can perform\r with some sophistication.\r\n\r There are a number of murine models in which the T cell responses can be exacerbated by\r depleting neutrophils, implying they have a regulatory role . This suppression of T cell\r responses by neutrophils requires close contact and development of an immunological synapse\r -perhaps as the mediators thought responsible, reactive oxygen species and H2O2 do not\r diffuse far. Uptake of apoptotic or necrotic neutrophils also inhibits DC antigen\r presentation and co-stimulation, resulting in reduced T cell responses-a situation which can\r be exploited by pathogens. For example, neutrophils capture L. major and are subsequently\r engulfed by DCs, suppressing antigen presentation and T cell priming\r\n\r NE was also shown to inhibit maturation and function of dendritic cells, including expression\r of the costimulatory molecules CD40, CD80 and CD86 Inflammatory Lung Secretions Inhibit\r Dendritic Cell Maturation and Function via Neutrophil Elastase.(16)\r\n\r Inhibitor of elastase in covid-19 infection :\r\n\r 1. Alvelestat was developed as treatment for lung diseases like Chronic Obstructive\r Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are\r responsible for inflammation and damage to the lungs that can lead to COPD symptoms.\r\n\r Alvelestat Inhibitor of elastase stimulate murine B lymphocyte differentiation into IgG-\r and IgA-producing cells via immunoglobulin class switching and inducing also known as\r isotype switching, isotypic commutation or class-switch recombination (CSR), is a\r biological mechanism that changes a B cell's production of immunoglobulin from one type\r to another, such as from the isotype IgM to the isotype IgG\r\n\r A study demonstrated that depletion of neutrophils improves the production of mucosal\r IgA and IgG after sublingual immunization with Bacillus anthracis edema toxin as\r adjuvant. These past studies also demonstrated that an inverse correlation exists\r between the number of neutrophils and production of IgA by B cells. Using specific\r inhibitors of elastase, we addressed whether the elastase activity of neutrophil could\r be the factor that interferes with production of IgA and possibly other immunoglobulin\r isotypes. We found that murine splenocytes and mesenteric lymph node cells cultured for\r 5 days in the presence of neutrophil elastase inhibitors secreted higher levels of IgG\r and IgA than cells cultured in the absence of inhibitors and also,This treatment\r however, increased the frequency of CD4+ T cells.(17) As a mucosal targeted virus,\r SARS-CoV-2 would be expected to generate secretory IgA (sIgA) and induce strong mucosal\r immunity. Indeed, the mucosal anti-viral immunity has been shown to result in part from\r the IgA-mediated interactions with the pathogenic microorganisms to prevent pathogens\r from adhering to the cell surface.(17) Upregulated IgA production may be the result of\r increased levels of TGF-β and IL-10 that promote antibody switching in SARS-CoV-2\r infection.(17) A study reported that depletion of neutrophils before systemic injection\r of vaccines increased the magnitude of antigen-specific CD4+ T cell responses, and the\r levels of antigen-specific serum IgG responses .(18)\r\n\r Alvelestat and Sivelestat were found to stimulate AID mRNA synthesis. The NE inhibitors\r also induced expression of BAFF, APRIL and IL-10 mRNA in a dose-dependent manner.\r Neutrophil elastase and the related serine proteases cathepsin G and proteinase 3, were\r shown to regulate cytokine responses through activation or degradation of cytokines,\r cytokine receptors, or toll-like receptor .(18) This is consistent with our finding that\r NE inhibitors stimulate IL-10 expression, but also BAFF and APRIL in cultures of\r splenocytes. IL-10 was reported to regulate expression of AID for induction of Ig CSR.\r (19) and it is wellestablished that IL-10 facilitates Ig class switching for production\r of IgA (20). Thus, these data suggest that NE inhibitors stimulate antibody production\r through stimulation of AID and inhibition of the activation/degradation of cytokines and\r cytokine receptors by elastase. NE was also shown to inhibit maturation and function of\r dendritic cells, including expression of the costimulatory molecules CD40, CD80 and CD86\r .(21). Thus, the presence of neutrophil inhibitors may have promoted the maturation of\r dendritic cells and their expression BAFF and APRIL and perhaps costimulatory molecules\r (i.e., CD40) for enhanced antibody production. Although Alvelestat and Sivelestat are\r specific NE inhibitors, one should consider that they might also inhibit related\r elastase-like enzymes. In this regard, activated human B cells were reported to express\r a trypsin-like serine protease on the cell surface .(22) Concluding remarks It was\r previously shown that neutrophil peptide defensins enhance IgG, but not IgA responses\r against nasally co-administered vaccine antigens .(23) Here, the study have shown that\r the serine protease activity of neutrophil elastase, and possibly other serine protease\r such as B cell elastase, also participate in the regulation of B cell biology and\r adaptive immunity. However, unlike neutrophil peptide defensins, NE negatively regulate\r differentiation of B lymphocytes into IgG and IgA secreting cells. The presence of AID\r generally improves antibody-based immunity.(24).\r\n\r High Neutrophils in COVID -19 infected patients are capable of causing severe damage to\r the lung tissue by releasing toxic proteases and reactive oxygen species if not\r counterbalanced by the antiproteases.\r\n\r 2. All-trans retinoic acid (RA) has beneficial effects when used in a variety of\r inflammatory skin conditions. In a study, the authors found that RA inhibited superoxide\r anion production and proteolytic enzyme release by human and rat neutrophils.\r Concomitantly, the authors found that RA-treated neutrophils were less able than\r untreated neutrophils to injure endothelial cells in culture even though the adhesion of\r the RA-treated neutrophils to endothelial cell monolayers was not diminished. Inhibition\r of cytotoxicity occurred over the same range of concentrations that inhibited oxygen\r radical formation and protease release. In additional studies, it was observed that\r pretreatment of endothelial cells with RA-induced resistance to subsequent injury by\r activated neutrophils. Finally, in vivo studies showed that pretreatment of rats for 3\r days with RA (1-10 mg/day, IP) reduced the degree of injury in the lungs and skin sites\r after treatment with bovine serum albumin and antibodies to bovine serum albumin in the\r reverse-passive Arthus reaction. Thus, RA can modulate neutrophil-mediated endothelial\r cell injury by an effect on both the neutrophils and their target cells. Together, these\r effects may underlie the reduction in immune complex-mediated injury seen in\r experimental animals. The beneficial effects that retinoids have in a variety of\r inflammatory skin diseases may likewise be a reflection of their effects on the\r physiology of both neutrophils and endothelial cells.\r\n\r Oral retinyl palmitate or retinoic acid corrects mucosal IgA responses toward an intranasal\r influenza virus vaccine in vitamin a deficient mice. Retinoids inhibit inflammatory TH17 T\r cell responses, promote regulatory T cell (Treg) responses, and regulate expression of\r toll-like receptors (TLRs) .(57)\r\n\r So, the principal investigator expects that retinoic acid will be effective in covid -19\r patients better than the other neutrophil elastase inhibitor like Alvelestat because Attia et\r al (2018) demonstrated that Sivelestat reduced secretion of IgM in a dose-dependent manner ,\r IgM type of antibodies which is very important in viral neutralization and on the other hand\r retinoic acid stops neutrophil-mediated endothelial cell injury by an effect on both the\r neutrophils and their target cells.\r\n\r Seconed drug is Isotretinoin(13cis RA) and ATRA may be able to inhibit COVID 2019 infection\r via inducing the antiviral immunity and this is discussed as follow :\r\n\r A study demonstrated that 13 cis retinoic is used in treating Emphysema (emphysema is a lung\r condition that causes shortness of breath), Since an effective immune response against viral\r infections depends on the activation of cytotoxic T cells that can clear infection by killing\r virus-infected cells , boosting the numbers and function of T cells in COVID-19 patients is\r critical for successful recovery. A recent study reported that the 82.1% of COVID-19 cases\r displayed low circulating lymphocyte counts. A CoV infects macrophages, and then macrophages\r present CoV antigens to T cells. This process leads to T cell activation and differentiation,\r including the production of cytokines associated with the different T cell subsets (Th17),\r followed by a massive release of cytokines for immune response amplification. The continued\r production of these mediators due to viral persistence has a negative effect on NK, and CD8 T\r cell activation.(25)\r\n\r Recent study of 522 COVID patients and 40 healthy controls from two hospitals in Wuhan, China\r demonstrated that T cell numbers are negatively correlated to serum IL-6, IL-10 and TNF-α\r concentration, with patients in decline period showing reduced IL-6, IL-10 and TNF-α\r concentrations and restored T cell counts. T cells from COVID-19 patients have significantly\r higher levels of the exhausted marker programmed cell death protein(PD-1) as compared to\r health controls. Moreover, increasing PD-1 and Tim-3 expression on T cells could be seen as\r patients progressed from prodromal to overtly symptomatic stages, further indicative of T\r cell exhaustion. T cell exhaustion is a progressive loss of effector function due to\r prolonged antigen stimulation, characteristic of chronic infections. Dendritic cell\r inhibition is connected to exhaustion of CD8+ T cell polyfunctionality during chronic\r hepatitis C virus infection. CD8 T cells produce very effective mediators to clear\r nCoV2019.(26)\r\n\r Dendritic cells (DCs) play a key role in innate immune and adaptive immune responses. As the\r strongest antigen presenting cells in the organism, they effectively stimulate the activation\r of T lymphocytes and B lymphocytes, thus combining innate and adaptive immunity. Immature DCs\r have strong migration ability, and mature DCs can effectively activate T cells in the central\r link of startup, regulation, and maintenance of immune responses. Thus, once the maturation\r process of DCs is blocked, it directly affects the initiation of subsequent adaptive immune\r response. MERS-CoV-2 is able to affect human dendritic cells and macrophages in-vitro\r .Productive replication of Middle East respiratory syndrome coronavirus in monocyte-derived\r dendritic cells modulates innate immune response.(27)\r\n\r Another study proposed that C -C chemokine receptor type 4 (CCR4) contributes to T cell lung\r homing imprinting. It was found that lung DCs induce the expression of CCR4 on T cells. Lung\r DCs-activated T cells traffic more efficiently into the lung and protect against influenza\r more effectively compared with T cells activated by DCs from other tissues. Lim and\r colleagues suggested that CXCR4 plays a role in CD8+ T cell migration to airway tissues.(28)\r\n\r Dendritic cell inhibition is connected to exhaustion of CD8+ T cell polyfunctionality during\r chronic hepatitis C virus infection. CD8 T cells produce very effective mediators to clear\r nCoV2019.(29)\r\n\r Presence of RA in different tissues is very imprtant for immune induction and fighting viral\r infection, for example, RA is present at high concentrations in the small intestine due to\r metabolizing dietary vitamin A by gut epithelial cells. In this local environment, RA\r activate and primes dendritic cells (DCs) to become CD103+ DCs that produce RA.3, 4CD103+ DCs\r are migratory cells that activate naive T cells in mesenteric lymph nodes to become effector\r T cells that contribute to both intestinal homeostasis and immunity.and also RA is an\r important signal that induces IgA-producing B cells. The gut homing T cells and B cells play\r essential roles in protecting the digestive tract from pathogens.(30) Retinoic acid (atRA)\r can inhibit the spontaneous apoptosis of activated human T lymphocytes in vitro. 13-cis RA\r activates Th2 cytokine production Enhanced circulating dendritic cell numbers.(40)\r\n\r So, according to this previous studies the principal investigator suggests that T cells\r lymphopenia and exhaustion may be resulted by Dendritic cells (DCs) infection and inhibition\r by MERS-CoV-2.\r\n\r Retinoic acid has profound effects on cellular proliferation and differentiation. Moreover,\r it has been reported that ATRA exhibits both anti-inflammatory and immunoregulatory effects.\r Recent studies have shown that FOXP3 expression and the immune function of Regulatory T cells\r (Tregs ) can be enhanced by ATRA in the immune system of both patients and mic.13Retinoic\r acid (RA) is produced by a number of cell types, including macrophages and dendritic cells,\r which express retinal dehydrogenases that convert vitamin A to its main biologically active\r metabolite, all-trans RA. All-trans RA binds to its nuclear retinoic acid receptors that are\r expressed in lymphoid cells and act as transcription factors to regulate cell homing and\r differentiation. RA production by CD103+ dendritic cells and alveolar macrophages functions\r with TGF-b to promote conversion of naive T cells into Foxp3+ regulatory T cells and,\r thereby, maintain mucosal tolerance.(50) So, principal investigator expects high inducing of\r Dendritic cells (DCs) by retinoic acid treatment which will lead to T cells activation and\r migration with less exhaustion phenomenon.\r\n\r Researchers from Wenzhou, China looked at clinical laboratory features including lipid levels\r of patients with COVID 19. They found dramatic reductions in the cholesterol levels of\r patients infected with COVID 19, compared with healthy controls .The study provides data to\r suggest that cholesterol levels decline quite rapidly during the early stages of infection\r and increase as the patient starts to recover. Therefore, indicating that cholesterol may\r have an important role to play in defending the body against such infections According to our\r protocol depending on previous studies the principal investigator demonstrated that there is\r a strong relation between immune system and cholesterol levels . :-\r\n\r Cellular cholesterol is a component of the plasma membrane and is also essential in cell\r proliferation. Regulation of intracellular cholesterol levels has been proposed as a\r mechanism to regulate T cell and macrophages proliferation. Intracellular cholesterol level\r is regulated by two competing pathways, cholesterol uptake and efflux, and ABCA1 plays a\r major role in the cholesterol efflux pathway. The ATRA induces ABCA1 expression and\r ABCA1-dependent cholesterol efflux in activated primary human CD4+ T cells implying that RA\r could affect T cell functions by regulating the cellular cholesterol levels.(51) ATRA\r upregulates ABCA1 expression only in activated CD4+ T cells, indicating that induction of\r ABCA1 by ATRA and 13 cis Retinoic Acid may play an important role in immune response.\r\n\r Retinoic acid and liver X receptor agonist synergistically inhibit HIV infection in CD4+ T\r cells by up-regulating ABCA1-mediated cholesterol efflux.(52)(53)\r\n\r RA also acts directly on macrophages at both mucosal sites and other immunological sites.\r AtRA modulates peritoneal macrophage activation by endotoxin and IFN-γ by suppressing TNF\r production and nitric oxide (NO) synthesis .In addition, at RA inhibits the expression of\r PGE2 and COX-2 and the release of TNF, which are induced by bacterial lipopolysaccharide\r (LPS) in murine peritoneal macrophages .(54)\r\n\r A study reported recently that substance (ATRA) have preventive effects on pulmonary fibrosis\r by inhibiting IL-6-dependent proliferation and TGF-β1-dependent trans differentiation of lung\r fibroblasts. Also, another studies demonstrated that 13-cis-retinoic acid and other retinoid\r analogs inhibit IL-1-induced IL-6 production and that this effect is analog-specific and, at\r least partially, transcriptionally mediated. This effect was dose-dependent with an IC50 of\r 10(-7) M RA and significant inhibition being noted with doses of RA as low as 10(-8) M. IL-10\r production was inhibited by ATRA administration.(55)\r\n\r A study demonstrated that TLR3(-/-), TLR4(-/-), and TRAM(-/-) mice are more susceptible to\r SARS-CoV than wild-type mice but experience only transient weight loss with no mortality in\r response to infection. In contrast, mice deficient in the TLR3/TLR4 adaptor TRIF are highly\r susceptible to SARS-CoV infection, showing increased weight loss, mortality, reduced lung\r function, increased lung pathology, and higher viral titers . New studies showed that the\r high level of IFN-α/β produced from the TLR3-IRF3/IRF7 pathway and IFN-β is the reason for\r inhibiting DENV replication. 13Cis retinoic Acid induced significant upregulation of\r toll-like receptor 3 (TLR3) resulting in an immune response to dsRNA intermediate which can\r be partially generated during CoV-2 replicationTLR3 sensitized by dsRNA and cascades of\r signaling pathways (IRFs and NFκB activation, respectively) are activated to produce type I\r IFNs.(56)\r\n\r .\r\n\r Oral retinyl palmitate or retinoic acid corrects mucosal IgA responses toward an intranasal\r influenza virus vaccine in vitamin a deficient mice. Retinoids inhibit inflammatory TH17 T\r cell responses, promote regulatory T cell (Treg) responses, and regulate expression of\r toll-like receptors (TLRs) .(57) In vitro treatment of normal human monocytes with all-trans\r retinoic acid (ATRA) down-regulates TLR-2 expression (58), but this effect has not been\r examined in patients treated with systemic retinoids. Isotretinoin (13-cis retinoic acid;\r 13-cis RA) is the only drug capable of inducing a long-term or permanent remission of acne;\r however, the mechanisms leading to this durable response are unknown. Given the role of TLR-2\r in initiating immune responses to P. acnes, we hypothesized that down-regulation of TLR-2 on\r monocytes and/or the induction of Treg responses in vivo may represent mechanisms by which\r isotretinoin exerts its long-term effects.\r\n\r Isotretinoin(13cis RA) may be able to inhibit COVID 2019 entry via down regulation of ACE2 ,\r AT1 protein and Ang II-mediated intracellular calcium release rather than inhibition of\r interleukin-6 (IL-6) and this is discussed as follow :\r\n\r Many authors misunderstands the difference between ARBs, which block ATR1 receptors and the\r hypothesised drug that could block the COVID-19 binding site on ACE2 receptor, which is\r totally different from ATR1 and 2.\r\n\r The COVID-19 pandemic caused by SARS-COV-2 has infected over 2,000,000 people causing over\r 150,000 deaths.(59) A key host cellular protein required for the virus entry is\r angiotensin-converting enzyme 2 (ACE2) whose expression has been demonstrated in many tissues\r including alveolar epithelial type II cells in lungs, oral mucosa and intestine, heart,\r kidney, endothelium and skin. ACE2-expressing cells can act as home cells and are prone to\r SARS-CoV-2 infection as ACE2 receptor facilitates cellular viral entry and replication.(60) A\r study demonestrated that patients with hypertension and diabetes mellitus may be at higher\r risk of SARS-CoV-2 infection, as these patients are often treated with ACE inhibitors (ACEIs)\r or angiotensin II type-I receptor blockers (ARBs), which have been previously suggested to\r increase ACE2 expression.(61) In another study by Sinha et al who analyzed a publicly\r available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug\r treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest\r down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are\r currently being investigated in clinical trials for treating COVID-19 (chloroquine,\r thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov),\r none of which was found to significantly alter ACE2 expression (P>0.1) Moreover, another\r study demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors\r which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should\r be targeted in COVID-19 treatment by performing target-based virtual ligand screening.As\r Principal Investigator discussed before that (13cRA) is the strongest down-regulator of ACE2.\r\n\r The principal investigator expects that 13cRA can inhibit or dowenrgulat ACE2 by direc\r interaction and binding with the transmembrane ACE2, Suggesting its therapeutic potential in\r preventing the entry of COVID 2019 to the host cell.\r\n\r Previous studies on the related severe acute respiratory syndrome coronavirus (SARS-CoV) and\r SARS-CoV FP FP have shown that calcium (Ca2+) plays an important role for fusogenic activity\r via a Ca2+ binding pocket with conserved glutamic acid (E) and aspartic acid (D)\r residuesdemonstrated that intracellular Ca2+ enhances MERS-CoV WT PPs infection by\r approximately two-fold and that E891 is a crucial residue for Ca2+interaction. Electron spin\r resonance revealed that this enhancement could be attributed to Ca2+ increasing MERS-CoV FP\r fusion-relevant membrane ordering. Intriguingly, isothermal calorimetry titration showed that\r MERS-CoV FP binds one Ca2+, as opposed to SARS-CoV FP which binds to two Ca2+ ion.(62)\r\n\r Angiotensin II increases the intracellular calcium activity in podocytes of the intact\r glomerulus. The L-type Ca2+ channel blocker nicardipine did not influence the Ang II-mediated\r [Ca2+] increase and it has been postulated that SARS-CoV-2 binding to ACE2 may attenuate\r residual ACE2 activity, skewing the ACE/ACE2 balance to a state of heightened angiotensin II\r activity leading to pulmonary vasoconstriction and inflammatory and oxidative organ damage,\r which increases the risk for acute lung injury (ALI). AngII via AT1 receptors upregulates\r many proinflammatory genes, such as vascular cell adhesion molecule-1 (VCAM-1), intercellular\r adhesion molecule-1 (ICAM-1), interleukin-6 (IL-6).30 but 13cis RA specifically\r down-regulated the AT1 protein in a dose- and time-dependent manner. Down-regulation of the\r AT1 expression leads to reduced AngII-mediated intracellular calcium release Similarly with\r receptor down-regulation, Treatment with 13cRA resulted in a significant reduction in AT1\r mRNA .(63)\r\n\r Finally, the principal investigator expects that Isotretinoin will help in antibody induction\r against COVID-19 via inducing different types of antiviral immune factors and also,\r decreasing of COVID -19 hyper mutation by blocking its ACE2 receptors and preventing the\r virus from cell entry and replication and this will give the immune system time to recognize\r COVID -19.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of\r lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires\r admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was\r supported by positive pressure mechanical ventilation (including non-invasive and invasive\r mechanical ventilation, PEEP>=5cmH2O))\r\n\r Exclusion Criteria:\r\n\r Age < 18 Pregnant Allergic to experimental drugs and patients have the following\r conditions:\r\n\r 1. Hypercholesterolemia\r\n\r 2. Hypertriglyceridemia\r\n\r 3. Liver disease\r\n\r 4. Renal disease\r\n\r 5. Sjögren syndrome\r\n\r 6. Pregnancy\r\n\r 7. Lactation\r\n\r 8. Depressive disorder\r\n\r 9. Body mass index less than 18 points or higher than 25 points\r\n\r 10. Contraindications for hormonal contraception or intrauterine device.\r\n\r 11. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell\r transplantation\r\n\r 12. Patients receiving anti-hcv treatment\r\n\r 13. Permanent blindness in one eye\r\n\r 14. History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of\r retinal detachment or eye surgery\r\n\r 15. The competent physician considered it inappropriate to participate in the study\r\n\r 16. HIV infection or other immunodeficiency or with an absolute neutrophil count ≤1.0 ×\r 109/L\r\n\r 17. Abnormal liver biochemistry (alanine aminotransferase, aspartate aminotransferase,\r gamma-glutamyl transferase) >1.5 × upper limit of normal or total bilirubin > upper\r limit of normal (unless Gilbert's disease with normal conjugated bilirubin)\r\n\r 18. Any of the following laboratory abnormalities are present at baseline:\r\n\r - Platelet count <150×109/L\r\n\r - Serum albumin ≤ 3.5 g/dL\r\n\r - INR ≥1.2\r\n\r - CPK ≥ ULN.\r\n\r 19. Significant liver fibrosis as evidenced by Fibrosis-4 (FIB-4) score >3.25\r\n\r 20. History of hypersensitivity to retinoic acid or any of its excipients or the class of\r neutrophil elastase inhibitors Known hypersensitivity to medications used in the study\r procedures (e.g. midazolam, fentanyl, and lidocaine for bronchoscopy)\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
756
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEffect of Early Mobilization on Length of Stay, Recovery and Readmission Rate of Patients After CABG or AVR/MVR Surgery\n\n**Clinical Trial Summary:**\n\nThe present study will investigate the volume and extent of the expected physiological\r effects of \"early mobilization\" on the prevention of the clinical illness' detrimental\r sequelae and on the functional recovery promotion of CABG, AVR and MVR patients.\r Consequently, it will investigate if the improved health outcomes may limit the number and\r intensity of complications and thus if it may speed up hospital discharge.\n\n**Clinical Trial Detailed Description:**\n\nAlthough the effects of \"early mobilization\" have been studied mainly in the intensive care\r unit setting, the findings could be applied to the surgical units' patients too, since they\r share common physiological and clinical characteristics. In the literature the effectiveness\r of \"early mobilization\" in the length of hospital stay and recovery of the patients operated\r for coronary artery bypass graft and heart valve replacement in the cardiac surgery setting,\r is unknown.\r\n\r The term \"early mobilization\" is not restricted to a time factor procedure but contains the\r provision of a customized dynamic set of physical therapy techniques which in studies are\r variably determined in terms of duration, intensity, frequency and content.\r\n\r The aim of the study is to determine the clinical effectiveness of the intensive early\r mobilization physical therapy intervention compared with standard care of physical therapy in\r the cardio-thoracic surgery clinic of Papageorgiou General Hospital of Thessaloniki.\r\n\r The present study will investigate the volume and extend of the expected physiological\r effects of \"early mobilization\" on the prevention of the clinical illness' detrimental\r sequelae and on the functional recovery promotion, hospital mortality and readmission rate of\r CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes\r may limit the number and intensity of complications and thus may speed up hospital discharge.\r In the first group of the experimental design, patients will be treated with an intensive\r early mobilization protocol and the patients of the second group will receive a standard care\r physical therapy treatment. Controlling for the detailed baseline characteristics that will\r be assessed during medical history at admission, potential bias will be limited from\r unmeasured confounders of the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Elective CABG or AVR or MVR surgery\r\n\r - No previous CABG or valve surgery\r\n\r - Isolated / multivessel CABG\r\n\r Exclusion Criteria:\r\n\r - Current neurological disorders\r\n\r - Previous cerebral vascular accident with residual neurological deficit significant\r enough to limit exercise\r\n\r - Significant limiting comorbidities that would prevent full participation\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
757
