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{
"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\nRetrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke\n\n**Clinical Trial Summary:**\n\nRetrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke\r rates following TAVI are roughly 3%. There are several device and procedure related\r characteristics which may increase the risk of stroke. We will examine if there is a signal\r in the UK registry. This will be important is TAVI is to be extended down to lower risk\r patient cohorts.\n\n**Clinical Trial Detailed Description:**\n\nRetrospective analysis of all patients receiving TAVI in the UK. Stroke rates following TAVI\r are roughly 3%. There are several device and procedure related characteristics which may\r increase the risk of stroke. We will examine if there is a signal in the UK registry. This\r will be important is TAVI is to be extended down to lower risk patient cohorts.\r\n\r Factors to be examined include (but not limited to):\r\n\r need for Pre-procedure Balloon aortic Valvuloplasty (BAV) Need for two valves need for\r post-dilatation need for rapid ventricular burst pacing\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Had TAVI procedure in UK\r\n\r Exclusion Criteria:\r\n\r - Nil\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
|
601
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[
{
"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 Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve\n\n**Clinical Trial Summary:**\n\nThe Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a\r prospective Italian registry including several centers performing TAVI, collecting baseline,\r procedural and outcome data.\n\n**Clinical Trial Detailed Description:**\n\nAortic valve stenosis is the most common degenerative valve disease in the elderly, the\r prevalence is about 1-2% in the age group> 65 years and 4% in patients aged> 85. The natural\r history is characterized by a poor prognosis with a survival rate of 62% at 1 year, 32% at 5\r years and 18% at 10 years from symptom onset. Predictors of death were age> of 75 years, poor\r left ventricular ejection fraction, congestive heart failure, chronic obstructive pulmonary\r disease, severe mitral regurgitation and pulmonary hypertension.\r\n\r The gold standard therapy, with improved survival, for severe aortic stenosis is the surgical\r aortic valve replacement with mechanical or biological prosthesis. Cardiac surgery is therapy\r of choice for patients with severe aortic valve stenosis with left ventricular dysfunction or\r when symptomatic for lipothymia or syncope, angina pectoris, heart failure.\r\n\r Criteria for high surgical risk are: left ventricular failure, coronary artery disease,\r previous cardiac surgery for coronary artery bypass , chronic obstructive pulmonary disease,\r and/or advanced age and comorbidity , which can be a contraindication to intervention.\r Frequently cardiac surgery is not performed in elderly patients for the high surgery risk. In\r the Euro Heart Survey up to 33% of patients with single valve disease, New York Heart\r Association class III or IV, were not operated for concomitant disease or reduced life\r expectancy.\r\n\r The need to provide a therapeutic option for patients considered at high surgery risk, has\r stimulated the development of prosthetic valve implantable with a percutaneous transcatheter\r techniques. The percutaneous treatment of valvular aortic stenosis has potential advantages\r in terms of reduction of hospitalization of elderly patients with high risk of peri-operative\r mortality and morbidity, as well as avoiding treatment with oral anticoagulants. The\r experience up to now is very positive, with immediate favorable results in terms of\r hemodynamic and clinical improvement. Since the procedure is at initial stage of clinical\r application, it becomes necessary a uniform and standardized data collection to assess the\r effectiveness of the procedure, the incidence of acute and late complications, and the\r performance of the biological valve prosthesis.\r\n\r The investigators propose the establishment of an observational registry of percutaneous\r aortic valve replacement performed in the Italian Interventional Cardiology Laboratory.\r\n\r The objectives are:\r\n\r - Record the clinical criteria used to asses indication for percutaneous aortic valve\r replacement in different centers\r\n\r - Record the anatomical and morphological criteria of vascular access and thoraco\r abdominal aorta, evaluated with noninvasive and invasive diagnostic tests\r (echocardiography, multislice angiographic computed tomography, aortography) in\r particular calcification and tortuosity of aorto-iliac-femoral axis, degree of\r calcifications of the aortic valve and thoracic aortic wall calcifications.\r\n\r - Record the types of devices used for percutaneous aortic valve replacement\r\n\r - Observe different way of procedure (type of access, anesthetic protocols, procedural\r delay, aortic valvuloplasty, and so forth)\r\n\r - Follow the procedure-related complications and / or of prosthesis implantation.\r\n\r - Acute complications:\r\n\r - Cerebral ischemia\r\n\r - Arrhythmias\r\n\r - Pericardial effusion / cardiac tamponade\r\n\r - Aortic valve insufficiency\r\n\r - Periprosthesis insufficiency\r\n\r - Myocardial ischemia\r\n\r - Kidney diseases\r\n\r - Conversion to cardiac surgery\r\n\r - Complications related to arterial vascular access\r\n\r - Late complications\r\n\r - Residual aortic valve insufficiency\r\n\r - Arrhythmias with need of pacemaker\r\n\r - Coronary Ischemia\r\n\r - Kidney diseases\r\n\r - Endocarditis\r\n\r - Post Procedure hospital stay\r\n\r - Evaluate the results at 30 days, 6, 12, 18 and 24 months of follow up:\r\n\r - echocardiographic mean transvalvular aortic gradient\r\n\r - valvular and/or periprosthesis insufficiency\r\n\r - left ventricular ejection fraction\r\n\r - Evaluate the clinical outcomes at 30 days, 6, 12, 18 and 24 months of follow up\r\n\r - New York Heart Association functional class\r\n\r - Medical therapy for heart failure\r\n\r - Number of hospitalization for heart failure\r\n\r Information obtained will be analyzed and used to standardize and make more appropriate\r indications for percutaneous aortic valve replacement to improve and standardize the\r protocols of procedure, to assess the immediate and long-term effectiveness of the technique,\r to monitor acute and late complications related and especially to verify the performance of\r tissue valves in the medium to long term.\r\n\r The hemodynamics centers wishing to join the register will send a completed form to the\r steering committee. Once registered they will receive an identification code and pass word\r for recording data.\r\n\r Registration of patients that underwent percutaneous aortic valve replacement with prosthetic\r heart valves with the CE mark, consecutively enrolled during period of 24 months.\r\n\r Use of paper and electronic case report forms, divided into 4 parts:\r\n\r I. Personal details, medical history, clinical assessment / Instrumental II. procedure III.\r Post-procedure hospital stay (24 hours, 48 hours, discharge) IV. Follow up to 30 days, 6\r months, 12 months, 18 months, 24 months\r\n\r The data will be compiled and analyzed on a quarterly basis and discussed with the\r participating centers with semi-annual meetings\r\n\r Primary end-points will be:\r\n\r 1. Feasibility of the procedure (functioning of the device, procedural success)\r\n\r 2. Access through the stenotic native aortic valve\r\n\r 3. Effectiveness of the positioning of the valve\r\n\r 4. Removal of the transport system\r\n\r 5. Procedural success will be determined by the efficacy of the valve system with a\r reduction of the gradient, and no hemodynamically significant valvular regurgitation, as\r assessed by angiography and color Doppler echocardiography\r\n\r 6. Major intraprocedural adverse events at 30 days, 3, 6, 12, 18 and 24 months\r\n\r 1. Major arrhythmias\r\n\r 2. Myocardial infarction,\r\n\r 3. Cardiac tamponade\r\n\r 4. Malfunctioning valve\r\n\r 5. Emergency surgical aortic valve replacement\r\n\r 6. Emergency aorto-coronary bypass or percutaneous coronary angioplasty\r\n\r 7. Cardiogenic shock\r\n\r 8. Infective endocarditis\r\n\r 9. Stroke or transient ischemic attacks\r\n\r 10. Aortic dissection\r\n\r 11. Dissection of the peripheral vessel\r\n\r 12. Vascular perforation\r\n\r 13. Acute occlusion of the artery access\r\n\r 14. Major bleeding\r\n\r 15. Death\r\n\r 7. New York Heart Association functional class at 30 days, 6, 12, 18 and 24 months\r\n\r 8. Left ventricle ejection fraction measured by echocardiography at 30 days, 6, 12, 18 and\r 24 months\r\n\r 9. Valve functioning: valve area, residual mean gradient, aortic regurgitation assessed\r with color Doppler echocardiography at 30 days, 6, 12, 18 and 24 months\r\n\r 10. Incidence of paravalvular regurgitation at 30 days, 6, 12, 18 and 24 months\r\n\r 11. Incidence of infective endocarditis at 30 days, 6, 12, 18 and 24 months\r\n\r 12. Incidence of vascular complications needs surgery\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients in whom transcatheter aortic valve implantation is attempted at participating\r center.\r\n\r Exclusion Criteria:\r\n\r - None except failure to obtain 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
|
602
|
[
{
"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 Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis\n\n**Clinical Trial Summary:**\n\nThis trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The\r first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose\r (SAD) treatment group. The second group will enroll adult subjects with CF, including those\r on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane\r conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group.\r Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for\r a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will\r enroll adult subjects with CF, including those on background treatment with KALYDECO® and\r those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts.\r Approximately 136 subjects will be enrolled.\n\n**Clinical Trial Detailed Description:**\n\nPART A The SAD treatment group is comprised of 3 cohorts where subjects will be randomized to\r either PTI-428 or placebo. Following the conclusion of at least 3 SAD treatment groups, a set\r of adult subjects diagnosed with CF will participate in an assigned MAD treatment group. The\r MAD treatment group is comprised of 3 cohorts. MAD Cohort 1 will enroll adult subjects with\r CF currently on stable ORKAMBI® background therapy for a minimum of 3 months at the time of\r randomization. MAD Cohorts 2 and 3 will enroll adult subjects with CF who are not currently\r on any background therapies. Subjects in all MAD cohorts will be randomized to either PTI-428\r or placebo. Each dose will be administered once daily (QD) for a total of 7 Days.\r\n\r PART B Following the conclusion of MAD Cohort 1, a set of adult subjects diagnosed with CF\r currently on stable ORKAMBI® background therapy for a minimum of 3 months will participate in\r Part B. The Part B Phase II treatment group is comprised of 2 cohorts where subjects will be\r randomized to either PTI-428 or placebo. Each dose will be administered QD for a total of 28\r days.\r\n\r PART C Following the conclusion of Part B Phase II, a set of adult subjects diagnosed with CF\r will participate in Part C. The Part C Phase II treatment group is comprised of 3 cohorts.\r Part C Cohort 1 will enroll adult subjects with CF who are eligible to take, but not\r currently taking, ORKAMBI® in accordance with the approved label. Part C Cohort 2 will enroll\r adult subjects with CF currently on stable KALYDECO® background therapy for a minimum of 3\r months at the time of randomization. Part C Cohort 3 will enroll adult subjects with CF who\r are not currently on any background therapies and are pancreatic sufficient. Each PTI-428 or\r placebo dose will be administered QD for a total of 28 days.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Confirmed diagnosis of CF.\r\n\r - Forced expiratory volume in 1 second (FEV1) 40-90% predicted.\r\n\r - Non-smoker and non-tobacco user for a minimum of 30 days prior to screening and for\r the duration of the study.\r\n\r Exclusion Criteria:\r\n\r - Participation in another clinical trial or treatment with an investigational agent\r within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1.\r\n\r - History of cancer within the past five years (excluding cervical CIS with curative\r therapy for at least one year prior to screening and non-melanoma skin cancer).\r\n\r - History of organ transplantation.\r\n\r - Any sinopulmonary infection or CF exacerbation requiring a change or addition of\r medication (including antibiotics) within 1 month of Study Day 1 or any other\r clinically significant infection as determined by the investigator within 1 month of\r Day 1.\r\n\r - History of alcohol or drug abuse or dependence within 12 months of screening as\r determined by the Investigator.\r\n\r - Male and female of child-bearing potential, unless they are using highly effective\r methods of contraception during participation in the clinical study and for 4 weeks\r after termination from study.\r\n\r - Pregnant or nursing 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
|
603
|
[
{
"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\nProphylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion\n\n**Clinical Trial Summary:**\n\nOur double-blinded, randomized control trial will assess the effect of nebulized racemic\r epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures.\r The investigators have had success in managing post-operative dysphagia in patients\r undergoing ACDF with the administration of this drug. Half of the participants will review\r nebulized epinephrine. The other half will receive placebo.\n\n**Clinical Trial Detailed Description:**\n\nBased on data from the National Inpatient Sample from 2002-2012, patients undergoing elective\r primary ACDF, diagnosed with dysphagia (4% of total patients), had a two-fold increase in\r mean length of stay (4.03 compared to 1.56 days; p < 0.001) and a substantial increase in\r their total hospital charges (p < 0.001) versus those not diagnosed with dysphagia. There are\r very few level I studies which describe successful management of these complications.\r Steroids have shown promise, however, there exist concerns for consequent delayed bony\r fusion. Racemic epinephrine is a mixture of both the R and L isomers of epinephrine which\r theoretically results in a milder side effect profile and longer shelf-life versus the\r standard L-epinephrine. Traditionally, racemic epinephrine has been administered in a\r nebulized form for the treatment of severe asthma, laryngeal edema, and bronchiolitis. The\r most severe side effects that have been reported include tachyarrhythmias and paradoxical\r bronchospasms, although these reports are rare and limited mainly to single case reports or\r case series. It confers its therapeutic effect through Racemic α-adrenergic and β-adrenergic\r mediated vasoconstriction of mucosal vasculature decreasing edema and in the respiratory\r tract, inducing bronchodilation. The PI, has been utilizing nebulized racemic epinephrine at\r standard dosages (1 unit of 0.5 ml of 2.25% racemic epinephrine) for the treatment of severe\r post-operative dysphagia in patients undergoing ACDF for 20 years. The investigator has\r achieved marked success with this intervention with no notable associated complications.\r Despite being successfully utilized in this manner for many years in small pockets of the\r spine community, the use of prophylactic racemic epinephrine for the management of dysphagia\r has not been described in the literature. The investigators hope to be able to fill this\r important knowledge-gap with our study data.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients > 18 years of age\r\n\r 2. Primary two and three-level ACDF between C3-7\r\n\r 3. Approved pre-authorization to undergo the procedure\r\n\r Exclusion Criteria:\r\n\r 1. Patients < 18 years of age\r\n\r 2. Patients who are unable to give their own consent\r\n\r 3. Revision ACDF\r\n\r 4. Combined anterior-posterior surgeries\r\n\r 5. Surgeries involving C2-C3 or C7-T1\r\n\r 6. Surgeries related to trauma, infection, or tumor\r\n\r 7. Patients with baseline swallowing dysfunction\r\n\r 8. Patients currently on steroids\r\n\r 9. Patients with severe cardiac disease\r\n\r 10. Uncontrolled diabetics as defined by patients with a HbA1C > 8%\r\n\r 11. Patients with known allergy to epinephrine\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
|
604
|
[
{
"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 ALIGN-AS EFS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study\n\n**Clinical Trial Summary:**\n\nTo collect information about treatment for severe aortic stenosis (AS), which affects the\r aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which\r decreases blood flow from the heart and causes symptoms such as chest pain, fainting and\r shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve\r replacement surgery.\n\n**Clinical Trial Detailed Description:**\n\nThis study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is\r a minimally invasive procedure designed to replace the aortic valve inside the heart. This\r less invasive surgical approach called TAVR is offered to those patients who are high risk\r for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be\r performed using the JenaValve Pericardial TAVR System.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient with severe degenerative native aortic stenosis (AS).\r\n\r - Patient at high risk for open surgical valve replacement\r\n\r - Patient symptomatic according to NYHA functional class II or higher\r\n\r Exclusion Criteria:\r\n\r - Congenital uni- or bicuspid aortic valve morphology\r\n\r - Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\r\n\r - Endocarditis or other active infection\r\n\r - Need for urgent or emergent TAVR procedure for any reason\r\n\r - Cardiogenic shock or hemodynamic instability requiring inotropic support or\r ventricular assist 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
|
605
|
[
{
"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 Medtronic TAVR 2.0 US Clinical Study\n\n**Clinical Trial Summary:**\n\nThe study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter\r Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who\r are considered at high through extreme risk for surgical aortic valve replacement\n\n**Clinical Trial Detailed Description:**\n\nProspective, single arm, multi-site study. Patients will be seen at pre and post procedure,\r discharge, 30 days, 6 months, 1 year, and annually up to 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area\r index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR\r maximal aortic valve velocity >4.0 m/sec by resting echocardiogram\r\n\r 2. Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥\r high risk for aortic valve replacement due to frailty or co-morbidities\r\n\r 3. Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II\r or greater\r\n\r 4. 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. Any condition considered a contraindication for placement of a bioprosthetic valve\r (eg, subject is indicated for mechanical prosthetic valve)\r\n\r 2. A known hypersensitivity or contraindication to any of the following which cannot be\r adequately pre medicated:\r\n\r - aspirin or heparin (HIT/HITTS) and bivalirudin\r\n\r - ticlopidine and clopidogrel\r\n\r - nitinol (titanium or nickel)\r\n\r - contrast media\r\n\r 3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet\r count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or\r hypercoagulable states\r\n\r 4. Untreated clinically significant coronary artery disease requiring revascularization\r\n\r 5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF)\r <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography\r\n\r 6. End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.\r\n\r 7. Ongoing sepsis, including active endocarditis\r\n\r 8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or\r drug eluting stent performed within 30 days prior to study procedure\r\n\r 9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within 10 weeks of Heart Team assessment\r\n\r 10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or\r mechanical hemodynamic support\r\n\r 11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or\r transient ischemic attack (TIA)\r\n\r 12. Gastrointestinal (GI) bleeding that would preclude anticoagulation\r\n\r 13. Subject refuses a blood transfusion\r\n\r 14. 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 15. Estimated life expectancy of less than 12 months due to associated non-cardiac\r co-morbid conditions\r\n\r 16. 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 17. Currently participating in an investigational drug or another device study (excluding\r registries)\r\n\r 18. Evidence of an acute myocardial infarction ≤30 days before the study procedure\r\n\r 19. Need for emergency surgery for any reason\r\n\r 20. Liver failure (Child-Pugh class C)\r\n\r 21. Subject is pregnant or breast feeding\r\n\r 22. Pre existing prosthetic heart valve in any position\r\n\r 23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)\r\n\r 24. Severe mitral regurgitation\r\n\r 25. Severe tricuspid regurgitation\r\n\r 26. Moderate or severe mitral stenosis\r\n\r 27. Hypertrophic obstructive cardiomyopathy\r\n\r 28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac\r mass, thrombus, or vegetation\r\n\r 29. Congenital bicuspid or unicuspid valve verified by echocardiography\r\n\r 30. Access vessel diameter <5.5 mm or <6.0 mm for patent left internal mammary artery\r (LIMA)\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"
}
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possibly relevant
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606
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[
{
"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 Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study)\n\n**Clinical Trial Summary:**\n\nNew strategies are needed to early detect myocardial involvement in these diseases.\r Histological studies showed that diffuse fibrosis and cardiomyocyte hypertrophy precede the\r LV remodelling (dilatation) observed by cardiac imaging. Quantification of LV diffuse\r myocardial fibrosis using magnetic resonance imaging (MRI) could reach this goal. Recently,\r contrast enhanced cardiac MRI has been used to measure the extracellular volume fraction\r (ECV) of the myocardium, and it has been able to detect diffuse myocardial fibrosis. In\r diseases in which increased collagen deposition enlarges the extra-cellular space, the ECV\r can act as a fibrosis index. ECV is correlated with the amount of fibrosis measured by\r histology. Left ventricular overloads induced by regurgitant VHD result in cardiomyocyte\r hypertrophy and diffuse fibrosis. Other methods can be used to estimate the degree of\r myocardial fibrosis such as the serum level of galectine-3 or ST2. Moreover, although the\r pathophysiological mechanisms leading to the occurrence of myocardial fibrosis differ in\r patients with various cardiac diseases, the cellular effectors of fibrotic remodelling are\r common and involve similar signalling pathways. At the cellular level, key progression of\r ventricular hypertrophy is associated with increased cardiomyocytes apoptosis and fibrosis,\r suggesting that these two processes are responsible for the transition.\r\n\r To our knowledge, no study has analysed the impact of the rate of myocardial diffuse\r fibrosis, non-invasively estimated by ECV, in the risk of LV dysfunction during MR and AR,\r especially after surgery. The measurement of ECV could become an important tool for risk\r stratification in left-sided regurgitant VHD. Thus, it would provide an early marker of LV\r myocardial involvement before the occurrence of global remodeling, might help physicians in\r surgical decision, and would improve prognosis. This is an innovative original project\r because it uses modern imaging modalities to answer to a crucial question. The clinical\r implications would be important because this work would modify the international surgical\r indications of MR and AR in order to finally improve the prognosis of patients with this\r frequent heart disease. Moreover, investigators will analyze the genetic factors that can\r influence the myocardial reaction resulting from these regurgitations, which will improve the\r quality of this work and offer new future perspectives.\r\n\r Investigators hypothesize that the ECV measurement could be used as an early predictor of LV\r dysfunction in the left-sided valve regurgitations.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All consecutive patients referred for organic MR and/or AR at least moderate to severe\r according to the ESC guidelines criteria⁴ will be eligible. The moderate to severe\r criteria will defined by echocardiography as followed:\r\n\r - MR: an effective regurgitant orifice area (EOA) >30mm2 and/or a regurgitant volume\r (RV) >45mL\r\n\r - AR: an EOA >20mm2 and/or a RV >45mL\r\n\r Exclusion Criteria:\r\n\r - Age < 18 years\r\n\r - Pregnancy\r\n\r - Impossibility to maintain a decubitus position\r\n\r - Arrhythmia that do not allow an ECG synchronization during MRI\r\n\r - Hemodynamic instability\r\n\r - Indication of urgent surgery\r\n\r - Known coronary artery disease\r\n\r - Severe arterial hypertension\r\n\r - Cardiomyopathy\r\n\r - Claustrophobia\r\n\r - Gadolinium intolerance\r\n\r - Implantable medical devices that do allow to perform MRI\r\n\r - Severe renal insufficiency with clearance <35 mL/min\r\n\r - Vulnerable patients\r\n\r - Acute infective endocarditis\r\n\r - Aortic dissection\r\n\r - Moderate or severe mitral stenosis (mitral area <1.5cm2/m2)\r\n\r - Moderate or severe aortic stenosis (aortic area <0.8cm2/m2, or Vmax>3m/s, or mean\r gradient>30mmHg)\r\n\r - Previous cardiac 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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607
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[
{
"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\nPerformance of the CARDIOGARD Cannula\n\n**Clinical Trial Summary:**\n\nThis is a single center, prospective study:\r\n\r The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the\r control group.\n\n**Clinical Trial Detailed Description:**\n\nPatients referred for CPB procedure will be offered to participate in the study. Patients\r will be asked to sign an informed consent form (ICF), prior to performing any study related\r procedures.\r\n\r The point of enrollment is the time at which a patient signs and dates the ICF. Following\r enrollment, the patient will undergo screening evaluation (including Neurological assessment)\r to determine eligibility. Screening failures will be identified on a screening log. Patients\r who are found to meet all inclusion criteria and none of the exclusion criteria will compose\r the evaluable cohort of the study. Screening failure subjects will not be counted as part of\r the target patient sample size nor will they be included in the analysis.\r\n\r Patients in the randomized phase will have surgery with the CardioGard Cannula or comparator\r cannulae and will remain blinded to their group assignment through the 30 days follow-up\r evaluation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass\r which is expected to last up to 6 hours.\r\n\r 2. Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an\r elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined\r aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG).\r\n\r 3. The patient is >50 and <85 years of age.\r\n\r 4. The patient's body weight is compatible with blood net flow of 4 - 5 [l/min].\r\n\r 5. Patient with left ventricular ejection fraction >30% as assessed by either\r echocardiography, angiography or by radio nuclear assessment (MUGA)\r\n\r 6. The patient is willing to participate as evidenced by signing the written informed\r consent.\r\n\r 7. Male or non-pregnant female patient (Note: Females of child bearing potential must\r have a negative pregnancy test)\r\n\r Exclusion Criteria:\r\n\r 1. Patient with abnormal clotting mechanism: PT 60%, PTT>2 the normal.\r\n\r 2. Patient with an aortic trauma.\r\n\r 3. Patient contraindicated for open heart surgery under bypass machine.\r\n\r 4. Patient undergoing a re-do procedure.\r\n\r 5. Patient intended for an operation performed using minimally invasive surgical\r techniques (e.g., mini-sternotomy)\r\n\r 6. Patient with pathologies which affect his/her neurological condition.\r\n\r 7. Patient in whom emergency operation is required.\r\n\r 8. Patient with a known allergy to Heparin\r\n\r 9. Patient with major co-morbid condition(s) that could limit the patient's ability to\r participate in the study, or impact the scientific integrity of the study, including\r but not limited to:\r\n\r - previous stroke\r\n\r - critical preoperative state\r\n\r - poor ventricular function\r\n\r - severe pulmonary hypertension [19]\r\n\r - Atheroembolism\r\n\r - history of cardiac failure [20]\r\n\r 10. Current use of drugs that might result in high surgical risk or significant\r postoperative complication.\r\n\r 11. Psychological instability, inappropriate attitude or motivation.\r\n\r 12. Patients with life threatening debilitating disease other than cardiac.\r\n\r 13. Subjects currently enrolled in another investigational device or drug trial that has\r not completed the primary end point or that clinically interferes with the current\r study endpoints.\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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608
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[
{
"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 Kidney Injury Genomics and Biomarkers in TAVR Study\n\n**Clinical Trial Summary:**\n\nIn the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly\r utilized alternative procedure for replacing a stenotic aortic valve. This study collects\r clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in\r order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR\r and to identify key clinical and procedural predictors of AKI. This study seeks to identify\r blood and urine biomarkers that can be used for early detection of AKI around the time of the\r procedure. The study seeks to assess for novel genetic variants associated with development\r of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and\r biomarkers that are associated with adverse cardiovascular events after TAVR and to further\r explore how these events may inter-relate with acute kidney injury.\n\n**Clinical Trial Detailed Description:**\n\nThis study enrolls patients who have aortic stenosis who undergo TAVR at the University of\r Texas Southwestern Medical Center University Hospital. Development of post-TAVR AKI defined\r according to the Kidney Disease: Improving Global Outcomes (KDIGO) SCr based and urine output\r based criteria will be ascertained. Patients will be followed during primary hospitalization\r and during the 5 years following TAVR for adverse kidney outcomes as well as potentially\r related adverse cardiovascular outcomes. Clinical and procedural data is collected for each\r study patient. All subjects will have paired blood and urine collection done pre-TAVR, 6\r hours after aortic valve prosthesis deployment, and on post-procedure days 1 and 2. Subjects\r who develop AKI will also have paired blood and urine samples collected on days 3, 4 and 5.\r Patients receive follow-up questionnaires by mail or email asking about hospitalizations as\r well as visits to cardiology, nephrology and primary care physicians. Questionnaires will\r also ask about health-related quality of life using validated study questionnaires. Patient\r follow-up will occur at regular intervals until 5 years after TAVR procedure.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria: Subjects are eligible to participate if they are undergoing TAVR for\r aortic stenosis at the University of Texas Southwestern Medical Center.\r\n\r Exclusion Criteria:\r\n\r 1. The patient cannot or will not provide informed consent.\r\n\r 2. The patient is aged less than 18 years.\r\n\r 3. The patient's pre-procedural hematocrit is less than 25%.\r\n\r 4. The patient has known hepatitis C and/or human immunodeficiency virus infection\r\n\r 5. In the opinion of the principal investigator, the patient will be unlikely to complete\r long-term follow up for medical or social reasons.\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
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609
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[
{
"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\nPost TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study\n\n**Clinical Trial Summary:**\n\nEvaluation of a strategy of selected revascularization guided on myocardial ischemia\r detection after the TAVI procedure by using single photon emission computed tomography\r (SPECT) myocardial perfusion imaging.\n\n**Clinical Trial Detailed Description:**\n\nBackground: Percutaneous coronary intervention (PCI) is usually proposed to patients with\r aortic stenosis (AS) before TransAortic Valve Implantation (TAVI) when significant coronary\r stenosis is detected on preprocedural coronary angiography. However, the benefit of a\r systematic revascularisation is unknown and may have specific complications in elderly and\r frail patients.\r\n\r Aims: The investigators proposed a strategy of selected revascularization guided on\r myocardial ischemia detection after the TAVI procedure by using single photon emission\r computed tomography (SPECT) myocardial perfusion imaging.\r\n\r Methods: This prospective open label clinical trial will include 71 consecutive patients with\r significant coronary artery disease (CAD) defined by one or more significant coronary\r stenosis in patients admitted for TAVI. Myocardial SPECT imaging will be performed in all\r patients at 1-month follow-up after the TAVI procedure. Targeted PCI will be performed only\r in patients with significant related ischemia (> 10 % myocardial perfusion defect).\r\n\r The primary outcome criterion is a composite criterion of feasibility and safety including\r all causes of death, stroke, major bleedings, major vascular complications, per procedural\r myocardial infarction, coronary revascularization or rehospitalisation for cardiac cause at 6\r month follow-up.\r\n\r Hypothesis: An alternative management of CAD guided by significant myocardial ischemia\r detection after TAVI could reduce the risk of unnecessary revascularization, the\r complications and the costs inherent to these procedures and a phase II trial is requiring to\r the evaluate this innovative and less invasive strategy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients older than 18 years\r\n\r - Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient\r higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on\r echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a\r major epicardial coronary artery or ≥50% for left main\r\n\r - Patients is not candidate for surgical aortic valve replacement after the\r multidisciplinary heart team decision.\r\n\r Exclusion Criteria:\r\n\r - Recent acute coronary syndrome (within 30 days before randomization),\r\n\r - Unprotected left main disease\r\n\r - Critical stenosis (>90%) of Left Anterior Descending artery (LAD),\r\n\r - Significant angina (CCS class more than 2)\r\n\r - Active bleeding,\r\n\r - Contraindication for tomographic technetium-99 assessment or dipyridamole injection\r\n\r - Previous enrollment in a other study\r\n\r - Impossibly to obtain 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:** definitely relevant"
}
] |
definitely relevant
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610
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[
{
"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\nTransfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the safety and performance of the HLT System in\r patients with severe aortic stenosis who present at High Risk for aortic valve replacement\r surgery.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. 70 years of age or older\r\n\r 2. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis\r with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve\r gradient >40 mmHg or peak aortic valve velocity >4 m/sec\r\n\r 3. Symptomatology due to 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 4. Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or\r perimeter\r\n\r 5. STS score of ≥8, or documented heart team agreement of high risk for surgical aortic\r valve replacement (SAVR) due to frailty or comorbidities.\r\n\r 6. Geographically available, willing to comply with follow up and able to provide written\r informed consent\r\n\r Exclusion Criteria:\r\n\r 1. Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve\r eccentricity (calcific or otherwise) that in the opinion of the investigator could\r compromise procedural success.\r\n\r 2. Patients at high risk for coronary obstruction in the opinion of the investigator\r (e.g. combination of a coronary height < 12 mm and coronary sinus diameter < 30 mm)\r\n\r 3. Patients with low flow/low gradient aortic stenosis\r\n\r 4. Patients with significant annular calcification (e.g. Agatston score > 4000)\r\n\r 5. Pre-existing prosthetic heart valve in any position, or prosthetic ring\r\n\r 6. Severe aortic, mitral or tricuspid valve regurgitation\r\n\r 7. Moderate to severe mitral stenosis\r\n\r 8. Myocardial infarction within the past 30 days*\r\n\r 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\r\n\r 10. LVEF < 30%\r\n\r 11. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds\r of systemic pressure\r\n\r 12. Hemodynamic instability requiring inotropic drug therapy within the past 14 days\r\n\r 13. Untreated clinically significant coronary artery disease requiring revascularization\r\n\r 14. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which,\r in the opinion of the investigator, precludes safe implant delivery\r\n\r 15. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia,\r history of bleeding diathesis or coagulopathy\r\n\r 16. Patient ineligible for or refuses blood transfusions\r\n\r 17. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive\r calcification, severe tortuosity or vessels < 6 mm) that would preclude passage of\r catheters from the femoral arterial access to the aorta as evidenced by peripheral\r MSCT\r\n\r 18. Active peptic ulcer or gastrointestinal bleeding within the past 90 days*\r\n\r 19. Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic\r attack) within past 6 month, or treatment of carotid stenosis within past two months*\r\n\r 20. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage\r renal disease requiring chronic dialysis\r\n\r 21. Active infection requiring ongoing treatment\r\n\r 22. Need for emergent surgery or intervention other than the investigational procedure\r\n\r 23. Any therapeutic invasive cardiac procedure performed or planned to perform within 30\r days of the index procedure, except for PCI which is within 7 days of the index\r procedure*\r\n\r 24. Hypersensitivity or contraindication to procedural medication and device materials\r (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated\r\n\r 25. Life expectancy < 1 year due to non-cardiac co-morbid conditions\r\n\r 26. Currently participating in any investigational drug or device studies that may\r confound the results of this study\r\n\r 27. History of any cognitive or mental health status that would interfere with study\r participation\r\n\r 28. Following surgical consultation, patient is deemed inoperable in the event that\r surgical intervention is required after HLT valve implantation attempt.\r\n\r - At the time of procedure, if a subject's medical status has changed since\r enrollment, the subject shall be re-evaluated for eligibility\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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[
{
"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\nPodocan and Wnt Pathway in the Development of Aortopathy in Bicuspid Valve Disease\n\n**Clinical Trial Summary:**\n\nBicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with\r valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to\r play role in abnormal aortic distensibility and stiffness with impairment of aortic\r elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not\r understood completely. In a recent study podocan is found in extracellular matrix (ECM) of\r human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no\r current effective therapy that can alter the progression of aortic dilatation in bicuspid\r valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated aorta\r and aortic dissection. In this study the aim is to investigate the association between\r podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide\r more effective and physiological understanding of disease process and potential target in\r prevention and treatment for aortopathy.\n\n**Clinical Trial Detailed Description:**\n\nPatients with known BAV will be enrolled in two inclusion criteria categories:\r\n\r - Group A: Patients who are scheduled to have a cardiac MRI\r\n\r Procedures for Group A: MRI will be used as a standard procedure to confirm the morphology of\r bicuspid valve especially in uncertain cases and to do accurate aortic measurements. Patients\r who agree to participate will provide informed consent prior to their cardiac MRI/CT. A 6\r minute walk test to measure baseline functional status will be performed after consent. All\r patients having a cardiac MRI/CT have an IV line placed as normal procedure. When then line\r has been placed, prior to contrast infusion a blood sample will be collected to test for\r circulatory Podocan and Wnt pathway molecules. At 24 months post procedure the following\r information will be collected from the participants' charts for endpoint analysis:\r\n\r - All cause mortality\r\n\r - Hospital admissions for Aortic dissection, Congestive heart failure, endocarditis or\r cardiac death\r\n\r - Valve replacement or aortic graft surgery\r\n\r - Group B: Patients who have already had an MRI within the past year\r\n\r Procedures for Group B: MRI will be used as a standard procedure to confirm the morphology of\r bicuspid valve especially in uncertain cases and to do accurate aortic measurements. Patients\r who agree to participate will report to the Clinical Research Division (CRD ) for a research\r visit to enroll in the study. At this visit, the patient will provide informed consent,\r complete a 6 minute walk test to measure baseline functional status , and will have blood\r drawn by venipuncture to obtain a blood sample to test for circulatory Podocan and Wnt\r pathway molecules. At 24 months post procedure the following information will be collected\r from the participants' charts for endpoint analysis:\r\n\r - All cause mortality\r\n\r - Hospital admissions for Aortic dissection, Congestive heart failure, endocarditis or\r cardiac death\r\n\r - Valve replacement or aortic graft surgery\r\n\r All patients who do undergo valve replacement or aortic graft surgery within the 24 month\r follow up period, will have their valve tissue samples analyzed for podocan levels. These\r tissues are removed as a routine part of the surgery and sent to the clinical laboratory at\r Bassett. The number of tissue samples collected during this procedure can range from one to\r four based on the exact nature and location of the aortic pathology. The Bassett Clinical Lab\r will prepare additional paraffin blocks and slides of the tissue for the research study.\r\n\r A blood sample will also be taken at the time of the patient's post-op MRI to test for\r circulatory Podocan and Wnt pathway molecules. This usually occurs about 6-9 months after\r surgery.\r\n\r It is expected that 100 participants will be enrolled in the study over 18 months. This is a\r sample size of convenience for this pilot study based the current volume of patients\r undergoing cardiac MRI/CT for evaluation of valvular disease. Of these 100 patients, it is\r estimated that 25 will undergo surgery as described above within the study period.\r\n\r Baseline analysis will be performed to study the association between circulatory Podocan and\r Wnt regulatory molecules (Wnt-1, Wnt-3, Dkk-1, WIF-1, sFRP-1, sFRP-3) measured by ELISA in\r peripheral blood and tissue samples of aortic root/ascending aorta.\r\n\r Each participant's chart will be reviewed at the time of enrollment and the following\r variables will be abstracted from the medical record:\r\n\r - age,\r\n\r - gender,\r\n\r - ethnicity,\r\n\r - Most recent Ht, Wt, BP, HR\r\n\r - BMI\r\n\r - Tobacco use/history\r\n\r - Alcohol use/ history\r\n\r - Comorbidities\r\n\r - HTN\r\n\r - Hyperlipidemia\r\n\r - Diabetes\r\n\r - CKD\r\n\r - Cancer\r\n\r - CAD\r\n\r - Info from previous echocardiogram:\r\n\r - Ejection fraction\r\n\r - Valve area\r\n\r - Gradient\r\n\r - Info from previous cardiac cath (if done):\r\n\r - Presence/absence of coronary stenosis\r\n\r - Location and degree of stenosis\r\n\r - Aortic valve area\r\n\r - Calculation of valve area\r\n\r - Info from previous ECG:\r\n\r - Rhythm\r\n\r - LVH\r\n\r - Medications\r\n\r - Laboratory data:\r\n\r - Lipids\r\n\r - Chemistries\r\n\r - CBC\r\n\r - HgA1C\r\n\r - Troponin\r\n\r - BNP\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18 or greater\r\n\r - Patients with known BAV diagnosed by echocardiography, previous MRI, or cardiac CT\r\n\r - Scheduled for cardiac MRI or have had a cardiac MRI within the past year\r\n\r - Able to provide informed consent\r\n\r - Ambulatory and expected to be able to complete 6 minute walk test\r\n\r Exclusion Criteria:\r\n\r - Patients without BAV\r\n\r - Patients who have already had surgery for aortic valve problems and/or aortopathy\r\n\r - Unable to complete 6 minute walk test (ex. Wheelchair bound)\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"