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPositioning Imatinib for Pulmonary Arterial Hypertension\n\n**Clinical Trial Summary:**\n\nPulmonary Arterial Hypertension (PAH) is a rare condition in which a narrowing of blood\r vessels carrying blood through the lungs puts an increased work load on the heart; it has to\r work harder to pump blood through the lungs. While current treatments relieve some of the\r symptoms, they do not stop or reverse the disease in the affected blood vessels. Imatinib is\r a medicine licensed for some types of cancers. A published study has shown that imatinib can\r have beneficial effects on blood flow through the lungs and exercise capacity in patients\r with PAH, even when added to existing treatments. However, there have been concerns about its\r safety and tolerability. Imatinib continues to be prescribed occasionally on compassionate\r grounds, usually when other treatment options have been exhausted, and some patients feel\r better on the drug. To improve the investigator's understanding, the investigators of this\r study re-visits the use of Imatinib as a potential treatment for patients with PAH.\n\n**Clinical Trial Detailed Description:**\n\nWhat does the study involve?\r\n\r The study involves treatment of PAH patients with imatinib (study drug) for up to 24 weeks,\r and clinical assessments and tests to assess the drug's safety and tolerability.\r\n\r PAH patients will be seen at their local hospital by the PAH clinical research team. Before\r someone can start study, the study doctor (or clinical study team) will describe the clinical\r trial in detail. If a potential subject decides to participate, he/she will be asked to sign\r the informed consent form before any study procedures are done.\r\n\r Participants will be asked to come to their local hospital for clinical appointments. This\r includes a screening visit, a baseline visit, three clinical assessments and an end-of-study\r visit. In between, and at the very end of these, there will be six tele-visits (assessments\r over the phone). Each clinical appointment will be on a weekday morning or afternoon. No\r major lifestyle restrictions are required for these appointments.\r\n\r Participants will undergo clinical examinations and tests to monitor the severity of PAH and\r the response to the study drug. Clinical procedures include:\r\n\r - Questions about demographics, medical and medication history\r\n\r - Physical examination and record of vital signs (blood pressure, temperature, heart and\r respiratory rate)\r\n\r - Questionnaire about quality of life,\r\n\r - Assessments of PAH severity (WHO Functional Class, six-minute walk test, and Borg\r dyspnoea index)\r\n\r - Right heart catheterisation to assess response to the drug\r\n\r - Haematology and clinical chemistry blood tests to ensure safety\r\n\r - Serum pregnancy test and urine pregnancy tests (if applicable) to exclude pregnancy\r\n\r - Blood samples to measure the levels of the study drug in the circulation\r\n\r - Additional blood samples for future research on PAH and/or the mechanism of action of\r the drug\r\n\r - Electrocardiogram (ECG), and echocardiogram to assess the size, shape, pumping action\r and the extent of any damage to the heart\r\n\r - Brain MRI scan (or CT scan if MR is not indicated/tolerated) to exclude bleeding in the\r brain\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subjects aged between 18-75 years old\r\n\r 2. PAH which is idiopathic, heritable or associated with anorexigens\r\n\r 3. Subjects willing to be genotyped for genes that influence PDGF activity\r\n\r 4. Resting mean pulmonary artery pressure ≥25 mmHg, Pulmonary capillary wedge pressure\r ≤15 mmHg, PVR >5 wood units, and normal or reduced cardiac output , as measured by\r right heart catheterisation (RHC) at entry\r\n\r 5. Six-minute walking distance >50m at entry\r\n\r 6. Stable on an unchanged PAH therapeutic regime comprising at least 2 therapies licensed\r for PAH (any combination of endothelin receptor antagonist, phosphodiesterase\r inhibitor or prostacyclin analogue) for at least 1 month prior to screening\r\n\r 7. Able to provide written informed consent prior to any study mandated procedures\r\n\r 8. Contraception: Fertile females (women of childbearing potential) are eligible to\r participate after a negative highly sensitive pregnancy test, if they are taking a\r highly effective method of contraception during treatment and until the end of\r relevant systemic exposure. Fertile males who make use of condom and contraception\r methods during treatment and until the end of relevant systemic exposure in women of\r childbearing potential -full details are in included in the research protocol-\r\n\r Exclusion criteria:\r\n\r 1. Unable to provide informed consent and/or are non-fluent speakers of the English\r language\r\n\r 2. Hypersensitivity to Imatinib or to any of the excipients\r\n\r 3. Clinically-significant renal disease (confirmed by creatinine clearance <30 ml/min per\r 1.73m2)\r\n\r 4. Clinically-significant liver disease (confirmed by serum transaminases >3 times than\r upper normal limit)\r\n\r 5. Patients receiving oral and/or parenteral anticoagulants\r\n\r 6. Anaemia confirmed by haemoglobin concentration <10 g/dl\r\n\r 7. History of thrombocytopenia\r\n\r 8. Individuals known to have haemoglobinopathy sickle cell disease, thalassaemia\r\n\r 9. Hospital admission related to PAH or change in PAH therapy within 3 months prior to\r screening\r\n\r 10. History of left-sided heart disease and/or clinically significant cardiac disease,\r including but not limited to any of the following:\r\n\r 1. Aortic or mitral valve disease (stenosis or regurgitation) defined as greater\r than mild aortic insufficiency, mild aortic stenosis, mild mitral stenosis,\r moderate mitral regurgitation\r\n\r 2. Mechanical or bioprosthetic cardiac valve\r\n\r 3. Pericardial constriction, effusion with tamponade physiology, or abnormal left\r atrial size.\r\n\r 4. Restrictive or congestive cardiomyopathy\r\n\r 5. Left ventricular ejection fraction ≤50% (measured in echocardiogram at screening)\r\n\r 6. Symptomatic coronary disease\r\n\r 7. Significant (2+ for regurgitation) valvular disease other than tricuspid or\r pulmonary regurgitation\r\n\r 8. Acutely decompensated left heart failure within 1 month of screening\r\n\r 9. History of untreated obstructive sleep apnoea\r\n\r 11. Evidence of significant lung disease on high-resolution CT (if available) or recent\r (performed within 12 months) lung function, where FEV1 < 50% predicted and FVC < 70%\r predicted, and DLCO (or TLCO) < 50% predicted if any CT abnormalities; judged by the\r Site Physician\r\n\r 12. Patients with a history of uncontrolled systemic hypertension\r\n\r 13. Acute infection (including eye, dental, and skin infections)\r\n\r 14. Chronic inflammatory disease including HIV, and Hepatitis B\r\n\r 15. Women of childbearing potential who are pregnant or breastfeeding (if applicable)\r\n\r 16. Previous intracerebral haemorrhage\r\n\r 17. Patients who have received an Investigational Medicinal Product (IMP) within 5\r half-lives of the last dose of the IMP or 1 month (whichever is greater) before the\r baseline visit\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
758
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTranscatheter Aortic Valve Implantation in Western NORway\n\n**Clinical Trial Summary:**\n\nA prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who\r underwent TAVI at the Haukeland university hospital, Bergen, Norway.\n\n**Clinical Trial Detailed Description:**\n\nA prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who\r underwent TAVI at the Haukeland university hospital, Bergen, Norway between January 2012 and\r July 2019.\r\n\r Demographics, clinical data including cardiovascular risk factors, arterial and\r echocardiographic parameters were prospectively collected. The data on all-cause mortality\r will be collected. Echocardiograms (immediate before TAVI, at discharge after TAVI and at\r 6-12 months follow-up) will be analyzed. The main scientific objectives are:\r\n\r To assess survival benefits of TAVI according to baseline risk profile. To determine the\r echocardiographic predictors of left ventricular mass regression and left ventricular\r function recovery.\r\n\r To evaluate global LV load (Zva=valvular-arterial impedance) following TAVI. To assess the\r impact of various types of blood pressure responses immediately after TAVI on clinical\r outcomes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Hemodynamically severe aortic stenosis and symptoms\r\n\r 2. A decision of TAVI by Heart team\r\n\r 3. Patients undergoing TAVI (transcatheter aortic valve implantation)\r\n\r 4. Life expectancy > 1-2 years\r\n\r Exclusion Criteria:\r\n\r 1. Sever frailty\r\n\r 2. Severly reduced cognitive function\r\n\r 3. Multiple comorbid conditions\r\n\r 4. Technically not suited for TAVI\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
759
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\n\"SIMULATION MODELING OF CORONARY ARTERY DISEASE: A TOOL FOR CLINICAL DECISION SUPPORT\"\n\n**Clinical Trial Summary:**\n\nCoronary atherosclerosis (ATS) is a degenerative-inflammatory artery pathology underlying the\r different clinical manifestations of coronary heart disease (CHD), from stable angina due to\r constrictive plaque growth obstructing artery lumen, to acute coronary syndrome (ACS),\r secondary to abrupt lumen occlusion by atherothrombosis at the site of a ruptured or eroded\r plaque.\r\n\r Major coronary adverse events (MACE) are known to be related to local factors, the so called\r \"high risk plaque\" characterized by large lipid-necrotic core with a thin fibrous cap,\r intraplaque hemorrhage, rupture, erosion, and to systemic, patient-specific, factors,\r contributing to the atherogenic genotype/phenotype of the so called \"high risk patient\",\r presenting with an abnormally activated thrombogenic and/or inflammatory state or increased\r plasma levels of atherogenic lipid species.\r\n\r The huge social and economic impact of CHD in western and developing countries is primarily\r due to the difficulty to identify and predict, in the clinical context, which \"high risk\r plaque\" in which \"high risk patient\" will cause, independently of stenosis severity, an acute\r coronary event such as myocardial infarction or sudden coronary death, which are often the\r first manifestations of CHD in a large proportion of otherwise asymptomatic subjects. Plaque\r burden, compared to stenosis, is recognized as a better predictor of ACS and coronary CT\r angiography (CCTA) is considered as the optimal non-invasive coronary imaging modality to\r assess and quantify plaque burden and to evaluate the functional significance of a stenosis,\r by computationally estimating fractional flow reserve. Moreover, molecular studies of CHD\r patients have mostly examined associations with clinical cardiovascular outcomes:\r associations with coronary ATS assessed by quantitative CCTA may provide insight into the\r pathophysiological role of several molecular species in plaque formation and growth, and\r elucidate their potential role as discriminative biomarkers of CHD.\r\n\r Based on these considerations, aim of this study is to collect and analyze all\r patient-specific clinical and epidemiological data and patient phenotype and genotype\r blood-derived molecular information, and to combine them with local high resolution\r non-invasive CCTA imaging of actual plaque burden as well as, prospectively, of its increase\r or de novo formation over a clinically relevant timespan. The expected result, following\r local and systemic data integration and modeling, is to optimize early diagnosis and risk\r stratification of CHD beyond current clinical models and scores and to help improving primary\r and secondary prevention of MACE. The overall design of this diagnostic and prognostic\r framework has been proposed to Horizon 2020 EU Call PHC30 and approved by the European\r Commission (Grant Agreement PHC30-689068). The Consortium includes major clinical European\r University Hospitals specialized in CHD imaging and treatment and the project study has\r obtained the endorsement of the European Society of Cardiovascular Imaging.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. male and female subjects\r\n\r 2. aged 45-75 years\r\n\r 3. caucasian population\r\n\r 4. submitted to CCTA for suspected CHD between 2009 and 2012 (in the context of EVINCI\r and ARTreat FPVII studies) at the Hospitals reported in \"SMARTool Clinical Center\"\r document and satisfying the elegibility criteria reported above\r\n\r 5. submitted to clinical Follow-up in the last 6 months with stable clinical conditions\r and documented CHD or persistent intermediate/high probability of CHD\r\n\r 6. Signed informed consents (clinical and genetic)\r\n\r Exclusion Criteria:\r\n\r 1. Multi-vessel severe disease (3 vessels and/or LM disease with >90% stenosis).\r\n\r 2. Severe coronary calcification (CAC score > 600).\r\n\r 3. Having undergone surgical procedures related to heart diseases (CABG, valve\r replacement, CRT or CRTD treatment, any surgery of the heart or arteries).\r\n\r 4. Documented MACE at history (myocardial infarction, severe heart failure, recurrent\r angina) in the last 6 months with/without revascularization\r\n\r 5. Documented severe peripheral vascular disease (carotid, femoral)\r\n\r 6. Surgery of carotid and/or peripheral arteries or cerebral ischemic attack\r\n\r 7. History/surgery of Abdominal Aortic Aneurysm(AAA).\r\n\r 8. Severe Heart failure (NYHA Class III-IV)\r\n\r 9. LV dysfunction (left ventricle EF <40%).\r\n\r 10. Atrial fibrillation.\r\n\r 11. Lack of written informed consent (clinical consent and/or genetic consent)\r\n\r 12. Pregnancy (evaluated by urine test) and breastfeeding\r\n\r 13. Active Cancer\r\n\r 14. Asthma\r\n\r 15. Severe untreated Hypertension (arterial blood pressure ≥ 170/110 mmHg)\r\n\r 16. Cardiomyopathy or congenital heart disease\r\n\r 17. Significant valvular disease (hemodynamically significant valvular stenosis or\r insufficiency by echoDoppler)\r\n\r 18. Renal dysfunction (creatinine > 1.3 mg/dL)\r\n\r 19. Chronic Kidney Disease (eGFR < 30 ml/min/1.73 m2)\r\n\r 20. Hepatic failure (at least 3 of the following: albumin < 3.5 g/dL; prolonged\r prothrombin time-PT; jaundice; ascites)\r\n\r 21. Waldenstrom disease\r\n\r 22. Multiple myeloma\r\n\r 23. Autoimmune/Acute inflammatory disease\r\n\r 24. Previous severe adverse reaction to iodine contrast agent\r\n\r 25. Positivity at blood tests for HIV, Hepatitis B and C (CRF number 1-clinical\r evaluation)\r\n\r -\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
760
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCardiac Amyloidosis : Diagnostic Using Red Flag Signals\n\n**Clinical Trial Summary:**\n\nCardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However,\r its frequency remains underestimated, and diagnosis is often realized at late stages of the\r disease. A larger use of clinical and echographic Red Flag signals during routine\r echocardiographic examination may enhance the identification of early stage of the disease.\n\n**Clinical Trial Detailed Description:**\n\nThe objective is to evaluate the clinical and epidemiological aspects of cardiac amyloidosis\r using a systematic screening of even moderate left ventricular hypertrophy, taking into\r account the presence of Red Flag signals. Red Flag Signals will include history or symptoms\r of carpal tunnel syndrome, hearing loss, chronic gastrointestinal disorders, heart failure,\r cervical or lumbar stenosis, or echographic abnormalities such as apical sparring, increased\r left ventricular filling pressure, atrio-ventricular block.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Diagnosis of left ventricular hypertrophy defined by a parietal thickness\r (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram\r\n\r 2. Age equal or greater than 45 years\r\n\r 3. Current residency in Martinique, Guadeloupe or French Guyana\r\n\r 4. Ability to receive and understand research information\r\n\r 5. Ability to freely deliver informed written consent\r\n\r Exclusion Criteria:\r\n\r 1. Pregnant or breastfeeding woman\r\n\r 2. Severe uncontrolled hypertension\r\n\r 3. Chronic hemodialysis\r\n\r 4. Person under legal protection measures (guardianship, curatorship, safeguard of\r justice), and person deprived of liberty\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
761
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRight Ventricular Diastolic Dysfunction\n\n**Clinical Trial Summary:**\n\nHeart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are\r very commonly associated.\r\n\r Emphysema by increasing intrathoracic pressure appears to affect cardiac function.\r\n\r Interestingly, previous studies have shown a link between the telediastolic volume of the\r right ventricle (measured by RMI) and the intensity of emphysema.\r\n\r Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or\r accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.\r\n\r To verify this hypothesis the investigators will perform KT loop procedures in order to\r acquire intracardiac pressure/volume curves before and after lung volume reduction.\r\n\r The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac\r contractility and loading conditions.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - At least 40 years\r\n\r - A smoking history\r\n\r - Smoking cessation ≥ 6 months\r\n\r - FEV1/FVC ≤ 0,7\r\n\r - Severe emphysema (destruction ≥ 50%)\r\n\r - Peak tricuspid regurgitation velocity < 2,8 m/s or presence of other echocardiographic\r \"PH signs\"\r\n\r - 15% ≤ FEV1post ≤ 50%\r\n\r - Residual volume ≥ 175% predicted\r\n\r - TLC ≥ 100% predicted\r\n\r - Optimal medical management\r\n\r - 150m ≤ 6MWD ≤ 500m\r\n\r - mMRC ≥ 2\r\n\r - Physical activity ≥ 2/Week (≥ 30minutes)\r\n\r Exclusion criteria:\r\n\r - ≥2 hospitalizations/year for EACOPD\r\n\r - Recent EACOPD (≤ 3months)\r\n\r - ≥ 50ml mucus/day\r\n\r - PAPm ≥35mmHg\r\n\r - PaCO2 ≥ 55mmHg\r\n\r - Bubble ≥ 1/3 hemithorax\r\n\r - Lung fibrosis, bronchiectasis, lung cancer, homolateral surgery\r\n\r - Left ventricular ejection fraction ≤ 45%, unstable heart disease\r\n\r - Life expectancy ≤ 1 year\r\n\r - Contraindication to anesthesia\r\n\r - Allergy to nitinol or silicone\r\n\r - Corticotherapy ≥ 10mg/day\r\n\r - Patient under legal protection\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
762
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAddition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation\n\n**Clinical Trial Summary:**\n\nThe objective is to assess the influence of FEops HEARTguide on overall device success in\r TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV)\r platform selection (Cohort B).\n\n**Clinical Trial Detailed Description:**\n\nrationale:Transcatheter aortic valve implantation (TAVI) is increasingly used to treat\r patients with severe aortic stenosis. However, by extending the indication for TAVI,\r simulation may become increasingly important to improve procedure execution, safety and\r efficacy.\r\n\r objective: This study aims to assess the influence of FEops HEARTguide on overall device\r success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform\r selection (Cohort B).\r\n\r Study design: Prospective, observational multi-center trial with 2 cohorts Study Population:\r Cohort A patients with the following complex anatomy are included: BAV (Sievers 0 or 1) or\r functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots.\r\n\r Cohort B consecutive patients eligible for TAVI with Acurate TM and Lotus Edge TM valve\r\n\r Study Procedure: Participating sites identifies cases and decide if the patient is eligible\r for cohort A or B. The pre-procedural CT-scan will be uploaded to FEops HEARTguide. Heart\r Team decision 1 is according to the clinical routine, including valve type and size,\r pre-dilatation, post-dilatation, preferred implantation depth and comfort scale level.\r\n\r Heart Team decision 2 is after the simulation of FEops HEARTguide for the final\r pre-procedural planning. For Cohort A, FEops HEARTguide will give their information about\r sizing and implantation depth. For Cohort B, FEops HEARTguide will give two simulations, one\r with an Acurate valve and one with a Lotus Edge valve.\r\n\r The operator will make the final decision about the valve selection. After the procedure the\r implanted device, size and depth are recorded as standard of care. The follow-up period will\r be 30 days. A new CT-scan is recommended. However, this will not be mandatory for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Cohort A:\r\n\r 1. Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid\r Aortic Valve\r\n\r 2. Patients with a severely calcified aortic valve (Agatston score > 3000 for men,\r and > 1600 for women)\r\n\r 3. Patients with small anatomy defined by mean aortic annulus diameter < 20mm\r\n\r - Cohort B:\r\n\r 1. every patient accepted for TAVI and eligible for Acurate TM and Lotus Edge valve\r TM.\r\n\r Exclusion Criteria:\r\n\r - poor CT quality\r\n\r - previous aortic valve replacement\r\n\r - Permanent pacemaker at baseline\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
763
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients\n\n**Clinical Trial Summary:**\n\nDiscrepancies exist among aortic stenosis severity classification, patient symptom burden,\r and - in some cases - even survival. The new Stress Aortic Valve Index (SAVI) metric\r correlates better with transvalvular flow and might be a better predictor of symptoms and\r prognosis.\r\n\r The current study will demonstrate the value of SAVI (both non-invasive and invasive) in\r patients with moderate aortic stenosis.\r\n\r The population will consist of subjects at least 50 years old with moderate aortic stenosis\r (defined as aortic valve area >1.0 cm2 plus either maximal velocity 3.0-3.9 m/s or mean\r gradient 20-39 mmHg). Subjects with severe concomitant valve disease or severe\r unrevascularized coronary artery disease will be excluded, so that the isolated prognosis of\r aortic stenosis can be investigated.\r\n\r All subjects will undergo invasive SAVI measurements during catheterization. Furthermore\r patients will receive non-invasive testing with an exercise echocardiogram and computed\r tomography (CT) scan for non-invasive SAVI measurements.\r\n\r The short-term objective will compare SAVI with standard resting indexes for symptom burden,\r functional capacity, and biomarkers. The long-term objective will associate SAVI and standard\r resting indexes with clinical outcomes related to valvular disease. The investigators\r hypothesize that low SAVI (more marked AS during stress) will track with more symptoms and a\r worse prognosis.\r\n\r Nature and extent of the burden and risks associated with participation, benefit and group\r relatedness: The patients will have several study visits. The index visit will be planned to\r obtain informed consent and baseline parameters. The measurement visit(s) will consist of the\r invasive SAVI measurement, echocardiogram, stress echo imaging, 6-minute walk test, quality\r of life questionnaire, and the cardiac CT. During the final visit after 12 months, subjects\r will undergo a CT valvular calcium scan, quality of life questionnaire, and 6-minute walk\r test. Every subject will have an echocardiogram yearly as suggested by guideline criteria and\r could possibly be contacted until five years after enrollment. Blood samples will be drawn at\r baseline and the 1-year follow-up. Potentially the new SAVI metric could identify patients at\r higher risk among those with moderate gradient AS. However, since no outcome data currently\r exists regarding SAVI and prognosis, no conclusions could be derived from these measurements\r until study completion.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 50 years\r\n\r - Moderate aortic stenosis confirmed in the past 3 months by standard echocardiographic\r evaluation: aortic valve area >1.0 cm2 plus either maximal velocity 3.0-3.9 m/s or\r mean gradient 20-39 mmHg\r\n\r - Ability to undergo exercise stress testing\r\n\r - Ability to understand and the willingness to provide written informed consent\r\n\r Exclusion Criteria:\r\n\r A potential subject who meets any of the following criteria will be excluded from\r participation in this study\r\n\r - Any hemodynamic criterion for severe AS: maximal velocity >= 4 m/s, mean gradient >=\r 40mmHg, aortic valve area =< 1 cm2\r\n\r - Percutaneous coronary intervention or coronary artery bypass grafting in the past\r three months, or have revascularization planned in the near future\r\n\r - Known, unrevascularized, and severe coronary artery disease (for example a 90%\r diameter stenosis or FFR<0.7 in the proximal left anterior descending artery)\r\n\r - Impaired left ventricular function (ejection fraction <50%)\r\n\r - Unicuspid, bicuspid, or non-calcified aortic valve observed during echocardiography\r (note that later cusp fusion noted during study-related cardiac imaging will not\r exclude a subject)\r\n\r - Severe aortic regurgitation, mitral valve disease, tricuspid regurgitation, or a\r significant intracardiac shunt\r\n\r - Co-existing hypertrophic cardiomyopathy or severe septal hypertrophy >15mm\r\n\r - Persistent atrial fibrillation with uncontrolled ventricular response\r\n\r - Recent (within 6 weeks) acute coronary syndrome\r\n\r - Estimated glomerular filtration rate ≤30 mL/min or end-stage renal disease on\r replacement therapy (dialysis)\r\n\r - Severe COPD GOLD stage 3 or 4, home oxygen dependence, or ≥2 pulmonary inhalers (note\r that well-treated and stable asthma and GOLD stage 1 or 2 COPD is permitted)\r\n\r - Severe comorbid condition with life expectancy <2 years\r\n\r - Prior adverse reaction to dobutamine\r\n\r - Severe iodine contrast allergy\r\n\r - Pregnancy\r\n\r - Severe pulmonary hypertension with systolic pulmonary artery pressure greater than\r 50mmHg or isolated and symptomatic right ventricular failure\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
764
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nExploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess inter- and intra-rater reliability of the 6MWT in\r people with acute stroke who require various levels of assistance with walking.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - At least 18 years old\r\n\r - Primary diagnosis of an acute or hemorrhagic stroke\r\n\r - Admitted into the acute or acute rehab setting and is appropriate for physical therapy\r services.\r\n\r - Can ambulate with 1 person assistance and a device as needed, with no more than\r maximal assistance required. The patient must be able to independently advance the\r lower extremity forward, but can receive maximal assistance for blocking, bracing or\r postural control during ambulation.\r\n\r - Can stand and/or ambulate for at least 6 minutes\r\n\r Exclusion Criteria:\r\n\r - Hemodynamically unstable\r\n\r - Unstable medical co-morbidities such as: active bleeding, recurring seizures,\r uncontrolled hypertension (permissive HTN orders ok)\r\n\r - Patients with bilateral acute stroke\r\n\r - Patients who are unable to follow 1 step commands as determined by the screening\r physiatrist\r\n\r - Orthopedic co-morbidities that place a weight-bearing restriction on the lower\r extremities such as acute fracture, joint replacement, or other musculoskeletal injury\r\n\r - Any other condition that would limit a patient's ability to remain in a standing\r position with assistance for 6 minutes at a time.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
765