}
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definitely relevant
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{
"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\nSurgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3\r valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis\r (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed\r inoperable due to the extent of calcification.\n\n**Clinical Trial Detailed Description:**\n\nTechnical Success:\r\n\r Alive, with\r\n\r - Successful access, delivery and retrieval of the device delivery system, and\r\n\r - Deployment and correct positioning (including repositioning/recapture if needed) of the\r single intended device, and\r\n\r - No need for additional unplanned or emergency surgery or re-intervention related to the\r device or access procedure\r\n\r Device Success:\r\n\r Alive and stroke free, with\r\n\r - Original intended device in place, and\r\n\r - No additional surgical or interventional procedures related to access or the device\r since completion of the original procedure (i.e., exit from the cath lab/Operating\r Room(OR)), and\r\n\r - Intended performance of the device:\r\n\r - Structural performance: No migration, embolization, detachment, fracture,\r hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and\r\n\r - Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without\r producing the opposite (Stenosis = Mitral Valve Area (MVA) < 1.5cm2 and Mitral\r Valve (MV) gradient > 5mmHg, Insufficiency = Mitral Regurgitation (MR) >1+), and\r\n\r - Absence of para-device complications (e.g., Paravalvular Leak (PVL) > mild, need\r for a Permanent Pacemaker (PPM), erosion, Annular rupture or Aortic Valve (AV)\r Groove disruption, Left Ventricular Outflow Tract (LVOT) gradient increase >\r 10mmHg)\r\n\r Procedural Success:\r\n\r Device success, and\r\n\r - No device or procedure related Serious Adverse Events (SAEs) (Life threatening bleed;\r major vascular or cardiac structural complications requiring unplanned reintervention or\r surgery; stage 2 or 3 Acute Kidney Injury (includes new dialysis); Myocardial Infarction\r (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft\r (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope,\r ultrafiltration or mechanical circulatory support; prolonged intubation ( > 48 hours)\r\n\r 6.2 Secondary objective(s)\r\n\r Device Success (at 6 months and 1 year)\r\n\r - Subject success 1 year\r\n\r Device Success:\r\n\r Alive and stroke free, with\r\n\r - Original intended device in place, and\r\n\r - No additional surgical or interventional procedures related to access or the device\r since completion of the original procedure (i.e., exit from the cath lab/Operating Room\r (OR)), and\r\n\r - Intended performance of the device:\r\n\r - Structural performance: No migration, embolization, detachment, fracture,\r hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and\r\n\r - Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without\r producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg,\r Insufficiency = MR >1+), and\r\n\r - Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion,\r Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject has severe native mitral annular calcification associated with mitral stenosis\r and/or regurgitation. Qualifying echo must be within 60 days of the date of the\r procedure.\r\n\r - Subject has a clinical indication for mitral valve replacement, as demonstrated by\r reported New York Heart Association (NYHA) Functional Class II or greater.\r\n\r - The subject is at least 22 years old.\r\n\r - The Heart Team agrees that the subject is high risk or inoperable for surgical mitral\r valve repair or replacement (MVR), based on a conclusion that the probability of death\r or serious, irreversible morbidity exceeds the probability of meaningful improvement.\r The following concomitant procedures, are allowed: MAZE, Tricuspid Valve Procedures\r (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and\r septal myectomy.\r\n\r - The study subject 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) of the respective clinical site.\r\n\r - The study subject agrees to comply with all required post-procedure follow-up visits\r\n\r Exclusion Criteria:\r\n\r - Evidence of an acute myocardial infarction (MI) ≤ 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 - Any therapeutic invasive cardiac procedure resulting in a permanent implant that is\r performed within 30 days of the index procedure (unless part of planned strategy for\r treatment of concomitant coronary artery disease).\r\n\r - Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8\r g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL).\r\n\r - Hemodynamic or respiratory instability requiring vasoactive medications, mechanical\r ventilation at time of procedure.\r\n\r - Need for emergency surgery for any reason.\r\n\r - Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) <\r 30%.\r\n\r - Severe right ventricular dysfunction\r\n\r - Pregnancy, lactation, or planning to become pregnant\r\n\r - Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active\r infective endocarditis.\r\n\r - Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without\r treatment or 30 days prior to procedure with definitive treatment.\r\n\r - A known contraindication or hypersensitivity to all anticoagulation regimens, or\r inability to be maintained on oral anticoagulant following the study procedure.\r\n\r - End stage renal disease requiring dialysis\r\n\r - Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic\r attack (TIA) within 30 days of the procedure.\r\n\r - Estimated life expectancy < 12 months\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"
}
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possibly relevant
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613
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[
{
"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 Plasma Serotonin and Aortic Stenosis: a Pilot Study.\n\n**Clinical Trial Summary:**\n\nThe goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine\r (5-HT) in patient with increased severity of aortic stenosis and increased weight cardiac\r muscle.\n\n**Clinical Trial Detailed Description:**\n\nCalcific aortic stenosis is the most frequent valve disease in adults. Without therapeutic\r strategy, this disease leads to heart failure and death. Surgical aortic valve replacement is\r now a well tolerated cardiac surgery leading to excellent outcomes. Until recently, calcific\r aortic stenosis was considered to be histopathologically degenerative or passive in origin.\r It is now recognized, however, as a complex cellular process with features of\r atherosclerosis. It has been observed that drugs may slow dawn the progression of aortic\r stenosis in observational studies.\r\n\r It has been suggested that serotonin, a monoamine neurotransmitter and a peripheral signal\r mediator, may be involved in the progression of aortic stenosis and also in its consequences\r on myocardium hypertrophy.\r\n\r In the blood, serotonin in mainly stored in platelets, which release serotonin involved in\r post-injury vasoconstriction, thrombus formation, fibrosis and atherogenesis.\r\n\r This study hypothesized those patients with aortic stenosis exhibit higher circulating\r serotonin levels than their counterparts without heart disease. In addition to circulating\r serotonin, its metabolite 5-HIAA will be systematically measured on all patients.\r\n\r This study would allow to determine the potential of plasma serotonin as a prognosis marker\r and perhaps suggest the discovery of new targets for treatment of aortic stenosis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Group 1 : non aortic stenosis\r\n\r - Goup 2, 3 and 4 : aortic stenosis\r\n\r Exclusion Criteria:\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
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614
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[
{
"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 Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether nitric oxide is effective in the treatment\r of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting\r endothelial dysfunction undergoing prolonged cardiopulmonary bypass.\n\n**Clinical Trial Detailed Description:**\n\nI. SUBJECT ENROLLMENT\r\n\r 1. Methods of enrollment, including procedures for patient registration. Patients will be\r screened in the \"Cardiac surgery pre-operative clinic\", Massachusetts General Hospital\r (MGH) Cox building floor 6 (before surgery). If the patient is eligible and after\r obtaining the consent of the primary cardiac surgeon, the patient will be approached for\r consent to participate in this clinical trial. Consent will be obtained exclusively from\r the patient, and not from a surrogate, because cardiac surgery is usually a scheduled\r procedure. The obtaining of the consent directly from the patient is preferred, since\r there will be the opportunity of interaction with the patient when he/she is fully\r awake. After consent is obtained, the patient will be randomized to the study group. A\r de-identified code will be assigned to the patient and registered on a dedicated\r enrollment log.\r\n\r 2. Procedures for obtaining informed consent (including timing of consent process).\r Patients will be screened in the \"Cardiac surgery pre-operative clinic\", MGH Cox\r building floor 6 (before surgery). If a patient is eligible for the study and after\r obtaining the consent of the primary cardiac surgeon, the patient will be approached to\r consent to participate in the clinical trial. There is no need for surrogate consent for\r this trial, as explained above. Signing the Informed Consent Form will be requested for\r participation in the study. Personal Medical Information (PMI) will be accessed by the\r investigator(s) only for study purposes. Patients who choose not to participate in this\r study will receive standard care according to the procedures of the ICU, without any\r repercussion.\r\n\r 3. Treatment assignment and randomization (if applicable). To ensure a robust and unbiased\r approach, randomization should account for demographic characteristics of the patients\r (i.e.: age, sex) and glomerular filtration rate (GFR). Only patients who are cared for\r by experienced anesthesiologists and cardiac surgeons (more than 5 years of staff\r experience) will participate in this study. The patients will be randomized to receive\r either NO (study drug) or N2 (placebo) alone. In order to account for an elevated\r baseline pulmonary artery pressure, patients with pre-operative mean PAP ≥30 mmHg will\r be allocated equally to the two groups during the stratified randomization process. The\r random allocation sequence will be created using a computerized random generation\r program. The randomization will be in blocks of 10 patients. The intervention will\r consist of administering the test gas via the cardiopulmonary bypass (CPB) machine and\r after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and\r thereafter via the mechanical ventilator in the Intensive Care Unit (ICU). When patients\r are extubated they will breathe test gas via a facemask or nasal prongs. Test gas\r administration will commence at the onset of CPB and last for 24 hours. At the end of 24\r hours, inhaled NO (iNO) will be weaned and discontinued while carefully monitoring\r hemodynamics for a period of 2-4 hours. Local guidelines for NO gas discontinuation will\r be followed. Using commercially available tanks of Nitric Oxide (Airgas Inc, Radnor\r Township, Pennsylvania) or volumetrically-calibrated flowmeters, pure N2 (placebo) or\r 850 ppm NO gas in N2 will be mixed with pure oxygen (O2) or air to obtain the desired\r concentration of O2 and, in the NO treatment group, a final concentration of 80 ppm NO.\r For safety, nitric oxide, nitrogen dioxide (NO2), O2 and methemoglobin (Met-Hb) levels\r will be continuously monitored by the personnel unblinded to the study. Patients in the\r placebo (N2) group will receive nitrogen test gas during the same 24 hour-period. The\r inspired oxygen levels will be maintained at the usual levels required for routine\r post-operative care. No changes to the usual and customary standards of care for any\r intraoperative or postoperative treatment will be made during the study period.\r\n\r 4. Blinding procedure for Nitric Oxide and Nitrogen delivery. A double-blind study will be\r performed to avoid potential patient and investigator bias, the study is blinded to:\r participants, perfusionists, surgeons, anesthesiologists, ICU physicians and the nursing\r staff. The test gas tank and the gas delivery system in the operating room (OR) and at\r the bedside will be masked. The respiratory therapist in the ICU and a member of the\r study staff will be unblinded and will prepare the appropriate test gas tanks and NO/N2\r meters. Blood Met-Hb levels and NO/NO2 concentrations are safety concerns that the\r respiratory therapist and one member of the study staff will monitor and regulate (NO2\r levels will be maintained below 5 ppm, and Met-Hb below 5%, if necessary by reducing NO\r concentration to 40 ppm or less according to MGH guidelines NO therapy).\r\n\r II. STUDY PROCEDURES a. Study visits and parameters to be measured (e.g., laboratory tests,\r x-rays, and other testing). SCREENING visit: Screening will take place in the \"Cardiac\r surgery pre-operative clinic\", MGH Cox building floor 6 (before surgery). Patients will be\r screened if they require prolonged CPB (>90 minutes on CPB, i.e., valve replacement ±\r coronary artery bypass grafting (CABG)) and if the primary cardiac surgeon of the patient\r agrees on enrolling the patient in the study.\r\n\r Screening consists of:\r\n\r - Review eligibility entry criteria of the study: inclusion/exclusion criteria will be\r reviewed.\r\n\r - Review the research protocol: This is a protected time for the subject to ask questions\r and become familiar with all aspects of the study protocol.\r\n\r - Administration of a brief questionnaire to determine endothelial function with the\r subject verbal assent on the day of pre-surgical evaluation. The questionnaire evaluates\r medical history, integrating clinical and laboratory data of screened patients. In males\r > 40 year old and females > 50 year old, endothelial dysfunction has been shown to be\r associated with at least one the following criteria: Previous coronary artery bypass\r graft or PTCA (+ stent); History or presence of intermittent claudication; Critical limb\r ischemia, or peripheral vascular disease with the Exception of vasculitis; History of\r transient ischemic attack and/or ischemic stroke; Diagnosis of diabetes (IDDM or NIDDM)\r requiring oral hypoglycemic agents or insulin; Hypercholesterolemia (total cholesterol >\r 200 mg/dl or LDL > 160 mg/dl) treated with statins, ion- exchange resins or other oral\r agents; BMI > 40; Hypertension (SBP 140 ≥ mmHg) treated with antihypertensive drugs;\r Active smoking ≥ 10 pack - years\r\n\r - Consent form: The subject will be asked to sign the consent form.\r\n\r Laboratory tests will be reviewed by the same physician, and if inclusion/exclusion criteria\r are met, subjects will be enrolled.\r\n\r RANDOMIZATION. Patients will be randomly allocated to one of the test gas study groups\r (inhaled 80 parts per million (ppm) nitric oxide in nitrogen) or the placebo group (inhaled\r N2). The intervention will consist of giving the test gas both via the CPB machine and after\r CPB via the anesthetic circuit, and thereafter via the mechanical ventilator and/or with face\r mask/nasal prongs in the ICU/ward. Test gas administration will commence at the onset of CPB\r and last for 24 hours. At the end of 24 hours, iNO will be weaned and discontinued while\r carefully monitoring hemodynamics for a period of 2-4 hours. Local guidelines for iNO\r discontinuation will be adopted. Using an Inovent (Ikaria Inc, N.J., USA) or\r volumetrically-calibrated flowmeters, pure nitrogen (placebo) or 850 ppm NO gas in N2 is\r mixed with pure O2 or air to obtain a final concentration of 80 ppm NO. During CPB the test\r gas is delivered through the extracorporeal oxygenator, after CPB the NO is delivered through\r the inspiratory limb of the anesthetic or ventilator circuit. NO, NO2 and O2 and\r methemoglobin levels are monitored by an unblinded observer. Patients in the placebo group\r will receive nitrogen test gas during the same 24 hour-period. When patients are extubated\r they will breathe test gas via a face mask or nasal prongs. The inspired oxygen levels will\r be maintained at the usual levels required for routine post-operative care. The test gas tank\r in the OR and at the bedside will be covered and blinded from the clinicians treating the\r patient. Only the respiratory therapist in the ICU and a member of the study staff will be\r unblinded and will prepare the appropriate test gas tanks and NO/N2 meters. No changes to the\r usual and customary standards of care for any intraoperative or postoperative treatments will\r be made during the study period.\r\n\r III. MONITORING AND QUALITY ASSURANCE\r\n\r 1. Independent monitoring of source data. Informed consent forms, case report forms, and\r data will be reviewed by the principal investigator following enrollment of every 5\r subjects and an independent data and safety monitor following enrollment of every 50\r subjects to the protocol to ensure safety of the study subjects. The safety data that\r will be reviewed includes: patient-, nurse-, research-assistant, or\r investigator-reported adverse events such as reason for early termination of the\r protocol, or adverse reaction to NO. Other data to be reviewed includes appropriate\r handling and processing of blood samples and maintenance of patient confidentiality\r throughout the study.\r\n\r 2. Safety monitoring (e.g., Data Safety Monitoring Board, etc.). An interim analysis by a\r Data Safety management Board (DSMB) comprised of 3 members is planned at reaching 50% of\r the study population (125 patients enrolled). The study will only be stopped if the\r interim analysis detects a significant increase of mortality, acute kidney injury (AKI),\r need for renal replacement therapy (RRT), myocardial infarction (MI), post-operative\r hemorrhage, other significant morbidity in the NO test gas group.\r\n\r Members of the Data Safety Management Board (DSMB) consist of an anesthesiologist with\r clinical expertise in NO, a cardiologist and a nephrologist.\r\n\r 3. Outcomes monitoring. Plasma creatinine will be measured daily until day 7 after CPB or\r until discharge from the hospital if this occurs earlier. Urine output will be assessed\r until day 7 after CPB or until discharge from the hospital if this occurs earlier.\r Follow up will be completed at 1 year after surgery as described in \"V. Study\r procedure\".\r\n\r 4. Adverse event reporting guidelines. The principal investigator will review any adverse\r events immediately following their occurrence and report them to the Institutional\r Review Board (IRB) in accordance with Partners Investigator guidelines. Specifically,\r for this study, serious adverse events will be reported by phone, fax, or email within\r 24 hours to the Human Research Committee (HRC), followed by a full written report within\r 10 business/14 calendar days. Mild or moderate adverse events will be presented in\r progress reports at continuing reviews.\r\n\r Stopping rules. The review and decision regarding altering or stopping the protocol will be\r performed by the principal investigator together with the DSMB. Mild or moderate adverse\r events will be presented in progress reports at continuing reviews. Protocol exit criteria\r will be:\r\n\r 1. Acute worsening hypotension: decrease in mean blood pressure of > 20 mmHg not\r attributable to other causes, i.e., hypovolemia, hemorrhage, sepsis, acute heart\r failure.\r\n\r 2. Sudden worsening of hypoxemia: decrease of peripheral oxygen saturation (SatO2) < 70% at\r 100% of inspiratory oxygen fraction (FiO2) not attributable to other causes, i.e.,\r pulmonary edema, acute respiratory distress syndrome (ARDS), pulmonary embolism.\r\n\r 3. An increase in NO2 levels > 5 ppm from baseline or any life-threatening symptom\r potentially attributed to NO administration by the physician investigator.\r\n\r IV. BIOSTATISTICAL ANALYSIS\r\n\r a. Specific data variables being collected for the study\r\n\r Preoperative collection of patient data from the MGH electronic medical chart (EPIC) will\r include:\r\n\r - Patient demographics\r\n\r - Past and current medical and surgery history and therapy\r\n\r - Co-morbidities\r\n\r - Pertinent cardiopulmonary test results: i.e., echocardiography, cardiac catheterization,\r pulmonary function tests, and chest imaging).\r\n\r Prospective collection of patient data will include:\r\n\r - ICU and length of hospital stay\r\n\r - Duration of mechanical ventilation\r\n\r - Hospital course\r\n\r - Intrahospital mortality and mortality at 6 weeks, 90 days and 1 year after cardiac\r surgery.\r\n\r - Activity of daily living at and postoperative health related quality of life (PROMIS\r questionnaire for global health) at 6 weeks, 90 days and 1 year after surgery.\r\n\r - Nonfatal stroke before surgery and at 6 weeks after surgery\r\n\r - Perioperative and non-perioperative nonfatal myocardial infarction, as defined by the\r third universal definition of MI released in 2012 by the European Society of Cardiology\r (ESC)/American College of Cardiology Foundation (ACCF)/American Heart Association\r (AHA)/World Heart Federation (WHF)\r\n\r - Renal failure requiring dialysis at any time during hospitalization and at 6 weeks, 90\r days and 1 year after cardiac surgery.\r\n\r - Acute Kidney Injury as difened by KDIGO criteria.\r\n\r - Organ dysfunction assessed daily in ICU by using Sequential organ failure assessment\r (SOFA).\r\n\r - Delirium assessed daily in the first 7 days after surgery by using the confusion\r assessment method for intensive care unit (CAM-ICU).\r\n\r - Cardiovascular support: vasopressors and inotropic agents requirement\r (Vasoactive-inotropic score), need for balloon pump or ventricular-assist device.\r\n\r - Post-operative infections, cardiac arrhytmias and non cardiac complications.\r\n\r Samples to be collected:\r\n\r 1. Blood samples will be collected before surgery, at the end of surgery, each day until\r day 7 after the cardiac procedure or until hospital discharge if before day 7, and at 6\r weeks. The samples will be tested for: creatinine (after surgery, 24 hours after the end\r of CPB, 48 hours after the end of CPB, POD3, POD4, POD5, POD6, POD7 and 6 weeks) and\r biomarkers for kidney injury (immediately before CPB, 15 minutes after the end of CPB,\r 24 hours after the end of CPB, 48 hours after the end of CPB and at 6 weeks). Urine\r samples will be collected for urinary biomarkers of kidney injury immediately before\r CPB, 15 minutes after the end of CPB, 24 hours after the end of CPB, 48 hours after the\r end of CPB and at 6 weeks.\r\n\r 2. Statistical methods. The primary aim of this study is to determine whether\r supplementation with NO decreases the incidence of AKI in patients with signs and\r symptoms suggesting endothelial dysfunction. A total of 250 cardiac-surgery patients\r will be enrolled, requiring more than 90 minutes of CPB. The two arms will be compared\r for homogeneity of baseline characteristics (age, weight, sex, and GFR), intraoperative\r course (CPB time, amount of blood transfusions) and postoperative data (post-operative\r transfusions, adverse events directly related to surgery procedures). To examine\r differences between the two groups, we will use an unpaired Student's t-test for\r continuous variables with a normal distribution, a Mann-Whitney U test for continuous\r variables that are not normally distributed and a Fisher's exact test for dichotomous\r variables. Continuous variables will be described as mean±standard deviation (SD) when\r normally distributed, median with interquartiles (IQR) when not normally distributed, or\r count (%) if a dichotomous variable. The change in the laboratory markers over time and\r between the two groups will be tested with a repeated measures ANOVA. The incidence of\r AKI and postoperative adverse events after prolonged CPB will be described in terms of\r relative risk with significance level and confidence intervals for the two groups. Based\r on the occurrence of missing data, the strategy to manage them will be decided. However,\r our aim would be not to use any kind of imputation.\r\n\r 3. Power analysis. The sample size of this trial was calculated based on the primary\r endpoint: the reduction of AKI incidence. Despite we do not have track incidence, AKI is\r very common in our MGH patients after open-heart surgery, and it is reasonable to assume\r that AKI incidence is similar to those recent reports from US and European studies at\r major academic centers CPB (AKI incidence has been reported to be between 50 to 60%). In\r our prior trial on NO in cardiac surgery, the sample size was calculated to find a 30%\r reduction in the incidence of AKI (n=212 in that trial). We estimate a greater (35%)\r reduction in the incidence of AKI because we anticipate that this population with signs\r and symptoms of endothelial dysfunction will be more affected by the beneficial\r therapeutic properties of NO. Thus, in the NO group the incidence of AKI is expected to\r decrease from 55% to 35.75%. The sample size needed to detect a difference, assuming an\r alpha error of 0.05 (two-sided test) and a study power of 0.8, is 114 patients per\r group. In order to account for possible dropouts, we increased our sample size by 10%.\r We will enroll 250 patients, 125 in the NO group and 125 patients in the control (N2)\r group.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Provide written informed consent\r\n\r 2. Age ≥ 18 years of age\r\n\r 3. Elective cardiac or aortic surgery with CPB>90 minutes\r\n\r 4. Stable pre-operative renal function without evidence of plasma creatinine level\r increase of ≥ 0.3 mg/dL over the prior 3 months and without renal replacement therapy\r (RRT).\r\n\r 5. Clinical evidence of endothelial dysfunction assessed by a specifically designed\r questionnaire.\r\n\r Exclusion Criteria:\r\n\r 1. eGFR less than 30 ml/min/1.73 m2\r\n\r 2. Emergent cardiac surgery.\r\n\r 3. Life expectancy < 1 year at the time of enrollment.\r\n\r 4. Hemodynamic instability as defined by a systolic blood pressure <90 mmHg.\r\n\r 5. Mean pulmonary artery pressure ≥ 40 mm Hg and PVR > 4 Wood Units.\r\n\r 6. Left ventricular ejection fraction < 30% by echocardiography obtained within three\r months of enrollment\r\n\r 7. Administration of one or more Packed Red Blood Cells (RBCs) transfusion in the week\r prior to enrollment.\r\n\r 8. X-ray contrast infusion less than 48 hours before surgery.\r\n\r 9. Evidence of intravascular or extravascular hemolysis from any other origin:\r\n\r i. Intravascular: Intrinsic RBCs defects leading to hemolytic anemia (eg, enzyme\r deficiencies, hemoglobinopathies, membrane defects). Extrinsic: liver disease,\r hypersplenism, infections (eg, bartonella, babesia, malaria), treatment with oxidizing\r exogenous agents (eg, dapsone, nitrites, aniline dyes), exposure to other hemolytic\r agents (eg, lead, snake and spider bites), lymphocyte leukemia, autoimmune hemolytic\r disorders.\r\n\r ii. Extravascular: Infection (eg, clostridial sepsis, severe malaria), paroxysmal cold\r hemoglobinuria, cold agglutinin disease, paroxysmal nocturnal hemoglobinuria, iv\r infusion of Rho(D) immune globulin, iv infusion of hypotonic solutions.\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\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"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."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nTransfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA\n\n**Clinical Trial Summary:**\n\nTo evaluate the safety and performance of the HLT System in patients with severe aortic\r stenosis who present at high risk for aortic valve replacement surgery.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. 70 years of age or older\r\n\r 2. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis\r with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve\r gradient >40 mmHg or peak aortic valve velocity >4 m/sec\r\n\r 3. Symptomatology due to 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 4. Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or\r perimeter\r\n\r 5. STS score of ≥8, or documented heart team agreement of high risk for surgical aortic\r valve replacement (SAVR) due to frailty or comorbidities.\r\n\r 6. Geographically available, willing to comply with follow up and able to provide written\r informed consent\r\n\r Exclusion Criteria:\r\n\r 1. Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve\r eccentricity (calcific or otherwise) that in the opinion of the investigator could\r compromise procedural success.\r\n\r 2. Patients at high risk for coronary obstruction in the opinion of the investigator\r (e.g. combination of a coronary height < 12 mm and coronary sinus diameter < 30 mm)\r\n\r 3. Patients with low flow/low gradient aortic stenosis\r\n\r 4. Patients with significant annular calcification (e.g. Agatston score > 4000)\r\n\r 5. Pre-existing prosthetic heart valve in any position, or prosthetic ring\r\n\r 6. Severe aortic, mitral or tricuspid valve regurgitation\r\n\r 7. Moderate to severe mitral stenosis\r\n\r 8. Myocardial infarction within the past 30 days*\r\n\r 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\r\n\r 10. LVEF < 30%\r\n\r 11. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds\r of systemic pressure\r\n\r 12. Hemodynamic instability requiring inotropic drug therapy within the past 14 days\r\n\r 13. Untreated clinically significant coronary artery disease requiring revascularization\r\n\r 14. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which,\r in the opinion of the investigator, precludes safe implant delivery\r\n\r 15. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia,\r history of bleeding diathesis or coagulopathy\r\n\r 16. Patient ineligible for or refuses blood transfusions\r\n\r 17. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive\r calcification, severe tortuosity or vessels < 6 mm) that would preclude passage of\r catheters from the femoral arterial access to the aorta as evidenced by peripheral\r MSCT\r\n\r 18. Active peptic ulcer or gastrointestinal bleeding within the past 90 days*\r\n\r 19. Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic\r attack) within past 6 month, or treatment of carotid stenosis within past two months*\r\n\r 20. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage\r renal disease requiring chronic dialysis\r\n\r 21. Active infection requiring ongoing treatment\r\n\r 22. Need for emergent surgery or intervention other than the investigational procedure\r\n\r 23. Any therapeutic invasive cardiac procedure performed or planned to perform within 30\r days of the index procedure except for PCI which is within 7 days of the index\r procedure*\r\n\r 24. Hypersensitivity or contraindication to procedural medication and device materials\r (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated\r\n\r 25. Life expectancy < 1 year due to non-cardiac co-morbid conditions\r\n\r 26. Currently participating in any investigational drug or device studies that may\r confound the results of this study\r\n\r 27. History of any cognitive or mental health status that would interfere with study\r participation * At the time of procedure, if a subject's medical status has changed\r since enrollment, the subject shall be re-evaluated for eligibility.\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\"."
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[
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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616
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"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\nOpen-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the effect of perhexiline on exercise performance\r (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe\r heart failure following dosing for 16 weeks.\n\n**Clinical Trial Detailed Description:**\n\nPatients with hypertrophic cardiomyopathy and symptoms without severe outflow obstruction\r will be eligible to participate. Enrollment will be limited to subjects who are unable to\r attain 75% of their maximum predicted MVO2 at cardiopulmonary exercise testing. Subjects with\r genetic evidence of CYP2D6 poor metabolizer status will be excluded.\r\n\r Subjects will undergo functional testing at baseline with CPEX testing and 6 minute walk\r distance testing. They will begin perhexiline orally, and the dose will be adjusted according\r to plasma level testing. For the first 8 week period, the target therapeutic range will be\r 100-300 ng/mL, and for the second 8 week period, the range will be 300-500 ng/mL. Functional\r testing will be repeated at the end of both periods.\n\n**Clinical Trial Eligibility Criteria:**\n\nKey Inclusion Criteria:\r\n\r - Hypertrophic cardiomyopathy with symptoms of moderate-to-severe heart failure\r\n\r - Left ventricular hypertrophy with maximum LV wall thickness ≥ 15 mm\r\n\r - Left ventricular ejection fraction ≥ 50%\r\n\r - Able to perform exercise testing but unable to exceed 75% of the predicted\r age-adjusted maximum level\r\n\r Key Exclusion Criteria:\r\n\r - CYP2D6 Poor Metabolizer (PM) status\r\n\r - History of a known chronic liver disease\r\n\r - ALT, AST, alkaline phosphatase, or LDH > 1.5 x upper limit of normal\r\n\r - Total Bilirubin > 2.0 x upper limit of normal\r\n\r - Severe LV outflow obstruction\r\n\r - Asymptomatic patients or cardiomyopathy-related criteria as per protocol\r\n\r - QT interval related criteria as per protocol\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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617
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[
{