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores\n\n**Clinical Trial Summary:**\n\nSingle arm, observational trial of Transcatheter Aortic Valve Implantation (TAVI) with the\r Medtronic Evolut R and Evolut Pro The primary objective of this trial is to evaluate device\r success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors\r for adverse surgical outcomes not captured by the traditional risk scores and therefore of\r intermediate surgical risk.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to investigate the safety and efficacy of transcatheter aortic\r valve implantation (TAVI) in septuagenarians with severe, symptomatic Aortic Stenosis (AS)\r and risk factors for adverse surgical outcomes not captured by the traditional risk scores\r and therefore of intermediate surgical risk.\r\n\r The primary objective of this trial is to evaluate device success of TAVI with the Evolut R\r and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not\r captured by the traditional risk scores and therefore of intermediate surgical risk.\r\n\r The secondary objective is to assess early safety (at 30 days) and clinical efficacy (after\r 30 days) of the TAVI procedure.\r\n\r Exploratory objective: comparative health economics in septuagenarians with symptomatic\r severe aortic stenosis and intermediate surgical risk treated with Transcatheter Aortic Valve\r Implantation (TAVI) vs Surgical Aortic Valve Replacement (SAVR) (matched historic cohort)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age 75-79\r\n\r 2. Subject must have Society of Thoracic Surgeons (STS) score >=4% and <=8%\r\n\r 3. Subject must have at least one from the risk factors presented below:\r\n\r i. Severely atherosclerotic or porcelain aorta ii. Internal Mammary Artery (IMA) or\r other conduit(s) crossing midline and/or adherent to posterior table of sternum iii.\r Pre-existing mechanical valve in any other position iv. Severe right ventricular\r dysfunction v. Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis\r or other skeletal abnormalities, evidence of severe radiation damage, history of\r multiple recurrent pleural effusions causing internal adhesions) vi. Severe liver\r disease/cirrhosis vii. Frailty viii. Malignancy with life expectancy that exceeds 24\r months ix. Renal replacement therapy with creatinine levels >200mmol/L or 2.26 mg/dl\r\n\r 4. Heart team consisting of at least one interventional cardiologist and one cardiac\r surgeon agree on indication and treatment proposal, based on their clinical judgment\r (including anatomy assessment, risk factors, etc)\r\n\r 5. Critical aortic valve area defined as an initial aortic valve area of <=1cm2 or aortic\r valve index <0.6cm2/m2\r\n\r 6. In presence of normal left ventricular function:\r\n\r 1. Mean gradient >40mmHg OR Vmax>4m/sec OR\r\n\r 2. In presence of low flow, low gradient severe AS, a dobutamine stress echo must be\r conducted that demonstrates presence of contractile reserve defined as follows\r >=20% increase in stroke volume and mean gradient >40mmHg\r\n\r 7. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York\r Heart Association (NYHA) Functional Class II or greater\r\n\r 8. The subject is suitable for direct TAVI not preceded by balloon valvuloplasty\r according to the judgment of the treating physicians\r\n\r 9. The subject and the treating physician agree that the subject will return for all\r required post procedure follow-up visits.\r\n\r Exclusion Criteria:\r\n\r 1. Hypersensitivity or contraindication to aspirin, heparin, clopidogrel, coumadin,\r nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;\r\n\r 2. Blood dyscrasias as defined: leukopenia (WBC<1000/mm3), thrombocytopenia (platelet\r count <50.000cells/mm3), history of bleeding diathesis or coagulopathy;\r\n\r 3. Ongoing sepsis, including active endocarditis\r\n\r 4. Any condition considered a contraindication to extracorporeal assistance;\r\n\r 5. Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within six weeks prior treatment\r\n\r 6. Cardiogenic shock manifested by low cardiac output, vasopressor dependence or\r mechanical hemodynamic support;\r\n\r 7. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack\r (TIA)\r\n\r 8. Active gastrointestinal (GI) bleeding within the past 3 months\r\n\r 9. Subject refuses a blood transfusion;\r\n\r 10. Severe dementia (resulting in either inability to provide informed consent for the\r trial/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits);\r\n\r 11. Multivessel coronary artery disease with a Syntax score >22\r\n\r 12. Estimated life expectancy of less than 24 months due to associated non-cardiac\r comorbid conditions\r\n\r 13. Other medical, social, or psychological conditions that in the opinion of the\r investigator precludes the subject from appropriate consentor adherence to the\r protocol required follow-up exams;\r\n\r 14. Currently participating in an investigational drug or another device trial (excluding\r registries)\r\n\r 15. Evidence of an acute myocardial infarction <=30 days before the index procedure\r\n\r 16. Need for emergency surgery for any reason\r\n\r 17. Uncontrolled atrial fibrillation\r\n\r Anatomical Exclusion Criteria:\r\n\r 18. Native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging;\r\n\r 19. Mixed aortic valve disease [aortic stenosis and aortic regurgitation with predominant\r aortic regurgitation (3-4+]\r\n\r 20. Severe mitral or severe tricuspid regurgitation\r\n\r 21. Severe mitral stenosis;\r\n\r 22. Hypertrophic obstructive cardiomyopathy\r\n\r 23. Echocardiographic or Multislice Computed Tomography (MSCT) evidence of intracardiac\r mass, thrombus or vegetation\r\n\r 24. Anatomy of the aortic root and ascending aorta not suitable for TAVI with Evolut R or\r Evolut Pro system (aortic root angulation >70 degrees for femoral and left subclavian\r access or >30 degrees for right subclavian access)\r\n\r 25. Congenital bicuspid or unicuspid valve verified by echocardiography Vascular Exclusion\r Criteria\r\n\r 26. Transarterial access not able to accommodate an 16 French sheath\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
766
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRandomized, Open-label Trial of Inhibitory Effect of Evogliptin on Progression of CAVD\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess an inhibitory effect of Evogliptin on the progression\r of mild-to-moderate aortic stenosis in patients with T2DM and calcific aortic stenosis.\n\n**Clinical Trial Detailed Description:**\n\nDespite a lot of clinician's efforts to develop an effective medical treatment of calcific\r aortic valve disease (CAVD) for decades, there is no scientifically-proved medical treatment\r yet. Since the pathological features of CAVD are characterized by inflammatory cell\r infiltration and lipid deposition, as in atherosclerosis, statin drugs that are proved to be\r effective in the treatment of cardiovascular disease, have been used in the most recent\r randomized clinical trials; however, different types of medications showed negative results\r and thus, CAVD represents an unmet clinical need.\r\n\r Researchers of Asan Medical Center have proved that dipeptidyl-peptidase-4 (DPP-4)-IGF\r (insulin-like growth factor)-1 axis is important for pathologic osteoblast transformation of\r valvular interstitial cell (VIC), and reported that the administration of DPP-4 inhibitor\r prevents the calcification effectively in the actual animal model of CAVD. Under a normal\r condition, IGF-1 suppresses the pathologic transformation of VIC; however, when endothelial\r cells are damaged due to aging or various pathological conditions, DPP-4 expression is\r increased in valvular tissue. Since DPP-4 acts as an enzyme that degrades IGF-1, it reduces\r normal IGF-1 activity and increases transformation of VIC to osteoblast, causing pathological\r calcification and worsening CAVD.\r\n\r After comparing six different DPP-4 inhibitors, researchers of Asan Medical Center discovered\r that evogliptin has higher cardiac tissue distribution compared to other DPP-4 inhibitors. In\r addition, the DPP-4 inhibitors with high cardiac tissue distribution have shown decreased\r incidence rate of severe CAVD in the retrospective study. Based on these findings, this study\r will examine the effect of evogliptin on progression of CAVD.\r\n\r The study is a randomized, open-label trial of evogliptin in subjects with T2DM and\r moderate-to-severe CAVD. Subjects who have agreed to participate in the study and signed the\r ICF will undergo a screening period and those who meet the eligibility criteria will be\r randomized in a 1:1 ratio to evogliptin or non-evogliptin group. The subjects will take the\r drug for 96 weeks and will be closely monitored for efficacy. The effectiveness of evogliptin\r on inhibition of CAVD progression will be evaluated by comparing the change in aortic valve\r calcium volume in the evogliptin group against that of the non-evogliptin group.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male and female aged 19 years or older\r\n\r 2. Subjects who were diagnosed with type 2 diabetes mellitus and being treated with oral\r hypoglycemic drugs\r\n\r 3. Subjects whose Doppler echocardiography or Heart CT performed within 8 weeks prior to\r or during Screening Visit (Visit 1) is satisfying any of the followings:\r\n\r - Doppler echocardiogrphy (aortic valve calcification and/or hypertrophy with\r aortic peak velocity≥2.0 m/s); or\r\n\r - Heart CT (aortic valve calcium score≥300 AU)\r\n\r 4. Subjects who decided to take part in this study on his/her own volition after\r listening to the details of this study\r\n\r Exclusion Criteria:\r\n\r 1. Subjects with severe aortic valve stenosis (aortic peak velocity>4.0 m/s, mean\r pressure gradient >40 mmHg, or aortic valve area≤0.75 cm2)\r\n\r 2. Subjects with left ventricular ejection fraction < 40%\r\n\r 3. Heart failure patients: Subjects with heart failure of NYHA functional class II-IV\r\n\r 4. Subjects with an estimated glomerular filtration rate (eGFR) of <30ml\r\n\r 5. Subjects with type 1 diabetes or diabetic ketoacidosis\r\n\r 6. Subjects with serious hypersensitivity to DPP-4 inhibitors\r\n\r 7. Subjects who have received/are receiving any of the following medication therapies:\r\n\r - Vitamin K\r\n\r - Calcium supplement (or osteoporosis medication)\r\n\r 8. Subjects whose aortic valve stenosis is not caused by degenerative or bicuspid valve\r disease (e.g. rheumatic valve disease)\r\n\r 9. Subjects who have received or are expected to receive (as of Visit 1) aortic valve\r surgery during the study.\r\n\r 10. Subjects for whom a two-year clinical course investigation is not possible due to\r malignant tumor or cerebrovascular disease\r\n\r 11. Pregnant or lactating women\r\n\r 12. Women of childbearing potential who are sexually active and do not agree to use proper\r contraception during the study\r\n\r - Proper contraception means physical barrier method including condom,\r contraceptive diaphragm or cervix cap. The use of contraceptive or oral\r contraceptive containing hormones that may induce drug-drug interaction with the\r investigational product is not allowed during the study (with the exception of an\r oral contraceptive administered to cure menopausal symptoms, only if the dosage\r has been consistent for the past 8 weeks)\r\n\r 13. Any other subjects deemed not eligible for this study by an investigator\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
767
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEpidemiology and Long-term Outcome of Patients With VHD\n\n**Clinical Trial Summary:**\n\nValvular heart diseases are significant problem in Polish population. Coexistence of coronary\r artery disease in patients with VHD increases the risk of death and affects further\r therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term\r prognosis among patients with VHD.\n\n**Clinical Trial Detailed Description:**\n\nValvular heart diseases are significant problem in Polish population. Coexistence of coronary\r artery disease in patients with VHD increases the risk of death and affects further\r therapeutic strategy.\r\n\r Patients with moderate and severe valvular heart diseases are included into the study. The\r set of variables subject to interpretation consisted of demographic data, medical history,\r result of coronary angiography, and type of applied percutaneous and surgical treatment\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Valvular heart disease in moderate and severe stages\r\n\r Exclusion Criteria:\r\n\r - Age < 18 years old\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
768
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies the effect of nivolumab in combination with blinatumomab compared\r to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL)\r that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in\r this study. Blinatumomab is an antibody, which is a protein that identifies and targets\r specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer\r cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a\r medicine that may boost a patient's immune system. Giving nivolumab in combination with\r blinatumomab may cause the cancer to stop growing for a period of time, and for some\r patients, it may lessen the symptoms, such as pain, that are caused by the cancer.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To compare rate of minimal residual disease (MRD) negative second remission (Rem-2) after\r up to two cycles of reinduction with blinatumomab versus (vs.) blinatumomab/nivolumab in\r Group 1 patients aged >= 1 to < 31 years old with first relapse of CD19+ B-ALL.\r\n\r II. To compare event-free survival (EFS) PI (EFS post-induction) between consolidation with\r blinatumomab vs. blinatumomab/nivolumab in Group 3 patients aged >= 1 to <31 years old with\r first relapse of CD19+ B ALL.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the safety and tolerability of blinatumomab/nivolumab in patients aged >= 1 to\r < 31 years old with first relapse of CD19+ B ALL.\r\n\r II. To compare EFS post-induction between blinatumomab vs. blinatumomab/nivolumab in Group 2\r patients aged >= 1 to < 31 years old with first relapse of CD19+ B ALL.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. In Group 1 patients, compare EFS between blinatumomab monotherapy and\r blinatumomab/nivolumab arms as compared to similar patients treated on the predecessor trial\r AALL1331.\r\n\r II. In Group 1 patients, compare toxicity as defined by grade 3 or greater adverse events\r during the first cycle of blinatumomab or blinatumomab/nivolumab to similar patients treated\r with block 1 of cytotoxic chemotherapy on the predecessor trial AALL1331.\r\n\r III. In Group 2 patients with MRD >= 0.1% after vincristine sulfate, dexamethasone, pegylated\r asparaginase, and doxorubicin hydrochloride (VXLD), compare MRD negative second remission\r (Rem-2) rate after the first cycle of immunotherapy between blinatumomab monotherapy and\r blinatumomab/nivolumab arms.\r\n\r IV. In patients with Down syndrome (DS) with first relapse of B-ALL, describe the safety,\r tolerability and efficacy (as defined by MRD negative second remission, Rem-2) after up to\r two cycles of blinatumomab/nivolumab.\r\n\r OUTLINE: Patients >= 18 years old with marrow +/- extramedullary (EM) relapse of any duration\r after initial diagnosis, or patients < 18 years old with marrow +/- EM relapse < 24 months\r after initial diagnosis are assigned to Group 1. Patients < 18 years old with marrow +/- EM\r relapse >= 24 months from initial diagnosis, or all isolated extramedullary (IEM) relapses >=\r 1 to < 31 years old are assigned to Groups 2-3 re-induction. Patients with DS are assigned to\r Arm G. NOTE: Patients in Group 1 and DS patients with white blood cells (WBC) >= 30,000/uL,\r CNS 2/3 disease, or testicular disease must first receive 1 of 3 pre-immunotherapy\r treatments.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR PATIENTS WITH WBC >= 30,000/uL: Patients receive methotrexate\r (MTX) intrathecally (IT) or cytarabine IT or intrathecal triple therapy (ITT) consisting of\r MTX, hydrocortisone sodium succinate, and cytarabine IT at the time of diagnostic lumbar\r puncture (LP) or on day 1 (if intrathecal therapy is given with relapse diagnostic LP < 7\r days prior to the start of protocol therapy). Patients also receive dexamethasone\r intravenously (IV) or orally (PO) twice daily (BID) on days 1-5, vincristine sulfate IV push\r over 1 minute or via infusion on day 1. Patients with DS also receive leucovorin calcium PO\r or IV every 6 hours (q6h) for 2 doses on day 2 or at 24 and 30 hours after each MTX or ITT\r dose. Patients should proceed to the next cycle when CNS 1 and no testicular disease is\r present, no sooner than Day 8 and no later than Day 15.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR CNS 2/3 DISEASE: Patients receive MTX IT or cytarabine IT\r twice weekly (Q2W) for 5-7 doses or Intrathecal Triple Therapy (ITT) IT Q2W for 3-4 doses\r until patient is CNS 1. Patients with DS also receive leucovorin calcium PO or IV q6h for 2\r doses at 24 and 30 hours after each MTX or ITT dose. Patients should proceed to the next\r cycle when CNS 1 and no testicular disease is present, no sooner than Day 15 and no later\r than Day 24.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR TESTICULAR DISEASE: Patients receive MTX IT, cytarabine IT,\r or ITT IT on days 1 and 15 (day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy). Patients with DS also receive\r leucovorin calcium PO or IV q6h for 2 doses on days 2 and 16 or at 24 and 30 hours after each\r IT MTX or ITT dose. Males with testicular disease at relapse undergo radiation once daily\r (QD) for a total of 12 fractions over 12 days. Patients should proceed to the next cycle when\r CNS 1 and no testicular disease is present, no sooner than Day 15 and no later than Day 22.\r\n\r GROUP 1: Patients are randomized to Arm A or Arm B.\r\n\r ARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via\r continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1\r and 15 of cycle 1 (MTX on day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy), and MTX IT on days 1 and 15\r of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r ARM B: Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A.\r Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1\r and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r GROUPS 2-3 REINDUCTION: Patients receive vincristine sulfate IV push over 1 minute or via\r infusion on days 1, 8, 15, and 22, dexamethasone PO or IV on days 1-14, doxorubicin\r hydrochloride IV over 1-15 minutes on day 1, MTX IT on days 1, 8, and 29 (day 1 may be\r omitted if intrathecal therapy is given with relapse diagnostic LP < 7 days prior to the\r start of protocol therapy) (days 8 and 29 for CNS 1/2 patients at relapse only), pegaspargase\r intramuscularly (IM) or IV over 1-2 hours on days 2 and 16, cytarabine IT on days 4 and 11\r (CNS 2 patients at relapse only), then Q2W until 3 consecutive samples are clear of blasts,\r and ITT IT on days 8, 15, 22, and 29 (CNS 3 patients at relapse only). Treatment continues in\r the absence of disease progression or unacceptable toxicity.\r\n\r GROUP 2: The following patients are randomized to Arm C or Arm D: 1) >= 1 to < 31 years old,\r IEM relapse < 18 months from diagnosis, regardless of MRD after Re-Induction. 2) < 18 years\r old with marrow relapse >= 24 to < 36 months from diagnosis regardless of MRD after\r Re-Induction, 3) >= 1 to < 31 years old, IEM relapse >= 18 months, and MRD >= 0.1% after\r Re-Induction, 4) < 18 years old with marrow relapse >= 36 months, and MRD >= 0.1% after\r Re-Induction.\r\n\r ARM C: Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via\r continuous IV infusion on days 1-28 of cycles 1 and 2, and MTX IT on days 1 and 15 of cycles\r 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal MTX is given < 7 days prior to the\r start of cycle 1 ). Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r ARM D: Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also\r receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle\r 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or\r unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop study treatment\r or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle 1 proceed to\r cycle 2.\r\n\r GROUP 3: The following patients are randomized to Arm E or Arm F: 1) >= 1 to < 31 years old\r with IEM relapse >= 18 months from diagnosis and MRD < 0.1% after Re-Induction, 2) < 18 years\r old with marrow relapse >= 36 months from diagnosis and MRD < 0.1% after Re-Induction.\r\n\r ARM E:\r\n\r IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, and MTX IT on days 1 and 15 (day 1 may\r be omitted from cycle 1 if intrathecal therapy is given < 7 days prior to the start of this\r cycle).Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2.\r\n\r CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate\r IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on\r days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide\r IV over 90-120 minutes on days 43 and 50, thioguanine PO once daily (QD) on days 43-49, and\r cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 44-47 and 51-54. CNS 1/2\r patients at relapse also receive MTX IT on days 1 and 43 and PO q6h for 4 doses on day 22,\r and leucovorin calcium PO q6h for 2 doses on day 24. CNS 3 patients at relapse also receive\r ITT IT on days 1 and 43, intermediate dose MTX IV over 36 hours on day 22, and leucovorin\r calcium IV or PO q6h on days 24 and 25. Treatment repeats every 8 weeks for 2 cycles in the\r absence of disease progression or unacceptable toxicity.\r\n\r IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28,\r and MTX IT on days 1 and 15.\r\n\r MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine\r sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on\r days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3\r patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.\r Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the\r absence of disease progression or unacceptable toxicity.\r\n\r MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS ONLY): Beginning between the first and second\r cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21,\r vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and\r pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse\r undergo cranial radiation in the form of 3-dimensional (D)-conformal radiation therapy (CRT)\r over 5 days per week for a total of 10 treatments.\r\n\r ARM F:\r\n\r IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days\r 11-25 of cycle 1 and on days 1 and 15 of cycles 2 and 3, and MTX IT on days 1 and 15 (day 1\r may be omitted from cycle 1 if intrathecal therapy is given with < 7 days prior to the start\r of this cycle). Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2.\r\n\r CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate\r IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on\r days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide\r IV over 90-120 minutes on days 43 and 50, thioguanine PO QD on days 43-49, and cytarabine IV\r over 1-30 minutes or SC on days 44-47 and 51-54. CNS 1/2 patients at relapse also receive MTX\r IT on days 1 and 43 and PO q6h for 4 doses on day 22, and leucovorin calcium PO q6h for 2\r doses on day 24. CNS 3 patients at relapse also receive ITT IT on days 1 and 43, intermediate\r dose MTX IV over 36 hours on day 22, and leucovorin calcium IV or PO q6h on days 24 and 25.\r\n\r IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28,\r nivolumab IV over 30 minutes on days 1 and 15 and MTX IT on days 1 and 15.\r\n\r MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine\r sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on\r days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3\r patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78.\r Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the\r absence of disease progression or unacceptable toxicity.\r\n\r MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS): Beginning between the first and second\r cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21,\r vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and\r pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse\r undergo cranial radiation in the form of 3D-CRT over 5 days per week for a total of 10\r treatments in the absence of disease progression or unacceptable toxicity.\r\n\r ARM G (DS PATIENTS): Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11\r and 25 of cycle 1 and days 1 and 15 of cycle 2, and MTX IT, cytarabine IT, or ITT IT on days\r 1 and 15 of cycle 1 (MTX on day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy), MTX IT on days 1 and 15 of\r cycle 2, and leucovorin calcium IV or PO q6h for 2 doses on days 2 and 16.\r\n\r Patients with MRD < 0.01% are eligible to come off protocol therapy to receive Consolidation\r therapy at the end of Cycle 1, or may choose to proceed to Arm G, Cycle 2.\r\n\r After completion of study treatment, patients are followed up every 3 months for 1 year.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must be >= 1 and < 31 years at time of enrollment\r\n\r - Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in\r one of the following categories:\r\n\r - Isolated bone marrow relapse\r\n\r - Isolated central nervous system (CNS) (excluding known optic nerve/retinal and\r CNS chloromas) and/or testicular relapse\r\n\r - Combined bone marrow with extramedullary relapse in the CNS (excluding known\r optic nerve/retinal and CNS chloromas) and/or testes\r\n\r - Patients with Down syndrome (DS) are eligible in the following categories:\r\n\r - Isolated bone marrow relapse\r\n\r - Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS\r chloromas) and/or testicular relapse\r\n\r - Patients must have a performance status corresponding to Eastern Cooperative Oncology\r Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and\r Lansky for patients =< 16 years of age\r\n\r - Patients must have fully recovered from the acute toxic effects of all prior\r chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n\r - Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in\r the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19\r expression\r\n\r - Radiation therapy (RT): >= 3 months must have elapsed if prior RT. This includes\r any patient requiring urgent radiation to any sites of extramedullary disease\r prior to enrollment (e.g. retinal/optic nerve involvement)\r\n\r - Hematopoietic stem cell transplant (HSCT): Patients must not have had a prior\r hematopoietic stem cell transplant\r\n\r - A single intrathecal chemotherapy at the time of relapse will be allowed. If < 7\r days have elapsed between this intrathecal therapy (IT) and the start of protocol\r therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine,\r or triple intrathecal) may be omitted\r\n\r - In the 28 days prior to enrollment, up to five days of post-relapse,\r pre-enrollment therapy (steroid and/or hydroxyurea only) is permissible\r\n\r - Group 1 and Down syndrome patients who received pre-enrollment therapy and\r have a white blood count (WBC) >= 30,000/ul at the time of enrollment must\r receive protocol specified cytoreductive therapy with vincristine and\r dexamethasone, and no \"washout\" is required\r\n\r - Group 1 and Down syndrome patients who received pre-enrollment therapy and\r have a WBC < 30,000/ul at the time of enrollment must be given a 24 hour\r \"washout\" before starting immunotherapy\r\n\r - Note: There is no waiting period or \"washout\" for patients who relapse while\r receiving upfront therapy\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70\r mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows (within 5\r calendar days prior to enrollment):\r\n\r - Age: Maximum serum creatinine (mg/dL)\r\n\r - 1 to < 2 years: 0.6 (male), 0.6 (female)\r\n\r - 2 to < 6 years: 0.8 (male), 0.8 (female)\r\n\r - 6 to < 10 years: 1 (male), 1 (female)\r\n\r - 10 to < 13 years: 1.2 (male), 1.2 (female)\r\n\r - 13 to < 16 years: 1.5 (male), 1.4 (female)\r\n\r - >= 16 years: 1.7 (male), 1.4 (female)\r\n\r - Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by\r echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram\r\n\r - No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if\r there is clinical indication for determination.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met\r\n\r Exclusion Criteria:\r\n\r - Patients with B-lymphoblastic lymphoma (B-LLy)\r\n\r - Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia\r\n\r - Patients with Philadelphia chromosome positive (Ph+) B-ALL\r\n\r - Patients with mixed phenotype acute leukemia (MPAL)\r\n\r - Patients with known Charcot-Marie-Tooth disease\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype\r\n\r - Patients with active, uncontrolled infection defined as:\r\n\r - Positive bacterial blood culture within 48 hours of study enrollment\r\n\r - Receiving IV or PO antibiotics for an infection with continued signs or symptoms.\r Note: Patients may be receiving IV or oral antibiotics to complete a course of\r therapy for a prior documented infection as long as cultures have been negative\r for at least 48 hours and signs or symptoms of active infection have resolved.\r For patients with clostridium (C.) difficile diarrhea, at least 72 hours of\r antibacterial therapy must have elapsed and stools must have normalized to\r baseline.\r\n\r - Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with\r clinical signs of infection. Fever without clinical signs of infection that is\r attributed to tumor burden is allowed as long as blood cultures are negative for\r > 48 hours\r\n\r - A positive fungal culture within 30 days of study enrollment or active therapy\r for presumed invasive fungal infection\r\n\r - Active viral or protozoal infection requiring IV treatment\r\n\r - Patients known to have one of the following concomitant genetic syndromes: Bloom\r syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome\r or any other known bone marrow failure syndrome are not eligible. Of note, patients\r with known human immunodeficiency virus (HIV) infection on effective anti-retroviral\r therapy with undetectable viral load for at least the last 6 months prior to\r enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who\r have been treated and have no viral detectable burden are also eligible\r\n\r - Patients with significant central nervous system pathology that would preclude\r treatment with blinatumomab, including history of severe neurologic disorder or\r autoimmune disease with CNS involvement\r\n\r - Note: Patients with a history of seizures that are well controlled on stable\r doses of anti-epileptic drugs are eligible Patients with a history of\r cerebrovascular ischemia/hemorrhage with residual deficits are not eligible.\r Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible\r provided all neurologic deficits have resolved\r\n\r - Patients with an active known/suspected autoimmune disease are not eligible. However,\r patients with type I diabetes mellitus, hypothyroidism only requiring hormone\r replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring\r systemic treatment, or conditions not expected to recur in the absence of an external\r trigger are permitted to enroll\r\n\r - Group 1 and DS patients with known non-hematopoietic, non-CNS/testicular\r extramedullary disease (i.e., chloromatous disease) are not eligible\r\n\r - Note: Group 2 and 3 patients with known non-hematopoietic, non-CNS/testicular\r extramedullary disease (i.e., chloromatous disease) are eligible provided that\r this is NOT the only site of relapsed disease\r\n\r - Female patients of childbearing potential are not eligible unless a negative pregnancy\r test result has been obtained within 7 days prior to enrollment. Patients who are\r sexually active and of reproductive potential are not eligible unless they agree to\r use an effective contraceptive method for the duration of this study. Men with female\r partners of childbearing potential should use effective contraception during the\r duration of their treatment. The effect of blinatumomab on fertility has not been\r evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing\r potential (WOCBP) not using contraception. Females of reproductive potential must use\r effective contraception during treatment and for at least 48 hours after the last dose\r of blinatumomab. Studies in animal models have shown that nivolumab can adversely\r impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy.\r WOCBP receiving nivolumab must continue contraception for a period of at least 5\r months after the last dose of nivolumab. It is unknown whether nivolumab is present in\r breast milk, thus breastfeeding should be discontinued while a patient is receiving\r nivolumab. Men receiving nivolumab and who are sexually active with WOCBP must\r continue contraception for 7 months after the last dose of nivolumab\r\n\r - Lactating females are not eligible unless they agree not to breastfeed their infants.\r It is unknown whether blinatumomab or its metabolites are excreted in human breast\r milk. Women are not permitted to breastfeed while receiving blinatumomab and for the\r last 48 hours after the last blinatumomab dose. Due to the potential for serious\r adverse reactions in the breastfed infant, women are not permitted to breastfeed\r during treatment and for 5 months after the last nivolumab dose\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
769
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPrognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease\n\n**Clinical Trial Summary:**\n\nThis study investigates the association between level of suPAR and valvular heart disease in\r patients who have severe aortic stenosis or severe aortic regurgitation using commercially\r available suPARnostic standard enzyme-linked immunosorbent assay (ViroGates, Denmark)\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 19 yrs\r\n\r - Severe aortic stenosis or severe aortic regurgitation\r\n\r - Agree to consent for self\r\n\r - Can follow-up for the next 2 years\r\n\r Exclusion Criteria:\r\n\r - Pre-existing acute kidney injury\r\n\r - Pre-existing end stage kidney disease: estimated glomerular filtration rate (eGFR) ≤15\r ml/min/1.73m2 or receiving renal replacement therapy\r\n\r - On ECMO or IABP\r\n\r - Life expectancy < 12 months\r\n\r - Pregnancy\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
770
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRisk Factors and Computed Tomography Findings in COVID-19.\n\n**Clinical Trial Summary:**\n\nIn the SARS-CoV2 pandemic, imaging studies proved its diagnostic utility to determine the\r severity of lung involvement. Computed tomography (CT) is a state-of-the-art study proven to\r be a highly sensitive diagnostic test complemented by RT-PCR testing to determine the disease\r and the degree of severity.\r\n\r In March 2020, the Dutch Society of Radiology developed a standardized assessment scheme for\r COVID-19 lung disease, called CO-RADS. This system proposes a level of suspicion of pulmonary\r involvement of COVID-19, based on the simple chest tomography findings. The level of\r suspicion ranges from very low (CO-RADS 1) to very high (CO-RADS 5), with two additional\r categories involving a technically deficient study (CO-RADS 0) and a positive RT-PCR test for\r SARS -CoV-2 known before tomography (CO-RADS 6).\r\n\r For its part, acute respiratory damage secondary to SARS-COV2 pneumonia causes acute\r respiratory distress syndrome, which warrants immediate medical attention. During the\r evaluation and triage of patients with suspected or confirmed SARS-COV2 infection, it is a\r challenge for health personnel given that the severity and clinical presentation is highly\r variable. The patient's risk stratification is carried out using previously established and\r validated risk scales and is a fundamental tool for making clinical decisions. Some of the\r risk indices and scales have been developed and used in the pandemic epicenters, such as\r China and Europe. Useful for the clinician is the national early warning scale (NEWS 2),\r severe disease risk assessment score (COVID-GRAM), the rapid severity index for COVID-19\r (qCSI), evaluation score of Modified sequential organ failure (mSOFA), the sepsis-induced\r coagulopathy score (SIC), the ROX index as a predictor of success to the high-flow nasal\r cannula. The evaluation of the risk of thrombotic complications such as the Padua risk, of\r cardiac complications such as QT segment prolongation, through the Tisdale risk score.\r\n\r Risk stratification is essential in the current COVID-19 pandemic situation; upon admission,\r the clinician will discern if the patient requires in-hospital medical treatment, the risk of\r severe disease, and progression to assisted mechanical ventilation.\r\n\r This work aims to establish whether the severity of the findings identified by cardiac\r tomography upon admission and the risk established by the different established prognostic\r indices.\n\n**Clinical Trial Detailed Description:**\n\nIntroduction\r\n\r In the SARS-CoV2 pandemic, imaging studies proved its diagnostic utility to determine the\r severity of lung involvement. Computed tomography (CT) is a state-of-the-art study proven to\r be a highly sensitive diagnostic test complemented by RT-PCR testing to determine the disease\r and the degree of severity.\r\n\r In March 2020, the Dutch Society of Radiology developed a standardized assessment scheme for\r COVID-19 lung disease, called CO-RADS. This system proposes a level of suspicion of pulmonary\r involvement of COVID-19, based on the simple chest tomography findings. The level of\r suspicion ranges from very low (CO-RADS 1) to very high (CO-RADS 5), with two additional\r categories involving a technically deficient study (CO-RADS 0) and a positive RT-PCR test for\r SARS -CoV-2 known before tomography (CO-RADS 6).\r\n\r Acute respiratory damage secondary to SARS-COV2 pneumonia causes acute respiratory distress\r syndrome, which must meet the Berlin criteria. The evaluation and triage of patients with\r suspected or confirmed SARS-COV2 infection is a challenge for emerging healthcare systems.\r The risk stratification of the patient is carried out with previously established and\r validated risk scales.\r\n\r However, scales such as the national early warning scale (NEWS 2) are an option for health\r personnel, NEWS 2 determines the degree of illness of a patient and promotes intensive care\r intervention. It includes assessing oxygen saturation, hypercapnic respiratory failure\r (usually chronic obstructive pulmonary disease), confusion, disorientation, delirium, or any\r reduction in the Glasgow coma scale as potential findings of clinical deterioration. With a\r score of 0-4, it grants a low risk. It recommends the evaluation carried out by a competent\r registered nurse or equivalent to decide the change in the frequency of clinical follow-up or\r the intensification of care, on the contrary with a score of more than 7, grants high risk\r and recommends Emergency Assessment by a clinical or intensive care team and is usually\r transferred to a higher level of care.\r\n\r Predicting the development of severe pneumonia and the need for ventilatory support is vital\r for the clinician, as is the scale of COVID-GRAM; which assesses abnormalities in\r radiography, age of the patient, hemoptysis, dyspnea, state of consciousness, number of\r comorbidities, neutrophil/lymphocyte index, lactic dehydrogenase and direct bilirubin. It\r establishes three risk groups: the mild one with a risk of critical illness of less than 1.7%\r and the high risk of more than 40.4%.\r\n\r The even more simplified rapid severity index for COVID-19 (qCSI) predicts the risk of acute\r respiratory disease in 24 hours in patients admitted from the emergency department. Only the\r heart rate, oxygen saturation, and oxygen flow to the patient are quantified. A score less\r than or equal to 3 gives a low risk with a critical illness risk of 4%, while a score of\r 10-12 gives a high risk and a critical illness probability of 57%.\r\n\r Regarding sepsis evaluation, the mSOFA scale implemented in 2010 and validated in 2019 can\r predict in-hospital mortality and 30 days, with a minimum score of 0-7 that translates\r mortality of 0% and a score greater than 11 translates mortality of 58%. The risk of\r coagulopathy induced by sepsis secondary to COVID-19 will be present, and the sepsis-induced\r coagulopathy score scale (SIC) refers to the diagnosis of coagulopathy when the score is more\r significant than four, or the INR is greater than or equal to 3.\r\n\r On the other hand, oxygen therapy is a cornerstone in the treatment of respiratory distress\r secondary to SARS-COV2 pneumonia; therapy with high flow nasal cannula (CNAF) in the\r treatment of acute respiratory failure (ARF), the ROX index (IROX) has been proposed as a\r predictor of the success of CNAF at 2, 6 and 12 h of a treatment since it is essential to\r have tools that allow us to detect failure early of the technique since a delay in intubation\r can lead to increased mortality. A ROX index less than 3.85 predicts a high risk of the need\r for intubation, and a value of 4.88 predicts a low risk of intubation.\r\n\r In the present pandemic, numerous reports of the coexistence of a hyper coagulant state\r secondary to COVID-19 infection have become evident, so evaluating the thrombotic risk and\r initiation of anticoagulation is essential and accepted in the standard treatment in patients\r with SARS infection -COV2. The Padua Risk is used; it is a simple risk assessment (MSER) that\r can help clinicians discriminate between the high and low risk of venous thrombus embolism\r (VTE). A score greater than or equal to four was not associated with VTE during or after\r hospitalization; however, a Padua score of ≥4 was associated with higher mortality.\r\n\r Regarding the therapeutics to be used, all drugs' adverse effect is known, which is why it is\r necessary to scrutinize some used in SARS-CoV2 infection, such as the use of certain\r antimalarials, antibiotics, and antivirals-leading to alterations in heart rhythm, the\r Tisdale risk score for the risk of QT segment prolongation more significant than 500 ms\r during hospitalization. A Tisdale score less than 6 translates to a low risk of QT\r prolongation, while a score of more than 11 translates to high risk, and it is recommended to\r consult with the pharmacist, adjust the risk factors as much as possible and use alternative\r medications if possible.\r\n\r Risk stratification is essential in the current COVID-19 pandemic situation; upon admission,\r the clinician will discern if the patient requires in-hospital medical treatment, the risk of\r severe disease, and progression to assisted mechanical ventilation. This work aims to\r establish whether the severity of the findings identified by cardiac tomography upon\r admission and the risk established by the different established prognostic indices.\r\n\r Problem Statement\r\n\r The severity of the disease is influenced by comorbidities resulting from complications or\r death in any disease. In SARS-CoV2, it is known that conditions such as diabetes mellitus,\r obesity, systemic arterial hypertension, neoplastic or autoimmune disease can increase the\r risks of fatal outcomes. However, timely decisions to offer optimal therapy are a priority in\r the present global health situation.\r\n\r In this COVID-19 pandemic, the risk indices and scales are of vital importance in the correct\r risk stratification of the patient with SARS-CoV2 infection, which leads to a better medical\r approach decision, which therefore leads to better outcomes.\r\n\r Research Question\r\n\r Will the prognostic indices and the specific staging allow us to identify with greater\r certainty a clinical state of severity in patients infected with SARS-CoV2?\r\n\r Justification\r\n\r Despite the significant advances in basic and clinical research during this year, severe\r SARS-CoV2 pneumonia and sepsis with multiple organ failure have been the leading cause of\r morbidity and mortality in intensive care units worldwide. The analysis of the\r pathophysiological mechanisms responsible for this pandemic has allowed us to recognize some\r critical points for its control and therapeutic management; however, it is necessary to\r search for new, mainly preventive treatments where the critical measures of timely\r recognition of patients who can evolve to a deleterious condition.\r\n\r The management and therapeutic decision granted to patients admitted for COVID-19 infection\r in a hospital should be uniformly known by the health personnel who treat them. However, for\r those specific points are required, easy to obtain at any healthcare center's disposition.\r\n\r Although many indices allow follow-up to regulate medical behavior, many fatal outcomes were\r related to the non-standardization and interpretation of the clinical data that the patient\r had at the time of requesting medical attention. The use of imaging studies when suspected of\r COVID-19 was a universal decision that allowed to regulate therapeutic decisions and\r hospitalization of the patient. The ambiguity and variability of the clinical expression that\r patients infected with SARS-CoV2 presented at the time of the first evaluation in the\r emergency department are known.\r\n\r It is necessary to analyze the performance of the various indices and the data provided by\r tomography to determine if there are relevant parameters from the beginning that subsequently\r led them to be critically ill.\r\n\r This study intends to evaluate the correlation of the severity indices by computed tomography\r and the clinical risk indices. These clinical and laboratory variables are evaluated in the\r patient's first contact concerning their health status and clinical outcome.\r\n\r Goals\r\n\r Overall objective:\r\n\r • Determine the severity and prognosis of COVID-19 through computed tomography evaluation and\r the patient's various risk indices in their initial medical evaluation.\r\n\r Particular objectives:\r\n\r - Describe the findings in lung computed tomography in COVID-19 (ground glass, pleural\r effusion, pneumothorax, areas of condensation, etc.).\r\n\r - Calculate CO-RADS\r\n\r - Calculate the score for pneumonia severity (CURB-65).\r\n\r - Calculate the COVID-GRAM score.\r\n\r - Calculate the neutrophil/lymphocyte ratio.\r\n\r - Calculate the modified sequential organ failure assessment (mSOFA) score.\r\n\r - Calculate the sepsis-induced coagulopathy (SIC) score\r\n\r - Calculate the ROX ratio\r\n\r - Calculate the rapid COVID-19 severity index (qCSI)\r\n\r - Calculate the arterial alveolus gradient score.\r\n\r - Calculate Tisdale score for risk of QT prolongation.\r\n\r - Calculate the Berlin score for ARDS.\r\n\r Hypothesis\r\n\r Alternative hypothesis:\r\n\r The CO-RADS by computed tomography and the combined initial risk stratification indices\r establish severity and prognosis in patients with COVID-19 infection.\r\n\r Materials and methods\r\n\r Study design.\r\n\r It is a retrospective, observational, comparative, and cross-sectional study at the Ignacio\r Chávez National Institute of Cardiology. Patients will be evaluated in whom, through the\r initial triage, a computed tomography (CT) scan was requested due to suspected pneumonia due\r to COVID-19, between April 1 and August 28, 2020.\r\n\r Sample size calculation\r\n\r This is a study calculated to determine the severity using computed tomography and its\r correlation with the indices, with which 236 subjects have been calculated in the recruitment\r of patients with an objective sample. This method approaches the calculation of the different\r forecasts determined by correlation.\r\n\r Origin of the subjects.\r\n\r Patients admitted to the emergency department, coronary unit, or post-surgical therapy unit\r of the National Institute of Cardiology Ignacio Chávez.\r\n\r Analysis strategy\r\n\r Continuous variables will be expressed as mean with standard deviation; categorical variables\r are expressed as frequencies and percentages. The normality of the variables will be\r evaluated using the Shapiro-Wilk test. Those variables with normal distribution will be\r analyzed with parametric tests (Student's t-test). Various non-parametric tests\r (Mann-Whitney, Kruskal-Wallis test, or Wilcoxon signed-rank test depending on the particular\r case) will be used to contrast variables without Gaussian distribution. For the multivariate\r analysis, binary logistic regression analysis or a multivariate regression escalation will be\r performed depending on the findings.\r\n\r Ethical considerations\r\n\r This protocol will be sent for review by the Ethics and Research Committees of the Ignacio\r Chávez National Institute of Cardiology and will be based on the Declaration of Helsinki's\r recommendations. The anonymity of all patients will be preserved. It is an observational\r study without intervention, so that it will be initiated through the authorization of the\r Research Committee's decision.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients who go to the emergency department meet the criteria for a suspected,\r probable, or confirmed case of COVID-19 infection.\r\n\r - Patients who have undergone a simple chest tomography during their stay in the INC\r Emergency Department.\r\n\r - Patients whose information and data availability can be obtained through the triage's\r electronic clinical record carried out in the emergency department and coronary unit.\r\n\r - Patients with clinical data, laboratory data, oxygen saturation, and inspired oxygen\r fraction are necessary to evaluate prognostic indices.\r\n\r - Test for SARS-CoV2 infection by RT-PCR reported as positive, negative, or not\r performed, but with suspicion of COVID-19.\r\n\r - Patients who have had an arterial blood gas.\r\n\r Exclusion Criteria:\r\n\r - Patients with incomplete clinical, laboratory, blood gas parameters.\r\n\r - Patients in whom saturation and initial FiO2 are not reported.\r\n\r - Patients referred to another Hospital during their initial evaluation.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
771
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSetting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe\n\n**Clinical Trial Summary:**\n\nNon-interventional, multi-center, international registry in patients with severe aortic\r stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK\r Registry aims to implement standardized, reproducible and scalable quality improvement\r measures, which will help to reduce resource requirements, intensive care unit bed occupancy\r and overall length of hospitalization with uncompromised patient safety.\r\n\r The registry will consist of the following phases:\r\n\r - Retrospective phase (purpose: capture the status quo of each site prior to any Quality\r of Care improvement measures): The TAVI of patients being eligible for retrospective\r documentation must have been performed prior to the site's enrollment into the BENCHMARK\r prospective phase (follow-up: 30 days, 12 months).\r\n\r - Education phase: Each center will undergo an online BENCHMARK education. The contents of\r the education will be: Reflection on treatment pathways with the TAVI team, education on\r 8 defined Quality of Care improvement measures, followed by a center self-assessment (to\r self-assess the current alignment of hospital performance with the BENCHMARK Quality od\r Care measures).\r\n\r - Implementation phase: After having self-assessed the current alignment of hospital\r performance with the following BENCHMARK Quality of care measures, each center will\r start to introduce the tailored Quality of Care improvement measures to their hospital\r routine within a time frame of 2 months.\r\n\r - Prospective phase (purpose: to document the effects of defined quality of care\r improvement measure and to make sure patient safety is as least as good as in the\r retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)\n\n**Clinical Trial Detailed Description:**\n\nTranscatheter aortic valve implantation (TAVI) has become standard of care in patients\r suffering from severe, symptomatic aortic stenosis, irrespective of risk. However, despite\r the advances in valve technology and implantation techniques, there is still no consensus on\r how to effectively screen, manage and discharge patients undergoing such an intervention.\r\n\r In an effort not to lose grounds because of an increasing inner-hospital competition for\r resources including intensive care unit (ICU) and general hospital beds, there is a need for\r a streamlined Quality of Care (QoC) pathway that delivers the procedure more efficient, but\r with at least the same patient safety. In this context, the recent FAST-TAVI and North\r American Multidisciplinary, Multimodality, But Minimalist (3M) studies have shown that\r optimized risk assessment and patient management results in a more effective, as least as\r safe treatment pathway and a reduced length of stay (LoS).\r\n\r The results gain importance especially in a situation where patients suffering from the\r coronavirus disease compete for hospital resources throughout Europe. Using a clear set of\r Quality of Care criteria, the BENCHMARK registry aims to document the progress that can be\r made if tailored Quality of Care improvement measures are initiated.\r\n\r The hypothesis is that the implementation of standardized, reproducible and scalable Quality\r of Care improvement measures will help reducing resource requirements, intensive care unit\r bed occupancy and overall length of hospitalization with uncompromised patient safety.\r\n\r There will be up to 30 centers participating across Europe (Germany, Austria, Italy, France,\r Spain, Czech Republic, Romania). Each center will enroll 80 patients (retrospective\r documentation of 30 patients, prospective enrollment of 50 patients), resulting in 2400\r patients in total.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Retrospective phase:\r\n\r - Consecutive, severe symptomatic aortic stenosis patients who underwent transcatheter\r aortic valve implantation with a balloon-expandable transcatheter aortic valve prior\r to the center education on BENCHMARK QoC (Quality of Care) improvement measure (prior\r to the first education call)).\r\n\r - Patient is or was scheduled to undergo a 30 Day and 12 Months follow-up (30 Day and 12\r Months follow-up: hospital visit or phone call)\r\n\r - All patients irrespective of valve type or access route will be documented in an\r electronic Case Report Form (eCRF) based patient logbook.\r\n\r Prospective phase:\r\n\r - Consecutive patients with a diagnosis of severe symptomatic aortic stenosis admitted\r for TAVI with a balloon-expandable transcatheter heart valve after center education on\r BENCHMARK Quality of Care measures and after the center has passed the implementation\r phase.\r\n\r - All patients irrespective of valve type or access route will be documented in an eCRF\r based patient logbook.\r\n\r Exclusion Criteria:\r\n\r Retrospective phase:\r\n\r - Patients with largely incomplete data with respect to the aims of the project.\r\n\r - Patients without signed informed consent / data protection statement (according to\r requirements of local ethical committee).\r\n\r - Pregnant women at the time of the TAVI.\r\n\r Prospective phase:\r\n\r - Patients without signed informed consent prior to the TAVI procedure (data protection\r statement included; ideally covered by hospital routine to enable consecutiveness).\r\n\r - Pregnant women at the time of the TAVI.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
772
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDiastolic dYsfunctioN AssessMent in critICally Ill Patients\n\n**Clinical Trial Summary:**\n\nThe role of the left ventricular diastolic function (LVDD) in the weaning failure from\r mechanical ventilation in unclear. Specifically, is unclear whether the outcome of the\r weaning process could be affected by a pre-existing LVDD (before ICU admission), or by the\r worsening of a chronic pattern, or by a de-novo LVDD presentation.\n\n**Clinical Trial Detailed Description:**\n\nBedside echocardiography plays a critical diagnostic role in patients with heart failure,\r being other examinations (i.e., physical examination, electrocardiogram, and chest\r radiograph) unable to provide key information to discriminate between diastolic and systolic\r heart failure. Transthoracic echocardiography (TTE) can assess diastolic function by means of\r the doppler filling pattern, and can non-invasively measure intracardiac pressure at the\r bedside.\r\n\r During sinus rhythm, diastolic flow shows the E and A waves, which reflects early diastolic\r filling and atrial contraction in the late diastole, respectively. Velocity of blood flow\r across the mitral valve depends on the trans-mitral pressure gradient; then, E-wave velocity\r is influenced both by the rate of early diastolic relaxation and by the left atrial pressure.\r Changes of the velocity pattern can suggest left ventricular diastolic function (LVDD) and\r prognosis, although mitral inflow patterns are highly susceptible to loading conditions\r (mainly left atrial pressure). LVDD is quite is a condition quite common in the population. A\r cross-sectional survey of over 2000 randomly selected Minnesota residents aged 45 years or\r older found an incidence of LVDD almost five times higher than LV systolic dysfunction (28%\r vs. 6%, respectively), which was a strong predictor of mortality (hazard ratio ranging from\r 8.3 for mild LVDD to 10.2 for at-least-moderate LVDD).\r\n\r In a randomly recruited population sample (n = 539; 50.5% women; mean age, 52.5 years), the\r prevalence of the LVDD in those patients older than 50 y.o. was of about 50%5.\r\n\r Doppler echocardiography could be a noninvasive tool for the detection of weaning-induced\r left ventricular filling pressure elevation. Transmitral flow can help measure peak Doppler\r velocities of E and A waves. E/A ratio has been proposed to estimate the left ventricular\r filling pressure. Tissue Doppler imaging can measure early diastolic mitral annular velocity\r (E'), which is a load-independent indicator of myocardial relaxation. The combination of\r tissue Doppler imaging and pulsed Doppler transmitral flow can allow the computation of the\r E/E' ratio, which is one of the best echocardiographic estimate of left ventricular filling\r pressure.\r\n\r The role of LVDD in critically ill patients is probably greatly underestimated by\r intensivists, probably because in the past diastolic function was difficult to evaluate at\r the bedside6. The LVDD in intensive care unit (ICU) patients can affect the outcome of\r weaning from mechanical ventilation, especially in septic patients. In fact, cardiogenic\r pulmonary edema has been recognized as a highly incident cause of weaning failure.\r Unsuccessful weaning from mechanical ventilation occurs in approximately 20% of patients and\r is related to prolonged mechanical ventilation, length of stay in the intensive care unit,\r and increased morbidity and mortality. It has been proved that a spontaneous breathing trial\r (SBT) increases the left ventricular filling pressure, leading to cardiogenic pulmonary edema\r and impaired gas exchange.\r\n\r However, studies focused on the impact of that medical condition on weaning showed\r conflicting results. Moreover, heterogeneous definitions and measurements of LVDD have been\r provided, associated to different form of SBTs. Furthermore, the majority carried out a\r cross-sectional assessment of the LVDD before and after the SBT, not including changes in the\r diastolic function during the ICU stay. All these variables limit the comparability and the\r clinical applications of these studies.\r\n\r Moreover, LV diastolic function depends on myocardial relaxation, LV stiffness, and filling\r pressures, which are frequently impaired during the ICU stay (e.g., progression of the\r disease, volume resuscitation, positive end-expiratory pressure, administration of inotropes,\r vasopressors, etc). It is still uncertain whether the SBT failure could be affected by\r pre-existing conditions (i.e. a LVDD present at the ICU admission) or by a worsening of the\r cardiac function after the ICU admission.\r\n\r As a matter of fact, the assessment of LVDD at the bedside is not routinely performed before\r the SBT and the role of the degree of the LVDD in still not defined. Moreover, it unclear\r whether the outcome of the weaning process could be affected by a pre-existing LVDD (before\r ICU admission), or by the worsening of a chronic pattern, or by a de-novo LVDD presentation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Expected to be ventilated for >48 hours\r\n\r - Age > 50\r\n\r Exclusion criteria:\r\n\r - Atrial fibrillation (at the admission or during ICU stay);\r\n\r - Neuromuscular disorders;\r\n\r - Home ventilation prior to admission;\r\n\r - Palliative intubation;\r\n\r - Intubation for an indication to tracheostomy;\r\n\r - Poor acoustic window (after the first assessment);\r\n\r - Severe mitral and/or aortic valve stenosis or regurgitation.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