"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\nCombination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations\n\n**Clinical Trial Summary:**\n\nThis randomized phase III trial studies how well combination chemotherapy works in treating\r young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come\r back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase\r inhibitor (TKI) sensitive mutations. Chemotherapy drugs, work in different ways to stop the\r growth of cancer cells, either by killing the cells, by stopping them from dividing, or by\r stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving\r the drugs in different doses and in different combinations may kill more cancer cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine if the administration of post-Induction age-adjusted intrathecal triple\r therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance high-dose\r methotrexate (IMHDM) backbone will improve 5-year disease-free survival (DFS) of children\r with high-risk (HR) B-acute lymphoblastic leukemia (ALL) compared to age-adjusted intrathecal\r (IT) methotrexate (MTX). (Completed effective March 19, 2018) II. To determine, in a\r randomized fashion, if the cyclophosphamide + etoposide containing regimen (Experimental Arm\r 1) will improve the 4-year DFS of children, adolescents, and young adults with very high-risk\r (VHR) B-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (Control\r Arm). (Completed effective February 15, 2017)\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To determine the toxicity and tolerability of post-Induction age-adjusted ITT compared to\r age-adjusted IT MTX in children with HR B-ALL. (Completed effective March 19, 2018) II. To\r determine the toxicity and tolerability of Experimental Arm 1 compared to the Control Arm in\r children, adolescents, and young adults with VHR B-ALL. (Completed effective February 15,\r 2017) III. To determine whether a single-arm, modified Induction with limited anthracycline\r exposure and post-Induction therapy regimen with MBFM-interim maintenance intermediate dose\r methotrexate (IMIDM) and reduced vincristine (vincristine sulfate)/steroid pulse frequency\r and enhanced supportive care in children with Down syndrome (DS) and HR B-ALL will result in\r a >= 65% 5-year DFS and < 10% Induction mortality.\r\n\r IV. To describe the outcomes for children and young adults with Philadelphia chromosome\r (Ph)-like B-ALL and a predicted TKI-sensitive mutation treated with dasatinib plus\r MBFM-IMHDM.\r\n\r V. To determine the toxicity and tolerability of MBFM-IMIDM in children with DS and HR B-ALL.\r\n\r VI. To estimate overall survival (OS) rates both overall and by regimen a) for HR B-ALL and\r b) VHR B-ALL patients.\r\n\r VII. To determine the incidence of osteonecrosis (ON), defined by magnetic resonance (MR)\r imaging, and to characterize the natural history of clinically silent ON in children,\r adolescents, and young adults 10 years of age and greater and to assess the role of drugs\r (i.e., asparaginase and methotrexate) in addition to corticosteroids, in the risk for\r development of ON. (Completed accrual July 2016) VIII. To determine if the prevalence of\r cognitive deficits measured by CogState, in children (ages 6 to < 13 years) with HR- and VHR\r B-ALL at 1 year off therapy, is significantly higher than the normative population (> 14%) in\r the following domains: working memory, executive function, visual motor, processing speed,\r and visual attention.\r\n\r EXPLORATORY OBJECTIVE:\r\n\r I. To determine if the reduction of minimal residual disease (MRD) from end-Induction to\r end-Consolidation is greater for children, adolescents, and young adults with VHR B-ALL\r receiving Experimental Arm 1 compared to the Control Arm. (Closed effective October 20, 2017)\r\n\r OUTLINE:\r\n\r INDUCTION THERAPY:\r\n\r Patients without Down syndrome receive induction chemotherapy comprising cytarabine\r intrathecally (IT) on day 1 (and twice weekly thereafter for CNS2 patients [except for days 8\r and 29]); vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, and 22;\r daunorubicin hydrochloride IV over 1-15 minutes on days 1, 8, 15, and 22; dexamethasone\r orally (PO) or IV twice daily (BID) on days 1-14 (patients under 10 years old) or prednisone\r PO or IV BID on days 1-28 (patients at least 10 years old); pegaspargase IV over 1-2 hours on\r day 4; and methotrexate IT on days 8 and 29 for CNS1 and CNS2 patients (plus days 15 and 22\r for CNS3 patients). Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r Participants are stratified to 1 of 3 disease groups: HR B-ALL, VHR B-ALL and PH-like B-ALL a\r predicted TKI-sensitive mutation.\r\n\r GROUP I - HR B-ALL: Patients are randomized to 1 of 2 treatment arms. (RANDOMIZATION CLOSED\r 03/19/2018)\r\n\r CONSOLIDATION THERAPY (C):\r\n\r ARM A HR B-ALL C: Patients receive consolidation therapy comprising cyclophosphamide IV over\r 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or subcutaneously (SC) on\r days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42,\r methotrexate IT on days 1, 8, 15, and 22; vincristine sulfate IV over 1 minute on days 15,\r 22, 43, and 50; and pegaspargase IV over 1-2 hours on days 15 and 43. Patients with\r continuing clinical evidence of testicular leukemia undergo radiotherapy (RT) QD, 5 days a\r week, for approximately 2½ weeks (12 fractions total). Treatment continues for 56 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r ARM B HR B-ALL C: Patients receive consolidation therapy as in Arm I HR B-ALL C. Patients\r also receive ITT comprising methotrexate, hydrocortisone sodium succinate, and cytarabine on\r days 1, 8, 15, and 22. Patients with testicular leukemia also undergo RT as in Arm I HR B-ALL\r C. (CLOSED 03/19/2018)\r\n\r INTERIM MAINTENANCE THERAPY (IM) ARM A HR B-ALL IM: Patients receive IM therapy comprising\r vincristine sulfate IV over 1 minute on days 1, 15, 29, and 43; high-dose methotrexate IV\r over 24 hours on days 1, 15, 29, and 43; leucovorin calcium PO or IV on days 3-4, 17-18,\r 31-32, and 45-46; methotrexate IT on days 1 and 29; and mercaptopurine PO on days 1-56.\r Treatment continues for 63 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r ARM B HR B-ALL IM: Patients receive ITT on days 1 and 29 and IM therapy as in Arm I HR-ALL\r IM. Treatment continues for 63 days in the absence of disease progression or unacceptable\r toxicity. (CLOSED 03/19/2018)\r\n\r DELAYED INTENSIFICATION THERAPY (DI):\r\n\r ARM A HR B-ALL DI: Patients receive DI therapy comprising vincristine sulfate IV over 1\r minute on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-7 and 15-21;\r doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; methotrexate IT on days\r 1, 29, and 36; pegaspargase IV over 1-2 hours on days 4 and 43; cyclophosphamide IV over\r 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and\r thioguanine PO QD on days 29-42. Treatment continues for 56 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r ARM B HR B-ALL DI: Patients receive ITT on days 1, 29, and 36 and DI therapy as in Arm I HR\r B-ALL DI. (CLOSED 03/19/2018)\r\n\r MAINTENANCE THERAPY (M):\r\n\r ARM A HR B-ALL M: Patients receive maintenance therapy comprising vincristine sulfate IV over\r 1 minute on days 1, 29, and 57; methotrexate IT on day 1 (also day 29 of courses 1-4);\r prednisone PO BID on days 1-5, 29-33 (may receive methylprednisolone IV if PO is not\r tolerated), and 57-61; mercaptopurine PO QD on days 1-84; and methotrexate PO on days 8, 15,\r 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 2 years\r (females) or 3 years (males) in the absence of disease progression or unacceptable toxicity.\r\n\r ARM B HR B-ALL M: Patients receive ITT on day 1 (also day 29 of courses 1-4) and maintenance\r therapy as in Arm I HR B-ALL M. Treatment repeats every 12 weeks for 2 years (females) or 3\r years (males) in the absence of disease progression or unacceptable toxicity. (CLOSED\r 03/19/2018)\r\n\r GROUP II: VHR B-ALL: Patients are randomized to 1 of 3 treatment arms. (RANDOMIZATION CLOSED\r 02/15/2017)\r\n\r CONSOLIDATION THERAPY PART I: In all arms, patients receive cyclophosphamide IV over 30-60\r minutes on day 1; cytarabine IV over 1-30 minutes or SC on days 1-4 and 8-11; mercaptopurine\r PO QD on days 1-14; methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3\r patients); vincristine sulfate IV over 1 minute on days 15 and 22; and pegaspargase IV over\r 1-2 hours on day 15. Patients with continuing clinical evidence of testicular leukemia\r undergo RT QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment\r continues for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r CONSOLIDATION THERAPY PART II:\r\n\r ARM A VHR B-ALL C (CONTROL ARM): Patients receive consolidation therapy comprising\r cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on\r days 29-32 and 36-39; mercaptopurine PO QD on days 29-42; vincristine sulfate IV over 1\r minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues\r for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r ARM B VHR B-ALL C (EXPERIMENTAL ARM 1): Patients receive consolidation therapy comprising\r cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on\r days 29-33; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over\r 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or\r unacceptable toxicity. (CLOSED 02/15/2017)\r\n\r ARM C VHR B-ALL C (EXPERIMENTAL ARM 2): Patients receive clofarabine IV over 2 hours on days\r 29-33 and consolidation therapy as in Arm B VHR B-ALL C. (CLOSED 9/12/2014)\r\n\r INTERIM MAINTENANCE THERAPY PART I: In all arms, patients receive vincristine sulfate IV over\r 1 minute on days 1, 15, 29, and 43; high-dose methotrexate IV over 24 hours on days 1, 15,\r 29, and 43; leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46; mercaptopurine\r PO QD on days 1-56; and methotrexate IT on days 1 and 29. Treatment continues for 63 days in\r the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY PART I: In all arms, patients receive vincristine sulfate IV\r over 1 minute on days 1, 8, and 15; dexamethasone PO or IV BID on days 1-7 and 15-21;\r doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; methotrexate IT on day\r 1; and pegaspargase IV over 1-2 hours on day 4. Treatment continues for 28 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY PART II:\r\n\r ARM A VHR B-ALL DI (CONTROL ARM): Patients receive DI therapy comprising cyclophosphamide IV\r over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39;\r thioguanine PO QD on days 29-42; methotrexate IT on days 29 and 36; vincristine sulfate IV\r over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment\r continues for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r ARM B VHR B-ALL DI (EXPERIMENTAL ARM 1): Patients receive DI therapy comprising\r cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on\r days 29-33; methotrexate IT on days 29 and 36; vincristine sulfate IV over 1 minute on days\r 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in\r the absence of disease progression or unacceptable toxicity. (CLOSED 02/15/2017)\r\n\r ARM C VHR B-ALL DI (EXPERIMENTAL ARM 2): Patients receive clofarabine IV over 2 hours on days\r 29-33 and DI therapy as in Arm II B VHR B-ALL DI. (Closed as of 9/12/2014)\r\n\r INTERIM MAINTENANCE THERAPY PART II: In all arms, patients receive vincristine sulfate IV\r over 1 minute and methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on\r days 1, 11, 21, 31, and 41; pegaspargase IV over 1-2 hours on days 2 and 22; and methotrexate\r IT on days 1 and 31. Treatment continues for 56 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINENTANCE THERAPY: Patients with CNS3 disease at diagnosis undergo RT QD over 4 weeks (10\r fractions total). In all arms, patients receive vincristine sulfate IV over 1 minute on days\r 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61 (may receive\r methylprednisolone IV if PO is not tolerated); methotrexate PO on days 8, 15, 22, 29, 36, 43,\r 50, 57, 64, 71, and 78 (except on methotrexate IT days); mercaptopurine PO QD on days 1-84;\r methotrexate IT on day 1 (also day 29 of courses 1 and 2 for CNS patients who did not undergo\r RT). Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence\r of disease progression or unacceptable toxicities.\r\n\r GROUP III: PH-LIKE PREDICTED TKI-SENSITIVE KINASE MUTATION:\r\n\r CONSOLIDATION THERAPY: Patients receive dasatinib PO QD on days 1-56, cyclophosphamide IV\r over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11,\r 29-32 and 36-39, mercaptopurine PO on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15\r and 22 (days 1 and 8 only for CNS3 patients), vincristine sulfate IV over 1 minute on days\r 15, 22, 43 and 50, and pegaspargase IV over 1-2 hours on days 15 and 43. Treatment continues\r for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r INTERIM MAINTENANCE THERAPY I: Patients receive dasatinib PO QD on days 1-63, vincristine\r sulfate IV over 1 minute on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours\r on days 1, 15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46,\r methotrexate IT on days 1 and 29, and mercaptopurine PO on days 1-56. Treatment continues for\r 63 days in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY: Patients receive dasatinib PO QD on days 1-56, vincristine\r sulfate IV over 1 minute on days 1, 8, 15, 43, and 50, dexamethasone PO or IV on days 1-7 and\r 15-21, doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8 and 15, methotrexate IT on\r days 1, 29 and 36, pegaspargase IV over 1-2 hours on days 4 and 43, cyclophosphamide IV over\r 30-60 minutes day 29, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, and\r thioguanine PO on days 29-42. Treatment continues for 56 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r INTERIM MAINTENANCE THERAPY II: Patients dasatinib PO QD on days 1-56, vincristine sulfate IV\r over 1 minute days 1, 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or\r 10-15 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 days 2 and 22.\r\n\r MAINTENANCE THERAPY: Patients receive dasatinib PO QD on days 1-84, vincristine sulfate IV\r over 1 minute on days 1, 29 and 57, prednisone PO BID or IV on days 1-5, 29-33 and 57-61,\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71 and 78 (omit on days when MTX\r [IT] is given), mercaptopurine PO on days 1-84, methotrexate IT on day 1 (also day 29 of\r course 1 and 2, for patients who did not receive CNS radiation). Treatment repeats every 12\r weeks for 2 years (females) or 3 years (males) in the absence of disease progression or\r unacceptable toxicities.\r\n\r Participants with Down syndrome are assigned to DS HR B-ALL:\r\n\r INDUCTION THERAPY: All patients receive cytarabine IT on day 1; vincristine sulfate IV over 1\r minute on days 1 and 8, dexamethasone PO or IV BID (patients under 10 years old) or\r prednisone PO BID (patients at least 10 years old) on days 1-14 (may receive\r methylprednisolone IV if PO is not tolerated), pegaspargase IV over 1-2 hours on day 4;\r methotrexate IT on day 8; and leucovorin calcium PO on days 10-11. Treatment continues for 14\r days in the absence of disease progression or unacceptable toxicity.\r\n\r RAPID EARLY RESPONDERS (RER): Patients receive induction therapy comprising vincristine\r sulfate IV over 1 minute on days 15 and 22; dexamethasone PO BID (patients under 10 years\r old) or prednisone PO BID (patients at least 10 years old) on days 15-28; methotrexate IT on\r day 29 (also days 15 and 22 for CNS3 patients); and leucovorin calcium PO on days 31-32 (also\r days 17-18 and 24-25 for CNS3 patients). Treatment continues for 14 days in the absence of\r disease progression or unacceptable toxicity.\r\n\r SLOW EARLY RESPONDERS (SER): Patients receive daunorubicin hydrochloride IV over 1-15 minutes\r on day 15 and Induction therapy as RER patients. Treatment continues for 14 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r CONSOLIDATION THERAPY: All patients receive cyclophosphamide IV over 30-60 minutes on days 1\r and 29; cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39;\r mercaptopurine PO QD on days 1-14 and 29-42; vincristine sulfate IV over 1 minute on days 15,\r 22, 43, and 50; pegaspargase IV over 1-2 hours on days 15 and 43; methotrexate IT on days 1,\r 8, 15, and 22 (days 1 and 8 only for CNS3 patients); and leucovorin calcium PO on days 3-4,\r 10-11, 17-18, and 24-25. Patients with continuing clinical evidence of testicular leukemia\r undergo RT QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r INTERIM MAINTENANCE THERAPY: Patients receive vincristine sulfate IV over 1 minute on days 1,\r 15, 29, and 43; intermediate dose methotrexate IV over 24 hours on days 1, 15, 29, and 43;\r leucovorin calcium PO or IV on days 2-3, 17-18, 31-32, and 45-46; mercaptopurine PO QD on\r days 1-56; and methotrexate IT on days 1 and 29. Treatment continues for 63 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on\r days 1, 8, 15, 43, and 50; dexamethasone PO BID or IV on days 1-7 and 15-21; doxorubicin\r hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on\r days 4 and 43; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO QD on days\r 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; methotrexate IT on days\r 1, 29, and 36; and leucovorin calcium PO on days 3-4, 31-32 and 38-39.\r\n\r MAINTENANCE THERAPY: Patients with CNS3 disease undergo RT QD, 5 days a week, for 2 weeks (10\r fractions total). Patients receive vincristine sulfate IV over 1 minute on day 1; prednisone\r PO BID or IV on days 1-5 (may receive methylprednisolone IV if PO not tolerated);\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO QD\r on days 1-84; and methotrexate IT on day 1 (also day 29 of courses 1-4 for CNS3 patients who\r did not undergo RT). Treatment repeats every 12 weeks for 2 years (females) or 3 years\r (males) in the absence of disease progression or unacceptable toxicities.\r\n\r After completion of study treatment, patients are followed up periodically for 10 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must be enrolled on APEC14B1 and consented to Eligibility Screening on the\r Part A consent form prior to enrollment on AALL1131\r\n\r - White Blood Cell Count (WBC) Criteria\r\n\r - Age 1-9.99 years: WBC >= 50 000/uL\r\n\r - Age 10-30.99 years: Any WBC\r\n\r - Age 1-30.99 years: Any WBC with:\r\n\r - Testicular leukemia\r\n\r - CNS leukemia (CNS3)\r\n\r - Steroid pretreatment\r\n\r - Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health\r Organization [WHO] classification) (also termed B-precursor acute lymphoblastic\r leukemia); patients with Down syndrome are also eligible\r\n\r - Organ function requirements for patients with Ph-like ALL and a predicted\r TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase\r mutation must have assessment of organ function performed within 3 days of study entry\r onto the dasatinib arm of AALL1131\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70mL/min/1.73\r m^2 or a serum creatinine based on age/gender as follows:\r\n\r - Age: Maximum Serum Creatinine (mg/dL)\r\n\r - 1 to < 6 months: 0.4 (male) 0.4 (female)\r\n\r - 6 months to < 1 year: 0.5 (male) 0.5 (female)\r\n\r - 1 to < 2 years: 0.6 (male) 0.6 (female)\r\n\r - 2 < 6 years: 0.8 (male) 0.8 (female)\r\n\r - 6 to < 10 years: 1.0 (male) 1.0 (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 - Direct bilirubin =< 3 x upper limit of normal (ULN) for age, and\r\n\r - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 10 x\r upper limit of normal (ULN) for age\r\n\r - Shortening fraction >= 27% by echocardiogram, or ejection fraction >= 50% by gated\r radionuclide study\r\n\r - Patients must have an electrocardiogram (EKG) fewer than 6 days prior to\r enrollment on the dasatinib arm; patients who have had cardiac assessments by\r echocardiogram or radionuclide scan at the beginning of induction do not need to\r have these repeated prior to study entry; correct QT interval (QTc) < 450 msec on\r baseline electrocardiogram as measured by the Friderica or Bazett formula\r\n\r - No major conduction abnormality (unless a cardiac pacemaker is present)\r\n\r - No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at\r sea level if there is clinical indication for determination\r\n\r - Patients with seizure disorder may be enrolled if on anticonvulsants and well\r controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine,\r phenytoin, primidone, phenobarbital) should be avoided\r\n\r - Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive\r Functioning study\r\n\r - Patients must be aged 6 to 13 years at time of B-ALL diagnosis, enrolled on\r AALL1131\r\n\r - Patients must be English-, French- or Spanish-speaking (languages in which the\r assessment is available)\r\n\r - Patients must have no known history of neurodevelopmental disorder prior to\r diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William's Syndrome, mental\r retardation)\r\n\r - Patients must have no significant visual impairment that would prevent computer\r use and recognition of the visual test stimuli\r\n\r - Eligibility criteria for the National Cancer Institute (NCI) standard risk patients\r from AALL0932 enrolling on this study at the end of Induction\r\n\r - Effective March 19, 2018, patients enrolled on AALL0932, without Down syndrome,\r meeting the following criteria will NOT be eligible to continue on AALL0932 or the HR\r B-ALL stratum of this study at the end of Induction:\r\n\r - Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day\r 8 peripheral blood (PB) minimal residual disease (MRD) >= 1% and day 29 bone\r marrow (BM) MRD < 0.01%\r\n\r - With favorable cytogenetics (ETV6-RUNX1 or double trisomies 4+10), with any day 8\r PB MRD and day 29 BM MRD >= 0.01%\r\n\r - Both NCI standard risk (SR) and HR patients without Down syndrome and with\r testicular disease at diagnosis, who do not meet other VHR criteria\r\n\r - Effective Amendment 6, patients enrolled on AALL0932, without Down syndrome, meeting\r the following criteria will NOT be eligible to continue on AALL0932 or the VHR stratum\r of AALL1131:\r\n\r - Intrachromosomal amplification of chromosome 21 (iAMP21)\r\n\r - Mixed-lineage leukemia (MLL) rearrangement\r\n\r - Hypodiploidy (n < 44 chromosomes and/or a deoxyribonucleic acid [DNA] index <\r 0.81)\r\n\r - Induction failure (M3 BM at day 29)\r\n\r - Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day\r 29 BM MRD >= 0.01%\r\n\r - Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will\r NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR\r B-ALL stratum of this study at the end of Induction:\r\n\r - Day 29 MRD >= 0.01%\r\n\r - MLL rearrangement\r\n\r - Hypodiploidy (n < 45 chromosomes and/or DNA index < 0.81)\r\n\r - DS HR B-ALL patients initially enrolled on AALL0932 or this study who have Induction\r failure (M3 BM day 29) or Philadelphia chromosome (BCR-ABL1) will not be eligible for\r post-Induction therapy on either trial (AALL0932 or AALL1131)\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 - 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 any cancer diagnosed prior to the initiation\r of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed\r after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving\r prior steroid therapy may be eligible for AALL1131\r\n\r - Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this\r study but may be eligible to enroll in a successor Children's Oncology Group (COG)\r Philadelphia positive (Ph+) ALL trial by day 15 Induction\r\n\r - DS HR B-ALL patients with Induction failure or BCR-ABL1\r\n\r - Female patients who are pregnant are ineligible since fetal toxicities and teratogenic\r effects have been noted for several of the study drugs\r\n\r - Lactating females are not eligible unless they have agreed not to breastfeed their\r infant\r\n\r - Female patients of childbearing potential are not eligible unless a negative pregnancy\r test result has been obtained\r\n\r - Sexually active patients of reproductive potential are not eligible unless they have\r agreed to use an effective contraceptive method for the duration of their study\r 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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{
"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\nInhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial\n\n**Clinical Trial Summary:**\n\nThe enormous and rapidly growing burden of Heart Failure with Preserved Ejection Fraction\r (HFpEF) has led to a need to understand the pathogenesis and treatment options for this\r morbid disease. Recent research from the investigator's group and others have shown that\r pulmonary hypertension (PH) is highly prevalent in HFpEF, and right ventricular (RV)\r dysfunction is present in both early and advanced stages of HFpEF.\r\n\r These abnormalities in the RV and pulmonary vasculature are coupled with limitations in\r pulmonary vasodilation during exercise. There are no therapies directly targeted at the\r pulmonary vasculature that have been clearly shown to be effective in HFpEF. A recent study\r by Mayo Clinic Investigators has demonstrated pulmonary vasodilation with dobutamine (a beta\r 2 agonist) in HFpEF. As an intravenous therapy, this is not feasible for outpatient use.\r\n\r In the proposed randomized, placebo-controlled double blinded trial, the investigators seek\r to evaluate whether the commonly used inhaled bronchodilator albuterol (a beta 2 agonist),\r administered through a high-efficiency nebulizer device that achieves true alveolar drug\r delivery, improves pulmonary vascular resistance (PVR) at rest and during exercise in\r patients with HFpEF as compared to placebo. This has the potential to lead to a simple cost\r effective intervention to improve symptoms in HFpEF, and potentially be tested in other World\r Health Organization (WHO) Pulmonary Hypertension groups. PVR is an excellent surrogate marker\r for pulmonary vasodilation and has been used in previous early trials of PH therapy.\n\n**Clinical Trial Detailed Description:**\n\nPreliminary studies to support feasibility: Recent research from the investigator's group has\r shown that right ventricular (RV) dysfunction is present in a third of patients with HFpEF\r and the presence of pulmonary vascular disease and pulmonary hypertension (PH) is very high\r (related to both pulmonary venous hypertension as well as pulmonary vascular disease). Both\r of these have been associated with adverse outcomes and exercise intolerance but no therapy\r is currently available directly targeted at the pulmonary vasculature in HFpEF.\r\n\r The investigators recently demonstrated significant improvements in pulmonary vascular\r function with dobutamine (a β2 agonist) administered acutely in HFpEF. As an intravenous\r therapy, this is not suitable for chronic outpatient use. Hospitalized patients with heart\r failure often demonstrate symptomatic improvement with inhaled β2 agonist therapy, even in\r the absence of pulmonary disease, and animal studies have also shown improved resolution of\r pulmonary edema with albuterol. In the proposed randomized, double blinded placebo-controlled\r trial, the investigators seek to evaluate whether the commonly used inhaled bronchodilator\r albuterol, administered through a high-efficiency nebulizer device, improves pulmonary\r vascular function in patients with HFpEF-PH as compared to placebo. This has the potential to\r lead to a simple cost effective intervention to improve symptoms in HFpEF-PH, and potentially\r be tested in other WHO PH groups.\r\n\r In the absence of frank signs of congestive heart failure, patients with early HFpEF can only\r be reliably diagnosed by exercise right heart catheterization, which is routinely performed\r at Mayo Clinic as part of the evaluation of patients with unexplained dyspnea. The presence\r of elevated pulmonary capillary wedge pressures (PCWP) at rest (>15 mmHg) or with exercise\r (>25 mmHg); and elevated mean pulmonary artery pressures at rest (>25 mm Hg) and with\r exercise (>40 mmHg) has been used to invasively diagnose HFpEF with exercise pulmonary\r hypertension with a high degree of validity and reliability. Just as exercise stress unmasks\r abnormalities in left ventricular (LV) diastolic function in early stage HFpEF, the\r investigators have very recently shown that exercise stress reveals early abnormalities in\r pulmonary artery vascular function as compared to controls without HF that are not apparent\r from resting data alone.\r\n\r Using objective diagnoses of HFpEF and exercise induced PH, the investigators seek to\r evaluate the hemodynamic changes with exercise in pulmonary vascular resistance, peak cardiac\r output and subjective dyspnea before and after inhaled albuterol therapy for pulmonary\r vasodilation.\r\n\r Study design: This study will be performed in a randomized, double blind placebo-controlled\r fashion using inhaled albuterol or inhaled saline (prepared by research pharmacy)\r administered through a novel high-efficiency nebulizer in a 1:1 fashion. Patients will\r undergo right heart catheterization (RHC) with expired-gas analysis using high Fidelity\r micromanometer catheters at rest and with exercise, at baseline and following treatment with\r study drug, using a novel study design that the investigators have previously utilized and\r reported. Rest and exercise measurements will be repeated after receiving inhaled albuterol\r or control therapy.\r\n\r Patients referred to the cardiac catheterization laboratory for invasive exercise stress\r testing will be prospectively recruited. Standard RHC using high fidelity micromanometers\r (Millar Instruments) will be performed at rest and during supine exercise with simultaneous\r expired gas analysis (MedGraphics) as is our current practice. The protocol is rest-20 Watts\r exercise x 5 minutes, and then graded workload increases in 10-20 Watt increments (3 minute\r stages) to exhaustion. Hemodynamic, arterial and mixed venous blood gas and expired gas data\r are acquired at rest, during each exercise stage and at peak exercise. Venous blood samples\r will be obtained at rest and at peak exercise. Perceived symptoms of dyspnea and fatigue will\r be quantified using the Borg dyspnea and effort scores at each stage of exercise. Limited\r echocardiography will be performed by a cardiologist skilled in imaging focused on measures\r of RV morphology and function.\r\n\r After the initial exercise study and hemodynamics have returned to baseline, study drug\r (normal saline placebo or albuterol 2.5 mg) will be inhaled through a high efficiency\r nebulizer over 5 minutes. After a 10 minute observation period, resting hemodynamic and\r expired gas data will be acquired exactly as in the initial run. Subjects will then repeat\r the 20 Watt x 5 minutes exercise phase. Subjects will repeat exercise only at the 20 Watt\r stage, rather repeating the entire study. This is done to increase the feasibility and\r shorten the time of the case. The investigators have previously observed that the vast\r majority (>85%) of the elevation in cardiac filling pressures and reduction in venous oxygen\r content in people with HFpEF occurs at the low 20 Watt workload, so repeating exercise\r hemodynamic assessment at this load should be sufficient to detect any clinically meaningful\r treatment effect from albuterol.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Heart Failure with Preserved Ejection Fraction (HFpEF)\r\n\r - Normal left ventricular ejection fraction (≥50%)\r\n\r - Elevated Left Ventricular filling pressures at cardiac catheterization (defined as\r resting Pulmonary Capillary Wedge Pressure>15 mmHg and/or ≥25 mmHg during exercise).\r\n\r Exclusion Criteria:\r\n\r - Prior albuterol therapy (within previous 48 hours)\r\n\r - Current long acting inhaled beta agonist use\r\n\r - Significant hypokalemia (<3meq/L)\r\n\r - Significant valvular disease (>moderate left-sided regurgitation, >mild stenosis)\r\n\r - High output heart failure\r\n\r - Severe pulmonary disease\r\n\r - Unstable coronary disease\r\n\r - Constrictive pericarditis\r\n\r - Restrictive cardiomyopathy\r\n\r - Hypertrophic cardiomyopathy\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"
}
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possibly relevant
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619
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[
{
"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\nWhole Exome Sequencing in Bicuspid Aortic Valve Patients\n\n**Clinical Trial Summary:**\n\nBicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined\r by the presence of two sigmoid valves instead of three. It is conventionally associated with\r histological abnormalities of the wall of the ascending aorta, risk factors of aortic\r dystrophy observed in 50% of cases, and dissection. Long considered an accident of\r development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and\r aortic dystrophy suggests the existence of a genetic predisposition and a common genetic\r origin for these two pathologies.\r\n\r Data on the genetic basis of the BAV are still limited, but the existence of a large\r phenotypic diversity suggests the involvement of other genes. The establishment of large\r collections of DNA will allow great advances in this field.\r\n\r The purpose of this project is to confirm the existence of a genetic determinism at the\r origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying\r genetic defects associated with the presence of a BAV in a series of candidate genes.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - bicuspid aortic valve, confirmed by transthoracic or transesophageal echocardiography\r\n\r - With or without an aneurysm of the ascending thoracic aorta nonsyndromic\r\n\r Exclusion Criteria:\r\n\r - aortic syndromic pathology\r\n\r - antecedent of acute articular rhumatism\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"
}
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definitely relevant
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620
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[
{
"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\nNovel Cardiac Imaging Prognostic Markers of Clinical Outcome in Patients With Chronic Aortic Regurgitation\n\n**Clinical Trial Summary:**\n\nSevere aortic regurgitation is a common valvular heart disease with prevalence of\r approximately 1%, affecting rather younger patients. The surgical treatment is the only\r causal treatment; it is recommended in patients with severe symptomatic aortic regurgitation.\r The optimal timing of the surgery is crucial because there is a certain risk of perioperative\r mortality and most patients require lifelong anticoagulation therapy. It is widely accepted,\r that asymptomatic patients with severely dilated left ventricle with systolic impairment have\r worse postoperative prognosis. We aim to evaluate native myocardial T1 relaxation time\r derived from cardiac magnetic resonance and global longitudinal left ventricular strain\r measured by echocardiography. These parameters are related to diffuse myocardial fibrosis and\r we expect to identify the cut off values, which correlate with further clinical course. This\r might enable better timing of the surgical treatment with the optimal postoperative left\r ventricular reverse remodelling and improved patient prognosis.\n\n**Clinical Trial Detailed Description:**\n\nIntroduction:\r\n\r Chronic aortic regurgitation is a common valvular heart disease with prevalence of\r approximately 1% in European population; affecting rather younger patients. The most common\r causes of chronic aortic regurgitation in developed countries are calcific aortic valve\r disease and bicuspid aortic valve. Another relatively frequent cause of the chronic aortic\r regurgitation is the aortic root dilation, which is genetically determined and it is also\r frequently diagnosed in younger patients. According to current guidelines for valvular heart\r disease, surgical treatment is recommended for patients with the severe symptomatic aortic\r regurgitation and for patients with the severe asymptomatic aortic regurgitation when left\r ventricular ejection fraction (LV EF) is < 50% or if other cardiothoracic surgery is planned\r (Class I). Current guidelines also recommend considering surgical strategy (Class IIa) in\r asymptomatic patients with severe aortic regurgitation, left ventricular ejection fraction\r (LV EF) ≥ 50% and left ventricular end-systolic diameter > 50 mm or indexed diameter > 25\r mm/m2. There are two reasons for considering this earlier surgical treatment. Surgical\r techniques and perioperative treatment have improved recently and postoperative patient\r outcome are significantly better. There is also strong evidence that left ventricular (LV)\r diameter decreases shortly after surgery but left ventricular ejection fraction (LV EF)\r remains unchanged in majority of patients and left ventricular ejection fraction (LV EF) is\r one of the main determinants of patient's future quality of life and life expectancy.\r However, surgical correction might be indicated too late in clinical practice, typically in\r women. The Mayo Clinic authors group reported that women exhibit an excess late mortality\r compared to male population. They showed that women were severely symptomatic at the time of\r surgery compare to male population where left ventricular (LV) enlargement was more frequent.\r Bonow at al reported 33% incidence of clinical events, death and deterioration of left\r ventricular ejection fraction (LV EF), in natural history of asymptomatic patients with\r severe aortic regurgitation and preserved left ventricular ejection fraction (LV EF).\r\n\r The optimal timing of surgical treatment is crucial but it has not been clearly established\r yet. New methods of identifying subclinical left ventricular (LV) function impairment are\r needed for better timing of the surgical strategy. Clinical follow-up with routine\r echocardiography study is recommended every 6 to12 months in patients with severe\r asymptomatic aortic regurgitation because sudden deterioration of left ventricular (LV)\r function might occur and we aim to operate on our patients before this happens. It is clear\r other parameters are needed than only left ventricular ejection fraction (LV EF) and left\r ventricular (LV) size. Diffuse myocardial fibrosis is a common feature of pathophysiology of\r the chronic left ventricular (LV) overload. Left ventricular ejection fraction (LV EF) and\r left ventricular (LV) size are less sensitive and non-specific markers of this process.\r Fortunately several novel methods of non-invasive quantification of the diffuse myocardial\r fibrosis have been introduced recently. The most promising method is the magnetic resonance\r imaging (MRI) - derived T1 relaxation time mapping introduced by Messroghli in 2004, Modified\r Look-Locker inversion recovery (MOLLI) sequence. Based on published data, MRI derived native\r T1 relaxation time is a reliable marker of diffuse myocardial fibrosis. The native T1\r relaxation time with cut off value of ≥ 1010 ms is an accurate marker of extensive (>30%)\r myocardial fibrosis with high sensitivity and specificity (Ss=90%, Sp=73%, area under curve\r (AUC) =0.82). Extracellular myocardial volume (ECV) calculated from MOLLI sequence is also a\r sensitive marker of diffuse myocardial fibrosis and extracellular myocardial volume (ECV)\r cutoff value of ≥ 0.315 showed high accuracy to identify extensive (> 30%) myocardial\r collagen content (Ss=80%, Sp=90%, AUC =0.85). Speckle tracking echocardiography is another\r promising imaging method for diffuse myocardial fibrosis. Two-dimensional LV global\r longitudinal strain (GLS) has a potential to discover subclinical left ventricular (LV)\r functional impairment\r\n\r Project Plan:\r\n\r 1. All patients will be scanned by MRI including Modified Look-Locker inversion recovery\r (MOLLI) within one week after inclusion and all complete and anonymized studies will be\r sent to CoreLab in IKEM. Off-line analysis will consist of the left and right ventricle\r volumetric and ejection fraction assessment. The aortic regurgitation will be measured\r using methods of flow sequence at sinotubular junction level (phantom correction\r required) and ventricular stroke volume difference. Modified Look-Locker inversion\r recovery (MOLLI) sequence will be acquired before, 10 and 15 minutes after contrast\r agent administration. T1 relaxation time will be measured within interventricular septum\r and ECV will be calculated from T1 relaxation time of the myocardium and the blood pool.\r Off-line analysis will be performed by two independent operators blinded to clinical and\r ECHO findings and intra- and inter-observer variability will be calculated.\r\n\r 2. All patients will undergo 2-D and 3-D transthoracic echocardiography within one week\r after inclusion and every six months during follow-up in each participating centre. All\r full volume anonymized studies will be sent to the CoreLab in IKEM. Off-line analysis of\r the left ventricular ejection fraction (LV EF),left ventricular (LV) volume, left\r ventricular (LV) mass, speckle tracking left ventricular (LV) global longitudinal strain\r (GLS), radial strain and left ventricular (LV) twist will be performed by two\r independent operators in a blinded fashion. Similarly aortic regurgitation grade will be\r assessed by two operators using colour Doppler, vena contracta measurement, and Doppler\r flow measurements. Inter- and intra-observer variability will be than calculated.\r\n\r 3. In all patients 12-lead electrocardiogram (ECG) will be recorded and blood sample will\r be taken during each visit. Brain natriuretic peptide serum level will be measured\r routinely at each participating centre. One blood sample will be stored frozen at -80 C°\r for further analysis including for example galectin levels, etc. This specific analysis\r will be performed in 1.Faculty of Medicine Charles University in Prague under the\r supervision of Prof. Sedmera.\r\n\r 4. Sub-study.\r\n\r 1. All patients who will be scheduled for aortic valve surgery during follow-up\r (strictly according to current guidelines) will undergo perioperative myocardial\r needle biopsy from interventricular septum in each participating centre. All\r myocardial samples will be processed and analysed in 1.Faculty of Medicine Charles\r University in Prague under the supervision of Prof. Sedmera.\r\n\r 2. All patients who will be scheduled for aortic valve surgery during follow-up will\r undergo repeat magnetic resonance imaging (MRI) study including Modified\r Look-Locker inversion recovery (MOLLI) sequence within 1-3 months prior to the\r operation and 6-12 month after the operation. The complete study will be repeated\r as described above. Postoperative left ventricular (LV) remodelling will be\r precisely assessed by off-line analysis. A correlation of the left ventricular (LV)\r remodelling and preoperative regurgitation grade as assessed by magnetic resonance\r imaging (MRI) and echocardiography (ECHO) will be calculated. Postoperative left\r ventricular (LV) remodelling will be also correlated with preoperative T1\r myocardial relaxation time, extracellular volume (ECV) and global longitudinal\r strain (GLS).\r\n\r Project Hypothesis:\r\n\r 1. We hypothesize that the increased native T1 longitudinal relaxation time as assessed by\r T1 mapping (Modified Look-Locker inversion recovery sequence) > 1010 ms and decreased\r global longitudinal strain (GLS) < 17 % are novel potent prognostic markers of clinical\r deterioration in patients with moderate to severe and severe chronic asymptomatic aortic\r regurgitation despite preserved left ventricular ejection fraction (LV EF).\r\n\r 2. We hypothesize that inter- and intra-observer variability of the aortic regurgitation\r severity assessment will be lower for the magnetic resonance imaging (MRI) study than\r for the echocardiography (ECHO) study.\r\n\r 3. We hypothesize that the degree of postoperative left ventricular (LV) recovery (decrease\r of the left ventricular (LV) volume and left ventricular (LV) mass) will correlate\r better with preoperative magnetic resonance imaging (MRI) regurgitation grade assessment\r rather than with echocardiography (ECHO) derived grade.\r\n\r CoreLab The CoreLab will be located in Institute for Clinical and Experimental Medicine\r (IKEM) centre. All full volume anonymized magnetic resonance imaging (MRI) and 2-D and 3-D\r echocardiography (ECHO) studies will be sent to this CoreLab for off-line analysis. Two\r independent operators, specialists in the field of magnetic resonance imaging (MRI) and\r echocardiography (ECHO), will review all studies in a fully blinded fashion. One operator\r will repeat the analysis at least one month after the first reading. Inter- and\r intra-individual variability will then be calculated.\r\n\r Myocardial biopsy and histology Myocardial sample will be obtained by experienced surgeon in\r all patients undergoing cardiothoracic surgery of the aortic valve. Under visual control a\r deep myocardial needle (SuperCore™ Semi-Automatic Biopsy Instrument 16 gauge x 9 cm) biopsy\r will be performed from the basal interventricular septum via the left ventricular outflow\r tract approach. A myocardial sample will be immersed immediately in 10% buffered formalin,\r embedded in paraffin blocks and later on sectioned at 3 micrometres (μm) thickness and\r stained with Picrosirius Red (PSR). PSR is a collagen specific stain and is an optimal tool\r for collagen quantification using normal light and also polarized light, which is helpful to\r distinguish between new and more matured collagen fibres. Percentage of myocardial fibrosis\r will be calculated as the ratio of Picrosirius Red (PSR)-positive area over total area using\r Image J software with differential thresholding. Histology analysis will be performed by\r experienced specialist on this field in a fully blinded fashion.\r\n\r Laboratory analysis Fasting blood samples will be obtained during each visit and serum level\r of Hemoglobin, C-reactive protein, Hemoglobin A1c, Creatinine and Glucose level, Brain\r Natriuretic Peptide, Galectin 1 and 3 level will be measured. Creatinine clearance will be\r calculated using Cockcroft-Gault equation. One sample of frozen plasma will be stored for\r further analysis (but not for genetic analysis).\r\n\r Number of included patients 100 - 150 patients in total.\r\n\r Data Collection Patient data will be collected in one database system shared on-line with all\r centres. It will require an identification code for a patient and a centre. Under no\r circumstances will the patient data such as name, identification number (ID), address or\r other contact details be collected.\r\n\r Study duration 2016 - 2022 (2 years recruitment + 5 years follow-up)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\r\n\r 1. Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4\r (severe)\r\n\r 2. No indication for the surgical treatment at the time of enrolment\r\n\r 3. LV EF ≥ 50 %\r\n\r 4. Absence of more than mild concomitant valve disease or complex congenital heart\r disease\r\n\r Exclusion Criteria\r\n\r 1. Age < 18 years\r\n\r 2. Clearance Creatinine < 30 mL/min\r\n\r 3. Contraindication of magnetic resonance (implanted active device, ferromagnetic implant\r incompatible with magnetic resonance scanner, aneurysm clip, metallic fragment in the\r eye or near sensitive tissue)\r\n\r 4. 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:** possibly relevant"
}
] |
possibly relevant
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621
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[
{
"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 and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI\n\n**Clinical Trial Summary:**\n\nEarly development of calcified aortic valve disease (CAVD) is a commonly occurring\r complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two\r leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the\r aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may\r lead to necessity of valve replacement, since to date, no other therapies have been shown\r effective in the treatment of CAVD.\r\n\r The primary objective of our study is to test the hypothesis that supplementation of vitamin\r K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation\r of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of\r calcification.\r\n\r In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2\r or placebo group. To assess the calcification process in a detailed manner in these patients,\r a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has\r been shown to bind to regions of newly developing microcalcification in aortic valve tissue\r is used.\r\n\r We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic\r valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium\r score on CT and echocardiography after 18 months (secondary endpoints), when compared to\r placebo.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - known bicuspid aortic valve\r\n\r - calcified mild to moderate aortic valve stenosis on prior echocardiography\r\n\r - informed consent provided\r\n\r Exclusion Criteria:\r\n\r - absence of calcified aortic valve stenosis on echocardiography\r\n\r - presence of severe aortic valve stenosis\r\n\r - history of aortic valve repair or replacement\r\n\r - accepted atrial fibrillation\r\n\r - use of oral anticoagulants\r\n\r - claustrophobia\r\n\r - presence of a pacemaker, ICD or ferromagnetic materials in the body\r\n\r - life expectancy <2 years\r\n\r - Pregnancy (current or wish for near future)\r\n\r - soy allergy\r\n\r - use of vitamin K-containing supplements\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\"."
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[
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"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\nIbuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy\n\n**Clinical Trial Summary:**\n\nThis is a prospective, randomized, double-blinded, and placebo-controlled trial comparing\r oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open\r unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid\r (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal\r fentanyl), which can be continued. The patients will not be allowed to continue any\r over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing\r medications, that were not prescribed by the investigators during this study. Patients not\r receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill\r will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the\r investigators nor the research subjects will know if the subject is receiving a placebo\r versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be\r followed for 2 months after their surgery. The research aims to discover the appropriate\r amount of opioid medication to prescribe to patients undergoing an elective open inguinal\r hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination.\r The investigators expect that the subjects who take ibuprofen will use less\r oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute\r to reducing the surplus opioids prescribed by physicians after surgery, which can lead to\r opioid use disorders. This particular procedure is common in men, and the findings have the\r potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who\r undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.\n\n**Clinical Trial Detailed Description:**\n\nScreening Visit:\r\n\r Discuss the purpose of the study and the required completion of study-related questionnaires\r and their potential impact for active duty members. (research-driven) Obtain signed Informed\r Consent Document and HIPAA Authorization (research-driven).\r\n\r Review the patient's past medical history in Armed Forces Health Longitudinal Technology\r Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria.\r (research-driven) The investigators will record the subject's tobacco use history, alcohol\r use history, marijuana use history, other illicit drug use history, and previous\r non-prescription use of opioids. (standard of care) Obtain an overall pain score, from 0 to\r 100, with 100 being the worst pain imaginable. (research-driven) Obtain a localized pain\r score from 0 to 100, with 100 being the worst pain imaginable, which the patient attributes\r specifically to the hernia that is scheduled for surgical intervention. (research-driven)\r Instruct patients to discontinue use of any over-the-counter pain medications, such as\r ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the\r investigators during this study.\r\n\r Subjects will have the following blood test drawn, which include (research-driven):\r\n\r Fasting comprehensive metabolic panel (liver function, renal function, plasma glucose tests)\r via 1 venipuncture (5-10 milliliters, approximately 1-2 teaspoons of blood will be drawn)\r Subject's CMP results must be within 30 days of the day of surgery or it will need to be\r repeated.\r\n\r Women of childbearing potential will have a serum pregnancy test (5-10 milliliters,\r approximately 1-2 teaspoons of blood) or urine pregnancy test (10 drops or less than 1\r milliliter of urine) (research-driven). Visit 1 (may occur the same day as the screening\r visit or the same day as visit 2):\r\n\r The standard of care local anesthesia used for this type of surgery is bupivacaine. The\r surgeon will be reminded via a note in the medical record. (standard of care) Subjects will\r be randomized by the MOFMC Pharmacy into one of two naturally stratified groups (e.g., opioid\r naive patients and non-opioid naive patients), with further randomization into an opioid +\r ibuprofen study group or an opioid + placebo study group The MOFMC Pharmacy staff will\r maintain a key that can be used to un-blind the randomization scheme if needed for an\r emergent patient care issue. Study ID numbers will be used to maintain blinding and\r confidentiality. (research-driven)\r\n\r Opioid naive patients (used an opioid for less than 14 days in the past 6 months, and no\r history of opioid use disorder at any time) will be randomized into one of two groups:\r\n\r Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as\r needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325\r milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days.\r\n\r Group B: Subjects will be prescribed 800 milligrams of a placebo pill (containing corn\r starch) to be taken by mouth every 8 hours as needed for pain and 1 to 2 tablets of\r oxycodone/acetaminophen 5 milligrams 325 milligrams (Qty. 30) by mouth every 4 hours as\r needed for pain for 5 days.\r\n\r Non-Opioid naive patients (opioid use for more than 14 days in the past 6 months, or history\r of opioid use disorder) will be randomized into one of two groups:\r\n\r Group C: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as\r needed for pain for 5 days, in addition to their preferred opioid medication prescription.\r\n\r Group D: Subjects will be prescribed or advised to continue to take only their preferred\r current oral opioid prescription (codeine, hydrocodone, hydromorphone, morphine, methadone,\r oxymorphone, or transdermal fentanyl).\r\n\r Subjects will complete the Beck Depression Inventory-II or the Patient Health Questionnaire\r (PHQ-9) depression screen, and it will be reviewed on the same day of completion.\r (research-driven) Subjects will complete the Pre-Operative Activities Assessment Scale (AAS),\r and it will be reviewed on the same day of completion. (research-driven) Subjects will\r complete the Opioid Risk Tool (ORT) , and it will be reviewed on the same day of completion.\r (research-driven) Subjects will be asked \"How likely do you think it is that you will develop\r an addiction problem from pain medication you take after surgery?\" and chose from 1 of 4\r answers: 1: \"not at all\"; 2: \"unlikely\"; 3: \"somewhat likely\"; or 4: \"very likely\".\r (research-driven) Subjects will be asked \"On a scale of 0-100, with 0 being no pain and 100\r being the worst pain imaginable, what is your average level of pain at rest in the past 24\r hours?\" (research-driven) Subjects will be asked \"On a scale of 0-100, with 0 being no pain\r and 100 being the worst pain imaginable, what was your lowest level of pain when at rest in\r the past 24 hours? (research-driven) Subjects will be asked \"On a scale of 0-100, with 0\r being no pain and 100 being the worst pain imaginable, what was your highest level of pain\r when at rest in the past 24 hours? (research-driven) Subjects will be given a Medication and\r Pain Level Diary and will be instructed to complete it every day for 14 days beginning after\r their surgery. The investigators will record information from the subjects' surgery, for\r example: the start and end times of surgery and anesthesia, how long the surgery lasted, how\r difficult the surgery was, were the ilioinguinal, genitofemoral, or iliohypogastric nerves\r identified and were they protected, injured, or transected, and which opioids the\r anesthesiologist gives at any point during the case after incision. (research-driven) The\r preoperative instructions will include standardized verbal and written instructions: \"After\r your surgery, it is expected that the patient will experience a certain amount of pain for a\r short period of time. The patient will be prescribed pain medication that you should take\r only when you are in pain. If the patient is no longer experiencing pain, the patient should\r stop taking the medication. If the patient does not require all of the pain medication that\r was prescribed, the patient should record the amount of medication that was unused and then\r properly dispose of the remainder.\" (standard of care)\r\n\r Visit 2 (day of surgery-prior to surgery):\r\n\r Subjects will receive prescriptions for medications according to their randomization group.\r These prescriptions will be filled at the MOFMC pharmacy, which will perform the subjects'\r randomization assignments. The ibuprofen and placebo capsules will be delivered to the MOFMC\r Pharmacy after being compounded by Solutions Specialty Pharmacy. (research-driven) Subjects\r will complete the Pre-Operative AAS (approximately 5 minutes to complete), and it will be\r reviewed on the same day of completion. (research-driven) Research staff will record the\r start and end times of the surgery, record the amounts of standard of care pain medications\r used during their hospital stay, document any standard of care pain assessments that were\r performed, and document the anesthesia the subject received. (research-driven) Subjects will\r be reminded in the Post Anesthesia Care Unit (PACU) to complete their Medication and Pain\r Level Diary and reminded to complete it every day for the 60 days beginning after they are\r discharged from the hospital. (research-driven)\r\n\r Visit 3 (Post-Op day 0 Contact (at time of discharge from post-anesthesia care unit)):\r\n\r Subjects will be contacted by research team in person or via telephone and asked the\r following questions in this order (research-driven):\r\n\r On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is\r the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0\r being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when\r at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the\r worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours?\r What pain medications are the patient taking including the strength (in milligrams), and how\r many total doses have you taken since your surgery? Time of last opioid medication taken?\r Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete\r Subjects will be reminded to complete their Medication and Pain Level Diary.\r (research-driven)\r\n\r Visits 4-8 (Post-op Day 1 through Day 5 Contact (each visit every 24 hours plus or minus 4\r hours visit window):\r\n\r Subjects will be contacted by research team in person or via telephone and asked the\r following questions in this order (research-driven):\r\n\r On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is\r the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0\r being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when\r at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the\r worst pain imaginable, what was the highest level of pain since when at rest in the past 24\r hours? What pain medications have been taken, including the strength (in milligrams), and how\r many total doses have been taken since the last study visit? Time of last opioid medication\r taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete\r Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of\r completion. (research-driven) Subjects will be reminded to complete their Medication and Pain\r Level Diary. (research-driven)\r\n\r Visit 9 (Post-Op day 14 Contact (plus or minus 2 day visit window)):\r\n\r Subjects will be contacted by research team in person or via telephone at their\r Post-Operative Follow Up Visit and asked the following questions in this order (in-person)\r (research-driven):\r\n\r On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is\r the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0\r being no pain and 100 being the worst pain imaginable, what was your lowest level of pain\r since your when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and\r 100 being the worst pain imaginable, what was your highest level of pain since your when at\r rest in the past 24 hours? What pain medications are being taken including the strength (in\r milligrams), and how many total doses have been taken since the last study visit? Time of\r last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some,\r 3 = a lot, 4 = complete Subjects will complete the Post-Operative AAS, and it will be\r reviewed on the same day of completion. (research-driven).\r\n\r Subjects will return their Medication and Pain Level Diary and be issued a new one for the\r remainder of the study. (research-driven) Subjects will be reminded of the two remaining\r contacts. (research-driven)\r\n\r Visit 10 (Post-Op day 30 Contact (plus or minus 5 day visit window)):\r\n\r Subjects will be contacted by research team in person or via telephone and asked the\r following questions in this order (research-driven):\r\n\r On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is\r the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0\r being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when\r at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the\r worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours?\r What pain medications are being taken including the strength (in milligrams), and how many\r total doses have been taken since your last study visit? Time of last opioid medication\r taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete\r Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of\r completion. (research-driven).\r\n\r Subjects will be reminded to complete their Medication and Pain Level Diary.\r (research-driven)\r\n\r Visit 11 (Post-Op day 60 Contact (plus or minus 5 day visit window)):\r\n\r Subjects will be contacted by research team in person or via telephone and asked the\r following questions in this order (research-driven):\r\n\r On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is\r your average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0\r being no pain and 100 being the worst pain imaginable, what was the lowest level of pain\r since your when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and\r 100 being the worst pain imaginable, what was the highest level of pain when at rest in the\r past 24 hours? What pain medications are being taken including the strength (in milligrams),\r and how many total doses have been taken since the last study visit? Time of last opioid\r medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4\r = complete Was there a diagnosis of post-operative neuralgia at any point following your\r surgery? Was there a diagnosis of an inguinal hernia recurrence at any point following your\r surgery? Was there a diagnosis of a surgical site infection at any point following your\r surgery? Subjects will complete the Post-Operative AAS, and it will be reviewed on the same\r day of completion. (research-driven).\r\n\r The Medication and Pain Level Diary will not be collected from the patient. (research-driven)\n\n**Clinical Trial Eligibility Criteria:**\n\nPATIENTS MUST HAVE MILITARY INSURANCE TO PARTICIPATE\r\n\r Inclusion/exclusion criteria:\r\n\r Inclusion:\r\n\r - Active Duty members and DoD beneficiary patient 18 years or older\r\n\r - Elective, open unilateral inguinal herniorrhaphy using Lichtenstein (tension free with\r mesh) hernia repair technique Agree to take only the prescribed oral analgesic\r medication (oxycodone/acetaminophen), plus or minus ibuprofen, for the initial\r fourteen-day post-operative period, with allowed exception of any currently prescribed\r opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone,\r transdermal fentanyl), which can be continued.Agree to honestly complete a depression\r screening questionnaire, illicit drug use personal history and questionnaire, and\r physical activity assessment questionnaire, with the knowledge that if the patient is\r an active duty member, this information could result in a referral to medical or\r command authorities for potential Uniform Code of Military Justice (UCMJ) violations\r or concerns for subject health and fitness for duty.\r\n\r Exclusion:\r\n\r - Subjects who are pregnant or nursing.\r\n\r - Patients who refuse to complete the illicit drug use, physical activity, and\r depression questionnaires.\r\n\r - Strangulated, incarcerated, or otherwise emergent, urgent, and non-elective inguinal\r herniorrhaphy.\r\n\r - Those patients who are allergic to, refuse to take, or are otherwise unable to take\r oxycodone, ibuprofen, or acetaminophen medication orally for post-operative pain\r management.\r\n\r - Patients on pain contracts, or under the care of a pain medicine specialist for\r management of chronic pain at the time of surgery.\r\n\r - Subjects with serum creatinine level > 1.3 mg/dL as measured at the baseline study\r visit.\r\n\r - Subjects with serum aspartate transaminase (AST) greater than 3 times the upper limit\r of normal (level >102 U/L)\r\n\r - Subjects with serum alanine transaminase (ALT) greater than 3 times the upper limit of\r normal (level > 165 U/L)\r\n\r - Subjects who do not speak, read, and write fluently in English.\r\n\r - Subjects with a history of cirrhosis.\r\n\r - Subjects enrolled in another clinical trial during the same period as their\r involvement as this study.\r\n\r - Subjects, who in the investigator's opinion, will be unable to complete a pain diary\r or follow-up visits, or otherwise not comply with the study protocol.\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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623
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[
{
"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\n4 Cities for Assessing CAlcification PRognostic Impact After TAVI\n\n**Clinical Trial Summary:**\n\nTranscatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an\r alternative to conventional surgery for aortic stenosis cure. Despite a high rate of\r procedural success, some patients do not benefit from the procedure. The investigators\r hypothesis is that aortic stiffness may be of major prognostic significance after stenosis\r relief.\r\n\r The aim of this study is to test the prognostic impact of aortic stiffness estimated by the\r volume of calcifications of the thoracic aorta on the CT-scan performed systematically before\r the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4\r french cities (Lyon, Rouen, Paris, Clermont-Ferrand).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age > 18\r\n\r - Patient who underwent a transcatheter aortic valve implantation\r\n\r - Patient who provided informed, written consent to participate to FRANCE TAVI study\r\n\r - Patient for whom a CT-Scan performed before TAVI procedure is available.\r\n\r Exclusion Criteria:\r\n\r - none\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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624
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[
{
"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\nVegetarian Diet in Patients With Ischemic Heart Disease\n\n**Clinical Trial Summary:**\n\nOpen label, 4 week randomized, cross-over study to compare the effect of a vegetarian diet to\r a conventional (meat containing) diet based on the Swedish average meat consumption on a\r range of parameters with prognostic importance for cardiovascular disease.The study will be\r conducted in patients diagnosed with ischemic heart disease. We hypothesize that patients\r will benefit from a vegetarian diet as assessed by multiple risk markers for this type of\r disease with a primary focus on changes in oxidized LDL cholesterol.\n\n**Clinical Trial Detailed Description:**\n\nBackground\r\n\r Cardiovascular disease is the leading cause of death globally. Ischemic heart disease (IHD)\r contributes the most to this statistic and since 1990 the global burden of IHD has increased.\r It is estimated that 50 000 Swedish patients are hospitalized every year due to IHD. The risk\r of developing IHD is to a large extent determined by the existence and state of several\r modifiable risk factors including dietary habits, smoking, hypertension, diabetes mellitus,\r hyperlipidemia, high apolipoprotein B/ apolipoprotein A1-ratio, abdominal obesity, physical\r inactivity, alcohol consumption and psychosocial factors. High levels of oxidative stress,\r oxidized LDL cholesterol and the microbial metabolite trimethylamine N-oxide TMAO have been\r suggested to be associated with development of IHD.\r\n\r A plant-based (vegetarian) diet may provide cardiovascular health benefits through various\r mechanisms. Clinical studies suggest that a vegetarian diet has positive effects on\r low-density lipoprotein (LDL) cholesterol, oxidized LDL cholesterol, total cholesterol,\r triglycerides, apolipoprotein B, body mass index (BMI), inflammatory markers, blood pressure,\r arterial intima-media thickness, insulin sensitivity, glycated hemoglobin, (HbA1c) and\r fasting glucose levels. Through positive impacts on risk factors that a vegetarian diet is\r associated with a lowered incidence and mortality of IHD and an overall reduced mortality.\r\n\r A weakness of several prior long-term controlled studies comparing vegetarian and\r meat-containing diets is the lack of well-defined control diets leading to study\r heterogeneity. For example, some of the subjects on meat-containing diets consume great\r quantities of red meat, others eat substantial amounts of processed meat products and some\r eat mostly white meat and fish complicating interpretation of outcome. In cross-sectional or\r observational cohort studies comparing long-term vegetarians to long-term omnivores, results\r may be influenced by other lifestyle choices besides the studied diet, such as smoking and\r exercise.Furthermore, the participants in many previous studies were often healthy volunteers\r and not patients with overt cardiovascular disease.\r\n\r Purpose\r\n\r The objective is to perform an open label, 4 week randomized, cross-over study to compare the\r effect of a vegetarian diet to a conventional (meat containing) diet based on the Swedish\r average meat consumption on a range of parameters with prognostic importance for\r cardiovascular disease: lipids, inflammation, oxidative stress, BMI, HbA1c, apolipoprotein\r B/apolipoprotein A1-ratio, gut microbiota, endothelial function and quality of life. The\r study will be conducted in patients diagnosed with STEMI (ST-segment elevation myocardial\r infarction), non-STEMI (non-ST-segment elevation myocardial infarction) or angina pectoris\r and treated by percutaneous coronary intervention (PCI).\r\n\r Hypothesis\r\n\r The study hypothesis is that patients diagnosed with IHD can benefit from a vegetarian diet\r as assessed by multiple risk markers for this type of disease with a primary focus on changes\r in oxidized LDL cholesterol.\r\n\r Clinical relevance\r\n\r During the last decades the global mortality from IHD has remained unchanged regardless of\r development of new invasive and pharmacological treatments. Despite the fact that the\r prevalence and mortality from IHD have decreased in this country since 1990 and that the\r decrease most likely is due to lifestyle changes, IHD remains the leading cause of death in\r Sweden.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Stable ischemic heart disease and previous percutaneous coronary intervention (PCI.\r\n\r - Under optimal medical treatment including aspirin and cholesterol lowering drugs\r (statins)\r\n\r Exclusion Criteria:\r\n\r - PCI treatment during the last 30 days\r\n\r - Inability to provide informed consent\r\n\r - Already following a vegetarian or a vegan diet\r\n\r - Known vitamin B deficiency\r\n\r - Known food allergy\r\n\r - Previous obesity surgery or gastric bypass surgery\r\n\r - Life expectancy <1 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:** not relevant"
}
] |
not relevant
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625
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[
{
"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™ TA Delivery System in Patient With Severe Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nThe purpose of this investigation is to collect data pertaining to the safety and performance\r of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA\r Transapical Delivery System. This device is intended for treatment of subjects with severe\r aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR)\r surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive\r transapical implantation in a well-defined population.\n\n**Clinical Trial Detailed Description:**\n\nThis is a single arm, prospective, multicenter non randomised and open trial of the treatment\r of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via\r open heart surgery is considered to be high risk. All patients will be followed up to 5 years\r after the intervention.\r\n\r The primary objective is to evaluate the safety and performance of the study device in\r patients presenting with severe aortic stenosis considered to be high risk for surgery\r Secondary objective is to evaluate adverse events and study device performance.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subject must be at least 18 years old\r\n\r 2. Severe aortic stenosis defined as:\r\n\r - Mean aortic gradient > 40 mmHg or\r\n\r - Peak jet velocity > 4.0 m/s or\r\n\r - Aortic valve area of < 0.8 cm2\r\n\r 3. High risk patient determined by a multidisciplinary heart team consensus (cardiologist\r and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due\r to risk factors such as STS Score (8% or higher) or other co-morbid conditions\r unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease\r (COPD), chest deformities and irradiated mediastinum\r\n\r 4. NYHA Functional Class > II\r\n\r 5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the\r transapical approach is the most suitable access route for TAVI due to the presence of\r the following anatomic conditions:\r\n\r - porcelain aorta or\r\n\r - severely calcified or highly tortuous peripheral vasculature not appropriate for\r transfemoral transcatheter aortic valve implantation or\r\n\r - vessels too small for retrograde approach or\r\n\r - other anatomical conditions making transapical approach more suitable\r\n\r 6. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE\r\n\r 7. Patient willing to participate in the study and provides signed informed consent\r\n\r Exclusion Criteria:\r\n\r 1. Congenital unicuspid or bicuspid aortic valve or non-calcified\r\n\r 2. Extreme eccentricity of calcification\r\n\r 3. Severe mitral regurgitation (> Grade 3)\r\n\r 4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring\r\n\r 5. LV apex is not accessible via transapical access due to severe chest deformity\r\n\r 6. Previous surgery of the LV using a patch, such as the Dor procedure\r\n\r 7. Presence of apical LV thrombus\r\n\r 8. Calcified pericardium\r\n\r 9. Septal hypertrophy unacceptable for transapical procedure\r\n\r 10. Transesophageal echocardiogram (TEE) is contraindicated\r\n\r 11. ECHO evidence of intracardiac mass, thrombus, or vegetation\r\n\r 12. LVEF < 20% by ECHO\r\n\r 13. Need for emergency intervention for any reason within 30 Days of scheduled procedure\r\n\r 14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month\r prior to implant procedure\r\n\r 15. Untreated clinically significant coronary artery disease requiring revascularization\r within 30 days before or after the study procedure\r\n\r 16. Acute myocardial infarction within 1 month prior to implant procedure\r\n\r 17. Previous TIA or stroke within 6 months prior to implant procedure\r\n\r 18. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure\r\n\r 19. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit\r\n\r 20. History of bleeding diathesis, coagulopathy, refusal of blood transfusions or severe\r anemia (Hb<8 g/dL)\r\n\r 21. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP\r\n\r 22. Primary hypertrophic obstructive cardiomyopathy (HOCM)\r\n\r 23. Active infection or endocarditis\r\n\r 24. Hepatic failure (> Child B)\r\n\r 25. Chronic renal dysfunction with serum creatinine > 3.0 mg/dL or renal dialysis\r\n\r 26. Neurological disease severely affecting ambulation, daily functioning, or dementia\r\n\r 27. Life expectancy < 12 months due to non-cardiac co-morbid conditions\r\n\r 28. Intolerance to aspirin, clopidogrel, contrast media, or porcine tissue and allergy to\r nickel\r\n\r 29. Pregnant or breast-feeding women\r\n\r 30. For other severe illnesses of the patient (e.g. active carcinoma), the investigator\r shall decide on an individual basis whether the patient is not to be included in the\r study\r\n\r 31. Currently participating in an investigational drug or another device 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:** possibly relevant"
}
] |
possibly relevant
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626
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[
{
"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\nEvaluation of Length of Stay After TF-TAVI\n\n**Clinical Trial Summary:**\n\nTranscatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the\r first-in-man TAVI performed in 2002. With increasing experience and improvements in valve\r design, the \"minimalist\" approach to transfemoral TAVI (using local anesthesia and\r fluoroscopic guidance) has become an attractive concept, and the technical feasibility of\r this approach has been well documented.\r\n\r While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the\r FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry\r (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time\r period of 2007 to 2012. More contemporary data from other centers has been published showing\r that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly\r minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains\r indeterminate with a lack of formal consensus.\r\n\r Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential\r advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly\r patients in addition to cost-saving benefits. Rouen University Hospital has previously\r published a retrospective study on the feasibility and safety of early discharge, in which\r discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our\r patients. Pre-existing pacemaker and the absence of acute kidney injury were independent\r predictors of a successful early discharge. Moreover, in a prospective study, Rouen\r University Hospital recently shown that early discharge afterelective TF-TAVI with\r SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no\r evident compromise in safety. Factors associated with failure of early discharge were\r postprocedural blood transfusion and permanent pacemaker implantation. But currently, there\r are no guidelines for the length of stay after a TF-TAVI.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Stable patients with severe symptomatic aortic stenosis\r\n\r - Patient undergoing planned TF-TAVI with the SAPIEN-3 prosthesis,\r\n\r - TF-TAVI using a minimalist approach of local anesthesia and conscious sedation\r\n\r Exclusion Criteria:\r\n\r - The use of other (than Edwards SAPIEN-3 or XT) transcatheter aortic valve devices.\r\n\r - TF-TAVI requiring general anesthesia or surgical cut-down.\r\n\r - TF-TAVI performed in unstable patients or on an urgent/emergent basis.\r\n\r - Non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc).\r\n\r - Discharge back home impossible (including transfer in another hospital)\r\n\r - Programmed transfer to another hospital\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
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627
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[
{
"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[Trial of device that is not approved or cleared by the U.S. FDA]\n\n**Clinical Trial Summary:**\n\n\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\n\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
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628
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[
{
"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\nSaint Luc Valve Registry\n\n**Clinical Trial Summary:**\n\nThe \"Cliniques Universitaires Saint Luc\" are one of the high specialized center in valvular\r heart diseases and valvular heart surgery. Aortic stenosis, mitral and aortic regurgitation\r are the three valve pathology that are mainly frequent and studied.\r\n\r International guidelines in the management of valvular heart diseases are based on few\r limited old studies, mainly retrospective. And, a matter of concern is staying, about the\r timing of surgery for asymptomatic patients.\r\n\r A prospective registry will help us to better understand the pathologies and try to better\r define guidelines criteria for surgery.\n\n**Clinical Trial Detailed Description:**\n\nWith this prospective registry, all patients with aortic stenosis, mitral and aortic\r regurgitation will be followed. The investigators will find followed patients not yet\r operated or until surgery, but also patient after surgery according to the presence or\r abscence of guidelines criteria.\r\n\r It will permit to compare different kind of management of patients with valvular heart\r disease and to better define guidelines criteria for surgery.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Presence of aortic stenosis, mitral or aortic regurgitation at the time of an\r echocardiography at the \"Cliniques Universitaires Saint Luc\".\r\n\r Exclusion Criteria:\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
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629
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[
{
"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\nLp(a) and Aortic Valve Calcification\n\n**Clinical Trial Summary:**\n\nAortic valve stenosis (AVS), the most common form of valve disease in the western world,\r afflicts more than 1 million individuals in North America [1] and the burden of AVS is high\r and is expected to double within the next 50 years [2]. Medical therapy to prevent\r development or reduce progression of AVS is currently not available and the only effective\r treatment for AVS is aortic valve replacement, for which costs have been estimated up to\r 120,000$ [3,4]. Recently, we and others have identified rs10455872 at the LPA locus as a\r susceptibility single nucleotide polymorphism (SNP) for aortic valve calcification (AVC) and\r AVS [5,6] and rs10455872 is associated with elevated plasma lipoprotein (Lp)(a) levels [7].\r Lp(a) is a LDL-like particle consisting of hepatically synthesized apolipoprotein B-100 that\r is noncovalently bound to the plasminogen-like glycoprotein apolipoprotein(a) [8]. Lp(a)\r promotes atherosclerotic stenosis, and possibly thrombosis, and has been hypothesized to\r contribute to wound healing, each of which could explain an association with AVS [9,10].\r Lp(a) is relatively refractory to both lifestyle and drug intervention, with only nicotinic\r acid and monoclonal antibody inhibition of the proprotein convertase subtilisin/kexin type 9\r that have showed reductions in Lp(a) levels [11,12]. However, the evidence that patients with\r AVS could be characterized by high Lp(a) levels is scarce. Glader et al. [13] showed that\r plasma levels of Lp(a) were almost 1.5-fold higher in 101 patients with AVS compared to\r matched controls, although this relationship did not reach statistical significance.\r Subsequent studies have also reported an association between elevated plasma Lp(a) levels and\r higher prevalence of AVS. More specifically, Kamstrup and colleagues [14] reported that\r elevated Lp(a) levels and corresponding genotypes were associated with increased risk of AVS\r in the general population with levels >90 mg/dL predicting a threefold increased risk. We\r have measured Lp(a) and oxidized phospholipids plasma levels in 220 patients with\r mild-to-moderate calcific AVS enrolled in the Aortic Stenosis Progression Observation:\r Measuring Effects of Rosuvastatin (ASTRONOMER) trial [15]. Results of this study suggest that\r high Lp(a) and oxidized phospholipids both predict calcific AVS progression, especially in\r younger patients with calcific AVS. We also found that statin therapy considerably increased\r both Lp(a) and oxidized phospholipids levels. Whether the fact that statins increase these\r risk factors for calcific AVS might explain at least to a certain extent why statins failed\r to promote calcific AVS regression or stabilization in at least four trials, including\r ASTRONOMER.\r\n\r Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by\r mutations in the LDL receptor gene that disrupt normal clearance of LDL. Phenotypic features\r characteristic of the disease's heterozygous form are 2- to 3-fold raise in plasma\r LDL-cholesterol concentrations, tendinous xanthomatosis and premature atherosclerotic\r coronary artery disease. High Lp(a) levels have been shown to explain residual cardiovascular\r disease risk in FH [16,17]. Recent studies have demonstrated that FH heterozygotes have\r elevated AVC compared with non-FH subjects [18] and that Lp(a) levels were positively\r correlated with AVC in asymptomatic FH heterozygotes [19]. Vongpromek et al. [19]\r demonstrated that plasma Lp(a) concentration is a independent risk factor for AVC in a cohort\r of 129 asymptomatic heterozygous FH patients aged between 40 and 69 years. In this study, AVC\r was significantly associated with plasma Lp(a) level, age, body mass index, blood pressure,\r duration of statin use, cholesterol-year score and coronary artery calcification (CAC) score.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Men or women with heterozygous FH aged between 18 and 80 years\r\n\r - FH patient carrying a documented mutation in the LDL receptor gene\r\n\r - Subjects must be willing to give written informed consent and able to adhere to visit\r schedule\r\n\r Exclusion Criteria:\r\n\r - Men or women < 18 or > 80 years\r\n\r - Non-FH subjects\r\n\r - History of alcohol or drug abuse within the past 2 years\r\n\r - Subjects who are in a situation or have any condition that, in the opinion of the\r investigator, may interfere with optimal participation in 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
|
630
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[
{
"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\nSafety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nSafety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis\n\n**Clinical Trial Detailed Description:**\n\nTo evaluate the safety and efficacy of Transfemoral Transcatheter Aortic Valve Implantation\r using SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in patients\r presenting with symptomatic severe aortic stenosis and with difficulty to safely undergo\r conventional surgical aortic valve replacement (AVR)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. At least one cardiologist and one cardiac surgeon agree that it is difficult for the\r patient to receive a surgical procedure due to medical factors such that the subject\r has various comorbidities and he/she is more likely to die or suffer from severe\r diseases than to have significant improvements by a surgical procedure.\r\n\r 2. Subject has senile degenerative aortic valve stenosis with:\r\n\r - mean gradient > 40 mmHg, or maximum jet velocity greater than 4.0 m/sec by either\r resting or dobutamine stress echocardiogram, or simultaneous pressure recordings\r at cardiac catheterization\r\n\r - AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5\r cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac\r catheterization\r\n\r 3. Subject is symptomatic from his/her aortic valve stenosis (AS), as demonstrated by New\r York Heart Association (NYHA) Functional Class II or greater.\r\n\r 4. The subject has been informed of the nature of this trial, agrees to its provisions\r and has provided written informed consent as approved by the IRB of the respective\r clinical site.\r\n\r 5. The subject or the subject's legal representative agrees to visit the site where\r he/she receives index procedure for all required post-procedure follow-ups.\r\n\r Exclusion Criteria:\r\n\r 1. Evidence of an acute myocardial infarction ≤ 30 days (The procedure day is counted as\r day 0.) before the implant procedure\r\n\r 2. Any percutaneous coronary or peripheral interventional procedures, including\r placements of bare metal stents are performed within 30 days prior to the implant\r procedure, or any drug eluting stents are placed within 6 months (One month is counted\r as 30 days.) prior to the implant procedure\r\n\r 3. Untreated clinically significant coronary artery disease (CAD) requiring\r revascularization\r\n\r 4. Blood dyscrasias as defined:\r\n\r leukopenia (WBC < 1,000/mm3), thrombocytopenia (platelet count <50,000 cells/mm3),\r history of bleeding diathesis or coagulopathy\r\n\r 5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or\r mechanical hemodynamic support\r\n\r 6. Need for emergency surgery for any reason\r\n\r 7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as\r measured by resting echocardiogram\r\n\r 8. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\r prior to the implant procedure (except mild TIA related to aortic stenosis)\r\n\r 9. End stage renal disease requiring chronic dialysis or serum creatinine > 3.0 mg/dL\r\n\r 10. Active Gastrointestinal (GI) bleeding within 3 months prior to the implant procedure\r\n\r 11. A known hypersensitivity or contraindication to any of the following which cannot be\r adequately pre-medicated:\r\n\r - Aspirin\r\n\r - Heparin (HIT/HITTS)\r\n\r - Nitinol (titanium or nickel)\r\n\r - P2Y12 inhibitors (such as Ticlopidine etc.)\r\n\r - Contrast media\r\n\r 12. Ongoing sepsis, including active endocarditis\r\n\r 13. Subject refuses a blood transfusion\r\n\r 14. Life expectancy < 12 months due to associated non-cardiac comorbid conditions\r\n\r 15. Other medical, social, or psychological conditions that in the opinion of a principal\r investigator or sub-investigator precludes the subject from appropriate consent\r\n\r 16. Severe dementia (unable to provide informed consent for the treatment/procedure,\r unable to live an independent life outside of a chronic care facility, or expected to\r be fundamentally unable to undergo rehabilitation after the procedure, or unable to\r come to the site for follow-up visits)\r\n\r 17. Currently participating in other trials of investigational drugs or other\r investigational devices\r\n\r 18. Native aortic annulus size < 21 mm or > 27 mm per the baseline diagnostic imaging\r\n\r 19. Pre-existing prosthetic heart valve and / or prosthetic ring in any position\r\n\r 20. Mixed aortic valve disease (aortic stenosis and predominant aortic regurgitation\r (3-4+))\r\n\r 21. Moderate to severe (3-4+) or severe (4+) mitral regurgitation or severe (4+) tricuspid\r regurgitation\r\n\r 22. Moderate to severe mitral stenosis\r\n\r 23. Hypertrophic obstructive cardiomyopathy\r\n\r 24. New or untreated echocardiographic evidence of intracardiac mass, thrombus or\r vegetation\r\n\r 25. Congenital bicuspid or unicuspid valve verified by echocardiograph\r\n\r 26. Extreme eccentric calcification of the native aortic valve\r\n\r 27. Transesophageal echocardiogram (TEE) is contraindicated.\r\n\r 28. Scheduled surgical or percutaneous procedure to be performed prior to 1-month visit\r post-implant procedure\r\n\r 29. Hepatic failure (Child C or more)\r\n\r 30. Aortic or peripheral condition NOT appropriate for transfemoral implant due to the\r size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral\r arteries\r\n\r 31. Thoracic or abdominal aortic aneurysm\r\n\r 32. Woman who is pregnant, breastfeeding or willing to become pregnant\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
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631
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[
{
"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\nSafety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation\n\n**Clinical Trial Summary:**\n\nA prospective, multicenter, nonrandomized, single-arm, clinical study.\n\n**Clinical Trial Detailed Description:**\n\nTo evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of\r patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for\r surgery.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Signed Informed Consent\r\n\r 2. Age ≥18years of age\r\n\r 3. Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA\r rating of NYHA ≥ II\r\n\r 4. Has undergone the diagnosis of at least one interventional cardiologist and two\r cardiac surgeons: the patients are contraindicated for traditional open heart valve\r replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible\r complications, or other influential post-operative factors [such as severe\r calcification in the ascending aorta and aortic valve, weak physical condition, chest\r deformities, severe liver diseases, severe lung diseases, etc.] or high risk for\r surgery (LogEuroSCORE≥20% and or STS≥8)\r\n\r 5. Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons\r that the patient may benefit from a valve implantation\r\n\r 6. Severe aortic stenosis with electrocardiography results as follows: mean transvalvular\r pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s,\r aortic valve area < 0.8 cm2 (or AVA index < 0.5 cm2/m2); and/or severe aortic\r regurgitation, electrocardiography results show symptomatic moderate regurgitation or\r severe regurgitation\r\n\r 7. Without severe pulmonary arterial hypertension\r\n\r 8. The patient is willing to cooperate with all follow-up visits.\r\n\r Anatomical Inclusion Criteria:\r\n\r 9. Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements;\r\n\r 10. Ascending aortic diameter <50mm at the sinotubular junction.\r\n\r Exclusion Criteria:\r\n\r 1. Patients with infection or who have any sign of infection\r\n\r 2. Previous history of endocarditis or patients with active endocarditis\r\n\r 3. Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non\r Q-wave MI with creatine kinase, an increase in troponin T)\r\n\r 4. Any cardiac mass discovered during echocardiography, left ventricular or atrial\r thrombosis\r\n\r 5. Suffering from uncontrollable atrial fibrillation\r\n\r 6. Hereditary hypertrophic cardiomyopathy\r\n\r 7. Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater)\r\n\r 8. Has previously undergone aortic valve implantation (mechanical valve or biological\r valve frame)\r\n\r 9. Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications,\r nitinol or porcine products\r\n\r 10. Is known to be contraindicated for or is allergic to all anti-coagulants or is unable\r to use anti-coagulants during the study\r\n\r 11. Is known to have one of the following conditions (according to evaluations beginning\r from screening through the day of the procedure):\r\n\r - Other diseases that may reduce the life expectancy to less than 12 months (such\r as clinically recurrent or metastatic cancer, congestive heart failure, etc.)\r\n\r - Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.)\r\n\r - Plans to undergo surgery that may result in non-compliance with the study\r protocol or that may cause confusion in data interpretation.\r\n\r 12. Has experienced a cerebrovascular accident (CVA) within the last 6 months\r\n\r 13. Patients suffering from stenosis of the carotid, internal carotid, or vertebral\r arteries (70%)\r\n\r 14. White cell count <3×109/L, platelet count<50×109/L\r\n\r 15. Hemoglobin <90 g/L\r\n\r 16. Severely lowered left ventricular function, left ventricular ejection fraction < 20 %\r\n\r 17. Aortic aneurysm in the abdomen or chest\r\n\r 18. Hepatic encephalopathy or acute active hepatitis\r\n\r 19. Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L)\r\n\r 20. Prone to bleeding, has a history of clotting disorders or refuses blood transfusions\r\n\r 21. Active ulcer or active gastrointestinal (GI) bleeding\r\n\r 22. Suffering from nervous system diseases that severely influence the patients' ability\r to move or to perform daily activities\r\n\r 23. Patients with severe dementia\r\n\r 24. Any reason for emergent surgery\r\n\r 25. Taking part in other clinical trials for pharmaceuticals or medical devices\r\n\r 26. Those who are pregnant, plan to become pregnant, or who are taking estrogen or\r estrogen-like drugs (women suspected of being pregnant must test negative on a urine\r pregnancy test or for chorionic gonadotropin serum).\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
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632
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[
{