773
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nValidation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nA novel, image-based model for estimation of the pressure gradient across stenosed aortic\r valves is compared against invasively measured pressure gradients from clinical routine.\n\n**Clinical Trial Detailed Description:**\n\nUsing temporally resolved computed tomography images, the patient-specific geometry of the\r stenosed aortic valve during peak systole is reconstructed. Using this geometry, the\r projected area of the aortic valve's orifice (AVA) is calculated. Additionally, the left\r ventricular geometry is reconstructed for the complete heart cycle. Using the information of\r the left ventricular volume change, the patient-specific flow profile and peak-systolic flow\r (Q)is calculated. Using this information, the pressure gradient is calculated using a power\r law estimation of the form PG = a * AVA^b * Q^c. The model generation and parameter fit is\r described in [1].\r\n\r To validate this model, retrospective data of patients receiving a catheter-based replacement\r of the aortic valve (TAVI) is collected. For those patients, CT images are already acquired\r for treatment planning and the invasive pressure measurements are performed during\r replacement of the aortic valve. Therefore, no additionally steps are required. Using the CT\r images the patient-specific aortic valve area ad flow rate are calculated. This information\r is then used for estimation of the pressure gradient using the power law model. The\r catheter-based pressure gradient is calculated as the difference between the peak-systolic\r pressure in the left ventricle and the ascending aorta before implantation of the prosthesis.\r\n\r [1] Franke et al.; Towards improving the accuracy of aortic transvalvular pressure gradients:\r rethinking Bernoulli; Medical & Biological Engineering & Computing (2020);\r https://doi.org/10.1007/s11517-020-02186-w\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - aortic valve stenosis\r\n\r - treatment via TAVI\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
774
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE\n\n**Clinical Trial Summary:**\n\nThis is a multi-center study conducted at 13 sites in 3 countries (Singapore, New Zealand,\r and the United Kingdom). Approximately 360 patients with an acute myocardial infarction (AMI)\r will be randomized in a ratio of 1:1 ratio to receive AZD5718 125 mg or placebo for 12\r months.\n\n**Clinical Trial Detailed Description:**\n\nPASSIVATE is a randomized, double-blind, placebo-controlled Phase IIa trial that investigates\r how 12 months of treatment with AZD5718 modifies coronary plaque volume. Patients with recent\r STEMI or NSTEMI will receive an additional oral dose of AZD5718 (or placebo) once daily to\r standard clinical care for 12 months. The primary hypothesis being tested in PASSIVATE is\r that 12 months of treatment with AZD5718 attenuates the progression of non-calcified plaque\r (NCP) volume on serial computed tomography coronary angiography (CTCA) studies.\r\n\r Patients who gave consent (within 30 days after their index event) will undergo a CTCA scan\r and start treatment (AZD5718 or Placebo). The treatment duration will be 12 months. During\r the treatment period, patients will come to the clinic for follow-ups. At 12 months (end\r treatment), the patients will undergo their 2nd CTCA scan. A follow-up visit will be\r performed 4 weeks after the last dose in order to ensure the safety and well-being of the\r patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - hospitalised for STEMI or non-STEMI, as defined by the 4th universal definition of MI\r\n\r - underwent coronary angiography during the index hospitalisation showing at least one\r epicardial coronary artery with ≥50% stenosis and a 2nd epicardial coronary artery\r with ≥20% stenosis on the coronary angiogram\r\n\r - Body Mass Index (BMI) ≥18 to ≤35 kg/m2\r\n\r - White Blood Cell count ≥ 8.2 X 103/uL during admission\r\n\r Exclusion Criteria:\r\n\r - Prior coronary artery bypass grafting (CABG)\r\n\r - CABG planned within 12 months of admission\r\n\r - Known history of drug or alcohol abuse within 5 years of screening\r\n\r - History of QT prolongation associated with other medications that required\r discontinuation of that medication\r\n\r - Congenital long QT syndrome\r\n\r - Systolic blood pressure persistently <90 mm Hg or HR<40 beats per minute at time of\r enrolment\r\n\r - ALT >2 x ULN, cirrhosis, recent hepatitis, or positive screening test for hepatitis B\r (hepatitis B surface antigen) or other viral hepatitis\r\n\r - Uncontrolled Type 1 or Type 2 DM defined as HbA1c >10% or 74.9 mmol/mol (by IFCC)\r\n\r - Any planned coronary revascularisation, valve surgery, or cardiac resynchronisation\r within 7 months after randomisation\r\n\r - Any concomitant medications known to be associated with Torsades de Pointes or potent\r inducers of cytochrome P450 3A4 (CYP3A4)\r\n\r - Planned treatment with zileuton, leukotriene receptor antagonists (e.g., montelukast)\r during trial\r\n\r - Participated in another interventional clinical study with an investigational\r pharmaceutical product during the last 3 months\r\n\r - Known hypersensitivity to drugs with a similar chemical structure or class of study\r drugs or any of the excipients of the product\r\n\r - Known conditions that either increase the risk of performing the CT or make the\r procedure technically impractical\r\n\r - No severe asthma attack that require emergency treatment or hospitalisation in the\r past 6 months\r\n\r - Had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically\r ventilated), and/or had a confirmed case of COVID-19 within 4 weeks of Screening Visit\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
775
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMechanisms of Excess Risk in Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nAortic stenosis (AS) is caused by narrowing of one of the main heart valves. Replacing the\r valve is the only treatment to prevent the heart from failing or death. The timing of\r replacement is currently often too late - half of patients are left with permanent scarring\r and a quarter die within 3.5 years.\r\n\r Studies are underway to see if earlier replacement makes a difference. But for those with\r scarring of the heart, there is currently no tailored treatment. I want to change this by\r understanding why and how patients with scar are dying and what the investigators can do to\r prevent this.\r\n\r In this study, the investigators will use a heart scan (MRI) to detect scarring before valve\r replacement. After replacement, patients will receive a tiny monitor (paper clip size), which\r the investigators inject underneath the skin. This monitor continuously checks the heartbeat\r and can detect increased body fluid due to heart failure. The investigators will monitor\r patients for an average of 3 years to see if scarring is linked to abnormal heart rhythms and\r heart failure.\r\n\r Once the investigators know how and why, the investigators can target patients with available\r medications and design studies using specialised treatments, eg defibrillator implantation,\r to protect patients with scar from dying.\n\n**Clinical Trial Detailed Description:**\n\nValvular heart disease (VHD) affects around 1.5 million people above the age of 65 across the\r UK and is set to nearly double by 2050. Aortic Stenosis (AS) is the most common VHD in the\r UK, affecting 3% of those over 75 with more than 11,000 people requiring aortic valve\r replacement (AVR) in the UK each year (>100,000 world-wide). Current guidelines recommend AVR\r to improve survival and symptom status when AS symptoms emerge or there is a reduction in\r left ventricle (LV) function (1), but years of excessive haemodynamic load result in an \"AS\r cardiomyopathy\" with LV hypertrophy, remodelling, diffuse and focal scar. The investigators,\r and others, have shown that these changes lead to an excess in morbidity and mortality, but\r the mechanisms of increased risk is unclear.\r\n\r Patients undergoing aortic valve replacement for severe aortic stenosis have a shorter life\r expectancy compared with the general population (2). Years of excessive haemodynamic load\r result in an \"AS cardiomyopathy\" with LV hypertrophy, remodelling, diffuse and focal scar.\r The investigators and others have shown that these changes to the heart muscle are associated\r with poor outcome. But the mechanism of how heart muscle damage leads to excess mortality is\r poorly understood.\r\n\r The proposed study will enhance our understanding of the residual risk after AVR and reveal\r the modes and substrate of mortality. Heart failure and heart rhythm disturbances\r (arrhythmias) are likely downstream effects of heart muscle damage, but without understanding\r the mode of death (heart failure, arrhythmia or other), the investigators are unable to\r target therapeutic strategies to improve outcomes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with symptomatic severe aortic stenosis referred for surgical or\r transcatheter AVR (one out of: effective orifice area [EOA] <1.0 cm2 , indexed EOA of\r 0.6cm/m2, peak velocity >4.0 m/s or mean gradient >40mmHg).\r\n\r Exclusion Criteria:\r\n\r - More than moderate valve disease other than AS\r\n\r - Diagnosis of dilated or hypertrophic cardiomyopathy, pregnancy/breast feeding\r\n\r - eGFR <30ml/min, CMR incompatible devices\r\n\r - Inability to complete the protocol\r\n\r - Other conditions that would prevent participation in the study.\r\n\r - Adenosine perfusion will not be performed in patients with AV block, severe\r asthma/COPD or LVEF<40%.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
776
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStaged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement\n\n**Clinical Trial Summary:**\n\nPatients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant\r coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty\r about the benefits and the optimal timing of revascularization for such patients. There is\r currently clinical equipoise regarding the management of concomitant CAD in patients\r undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary\r intervention (PCI) (either before or after TAVR), while others follow an alternative strategy\r of medical management.\r\n\r The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR\r expands to lower risk patients, and potentially becomes the preferred therapy for the\r majority of patients with severe aortic stenosis, the optimal management of concomitant\r coronary artery disease will be of increasing importance.\r\n\r The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical\r therapy, a strategy of complete revascularization involving staged PCI using drug eluting\r stents to treat all suitable coronary artery lesions is superior to a strategy of medical\r therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial\r Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart\r Failure.\r\n\r The study will be a randomized, multicenter, open-label trial with blinded adjudication of\r outcomes. Patients will be screened and consented for elective transfemoral TAVR and\r randomized within 24 hours of successful balloon expandable TAVR.\r\n\r Complete Revascularization:\r\n\r Staged PCI using third generation drug eluting stents to treat all suitable coronary artery\r lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment\r with PCI and have a >70% visual angiographic diameter stenosis. Staged PCI can occur any time\r from 1 to 45 days post successful transfemoral TAVR.\r\n\r Vs. Medical Therapy Alone:\r\n\r No further revascularization of coronary artery lesions.\r\n\r All patients, regardless of randomized treatment allocation, will receive guideline-directed\r medical therapy consisting of risk factor modification and use of evidence-based therapies\r The COMPLETE TAVR study will help address the current lack of evidence in this area. It will\r likely impact both the global delivery of health care and the management and clinical\r outcomes of all patients undergoing TAVR with concomitant CAD.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Men and women with severe symptomatic aortic valve stenosis defined as: [aortic valve\r area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2] AND [Jet velocity ≥ 4.0 m/s or\r mean gradient ≥ 40 mmHg] AND [NYHA Functional Class ≥ 2 OR abnormal exercise test with\r severe SOB, abnormal blood pressure response, or arrhythmia]\r\n\r AND\r\n\r - Coronary artery disease defined as: (at least 1 coronary artery lesion of >70% visual\r angiographic diameter stenosis in a vessel that is at least 2.5 mm in diameter and\r that is amenable to treatment with percutaneous coronary intervention (PCI))\r\n\r AND\r\n\r - Consensus by the Multidisciplinary Heart Team that the patient is suitable for\r elective transfemoral transcatheter aortic valve replacement (TAVR) with a balloon\r expandable transcatheter heart valve AND would receive a bypass with an anastomosis\r distal to the coronary artery lesion(s) if they were undergoing surgical aortic valve\r replacement.\r\n\r AND\r\n\r - Succcessful TAVR with balloon-expandable transcatheter heart valve within the past 24\r hr.\r\n\r Exclusion Criteria:\r\n\r - PCI already performed within 90 days or during elective transfemoral TAVR\r\n\r - Planned revascularization of coronary artery lesion(s)\r\n\r - Planned surgical revascularization\r\n\r - Non-cardiovascular co-morbidity reducing life expectancy to < 5 years\r\n\r - Any factor precluding 5-year follow-up\r\n\r - Prior coronary artery bypass grafting surgery or surgical valve replacement\r\n\r - Aortic annulus diameter < 16 mm or > 28 mm (3D imaging)\r\n\r - Severe aortic regurgitation (> 3+) or mitral regurgitation (> 3+)\r\n\r - Severe left ventricular dysfunction (LVEF < 30%)\r\n\r - Severe calcification of aortic valvar complex (esp. left ventricular outflow tract)\r\n\r - Vascular anatomy not suitable for safe femoral access\r\n\r - Low coronary takeoff (high risk for obstruction)\r\n\r - Acute myocardial infarction within 1 month\r\n\r - Stroke or transient ischemic attack within 90 days\r\n\r - Renal insufficiency (eGFR < 30 ml/min) and/or renal replacement Rx\r\n\r - Hemodynamic or respiratory instability\r\n\r - Frailty (objective assessment as per the essential frailty toolset)\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
777
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMedtronic Evolut™ EXPAND TAVR I Feasibility Study\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™\r PRO+ TAVR System for the treatment of moderate, symptomatic aortic stenosis and severe,\r asymptomatic aortic stenosis.\n\n**Clinical Trial Detailed Description:**\n\nSingle-arm, two-cohort, descriptive, multi-center, international\r\n\r All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups\r will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually\r through 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nKey Inclusion Criteria: Cohort A (Moderate, Symptomatic Aortic Stenosis)\r\n\r - Moderate aortic stenosis (aortic valve area >1.0 cm^2 & <1.5 cm^2)\r\n\r - New York Heart Association (NYHA) functional classification ≥II, with symptoms\r attributable to aortic stenosis\r\n\r - Left Ventricular Ejection Fraction (LVEF) >20% by 2-D echo\r\n\r Key Exclusion Criteria: Cohort A (Moderate, Symptomatic Aortic Stenosis)\r\n\r - Age <65 years\r\n\r - Class I indication for cardiac surgery\r\n\r - Bicuspid, unicuspid, or quadricuspid aortic valve\r\n\r - In need of and suitable for coronary revascularization\r\n\r Key Inclusion Criteria: Cohort B (Severe, Asymptomatic Aortic Stenosis)\r\n\r - Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area\r index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec\r\n\r - Subject denies symptoms attributable to aortic stenosis, including but not limited to:\r\n\r - Dyspnea on rest or exertion\r\n\r - Angina\r\n\r - Syncope in the absence of another identifiable cause\r\n\r - Fatigue\r\n\r - Left Ventricular Ejection Fraction (LVEF) >50%\r\n\r Key Exclusion Criteria: Cohort B (Severe, Asymptomatic Aortic Stenosis)\r\n\r - Age <65 years\r\n\r - Class I indication for cardiac surgery\r\n\r - Bicuspid, unicuspid, or quadricuspid aortic valve\r\n\r - In need of and suitable for coronary revascularization\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
778
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nProspective 4D CTA of BAV Competence\n\n**Clinical Trial Summary:**\n\nThe study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5\r years. CTA is often standard of care for BAV patients, but patients in this study will\r receive a higher radiation dose with a 4D imaging protocol. There may also be patients\r enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not\r required for clinical care.\n\n**Clinical Trial Detailed Description:**\n\nThe bicuspid aortic valve (BAV) is the most common congenital heart disease. The purpose of\r this study is to better understand the anatomy of physiologically normal, or competent, BAVs\r without stenosis or insufficiency (AI) in order to support evidence-based standardization of\r BAV repair surgery. Men and women over 18 years of age with a diagnosis of BAV and minimal\r aortic valve calcification at baseline will undergo annual 4D computed tomography angiography\r (CTA) scans, routine transthoracic echocardiograms, and history and physical assessments over\r the course of the 5-year study period. Patients who are pregnant, have renal insufficiency\r (creatinine 2 mg/dL), or who have a contraindication to intravenous contrast will be\r excluded. Patients will be stratified into study groups according to baseline AI:\r approximately half of patients will have no to mild AI at baseline and the other half will\r have moderate to severe AI at baseline. Anatomical measurements will be obtained from the 4D\r CTA scans and analyzed at each phase of the cardiac cycle, as well as longitudinally. The 4D\r CTA imaging and analysis will not impact medical care of the study participants; the\r anatomical measurements will be used in the future as evidence-based standards for\r determining valve repair candidacy for BAV patients with AI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - At least 18 years of age\r\n\r - Documented bicuspid aortic valve identified via clinical imaging (e.g., CT, MRI, or\r echocardiogram) with minimal calcification at the time of enrollment\r\n\r - Participant must sign the informed consent form\r\n\r Exclusion Criteria:\r\n\r - Pregnancy (determined by point of care urine pregnancy test)\r\n\r - Renal failure (estimated Glomerular Filtration Rate (eGFR) < 30), precluding them from\r receiving intravenous contrast)\r\n\r - Documentation of previous intravenous contrast allergy (unless they are having a CT\r with steroid preparation as part of routine clinical care)\r\n\r - Previous aortic valve replacement\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
779
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery\n\n**Clinical Trial Summary:**\n\nA randomized clinical trial will be performed in parallel, placebo controlled, double-blind\r to evaluate the effectiveness of the association Bromelina and Horse-chestnut (titrated in\r escin) (Noflogo®, Mavenpharma s.r.l., Rome, Italy) in the management of post trauma-surgery\r following surgery periodontal and implant surgery.\n\n**Clinical Trial Detailed Description:**\n\nAt least 50 volunteers between the ages of 18 and 50, will be enlisted, with the need to\r perform one of the interventions described above and that fall within the criteria of\r inclusion.\r\n\r The study will be carried out in accordance with the Helsinki Declaration on In Vivo Studies\r and will be initiated with the approval of the Internal Review Board of the University of\r L'Aquila.\r\n\r The protocol follows the guidelines of the CONSORT Statement for parallel studies and will be\r recorded on the data base clinicaltrials.gov.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria: To be treated patients will not have to show signs of gingival\r inflammation. Patients undergoing periodontal surgery should have completed non-surgical\r causal therapy and presented FMBS and FMPS values of 20%.\r\n\r Exclusion Criteria:All subjects with positive anamensis for relevant systemic pathologies\r (renal, cardiovascular, hepatic, infectious, neoplastic and diabetological), treatment with\r anti-inflammatory and/or antibiotics in the two weeks preceding the start of the trial will\r be excluded, history of allergy to one or more components of the medication to be tested,\r pregnant women.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
780
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nChange in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities\n\n**Clinical Trial Summary:**\n\nChange in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic\r Valve Implantation in patients with concomitant coronary artery disease and severe aortic\r stenosis.\r\n\r Severe aortic stenosis is the most common indication of valvular replacement in developed\r countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic\r stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its\r prognostic impact is not clearly established, and available studies uncommonly used\r functional assessment of severity from a coronary stenosis to stratify the risk in this\r situation.\r\n\r Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous\r coronary intervention (PCI) in clinical practice. Its use is not validated in patients with\r severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to\r microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After\r aortic valvular replacement, a myocardial reverse remodeling is described, generating a\r decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary\r microcirculatory reserve is not known. Some studies have shown improvement in coronary\r reserve immediately after TAVI and this effect seemed to last long after treatment.\r\n\r The aim of the study is to assess the effects of inverse myocardial remodeling on coronary\r microcirculatory function and its association with FFR values before and after TAVI.\n\n**Clinical Trial Detailed Description:**\n\nThis monocentric and prospective observational study aims to include patients with stable\r coronary artery disease and undergoing TAVI for severe aortic stenosis via transfemoral\r access, from November 2020 at Nantes University Hospital, France.\r\n\r All patients have severe symptomatic aortic stenosis, secondary to degenerative disease\r confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2)\r and significant epicardial coronary stenosis (> or = 50%) assessed by coronarography\r performed in systematic preoperative work-up. These patients are deemed for TAVI and a\r first-line medical treatment for CAD, after heart team decision.\r\n\r The collegially chosen strategy to manage CAD in this population consists in assessing\r hemodynamic parameters from a coronary stenosis during the TAVI procedure, using functionals\r tests for ischemia (FFR, IMR, CFR) from a concomitant coronarography. Patients will be\r routinely admitted in hospital 6 months after TAVI, for clinical and echocardiographic\r reassessment, and coronarography control. Functional tests will be repeated and according to\r results, continuation of medical therapy or PCI is proposed, at operator's discretion.\r\n\r All procedures are performed within the same site by 1 medical team including 4\r interventional cardiologists.\r\n\r Before the TAVI procedure, a computerized multi-sliced tomography is systematically performed\r to validate the percutaneous approach by femoral access and to choose which prothesis model\r will be used.\r\n\r In most cases, TAVI procedure are performed under local anesthesia and mild sedation, under\r anesthetist supervision.\r\n\r The common femoral artery is punctured by percutaneous approach, above the femoral\r bifurcation and a 16-French sheath is inserted.\r\n\r Three available models of aortic bioprothesis are implanted in our center, the Sapien 3\r (EDWARDS Lifescience) the Corevalve Evolute R (Metdtronik) and the Accurate Neo 2 (Boston\r Scientific) Two Perclose ProGlide devices (Abbott Vascular) are used to perform the\r perpendicular preclosing. After the deployment of the prosthesis, the TAVI sheath is removed\r and the nodes from the two previously placed ProGlide devices are tightened. Final femoral\r angiographic control is not systematic.\r\n\r Concomitant coronarography is performed by radial artery access site, using a 6-French\r sheath.\r\n\r Hemodynamics measures are recorded by PressureWire X Guidewire (Abott Vascular) wireless\r devices to a computer and processed by the CoroFlow Coroventis software (Abbott Vascular) to\r carry out multimodal physiological evaluation. FFR, CFR, and IMR measures will be repeated\r before and immediately after valve implantation. These parameters will be reassessed 6 months\r after TAVI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adults older than 18 years. For female of childbearing age, active contraceptive\r method is recommended.\r\n\r - patients with severe symptomatic aortic stenosis secondary to degenerative disease\r confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area\r <1 cm2) and with significant coronary artery disease (epicardial coronary stenosis\r angiography > or = to 50%)\r\n\r Exclusion Criteria:\r\n\r - Severe CAD with tritroncular lesions or severe stenosis (>90 %) of left main artery or\r proximal left anterior descending artery\r\n\r - Lack of viability in myocardial territory of interest\r\n\r - History of bypass coronary surgery or heart transplantation\r\n\r - Severe left ventricular systolic dysfunction, characterized by an ejection\r fraction < 35 %\r\n\r - Severe renal impairment (Creatinine clearance <30 ml/min/1.73 m2)\r\n\r - Absolute contraindication to intravenous adenosin\r\n\r - Pregnant or nursing women Patients under guardianship, curatorship, or protection\r of justice\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
781