"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 Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess the safety and effectiveness of newly initiated\r dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in\r comparison to newly initiated rivaroxaban users and newly initiated apixaban users\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18+ on index date\r\n\r - Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban\r identified by pharmacy claim during the study period. The first dispensing date of\r either study drug will be defined as the index date;\r\n\r - Patients must be treatment naïve from all OAC use prior to the first NOAC\r prescription, during study period.\r\n\r - Patients must have at least 12 months of continuous eligibility prior to the index\r date;\r\n\r - Patients must have at least one diagnosis code of atrial fibrillation, defined as\r International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM\r diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index\r period.\r\n\r Exclusion Criteria:\r\n\r Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC\r drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the\r pre-index period\r\n\r Having at least one claim for alternative indications; orthopedic procedures, Venous\r thromboembolism (VTE) (includes deep vein thrombosis (DVT ) & PE)) and the index NOAC\r prescription at the same time, or, the alternative indication for anticoagulant occurring\r within 3 months prior to index date in pre-period Having at least one claim with any of the\r following diagnoses or procedure codes in order to exclude patients with \"transient\" causes\r of Afib (3 months prior to index date in pre-period):\r\n\r - Cardiac surgery\r\n\r - Pericarditis\r\n\r - Myocarditis Having at least one medical claim with any of the following diagnoses or\r procedures codes in order to exclude patients with \"valvular\" Afib (pre-period):\r\n\r - Mitral stenosis\r\n\r - Mitral stenosis with insufficiency\r\n\r - Mitral valve stenosis and aortic valve stenosis\r\n\r - Mitral valve stenosis and aortic valve insufficiency\r\n\r - Diseases of other endocardial structures\r\n\r - Other and unspecified rheumatic heart diseases\r\n\r - Open heart valvuloplasty without replacement\r\n\r - Open and other replacement of unspecified heart valve\r\n\r - Open and other replacement of aortic valve\r\n\r - Open and other replacement of mitral valve\r\n\r - Open and other replacement of pulmonary valve\r\n\r - Open and other replacement of tricuspid valve\r\n\r - Heart valve replaced by transplant\r\n\r - Heart valve replaced by a mechanical device/prosthesis\r\n\r - Atrioventricular valve repair\r\n\r - Aortic valve valvuloplasty\r\n\r - Unlisted procedure, cardiac surgery\r\n\r - Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic\r approach\r\n\r - Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for\r catheter-delivered aortic valve replacement; without cardiopulmonary bypass\r\n\r - Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for\r catheter-delivered aortic valve replacement; with cardiopulmonary bypass\r\n\r - Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other\r than homograft or stentless valve\r\n\r - Valvuloplasty, mitral valve, with cardiopulmonary bypass\r\n\r - Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring\r\n\r - Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with\r or without ring\r\n\r - Replacement, mitral valve, with cardiopulmonary bypass\r\n\r - Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach\r\n\r - Replacement, pulmonary valve\r\n\r - Valvectomy, tricuspid valve, with cardiopulmonary bypass\r\n\r - Valvuloplasty, tricuspid valve; without ring insertion\r\n\r - Valvuloplasty, tricuspid valve; with ring insertion\r\n\r - Replacement, tricuspid valve, with cardiopulmonary bypass\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
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633
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[
{
"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\nAscending Aortic Dilation in BiAV After TAVR\n\n**Clinical Trial Summary:**\n\nThis study sought to evaluate changes in ascending aorta size after transcatheter aortic\r valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients\r with tricuspid aortic valve (TAV).\n\n**Clinical Trial Detailed Description:**\n\nThe growth rate of ascending aorta was calculated as annual growth rate using baseline and\r the last echocardiography. The difference in ascending aorta growth rates between the two\r groups (BiAV and TAV) were analyzed by independent t-test.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Severe AS who underwent TAVR\r\n\r Exclusion Criteria:\r\n\r - ascending aorta more than 50mm\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
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634
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[
{
"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\nPCSK9 Inhibitors in the Progression of Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nInvestigators plan evaluate whether PCSK9 inhibitors, a medication that can lower\r lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis,\r through a randomized controlled trial.\n\n**Clinical Trial Detailed Description:**\n\nAortic valve disease is the most common form of heart valve disease and is a major burden to\r society. Aortic valve disease is also expected to become more prevalent with the aging. Among\r aortic diseases, 'aortic stenosis (AS)', which is a narrowing of the aortic valve, and leads\r to symptoms of heart failure and sometimes death.\r\n\r For treatment of AS, the valve in replaced in a surgical to percutaneous method. Regardless\r of the method, valve replacement has its potential costs and complications that is an\r important issue that needs to be solved. Therefore, controlling the progression of AS and\r increasing the efficacy of medical therapy before valvular replacement is needed, is an\r important medico-social problem.\r\n\r Regarding the pathophysiology of AS, an elevation of lipoprotein(a) and dyslipidemia have\r been reported to be associated with the progression of cardiovascular calcification.\r\n\r PCSK9 inhibitors, which is a medication that can control both lipoprotein(a) and dyslipidemia\r may be a effective medication to control the progression of AS.\r\n\r Therefore, investigators will perform a randomized control trial, to compare the effect of\r PCSK9 inhibitors vs. placebo in its influence to AS progression.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. The patient agrees to participate in this study by signing the informed consent form.\r Alternatively, a legally authorized patient representative may agree to the patient's\r participation in this study and sign the informed consent form.\r\n\r 2. The patient has a working diagnosis of aortic stenosis (mild to moderate), and has\r fair treatment compliance.\r\n\r Exclusion Criteria:\r\n\r 1. Age under 19 years old\r\n\r 2. Hypersensitivity to PCSK9 inhibitor\r\n\r 3. LDL cholesterol < 70mg/dL at baseline\r\n\r 4. Poor treatement compliance (The patient will need to visit the out-patient clinic\r every 2-weeks for medication)\r\n\r 5. Positive pregnancy test or is known to be pregnant\r\n\r 6. Any other reason the investigator deems the subject to be unsuitable for the study\r (e.g., Active malignant tumor, Any life-threatening condition with life expectancy\r less than 6months, etc.)\r\n\r 7. Any clinically significant abnormality identified at the screening visit, physical\r examination, laboratory tests, or electrocardiogram which, in the judgment of the\r investigator, would preclude safe completion of 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
|
635
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[
{
"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 the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access\n\n**Clinical Trial Summary:**\n\nExpand the indication of the Portico TF Delivery System and obtain approval of the\r Alternative Access Delivery System\n\n**Clinical Trial Detailed Description:**\n\nExpand the indication of the Portico TF Delivery System and obtain approval of the\r Alternative Access Delivery System to place a Portico transcatheter aortic valve through an\r alternative access site, specifically subclavian/axillary or transaortic (TAo) in subjects\r with symptomatic severe native aortic stenosis who are considered high surgical risk\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subject has provided written informed consent prior to uploading CT scan to core lab.\r\n\r 2. Subject is ≥ 18 years of age or legal age in host country.\r\n\r 3. Subject's aortic annulus diameter meets the range indicated in the Instructions for\r Use as measured by multislice CT conducted within 180 days prior to the index\r procedure.\r\n\r 4. Subject has senile degenerative aortic stenosis seen by echocardiography within 90\r days of index procedure as measured by:\r\n\r 1. mean gradient >40 mmHg\r\n\r 2. Peak velocity ≥ 4.0 m/s\r\n\r 3. Doppler Velocity Index <0.25\r\n\r 4. Aortic valve area (AVA) of ≤ 1.0 cm2 or indexed EOA ≤ 0.6 cm2/m2).\r\n\r 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional\r Classification of Class II, or greater or other symptoms of aortic stenosis (e.g.\r syncope).\r\n\r 6. Subject is deemed high operable risk and preferred TAVI delivery route is alternate\r access (subclavian/axillary or direct aortic) per the medical opinion of the center's\r heart team and confirmed by SSC.\r\n\r - High risk is defined as an STS mortality > 8% or documented heart team agreement\r ≥ high risk for SAVR due to frailty or co-morbidities\r\n\r Exclusion Criteria:\r\n\r 1. Subject is unwilling or unable to comply with all study-required follow-up\r evaluations.\r\n\r 2. Subject has a documented history of a cerebral vascular accident (CVA) or transient\r ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the\r index procedure.\r\n\r 3. Subject has carotid artery disease requiring intervention.\r\n\r 4. Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient\r index procedure.\r\n\r 5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid,\r quadricuspid or non-calcified as seen by echocardiography.\r\n\r 6. Subject has severe mitral valvular regurgitation.\r\n\r 7. Subject has severe mitral stenosis.\r\n\r 8. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any\r position.\r\n\r 9. Subject refuses any blood product transfusion.\r\n\r 10. Subject has resting left ventricular ejection fraction (LVEF) less than 20%.\r\n\r 11. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring\r revascularization.\r\n\r 12. Subject has had a percutaneous interventional or other invasive cardiovascular or\r peripheral vascular procedure less than or equal to 14 days prior to index procedure.\r\n\r 13. Subject has severe basal septal hypertrophy that would interfere with transcatheter\r aortic valve placement.\r\n\r 14. Subject has a history of, or is currently diagnosed with, endocarditis.\r\n\r 15. There is imaging evidence of intracardiac mass, thrombus, or vegetation.\r\n\r 16. Subject is considered hemodynamically unstable (requiring inotropic support or\r mechanical heart assistance).\r\n\r 17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to\r stabilize heart failure.\r\n\r 18. Subject with severe pulmonary disease as determined by STS score.\r\n\r 19. Subject is on chronic oral steroid therapy.\r\n\r 20. Subject has a documented hypersensitivity or contraindication to anticoagulant or\r antiplatelet medication.\r\n\r 21. Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0\r mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis.\r\n\r 22. Subject has morbid obesity defined as a BMI greater than or equal to 40.\r\n\r 23. Subject has ongoing infection or sepsis.\r\n\r 24. Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute\r anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,).\r\n\r 25. Anatomy falling outside the recommended values in the IFU, unless specifically\r approved by the Subject Selection Committee.\r\n\r 26. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90\r days prior to the index procedure.\r\n\r 27. Subject is currently participating in another investigational drug or device study,\r unless approved by the Sponsor.\r\n\r 28. Subject has/had emergency surgery for any reason within 30 days of the index\r procedure.\r\n\r 29. Subject has a life expectancy less than 1 year.\r\n\r 30. Subject has other medical, social or psychological conditions that, in the opinion of\r the Principal Investigator or the Subject Selection Committee, preclude the subject\r from study participation.\r\n\r 31. Subject is diagnosed with a state of dementia which would fundamentally complicate\r rehabilitation from the procedure or compliance with follow-up visits.\r\n\r 32. Subject has a documented allergy to contrast media that cannot adequately be treated,\r nitinol alloys, porcine tissue, or bovine tissue.\r\n\r 33. Significant aortic disease including abdominal aortic or thoracic aneurysm defined as\r maximal luminal diameter 5cm or greater\r\n\r 34. Subjects with severe pulmonary hypertension and severe RV dysfunction\r\n\r 35. Subjects with hypertrophic cardiomyopathy\r\n\r Transaortic Subject Cohort Specific Exclusion Criteria\r\n\r Subjects are not eligible for participation in the TAo access arm if they meet any of the\r following exclusion criteria:\r\n\r 1. Subject has a chest condition (anatomical or otherwise) that prevents TAo access.\r\n\r 2. Subject has pre-existing patent RIMA graft that would preclude access.\r\n\r 3. Subject has a porcelain aorta, defined as an extensive circumferential calcification\r of the ascending aorta that would complicate TAo access.\r\n\r Subclavian/Axillary Subject Cohort Specific Exclusion Criteria\r\n\r Subjects are not eligible for participation in the subclavian/axillary access arm if they\r meet any of the following exclusion criteria:\r\n\r 1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction\r of the 18/19 Fr delivery system.\r\n\r 2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.\r\n\r 3. Subject has a history of LIMA/RIMA graft that would preclude access\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"
}
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possibly relevant
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636
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[
{
"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 mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure\n\n**Clinical Trial Summary:**\n\nThis study will evaluate how the cardiovascular system interacts with mechanical hearts to\r provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the\r impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2)\r to define the primary determinant(s) of exercise capacity in heart failure patients before\r and after device implantation.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nAdvanced Heart Failure-\r\n\r Inclusion Criteria:\r\n\r - Individuals with severely reduced left ventricular systolic function that are\r scheduled to undergo LVAD insertion\r\n\r Exclusion Criteria:\r\n\r - uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA\r signal)\r\n\r - Individuals with clinical right ventricular failure, defined as moderate-severely\r reduced RV systolic function on echocardiography, or clinical evidence of RV failure\r (elevated jugular venous pressures, significant peripheral edema)\r\n\r - Individuals with moderate-severe preexisting aortic insufficiency, as these patients\r will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close\r the aortic valve and prevent worsening aortic insufficiency; and\r\n\r - Disorders that adversely influence exercise ability (e.g. arthritis, peripheral\r vascular disease, pulmonary disease)\r\n\r Mild Heart Failure -\r\n\r Inclusion Criteria:\r\n\r - Individuals with medically managed left ventricular systolic function that are NOT\r scheduled to undergo LVAD insertion\r\n\r - HF patients with ejection fraction <35-40%\r\n\r Exclusion Criteria:\r\n\r - Individuals requiring systemic anticoagulation with vitamin-K antagonists or\r new/direct oral anticoagulants (\"NOAC\"/\"DOAC\")\r\n\r - Disorders that adversely influence exercise ability (e.g. arthritis, peripheral\r vascular disease, pulmonary disease)\r\n\r - History of uncontrolled arrhythmias (e.g. ventricular tachycardia or nonsustained\r ventricular tachycardia).\r\n\r Healthy Controls -\r\n\r Inclusion Criteria:\r\n\r - Persons without a past medical history of cardiovascular disease or related disease (e.g.\r hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic\r attack) and are not taking any cardiac-related medications (e.g. antihypertensive\r medications)\r\n\r Exclusion Criteria:\r\n\r - Individuals requiring systemic anticoagulation with vitamin-K antagonists or\r new/direct oral anticoagulants (\"NOAC\"/\"DOAC\")\r\n\r - Disorders that adversely influence exercise ability (e.g. arthritis, peripheral\r ascular 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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637
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[
{
"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\nEndovascular Therapy for Renal Artery Stenosis in China\n\n**Clinical Trial Summary:**\n\nA multicenter prospective registry planned to recruit more than 5 000 patients with renal\r artery stenosis was carried out in China. This primary purpose of this study was to evaluate\r the safety and efficacy of renal artery revascularization in the real world. The secondary\r purpose was to investigate the etiologic distribution of renal artery stenosis and optimize\r the indications for renal artery revascularization.\n\n**Clinical Trial Detailed Description:**\n\nCurrently,the endovascular therapy of renal artery stenosis (especially atherosclerotic)\r remains in dispute. Some randomized control trials published in recent years (including\r ASTRAL and CORAL trials) showed the lack of additional benefit for renal artery\r revascularization compared with sole medical therapy. However,these randomized control trials\r presented a number of limitations including low numbers of patients and non-stringent\r inclusion criteria. Given clinical medical practice entering the era of big data, the\r large-sample real-word studies would be more objective to answer some pending issues of\r randomized controlled trial.Therefore,a multicenter prospective registry planned to recruit\r more than 5 000 patients with renal artery stenosis was carried out. This primary purpose of\r this study was to evaluate the safety and efficacy of renal artery revascularization in the\r real world. The secondary purpose was to investigate the etiologic distribution of renal\r artery stenosis and optimize the indications for renal artery revascularization.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age ≥ 14 at the time of informed consent\r\n\r 2. Diameter reduction of renal artery or main branch of renal artery≥ 60%,and ≥2 of four\r following conditions met:1)systolic hyperemic pressure gradient >20 mm Hg,2)captopril\r renoscitigraphy positive in the lesion side\r\n\r ,3)renin-angiotensin-aldosterone system significantly activated and 4)severe reduction\r (>25%) of glomendar filtration rate in the lesion side\r\n\r 3. office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg\r while receiving 3 antihypertensive drugs,or office systolic blood pressure ≥160 mmHg\r and/or diastolic blood pressure ≥100 mmHg without antihypertensive drugs\r\n\r 4. Serum creatinine level<264umol/L\r\n\r 5. Length of ipsilateral kidney ≥7.0 cm and glomendar filtration rate ≥10 ml／min\r\n\r 6. Urine protein <2+\r\n\r Exclusion Criteria:\r\n\r 1. Unable to provide informed consent\r\n\r 2. Unstable condition and unable to tolerate interventional therapy\r\n\r 3. intolerance to antiplatelet drugs or contrast medium\r\n\r 4. vascular anatomy not suitable for endovascular therapy\r\n\r 5. Pregnant, nursing, or planning to be pregnant\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
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638
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[
{
"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\nREPRISE China - Clinical Evaluation in China\n\n**Clinical Trial Summary:**\n\nTo evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter\r aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native\r aortic stenosis who are considered at high risk for surgical valve replacement.\n\n**Clinical Trial Detailed Description:**\n\n1. A independent Clinical Events Committee (CEC) will adjudge the safety endpoint.\r\n\r 2. Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's\r assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review\r Committee [CRC]).\r\n\r 3. Monitor will review the source data regularly to compare the EDC to ensure the data\r entry can be accuracy, completeness, or representativeness.\r\n\r 4. Will recruit maximum 62 subjects in maximum 6 sites\r\n\r 5. Boston Scientific's Standard Operating Procedures to address operations and analysis\r activities, such as patient recruitment, data collection, data management, data\r analysis, reporting for adverse events, and change management.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 70 years.\r\n\r - Subject has documented calcific, severe native aortic stenosis with an initial AVA of\r <1.0 cm2 (or AVA index of <0.6 cm2/m2), and a mean pressure gradient ≥40 mm Hg or jet\r velocity ≥4.0 m/s or doppler velocity index ≤0.25, as measured by echocardiography\r and/or invasive hemodynamics.\r\n\r - Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the\r center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case\r Review Committee [CRC]).\r\n\r - Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.\r\n\r - There is agreement by the heart team (which must include a site investigator\r interventionalist and a site investigator cardiac surgeon) that subject is at high\r operative risk for surgical valve replacement (see note below for definition of high\r risk, the required level of surgical assessment, and CRC confirmation) and that TAVR\r is appropriate. Additionally, subject has at least one of the following.\r\n\r - Society of Thoracic Surgeons (STS) score ≥ 8% -OR-\r\n\r - If STS < 8%, subject has at least one of the following conditions:\r\n\r - Hostile chest\r\n\r - Porcelain aorta\r\n\r - Severe pulmonary hypertension (> 60 mmHg)\r\n\r - Prior chest radiation therapy\r\n\r - Coronary artery bypass graft(s) at risk with re-operation\r\n\r - Severe lung disease (need for supplemental oxygen, FEV1 < 50% of predicted,\r DLCO < 60%, or other evidence of severe pulmonary dysfunction)\r\n\r - Neuromuscular disease that creates risk for mechanical ventilation or\r rehabilitation after surgical aortic valve replacement\r\n\r - Orthopedic disease that creates risk for rehabilitation after surgical\r aortic valve replacement\r\n\r - Childs Class A or B liver disease (subjects with Childs Class C disease are\r not eligible for inclusion in this trial)\r\n\r - Frailty as indicated by at least one of the following: 5-meter walk > 6\r seconds, Katz ADL score of 3/6 or less, body mass index < 21, wheelchair\r bound, unable to live independently\r\n\r - Age ≥ 90 years\r\n\r - Other evidence that subject is at high risk for surgical valve replacement\r (CRC must confirm agreement with site heart team that subject meets high\r risk definition)\r\n\r - Heart team (which must include a cardiac interventionalist and an experienced cardiac\r surgeon) assessment that the subject is likely to benefit from valve replacement.\r\n\r - Subject (or legal representative) understands the study requirements and the treatment\r procedures, and provides written informed consent\r\n\r - Subject, family member, and/or legal representative agree(s) and subject is capable of\r returning to the study hospital for all required scheduled follow up visits.\r\n\r Exclusion Criteria:\r\n\r - Subject has a congenital unicuspid aortic valve or Sievers Type 2 bicuspid aortic\r valve.\r\n\r - Subject has had an acute myocardial infarction within 30 days prior to the index\r procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice\r normal in the presence of CK-MB elevation and/or troponin elevation).\r\n\r - Subject has had a cerebrovascular accident or transient ischemic attack within the\r past 6 months prior to study enrollment.\r\n\r - Subject has end-stage renal disease or has serum creatinine > 3mg/dl or has creatinine\r clearance rate <45ml/min.\r\n\r - Subject has a pre-existing prosthetic aortic or mitral valve.\r\n\r - Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.\r\n\r - Subject has a need for emergency surgery for any reason.\r\n\r - Subject has a history of endocarditis within 6 months of index procedure or evidence\r of an active systemic infection or sepsis.\r\n\r - Subject has echocardiographic evidence of new intra-cardiac vegetation or\r intraventricular or paravalvular thrombus requiring intervention.\r\n\r - Subject has platelet count < 50,000 cells/mm3 (50×109/L) or > 700,000 cells/mm3\r (700×109/L), or white blood cell count < 1,000 cells/mm3 (1×109/L).\r\n\r - Subject requires chronic anticoagulation therapy after the implant procedure and\r cannot be treated with warfarin (other anticoagulants are not permitted in the first\r month) for at least 1 month concomitant with either aspirin or clopidogrel.\r\n\r - Subject has had a gastrointestinal bleed requiring hospitalization or transfusion\r within the past 3 months, or has other clinically significant bleeding diathesis or\r coagulopathy that would preclude treatment with required antiplatelet regimen, or will\r refuse transfusions\r\n\r - Subject has known hypersensitivity to contrast agents that cannot be adequately\r pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors,\r heparin, nickel, tantalum, titanium, or polyurethanes\r\n\r - Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid\r conditions based on the assessment of the investigator at the time of enrollment\r\n\r - Subject has hypertrophic obstructive cardiomyopathy\r\n\r - Subject has any therapeutic invasive cardiac or vascular procedure within 30 days\r prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker\r implantation, which is allowed)\r\n\r - Subject has untreated coronary artery disease, which in the opinion of the treating\r physician is clinically significant and requires revascularization\r\n\r - Subject has severe left ventricular dysfunction with ejection fraction < 20%\r\n\r - Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic\r support or mechanical support devices\r\n\r - Subject has severe vascular disease that would preclude safe access (e.g., aneurysm\r with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing\r of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid\r or vertebral disease)\r\n\r - Subject has thick (> 5 mm) protruding or ulcerated atheroma in the aortic arch\r\n\r - Subject has an enlarged ascending aorta with the diameter > 50mm\r\n\r - Subject has arterial access that is not acceptable for the study device delivery\r system as defined in the device Instructions For Use\r\n\r - Subject has current problems with substance abuse (e.g., alcohol, etc.)\r\n\r - Subject is participating in another investigational drug or device study that has not\r reached its primary endpoint\r\n\r - Subject has untreated conduction system disorder (e.g., Type II second degree\r atrioventricular block) that in the opinion of the treating physician is clinically\r significant and requires a pacemaker implantation. Enrollment is permissible after\r permanent pacemaker implantation\r\n\r - Subject has severe incapacitating dementia\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
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639
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[
{
"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\nMini-invasive Balloon Aortic Valvuloplasty\n\n**Clinical Trial Summary:**\n\nThe spreading of transcatheter aortic valve implantation has paradoxically increased the\r spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is\r currently used as destination therapy for patients excluded from transcatheter aortic valve\r implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic\r valve replacement, or as a stratification tool for selected high-risk patients who cannot be\r immediate candidates for transcatheter aortic valve implantation. Moreover, it has been\r recently showed that transcatheter aortic valve implantation without balloon aortic\r valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon\r aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve\r implantation, mainly related to access site or temporary pacemaker implantation. Thus, a\r transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular\r support wire could be extremely appealing.\n\n**Clinical Trial Detailed Description:**\n\nConsecutive patients with severe aortic stenosis with indication to aortic balloon\r valvuloplasty will be enrolled. An ad hoc informed consent for the procedure will be obtained\r from all patients.\r\n\r This is a prospective observational study. The Investigators will include patients where\r aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker\r implantation. The aim is to register and monitor the effectiveness and safety of this\r approach. Details regarding management of radial access and pacing with 0.035 wire can be\r found in the references reported below. The primary endpoint will be the 30-day occurence of\r minor and major vascular complications according VARC 2 classification. The safety endpoint\r will be the absence of intra- or periprocedural major complications in transradial balloon\r aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical\r intervention.\r\n\r The feasibility endpoint will be a procedural success rate ≥90%. The efficacy endpoint will\r be a reduction of the mean invasive gradient >30%. At baseline, Handgrip strength test will\r be performed and angiography of the instrumented arm will be performed at the beginning and\r at the end of the procedure. All patients will be prospectively followed-up for at least 30\r days and all adverse events will be recorded. All patients will be assessed also for frailty\r according the clinical frailty scale (CFS). During the 30-day follow-up visit two independent\r blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip\r strength test in in both arms in all patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty\r\n\r Exclusion Criteria:\r\n\r - cardiogenic shock\r\n\r - bilateral absence of radial pulse\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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640
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"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 of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in AF Undergoing TAVI\n\n**Clinical Trial Summary:**\n\nStudy category and Rationale Clinical study, Category A.\r\n\r Clinical Phase: Post market study\r\n\r Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral\r anticoagulation and provides at the same time an at least equally good protection from\r strokes and peripheral embolism. It may therefore be an attractive alternative to oral\r anticoagulation in the patient population undergoing transcatheter aortic valve implantation\r (TAVI): the concept of LAAO is based on the fact that thrombus formation in atrial\r fibrillation occurs in >90% in the left atrial appendage (LAA). Mechanical occlusion of the\r LAA reduces the stroke risk by eliminating the source of thrombus formation. In the here\r proposed \"Randomized Comparison of Left Atrial Appendage Occlusion versus Standard Medical\r Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve\r Implantation\", study we test the hypothesis, that LAAO is superior to standard medical\r therapy in the high-risk TAVI population. This hypothesis has not been investigated by\r previous studies so far.\r\n\r Overall Objective(s): Overall objective: to compare the safety (and efficacy) of LAAO using\r the St. Jude left atrial appendage closure device with standard medical therapy in a\r prospective, multi-center, randomized trial in patients undergoing TAVI in routine clinical\r practice.\r\n\r Primary Objective: To assess the safety of the device intervention with regard to stroke\r prevention and prevention of bleeding complications in a patients population at high risk of\r stroke and bleeding.\r\n\r Secondary Objectives: Short-term (procedural) safety of device intervention is assessed (rate\r of successful deployment of a left atrial appendage occluder; rate of kidney failure). As a\r further secondary objective, long-term effects of device intervention on stroke and bleeding\r prevention as well as mortality are assessed and compared to medical therapy.\r\n\r Outcome(s): Primary: Composite endpoint of ischemic and hemorrhagic neurologic events,\r peripheral embolism, life-threatening/disabling and major bleeding complications and\r cardiovascular mortality at 1 year\r\n\r Secondary: All deaths (cardiac and non-cardiac) at 30 days, 1, 3, and 5 years Device success\r at 30 days\r\n\r In-hospital acute kidney injury (AKI)\r\n\r Study design: An investigator-initiated, randomized, multicenter, non-blinded, all-comers\r study\r\n\r Measurements and Procedures: 80 patients in atrial fibrillation undergoing TAVI will be\r randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or SMT at the\r operators' discretion (medical group; antiplatelet therapy and oral anticoagulation or oral\r anticoagulation alone). All patients will be followed for up to 5 years. The primary analysis\r will be performed at 30 days and after completion of a 1-year follow-up.\r\n\r 80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded\r fashion (1:1 randomization) to LAAO (device group) or standard medical therapy (SMT) at the\r operators' discretion (medical group; antiplatelet therapy, oral anticoagulation or oral\r anticoagulation alone).\r\n\r Estimated duration for the main investigational plan from start of screening of first\r participant to last participant processed and finishing the study: 6 years\n\n**Clinical Trial Detailed Description:**\n\nBackground and Rationale\r\n\r Transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment option for\r patients suffering from severe symptomatic aortic stenosis. Superiority of TAVI over medical\r treatment has been shown in the randomized PARTNER B trial followed by the PARTNER A trial\r showing non-inferiority over a more invasive open-heart surgical aortic valve replacement in\r high-risk patients. Over the last years, many patients have been successfully treated with\r TAVI worldwide.\r\n\r Peri- and post-procedural morbidity differed considerably between the surgical and\r interventional treatment group in the PARTNER A trial: while major bleeding (19.5% vs 9.3% at\r 30 days) and new onset atrial fibrillation (16% vs 8.6% at 30 days) occur more often in\r surgically treated patients, vascular access complications (3.8 vs 17% at 30 days) and\r neurologic events (5.5% vs 2.4% at 30 days) are more frequently encountered in the TAVI\r population. The higher rate of neurologic events in the TAVI group was of particular concern,\r given its association with a higher mortality and the clinical impact of major neurologic\r events on patient's quality of life and daily functioning. Only about 40-50% of strokes occur\r intra-procedurally, followed by a higher hazard rate in the first week and a constant hazard\r thereafter. After 30 months, the surgical group experienced a numerically higher stroke rate,\r although not statistically significant. Measures to reduce procedural and post-procedural\r stroke rate were and are still looked for.\r\n\r While procedural strokes can be most likely reduced by improvements in valve delivery systems\r (smaller delivery systems) and more operator experience, cerebral protection devices are\r currently tested in trials but preliminary results are rather disappointing. Risk factors for\r post-procedural strokes after TAVI are a previous history of stroke, more extensive\r peripheral vascular disease, and higher functional class.\r\n\r A subgroup of patients of particular concern are patients suffering from atrial fibrillation:\r predictor of early (day 1-30) cerebrovascular events was new-onset atrial fibrillation (OR\r 2.76), whereas chronic atrial fibrillation was a predictor (OR 2.84) for the occurrence of\r late (>30 days) cerebrovascular events. Amat-Santos reported a higher rate of\r strokes/systemic embolism in patients with in hospital new onset atrial fibrillation after\r TAVI (13.6% vs 3.2% after 30 days). Patients diagnosed with new onset atrial fibrillation\r during or after the procedure in which no anticoagulation was initiated experienced an\r alarmingly high 30-day stroke rate of 40%.\r\n\r Despite these results and the high prevalence of atrial fibrillation (AF) of about 33% in the\r overall TAVI population, only 30% of AF patients were on vitamin K antagonists (VKA) before,\r and only 70% after TAVI. While oral anticoagulation is an effective medical treatment for\r ischemic stroke prevention in these patients, it is often withheld from patients given their\r high risk of bleeding. TAVI patients typically not only suffer from much co-morbidity and are\r poly-medicated, but also suffer from a lot of bleeding risk factors. The bleeding risk score\r (HASBLED score) expresses the risk of major bleeding with a scoring system consisting of 9\r individual risk factors for bleeding; a patient is at high risk for bleeding, if 3 or more\r factors are present. The stroke risk score (CHA2DS2-Vasc score) comprises of 9 individual\r risk scores for stroke in patients suffering from atrial fibrillation. Both risk scores share\r common risk factors, such as age, hypertension and previous stroke. It is therefore not\r surprising that patients at highest risk for stroke are at the same time at highest risk for\r major bleedings. The TAVI population forms such a high risk group with a high prevalence of\r the above risk factors: average patients age in the PARTNER trial was 84 years, with 11%\r showing severe renal impairment, about 75% had an indication for concomitant acetylsalicylic\r acid use and all suffered per definition from heart failure. In Stortecky's study on TAVI\r patients suffering AF, the average CHA2DS2-Vasc score was 4.5, with >95% of patients having a\r score >3.\r\n\r Left atrial appendage occlusion (LAAO) allows avoiding oral anticoagulation and provides at\r the same time an at least equally good protection from strokes and peripheral embolism. It\r may therefore be an attractive alternative to oral anticoagulation in the TAVI patient\r population: the concept of LAAO is based on the fact that thrombus formation in atrial\r fibrillation occurs in >90% in the left atrial appendage (LAA). Mechanical occlusion of the\r LAA reduces the stroke risk by eliminating the source of thrombus formation.\r\n\r Clinical studies proved this concept to be true: the PROTECT-AF study randomized >700\r patients to either LAA occlusion or medical therapy (VKA). At one year, non-inferiority of\r LAAO was proven, with numerically less embolic events in the LAAO group. At a European\r conference (EuroPCR conference) 2013, Holmes (principal investigator of the PROTECT-AF trial)\r reported 4-year follow-up data with a significant 40% reduction of the composite of\r stroke/peripheral embolism/cardiovascular death and a 34% reduction of all cause mortality in\r the LAAO group as compared to oral anticoagulation. By reducing bleeding complications, it\r can be anticipated that morbidity and mortality will continue to diverge between the two\r groups. Comparable results from a large registry using Amplatzer devices (St. Jude Medical,\r St. Paul, USA) for LAAO were reported: after an average follow-up of 32 months,\r cardiovascular death, stroke, and peripheral embolism occurred in 7% of patients. In the\r latter study, oral anticoagulation was instantly stopped after LAAO in all patients.\r\n\r In the here proposed \"Randomized Comparison of Left Atrial Appendage Occlusion versus\r Standard Medical Therapy of Atrial Fibrillation in Patients Undergoing Transfemoral\r Transcatheter Aortic Valve Implantation\", study the investigators test the hypothesis, that\r LAAO is superior to standard medical therapy in the high-risk TAVI population. This\r hypothesis has not been investigated by previous studies so far. The design is an\r investigator-initiated, randomized, multicenter, non-blinded, all-comers study. It is\r understood, that this is a pilot trial with the intention to prove safety, but which is\r underpowered to show superiority over medical therapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Severe aortic valve stenosis with an indication for aortic valve replacement (e.g.,\r symptomatic patient, decreased left ventricular (LV) function)\r\n\r - Suitable anatomy for transfemoral TAVI with the Portico Transcatheter Aortic Valve\r System (ileofemoral arterial diameter, annulus-coronary distance, annulus diameter)\r\n\r - No mobile thrombus in the LA or LAA precluding LAAO\r\n\r - Atrial fibrillation with a CHA2DS2-Vasc-Score >=1. No limitation regarding the nature\r of atrial fibrillation (paroxysmal, permanent, persistent)\r\n\r Exclusion Criteria:\r\n\r - Pregnancy\r\n\r - Known intolerance to aspirin, heparin, contrast media or clinically manifest nickel\r allergy\r\n\r - Inability to provide informed consent\r\n\r - Mechanical heart valve or other indication for oral anticoagulation (i.e. recent\r pulmonary embolism)\r\n\r - Contraindication for oral anticoagulation\r\n\r - Currently participating in another 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"
}
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definitely relevant
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641
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[
{
"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 Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS\n\n**Clinical Trial Summary:**\n\nAortic stenosis is the most common valvular disease in the Western world. It is caused by\r progressive narrowing of the aortic valve leading to increased strain on the heart muscle\r which has to work increasingly hard to pump blood through the narrowed valve. Over time the\r heart muscle thickens to generate more force, but eventually the heart fails leading to death\r if the valve is not replaced with an operation. No medical treatments exist to stop or\r reverse the heart valve narrowing. Current clinical guidelines suggest that an operation\r should be performed only when symptoms develop or the heart muscle is visibly weak on cardiac\r ultrasound scanning. However, symptoms can be difficult to interpret and in many patients the\r heart muscle has become irreversibly damaged and the heart fails to recover following\r surgery.\r\n\r Using MRI scans of the heart, the investigators have identified heart scarring which seems to\r develop as the heart muscle thickens. Several studies now show that people who have developed\r this scarring are more likely to suffer poor outcomes including death. The investigators have\r also identified clinical risks that predict the presence of scarring.\r\n\r The investigators propose a study where patients with severe aortic stenosis but no\r indications for valve replacement as per current guidelines are assessed for those clinical\r risks. If a participant's risk of having scarring is higher they will undergo a cardiac MRI\r scan. If scarring is present participants will be randomised to routine clinical care, or\r referral for valve replacement surgery. Participants with no evidence of scarring will be\r randomised routine care with study follow or not. The investigators of this study hypothesize\r that early surgery will lead to fewer complications and reduced risk of death compared to\r standard care.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Severe aortic stenosis (aortic valve jet velocity ≥4.0 m/s, or aortic valve area\r indexed to body surface area <0.6cm2/m2 with aortic jet velocity ≥3.5m/s)\r\n\r 2. Age over 18 years\r\n\r 3. No symptoms attributable to aortic stenosis that require aortic valve replacement\r\n\r Exclusion Criteria:\r\n\r 1. Deemed lower risk for mid-wall fibrosis on screening\r\n\r 2. Planned cardiac surgery\r\n\r 3. Previous valve replacement\r\n\r 4. Severe hypertension (systolic >180 or diastolic >110 mmHg)\r\n\r 5. Acute pulmonary oedema or cardiogenic shock\r\n\r 6. Left ventricular ejection fraction <50% on cardiac MRI\r\n\r 7. Significant abnormalities on cardiac MRI that would prevent enrolment\r\n\r 8. Coexistent severe aortic regurgitation or mitral regurgitation\r\n\r 9. Coexistent mitral stenosis greater than mild in severity\r\n\r 10. Coexistent hypertrophic cardiomyopathy or cardiac amyloidosis\r\n\r 11. Any contraindication to MRI scanning (such as permanent pacemaker)\r\n\r 12. Advanced renal impairment (glomerular filtration rate <30 mL/min/1.73 m2)\r\n\r 13. Pregnancy or breast feeding\r\n\r 14. Patient judged to be unfit to be considered for aortic valve replacement or\r transcatheter aortic valve implantation\r\n\r 15. Patient declines to consider undergoing valve replacement surgery or transcatheter\r aortic valve implantation\r\n\r 16. Inability to give informed consent\r\n\r 17. Previous randomisation into this 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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642
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[
{
"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\nPrehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement\n\n**Clinical Trial Summary:**\n\nIn this pilot study, investigators aim to identify patients undergoing TAVR who are at\r elevated risk for adverse clinical events due to decreased exertional capacity and physical\r deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy\r is safe in these patients. Lastly, investigators aim to assess the efficacy of\r prehabilitation\r\n\r 1. to improve physical functioning by the time of TAVR and to sustain benefit through 30\r days post-procedure; and\r\n\r 2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and\r quality of life.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject must be ambulatory (with or without an assist device)\r\n\r - Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by\r the Heart Team.\r\n\r - Subject requires 6.0 seconds or longer to complete a 15ft walk test\r\n\r - Subject must be able to move between sitting and standing without assistance from\r another person.\r\n\r - Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via\r transfemoral access\r\n\r - Subject is 18 years of age or greater\r\n\r - Subject is willing to give consent and participate in the study\r\n\r Exclusion Criteria:\r\n\r - Subject is incapable of following instructions\r\n\r - Subject is unable to meet the minimum required physical therapy visits\r\n\r - Subject has other medical conditions rendering it unsafe, in the opinion of the\r Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or\r physical therapy conditioning prior to TAVR\r\n\r - Subject has significant severe un-revascularized epicardial coronary 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
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643
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[
{
"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\nEvaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation\n\n**Clinical Trial Summary:**\n\nPatients with aortic stenosis present many risk factors for endothelial dysfunction (arterial\r hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is\r likely that a significant number of patients suffer from pre-existing endothelial dysfunction\r that can be evaluated by a molecular approach.\r\n\r To date, the replacement of the aortic valve can be performed by surgery with extracorporeal\r circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.\r\n\r Two recent studies have demonstrated a sustained improvement in endothelial function with\r TAVI. On the contrary, studies have demonstrated that post-operative complications\r (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure)\r after surgery with extracorporeal circulation (CEC) could be the result of the interaction\r between pre-existing endothelial dysfunction And the \"operative\" aggression associated with\r the CEC.\r\n\r Thus, patients with preexisting involvement of endothelial function would develop vascular\r dysfunction after valvular replacement due to \"endothelial activation\" related to CEC. This\r phenomenon would not exist in TAVI, and would explain the absence of so-called vascular\r dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome,\r disseminated intravascular coagulation).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient ≥ 18 years.\r\n\r - Patient operated on aortic valvular replacement by bioprosthesis in surgery + CEC or\r TAVI\r\n\r - Signed consent.\r\n\r - Affiliation to Social Security\r\n\r Exclusion Criteria:\r\n\r - Any other cardiac surgery\r\n\r - Mechanical aortic valve replacement\r\n\r - Permanent Ac / Fa.\r\n\r - Pregnant woman.\r\n\r - Curative anticoagulation (AVK, NANCO, heparin).\r\n\r - Patient under tutelage or curatelle.\r\n\r - Refusal of the patient.\r\n\r - Participation in another study.\r\n\r - Preoperative sepsis\r\n\r - Minor or adult, under guardianship or curatorship\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
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644
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[
{
"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\nUlinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass\n\n**Clinical Trial Summary:**\n\nRetrospective study determine whether ulinastatin enhances postoperative pulmonary\r oxygenation after cardiopulmonary bypass (CPB).\n\n**Clinical Trial Detailed Description:**\n\nThis retrospective study evaluate patients who underwent aortic valvular surgery under\r moderate hypothermic CPB. The patients were classified into two groups: patients in whom\r high-dose ulinastatin (10,000 U/kg and 5,000 U/kg/h) was administered during CPB (Group-U);\r and patients in whom ulinastatin was not administered (Group-C). We measured PaO2/FiO2 at the\r following time points: before CPB (Pre-CPB), 2 hours after weaning from CPB (Post-CPB) and\r within 6 hours after admission to the ICU. The lengths of ventilator care and ICU stay were\r also reviewed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients who underwent aortic repair or replacement under moderate hypothermic CPB\r\n\r Exclusion Criteria:\r\n\r - Preoperative:\r\n\r < 19 years old, > 85 years old, emergency operation, reoperation, left ventricular ejection\r fraction < 50%, arrhythmia, ischaemic myocardial disease, uncontrollable hypertension or\r hypotension, pericardial disease, pre-existing hepatic dysfunction, pre-existing renal\r dysfunction or underlying lung disease.\r\n\r - Intraoperative:\r\n\r intraoperative application of an intra-aortic balloon pump, administration of steroids or\r tranexamic acid, and transfusion of fresh frozen plasma or platelet concentrates during\r CPB.\r\n\r - Postoperative:\r\n\r reoperation for surgical correction of intractable postoperative bleeding within 2 hours\r after the end of surgery and transfusion of any banked blood products.\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
|
645
|
[
{
"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\nCombination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia\n\n**Clinical Trial Summary:**\n\nThe objective of this clinical study is to evaluate the efficacy and safety by comparing the\r fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment\r group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with\r essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Voluntarily provided a written consent to participate in this clinical study\r\n\r 2. Male or female adults aged 19-70 years\r\n\r 3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening\r visit (V1)\r\n\r 4. Uncontrolled blood pressure (140 mmHg ≤ mean Sitting systolic blood pressure(SiSBP) <\r 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy\r\n\r 5. Subjects who meet the following criteria of fasting serum lipid levels confirmed at\r the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC)\r\n\r 6. Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3)\r\n\r 7. Able to understand this study, be cooperative in the execution of the study, and\r participate in the study until its completion\r\n\r Exclusion Criteria:\r\n\r 1. Severe hypertension with mean Sitting systolic blood pressure(SiSBP) ≥180 mmHg or\r Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the\r baseline visit (V2, or orthostatic hypotension accompanied by symptoms\r\n\r 2. Differences between arms greater than 20 mmHg for Sitting systolic blood\r pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on\r 3 consecutive readings at the screening visit (V1)\r\n\r 3. Secondary hypertension patients: Secondary hypertension is not limited to the\r following diseases; (e.g., renovascular disease, adrenal medullary and cortical\r hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral\r renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney\r disease)\r\n\r 4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline\r visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit of normal\r at the pre-baseline visit (V2))\r\n\r 5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or\r ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular\r disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass\r graft, etc. within 6 months prior to the screening visit (V1)\r\n\r 6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter;\r or other arrhythmia conditions that are determined to be clinically significant by the\r investigator\r\n\r 7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease,\r aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve\r stenosis\r\n\r 8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic\r attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)\r\n\r 9. Pregnant or lactating women\r\n\r 10. Planning pregnancy during the study period or have childbearing potential but are not\r using acceptable contraceptive methods (Contraceptive methods: Refer to Section 10.1\r in this document.)\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
|
646
|
[
{
"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 Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nPrevious trials have shown that TAVR was a noninferior alternative to surgery in patients\r with severe aortic stenosis at intermediate surgical risk. However, patients with congenital\r bicuspid valve have been excluded in those trials. The purpose of this trial is to determine\r the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve\r stenosis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Severe, calcific bicuspid aortic stenosis.\r\n\r 2. Heart team agrees the patient has a risk of operative mortality and has an STS <8 and\r >3.\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) of the respective clinical site.\r\n\r Exclusion Criteria:\r\n\r 1. Ilio-femoral vessel characteristics that would preclude safe placement of the\r introducer sheath.\r\n\r 2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.\r\n\r 3. Severe aortic regurgitation (>3+).\r\n\r 4. Severe mitral regurgitation (>3+).\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
|
647
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[
{
"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\nTrial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit\n\n**Clinical Trial Summary:**\n\nIvabradine (IVA) has been shown to decrease the risk of hospitalizations for worsening Heart\r Failure and was associated with a trend towards improved mortality in the SHIFT1 trial.\r SHIFT1 excluded patients within 4 weeks of hospital discharge, so the efficacy and safety of\r IVA in this setting is less clear.\r\n\r In today's health care environment more and more patients that present to the Emergency\r Department (ED) for mild Acute Heart Failure (AHF) are being placed into observation unit and\r subsequently discharged, or discharged outright from the ED. This is not only a growing\r segment of patients, but also represents an important window of opportunity to intervene with\r a potentially effective therapy.\r\n\r Moreover, at this point in a patient's experience (being discharged after getting treated for\r exacerbation of Heart Failure), it's not clear that beta blockers (BB) should yet be\r increased/started due to the recent state of exacerbation.\r\n\r Standard treatment of worsened heart failure presenting to the ED or urgent care includes\r diuretics (e. g. furosemide) and vasodilators (e.g. ACE-I, ARB, Hydralazine/Isosorbide or\r ARNi), but according to usual standard of care, titration of beta blockade is often reserved\r for outpatient follow up after a period of demonstrated stability (in the ambulatory\r setting).\r\n\r This is in contradistinction to hospitalized patients, where patients have been observed by\r the treating team for days, presumably show stability and improvement, and starting low dose\r BB at the time of hospital discharge has been shown to be safe. As such these ED/Observation\r discharge patients are often not optimal candidates for intensification of BB at the time of\r release, and could be considered to be at maximally tolerated BB dose (for at least for 2-4\r weeks). This may represent a vulnerable period for these patients; its unknown in the setting\r of Observation discharge but evidence from hospitalized patients indicates that the highest\r daily risk of rehospitalization is in the days just after discharge. IVA may be effective\r post observation unit management (where lower risk Heart Failure (HF) patients are typically\r placed), to reduce heart rate (without decreasing contractility, such as a BB would) to help\r reduce the risk of hospitalization or emergency care, but safety and efficacy (in terms of\r heart rate lowering) in this setting has not been previously explored.\r\n\r Additionally, the SHIFT1 trial lacked African Americans and this unique patient population\r has not been previously studied with IVA. The investigating sites serve a predominantly\r African American patient population. Therefore the proposed study represents an important\r opportunity to gather data on IVA effect in this understudied group of patients.\n\n**Clinical Trial Detailed Description:**\n\nSubjects will be enrolled at the time of discharge from the observation unit (visit 1), all\r baseline procedures will be performed at this time, these would include blood draw for\r biomarker assessments, vitals, physical examination, and IP dispensation. At the baseline\r visit, the study team will schedule a follow-up appointment post Day 28 +/- 2 (Visit 3) with\r the subject's primary care physician(PCP)/cardiologist, if the subject does not have their\r own PCP/cardiologist the study team will schedule and facilitate this appointment with the\r Gateway Clinic. A list of current medications and doses will be provided. At Day 14 +/-1\r (visit 2) the subject will return for a follow up visit for IP accountability and titration\r (if needed), BB uptitration (if needed), replacement of the HR monitor (Zio patch),\r assessment of any adverse events, ECG, vital signs, and will undergo a physical examination.\r At Day 28 +/-2 (visit 3), the patient will return for study exit procedures, which include\r blood draw for biomarker assessments, vitals, physical examination, assessment of adverse\r events (if any), and IP return.\r\n\r As with any clinical trial, no un-blinding will occur unless there is a concern for patient\r safety, as this could affect the integrity of data. The study team will provide the patient\r and patient's PCP/cardiologist a clinical summary, inclusive of ECGs. On-going management for\r the patient's condition will be at the discretion of their PCP/cardiologist and will not be\r influenced directly by participation in this study.\r\n\r At Randomization the initial Ivabradine dose will be 5 mg BID. At Day 14 follow up,\r medication adjustments will be made (if needed). At Day 28 follow up, IP will be permanently\r stopped.\r\n\r At the last visit, the study team will contact the patient's primary care physician and/or\r the cardiologist to notify that the patient has completed the study and is off study drug and\r it is now the PCP/cardiologist's discretion to prescribe open label ivabradine (Corlanor) to\r the patient or not, as clinically indicated. If the patient's primary care physician and/or\r cardiologist prescribes open label ivabradine (Corlanor) after the completion of the study,\r the patient or patient's insurance will be responsible for payment as this would then be part\r of routine clinical care.\r\n\r The Zio patch will be placed at discharge from the observation unit. At the 14-day follow-up\r the original Zio patch will be collected and a second one will be placed. At the 28-day\r follow-up the second Zio patch will be collected\r\n\r Based on the SHIFT1 study, the mean heart rate reduction with IVA is 8 bpm with a standard\r deviation of 13 bpm. A sample size of 57 in each group will have 90% power to detect a\r difference in means of 8.0 assuming that the common standard deviation is 13.0 using a two\r group t-test with a 0.05 two-sided significance level. To account for a projected dropout\r rate of 15%, 66 subjects will be enrolled in each group (132 total for the study over a\r 2-year period). Furthermore, the investigators expect that the enrollment centers will\r recruit a cohort that is 75% self-identified African Americans. This number (n=99) will\r provide 80% power to detect the same effect size when analyzed in African Americans only.\r\n\r For the safety endpoint (unplanned presentation for medical care), assuming an event rate of\r 25% at 1 month (estimated based on local hospital readmission rates), the sample size will\r provide 80% power to detect a doubling of the relative risk. If the Control group event rate\r is higher there will be greater power; for example, with an event rate of 35% we would have\r 98% power for risk ratio of 2.0 and 83% power for risk ratio of 1.75.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age >18 and <90.\r\n\r 2. Established HF with reduced ejection fraction (EF ≤35 %), assessment done within 12\r months of index visit.\r\n\r 3. Admitted under observation unit for management of AHF.\r\n\r 4. Heart rate ≥70 beats per minute, with sinus rhythm.\r\n\r 5. Receiving guideline based medical therapy in the judgement of the treating physician.\r\n\r 6. Patient currently on a Beta Blocker regimen. Achieved clinically determined\r stabilization during treatment under observation unit such that the treating physician\r is planning to discharge home without hospital admission.\r\n\r Exclusion Criteria:\r\n\r 1. Known intolerance to study drug.\r\n\r 2. End stage renal disease.\r\n\r 3. Plan to titrate BB at the time of discharge from the observation unit.\r\n\r 4. Any condition that in the opinion of the investigators will interfere with the ability\r to complete the study (e.g. history of extreme non-adherence, extreme psychosocial\r instability).\r\n\r 5. Inability to provide written informed consent.\r\n\r 6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a\r female after conception and until the termination of gestation, confirmed by a\r positive hCG laboratory test (women of childbearing age will be included only if they\r agree to use adequate contraceptive methods or engage in sexual abstinence).\r\n\r 7. Systolic Blood pressure less than 100 mmHg.\r\n\r 8. Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning\r demand pacemaker is present.\r\n\r 9. Severe hepatic impairment.\r\n\r 10. Pacemaker dependence (i.e. heart rate maintained exclusively by the pacemaker).\r\n\r 11. Concomitant use of strong CYP3A4 inhibitors. Examples of strong CYP3A4 inhibitors\r include azole antifungals (e.g., itraconazole), macrolide antibiotics (e.g.,\r clarithromycin, telithromycin), HIV protease inhibitors (e.g., nelfinavir), and\r nefazodone.\r\n\r 12. Concomitant use of diltiazem or verapamil that are not planned for discontinuation.\r\n\r 13. Severe, left sided valvular abnormalities (severe aortic stenosis, severe mitral\r stenosis, severe aortic insufficiency or severe mitral regurgitation.\r\n\r 14. Documented, prior to or at the time of randomization, restrictive amyloid\r cardiomyopathy, or acute myocarditis, or hypertrophic obstructive, restrictive, or\r constrictive cardiomyopathy.\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
|
648
|
[
{
"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\nIn Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance\n\n**Clinical Trial Summary:**\n\nAscending aorta aneurysmal disease is common and can be complicated by dissection or rupture.\r There is substantial variation in individual aneurysm progression: established risk factors\r for an accelerated aneurysm growth rate include initial size or localization, the presence of\r aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.\n\n**Clinical Trial Detailed Description:**\n\nAlthough there is an increased lifetime risk when the aortic diameter exceeds 6 cm,\r predicting aneurysm progression is nearly impossible and dissection and rupture also occur at\r diameters under 6 cm. The assessment of aortic hemodynamics and the presence of altered flow\r patterns, as well as distribution and changes in wall shear stress (WSS) and the oscillatory\r shear index (OSI), using 4D phase contrast cardiovascular magnetic resonance (CMR) may\r provide further insights in how aneurysms develop and in assessing the risk of dissection.\r The purpose of this study was to investigate in patients with dilated ascending aorta the\r flow patterns and vessel wall parameters in order to correlate these hemodynamics factors\r with changes in aorta size.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 18 years.\r\n\r - Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal\r echocardiography between 40 and 45 mm in case of presence of aortic valve disease,\r bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of\r absence of aortic valve disease, bicuspid aortic valve disease or connective tissue.\r\n\r - Informed consent for participation in the study\r\n\r Exclusion Criteria:\r\n\r - Contraindication to MRI\r\n\r - Patient's refusal to participate in the study and / or inability to express agreement\r or signing 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:** definitely relevant"
}
] |
definitely relevant
|
649
|
[
{
"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 Dysfunction in Cardiac Surgery Patients\n\n**Clinical Trial Summary:**\n\nTo establish the correlation between echocardiographic parameters of the RV, measured with\r TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the\r perioperative process when RV dysfunction occurs.\n\n**Clinical Trial Detailed Description:**\n\nMeasurements with echocardiography were done during cardiac surgery to observe the right\r ventricular dysfunction in the perioperative process\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - cardiac surgery patients\r\n\r - elective, isolated aortic valve replacement or coronary artery bypass grafting in\r combination with aortic valve replacement\r\n\r Exclusion Criteria:\r\n\r - age < 18\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"
}
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definitely relevant
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650
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[
{
"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\nReduction of Left Ventricular Hypertrophy After Eplerenone Therapy\n\n**Clinical Trial Summary:**\n\nObstructive sleep apnea syndrome (OSA) is the most frequent sleep disorder characterized by\r excessive decrease in muscle tone of the soft palate, the tongue and the posterior pharyngeal\r wall. It leads to airway collapse. In cases of decreased airway passage hypoventilation\r (hypopnea) occurs while periodic lack of airflow is called apnea. An obstructive sleep apnea\r syndrome is recognized as an independent cardiovascular risk factor. OSA is very common in\r patients with resistant hypertension. RAH is diagnosed when blood pressure remains elevated\r despite simultaneous use of 3 antihypertensive agents from different groups of drugs at\r optimal to maximum doses, including a diuretic.\r\n\r In patients with OSA frequent episodes of hypoxemia during sleep result in the repeated\r activation of the sympathetic nervous system. What is more, the episodes of respiratory\r disorders increases in levels of aldosterone serum concentration with following sodium and\r water retention and elevation of blood pressure finally. An increased aldosterone level also\r stimulates synthesis of collagen, promotes stiffening of the arterial wall, myocardial\r fibrosis with heart muscle remodeling and takes part in development of left ventricular\r hypertrophy (LVH) - common complication of hypertensive patients with OSA. Several studies,\r including the Sleep Heart Health Study have confirmed that severe OSA is associated with high\r prevalence of concentric hypertrophy through sympathetic activation and vasoconstriction.\r\n\r Eplerenone is a selective mineralocorticoid receptor inhibitor. It has no affinity for\r glucocorticoid, progesterone and androgen receptors and therefore has lower risk of side\r effects. Eplerenone lowers blood pressure and inhibits heart muscle fibrosis. The hypotensive\r effect is caused by reduction of fluid retention. Probably, in patients with OSA, a reduction\r of fluid accumulation especially at the level of the neck may contribute to lowering the\r resistance in the upper respiratory tract and in that way it may help to decrease the\r severity of OSA.\r\n\r As LVH remains a strong and independent predictor of total mortality and death from\r cardiovascular causes, in this study we want to assess whether the addition of Eplerenone to\r a standard antihypertensive therapy will favorably change left ventricular geometry. We also\r want to check if the addition the Eplerenone to a standard antihypertensive therapy could be\r an effective therapeutic option for patients with OSA and RAH.\n\n**Clinical Trial Detailed Description:**\n\n125 patients (78 men and 47 women) aged 18 - 65 years, with diagnosed resistant hypertension\r and moderate or severe OSA were included in the study, which was conducted in years 2014-2017\r in the Department of Hypertension, Angiology and Internal Medicine and the Department of\r Pulmonology, Allergology and Respiratory Oncology at the University of Medical Sciences in\r Poznan, Poland. 23 patients did not complete the study because they did not meet the\r inclusion criteria (10 patients) and did not follow the recommendations (13 patients). 102\r patients were randomized to two groups. In Group A, 50mg Eplerenone was administered orally\r once a day additionally for standard antihypertensive therapy. In Group B, standard\r antihypertensive therapy was not changed for 6 months of follow-up. RAH was recognized when\r in spite of the use of at least 3 antihypertensive agents (including a diuretic) in maximum\r doses, it was impossible to achieve the target values of BP (< 140/90 mmHg). The patients\r were taking on average 3,93 antihypertensive medications including diuretics (100% of\r patients), angiotensin-converting enzyme inhibitors (54% of patients), angiotensin II\r receptor antagonists (45.2% of patients), calcium antagonists (83.9% of patients), β-blockers\r (77.4% of patients), and α-blockers (22.6% of patients). The permission no. 565/14 to conduct\r the study was granted by the Ethics Committee of the University of Medical Sciences in\r Poznan. All patients gave an informed and written consent to participation in the study.\r Blood pressure measurements In all patients, during each visit, BP measurements were\r performed three times at rest in supine position, in standard conditions, using an upper arm\r blood pressure monitor BP monitor (Omron 705IT, Omron Healthcare, Kyoto, Japan). Ambulatory\r 24-hours BP automated monitoring (ABPM) was performed using a 24-hour ambulatory peripheral\r BP monitor TM2430 (A&D Medical, San Jose, California, United States). The frequency of\r measurements was every 15 minutes between 7:00 and 22:00 and every 30 minutes between 22:00\r and 7:00.\r\n\r Neck circumference measurement The neck circumference was measured in the midway of the neck,\r between the mid-cervical spine and mid-anterior neck, in standing position, with a flexible\r no-stretchable plastic tape, and approximated to the nearest 0.1 cm.\r\n\r Echocardiographic examination\r\n\r All patients underwent complete transthoracic echocardiographic study with Vivid S6 (GE\r Medical System, Tirat Carmel, Israel) with a 1,5 - 3,6 megahertz cardiac sector probe. A\r standard M-mode, two-dimensional and Doppler echocardiographic examination was performed\r according to the guidelines of American Society of Echocardiography. Three consecutive cycles\r were averaged for every parameter. The same experienced cardiologist who was blinded to the\r presence or absence of OSA performed all echocardiographic examinations. Left ventricular\r end-diastolic diameter (LVED), thickness of intraventricular septum at end diastole (IVS),\r left ventricular posterior wall at end diastole (LVPW) and left ventricular mass (LVM) were\r measured according to American Society of Echocardiography recommendations. The LVH was\r defined as the IVS or the LVPW>12 mm. The left ventricular mass was calculated using a simple\r and anatomically validated formula:\r\n\r LVM = 0.8 × 1.04 [(IVS + LVED + LVPW) 3 - LVED 3] + 0.6 LVM was calculated as corrected for\r height and LVM index (LVMI). The relative wall thickness (RWT) was calculated as (2×\r LVPW)/LVEDD, for which the normal limit is <0.42. Based on LVMI and RWT, the LV geometry was\r classified as normal (LVMI <115 g/m2 in men, <95 g/m2 in women and RWT <0.42), concentric\r remodeling (normal LVMI <115 g/m2 in men, <95 g/m2 in women and increased RWT >0.42),\r concentric hypertrophy (LVMI >115 g/m2 in men, >95 g/m2 in women and increased RWT >0.42) or\r eccentric hypertrophy (LVMI >115 g/m2 in men, >95g/m2 in women and normal RWT <0.42).\r\n\r Polysomnography (PSG) The probability of OSA was established at first on the base of Epworth\r Sleepiness Scale score. The evaluation of patients was performed in the Sleep Laboratory of\r the Department of Pulmonology, Allergology and Respiratory Oncology at the University of\r Medical Sciences in Poznan, Poland using a full-night polysomnographic monitoring system\r (EMBLA S4000, Remlogic, Denver, Colorado) with Somnologica studio 3.3.2 software (EMBLA,\r Broomfield, Colorado, United States). Standard electroencephalography monitoring, including\r frontal leads (F1, F2), central leads (C3, C4), occipital leads (O1, O2) and reference leads\r at the mastoids (M1, M2); electromyography and electrooculography methodology were performed\r according to The American Academy of Sleep Medicine (AASM) guidelines.\r\n\r Airflow was measured using nasal thermistors, and a nasal pressure transducer. Abdominal and\r thoracic movements were assessed by respiratory inductive plethysmography. Oximetry was\r measured using a disposable finger probe (oximeter flex sensor 8000 J, NONIN, Plymouth,\r Massachusetts, United States) placed on the index finger. Snoring sounds, heart rate also\r were recorded. Body position was monitored using body position sensor. Apnea was defined as a\r cessation of airflow lasting for more than 10 sec., and hypopnea as a discrete reduction (two\r thirds) of airflow and/or abdominal ribcage movements lasting for more than 10 sec. and\r associated with a decrease of more than 4% in oxygen saturation. Trained PSG technicians and\r sleep physicians using the criteria of Rechtschaffen and Kales, and in close concordance with\r scoring updates given by the American Academy of Sleep Medicine analyzed all studies. The\r apnea-hypopnea index (AHI) was defined by the total number of apneas and hypopneas per hour\r of sleep. The severity of OSA was determined as: mild (AHI 5-15), moderate (AHI 15 - 30) and\r severe (AHI ≥ 30) (21) on the basis of AHI Design of the study First visit Patients with\r previously diagnosed RAH and with suspected OSA (medical history, the Epworth scale\r assessment) were referred from an outpatient clinic to the hospital ward. After admission\r numerous laboratory tests and imaging, such as aldosterone and Plasma renin activity levels\r (ARO), both before and after tilting, creatinine, urea, GFR, sodium and potassium levels, pro\r B-type natriuretic peptide (BNP), thyrotrophin (TSH), free triiodothyronine (FT3), free\r thyroxine(fT4), 24-hour urine collection for electrolytes, as well as abdominal ultrasound\r examinations, computed tomography of the abdomen and Doppler ultrasound of the renal\r arteries, were performed to exclude secondary causes of arterial hypertension (other than\r primary hyperaldosteronism). What is more, office BP was measured three times at admission\r and afterwards 24-hours ABPM examination was conducted. All participants underwent also\r transthoracic echocardiography. After aforementioned diagnostics and after confirming RAH\r based on 24-hour ABPM, patients were referred to the Department of Pulmonology to perform\r polysomnography.\r\n\r In those patients in who moderate or severe OSA (AHI>15/h), had been confirmed, Eplerenone at\r the dose of 50 mg/day was randomly added to the previously used treatment regimen.\r\n\r Second visit After six months, office BP (measured three times in standard conditions as\r initially performed), 24-hour ABPM, echocardiography and polysomnography were repeated.\r\n\r Statistical analysis The normality of distribution of the analyzed variables was evaluated\r with the Shapiro-Wilk test and Kolmogorov-Smirnov test with the Lilliefors correction. The\r results of the tests showed that distributions of almost all parameters significantly\r differed from the normal distribution. Therefore, nonparametric methods were used in\r statistical analysis. The Wilcoxon signed-rank test was applied for the evaluation of the\r differences between the baseline values and those obtained after treatment. The t test was\r used for variables with normal distribution. Correlations between the values of the\r parameters were evaluated using the Spearman's rank correlation coefficient. P value of less\r than 0.05 was considered significant. The Statistica software, version 10, was used for the\r analysis (www. statsoft. com; license JGNP410B316631AR-J, Stat- Soft, Inc., 2011, Tulsa,\r Oklahoma, United States).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - confirmation of resistant hypertension(RAH). RAH was recognized when in spite of the\r use of at least 3 antihypertensive agents (including a diuretic) in maximum doses, it\r was impossible to achieve the target values of BP (< 140/90 mmHg).\r\n\r - diagnosing of moderate or severe sleep apnea (OSA) on the basis of apnoea-hypopnea\r index (AHI) in polysomnography. AHI was defined by the total number of apnoea's and\r hypopneas per hour of sleep. The severity of OSA was determined as: mild (AHI 5-15),\r moderate (AHI 15 - 30) and severe (AHI ≥ 30)\r\n\r - signing informed and written consent to participation in the study.\r\n\r Exclusion Criteria:\r\n\r - secondary hypertension (other than primary hyperaldosteronism),\r\n\r - myocardial infarction,\r\n\r - stroke within 6 months before the study,\r\n\r - congestive heart failure with New York Heart Association (NYHA) grade III-IV,\r\n\r - chronic kidney disease (GFR < 30 ml/min),\r\n\r - active addiction to alcohol or psychoactive substances,\r\n\r - active cancer 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
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651
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[
{
"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 Initiation of Post Sternotomy CArdiac Rehabilitation\n\n**Clinical Trial Summary:**\n\nThe main objective of this trial is to investigate the effects of starting exercise\r rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or\r Aortic/Mitral valve replacement (VR) surgery.\n\n**Clinical Trial Detailed Description:**\n\nThe trial will compare health improvements after cardiac rehabilitation, (CR) between\r participants randomly allocated to one of two groups: an early CR group starting exercise\r after 2 weeks, and a usual care group starting at 6 weeks. It will also collect information\r on the financial cost of earlier CR to both the health service and the patients.\r\n\r All primary and secondary outcome measures will be taken at baseline (1 week) and repeated at\r the start and end of 8 weeks exercise rehabilitation program (2 and 10 weeks from baseline\r for the early group, 6 and 14 weeks in the usual care group respectively) and at 12 months\r follow-up.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Coronary artery bypass graft, and mitral/aortic valve replacement patients recovering\r from sternotomy procedure eligible for cardiac rehabilitation\r\n\r - Able to provide written informed consent\r\n\r - Male or female 18 years of age or greater\r\n\r Exclusion Criteria:\r\n\r - Patients with any of the following:\r\n\r - Serious cardiac arrhythmias\r\n\r - Current neurological disorders or previous Cerebral Vascular Accident with\r residual neurological deficit significant enough to limit exercise\r\n\r - Enrolled on another clinical trial that involved exercise\r\n\r - Unable to enroll for duration of study\r\n\r - Patients who are unable to provide written consent.\r\n\r - Patients under the age of 18 or over the age of 90.\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
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652
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[
{
"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\nOCT in Borderline Coronary Artery Lesions\n\n**Clinical Trial Summary:**\n\nTo find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation\r and treatment of angiographically borderline coronary artery lesions in a Chinese population,\r and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the\r participants included in the study will be those that are found to have borderline coronary\r artery lesions on coronary angiography, in whom the investigators feel that OCT will be\r useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or\r whether optimal medical therapy is the most appropriate treatment modality. Those\r participants who declined OCT will be offered SPECT as an alternative method to assess and\r treat the borderline coronary artery stenosis.\r\n\r It is estimated that OCT guided \"PCI or not\" has a non-inferiority to SPECT's in the\r borderline coronary artery stenosis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The inclusion criteria for this study will be only those participants in whom\r diagnostic coronary angiography revealed borderline coronary artery lesion. These\r participants will undergo the OCT procedure, or alternatively ECT.\r\n\r Exclusion Criteria:\r\n\r - Exclusion criteria will be those participants with previous cardiogenic shock, stroke,\r renal dysfunction, and acute or chronic total occlusion coronary lesions.\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
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653
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[
{
"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 CMR Against Invasive Haemodynamics in Patients With HFpEF\n\n**Clinical Trial Summary:**\n\nHeart failure (HF) currently affects app. 2% of the western population and app. 10% of people\r >75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved\r (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year\r and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical\r cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no\r non-invasive measure provides a clear diagnosis.\r\n\r Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation\r of heart structure and function. New CMR parameters offer the possibility to describe the\r underlying pathological and physiological changes associated with HFpEF.\r\n\r The investigators propose to undertake the first systematic comparison between a CMR protocol\r and invasive haemodynamics as the best possible gold standard, as well as define the\r histopathological drivers in myocardial biopsies. The investigators will also examine the\r relations with tissue and serological biomarkers implicated in HFpEF and the role with\r standard and novel parameters by echocardiography. If successful, this study will provide\r tools for a reliable and accurate non-invasive characterization of patients with HFpEF,\r supporting the diagnosis and grading the severity of disease. This study will provide a\r reference basis for future diagnostic algorithms in HFpEF, both, for CMR and\r echocardiography, but also for their relative value in comparison to blood markers or\r invasive testing. In addition to a new pathway to acess the effects of current and novel\r therapeutic interventions, the investigators see the greatest potential in identifying a\r disease stage where the myocardial injury may be reversible.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nMain/reproducibility group:\r\n\r Inclusion Criteria:\r\n\r 1. Ability to provide informed consent\r\n\r 2. Typical HF symptoms (NYHA stage II-III) within the last 6 months\r\n\r 3. EF > 45 % with absence of structural heart disease on echocardiography (except left\r ventricular hypertrophy or left atrial enlargement)\r\n\r 4. Echocardiographic evidence of increased left ventricular filling pressures\r\n\r 1. E/E'sep >15 OR E/E'lat >12 OR Av E/E' >13 OR\r\n\r 2. E/E' >9 AND left atrial (LA) volume >34 ml/m2 OR systolic pulmonary artery\r pressure (PAsys): >35 mmHg;\r\n\r 5. Indication for invasive hemodynamic work-up\r\n\r 6. Unclear aetiology of heart failure\r\n\r 7. Adults: age >18 years\r\n\r Exclusion Criteria:\r\n\r 1. Patients unable or unwilling to provide informed consent\r\n\r 2. High likelihood of non-diagnostic PV loops of MR imaging (e.g. atrial fibrillation or\r high rate of premature ventricular contraction (PVC) (> 10 ventricular Extrasystole\r (VES)/minute), > 150 kg body weight, inability to lie flat or still)\r\n\r 3. Contraindication for invasive work-up (allergy to contrast agent, severe renal\r insufficiency with estimated glomerular filtration rate (eGRF) <30 ml/min)\r\n\r 4. Contraindications for a contrast enhanced CMR study (allergy to contrast agent,\r incompatible devices or implants (e.g. non-MR conditional pacemaker), severe\r claustrophobia)\r\n\r 5. Previous medical history of EF <45%\r\n\r 6. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g.\r amyloid, ischaemic heart disease, valvular disease)\r\n\r Age-gender matched controls:\r\n\r Inclusion Criteria:\r\n\r 1. Ability to provide informed consent\r\n\r 2. No current or history of symptoms, signs or therapy for heart disease\r\n\r 3. EF > 45 % with absence of structural heart disease on echocardiography (except left\r ventricular hypertrophy or left atrial enlargement)\r\n\r 4. Adults: age >18 years\r\n\r Exclusion Criteria:\r\n\r 1. Patients unable or unwilling to provide informed consent\r\n\r 2. High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of\r PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still)\r\n\r 3. Contraindications for a contrast enhanced CMR study (allergy to contrast agent,\r incompatible devices or implants (e.g. non-MR conditional pacemaker), severe\r claustrophobia, severe renal insufficiency with eGRF <30 ml/min))\r\n\r 4. Previous medical history of EF <45%\r\n\r 5. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g.\r amyloid, ischaemic heart disease, valvular disease)\r\n\r Healthy volunteers:\r\n\r Inclusion Criteria:\r\n\r 1. Ability to provide informed consent\r\n\r 2. No current or history of symptoms, signs or therapy for heart disease\r\n\r 3. EF ≥ 50 % with absence of structural heart disease on echocardiography\r\n\r Exclusion Criteria:\r\n\r 1. Contraindications for an MR study\r\n\r 2. High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of\r PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still)\r\n\r 3. Subjects unable or unwilling to provide informed consent\r\n\r 4. EF <50% in patient history\r\n\r 5. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g.\r amyloid, ischaemic heart disease, valvular 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
|
654
|
[
{
"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\nDVD Lifestyle Intervention\n\n**Clinical Trial Summary:**\n\nMost Veterans who receive VA healthcare have obesity (41%) or are classified as overweight\r (37%), putting them at higher risk for multiple serious chronic health conditions. Providing\r evidence-based behavioral weight management programs to Veterans with obesity is a priority\r for the VA National Center for Health Promotion and Disease Prevention (NCP). While the VA\r NCP's MOVE! program-primarily delivered with in-person group visits-helps Veterans with\r obesity lose weight, its reach has been limited because of various barriers to care. Some\r Veterans may do better with a program they can complete from home at their own pace. In this\r trial, study investigators are examining the effectiveness among Veterans of a previously\r proven self-directed lifestyle intervention (called DVD Lifestyle Intervention (D-ELITE))\r that targets modest, clinically meaningful weight loss over the course of a year using\r recorded video lessons (DVD or online streaming), written self-study aids, and optional\r lifestyle coaching. The study will compare participants randomly assigned to receive D-ELITE\r to those continuing in usual care on weight and self-reported general physical health status,\r one year after enrollment. Secondary outcomes include weight and general physical health\r status two years after enrollment; and obesity-related biometric measures (blood pressure and\r HbA1c) and self-report psychological and behavioral factors such as physical activity and\r sleep quality, at one- and two-years following enrollment.\r\n\r Veterans with obesity living in the western US were identified using the VA Corporate Data\r Warehouse (CDW), recruited to participate via mail and telephone, and randomly assigned to\r receive the study intervention or usual care alone. The study uses CDW to assess weight\r change and biometric outcomes. To assess self-report outcomes, participants completed\r questionnaires, by mail or telephone, at baseline and 12 months after randomization, and are\r currently completing 24-month follow-up questionnaires. The D-ELITE intervention focuses on\r gradual lifestyle behavior change aimed at improving eating habits and increasing physical\r activity. It encourages participants to gradually achieve and maintain a 5-10% loss of\r baseline body weight and at least 150 minutes of moderate-intensity physical activity, such\r as brisk walking, each week. The D-ELITE intervention program consists of watching one video,\r completing corresponding written self-guided learning materials, and tracking food intake and\r physical activity each week for the first 12 weeks, then working through 10 additional\r written handouts and continued food and activity tracking for the next nine months.\r Intervention participants have access to a lifestyle coach, as desired, for the full 12-month\r intervention period. In addition to patient outcomes, this study will examine the cost of\r delivering the intervention, information relevant to decision-makers and potential future\r dissemination. Evidence-based programs like this, which can be delivered remotely and with\r likely minimal resources required from the VA healthcare system, are greatly needed,\r especially now as the SARS-CoV-2 pandemic has required VA to rapidly transition to providing\r more remotely-delivered care.\r\n\r Impact: The DELITE trial has potential to provide the evidence needed for deciding whether a\r low-cost, low-technology, self-directed program can be used to expand the treatment of\r obesity to a population-based level by improving access to obesity treatment regardless of\r Veteran place of residence.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Recent VA primary care measured BMI between 30.0-44.9 kg/m2 (at facility in pacific or\r mountain time zone)\r\n\r - Access to DVD player or internet\r\n\r - Able to participate fully in all study protocol/procedures including informed consent\r\n\r Exclusion Criteria:\r\n\r - Inability to speak, read, or understand English\r\n\r - Recent weight loss interventions including use of prescription weight-loss\r medications, participation in group or individual weight loss programs provided by\r trained personnel, bariatric surgery (or plans for during the study period)\r\n\r - Expected weight loss because of alternate explanations such as from illness\r\n\r - High variability in weight due to fluctuations in volume status (ascites - liver\r disease, chronic heart failure)\r\n\r - Safety and/or adherence concerns due to severe physical or mental health issues, or\r life expectancy <24 months\r\n\r - Pregnant, lactating, or planning to become pregnant during the study period;\r\n\r - Participation in other intervention 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:** definitely relevant"
}
] |
definitely relevant
|
655
|
[
{
"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\nInfluence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study\n\n**Clinical Trial Summary:**\n\nThis translational study was designed to explore the association of the quantity and quality\r of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling\r and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The\r investigators expect to identify new biochemical factors and biomarkers in the crosstalk\r between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are\r involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.\n\n**Clinical Trial Detailed Description:**\n\nBackground: EAT has emerged as a new independent, and, potentially, modifiable cardiovascular\r risk factor for CAD. EAT volume assessed by computed tomography (CT) was independently\r associated with the presence of coronary stenosis, coronary calcification and myocardial\r ischemia in cross-sectional studies, and, prospectively, with major adverse cardiovascular\r events. Most of these clinical studies were, however, derived from community-based patients\r with low-to intermediate-risk profile and the role of EAT in high-risk patients is currently\r unclear. Accumulation of EAT has been also associated with left atrial (LA) dilation,\r presence, chronicity, and recurrence of atrial fibrillation (AF). Although there is evidence\r suggesting that EAT may be a major determinant of the LA vulnerable substrate of AF, the\r mechanisms in the causal pathway between the EAT and LA remodeling are not completely\r elucidated.\r\n\r Aims: The main aims are to investigate if the volume of the EAT on CT and EAT proteome\r assessed by SWATH-mass spectrometry are associated with extent, distribution and complexity\r of coronary stenosis and coronary artery calcification, left atrial strain and incidence of\r postoperative atrial fibrillation in patients with symptomatic severe aortic stenosis.\r\n\r Methods: This a prospective study enrolling symptomatic severe aortic stenosis patients\r referred to aortic valve replacement. The protocol includes preoperative detailed clinical\r and nutritional evaluations, echocardiography, CT, cardiac magnetic resonance imaging and\r invasive coronary angiography. During cardiac surgery, biopsies from the EAT, mediastinal and\r subcutaneous thoracic adipose tissues will be performed to undergo analysis of proteome using\r SWAT-mass spectrometry. Samples from the pericardial fluid, circulating and coronary sinus\r blood samples will be collected as well in order to find local and peripheral adipose\r tissue-derived biomarkers of the disease.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - symptomatic severe aortic stenosis patients (defined as aortic valve area of < 1 cm2\r or 0.6 cm2/m2 by transthoracic echocardiography) referred to aortic valve replacement.\r\n\r Exclusion Criteria:\r\n\r - diagnosis of acute coronary syndrome in the last 3 months.\r\n\r - prior history of persistent or permanent atrial or flutter fibrillation.\r\n\r - coexisting moderate to severe aortic valve regurgitation or moderate to severe mitral\r valve disease, bicuspid aortic valve.\r\n\r - left ventricular dilatation [end-diastolic volume index >75 mL/m²].\r\n\r - left ventricular ejection fraction <55%.\r\n\r - chronic renal failure stage 3 to 5 defined as glomerular filtration rate GFR estimated\r by Cockcroft-Gault formula adjusted for body surface area < 30 mL/min/1.73m².\r\n\r - moderate to severe chronic obstructive pulmonary disease defined as forced expiratory\r volume in one second <50% according to the 2011 Global Initiative for Chronic\r Obstructive Pulmonary Disease guidelines.\r\n\r - active malignancy (i.e. With no evidence of recurrence and no longer receiving active\r treatment).\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
|
656
|
[
{
"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\nO2 Tension During TAVI\n\n**Clinical Trial Summary:**\n\nHyperoxemia can produce various complications including oxidative stress and myocardial\r injury. We hypothesized that the normoxic group would have lower myocardial injury compared\r to hyperoxic group after transcatheter aortic valve replacement.\n\n**Clinical Trial Detailed Description:**\n\nHyperoxemia can produce various complications, such as excessive oxidative stress,\r hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant\r myocardial injury. Previous studies have been observed higher mortality in patient group\r maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the\r effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve\r replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group\r would have lower myocardial injury compared to hyperoxic group after TAVR.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Scheduled for transcatheter aortic valve replacement due to aortic stenosis\r\n\r Exclusion Criteria:\r\n\r - Transapical approach\r\n\r - Pre-procedural PaO2 < 65 mmHg or oxygen support therapy\r\n\r - Pre-procedural severe kidney injury (end-stage renal disease)\r\n\r - Pre-procedural chronic pulmonary disease, symptomatic asthma\r\n\r - Pre-procedural Tb-destroyed lung\r\n\r - Lung cancer\r\n\r - History of acute coronary syndrome within 6 months\r\n\r - History of stroke or transient ischemic attack within 6 months\r\n\r - Refuse to participate\r\n\r - Pregnant\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
|
657
|
[
{