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nValvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nThis is a prospective, controlled, single-arm clinical investigation for the treatment of\r subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational\r Ultrasound Therapy (PCUT) - First-In-Human\n\n**Clinical Trial Detailed Description:**\n\nCARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to\r treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a\r new ultrasound therapy based on a disruptive technology involving delivering an extremely\r precise and focused ultrasound beam to perform a reparative effect on the aortic valve\r leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving\r the overall clinical status related to the aortic valve stenosis. In this study, a brai-MRI\r is performed before the procedure and 24-72 hours after the procedure to detect\r cerebrovascular events.This is a FIM study\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017\r definition, including subjects with a bicuspid valve.\r\n\r - Patient is not eligible for TAVR/SAVR according to local Heart Team.\r\n\r - Age ≥18 years.\r\n\r - Subjects who are willing to provide a written informed consent prior to participating\r in the study.\r\n\r - Subjects who can comply with the study follow up or other study requirements.\r\n\r - Patient is eligible for the Valvosoft procedure according to CRC.\r\n\r Exclusion Criteria:\r\n\r - Subjects with any electrical device implanted.\r\n\r - Subjects with unstable arrhythmia not controlled by medical treatment.\r\n\r - Subjects with implanted mechanical valve in any position or bio prosthetic valve in\r aortic position.\r\n\r - Subjects with complex congenital heart disease.\r\n\r - Chest deformity.\r\n\r - Cardiogenic shock.\r\n\r - History of heart transplant.\r\n\r - Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral\r valve procedure, tricuspid valve procedure) within one month after treatment.\r\n\r - Thrombus in heart.\r\n\r - Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one\r month prior to enrolment*.\r\n\r - Subjects who are pregnant or nursing.\r\n\r - Subjects who are participating in another research study for which the primary\r endpoint has not been reached.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
782
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRomanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI\n\n**Clinical Trial Summary:**\n\nRO-TAVI is a national prospective, observational, multi-center registry registry of patients\r with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to\r assess patient care and outcomes.\n\n**Clinical Trial Detailed Description:**\n\nBackground: Since the establishment of transcatheter aortic valve implantation (TAVI) in\r Romania in 2015 there has been a growing number of interventions being performed by an\r increasing number of hospitals throughout the country. In 2018, there were more than 250\r implants, which are expected to grow in the following years by about 30% on an annual basis.\r\n\r Objective: This is a national quality assurance initiative to improve patient care and\r outcomes. It further serves as a database for the assessment of the safety and efficacy of\r TAVI and its financial implications (e.g. reimbursement).\r\n\r Design: National, prospective, observational, multi-center registry. All centers performing\r TAVI in Romania; minimum cases per center for inclusion: 20 cases/year-to-date Population:\r All patients undergoing TAVI in Romania at any of the participating centers with a CE-marked\r valve of any manufacturer given that they provide written informed consent.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - severe symptomatic aortic valve stenosis\r\n\r - high risk or patients deemed amenable for TAVI by a multidisciplinary team\r\n\r - signed informed consent to participate in the study\r\n\r Exclusion Criteria:\r\n\r - inadequate annulus size (<18 mm, >29 mm)\r\n\r - left ventricle thrombus\r\n\r - active endocarditis\r\n\r - high risk of coronary ostium obstruction\r\n\r - plaques with mobile thrombi in the ascending aorta, or arch\r\n\r - hemodynamic instability\r\n\r - estimated life expectancy <1 year\r\n\r - comorbidity suggesting lack of improvement of quality of life\r\n\r - other situations adjudicated by the local HeartTeam\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
783
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAdditive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A Plan)\n\n**Clinical Trial Summary:**\n\nAcute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic\r dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35\r cases per 100,000 cases per year between the ages of 65 and 75 years. Increased levels of the\r inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events.\r Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, the\r authors hypothesized that people with acute aortic syndrome but without hyperlipidemia might\r benefit from statin treatment.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - (1) Patients with aortic dissection/ulceration/intermural hematoma who underwent\r aortic arch replacement or endoluminal isolation or hybrid therapy;\r\n\r - (2) Paitents without clinically significant hyperlipidemia but with cardiovascular\r disease risk factors (such as male ≥45 years old, female ≥55 years old, hypertension,\r diabetes, chronic kidney disease, obesity, low HDL cholesterol, smoking, alcohol\r consumption, family history of early onset ischemic cardiovascular disease) and no\r previous use of statins;\r\n\r - (3) Patients are between 18 and 85 years old, male or female;\r\n\r - (4) Agree to participate in the study and sign the informed consent.\r\n\r Exclusion Criteria:\r\n\r - (1) Patients with allergy to statins;\r\n\r - (2) patients with active liver disease;\r\n\r - (3) patients with myopathy;\r\n\r - (4) Lactating women and pregnant women;\r\n\r - (5) Patients with mental diseases, drug and alcohol dependence;\r\n\r - (6) Refuse to participate in the study or sign the informed consent.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
784
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSecondhand Tobacco Smoke and Cardiovascular Disease\n\n**Clinical Trial Summary:**\n\nThis is a double-blind randomized placebo-controlled crossover clinical trial of efficacy and\r safety of an FDA-approved angiotensin receptor blocker (losartan) to improve cardiopulmonary\r outcomes in individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to\r prolonged exposure to secondhand tobacco smoke.\n\n**Clinical Trial Detailed Description:**\n\nSecondhand tobacco smoke (SHS) remains a major public health problem.This is important\r particularly as the generations that endured the highest amount of SHS exposure are aging,\r which could potentially accentuate the SHS-related occult health problems that may have been\r previously too subtle to be recognized. Although acute and subacute health effects of\r exposure to SHS have been studied, its long-term consequences have been more difficult to\r examine in part due to challenges with exposure assessment. Nonsmoking flight attendants (FA)\r who worked on commercial aircrafts before the enactment of the smoking ban were exposed to\r heavy SHS in aircraft cabin for many years, in a range similar to the nicotine exposure\r burden experienced by \"light\" smokers. The regularity of this intense exposure in the cabin\r work environment lends itself to relatively accurate SHS exposure quantification through\r employment history, and makes the exposed FA a unique population in which the long-term\r health effects of previous exposure to SHS could be examined as a form of \"natural\"\r experiment that is also generalizable to other SHS exposed populations.\r\n\r Over the past several years, the investigators recruited a nonsmoking cohort of FA with such\r history of cabin SHS exposure who had subclinical signs and symptoms of pulmonary disease.\r Furthermore, while the FA in this cohort had no history of known cardiovascular disease, and\r were able to perform well on maximum effort exercise testing, they had an abnormal\r cardiovascular (hypertensive) response to exercise (HRE) that was associated with their cabin\r SHS exposure. Subtle abnormal cardiovascular response to exercise in the absence of overt\r disease, such as what the investigators observed in this cohort, has been described in other\r populations with likely subclinical disease and is suggested to be associated with impaired\r cardiovascular function with potential future adverse outcomes. However, the underlying\r mechanisms that contribute to these abnormal cardiovascular responses are unclear, and the\r rationale for initiation of preventative medical interventions in this setting remains\r unproven. Thus, the nature and clinical significance of these subtle abnormalities demands\r further investigation.\r\n\r The hypothesis of this study is that:\r\n\r 1. Prolonged exposure to secondhand tobacco smoke (SHS), even when remote, is associated\r with occult cardiovascular disease as determined by (a) abnormal cardiac structure and\r function, (b) abnormal vascular structure and function, and (c) abnormal circulatory\r mediators, which altogether generate a hypertensive response to exertion and limit\r exercise capacity.\r\n\r 2. Management of hypertensive response to exercise (HRE) via blocking of the\r renin-angiotensin system, using an angiotensin-converting enzyme (ACE) receptor blocker,\r reduces the hypertensive response and improves exercise capacity, proxies for long-term\r cardiovascular health outcomes.\r\n\r The investigators will investigate the above hypothesis through the following specific aims:\r\n\r Specific Aim 1- Determine whether hypertensive response to exercise (HRE) is associated with\r abnormal cardiac and/or vascular structure and function in flight attendants (FA) with\r prolonged cabin SHS exposure but without overt cardiovascular disease. The investigators will\r perform cardiac magnetic resonance imaging (MRI) to measure myocardial dimensions and\r function including left ventricular (LV) mass, volume, ejection fraction (LVEF), and\r diastolic function. The investigators will also measure aortic stiffness by regional pulse\r wave velocity (PWV) measurement in the thoracic aorta from the MRI. The investigators will\r then examine the associations of these outcomes with SHS exposure and HRE.\r\n\r Specific Aim 2- Determine whether HRE is associated with abnormal circulatory markers of\r cardiovascular disease in those with prolonged SHS exposure but without overt disease. The\r investigators will examine subjects' peripheral blood samples for circulatory markers of\r systemic inflammation, vascular function, and prothrombotic state including ACE, C-reactive\r protein (CRP), endothelin-1 (ET-1), P-selectin, fibrinogen, and von Willebrand Factor (vWF).\r Moreover, the investigators will perform molecular phenotyping of peripheral blood monocytes,\r an important culprit in atherogenesis, using mass cytometry in search for a proinflammatory\r profile associated with cardiovascular disease. The investigators will then examine the\r associations of these outcomes with HRE and SHS exposure.\r\n\r Specific Aim 3- Determine whether short-term treatment with an ACE receptor blocker\r (Losartan) improves HRE and exercise capacity in those with prolonged exposure to SHS but\r without overt cardiovascular disease. The investigators will perform a placebocontrolled\r double-blind randomized controlled trial (RCT) in subjects with HRE but without known\r cardiovascular disease to determine the efficacy (and safety) of blocking the\r reninangiotensin system in reducing HRE and improving exercise capacity, a proxy for improved\r cardiovascular health.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Must be able to understand and provide informed consent.\r\n\r - Adults >= 40 years of age.\r\n\r - Must have a history of occupational exposure to secondhand tobacco smoke for at least\r 5 years such as flight attendants who worked for airlines before the smoking ban on\r aircrafts went into effect or casino workers who worked at casinos with no smoke-free\r policies.\r\n\r - Must have never smoked or have a remote history of light smoking defined as follows:\r\n\r - Lifetime smoking history equivalent to < 1 pack-year and\r\n\r - No smoking history for >= 20 years at the time of enrollment.\r\n\r Exclusion Criteria:\r\n\r - Inability or unwillingness of a participant to give written informed consent or comply\r with study protocol.\r\n\r - Subject is pregnant, breast-feeding, or plans to become pregnant.\r\n\r - Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin\r receptor blocker (ARB).\r\n\r - Known intolerance to ACE inhibitor or ARB.\r\n\r - History of angioedema.\r\n\r - Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial\r infarction, known cardiomyopathy).\r\n\r - Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or\r sitting.\r\n\r - Known unilateral or bilateral renal artery stenosis higher than 70%.\r\n\r - Renal insufficiency (Creatinine Clearance <30 mL/min by Cockcroft-Gault calculation).\r\n\r - Current regular use of NSAIDs defined as daily use on 5 or more days of the week for\r more than one month.\r\n\r - Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or\r higher at V1.\r\n\r - Current use of a potassium sparing diuretic.\r\n\r - History of clinically overt cardiovascular disease including: stable or unstable\r angina; chest discomfort and dyspnea with baseline exertion; symptomatic coronary\r artery disease (as defined by history of abnormal stress test; cardiac catheterization\r showing >70% coronary artery stenosis; history of revascularization; pathologic Q\r waves on EKG); poorly controlled resting hypertension (SBP>160/ DBP>95); congestive\r heart failure (CHF) (as defined by left ventricular ejection fraction (LVEF) <55%;\r physical exam findings of CHF; symptomatic pulmonary edema); significant (>mild)\r valvular heart disease; congenital heart disease; cardiac arrhythmias including\r frequent premature atrial or ventricular contractions (>5 per minute).\r\n\r - History of clinically overt pulmonary disease that may interfere with study\r procedures, including: greater than mild asthma, COPD, emphysema, chronic interstitial\r lung disease, and pulmonary hypertension.\r\n\r - Neuromuscular disorders or physical disability to perform exercise testing using an\r ergometer.\r\n\r - Significant history of recreational drug use other than marijuana as defined by:\r recreational drug use within the last 30 years of recruitment (or) recreational drug\r use at a frequency of more than once a month before 30 years.\r\n\r - Marijuana use more than once a week.\r\n\r - Other uncontrolled chronic illnesses which in the judgment of the study physician\r would interfere with completing study procedures.\r\n\r - Failure to keep screening appointments or other indicators of non-adherence.\r\n\r - Concomitant participation in another interventional study.\r\n\r - Subjects with BMI <15 or >40 kg/m2.\r\n\r - MRI Scan Participation Exclusion Criteria - The participants will be excluded from the\r MRI portion of the study if they have a metallic object embedded or implanted in their\r body that is incompatible with Magnetic Resonance (MR) scanning, including MR\r incompatible pacemaker or defibrillator.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
785
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMyeloid Cells in Aortic Valve Stenosis\n\n**Clinical Trial Summary:**\n\nInvestigators plan to characterize systemic inflammation and circulating immune cells in\r participants with moderate and severe calcific aortic valve disease and matched healthy\r controls.\n\n**Clinical Trial Detailed Description:**\n\nCalcific aortic valve disease (CAVD) is the most common type of valvular heart disease in the\r Western world. Due to the aging of the population, the impact of this disorder is expected to\r further increase in the next decades. The underlying pathophysiology remains incompletely\r defined and there are currently no effective medical treatments capable of altering its\r course, identifying a major unmet need in this growing population of patients.\r\n\r Based on the similarities between CAVD and atherosclerosis in pathophysiology and shared risk\r factors, it is now hypothesized that activation of the innate immune system contributes to\r the development of CAVD. Therefore, the investigators will perform an observational study to\r assess the role of activation of the innate immune system in CAVD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age > 18 years\r\n\r - Moderate to severe degenerative aortic valve stenosis as defined by transthoracic\r echocardiography according to the 2017 ESC/EACTS guidelines for the management of\r valvular heart disease.\r\n\r Exclusion Criteria:\r\n\r - Auto-inflammatory or auto-immune diseases\r\n\r - Use of anti-inflammatory drugs\r\n\r - Vaccination less than one month before inclusion\r\n\r - Bone marrow transplantation in medical history\r\n\r - Active hematological disease.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
786
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHANGZHOU Solution in Bicuspid AS Undergoing TAVR\n\n**Clinical Trial Summary:**\n\nTo compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus\r annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis\r (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding\r valves (SEVs): a randomized superiority trial\n\n**Clinical Trial Detailed Description:**\n\nTranscatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for\r severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients\r treated with TAVR had similar 30-day mortality as well as stroke and new pacemaker\r implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL,\r conversion to surgery and device failure. Event rates significantly decreased with the use of\r new-generation devices, but TAVR still showed better procedural results in TAV compared to\r BAV.\r\n\r Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are\r more common among TAVR candidates. Morphological characteristics at supra-annular structure\r (from annulus to the level of sinotubular junction) are quite complex in bicuspid AS,\r especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points\r provide the definition of the annulus plane, current CT-based annulus measurements might not\r be accurate under these circumstances. From previous single center clinical practice, \"waist\r sign\" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in\r patients with bicuspid AS, indicating that the supra-annular structure may serve a key role\r in anchoring the THV.\r\n\r Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for\r SEV implantation in bicuspid AS. From our single center experience, the device success rate\r and pacemaker implantation rate were relatively low.\r\n\r The aim of this study is to compare supra-annular sizing and THV implantation technique\r (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in\r bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement\r (TAVR) with self-expanding valves (SEVs).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 65 years\r\n\r - Age <65 years and age ≥ 60 years with high surgical risk after combing STS Risk\r Estimate, Katz activities of Daily Living, major Organ System Dysfunction and\r Procedure-Specific Impediment;\r\n\r - Severe, bicuspid aortic stenosis:\r\n\r - Mean gradient ≥40 mmHg\r\n\r - Maximal aortic valve velocity ≥4.0 m/sec\r\n\r - Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2)\r\n\r - NYHA classification ≥ II;\r\n\r - Type 0, type 1 (Sievers classification) by MDCT\r\n\r - Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;\r\n\r - Transfemoral TAVR\r\n\r - The study patient has been informed of the nature of the study, agrees to its\r provisions and has provided written informed consent as approved by the Institutional\r Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.\r\n\r Exclusion Criteria:\r\n\r - Any contra-indication for Self-expanding bioprosthetic aortic valve deployment\r\n\r - Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt<\r 50,000 cell/mL).\r\n\r - Active sepsis, including active bacterial endocarditis with or without treatment;\r\n\r - Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended\r treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥\r twice normal in the presence of MB elevation and/or troponin level elevation (WHO\r definition)].\r\n\r - Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.\r\n\r - Estimated life expectancy < 12 months (365 days) due to carcinomas, chronic liver\r disease, chronic renal disease or chronic end stage pulmonary disease.\r\n\r - Any Emergent surgery required before TAVR procedure.\r\n\r - A known hypersensitivity or contraindication to any of the following that cannot be\r adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin,\r clopidogrel,Nitinol (titanium or nickel),contrast media\r\n\r - Gastrointestinal (GI) bleeding that would preclude anticoagulation.\r\n\r - Subject refuses a blood transfusion.\r\n\r - Severe dementia (resulting in either inability to provide informed consent for the\r study/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits).\r\n\r - Other medical, social, or psychological conditions that in the opinion of the\r investigator precludes the subject from appropriate consent or adherence to the\r protocol required follow-up exams.\r\n\r - Currently participating in an investigational drug or another device study (excluding\r registries).\r\n\r - Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an\r identifiable cause) with obstruction (HOCM).\r\n\r - Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\r\n\r - Severe mitral stenosis amenable to surgical replacement or repair.\r\n\r - Aortic valve type cannot be determined (Sievers classification).\r\n\r - Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch\r atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing\r (especially with calcification and surface irregularities) of the abdominal or\r thoracic aorta, severe\"unfolding\" and horizontal aorta(Annular Angulation>70°).\r\n\r - Ascending aorta diameter > 50 mm.\r\n\r - Aortic or iliofemoral vessel characteristics that would preclude safe placement of the\r introducer sheath.\r\n\r - Patient is considered high risk for TAVR by CT corelab, including coronary\r obstruction, annular rupture and other severe TAVR-Related complications.\r\n\r - Previous pacemaker implantation.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
787
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImplantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip\n\n**Clinical Trial Summary:**\n\nThis is an investigator initiated, prospective study to demonstrate the safety and\r feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the \"V-Wave\r Shunt\" in patients immediately following percutaneous mitral valve repair using the MitraClip\r system.\n\n**Clinical Trial Detailed Description:**\n\nThe V-Wave Shunt is a device placed across the interatrial septum (IAS) by cardiac\r catheterization which allows for the transfer of blood from the left atrium (LA) to right\r atrium (RA). The intended effect is to reduce excessive left-sided cardiac filling pressures\r in patients with advanced heart failure (HF) and thus improve symptoms related to pulmonary\r congestion. All patients in the study must meet all anatomic and clinical eligibility in the\r FDA approved indications for use of the MitraClip in functional mitral regurgitation (MR).\r All patients must have persistence of New York Heart Association (NYHA) class III or\r ambulatory class IV HF symptoms despite maximally tolerated guideline directed medical\r therapy (GDMT) as assessed by a Cardiologist specialist in advanced heart failure (HF). All\r patients will have reduced left ventricular (LV) ejection fraction (EF) ≥ 20% and ≤ 50% and\r at least moderate to severe 3-4+ MR with a functional or combined functional and degenerative\r mechanism. Despite MitraClip treatment and maximum GDMT, these patients are at high risk for\r recurrent HF events and readmission, and thus there is an unmet need for further therapies to\r improve outcomes in this patient population.\r\n\r The existing transseptal puncture used for MitraClip placement will be used to place the\r V-Wave Shunt device after MitraClip placement.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. All patients must meet clinical and anatomic eligibility for commercial placement of\r MitraClip for functional MR, as specified by the MitraClip Instructions for Use (IFU).\r\n\r a. Clinical eligibility for MitraClip: i. Symptomatic secondary MR (moderate-severe [3+ or\r 4+] or greater) due to ischemic or non-ischemic cardiomyopathy ii. NYHA functional class\r III, or ambulatory IV iii. Maximization of GDMT as directed by the \"Heart Team\", including\r an interventional cardiologist (implanting physician), heart failure cardiologist, and\r cardiothoracic surgeon. This includes adequate treatment for systolic HF (LV dysfunction),\r rhythm disorders, and coronary disease, if applicable\r\n\r 1. An inhibitor of the reninangiotensin system (RAS inhibitor), including an angiotensin\r converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin\r receptor-neprilysin inhibitor (ARNI) and a beta-blocker (BB)\r\n\r 2. Other medications recommended for selected populations, e.g., mineralocorticoid\r receptor antagonist (MRA) or nitrates/hydralazine should be used in appropriate\r patients, according to the published guidelines.\r\n\r 3. Patient has been on stable HF medications as determined by the investigator, for at\r least 1 month, with the exception of diuretic therapy. Stable is defined as no more\r than a 100% increase or 50% decrease in dose within these periods.\r\n\r 4. Drug intolerance, contraindications, or lack of indications must be attested to by the\r investigator.\r\n\r 5. Receiving Class I recommended cardiac rhythm management device therapy.\r\n\r 1. If indicated by class I guidelines, cardiac resynchronization therapy (CRT),\r implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at\r least 3 months prior to device implantation\r\n\r 2. These criteria may be waived if a patient is clinically contraindicated for these\r therapies or refuses them and must be attested to by the investigator.\r\n\r iv. At least one hospitalization for heart failure in last year OR corrected BNP ≥ 300\r pg/mL or corrected NTproBNP ≥ 1500 pg/mL v. Heart team has determined that mitral valve\r (MV) surgery will not be offered as a treatment option b. Anatomic eligibility for\r MitraClip: i. LVEF ≥ 20% and ≤ 50% ii. LV end-systolic dimension ≤ 70 mm iii. MV orifice\r area > 4.0 cm2 by TEE iv. Minimal calcification in the grasping area v. No leaflet cleft in\r the grasping area vi. In patients with a degenerative component to MR, the following\r additional criteria must be met:\r\n\r 1. Flail width <15 mm\r\n\r 2. Flail gap <10 mm vii. The primary regurgitant jet is non-commissural, and in the\r opinion of the implanting investigator can be successfully be treated by the MitraClip\r (if a secondary jet exists, it must be considered clinically insignificant) viii.\r Transseptal catheterization and femoral vein access is feasible per investigator 2.\r Provide written informed consent for study participation and be willing and able to\r comply with the required tests, treatment instructions and follow-up visits.\r\n\r Exclusion Criteria:\r\n\r Preliminary Exclusion Criteria (PEC) - to assessed by the Preliminary Screen at the\r baseline visit:\r\n\r 1. Severe pulmonary hypertension, defined as RV systolic pressure or PA systolic pressure\r > 70 mmHg, or PVR > 4 Woods units, measured by any modality (TTE, TEE, cardiac MRI, or\r pulmonary artery catheterization [if data available]).\r\n\r 2. Moderate or severe RV dysfunction defined as TAPSE <12mm or RVFAC ≤25% as assessed on\r Baseline TTE, or qualitative assessment of severe RV dysfunction on TTE, TEE, or\r cardiac MRI.\r\n\r 3. Untreated severe (3+ to 4+) tricuspid or pulmonary regurgitation.\r\n\r 4. Untreated clinically significant coronary disease requiring revascularization\r\n\r 5. Coronary artery bypass grafting, percutaneous coronary intervention, transcatheter\r aortic valve implantation, or CRT-D implantation within 30 days\r\n\r 6. Aortic or tricuspid valve requiring surgery or transcatheter intervention\r\n\r 7. COPD requiring continuous home oxygen therapy or chronic outpatient steroid use\r\n\r 8. Cerebrovascular accident within prior 30 days\r\n\r 9. Known severe symptomatic carotid stenosis\r\n\r 10. Carotid surgery or stenting within prior 30 days\r\n\r 11. ACC/AHA Stage D heart failure\r\n\r 12. Presence of any of the following:\r\n\r 1. Hypertrophy cardiomyopathy, restrictive cardiomyopathy, constrictive\r pericarditis, or any other structural heart disease causing heart failure other\r than dilated cardiomyopathy of either ischemic or non-ischemic etiology\r\n\r 2. Infiltrative cardiomyopathy (e.g. amyloidosis, hemochromatosis, sarcoidosis)\r\n\r 13. Leaflet anatomy which may preclude MitraClip implantation\r\n\r 14. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without\r afterload reduction, cardiogenic shock or the need for inotropic support or\r intra-aortic balloon pump or other hemodynamic support device.\r\n\r 15. Need for surgery within 12 months\r\n\r 16. Life expectancy < 1 year due to non-cardiac conditions\r\n\r 17. Status 1 for cardiac transplant or history of cardiac transplant\r\n\r 18. Modified Rankin score ≥ 4 for disability\r\n\r 19. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve,\r or any prior transcatheter mitral valve procedure\r\n\r 20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation\r\n\r 21. Active endocarditis or active rheumatic heart disease or leaflets degenerated from\r rheumatic disease (i.e., noncompliant, perforated)\r\n\r 22. Active infection requiring antibiotic therapy\r\n\r 23. TEE is contraindicated or high risk\r\n\r 24. Pregnant or planning pregnancy within 12 months\r\n\r 25. Known hypersensitivity or contraindication to procedural medications that cannot be\r adequately treated\r\n\r 26. Known allergy to nickel.\r\n\r 27. Patient is otherwise not appropriate for the study as determined by the investigator\r or the Eligibility Committee, for which the reasons must be documented.\r\n\r 28. Patient belongs to a vulnerable population per investigator's judgment or patient has\r any kind of disorder that compromises his/her ability to give written informed consent\r and/or to comply with study procedures.\r\n\r Final Exclusion Criteria (FEC) - Assessed by the Final Screening, performed at time of\r cardiac catheterization prior to device placement (Study Intervention Visit)\r\n\r 29. Presence of severe pulmonary hypertension assessed by invasive hemodynamic measurement\r with pulmonary artery catheterization prior to MitraClip placement, defined as PA\r systolic pressure > 70 mmHg or PVR > 4 Woods units.\r\n\r 30. Anatomical anomaly on TEE that precludes implantation of the study device across the\r interatrial communication created by the MitraClip procedure, including:\r\n\r 1. A posterior rim between the septum secundum and aorta (i.e. aortic rim) of < 5\r mm.\r\n\r 2. Atrial septal aneurysm defined as ≥ 10 mm of phasic septal excursion into either\r atrium or a sum total excursion of ≥ 15 mm during the cardiorespiratory cycle,\r with a base of ≥ 15 mm.\r\n\r 31. Moderate or worse MR ≥2+ at the end of MitraClip treatment (i.e. MR must be <2+ by\r TTE, TEE, invasive hemodynamics, or left ventriculography)\r\n\r 32. Key hemodynamic exclusions after MitraClip treatment:\r\n\r 1. Mean LAP ≤ 20 mmHg following final result from MitraClip placement (i.e. mean LAP\r must be elevated > 20 mmHg after completion of MitraClip).\r\n\r 2. Difference between mean LAP and mean RAP < 5mmHg after MitraClip placement (i.e.\r difference between LAP - RAP must be ≥ 5 mmHg).\r\n\r 3. If the patient meets these hemodynamic exclusion criteria and mean arterial\r pressure (MAP) is < 90 mmHg, the MAP may be increased to ≥ 90 mmHg and repeat\r pressure measurements obtained in order to evaluate eligibility.\r\n\r i. IV fluids and medications may be given to support MAP to a goal ≥ 90 mmHg if\r necessary.\r\n\r 33. Patient is otherwise not appropriate for study as determined by the Investigator.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