"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\nPrimary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI\n\n**Clinical Trial Summary:**\n\nThis pilot study is a prospective, randomized, open-label trial that aims to assess the\r feasibility of comparing a primary Computed tomography/Cardiac computed tomography\r angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and\r invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI)\r procedure. The study will also estimate the rate of composite coronary adverse events\r (myocardial infarction, post procedural coronary revascularization and cardiovascular\r mortality) between the two arms at 90 days follow-up. The primary endpoint will be the\r feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1\r site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post\r procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days\r post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular\r complications events. This information will be used to inform the design of the definitive\r efficacy trial.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo,\r Aortic valve area of < 1.0cm2)\r\n\r - Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina)\r\n\r - Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least\r one interventional cardiologist and one cardiothoracic surgeon)\r\n\r Exclusion Criteria:\r\n\r - Severe renal dysfunction Glomerular filtration rate < 30 ml/min.\r\n\r - Severe left ventricular dysfunction LVEF ≤ 30%\r\n\r - Recent coronary angiography ≤ 6months from randomization\r\n\r - Recent PCI ≤ 6months from randomization\r\n\r - Recent or active acute coronary syndrome (New or worsening angina with or without\r positive biomarkers or ECG changes).\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
|
658
|
[
{
"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 TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation\n\n**Clinical Trial Summary:**\n\nAortic valve stenosis (AS) shows high and increasing prevalence in Western civilizations and\r leads to high morbidity and mortality. 15 years ago Alain Cribier performed the first\r catheter-based transfemoral aortic valve replacement at the University of Rouon. This\r historical step initiated a dramatic shift in the treatment of AS with more than 50% of\r patients being treated interventionally instead of the surgical approach, today.\r\n\r Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic\r valve stenosis but little is known about psychiatric comorbidities or frailty in these\r patients. Data from our group suggest an inflammatory trigger for depression and potentially\r other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are\r associated with considerable changes in the inflammatory state of the patients. However, no\r study has prospectively examined the interaction of these inflammatory markers and mood\r disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically,\r however, scientifically there is only emerging data with half of all PubMed-indexed\r publications being less than 18 months old and clinical use of various scores still under\r discussion.\r\n\r The \" Effect of interventional aortic valve replacement on emotional status, quality of life,\r frailty and inflammation\"-study is designed to fill these gaps in evidence. It will be a\r prospective epidemiological cohort study to recruit 102 patients with symptomatic severe\r aortic valve stenosis within 18 months. All of these patients will undergo standardized\r cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory\r analysis focussing on the inflammatory state. The study aims to integrate these\r interdisciplinary findings to optimize patient treatment.\n\n**Clinical Trial Detailed Description:**\n\nAortic valve stenosis (AS) shows a high prevalence in Western civilizations with an\r increasing incidence and is associated with high morbidity and mortality. AS is a\r degenerative disease and therefore the main reason for the increasing prevalence is the\r higher proportion of elderly patients in western societies. Untreated symptomatic AS is\r characterized by severe morbidity with mainly dyspnea, orthopnea and reduced exercise\r capacity. In addition, AS has a very high mortality (50-90% in 2 years), most often due to\r lung edema as a result of increased afterload of the left ventricle. So far, there is no\r medical treatment available improving mortality in these patients. For decades, the only\r known therapy has been surgical aortic valve replacement (SAVR), having shown a dramatic\r reduction in mortality. However, many of the patients suffering from AS are octogenarians or\r even older and also suffer from multiple comorbidities. Thus, many of these patients are\r considered inoperable using a surgical approach. Exactly 15 years ago Alain Cribier performed\r the first catheter-based transfemoral aortic valve replacement at the University of Rouon.\r This historical step initiated a dramatic shift in the treatment of AS with more than 50% of\r patients being treated interventionally instead of the surgical approach, today.\r\n\r Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic\r valve stenosis but little is known about psychiatric comorbidities or frailty in these\r patients. Data from our group suggest an inflammatory trigger for depression and potentially\r other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are\r associated with considerable changes in the inflammatory state of the patients. However, no\r study has prospectively examined the interaction of these inflammatory markers and mood\r disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically,\r however, scientifically there is only emerging data with half of all PubMed-indexed\r publications being less than 12 months old and clinical use of various scores still under\r discussion.\r\n\r The \" Effect of interventional aortic valve replacement on emotional status, quality of life,\r frailty and inflammation\"-study is designed to fill these gaps in evidence. It will be a\r prospective epidemiological cohort study to recruit 102 patients with symptomatic severe\r aortic valve stenosis within 18 months. All of these patients will undergo standardized\r cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory\r analysis focussing on the inflammatory state. The study aims to integrate these\r interdisciplinary findings to optimize patient treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Symptomatic aortic valve stenosis\r\n\r - Planned elective transcatheter aortic valve replacement\r\n\r - Willingness and ability to provide signed informed consent (IC) form prior to\r participation in any study-related procedures\r\n\r Exclusion Criteria:\r\n\r - Disease reducing life expectancy to < 1 year\r\n\r - Severe immune-system modulating or -affecting 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
|
659
|
[
{
"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 Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins\n\n**Clinical Trial Summary:**\n\nAortic stenosis (AE) is a disease that has been increasing steadily in recent years in most\r countries, including Spain.Risk factors for the development of AE include age,\r hypercholesterolemia, diabetes mellitus and arterial hypertension, the classic risk factors\r for the development of atherosclerosis. However, lipid-lowering therapy with statins and\r ezetimibe has not been shown to reduce the risk of long-term progression of AE by unknown\r mechanisms. All this suggests that subjects with HFhe have a high risk of developing AD,\r which has not been shown by the high coronary mortality in this population that precedes\r aortic calcification\n\n**Clinical Trial Detailed Description:**\n\nThe study includes a single clinical visit with collection of clinical data, blood extraction\r and the performance of a transthoracic echocardiogram. This visit may be made on different\r days, but always within 30 days of signing the informed consent.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Cases:\r\n\r - Age ≥ 65 years at the time of cardiac ultrasound\r\n\r - Genetically diagnosed HFH or in a first-degree relative\r\n\r - History of hypercholesterolemia with LDLc levels> 220 mg / dL without lipid-lowering\r treatment\r\n\r Controls:\r\n\r - Genetically Similar\r\n\r - Siblings of the normoccholesterolemic case, defined by LDLc <190 mg / dl without\r lipid-lowering treatment.\r\n\r - In the absence of available siblings, first cousins may be included.\r\n\r - In the presence of several siblings available, the same sex will be included,\r\n\r - Environmentally similar\r\n\r - Stable partner of the case with cohabitation> 25 years * Each case will have at least\r one control.\r\n\r Exclusion Criteria:\r\n\r - Personal history of cardiac rheumatic 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
|
660
|
[
{
"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\nPoint-of-care Ultrasound in Finland\n\n**Clinical Trial Summary:**\n\nThis study has two aims.\r\n\r 1. Deep venous thrombosis (DVT) is a common suspected medical condition. If it cannot be\r excluded clinically and using D-dimer, ultrasound examination is required. An option for\r traditional radiologist-performed ultrasound is a 2-point compression ultrasound\r (2-CUS). The safety of this technique is proven. However there does not exist any data\r on costs comparing traditional and 2-CUS pathways in primary health care. This study\r will evaluate the total cost of both pathways by conducting a cost-minimization\r analysis. It will also study the effect of a simple ultrasound education on the\r referrals to hospital due to suspected DVT.\r\n\r Hypothesis 1: Short education in ultrasound will reduce significantly referrals to\r hospital and save resources.\r\n\r 2. Length of stay (LOS) in emergency department (ED) is related to increased mortality,\r morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients\r with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be\r compared to those that have a radiology performed ultrasound examination. Further\r examination and accuracy of POCUS will be noted.\r\n\r Hypothesis 2: POCUS can shorten LOS significantly in selected clinical conditions\n\n**Clinical Trial Detailed Description:**\n\nThis study has two aims.\r\n\r 1. Deep venous thrombosis is a common suspected medical condition. If it cannot be excluded\r clinically and using D-dimer, ultrasound examination is required. An option for\r traditional radiologist-performed ultrasound is a 2-point compression ultrasound\r (2-CUS). The safety of this technique is proven. However there does not exist any data\r on costs comparing traditional and 2-CUS pathways in primary health care. This study\r will evaluate the total cost of both pathways by conducting a cost-minimization\r analysis. It will also study the effect of a simple ultrasound education on the\r referrals to hospital due to suspected DVT. T\r\n\r he study is performed in Saarikka Primary Care Public Utility, Saarijärvi, Finland.\r There are 15 general practitioners (GP) working. During year 2014, 2 of them were\r performing 2-CUS. 9 of the other GPs were trained during years 2015-2016 to perform a\r 2-CUS and hence 11 of 15 GPs are able to do 2-CUS in 2017.\r\n\r This is a register study. Referrals to hospital in 2014 (pre-training) and 2017\r (post-training) are examined and the difference is assumed to be because of training and\r new pathway. Based on population the expected number of referrals due to a suspected DVT\r should be approximately 100 annually and the expected number after intervention is 30.\r According to power analysis a reduction from 100 to 76 is statistically significant\r (p<0.05).\r\n\r Hypothesis 1: Short education in ultrasound will reduce significantly referrals to\r hospital and save resources.\r\n\r 2. Length of stay (LOS) in emergency department (ED) is related to increased mortality,\r morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients\r with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be\r compared to those that have a radiology performed ultrasound examination.\r\n\r This part started in Central Finland Central Hospital and Kuopio University Hospital 10/2017.\r Tampere university hospital will start at 5/2018.\r\n\r An average LOS in Central Finland Central hospital ED is approximately 150 minutes. In a\r randomly selected monday in January, 2017, the average time from a referral to radiologist to\r a finished radiologist statement was 86 minutes. The times in Kuopio university hospital are\r much longer.\r\n\r When an EP decides to perform a POCUS exam, they will recruit the patient in the study and\r fill a simple structured form. It is up to the EP treating the patient to decide if the\r patients needs POCUS. No additional examination because of this study is made on the patient.\r\n\r The detailed time stamps for the patient to register in the ED, first doctor visit and\r finished from the doctor are retrieved from the files. In a follow-up of 6 months it is noted\r if the patient had a further examination by radiologist and if it was an ultrasound, CT, or\r some other examination. The results from POCUS will be compared to the radiologist\r examination, surgery or autopsy results where available and appropriate.\r\n\r The control group is found from picture archive system (PACS) system with going through\r ultrasound examinations on the same days as POCUS examinations are made, with a referral\r question that a POCUS could answer, and referring unit being emergency department, and the\r same time points will be recorded.\r\n\r There exists plenty of research on a focused ultrasound examination performed mostly by\r emergency physicians. In certain clinical questions such as abdominal aorta aneurysm or\r gallbladder stones, the accuracy of POCUS is excellent.\r\n\r There also exists some research on POCUS effect on LOS compared to a standard ultrasound\r examination performed mostly by a radiologist. The reduction in LOS has been huge.\r\n\r There is no data on regarding the Finnish health care system in this field. Also this study\r aims to evaluate multiple POCUS indications in a single real life setting which is not\r published before.\r\n\r Hypothesis 2: POCUS can shorten LOS significantly in selected clinical conditions\r\n\r Quality assurance plan: non-existent Data checks: non-existent Source data verification: EP\r filling the research form fills in only the finding in POCUS. It cannot reliably be verified\r in any way. All other data comes from medical records.\r\n\r Data dictionary: Non-existent for now Standard operation procedures: Non-existent\r\n\r Sample size assesment:\r\n\r Part 1: a whole year prior and after intervention is evaluated. According to power analysis,\r change from 100 to 76 would be statistically significant. A reduction of 100 to 30 is\r expected.\r\n\r Part 2: According to expected LOS reduction of at least 86 minutes, the study should need\r only approximately 10 patients + control group to show statistical significance. However a\r group of 400 patients will be recruited. The purpose of this is to be able to perform quality\r sub-group analysis based on indication of POCUS but also the experience level of EP\r performing the POCUS examination.\r\n\r Plan for missing data: The study form in part 2 is the only reliable source for the POCUS\r results and if this is missing, the patient must be excluded. All other data is derived from\r the medical files statistics and should reliable.\r\n\r Statistical analysis: A cost-minimization analysis will be performed in part 1. Other\r statistical analysis methods will be decided later.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Emergency department patient\r\n\r - A suspected medical condition, that can be confirmed or excluded by basic POCUS exam,\r including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta\r aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb,\r pneumothorax, early pregnancy with non-specified location (confirming intrauterine\r pregnancy), hydronephrosis.\r\n\r - Emergency medicine specialist or resident decides to perform a POCUS exam\r\n\r Exclusion Criteria:\r\n\r - age under 18\r\n\r - not able to give informed consent in Finnish\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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661
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[
{
"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\nMechanism of Decompensation Evaluation - Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nAortic stenosis is the most common heart valve disease requiring intervention in high income\r countries. It is characterised by progressive valvular thickening, and restriction as well is\r hypertrophy and fibrosis of the left ventricle in response to pressure overload. The\r pathological processes in the left ventricle that ultimately result in heart failure and\r death are incompletely understood. Further elucidation of these processes and how they\r correlate with novel blood biomarkers may help us design new treatments and optimise the\r timing of surgical intervention.\r\n\r In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve\r replacement surgery will be invited for some simple tests (blood sampling, ECG,\r echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the\r disease valve retained. These will be examined histologically and pathological changes\r compared with results obtained from ECG, echocardiogram and blood tests.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\n- Inclusion Criteria (aortic stenosis group):\r\n\r - Age over 18\r\n\r - Severe aortic stenosis with planned aortic valve replacement\r\n\r Inclusion Criteria (control group):\r\n\r - Age over 18\r\n\r - Planned non-aortic valve cardiac or elective ascending aorta surgery\r\n\r Exclusion Criteria (aortic stenosis group):\r\n\r - Coexistent severe aortic or mitral regurgitation\r\n\r - Coexistent mitral stenosis greater than mild in severity\r\n\r - Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)\r\n\r - Acute pulmonary oedema or cardiogenic shock\r\n\r - Coexistent hypertrophic cardiomyopathy\r\n\r - Unable to give informed consent\r\n\r Exclusion Criteria (control group):\r\n\r - Significant aortic valve disease (mild aortic stenosis / regurgitation or greater)\r\n\r - Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)\r\n\r - Acute pulmonary oedema or cardiogenic shock\r\n\r - Coexistent hypertrophic cardiomyopathy\r\n\r - Unable 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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662
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[
{
"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\nIMaging Della PLAcca Carotidea\n\n**Clinical Trial Summary:**\n\nBackground-White matter hyperintensities (WMH), patchy areas of hyperintense signal on\r T2-weighted or Fluid Attenuated Inversion Recovery sequences on brain magnetic resonance\r imaging (MRI), are believed to reflect cerebral burden of ischemic damage and are associated\r to incident stroke, dementia and eventually mortality in otherwise healthy subjects. Also\r brain atrophy has been related with presence of carotid atherosclerosis and vascular\r cognitive impairment. Carotid atherosclerosis may contribute to the genesis of WMH. A recent\r meta-analysis by our group comprising 5306 subjects was able to demonstrate an association\r between the presence of carotid atherosclerosis and WMH (odds ratio, OR, 1.42, 95% confidence\r interval [CI] 1.22-1.66).\r\n\r Objective-To evaluate the relation between carotid artery plaque characteristics,\r cardiovascular risk factors and brain atrophy/WMH burden analyzed quantitatively as number\r and volume of lesions and as brain volumes, and progression over 18 months of follow up in\r subjects asymptomatic for cerebrovascular disease with a carotid artery stenosis <70%.\n\n**Clinical Trial Detailed Description:**\n\n- Ischemic stroke and vascular cognitive impairment pose a massive clinical, social and\r economic burden. Disruption of carotid plaques, often non-obstructive, with subsequent\r thrombosis and distal embolization is one of leading pathogenetic mechanism of ischemic\r stroke. The widespread use of brain magnetic resonance imaging (MRI) has enabled an\r increased recognition, especially in elderly subjects, of cerebral alterations in\r apparently healthy individuals.\r\n\r - Carotid plaque may be causative in the development of white matter hyperintensities\r (WMH, patchy areas of signal hyperintensity on T2-weighted and/or fluid attenuated\r inversion recovery -FLAIR- sequences), silent brain infarcts (SBI) and eventually brain\r atrophy.\r\n\r - The hypothesis of the investigators is that carotid plaques with features of\r vulnerability detected by multimodality imaging (including standard ultrasound, contrast\r enhanced ultrasound -CEUS-, contrast enhanced CT angiography) and larger extent of\r atherosclerotic process, even if determining only an intermediate degree of stenosis,\r could bear a more rapid progression of silent WMH and brain atrophy.\r\n\r - Carotid CT and CEUS allow fast and reproducible evaluation of plaque size and\r morphology, alongside with functional parameters. Plaque density and positive\r remodelling on CT have been repeatedly associated to histological features of plaque\r vulnerability. At the same time, when compared to standard duplex evaluation, CEUS\r allowed a better imaging definition of plaque margins and extension, and to evaluate\r intraplaque neovascularization. The latter associates with local inflammation and plaque\r vulnerability, and might give rise to plaque hematomas, which are among the substrates\r for lesion progression and for the development of atherothrombosis.\r\n\r - In the initial phase of the study also hybrid imaging with positron tomography and\r computed tomography angiography (PET/CTA) using 11C-PK11195 was used to detect and\r quantify intraplaque inflammation in humans.(7) C-PK11195 is a selective ligand for\r translocator protein, 18kDa (TSPO), which is highly expressed on the surface of\r activated monocytes/macrophages. This part of the study was prematurely stopped due to\r problems with the production of the radiotracer with 11[C] (only 13 patients were\r studied with this approach).\r\n\r Primary endpoints:\r\n\r - The primary endpoint is to identify independent predictors (plaque-related or\r patient-related) with the progression of WMH through multivariable logistic regression\r analysis.\r\n\r Progression of WMH was considered as dichotomous variable: progression versus no progression\r of WMH.\r\n\r - The co-primary end-point is to identify independent predictors (plaque-related or\r patient-related) with the progression of gray matter (GM)/all brain atrophy through\r multivariable logistic regression analysis. Progression of brain atrophy was considered as\r dichotomous variable: progression versus no progression of GM/all brain atrophy.\r\n\r Statistical considerations:\r\n\r The investigators calculated the sample size for multivariate logistic regression analysis\r with a power of 0.8 and an alpha of 0.05. The investigators will analyze the highest tertile\r of carotid plaques burden in terms of plaque volume versus others (see Sillesen, 2012). By\r definition, the prevalence of high burden atherosclerosis will be 33%. The investigators\r estimated a clinically relevant probability of progressing in terms of WMH in the high burden\r group to be 50%, while subjects without high burden plaques are estimated to progress in\r terms of WMH as the general population with carotid atherosclerosis in a similar time frame.\r This probability would be estimated to be around 15% (see Dufoil, 2005 and Pico, 2002). The\r estimated sample size would be 58 individuals.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - bearing an asymptomatic carotid stenosis of 30-70% in diameter, as established by\r Doppler-measured peak systolic flow velocity, according to the Society of Radiologists in\r Ultrasound Consensus Conference (Grant et al. Radiology 2003).\r\n\r Exclusion Criteria:\r\n\r - pregnancy or possibility of pregnancy,\r\n\r - history of allergic diathesis,\r\n\r - history of stroke or transitory ischemic attack,\r\n\r - previous carotid artery stenting or carotid endarterectomy,\r\n\r - history of autoimmune vasculitis,\r\n\r - History of drug abuse, alcohol abuse or any psychiatric or social condition which may\r contraindicate the participation to a clinical study\r\n\r - life expectancy of less than 18 months due to underlying medical conditions,\r\n\r - presence of cognitive impairment preventing the patient from providing informed\r consent,\r\n\r - Atrial fibrillation or previous cardiac surgery or positioning of intracardiac devices\r (excluded coronary stents) as potential confounding causes of cerebral ischemic\r damage,\r\n\r - Known patent foramen ovale (PFO) necessitating anti-platelet treatment\r\n\r - Current anti-coagulation,\r\n\r - Previous infections to the central nervous system (CNS)\r\n\r - Previous surgery to the CNS\r\n\r - History of anoxic damage to the CNS\r\n\r - Dementia\r\n\r - Contraindications to computed tomography angiography (CTA, estimated Glomerular\r Filtration Rate<60 mL/min; history of allergic reaction to iodinated contrast media),\r\n\r - Specific contraindication to MRI:\r\n\r - Claustrophobia\r\n\r - Sickle cell anemia\r\n\r - Systemic mastocytosis\r\n\r - Implanted cardiac devices (i.e. pacemakers, implantable cardioverter\r defibrillators)\r\n\r - Vascular clips\r\n\r - Vertebral distractors\r\n\r - Infusion pumps\r\n\r - Neurostimulators\r\n\r - Liquor derivations\r\n\r - Any device which could be dispositioned in the presence of a strong magnetic\r field\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"
}
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definitely relevant
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663
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[
{
"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\nEvaluation of LB in THA\n\n**Clinical Trial Summary:**\n\nThis study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of\r practice local injection containing plain bupivacaine.\n\n**Clinical Trial Detailed Description:**\n\nInvestigation of liposomal bupivacaine to determine if this drug is a valid alternative to\r standard of care local anesthesia based on evaluation in total hip arthroplasty This is a\r retrospective cohort study of consecutive patients undergoing THA at 3 hospitals within a\r U.S. healthcare system from January 2013 to July 2016. The control group received the\r standard of care undergoing THA (plain bupivacaine or ropivacaine), while the LB group\r received a mixture containing this drug as the alternative to the standard care. The outcome\r variables include hospital length of stay, readmissions, total hospital costs, patient pain\r scores, discharge disposition, morphine equivalent opioid consumption, and postoperative\r patient ambulation. Generalized linear models were employed to examine aforementioned\r outcomes controlling for age, gender, race, BMI, alcohol use, tobacco use, and surgeons..\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Males or females over the age of 18\r\n\r - have undergone a THA surgery during the period of interest January 2013 to July 2016).\r\n\r Exclusion Criteria:\r\n\r - excluded from the study based on the following criteria:\r\n\r 1. Concurrent, painful, physical condition or concurrent surgery that may require\r analgesic treatment in the postoperative period for pain that is not strictly\r related to the surgical treatment;\r\n\r 2. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder; and\r\n\r 3. Significant renal or hepatic insufficiency.\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
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664
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[
{
"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\nPositron Emission Tomography / Magnetic Resonance Imaging in Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nAortic stenosis is the most common valve disease requiring surgery in the Western world. It\r is defined by progressive calcification and fibrosis of the valve leaflets and restricted\r valve opening. This in turn exposes the heart muscle (left ventricle) to increasing pressure\r leading to heart muscle thickening (left ventricular hypertrophy, LVH) to normalise wall\r stress and maintain heart output (stroke volume). The only treatment available is relief of\r pressure overload by surgical or minimally invasive valve replacement (TAVI).\r\n\r Transthyretin (TTR) amyloidosis is a condition characterised by deposition of insoluble\r transthyretin protein (a small protein tetramer produced in the liver) in various tissues,\r predominantly in the heart. Although there are inherited forms caused by specific TTR gene\r mutations, most cases occur in older individuals with non-mutated TTR (wild-type). The\r finding of TTR plaques in elderly individuals is relatively common; in a post-mortem study\r 22-25% of patients over the age of 80 had evidence of cardiac amyloid deposition. However,\r there is significant progressive amyloid accumulation in a small percentage of individuals\r leading to heart muscle thickening and heart failure. No medical treatments are currently\r licensed although several agents are at advanced stages of clinical trials.\r\n\r As both the above conditions are increasingly common in the elderly population and\r characterised by increased heart muscle thickening, there is the potential for them to\r coexist unrecognised in individual patients. The prevalence of cardiac amyloidosis in\r clinical populations with significant aortic stenosis is not known however small series have\r estimated somewhere in the region of 6-29%. Other data have suggested that patients with\r aortic stenosis and concurrent cardiac amyloidosis have an adverse prognosis even despite\r AVR. It is therefore important to identify aortic stenosis patients with coexistent\r amyloidosis both in terms of predicting prognosis and because it may influence decisions\r about whether to proceed to valve intervention.\r\n\r PET/MR is an emerging technique, which combines the excellent temporal and spatial resolution\r of MRI with the sensitive molecular imaging of PET. PET/MR has significant advantages over\r PET/CT (the currently more widely used approach) in that it offers superior tissue\r characterisation, improved correction for cardiac and respiratory motion and major reductions\r in radiation exposure. Whilst there are concerns about its ability to provide reliable\r attenuation correction of the PET data, these issues appear to have been largely overcome\r with recent techniques proposed by our group. MR is also more naturally suited to the imaging\r of certain tissues in the body compared to CT including the left ventricular myocardium.\r\n\r In aortic stenosis, MRI has become the gold-standard technique for examining the heart muscle\r (myocardium) with the unique ability to assess its tissue composition. In particular both\r late gadolinium enhancement (LGE) and T1 mapping based techniques are able to detect heart\r scarring (fibrosis) which act as biomarkers of left ventricular decompensation and are\r strongly associated with poor patient outcomes. CMR is also the gold-standard non-invasive\r technique for detecting cardiac amyloid, which is associated with both a characteristic\r pattern of LGE and high native T1 values. However it is not currently able to differentiate\r between the two different types of cardiac amyloid TTR and AL amyloidosis, which have\r different prognoses and treatments. Preliminary studies conducted by our group have suggested\r that 18F-NaF PET when added to CMR can make this distinction on the basis that this tracer\r binds to TTR deposits but not AL deposits, may be able to differentiate between the two.\r Importantly we have also used the same PET tracer as a marker of calcification activity in\r the aortic valve, demonstrating its ability to predict disease progression and cardiac\r events.\r\n\r In this study, we will investigate whether PET/MR could be used as \"one-stop\" imaging in\r aortic stenosis in whom valve intervention is being considered to assess in detail functional\r and structural properties of both the valve and myocardium and identify cases of significant\r cardiac TTR amyloid deposition.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria (AS group)\r\n\r - Severe aortic stenosis\r\n\r - Referred for aortic valve intervention (surgical AVR / TAVI)\r\n\r - High clinical suspicion of amyloid (e.g. low-flow low-gradient AS, inappropriate LVH)\r\n\r - Age >70 years\r\n\r - Willing and able to comply with study protocol\r\n\r Exclusion Criteria (AS group)\r\n\r - Inability to give informed consent\r\n\r - Contraindication to MRI scanning (e.g. permanent pacemaker)\r\n\r - Significant renal impairment (eGFR <30 ml/min/1.73 m2)\r\n\r - Coexistent moderate or severe aortic regurgitation or mitral stenosis\r\n\r - Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)\r\n\r - Acute pulmonary oedema or cardiogenic shock\r\n\r Inclusion Criteria (Healthy volunteers)\r\n\r - No symptoms suggesting current cardiovascular disease\r\n\r - Age >70\r\n\r - Willing and able to comply with study protocol\r\n\r Exclusion Criteria (Healthy volunteers)\r\n\r - Inability to give informed consent\r\n\r - Contraindication to MRI scanning (e.g. permanent pacemaker)\r\n\r - Significant renal impairment (eGFR <30 ml/min/1.73 m2)\r\n\r - Known significant valvular heart disease (more than mild regurgitant valve lesion or\r any stenotic lesion)\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"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\nFunctional Assessment In TAVI: FAITAVI\n\n**Clinical Trial Summary:**\n\nThe aim of this study is to compare the clinical outcome of patients with severe aortic valve\r stenosis and associated significant coronary artery disease treated with TAVI and a\r percutaneous myocardial revascularization dictated according to two different strategies:\r\n\r 1. the Angiographically-guided strategy;\r\n\r 2. the Physiologically-guided strategy.\n\n**Clinical Trial Detailed Description:**\n\nNowadays there are no clear recommendations about treatment of coronary in patients with\r severe aortic valve stenosis eligible for percutaneous valve replacement, and those available\r rely on a \"common sense\", class C, level of evidence. No randomized trials debride the skein\r about the best strategy of revascularization in this complex group of patients. In\r particular, it remains unclear whether it is preferable a preventive treatment or an\r ischemia-driven revascularization and, in addition, if it is safer and better for patient's\r health a simultaneous or a staged strategy.\r\n\r The aim of this study is to compare the clinical outcome of patients with severe aortic valve\r stenosis and associated significant coronary artery disease treated with TAVI and a\r percutaneous myocardial revascularization dictated according to two different strategies.\r\n\r The Angiographically-guided strategy is that of aiming the most complete degree of\r revascularization based on angiographic evaluation (stenting all coronary stenosis of major\r branches >2.5mm, with a %DS>50% as evaluated by visual estimation).\r\n\r The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and\r leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded\r in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating\r the 0.80 FFR cut-off with different iFR cut-off values, according to recent observations and\r using the same study end-points.\r\n\r Particular attention will be dedicated to the eventual occurrence of clinical events in\r patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive\r (<0.89) iFR values to investigate the reliability of the FFR in the Aortic Stenosis setting.\r\n\r Both groups will receive the same TAVI strategy and optimal medical therapy. The study is\r designed as randomized, prospective, multi.center, open label, experimental trial with\r medical device. After discharge patients will be contacted at 30 days, 6 - 12 and 24 months\r after the procedure to assess the general clinical status and at 12 months to assess the\r occurrence of events included in the primary and secondary endpoints. The duration of study\r participation is 24 months for enrolment, ad 24 months for final follow-up.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age > 18 years\r\n\r 2. Written informed consent\r\n\r 3. Diagnosis of severe native aortic valve disease with the indication to endovascular\r valve replacement given by Heart Team\r\n\r 4. Diagnosis of at least one coronary stenosis >50% at angiography\r\n\r 5. No specific pharmacologic treatment is required to enter the study\r\n\r Exclusion Criteria:\r\n\r 1. Age < 18 years\r\n\r 2. Pregnancy\r\n\r 3. Lack of informed consent\r\n\r 4. Impaired left ventricular function\r\n\r 5. Signs or symptoms of acute (unstable) myocardial ischemia\r\n\r 6. Contraindication to adenosine administration (e.g., asthma, chronic obstructive\r pulmonary disease, heart rate <50 beats/min, and systolic blood pressure <90 mmHg)\r\n\r 7. Reduced survival expectancy due to severe co-morbidities (<1 year)\r\n\r 8. Impossibility to obtain follow-up information\r\n\r 9. The lack of any of inclusion criteria\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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666
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{
"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\nTRACER [F-18] RDG-K5 Carotid Plaque Imaging Study\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to investigate the ability of a new investigational agent\r compound [F-18] labeled RGD-K5 to detect unstable atherosclerotic plaque in the carotid\r artery of subjects being considered for carotid endarterectomy (CEA), and to confirm this\r ability through tissue analysis of samples of carotid artery plaques that will be collected\r during the planned carotid surgery. [F-18] RGD-K5 is a radioactive tracer used in imaging to\r detect active growth of new blood vessels and presence of macrophages. Patients with unstable\r plaque may be prone to rupture of the plaque due to increase in macrophage activity and\r growth of new blood vessels. [F-18] RGD-K5 is an investigational agent, which means that it\r has not yet been approved by the US Food and Drug Administration (FDA).\r\n\r Unstable atherosclerotic plaque that is prone to rupture is characterized by an increase in\r the number of macrophages and enhanced angiogenesis. Both neovascular endothelium and\r macrophages exhibit increased Alpha-v beta3 integrin expression. PET (Positron Emission\r Tomography) imaging of [F-18] RGD-K5 uptake may identify carotid plaque with increased\r inflammation and neovascularization and may therefore detect unstable plaque in participants\r with carotid artery stenosis.\r\n\r Prior to Dr. Tamarappoo's relocation to Cedars Sinai Medical Center (CSMC), 5 subjects were\r enrolled at the Cleveland Clinic where PET-CT (Positron Emission Tomography - Computed\r Tomography) was performed. 6 subjects will be scanned at Cedars using PET-MRI (Positron\r emission tomography-magnetic resonance imaging). Based on preliminary data with PET-CTA, the\r investigator strongly believes the study will be able to reproducibly detect significant\r [F-18] RGD-K5 uptake in plaque from symptomatic patients. Ultimately, demonstrating\r preferential [F-18] RGD-K5 uptake in symptomatic patients will significantly impact the way\r in which patients with carotid plaque (at risk for stroke) are treated and it may prevent\r unnecessary surgical and endovascular procedures in this population\n\n**Clinical Trial Detailed Description:**\n\nThe primary objectives of this exploratory study are:\r\n\r - To assess the uptake of [F-18] RGD-K5 by carotid plaque with PET/MRI imaging in\r participants prior to carotid endarterectomy and thereby determine if carotid plaque\r that causes significant stenosis [in participants being considered for carotid\r endarterectomy (CEA)] is characterized by increased integrin expression and enhanced\r angiogenesis.\r\n\r - To collect safety data of [F-18] RGD-K5 in participants with carotid atherosclerosis.\r\n\r Potential subjects will be identified and approached during an inpatient or outpatient\r clinical visit by a member of the research team. Potential subjects will be identified by\r their treating physicians and referred to the researchers. Patients' private and identifiable\r information will not be shared prior to receiving permission from the patient to do so\r\n\r Summary of research procedures:\r\n\r Physical exam and vital Signs:\r\n\r Height, weight, temperature, heart rate and blood pressure will be checked before beginning\r the imaging tests. Subjects' heart rate and blood pressure will be checked again after each\r of the two PET/MRI images, and as needed.\r\n\r Patients will also be asked about the presence of ICD, pacemaker or any metallic implants\r that would not be compatible with the MRI magnet (presence of MRI non-compatible devices will\r be an exclusion criteria)\r\n\r Blood Test:\r\n\r If labs have been done and the lab values meet the criteria to participate in this study, the\r investigators will not need to collect these labs again on the day of testing. If these labs\r have not been collected within 30 days prior to the research imaging tests, the investigators\r will draw a tube of blood to check kidney function and other necessary blood values prior to\r the research testing. Patients with a glomerular filtration rate (GFR) <40ml/min will be\r excluded from the study.\r\n\r Urine Pregnancy test:\r\n\r This will only need to be done in female subjects of childbearing potential. This will need\r to be checked prior to scheduling subjects' research imaging tests. If subjects' tests are\r schedules more than 2 days (48 hours) since first checked, this test will need to be\r rechecked on the day of subjects' research imaging testing.\r\n\r ECG:\r\n\r An ECG (electrocardiogram) will be done to assess subjects' heart rhythm before the testing\r begins, and after each of the PET scans.\r\n\r IV insertion:\r\n\r A catheter will be inserted into subjects' arm. It is through this IV catheter that the dose\r of [F-18] RGD-K5 will be given prior to imaging.\r\n\r Research PET/MRI Imaging of the Carotid Arteries:\r\n\r 2 hours after receiving the dose of [F-18] RGD-K5 PET/MRI imaging of subjects' neck (carotid\r arteries) will be performed. Subjects will be lying on subjects' back with a head fixation\r device supporting subjects' head to prevent Subjects from moving subjects' head while the\r images are taken. This scan will take about 30-45 minutes. Subjects will be permitted to get\r up and move around between receiving the radiotracer and imaging. Subjects will be asked to\r drink a glass of water before receiving the dose of [F-18] RGD-K5.\r\n\r Histology and Immunohistochemistry:\r\n\r During Subjects carotid endarterectomy(CEA) which is a clinically indicated procedure,\r atherosclerotic plaque will be removed. A sample of this plaque will be collected and taken\r to the histology laboratory at Cedars Sinai for analysis.\r\n\r Follow Up phone call:\r\n\r Subjects will be contacted by phone the day after subjects' PET scans to ask if Subjects have\r had any medical problems and what medications Subjects have taken since the PET scan. If\r Subjects were seen by a doctor to be evaluated for a medical problem, the investigators may\r ask permission to contact the doctor or hospital to obtain copies of subjects' medical\r records\r\n\r Research poses greater than minimal risk\r\n\r Anticipated benefits:\r\n\r There is no personal benefit to participants by participating in this research study.\r\n\r The knowledge to be gained from this research may be beneficial for other patients, society\r or science.\r\n\r The detection by the imaging protocol of unstable atherosclerotic plaque in the carotid\r artery will not result in any change in their standard of care.\r\n\r The potential benefit of the study to the patient is that it will allow the physician\r treating the patient to know the entire extent of the carotid plaque, plaque composition and\r will inform them of the anatomy of the carotid artery in question.\r\n\r Furthermore, it will provide information about plaque in the contralateral carotid artery and\r if that plaque has a high degree of inflammation. If a high inflammatory burden is noted in\r the contralateral carotid artery, there will be more vigilance in monitoring these patients.\r\n\r Summary of process by which confidentiality will be maintained:\r\n\r Research records will be stored in a locked cabinet in a secure location Electronic research\r records will be stored in a shared network folder on the CSMC network. The list linking the\r assigned code number to the individual subject will be maintained separately from the other\r research data. Only certified research personnel who are listed on the approved Institutional\r Review Board (IRB) application will be given access to identifiable subject information.\r Research related data and patient/subject information will never be stored on a researcher's\r personal (private) computer or laptop. Study data will be coded upon abstraction so that\r Direct Identifiers** are maintained separately from the data set.\r\n\r Summary of data and safety monitoring plan:\r\n\r The study will be monitored only by the study investigators and/or sponsor.\r\n\r How does participation in the research differ from the receipt of standard care:\r\n\r RISKS OF THE STUDY\r\n\r As with any research study, there may be adverse events or side effects that are currently\r unknown and it is possible that certain of these unknown risks could be permanent, serious or\r life threatening. The study doctor will inform subjects of any significant new information\r that is discovered during this trial.\r\n\r Risks of the Study Drug Based upon the toxicity profile to be administered as a single dose,\r the purity and impurity profile of [F-18] RGD-K5, no risk of adverse events is anticipated\r for this study.\r\n\r Radiation Risk:\r\n\r - It is very unlikely that participants will see any harmful effects because of the\r radiation exposure participants will receive from taking part in this study.\r\n\r - At high levels of exposure, scientists agree that radiation can cause cancer. This\r research study involves exposure to radiation from the RGDK5-PET scan. The total amount\r of radiation exposure participants will receive is equivalent to a uniform whole-body\r exposure of 0.8 rem. This is comparable to approximately three years' worth of radiation\r exposure from typical environmental sources (about 0.3 rem per year, which includes\r radon, natural background radiation, and cosmic rays). This is also comparable to 16% of\r the maximum annual exposure for radiation workers (5 rem) allowed by the Nuclear\r Regulatory Commission.\r\n\r MRI is not associated with any radiation risk.\r\n\r MRI non-compatible devices such as pacemakers, ICD (implantable cardioverter defibrillator)\r and metallic implants may cause artifacts in imaging and device malfunction as well as local\r tissue injury.\r\n\r Contrast used for MRI is associated with minimal risk among patients who are free of\r significant renal dysfunction.\r\n\r When injected into the body, gadolinium contrast medium makes certain tissues, abnormalities\r or disease processes more clearly visible on a magnetic resonance imaging scan. They are used\r to improve the clarity of the scanned images or pictures of the body's internal structures.\r\n\r Gadolinium contrast medium is given by intravenous injection.\r\n\r The risk of gadolinium contrast is minimal in patients without severe renal disease.\r\n\r The most common adverse effects of gadolinium agents are\r\n\r - Itching of the skin (5%)\r\n\r - Headache (4%)\r\n\r - Nausea (4%)\r\n\r - Very small risk of local pain\r\n\r - Hypersensitivity (allergic reaction)\r\n\r - Rarely (<1% of the time) it can cause low blood pressure and lightheadedness. This can\r be treated immediately with IV fluids.\r\n\r More serious allergic reactions that are life threatening are rare. Gadolinium is not safe\r for people with late stage kidney disease or who have had a liver transplant.\r Gadolinium-based contrast agents increase the risk for a rare, but serious adverse reaction,\r called nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the\r drugs. Patients with kidney disease are at increased risk of developing NSF. NSF may cause\r skin thickening, joint pain and/or swelling, causing feelings of burning, itching and pain\r that can be severe. In very rare cases, NSF can lead to lung and heart problems and may be\r life threatening. Participants will have a blood test to measure kidney function and if the\r blood test is abnormal, they will not be permitted to receive gadolinium.\r\n\r There is a very small risk of mild headache and local pain. Rarely (<1% of the time) it can\r cause low blood pressure and lightheadedness. This can be treated immediately with IV fluids.\r More serious allergic reactions that are life threatening are rare. Gadolinium is not safe\r for people with late stage kidney disease or who have had a liver transplant.\r\n\r As with all research procedures and administration of study drugs, subjects will be monitored\r at all times.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients presenting\r\n\r a. to the neurologist for evaluation of stroke or TIA (Symptomatic) with: i. Symptomatic\r patients with plaque ≥70% in at least one carotid artery that would be implicated as the\r source of embolus responsible for the stroke/TIA. b. or to the vascular surgeon for CEA\r (Asymptomatic) with: i. asymptomatic patients with a luminal stenosis of ≥70% in at least\r one carotid artery (stable plaque) referred for CEA ii. age-matched by deciles to\r symptomatic patients\r\n\r Exclusion Criteria:\r\n\r 1. stroke due to atrial fibrillation,\r\n\r 2. preexisting carotid stents in the artery of interest,\r\n\r 3. renal dysfunction defined as glomerular filtration rate (GFR) <40ml/min,\r\n\r 4. allergy to gadolinium based contrast agents,\r\n\r 5. Volunteers who have had four or more prior previous gadolinium contrast scans\r\n\r 6. metal implants incompatible with MRI or other condition that prohibits MRI,\r\n\r 7. pregnancy,\r\n\r 8. inability to provide informed consent and\r\n\r 9. age ≤18 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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667