788
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\n\"De Novo\" Atrial Fibrillation in Patients With Heart Failure: Incidence; Predictors and Relevance.\n\n**Clinical Trial Summary:**\n\nAtrial fibrillation (AF) represents a problem of great implications to patients with heart\r failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the\r presence of HF. Both conditions share risk factors and the presence of the one worsens the\r progress of the other. Therefore, the AF is not only relevant in terms of thromboembolic\r events. Timing of AF progression seems to be associated with an increase in all causes of\r mortality. Although, it is estimated that between 30%-40% of the patients with HF develop AF,\r given that in many cases it occurs with no apparent symptoms for the patients, is considered\r that the number of affected patients is greater. Since silent AF poses a problem of great\r impact in patients with HF, monitoring through continuous electrocardiographic registry could\r be useful in those patients with a higher risk of thromboembolic events. The purpose of this\r study is to understand the mechanism and biological and clinical relevance of the AF from a\r holistic approach. Trying to distinguish the symptomatic AF from the silent one using the\r implementation of insertable cardiac devices. The purpose of this study is 1. To determine in\r which percentage of patients with HF, episodes of AF both symptomatic and asymptomatic occur,\r as well as if the presence of AF represents an irrelevant fact in the progression of the\r insufficiency or in the contrary, it is the cause of the HF patients clinical decline. 2. To\r examine the presence of triggers of AF in patients with HF and to identify the presence of\r clinical markers, image markers of the atrium and left ventricle, as well as biomarkers which\r allow the risk of stratification and could mean future therapeutic targets.\n\n**Clinical Trial Detailed Description:**\n\nMulticenter prospective study formed by units with experience in the management of patients\r with HF (Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela,\r Spain; Hospital Clínico Universitario de Salamanca, Salamanca, Spain and Hospital\r Universitario Virgen de la Arrixaca, Murcia, Spain).\r\n\r Based on an AF development estimate of 30%, it has been estimated a minimum follow-up of 18\r months and a maximum of 36 months for obtaining robust conclusions. On the basis of\r previously reported data, it has been estimated that the annual rate of AF in patients 65\r years of age or older who have CHA2DS2VASc ≥ 2 and who have received an ICM is 6%. The\r enrolment of 300 patients had been estimated. The study would have 95% power to detect an\r episode of rapid atrial rate.\r\n\r Those patients with a CHA2DS2VASc ≥2 seen in the HF unit will be prospectively included. In\r these patients, the previous diagnosis of AF will be assessed by means of clinical history\r and medical records. Patients with previous AF will be excluded.\r\n\r Patients with preserved or intermediate LVEF will be defined according to current guidelines.\r\n\r - Patients with signs and symptoms of HF.\r\n\r - LVEF between 40 and 49 for \"mid-range\" and greater than or equal to 50 for those with\r LVEF preserved and at least one of these two criteria:\r\n\r - High natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL)\r\n\r - Relevant structural disease (left ventricular hypertrophy or dilatation left\r earphone).\r\n\r - Diastolic dysfunction.\r\n\r The data will be collected individually by each recruiting center and introduced in the\r online registration form that will be enabled (see next point). The definition of variables\r will be agreed upon among all recruiting centers. The information collected will be dumped\r into a database created specifically for this purpose and will be coordinated from the\r Hospital Clínico de Santiago de Compostela.\r\n\r Remote monitoring The CareLink remote monitoring system allows remote monitoring of patients,\r without the need to go to the hospital center. This system establishes a connection between\r the patient and the medical center, through the patient monitor that reads the information\r from the implanted device and transmits it to a secure server. This communication allows the\r transmission of clinically significant events or, in the case of wireless devices, the\r sending of alerts. In this way, the healthcare professional has information of the event and\r allows him to anticipate the evaluation and treatment with the consequent benefit for the\r patient.\r\n\r Biological characterization\r\n\r Human plasma samples: Total venous blood samples (10 ml) will be collected in EDTA tubes as\r anticoagulants and separated by centrifugation at 1500xg during 15 minutes plasma and\r cellular fractions. The supernatant and the cell pellet are transferred to tubes and stored\r at -80°C. The serological samples will be stored in each center of origin. Several\r determinations will be performed:\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with the previous diagnosis of HF with both preserved and depressed LVEF.\r Patients with preserved or intermediate LVEF will be defined according to current\r guidelines.\r\n\r 1. Patients with signs and symptoms of HFor b) LVEF between 40 and 49 for \"mid\r range\" and greater than or equal to 50 for those with LVEF preserved, high\r natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL)and at\r least one of these two criteria: Relevant structural disease (left ventricular\r hypertrophy or dilatation left earphone).\r\n\r Diastolic dysfunction.\r\n\r Exclusion Criteria:\r\n\r - Previous history of atrial fibrillation.\r\n\r - CHA2DS2VASc < 2.\r\n\r - Patients requiring ventricular pacing > 40 patients\r\n\r - Patients under cardiac resynchronization therapy pacemaker/devices.\r\n\r - Patients with severe valvulopathy.\r\n\r - Patients with reverseble\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
789
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIndexed Aortic Area in Bicuspid Aortic Valve Aortopathy\n\n**Clinical Trial Summary:**\n\nThis study aims to determine the relationship between the cross-sectional aortic area/patient\r height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic\r aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with\r smaller diameters than those recommended for surgical intervention by guidelines are still at\r risk of aortic complications attending an abnormally high indexed aortic area.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age >18 years\r\n\r - First-time surgery\r\n\r - Bicuspid aortic valve confirmed\r\n\r - Thoracic aortic aneurysm involving aortic root or ascending aorta\r\n\r Exclusion Criteria:\r\n\r - No available pre-operative cross-sectional imaging\r\n\r - Re-do surgery\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
790
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPredictors of Adverse Left Ventricular Remodeling and Final Infarct Size After Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction: A Strain Analysis Study Using Echocardiography and Feature Tracking Cardiac Magnetic Resonance\n\n**Clinical Trial Summary:**\n\nST-segment elevation myocardial infarction (STEMI) is one of the most important causes of\r death and disability around the world.\r\n\r The main goal in the management of acute myocardial infarction (AMI) is early restoration of\r coronary artery flow in order to preserve viable myocardium. Primary percutaneous coronary\r intervention (PCI) has proven to be superior to other reperfusion strategies in terms of\r mortality reduction and preservation of left ventricular (LV) function. Despite improvements\r in the treatment of MI, 30% of patients show LV remodeling post-MI. Over time, remodeling\r adversely affects cardiac function and can lead to significant morbidity and mortality. Early\r risk stratification is essential to identify patients who will benefit from close follow-up\r and intense medical therapy.\r\n\r The most widely investigated functional left ventricular (LV) characteristic to predict\r patient outcome after STEMI is LV ejection fraction (LVEF). Several structural LV\r characteristics have also shown to be important predictors of cardiovascular adverse events\r and death, including LV end diastolic volume (LVEDV), end systolic volume (LVESV) and mass\r (LVM).\r\n\r Cardiovascular magnetic resonance (CMR) imaging is the current reference standard for\r assessing ventricular volumes and mass. Adverse remodeling results from an inability of the\r heart to maintain geometry post MI in the context of large infarcts and increased wall\r stresses.\r\n\r The compensatory hypertrophic response of the remote non-infarcted myocardium (end diastolic\r wall thickness (EDWT) and end systolic wall thickness (ESWT)) might also play an important\r role in the remodeling after myocardial infarction but this needs to be investigated.\r\n\r Infarct size -as a crucial endpoint for adverse remodeling- is influenced by several factors:\r - the size of the area at risk (AAR) (myocardium supplied by the culprit vessel); residual\r flow to the ischemic territory (e.g., collateral flow); myocardial metabolic demand; and the\r duration of coronary occlusion.\r\n\r Assessment of the size and distribution of the infarction area after revascularization\r therapy can facilitate prompt and appropriate clinical intervention. Biomarkers such as\r troponin and creatine kinase are mainly used for AMI identification but lack myocardial\r specificity and may overestimate the (IS). Left ventricle ejection fraction (LVEF) fails to\r detect minimal and early pathological changes. The myocardial damage following STEMI can be\r assessed accurately by delayed gadolinium enhancement imaging using CMR imaging. In the acute\r phase of a STEMI, the extracellular space is increased in the infarct region due to a\r combination of necrosis, hemorrhage, and edema. The extent of hyper enhancement in the acute\r phase has been related to the outcome in patients with STEMI. However, later on the necrotic\r tissue is replaced by fibrotic scar tissue also with increased extracellular space. This\r process leads to ongoing 'infarct shrinkage' after the first week until the infarction\r reaches its final size after ∼30 days. - - Measurement of hyper enhancement in the acute\r phase of an infarction might therefore overestimate the necrotic infarct size, whereas 'final\r extent of hyper enhancement' is more precisely related to the amount of necrotic tissue. In\r STEMI patients the prognostic importance and predictors of the final infarct size are not\r fully elucidated.\r\n\r Myocardial strain is a quantitative index based on measuring myocardial deformation during a\r cardiac cycle. Major tools for detecting changes in myocardial strain include CMR tagging,\r CMR feature tracking (FT-CMR) and speckle tracking echocardiography (STE). Previous studies\r have shown an advantage of strain in sensitively and accurately diagnosing and assessing IS\r compared to traditional functional indexes. However, the degree to which strain analysis can\r reflect the infarction areas quantified by CMR, adverse LV remodeling as well as the\r diagnostic accuracy of this analysis is still under dispute. In the past 3 years in\r particular, newly developed three-dimensional (3D) STE has overcome the inherent shortcomings\r of two-dimensional (2D) STE.\n\n**Clinical Trial Detailed Description:**\n\nThe study will enroll 100 consecutive patients with acute STEMI presenting to Aswan Heart\r Centre catheterization-lab for primary PCI matching the selection criteria. Diagnosis of\r STEMI will be based upon:\r\n\r Sustained ST-segment elevation of at least 1 mm in at least 2 contiguous leads or\r new/presumably new left bundle branch block, plus\r\n\r - Typical anginal pain\r\n\r - or diagnostic levels of serum cardiac biomarkers\r\n\r - or imaging evidence of new loss of viable myocardium or new regional wall motion\r abnormality.\r\n\r The study patients will undergo primary PCI according to the recent practice guidelines and\r the local hospital policy in managing ST elevation MI patients. Echocardiography and CMR will\r be performed twice: within 48 hours of admission and 3 months following the index event.\r\n\r Management\r\n\r - Twelve-lead electrocardiogram will be recorded at baseline and 30-min post-procedure.\r The ST-segment changes will be evaluated in the single lead with the most prominent\r ST-segment elevation before intervention. The ST-segment elevation will be measured to\r the nearest 0.5 mm at 60 ms after the J point. Significant ST segment resolution (STR)\r is defined as a reduction in ST-segment elevation of 50% after 30 min of infarct artery\r recanalization .\r\n\r - Immediately before the procedure, patients will receive aspirin (300 mg), clopidogrel\r (600 mg), or ticagrelor (180 mg). Adjunctive pharmacological treatment during the\r procedure will include:\r\n\r 1. Unfractionated heparin as an initial bolus of 70 U/kg and additional boluses during\r the procedure to achieve an activated clotting time of 250 to 350 s (200 to 250 s\r if Glycoprotein IIb/IIIa (GPIIb/IIIa) antagonist is used). Heparin will be\r discontinued at the end of percutaneous coronary intervention.\r\n\r 2. The use of a GPIIb/IIIa antagonist during the procedure, primary PCI technique,\r indications, and methods of thrombectomy if indicated will be done under the\r regulations of the local hospital policy and the most recent practice guidelines.\r\n\r The following data will be collected:\r\n\r 1. Clinical data:\r\n\r These include age, gender, weight, height, body mass index, body surface area, smoking\r status, history of hypertension or diabetes mellitus, dyslipidemia, prior history of\r coronary artery disease (CAD), and previous coronary interventions. Times from onset of\r pain to first medical contact, to definitive diagnosis, to needle and to restoration of\r coronary flow will be recorded as well.\r\n\r 2. Laboratory work up:\r\n\r Complete blood count, INR, cardiac biomarkers (total CK, CK-MB, troponin), Brain\r natriuretic peptide (BNP), soluble suppression of tumorigenicity 2 (sST2), liver enzymes\r (ALT and AST), urea and creatinine, and serum electrolytes (Na, K).\r\n\r 3. Angiographic data:\r\n\r - The thrombolysis in myocardial infarction (TIMI) flow grade:\r\n\r TIMI flow grade will be assessed at three different time points; immediately after the\r diagnostic coronary angiography, after wiring the culprit vessel and at the end of the\r procedure.\r\n\r - TIMI 0 flow: refers to the absence of any antegrade flow beyond a coronary occlusion.\r\n\r - TIMI 1 flow: refers to faint antegrade coronary flow beyond the occlusion, with\r incomplete filling of the distal coronary bed.\r\n\r - TIMI 2 flow: refers to delayed or sluggish antegrade flow with complete filling of the\r distal territory.\r\n\r - TIMI 3 flow: refers to normal antegrade flow with complete filling of the distal\r territory.\r\n\r • The myocardial blush grade (MBG): Myocardial blush grade evaluates contrast density in\r the myocardial region of the infarct-related artery compared to regions of\r non-infarct-related arteries on coronary angiography. It will be reported at the end of\r the procedure.\r\n\r - MBG 0: no myocardial blush.\r\n\r - MBG 1: minimal myocardial blush or contrast density.\r\n\r - MBG 2: moderate blush or contrast density, but less than a contralateral or ipsilateral\r non infarct-related artery.\r\n\r - MBG 3: normal myocardial blush or contrast density similar to a contralateral or\r ipsilateral non infarct-related artery.\r\n\r When myocardial blush persisted (\"staining\"), this phenomenon suggested leakage of the\r contrast medium into the extravascular space, and will be graded 0 Angiographic incomplete\r reperfusion is defined as TIMI flow grade < 2 or MBG < 2.\r\n\r Echocardiography protocol:\r\n\r Patients will undergo transthoracic echocardiography using xMATRIX X5-1 phased array sector\r probe (1 - 5 MHz) of the Philips iE33 xMATRIX and EPIQ 7 machines (Philips Medical Systems,\r Andover, MA, USA). The blood pressure and heart rate during the study will be recorded.\r\n\r 1. Conventional echocardiography:\r\n\r Standard views will be obtained and analyzed in accordance with the American Society of\r Echocardiography guidelines. . The following variables will be noted:\r\n\r 1. Left ventricular ejection fraction: calculated by the modified Simpson's rule by\r tracing the endocardial border at end-diastole and end-systole in the two-chamber\r and four-chamber views.\r\n\r 2. Left ventricular end-diastolic and end-systolic volumes (LVEDV and LVESV): absolute\r values and indexed to body surface area.\r\n\r 3. Assessment of regional wall motion abnormalities: wall motion scores for the\r seventeen myocardial segments and wall motion score index.\r\n\r 4. Pulsed Doppler mitral inflow: E and A wave velocities, and E/A ratio.\r\n\r 5. Lateral and medial mitral annular tissue Doppler E', A', and S' wave velocities,\r lateral and medial E/E' ratios.\r\n\r 6. Left atrial volume: absolute and indexed to body surface area.\r\n\r 2. 2D Speckle tracking echocardiography (STE) of the left ventricle:\r\n\r 1. Image acquisition:\r\n\r Images will be acquired using the same probe for conventional echocardiography of\r the Philips machine. Digital loops will be acquired from basal, mid, and apical\r parasternal short axis views, and apical long-axis, two-chamber and four-chamber\r views. Frame rates have to be higher than fifty frames per second.\r\n\r 2. Strain analysis:\r\n\r The digitally stored clips will be analyzed offline using TomTec software. For each of\r the three apical views, the operator manually identifies three points: two on each side\r of the mitral valve, and a third at the apex of the left ventricle (LV). The software\r automatically detects the endocardium at end-systole and tracks myocardial motion during\r the entire cardiac cycle. The software automatically calculates the peak longitudinal\r and circumferential strain for each individual segment in a seventeen-segment left\r ventricle model, expressed as bull's eye, and calculates global longitudinal /\r circumferential strain by averaging local strains along the entire left ventricle. The\r software provides the strain curves for the 16 myocardial segments (excluding the apical\r cap). Using a similar process for the short axis views, the software automatically\r detects the endocardium and generates peak radial strain for each myocardial segment.\r\n\r 3. 3D Speckle tracking echocardiography (STE) of the left ventricle:\r\n\r 1. Image acquisition:\r\n\r • Three-dimensional echocardiography Images will be acquired using the same probe\r of the Philips machine for conventional echocardiography. Images will be acquired\r from the apical window, taking care to include the entire LV cavity within the\r pyramidal scan volume. The dataset will be acquired over 4 consecutive cardiac\r cycles during a short breath-hold to avoid stitching artifacts.\r\n\r 2. Strain analysis:\r\n\r - Offline analysis of global and regional longitudinal, circumferential, and\r radial strain will be performed using TomTec software.\r\n\r Cardiac Magnetic Resonance protocol:\r\n\r Studies will be performed on a 1.5 T unit (AERA [Siemens Medical System, Erlangen, Germany])\r using electrocardiographic triggering and a cardiac-dedicated phase-array coil. For the\r assessment of LV volumes and function, steady-state free precession breath-held cine images\r (bSSFP) will be acquired in the following orientations: vertical long axis, horizontal long\r axis and short axis. Standard parameters are: repetition time/echo time 3.6/1.8 ms; flip\r angle 50-70°; slice thickness 6 mm; matrix 160 × 256; field of view 350-400 mm; and temporal\r resolution 25 msec. The set of short axis images will encompass the left ventricle entirely,\r with a between slices gap of 2 mm. For delayed enhancement imaging, a dose of 0.15 mL of\r gadolinium per kilogram of body weight will be administered and images will be acquired 10\r minutes after contrast injection. The sequence used will be a segmented inversion recovery\r gradient-echo pulse sequence using the same image orientations as the cine images. Scan\r parameters are: TR/TE 4.01/1.25 ms, flip angle 15°, matrix 208 x256, and voxel size 1.6 x\r 1.3x5 mm3. T1 is adjusted to achieve optimal nulling of myocardial signal.\r\n\r All images will be analyzed offline using Philips IntelliSpace Portal V8.0 workstation\r (Philips Healthcare, Best, The Netherlands) for analysis of LV volumes, function, and infarct\r size.\r\n\r Feature tracking strain analysis:\r\n\r This will be performed offline using Segment Medviso software that estimates myocardial\r strain curves by computing inter-frame deformation fields using a tracking strategy based on\r non-rigid image registration. Instead of myocardial boundaries tracking only, the method uses\r the entire image content (i.e. blood pool and entire myocardium) during the optimization\r process. Circumferential and radial LV myocardial Lagrangian strain are evaluated on\r short-axis cine SSFP images; longitudinal Lagrangian strain is derived from vertical\r long-axis ones. First, both endo- and epicardial contours are manually drawn at end diastole\r in the long and short-axis. Contours are propagated automatically by the software throughout\r the cardiac cycle generating myocardial strain and strain rate curves, with both global and\r regional values.28\r\n\r Infarct size:\r\n\r This will be determined using the full width at half maximum (FWHM) technique, which uses\r half the maximal signal within the scar as the threshold. The total final infarct area is\r expressed as percentage of the LV volume, given by the sum of the volume of hyperenhancement\r on delayed contrast enhanced images (necrosis/scar) for all slices divided by the sum of the\r LV myocardial cross-sectional volumes (%LV).\r\n\r LV volumes, function, and strain analysis will be performed in both the baseline and\r follow-up CMR study; the final infarct size will be calculated from the follow-up study.\r\n\r A second follow-up visit will be scheduled at 6 months of the index event to collect the\r following data on clinical outcome:\r\n\r 1. Mortality (all-cause and cardiac)\r\n\r 2. Recurrent angina assessed by Canadian Cardiovascular Society (CCS) grading.\r\n\r 3. Re-infarction.\r\n\r 4. Target lesion revascularization (TLR): either repeat percutaneous or surgical\r revascularization for a lesion anywhere within the stent or the 5-mm borders proximal or\r distal to the stent.\r\n\r 5. Target vessel revascularization (TVR): Revascularization of the same vessel of the\r primary event either surgical or percutaneous other than TLR definition.\r\n\r 6. Re-hospitalization for heart failure. Data on compliance to medications will be reported\r as well. A written informed consent will be obtained from all patient\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - STEMI with time from symptom onset of <48 hours duration.\r\n\r Exclusion Criteria:\r\n\r I. Clinical exclusion criteria:\r\n\r 1. STEMI patients receiving fibrinolytic therapy.\r\n\r 2. Cardiogenic shock, clinical, hemodynamic, or electrical instability persisting after\r primary PCI.\r\n\r 3. History of prior ST elevation myocardial infarction.\r\n\r 4. Unsuccessful angiographic reperfusion (Thrombolysis In Myocardial Infarction [TIMI]\r flow grade <2).\r\n\r II. Contraindications to CMR:\r\n\r 1. Cerebral aneurysm clips\r\n\r 2. Cardiovascular implanted electronic devices\r\n\r 3. Electronic implant or device, eg, insulin pump or other infusion pump\r\n\r 4. Cochlear or otologic implant\r\n\r 5. Shunt (spinal or intraventricular)\r\n\r 6. Tissue expander (eg, breast)\r\n\r 7. Metallic foreign body, especially ocular\r\n\r 8. Penile prosthesis.\r\n\r 9. Patients with stage 4 or 5 chronic kidney disease (estimated glomerular filtration\r rate <30 mL/min/1.73 m2)\r\n\r 10. Known claustrophobia\r\n\r 11. Known/possible pregnancy\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
791
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nClinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)\n\n**Clinical Trial Summary:**\n\nThe objective of this study is to investigate safety and performance of the Free Margin Cusp\r sizer. The device will be used during aortic valve repair and sparing procedures as a caliper\r to measure the aortic valve free margin length at different stages of the procedure. The\r patient will be followed for one year clinically (at 1, 2, 6 and 12 months) and by\r echocardiography (at 6 and 12 months) to assess aortic valve function.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve\r regurgitation and or ascending aorta dilatation.\r\n\r Exclusion Criteria:\r\n\r - Acute aortic dissection;\r\n\r - Diffuse aortic valve calcification;\r\n\r - AV endocarditis;\r\n\r - Bicuspid, unicuspid or quadricuspid aortic valves;\r\n\r - Patients under the age of 18 years;\r\n\r - Patients above the age of 80 years.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
792
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases\n\n**Clinical Trial Summary:**\n\nProspective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of\r Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and\r paediatric patients. A very promising technique with the potential benefits of dodging oral\r anticoagulation, foreign material, and suitable for patients with small aortic annuli and in\r infectious endocarditis.\r\n\r Performing hemodynamic evaluation, assess the clinical implementation and report preliminary\r results at follow up .\n\n**Clinical Trial Detailed Description:**\n\nHeart valve disease signifies a severe growing public health problem in developing countries,\r with aortic valve stenosis being the most common issue. Heart valve disease is commonly\r initiated by atherosclerotic degenerative processes, congenital anomalies, or rheumatic\r process. Aortic valve replacement is the gold standard in the treatment of patients with\r severe aortic stenosis and aortic regurgitation. Mechanical valves are favoured in younger\r patients (<60 years) owing to longer life-time, whereas biological valves are used for\r elderly patients in order to evade oral anticoagulation.\r\n\r Options for aortic valve disease have improved in the last era including replacement, repair,\r and reconstructive options. A variety of creative techniques including leaflet extensions,\r neo-leaflet creation, resuspension or plication of prolapsing leaflets, and commissuroplasty\r to repair valves have been officially become skilled at, specially in pediatric population .\r In adults, the introduction of trans-catheter aortic valve inserting now permits treatment of\r degenerative aortic stenosis in the oldest and the highest risk patients. However, surgical\r treatment choices for pediatric patients with complex congenital aortic valve disease stay\r restricted.\r\n\r In recent years, much attention has been given to the Ozaki procedure, an alternative way of\r repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet\r reconstruction. Diseased leaflets are removed carefully. The distance between each commissure\r is measured with invented sizing apparatus. The new leaflet of the size corresponding to the\r measured value is trimmed with an original template from glutaraldehyde-treated autologous\r pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with\r each annulus. Commissural coaptation was secured with additional sutures. The coaptation of\r three new leaflets were always insured with direct vision.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject with AV disease.\r\n\r - Documented symptomatic moderate or greater aortic stenosis\r\n\r - small aortic annulus patients\r\n\r - A symptomatic aortic insufficiency patient with left ventricular dysfunction or\r significant left ventricular dilatation.\r\n\r - Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp\r prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic\r valve (especially in paediatric population), and aortic valve cusp perforation from\r endocarditis.\r\n\r - Concomitant intervention of the aortic root, Concomitant intervention of the aortic\r arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.\r\n\r Exclusion Criteria:\r\n\r - Patients with previous aortic valve surgery.\r\n\r - missing informed consent\r\n\r - Participation in another clinical research.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
793
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe CASPER Registry\n\n**Clinical Trial Summary:**\n\nThe CASPER study is a prospective, international, multicenter registry which aims to evaluate\r the use of an algorithm for choosing the size of the prosthesis to be implanted in patients\r with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29)\r and Evolut® R 34.\n\n**Clinical Trial Detailed Description:**\n\nSTUDY DESIGN\r\n\r This is an Investigator initiated, international, multicenter, prospective registry,\r enrolling 100 consecutive BAV patients who will undergo TAVI with the Evolut R/Pro\r (23-26-29)/Evolut R 34THV.\r\n\r Enrollment will be without limitation for each center (competitive enrollment). The\r indication for TAVI will be based on each local Heart Team decision. As per local\r institution's regulatory policy, each patient will provide a written informed consent for the\r TAVI procedure, anonymous data collection and analysis. Each center will use its own consent\r template.\r\n\r All data will be collected in an electronic clinical report form (eCRF).\r\n\r STUDY POPULATION Population\r\n\r All consecutive patients diagnosed with type 0 or type 1 bicuspid aortic valve stenosis or\r steno-insufficiency disease, undergoing transcatheter aortic valve implantation, as per local\r standard of care.\r\n\r CASPER algorithm\r\n\r The sizing of the THV will be performed according to the proposed algorithm.\r\n\r First step (\"calcium impact\"): subtract 1 mm in patients with aortic calcium volume ≥300 mm3\r (i.e. ≥ Class I); no subtraction in patients with aortic calcium volume <300 mm3 (i.e. Class\r 0).\r\n\r Second step (\"raphe impact\"): subtract 1 mm if the raphe length is ≥50% of the perimeter\r derived mean annulus diameter Further 0.5 mm will be subtracted if a high burden of calcium\r is distributed predominantly on the raphe site.\r\n\r In case of bicuspid Type 0 the second step should be skipped.\r\n\r Transcatheter Aortic Valve Implantation Procedure\r\n\r TAVI will be performed according to the local standards of care. Balloon valvuloplastywill be\r performed to prepare for TAVI deployment, at operator's discretion. Balloon size should not\r exceed the minimal diameter of the aortic annulus at baseline.\r\n\r TAVI deployment will be performed as the current best practices. All Centers will be\r encouraged to implant THV according to the two cusp alignment technique. If necessary, post\r dilatation will be performed, based on the final hemodynamics and aortic regurgitation\r assessment. The postdilatation will be performed according to the calcium burden with a\r balloon size diameter equal to the minor annulus diameter or to the mean diameter.\r\n\r Post-procedural MSCT scan\r\n\r The post-procedural MSCT scan must be performed between 2 and 30 days after the index\r procedure.\r\n\r Post implant measurements of THV dimensions (perimeter and area) will be obtained at inflow\r level, raphe level, and stent waist level (defined as the smallest dimension observed at any\r plane of the implanted prosthesis). If the raphe level corresponds to the stent waist level,\r only one measurement will be reported.\r\n\r Eccentricity index will be calculated for each level. Eccentricity will be defined as\r 1-(minimal diameter/maximal diameter) and will be calculated both at the inflow and at the\r narrowest level.\r\n\r The post-procedural raphe length (defined as the longest measurable dimension of the\r structure) will be measured at the same level of pre-procedural MSCT. The ratio between the\r pre and post-procedure raphe length will be calculated for the assessment of raphe\r shortening.\r\n\r Strut separation data will be acquired (maximal strut distance, mean strut distance, strut\r eccentricity index, i.e. maximal-minimal strut separation). The stent strut spaces will be\r measured separately at the inflow level, with the first stent strut defined as the strut\r closest to the commissure between the non-coronary and right coronary sinuses. The subsequent\r struts will be numbered clockwise in an ascending order (1-15 for the Evolut THV).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age ≥18 years.\r\n\r 2. NYHA≥2 and/or syncope and/or angina.\r\n\r 3. Patient judged by the Heart Team as indicated for TAVI.\r\n\r 4. Anatomical suitability for transfemoral or any alternative access TAVI, based on MSCT\r assessment and local expertise and preference.\r\n\r 5. Estimated life expectancy>1 year.\r\n\r Exclusion Criteria:\r\n\r 1. Age <18 years\r\n\r 2. Estimated life expectancy<1 year\r\n\r 3. Pure aortic regurgitation.\r\n\r 4. LVEF<20%\r\n\r 5. No baseline MSCT evaluation.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
794
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStandardized Invasive Hemodynamics for Elevated Gradients Post TAVR\n\n**Clinical Trial Summary:**\n\nThe DISCORDANCE TAVR study will determine the discordance between echocardiography-derived\r and invasive transaortic gradients, as determined by a consistent and reproducible technique\r (Standardized Invasive Hemodynamics) post-TAVR.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate\r hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR\r\n\r - Consensus by the Heart Team that the patient is suitable for Standardized Invasive\r Hemodynamics (SIH).\r\n\r Exclusion Criteria:\r\n\r - CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
795
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the clinical efficacy of a novel sustained dynamic\r compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing\r longitudinal weight-bearing computed tomographic imaging. Of particular focus will be\r assessment of compressive element recovery and its relation to fusion development over time\r and weight-bearing status. Additionally, the study will incorporate longitudinal fusion\r assessment to evaluate differences between three-dimensional weight-bearing computed\r tomography (WBCT) scans and two-dimensional radiographs (X-rays) at multiple points of the\r fusion process. Finally, the study will evaluate the differences in WBCT-based fusion\r assessment between automated and manual methodologies for fusion area calculation.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a collaborative effort between the Orthopedic Foot and Ankle Center, MedShape,\r Inc, and CurveBeam. This is a prospective investigation to assess the clinical outcomes of\r patients with a tibiotalocalcaneal arthrodesis with the Sustained Dynamic Compression\r Intramedullary Nail (DynaNail), including longitudinal assessment with weight-bearing CT. The\r investigators plan to enroll 45 patients. No placebo control will be used, as there is no\r other IM nail available capable of providing sustained compression. Additionally, given that\r many patients receiving this treatment have had prior failed treatments and face poor\r alternatives such as amputation, using a prior-generation IM nail as a control treatment\r would be unethical.\r\n\r Design:\r\n\r This is a prospective, single-group study. Patients of the Orthopedic Foot and Ankle Center\r who are scheduled to undergo TTC arthrodesis will be screened for eligibility and informed\r consent will be obtained from those who meet the inclusion/exclusion criteria. Subjects will\r be assessed pre-operatively and then at five post-operative intervals: 1 week, 6 weeks, 3\r months, 6 months, and 12 months. A WBCT scan will be obtained at each interval.\r\n\r Selection of Subjects:\r\n\r Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon\r or his/her physician assistant based on clinical exam and radiographic findings. Patients\r will be screened for eligibility by the research coordinator/ key personnel in close\r coordination with the surgeon and co-investigator.\r\n\r Pre-operative Questionnaire:\r\n\r After informed consent, the patients will be asked to complete patient reported outcomes\r questionnaires that are part of the SOS Registry associated with function and pain, including\r VAS, VR-12, FFI-R, FAAM, AOS, and AOFAS. The patients will also be asked to provide\r information related to prior medical history (including potential co-morbidities associated\r with non-union, i.e. tobacco usage, neuropathy, renal disease, obesity, etc.) and surgical\r history of the subject lower extremity.\r\n\r Surgery:\r\n\r The following surgical procedure is standard of care. The surgical procedure will involve\r both tibiotalar and talocalcaneal joint preparation through any approach (lateral, posterior,\r anterior with sinus tarsi). The use of supplemental bone graft is at the discretion of the\r treating surgeon but must be documented. The MedShape DynaNail will then be inserted\r according to the manufacturer's technique. The patient will be placed in a short leg splint\r and kept non-weight bearing initially. The patient will be discharged from the hospital when\r medically ready. Weight-bearing will start at seven weeks post-surgery.\r\n\r Follow-Up Visits and Questionnaires:\r\n\r The patient will return to clinic for visits at the following intervals after surgery: 1\r week, 6 weeks, 3 months, 6 months, and 12 months. At each of these time points, a clinical\r exam will be conducted, and SOS patient questionnaires will be administered, as well as a\r radiographic and clinical follow-up form. Additionally, radiograph and weight-bearing CT\r imaging will be obtained of both the ankle and subtalar joints. At 3 months and 12 months\r post-op, all X-ray and CT images will be de-identified, burned to a DVD, and copies will be\r sent to both co-sponsors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Meets indications for TTC arthrodesis and receives the DynaNail implant\r\n\r - Able to understand the requirements of the study\r\n\r - Willing to comply with the study protocol\r\n\r - Sign an Informed consent\r\n\r - 18 years of age or older\r\n\r Exclusion Criteria:\r\n\r - Investigator determines that the subject is unlikely to comply with the requirements\r of the study\r\n\r - Non-English speaker\r\n\r - Blind\r\n\r - Illiterate\r\n\r - Prisoner\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
796
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPrizValve® Transcatheter Aortic Valve Replacement Study\n\n**Clinical Trial Summary:**\n\nThe purpose of this clinical study is to evaluate the effectiveness and safety of the\r transcatheter aortic valve system in the treatment of patients with severe aortic stenosis\r who are at high risk of surgery or who are not suitable for surgery.\n\n**Clinical Trial Detailed Description:**\n\nThis study is an multicenter, single-arm, prospective, safety and performance clinical study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age ≥ 70 years ;\r\n\r 2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography:\r transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve\r blood flow rate ≥4m/s, or aortic Valve area<1.0cm2, or AVA <0.5cm2 /m2);\r\n\r 3. NYHA ≥ II;\r\n\r 4. Life expectancy> 12 months;\r\n\r 5. Patients who are anatomically suitable for transcatheter aortic valve implantation;\r\n\r 6. After evaluation by two or more cardiovascular surgeons, patients who are unsuitable\r for surgery; or patients who refuse surgery after sufficient communication by the\r surgeons and are at high risk of routine surgery;\r\n\r 7. Patients who can understand the purpose of the trial, voluntarily participate in and\r signed informed consent form, and are willing to accept relevant examinations and\r clinical follow-ups.\r\n\r Exclusion Criteria:\r\n\r 1. Acute myocardial infarction occurred within 1 month before this treatment;\r\n\r 2. Congenital single leaf aortic valve;\r\n\r 3. Any therapeutic cardiac operation (including placement of coronary drug-eluting\r stents) within 30 days;\r\n\r 4. The patient's heart has been implanted with other artificial heart valves, artificial\r rings, or severe mitral regurgitation (>3+);\r\n\r 5. Blood system diseases or abnormalities, including leukopenia (WBC<3×109/L), acute\r anemia (HB <90g/L), thrombocytopenia (PLT<50×109/L), bleeding constitution and\r coagulopathy ；\r\n\r 6. Untreated severe coronary artery stenosis that requires revascularization;\r\n\r 7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical\r heart assistance or mechanical ventilation;\r\n\r 8. Patients who need emergency surgery for any reason;\r\n\r 9. Hypertrophic cardiomyopathy with obstruction;\r\n\r 10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;\r\n\r 11. The echocardiogram indicates the presence of a heart mass, thrombus or vegetation;\r\n\r 12. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;\r\n\r 13. Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate\r anticoagulation and antiplatelet therapy;\r\n\r 14. The diameter of the aortic valve annulus <16mm or >28mm;\r\n\r 15. In any case, patients who refuse surgical treatment in emergency situations;\r\n\r 16. Cerebrovascular accident occurred within 3 months, not including transient ischemic\r attack;\r\n\r 17. Renal insufficiency is decompensated (creatinine>177umol/L), and/or end-stage renal\r disease requires long-term dialysis;\r\n\r 18. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm,\r obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of\r the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic\r aorta;\r\n\r 19. The iliac-femoral artery is severely obstructed with calcification, severely tortuous\r or unable to place the 1418F catheter sheath kit;\r\n\r 20. Active infective endocarditis or other active infections;\r\n\r 21. Aortic valve leaflets calcified plaque close to the coronary ostium;\r\n\r 22. Severe disability Alzheimer's disease and unable to take care of oneself in life;\r\n\r 23. Those who have participated in clinical trials of other drugs or medical devices\r before entering the group and have not yet reached the time limit of the primary\r research endpoint;\r\n\r 24. The researcher judged that the patient had poor compliance and could not complete the\r study as required.\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
797
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSAPIEN 3 Ultra EU PMS\n\n**Clinical Trial Summary:**\n\nThis study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve\r System in transcatheter aortic valve implantation centres that are implementing minimalist\r periprocedural practices and facilitating early discharge home.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, observational, single-arm, multicentre, post-market study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System\r\n\r 2. Less than 80 years of age at time of the procedure\r\n\r 3. Low surgical risk\r\n\r 4. Meets clinical and procedural requirements for early discharge\r\n\r 5. The subject or subject's legal representative has been informed of the nature of the\r study, agrees to its provisions and has provided written informed consent\r\n\r Exclusion Criteria:\r\n\r 1. Medical, social, or psychological conditions that preclude appropriate consent and\r follow-up, including subjects under guardianship\r\n\r 2. Considered to be part of a vulnerable population\r\n\r 3. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with\r COVID-19 with sequelae that could confound endpoint assessments\r\n\r 4. Cannot tolerate an anticoagulation/antiplatelet regimen\r\n\r 5. Active bacterial endocarditis\r\n\r 6. Participating in a drug or device study that has not reached its primary endpoint\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
798
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System\n\n**Clinical Trial Summary:**\n\nThis is a prospective, non-randomized, single arm, multicenter, multinational two-stage FIH\r feasibility followed by pivotal study in symptomatic patients with severe aortic stenosis.\n\n**Clinical Trial Detailed Description:**\n\nThe study consists of 7 visits spread out across two phases over 1 year. The clinical\r investigation will end at 30 days post-implantation. The subsequent 3-month, 6-month and\r 1-year follow-up (FU) visits will thus be considered post-market clinical follow-up (PMCF).\r\n\r The FIH study will start by evaluating the safety and feasibility of the device and study\r design of the Vienna Aortic Valve SE System in 10 patients with SSAS. The FIH patients must\r meet all study eligibility criteria. Safety and feasibility assessments for patients in the\r FIH period will include implantation success, hemodynamic performance and monitoring of\r adverse events (AEs). Early FIH data (i.e. data from the first 10 patients to have completed\r visit 3 at hospital discharge) will be provided to the Data and Safety Monitoring Board\r (DSMB) for review during which study enrollment will be paused. After reviewing the safety\r results from the FIH study, the DSMB will make a recommendation on whether the study may\r continue as planned. FIH patients will continue to be followed up for 1 year as per protocol.\r Data from the 10 FIH patients and the subsequent 75 patients will be analyzed together for\r the pivotal study endpoints.\r\n\r Upon a decision from the DSMB to proceed with the study, enrolment of patients will resume.\r\n\r The clinical investigation phase comprises 4 visits (V1 to V4). After implantation of the IMD\r at visit 2, early performance and safety assessment of the device will be performed at 30\r days (V4). The post-market surveillance phase comprises 3 visits (V5-V7), extending from 3\r months to 1 year post-implantation, to evaluate the long-term safety and performance profile\r of the device.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male and Female\r\n\r 2. Age ≥ 65 years at time of consent\r\n\r 3. Women of non-childbearing potential\r\n\r 4. Severe degenerative calcific native aortic valve stenosis with the following criteria\r assessed either by resting or dobutamine stress TTE:\r\n\r 1. Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and\r\n\r 2. Jet velocity > 4.0 m/s or mean gradient > 40 mmHg\r\n\r 5. Symptomatic aortic stenosis (AS), defined as a history of at least one of the\r following:\r\n\r 1. Dyspnea that qualifies at NYHA class II or greater\r\n\r 2. Angina pectoris\r\n\r 3. Cardiac syncope\r\n\r 6. Subject is considered at intermediate or high risk for surgical valve replacement\r based on at least one of the following:\r\n\r 1. EuroSCORE II ≥ 4%\r\n\r 2. Agreement by the Heart Team that subject is at high operative risk of serious\r morbidity or mortality with surgical valve replacement\r\n\r 7. The local Heart Team, including at least 1 cardiothoracic surgeon and 1 interventional\r cardiologist, deems the patient to be eligible for transfemoral TAVI.\r\n\r 8. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed\r tomography (CT) performed within 90 days prior to planned implantation\r\n\r 9. Adequate iliofemoral access with minimum average vessel diameter of ≥ 6.0mm and\r acceptable level of vessel calcification and tortuosity for safe placement of the\r introducer sheath\r\n\r 10. The distance from coronary ostia to aortic anulus > 12 mm\r\n\r 11. Patient (or legal representative) understands the study requirements and the treatment\r procedures and provides written informed consent.\r\n\r 12. The patient and the treating physician agree that the patient will return for all\r required post-procedure follow-up visits.\r\n\r Exclusion Criteria:\r\n\r Cardiovascular System:\r\n\r 1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.\r\n\r 2. Evidence of an acute myocardial infarction (MI) ≤ 30 days before the IMD implantation\r (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the\r presence of CK-MB elevation and/or troponin elevation).\r\n\r 3. Patient has had a cerebrovascular stroke or TIA within the past 90 days before IMD\r implantation.\r\n\r 4. Patient has a hypertrophic obstructive cardiomyopathy.\r\n\r 5. History of any therapeutic invasive cardiac procedure (including balloon aortic\r valvuloplasty) within 30 days prior to the planned IMD implantation (except for\r pacemaker implantation which is allowed).\r\n\r 6. Untreated clinically significant coronary artery disease requiring revascularization\r at the screening visit.\r\n\r 7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <\r 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography\r within 90 days prior.\r\n\r 8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic\r instability and vasopressor dependence, or mechanical hemodynamic support\r\n\r 9. Patients with clinically significant conduction abnormalities (clinically significant\r sinus bradycardia, sinus block or pauses, clinically significant atrioventricular\r (AV)-block >I) at screening and at time of valve implantation.\r\n\r 10. Patient has severe peripheral vascular disease:\r\n\r 1. including aortic aneurysm defined as maximal luminal diameter > 5 cm or with\r documented presence of thrombus, marked tortuosity, narrowing of the abdominal\r aorta, severe unfolding of the thoracic aorta or thick [> 5 mm], protruding or\r ulcerated atheroma in the aortic arch) or\r\n\r 2. symptomatic carotid or vertebral disease or successful treatment of carotid\r stenosis within 30 days before IMD implantation.\r\n\r 11. Patient with iliofemoral vessel characteristics that would preclude safe passage of\r the introducer [severe calcification, tortuosity (> two 90-degree bends), diameter <\r 6mm, or subject has had an aorto-femoral bypass]\r\n\r 12. Patient with active bacterial endocarditis within 6 months of planned IMD\r\n\r 13. Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass,\r thrombus or vegetation.\r\n\r 14. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring\r is not an exclusion).\r\n\r 15. Patient has severe mitral regurgitation, severe aortic regurgitation or severe\r tricuspid regurgitation, moderate or severe mitral stenosis.\r\n\r 16. Patient has a need for emergency surgery for any reason at time of screening and valve\r implantation.\r\n\r General:\r\n\r 17. Any condition considered a contraindication for placement of a bioprosthetic valve\r (e.g. patient with contraindication to oral antiplatelet therapy)\r\n\r 18. Patient with renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula)\r and/ or renal replacement therapy and/ or has serum creatinine level > 3.0 mg/dL or\r 265 µmol/L replacement therapy at the time of screening\r\n\r 19. Patient with significant pulmonary disease (FEV1 < 30%) or currently on home oxygen\r\n\r 20. Severe pulmonary hypertension (e.g., PA systolic pressure / systemic pressure >1 or\r mean pulmonary pressure > 55 mmHg assessed by echocardiography)\r\n\r 21. Patients with evidence of an active systemic infection or sepsis\r\n\r 22. Patient has a known hypersensitivity or contraindication to contrast media, bovine\r tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy\r (aspirin, ticlopidine or clopidogrel) or heparin.\r\n\r 23. Patient has a hemoglobin < 9 g/dL, platelet count < 50,000 cells/mm3 or > 700.000\r cells/mm3, or white blood cell count < 1.000 cells/mm3, history of bleeding diathesis\r or coagulopathy\r\n\r 24. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the\r past 3 months.\r\n\r 25. Patient refuses blood transfusions.\r\n\r 26. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid\r conditions based on the assessment of the investigator at the time of enrolment.\r\n\r 27. Patient is pregnant or breast feeding.\r\n\r 28. Severe dementia (resulting in either inability to provide informed consent for the\r study/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits).\r\n\r 29. Other medical, social, or psychological conditions that in the opinion of the\r Investigator precludes the patient from appropriate consent or adherence to the\r protocol required follow-up exams\r\n\r 30. Patient is currently participating in another investigational drug or device study\r that has not reached its primary endpoint (excluding observational studies).\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
799
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nNative T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis\n\n**Clinical Trial Summary:**\n\nThe study aims to test the diagnostic accuracy of native T1 mapping for the diagnosis of\r cardiac amyloidosis prospectively. The hypothesis is that native T1 mapping with a cut-off\r value of 1341ms (3 tesla CMR) in older patients with symptomatic heart failure, increased LV\r wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to\r diagnose cardiac amyloidosis (CA).\r\n\r As secondary measure, a web-based ATTR probability estimator for the diagnosis of CA will be\r evaluated.\n\n**Clinical Trial Detailed Description:**\n\nCardiac amyloidosis (CA) is an important differential diagnosis in older patients with\r symptomatic heart failure with preserved or mid-range ejection fraction and increased left\r ventricular wall thickness. The prevalence of CA among patients with heart failure and left\r ventricular (LV) hypertrophy is approximately 13%. However, diagnosis of CA is challenging\r because specific clinical signs are often lacking.\r\n\r Amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial T1\r values on cardiac magnetic resonance (CMR). Therefore, native T1 imaging provides a promising\r non-invasive method to identify CA.\r\n\r A preliminary retrospective analysis of 128 patients with increased LV wall thickness\r identified an area under the curve of 0.9954 (p<0.0001) for native T1 to detect CA. The\r optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%.\r\n\r The investigators aim to test the diagnostic accuracy of native T1 mapping with the threshold\r of 1341ms for the diagnosis of CA compared to the reference method prospectively. Moreover,\r the web-based ATTR probability estimator for the diagnosis of CA will be evaluated.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 60 years\r\n\r - Symptomatic heart failure (NYHA II-IV) with LVEF ≥40%\r\n\r - Increased LV wall thickness (≥12mm end-diastolic)\r\n\r - NT-proBNP ≥1000pg/mL\r\n\r - Elevated hs-troponin T ≥14ng/L\r\n\r Exclusion Criteria:\r\n\r - Contraindications for CMR\r\n\r - Acute myocarditis\r\n\r - Acute myocardial infarction <1 month\r\n\r - Severe aortic stenosis and RAISE score < 2 points\n\n**Patient Description:** \n\n48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.\nDuring this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.