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[
{
"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\nFinnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry\n\n**Clinical Trial Summary:**\n\nThe FinnValve investigators planned a nationwide registry to investigate the early and late\r outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve\r replacement (SAVR) in patients with aortic valve stenosis performed from 2008 to 2017 at five\r Finnish University Hospitals. Data will be collected in a dedicated electronic case report\r form.\n\n**Clinical Trial Detailed Description:**\n\nRationale of the study Uncertainty regarding the potential benefits of transcatheter aortic\r valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients\r with aortic valve stenosis (AS) requires well-designed studies with long-term data on the\r outcome of these patients. A Finnish nationwide registry would allow complementing of the\r knowledge gained from randomized trials by providing data on the outcome of a more inclusive\r patient population, within a Health Care System that reflects the actual clinical practice in\r Scandinavia. In fact, the internal validity attained in randomized trials is often achieved\r at the expense of uncertainty about generalizability, especially since the populations\r enrolled in such studies may differ in significant ways from those seen in practice.\r\n\r The choice among different surgical aortic valve prostheses is based on solid data with\r 20-year follow-up, which have shown significant risk of structural valve deterioration of\r bioprosthesis on the second decade after implantation. However, much less is known about the\r structural durability of TAVI prostheses beyond 3 years of follow-up. This nationwide\r registry would provide data on the durability of surgical bioprostheses as well as second and\r third generation TAVI prostheses at 7 years . Continuous follow-up of these patients will\r allow monitoring of the durability of these prostheses on the long run.\r\n\r Furthermore, the introduction of TAVI prompted a rapid development of minimally invasive\r surgical techniques and rapid deployment surgical bioprostheses in order to reduce the risk\r of early adverse events after SAVR. However, it is unclear whether these advances have a real\r clinical benefit on the early and late outcome of patients undergoing SAVR.\r\n\r Patients and Methods\r\n\r Patients operated on for AS at each Finnish University Hospitals from January 2008 to\r September 2017 will included in to this registry. The following inclusion and exclusion\r criteria will be considered:\r\n\r Inclusion criteria:\r\n\r - Patients aged >18 years\r\n\r - Primary aortic valve procedure with a bioprosthesis for AS with or without associated\r regurgitation.\r\n\r - TAVI and SAVR with or without associated coronary revascularization\r\n\r - TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze\r procedure and/or closure of the left atrial appendage.\r\n\r Exclusion criteria:\r\n\r - Patients who underwent any prior SAVR or TAVI\r\n\r - Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the\r ascending aorta.\r\n\r - Patients operated on for aortic valve endocarditis\r\n\r - Patients operated for isolated aortic valve regurgitation.\r\n\r Definition criteria for baseline and operative variables as well as early and late outcomes\r will be according to the Valve Academic Research Consortium (VARC) 2 guidelines (Kappetein et\r al. Eur J Cardiothorac Surg 2012;42:S45-60). Prosthetic valve structural deterioration and\r failure will be reported according to the last specific guidelines on this topic (Capodanno\r et al. Eur J Cardiothorac Surg. 2017;52:408-417). However, because of the lack of complete\r echocardiographic follow-up in these patients, valve structural valve deterioration will be\r classified only according to the definition criteria of severe hemodynamic structural valve\r deterioration of these guidelines.\r\n\r The late events of interest are all-cause mortality, stroke, myocardial infarction,\r myocardial revascularization, structural deterioration, non-structural valve dysfunction,\r repeated procedures on the aortic valve and implantation of permanent pace-maker. Data on\r these late events will be collected at each participating center. These will be further\r checked and implemented for patients residing outside the catchment areas by interrogation of\r the Finnish National Health Institute for Health and Welfare database as well as Statistics\r Finland database.\r\n\r Planned studies\r\n\r The following is a tentatile of study projects which will be accomplished from the FinnValve\r registry:\r\n\r 1. Late outcome of TAVI versus SAVR in intermediate risk patients\r\n\r 2. Late outcome of TAVI versus SAVR in low risk patients\r\n\r 3. Late outcome of TAVI and SAVR in high risk patients\r\n\r 4. Futility of TAVI (3-month analysis)\r\n\r 5. Mini- versus full-sternotomy SAVR\r\n\r 6. Perceval sutureless bioprosthesis: 5-year outcome\r\n\r 7. Late outcome of sutureless versus conventional stented bioprosthesis in isolated SAVR\r\n\r 8. Late outcome of sutureless SAVR versus transfemoral TAVI in low- and intermediate risk\r patients\r\n\r 9. Early and late outcome of TAVI versus SAVR in patients with recent acute heart failure\r\n\r 10. Early and late outcome of TAVI versus SAVR in bicuspid AS\r\n\r 11. Early and late outcome of TAVI versus SAVR in obese patients (BMI >29) at low- and\r intermediate risk\r\n\r 12. Early and late outcome of isolated TAVI versus TAVI plus percutaneous coronary\r intervention (PCI) in patients with coronary artery disease\r\n\r 13. Early and late outcome of TAVI plus PCI versus SAVR plus coornary artery bypass grafting\r (CABG)\r\n\r 14. Prognostic impact of Syntax score on the early and late outcome after TAVI\r\n\r 15. Early and late outcome of TAVI vs. SAVR in patients with prior CABG\r\n\r 16. Early and late outcome of second versus third generation TAVI prostheses\r\n\r 17. Early and late outcome of transfemoral versus transaortic TAVI\r\n\r 18. Early and late outcome of trans-subclavian artery versus trans-aortic TAVI\r\n\r 19. Early and late outcome of sutureless versus conventional stented bioprosthesis in SAVR\r plus CABG\r\n\r 20. Early and late outcome of Trifecta versus Perimount bioprosthesis in isolated SAVR\r\n\r 21. Thromboembolic events after TAVI and SAVR\r\n\r 22. Early and late outcome of TAVI in nonagenarians\r\n\r 23. Prognostic impact of permanent pace-maker implantation on the early and late outcome\r after TAVI and SAVR\r\n\r 24. Prognostic impact of mild paravalvular leakage on the late outcome after SAVR\r\n\r 25. Impact of preoperative atrial fibrillation on the late outcome of TAVI\r\n\r 26. Impact of preoperative atrial fibrillation on the late outcome of SAVR\r\n\r 27. Early and late outcome of TAVI vs. SAVR in patients aged 85 years or older\r\n\r Publications of results and PhD studies\r\n\r The results of these studies will be published in international, peer-reviewed journals in\r the fields of cardiology and cardiac surgery. Furthermore, data from this registry will be\r available for several doctoral study projects. At this stage, a proposal for PhD studies has\r been submitted by:\r\n\r 1. Marko Virtanen, MD (Tampere University Hospital);\r\n\r 2. Pasi Maaranen, MD (Tampere University Hospital)\r\n\r 3. Maina Jalava, MD (Turku University Hospital);\r\n\r 4. Tuomas Ahvenvaara (Oulu University Hospital);\r\n\r 5. Teemu Laakso (Helsinki University Hospital).\r\n\r Time schedule of data collection, checking and analysis\r\n\r - December 2017: start of data collection\r\n\r - End of April 2018: deadline for data collection\r\n\r - End of May 2018: data checking\r\n\r - June 2018-December 2019: analyses and writing of the planned studies.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients who underwent transcatheter (TAVI) or surgical aortic valve replacement\r (SAVR) for severe aortic valve stenosis\r\n\r - Patients aged >18 years\r\n\r - Primary aortic valve procedure with a bioprosthesis for AS with or without associated\r regurgitation.\r\n\r - TAVI and SAVR with or without associated coronary revascularization\r\n\r - TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze\r procedure and/or closure of the left atrial appendage.\r\n\r Exclusion Criteria:\r\n\r - Patients who underwent any prior SAVR or TAVI\r\n\r - Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the\r ascending aorta.\r\n\r - Patients operated on for aortic valve endocarditis\r\n\r - Patients operated for isolated aortic valve 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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668
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[
{
"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\nModeling Treated Recovery From Aphasia\n\n**Clinical Trial Summary:**\n\nStroke is the leading cause of adult disability in the United States, and aphasia is common\r following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia\r recover; however, very little is known about how different patients respond to different\r types of treatments.\r\n\r The purpose of this study is to understand how the following factors influence an\r individual's response to aphasia treatment: 1) biographical factors (e.g., age, education,\r gender), 2) post-stroke cognitive/linguistic abilities and learning potential, and 3) the\r location and extent of post-stroke brain damage. We are also interested in understanding the\r kinds of treatment materials that should be emphasized in speech/language treatment.\r\n\r Overall, the goal of the current research is to inform the clinical management of post-stroke\r aphasia by identifying factors that can predict how an individual will respond to different\r treatment methods.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months\r post-stroke\r\n\r - Primarily English speaker for the past 20 years\r\n\r - Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal\r implants, not claustrophobic)\r\n\r Exclusion Criteria:\r\n\r - History of a right hemisphere stroke (Bilateral stroke)\r\n\r - Clinically reported history of dementia, alcohol abuse, psychiatric disorder,\r traumatic brain injury, or extensive visual acuity or visual-spatial problems\r\n\r - Severely limited speech production and/or auditory comprehension that interferes with\r adequate participation in the therapy provided\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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669
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[
{
"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\nPathogenetic Basis of Aortopathy and Aortic Valve Disease\n\n**Clinical Trial Summary:**\n\nThe main purpose of this study is to define the complex genetic and pathogenic basis of\r thoracic aortic aneurysm (TAA) and other forms of aortopathy and/or aortic valve disease by\r identifying novel disease-causing genes and by identifying important genetic modifiers for\r aortic and aortic valve disease severity.\n\n**Clinical Trial Detailed Description:**\n\nThoracic aortic aneurysm (TAA) is a type of aortopathy describing dilation of the proximal\r aortic dimensions including the aortic root, which is a risk factor for aortic dissection and\r sudden cardiac death. TAA and other forms of aortopathy (e.g. aortic tortuosity or aortic\r hypoplasia/stenosis) develop in the presence or absence of additional cardiovascular\r malformations including bicuspid aortic valve. TAA is associated with connective tissue\r disorders (e.g. Marfan syndrome), and familial clustering has been identified in a\r significant proportion of nonsyndromic cases, establishing high heritability. Pedigree\r analysis of TAA kindreds clearly identifies complex inheritance; however, progress towards\r understanding the genetic basis of TAA and other forms of aortopathy and, ultimately, the\r susceptibility to aortic dissection remains incomplete. There is a clinical need to develop\r novel methods for predicting disease risk based on genotype and phenotype, to further\r elucidate the genetic and pathogenic mechanisms of aortopathy, and to improve medical and\r surgical therapies. The overarching hypothesis of this study is that individual genetic\r variation modulates susceptibility to disease severity and progression. The goals of this\r study are 1) to ascertain a cohort of subjects who have aortopathy and/or aortic valve\r disease including TAA or who have genetic risk for the development of aortopathy and/or\r aortic valve disease, 2) to collect paired blood and tissue samples from well-characterized\r subjects, family members of subjects, and controls to perform genome-wide DNA sequence,\r histopathologic, transcriptional, and proteomic analyses, and 3) to establish a tissue\r biorepository with detailed phenotype information to facilitate a broad spectrum of current\r and future studies.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Open to external enrollment:\r\n\r - Subjects with a genetic diagnosis of Marfan Syndrome (MDS), Loeys-Dietz Syndrome\r (LDS), or Vascular Ehlers-Danlos Syndrome (EDS); (Positive genetic testing or a\r previous cardiac study required to be eligible)\r\n\r - Family members of eligible subjects (Only family members of subjects with\r syndromic diagnoses are eligible for external enrollment at this time)\r\n\r - Closed to external enrollment:\r\n\r - Subjects with aortic disease including TAA* or dissection, aortic tortuosity, or\r aortic hypoplasia/stenosis (based on any cardiac imaging modality including\r echocardiography, CT, MRI, or angiography)\r\n\r - Subjects with aortic valve disease (bicuspid, unicuspid, or tricuspid disease)\r\n\r - Control subjects having tissue removed during a surgical procedure (e.g. coronary\r artery bypass graft surgery (CABG), cardiac transplant, etc.)\r\n\r Exclusion Criteria:\r\n\r • Inability or unwillingness to provide consent (assent when indicated)\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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670
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[
{
"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 Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nCoronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve\r (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced.\r The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard\r practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR)\r and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values,\r and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be\r consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same\r lesions.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of the study is to determine whether iFR assessment gives a valid assessment of\r coronary hemodynamics in patients with severe aortic stenosis.\r\n\r Several factors confound the interpretation of fractional flow reserve (FFR) in patients with\r severe aortic stenosis (AS) and intermediate severity coronary stenoses, and the widely\r accepted cut-off value of 0.80 may not be applicable to this patient population. Coronary\r flow reserve is known to be attenuated under conditions of left ventricular hypertrophy and\r severe AS, with one study showing improvement in coronary flow reserve after aortic valve\r replacement. Left ventricular hypertrophy produces fixed resistance secondary to external\r compression of the coronary microcirculation. This potentially results in failure to achieve\r maximal hyperemia with adenosine and can lead to false negative FFR results. Neurohormonal\r influences in aortic stenosis can further attenuate vasodilator response and potentially\r result in false negative FFR values. Both of these conditions result in the potential\r deferral of lesions which may have been hemodynamically significant in the absence of severe\r AS. At present, there are no studies which have demonstrated validity of FFR measurement in\r patients with severe AS. Here, the investigators propose a prospective study of iFR/FFR in\r patients with AS and indeterminate coronary lesions undergoing TAVR to understand the\r hemodynamic consequences of AS on iFR/FFR. The investigators hypothesize that iFR/FFR values\r will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the\r same lesions.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients who have coronary stenoses between 40-70% severity and who have severe\r aortic stenosis undergoing TAVR work-up.\r\n\r Exclusion Criteria:\r\n\r - Patients with documented intraprocedural hemodynamic instability, shock, or major\r adverse event (myocardial infarction, aortic rupture/dissection, stroke, left\r ventricular perforation, cardiac arrest).\r\n\r - Contraindication to adenosine, presence of cardiogenic shock, presence of acute\r coronary syndrome.\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
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671
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[
{
"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 Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System\n\n**Clinical Trial Summary:**\n\nThe purpose of this registry is to collect specific health and patient data to identify more\r precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™\r Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.\r\n\r Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™\r Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA\r population.\r\n\r As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in\r minimally invasive, transcatheter aortic valve replacement using transapical access in\r patients presenting with severe aortic valve stenosis.\n\n**Clinical Trial Detailed Description:**\n\nThe Primary Objective of this post-market registry is to collect specific health and patient\r characteristics to understand the indication for TA-TAVI and to further evaluate the safety\r and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical\r Delivery System in a specific TA population, consisting of 200 consented patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Symptomatic patients with severe aortic stenosis;\r\n\r - Institution heart team determines that aortic valve replacement ACURATE neoTM device\r using its transapical delivery system is appropriate;\r\n\r Exclusion criteria:\r\n\r - Patients unable or unwilling to give inform 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:** definitely relevant"
}
] |
definitely relevant
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672
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[
{
"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\nPhono- and Electrocardiogram Assisted Detection of Valvular Disease\n\n**Clinical Trial Summary:**\n\nThe diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac\r imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of\r significant VHD could both expedite access to life-saving therapies and reduce the need for\r costly testing. The FDA-approved Eko Duo device consists of a digital stethoscope and a\r single-lead electrocardiogram (ECG), which wirelessly pairs with the Eko Mobile application\r to allow for simultaneous recording and visualization of phono- and electrocardiograms. These\r features uniquely situate this device to accumulate large sets of auscultatory data on\r patients both with and without VHD.\r\n\r In this study, the investigators seek to develop an automated system to identify VHD by\r phono- and electrocardiogram. Specifically, the investigators will attempt to develop machine\r learning algorithms to learn the phonocardiograms of patients with clinically important\r aortic stenosis (AS) or mitral regurgitation (MR), and then task the algorithms to identify\r subjects with clinically important VHD, as identified by a gold standard, from naïve\r phonocardiograms. The investigators anticipate that the study has the potential to\r revolutionize the diagnosis of VHD by providing a more accurate substitute to traditional\r auscultation.\n\n**Clinical Trial Detailed Description:**\n\nPhono- and Electrocardiogram Assisted Detection of Valvular Disease (PEA-Valve Study)\r\n\r Specific aim(s) Aim 1: Can a machine learning algorithm derived from simultaneous phono- and\r electrocardiogram recordings reliably diagnose clinically important aortic stenosis?\r\n\r Aim 2: Can a machine learning algorithm derived from simultaneous phono- and\r electrocardiogram recordings reliably diagnose clinically important mitral regurgitation?\r\n\r Significance Valvular heart disease (VHD) is a common global health problem, with\r population-based studies showing a prevalence of 10% for aortic stenosis (AS) and 20% for\r mitral regurgitation (MR). New surgical and interventional advances allow for the treatment\r of patients at an older age or whose risk of intervention would previously have been\r untenable. Given that the incidence of both MR and AS increases with increasing age, there is\r a growing need to identify these conditions so as to offer disease-altering therapies.\r\n\r In current clinical practice, the diagnosis of VHD relies heavily on echocardiography. This,\r in turn, requires both a referral from a provider with a clinical suspicion for VHD,\r typically from an abnormality on auscultation, as well as access to the echocardiogram\r itself. MR and AS both result in reliably reproducible auscultatory findings: holosystolic\r and systolic crescendo-decrescendo murmurs, respectively. Yet despite this, auscultation as a\r diagnostic tool is notoriously poor: its accuracy to detect MR and AS ranges only from 5-40%.\r These factors all lead to concerns for underdiagnosis of these increasingly treatable\r conditions.\r\n\r Here, the investigators will address the needs for both greater access to and improved\r diagnostic accuracy of testing for VHD. The investigators will utilize a combination of\r phonocardiogram (PCG) and single-lead electrocardiogram (ECG) recordings, synced in real-time\r to a secure cloud-based server, using the Eko Duo electronic stethoscope. With these data,\r the investigators will develop and validate a machine learning algorithm to diagnose\r clinically important AS or MR. As the Eko Duo is essentially similar to a traditional\r stethoscope, an iconic tool widely accepted by patients and providers alike, its use to drive\r an automated detection algorithm is both feasible and attractive as a substitute for\r traditional auscultation. Furthermore, by shifting the burden of test interpretation away\r from the clinician and onto the algorithm, the investigators hypothesize that this will\r improve overall diagnostic accuracy.\r\n\r Methods Overview of design: Cross-sectional study of all subjects undergoing clinical\r echocardiograms at the UCSF adult echocardiography laboratory\r\n\r Study subjects Overview: The investigators will enroll adult subjects undergoing clinical\r echocardiograms at the UCSF Parnassus campus. These subjects will be grouped into derivation\r and validation cohorts sequentially, stratified by case status, so as to reach the expected\r sample size. Such grouping will occur after subject enrollment and data collection.\r\n\r Target Population: Adults with either moderate-to-severe to severe AS or moderate-to-severe\r to severe MR (cases) and adults with structurally normal hearts with minimal VHD (controls).\r In a more-stringent, parallel analysis, a target population of controls will be defined as\r having any degree of AS or MR less than moderate-to-severe.\r\n\r Accessible Population: Adults meeting the entry criteria undergoing clinical echocardiograms\r at the UCSF echocardiography laboratory amenable to participation.\r\n\r Sampling Scheme: The investigators will approach subjects presenting to the adult\r echocardiography laboratory at UCSF Parnassus consecutively. Additionally, the investigators\r will pre-screen subjects for a high likelihood of having AS or MR (based on indication for\r study and prior diagnoses in the APEX medical record) and selectively target their enrollment\r during situations where the enrollment capacity of the study coordinator is saturated.\r\n\r Recruitment Strategy: Introduction of study at time of registering for echocardiogram with a\r brochure or flyer, followed by in-person approaching of potential subjects while awaiting the\r clinical echocardiogram.\r\n\r Retention Strategy: None. The investigators will retain a master file of the medical record\r numbers to identify contact information in the future if deemed necessary.\r\n\r Measurements Overview: The study will focus on two measurements: 1) the gold standard\r assessment of VHD by echocardiogram, as reported by the UCSF echocardiography laboratory. 2)\r 30 second simultaneous PCG and single-lead ECG recordings by the Eko Duo device at each of\r the four standard cardiac auscultatory positions, with optional additional recordings with\r the Eko Core device. The study takes advantage of the fact that all clinical echocardiogram\r reports include these valvular assessments.\r\n\r Gold Standard: The echocardiogram is accepted as the gold standard for diagnosis of VHD\r severity by the cardiology community. To minimize the burden on the investigators, as well as\r reduce costs, the investigators will take advantage of that all clinical echocardiogram\r reports include assessments of VHD, which will serve as the gold standard. These reports\r follow American Society for Echocardiography (ASE) guidelines, which allow grading of VHD as\r follows: none, mild, moderate, or severe. The UCSF echocardiography laboratory includes\r additional categories of trace, mild-to-moderate, moderate-to-severe, and critical, allowing\r for interpretations where individual parameters within the study conflict. The primary\r measurement will be the final conclusion of severity of VHD for MR or AS, as reported by a\r board-certified cardiologist. The investigators will define \"clinically important\" VHD as\r that graded moderate-to-severe or worse, as this would encompass all levels of disease which\r could require direct intervention. In addition, the investigators will extract the entire\r echocardiography report, as well as the images of the echocardiogram files, so as to save the\r data for future use as new research questions arise.\r\n\r Device Measurements: Recordings of the simultaneous PCG and single-lead ECG will be performed\r for each subject in a standardized manner. Each subject will undergo 30 second recordings\r using the Eko Duo device at the four standard auscultation positions. Observers will be\r trained on the systematic method of obtaining measurements. Time and patient permitting, the\r investigators will also obtain the same recordings using the Eko Core device, which uses the\r same software but does not include ECG recording. As the device will allow visualization of\r the PCG during recording, the observer will get real-time feedback on positioning of the\r device to maximize the quality of the recording at each position. The investigators will plan\r for periodic review of recordings to ensure adequate data quality. The investigators\r anticipate that this flexibility and real-time feedback will improve the generalizability of\r the use of the device to a real-world (i.e. non-study) clinical situation.\r\n\r Confounders and Bias: The derivation and validation of the algorithms will occur remotely,\r after the clinical echocardiogram has been performed, and therefore with no effect on the\r outcome of the gold standard. The test may be influenced by the presence of other conditions\r causing systolic murmurs (including VHD other than AS or MR, or congenital heart disease).\r The investigators will include these measures from the echocardiogram report to compare test\r performance in those with and without these other conditions.\r\n\r Statistical issues Null Hypothesis: A machine learning algorithm cannot predict the presence\r of clinically important AS or MR.\r\n\r Sample Size Justification:\r\n\r - Sensitivity of Algorithm: 90%\r\n\r - Specificity of Algorithm: 90%\r\n\r - Target Likelihood Ratio (+) of Algorithm [LR(R)]: 9 (derived from Sn / [1 - Sp])\r\n\r - Minimum Likelihood Ratio (+) of Algorithm [LR(R)]: 5\r\n\r - Confidence Level = 0.95 (alpha = 0.05)\r\n\r - Confidence Interval [LR(R)]: 5.120-15.820\r\n\r - Sample Size = 110 per group; 330 per cohort (control, AS case, MR case); 660 overall\r (training and validation cohorts)\r\n\r - Summary: Assuming the sensitivity and specificity of the machine learning algorithm for\r detection of clinically important AS or MR are both 0.9, a total sample size of 660 is\r not expected to go below the threshold likelihood ratio of 5.0 in the 95% confidence\r interval in either the derivation or validation cohorts.\r\n\r - Justification of Critical Assumptions: The investigators assume that the algorithm can\r produce a sensitivity and specificity of 90% in detecting aortic stenosis or mitral\r regurgitation compared to hearts with no valvular disease, based upon prior published\r reports using neural networks, using sample sizes of under 100 cases. Furthermore, the\r investigators estimate a minimum likelihood ratio of 5 would be necessary for the test\r to be clinically useful. While this estimate works well for the validation set, the\r number needed for the derivation set is less clear; the estimates above are a\r conservative number. The investigators anticipate training the algorithm after\r enrollment of every 20 cases using a bootstrapping approach; this will provide interim\r test characteristics and help determine the true number needed for the derivation set.\r As this is, in part, a pilot study, identification of the true sensitivity and\r specificity of the test is in itself a valuable result.\r\n\r Analysis approach: The investigators will generate ROC curves (plotting Sn vs. 1-Sp) for\r algorithm scores for the validation set. Ultimately the investigators will generate 4 curves:\r two each for MR and AS, using algorithms generated by the primary (defining controls as\r having no greater than mild VHD) and secondary (defining controls as not having\r moderate-to-severe or greater VHD) approaches. Additionally, the investigators anticipate\r performing exploratory, descriptive analyses of the algorithm itself, by identifying clinical\r correlates to the characteristics most heavily weighted in detecting AS or MR.\r\n\r Miscellaneous Ethical considerations: No major concerns. Data will be securely stored on\r HIPAA compliant platforms. The study qualifies as minimal risk by UCSF CHR criteria.\r\n\r Pretest plans: Prior to study recruitment, study staff will collect data on themselves and\r providers to test the data collection system. During initial subject recruitment, study staff\r will review the process after each day to discuss roadblocks or concerns.\r\n\r Data Management Plan: Data from the study will come from two sources. Reports of\r echocardiograms, extracted from the electronic medical record (APEX), will be reviewed by\r study staff to generate the main database of disease characteristics. A master file linking\r subject identifiers with identifiable information, as well as extracted and de-identified\r echocardiogram reports and de-identified raw echocardiogram images will be stored on a secure\r research server used by the Division of Cardiology. Recorded PCG and ECG data (the actual\r study measurements) will be synced in real-time to a secure, HIPAA-compliant, cloud-based\r server managed by Eko Devices. At pre-specified times of algorithm training, the machine\r learning team (coordinated by Eko Devices) will be provided keys to the assignment of subject\r identifier to VHD category.\r\n\r Quality control measures: Periodic review of the recorded data will be performed by the study\r PI to ensure appropriate data quality.\r\n\r Timetable:\r\n\r Contract/Logistics Subject Enrollment Algorithm Development Analysis Publication Overall\r Timetable: 9 Months\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Able to provide consent\r\n\r - Undergoing a complete echocardiogram\r\n\r Exclusion Criteria:\r\n\r - Refusal to participate\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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673
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[
{
"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\nSafety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population\n\n**Clinical Trial Summary:**\n\nTo evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,\r California) transcatheter heart valve implantation (TAVI) in Chinese patients with\r symptomatic severe calcific aortic stenosis who are considered at high risk for surgical\r valve replacement.\n\n**Clinical Trial Detailed Description:**\n\nEdwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for\r this study.\r\n\r A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring\r transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical\r valve replacement who received a SAPIEN 3 THV.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subjects who are considered to be operable and high risk for surgical valve\r replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score\r is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or\r anatomical risk factors that would be considered high risk for surgery and documented\r by the heart team.\r\n\r 2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by\r one or more of the following within 60 days prior to the index procedure: AVA < 0.8\r cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity >\r 4.0m/sec.\r\n\r 3. NYHA Functional Class II or greater.\r\n\r 4. The study patient or the study patient's legal representative has been informed of the\r nature of the study, agrees to its provisions and has provided written informed\r consent as approved by the EC of the respective clinical site.\r\n\r 5. The study patient agrees to comply with all required postprocedure follow-up visits.\r\n\r Exclusion Criteria:\r\n\r 1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended\r treatment.\r\n\r 2. Aortic valve is a congenital unicuspid or is non-calcified.\r\n\r 3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic\r valve is bicuspid with no raphe (Sievers classification type 0).\r\n\r 4. Anomalous coronary artery that would interfere with proper placement of the valve.\r\n\r 5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant\r aortic regurgitation >3+).\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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674
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[
{
"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\nPersonalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial)\n\n**Clinical Trial Summary:**\n\nThe PACO trial is a randomized clinical trial conducted in Heart Centers of Kuopio and Turku\r university hospitals. The coronary artery disease, aortic valve stenosis and mitral valve\r insufficiency patients preparing for elective coronary artery bypass grafting (CABG), aortic\r valve replacement (AVR) or mitral valve repair (MVR) will be randomized to either\r intervention or control group. The specific operation groups (CABG, AVR and MVR) will be\r analyzed separately. The 7-day baseline measurements of sedentary behaviour (SB), physical\r activity (PA) and sleep will be conducted to the patients by using the RM42 accelerometer\r during the pre-operative month.\r\n\r After the cardiac procedure is completed and the patient is moved to post-operative ward, the\r control group patients will begin the standard post-operative rehabilitation program of the\r participating hospitals (activity guidance given by a physiotherapist). Patients in the\r intervention groups will follow the identical program but after discharge they will also\r receive personalized activity guidance through the combination of ExSed smart phone\r application, Suunto MoveSense accelerometer and cloud system during the first 90 days of\r post-operative rehabilitation. Weekly evolving daily goals to replace SB with PA (daily goals\r for steps, moderate PA, light PA and standing, and sitting time limit) will be designed for\r each patient of the intervention groups. A new daily step goal will be delivered from the\r cloud system to the patient's smart phone in the beginning of each week of the intervention.\r The daily step goal of the first intervention week is based on patient's walking distance\r assessed by a physiotherapist in post-operative ward. The following goals will be\r automatically evolved in the basis of patient's personal average step count of the previous\r week. The MoveSense accelerometer will measure accumulated levels of SB, PA and sleep, and\r transmit the data to user's ExSed application with Bluetooth. With information about\r accumulated levels of SB and PA, the application is able to guide the patient to accomplish\r the predefined activity goal. The guidance and motivation will be offered with pop-up\r notifications and histograms (columns are fulfilled according to patient's accumulated daily\r activity). The researches retain a remote access to the activity data of patients in the\r cloud system. The ExSed application will be connected to the cloud system with internet\r connection.\r\n\r In addition, the patients of the intervention groups will receive short video files (lasting\r from 1 to 3 minutes) containing exercise guidance from a physiotherapist specialized to\r cardiac operation patients. These videos are available on the ExSed application during the\r intervention. The physiotherapist will also contact each patient (by mobile phone) with\r structured contact form from 1 to 4 times in a month to make sure that the intervention is\r proceeding as designed.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - An eligible patient with coronary artery disease, aortic valve stenosis or mitral\r valve insufficiency scheduled for elective coronary artery bypass grafting, aortic\r valve replacement or mitral valve repair operation.\r\n\r - He / she does not have any severe disease or functional limitation limiting PA (other\r than CVD).\r\n\r - He / she is willing to wear a hip- and wrist-worn accelerometer.\r\n\r - He / she is willing and capable to use a smart phone application.\r\n\r Exclusion Criteria:\r\n\r - He / she ends up in prolonged intensive care after cardiac operation.\r\n\r - He / she has a memory disorder (i.e. Alzheimer's 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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675
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[
{
"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 SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nThis study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in\r subjects with severe, calcific AS who are at intermediate operative risk for standard aortic\r valve replacement.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram\r criteria:\r\n\r - Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2\r\n\r - Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg\r\n\r 2. New York Heart Association functional class ≥ II\r\n\r 3. Judged by the Heart Team to be at intermediate risk for open surgical therapy\r\n\r 4. The subject has been informed of the nature of the study, agrees to its provisions and\r has provided written informed consent.\r\n\r Exclusion Criteria:\r\n\r 1. Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis\r\n\r 2. Aortic valve is unicuspid, bicuspid or non-calcified\r\n\r 3. Pre-existing mechanical or bioprosthetic valve in any position.\r\n\r 4. Severe aortic regurgitation (> 3+)\r\n\r 5. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis\r\n\r 6. Ventricular dysfunction with left ventricular ejection fraction < 30%\r\n\r 7. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\r\n\r 8. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant\r procedure\r\n\r 9. Subjects with planned concomitant ablation for atrial fibrillation\r\n\r 10. Hypertrophic cardiomyopathy with obstruction\r\n\r 11. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR\r\n\r 12. Complex coronary artery disease:\r\n\r 1. Unprotected left main coronary artery\r\n\r 2. SYNTAX score > 32\r\n\r 3. Heart Team assessment that optimal revascularization cannot be performed\r\n\r 13. Iliofemoral vessel characteristics that would preclude safe placement of the\r introducer sheath\r\n\r 14. Significant abdominal or thoracic aortic disease that would preclude safe passage of\r the delivery system\r\n\r 15. Active bacterial endocarditis within 180 days of the valve implant procedure\r\n\r 16. Stroke or transient ischemic attack within 90 days of the valve implant procedure\r\n\r 17. Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within 30 days of the valve implant procedure\r\n\r 18. Severe lung disease (Forced Ejection Volume 1 < 50% predicted) or currently on home\r oxygen\r\n\r 19. Severe pulmonary hypertension\r\n\r 20. Hemodynamic or respiratory instability requiring inotropic support, mechanical\r ventilation or mechanical heart assistance within 30 days of the valve implant\r procedure\r\n\r 21. History of cirrhosis or any active liver disease\r\n\r 22. Renal insufficiency and/or renal replacement therapy at the time of screening\r\n\r 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or\r hypercoagulable states\r\n\r 24. Inability to tolerate or condition precluding treatment with antithrombotic therapy\r during or after the valve implant procedure\r\n\r 25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately\r treated with pre-medication\r\n\r 26. Significant frailty as determined by the Heart Team\r\n\r 27. Subject refuses blood products\r\n\r 28. Body mass index > 50 kg/m2\r\n\r 29. Estimated life expectancy < 24 months\r\n\r 30. Positive urine or serum pregnancy test in female subjects of childbearing potential\r\n\r 31. Currently participating in an investigational drug or another device 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:** possibly relevant"
}
] |
possibly relevant
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676
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[
{
"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\nEvaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve by Multimodal Imaging\n\n**Clinical Trial Summary:**\n\nThe objective is the development and validation of morphological markers informative of\r aortic dilatation in order to improve the precision of the risk of aneurysm of the thoracic\r aorta and of acute aortic syndrome for patients with bicuspid aortic valve (BAV).\r\n\r The primary objective of this study is to demonstrate a correlation between the aortic local\r pulse wave velocity (PWV) measured with MRI and the progression of the thoracic aorta\r diameters measured by MRI after a follow-up of 2 years.\n\n**Clinical Trial Detailed Description:**\n\nBackground Bicuspid Aortic Valve (BAV) is the most common congenital heart defect with\r prevalence around 1 to 2% of the general population . It is defined by the presence of two\r functional cusps with less than three parallel zones of apposition between the cusps. This\r different valve's morphology is associated with a spectrum of valvular (aortic stenosis and\r insufficiency) and aortic complications (aneurysm and dissection). Indeed, the valvular\r abnormality is associated with changes in the aortic arch with an increase in the incidence\r of ascending aortic aneurysm unrelated to valvular functional impairment. The mechanisms\r responsible for aortic involvement are still incompletely understood but combine, in varying\r proportions, a constitutional fragility (linked to a common embryological origin of the\r aortic valve and the aortic arch) and to the haemodynamic modifications, generated by the\r specific morphology of BAV .\r\n\r Current risk prediction of aneurysm development is currently performed only with the\r ascending aortic diameter, associated with history of aortic coarctation and familial history\r of dissection. Moreover, aortic dilatation may occur after aortic valve replacement alone,\r necessitating a second intervention, with a higher surgical risk. Improvement of the\r aortopathy evaluation is therefore a major stake in the evaluation of the BAV patient.\r\n\r Studies of the biomechanical properties of the BAV aortic wall converge towards an increase\r in arterial stiffness as well as in other elastopathies such as Marfan's disease. Thus,\r measurements of aortic distensibility in trans-thoracic echocardiography (TTE) or MRI, or the\r measurement of the Pulse Wave Velocity (PWV) are significantly different case of BAV compared\r to the general population. However, no prospective study has demonstrated the prognostic role\r of these morphological biomarkers in the prediction of aortic dilation.\r\n\r From a biomechanical point of view, the vessel's rupture appears when the mechanical stress\r applied to the wall exceeds the material resistance properties. The aortic resistance\r evaluation requires the use of different imaging modalities which propose the measurement of\r stiffness parameters. Circumferential stiffness (with TTE or MRI) can be evaluated by\r measuring the distensibility. In addition, longitudinal stiffness can be evaluated by\r measuring the local PWV.\r\n\r We aim at better defining the vascular involvement of BAV patients by determining the\r prognostic role of functional parameters as non-invasive predictive factors for aortic\r dilation.\r\n\r Hypothesis:\r\n\r 1.Main hypothesis The main hypothesis is that the progression of aortic dilation is dependent\r on the longitudinal and circumferential aortic stiffness in case of BAV.\r\n\r The investigators will therefore try to demonstrate a correlation between the local PWV\r measurements in MRI, combined with a simultaneous measurement of the non-invasive central\r pressure (SphygmoCor XCEL®, Atcor Medical ©), with the segmental aortic size progression. The\r investigators hope to define new biomarkers aortic dilation prediction.\r\n\r 1.Secondary hypothesis\r\n\r - The measurement of the local PWV of the common carotid artery, measured with UF, is\r correlated with the progression of the aortic dilation.\r\n\r - The measurement of aortic distensibility at the Valsalva sinus and ascending tubular\r aortic levels, measured in TTE or MRI, correlates with the progression of aortic\r dilation.\r\n\r Originality and innovative aspects - Prospective evaluation of the different aortic segments\r dilatation in case of BAV: Few studies have prospectively evaluated the aortic dilation\r progression in BAV. There are currently no prognostic markers of dilatation validated in this\r group.\r\n\r - Use of aortic MRI combined with central pressure measurement as a prognostic evaluation\r tool for aortopathy associated with BAV: Following the development of 4D MRI in\r cardiovascular imaging, evaluation of the aorta is possible by studying both the wall's\r movements during the cardiac cycle and the wall shear stress evaluation. This makes possible\r to obtain, at each part of the thoracic aorta, measures of circumferential distensibility,\r local PWV, and shear stress.\r\n\r Coupling these two imaging modalities is particularly interesting in the aortic evaluation of\r BAV due to the involvement of the flow changes in aortic stiffness.\r\n\r - Use of the common carotid artery stiffness as a prognostic evaluation tool for aortopathy\r associated with BAV independently of the aortic diameter Due to the common embryological\r origin of aorta and the common carotid arteries, aortopathy associated with BAV is associated\r with an increase in of the common carotid arteries stiffness.\r\n\r The evaluation of the carotid artery will therefore help to evaluate the correlation between\r carotid rigidity and progression of aortic dilation.\r\n\r - Evaluation of the local PWV as carotid stiffness biomarker Ultrasound analysis will also be\r innovative, with the use of a fine ultrasonic method with very high frame rate (more than\r 10,000 images per second) developed by the Langevin Institute (Mathias Fink, Michael Tanter\r and Mathieu Pernot). The collaboration between the Langevin Institute and the H.E.G. lead to\r numerous publications both in the vascular and cardiac levels. The vascular medicine\r department has an Aixplorer® prototype with vascular and cardiac applications on site. The\r advantage of this technology is its ultrafastecho mode with very high temporal resolution\r which allows the vascular level to visualize and to calculate the speed of the arterial pulse\r wave which is correlated to the local rigidity.\r\n\r The use of this innovative technique in aortic bicuspid will hopefully validate the\r evaluation of the carotid velocity of the pulse wave as an easily accessible prognostic\r marker of aortic dilation.\r\n\r Purpose of the research\r\n\r The objective is the development and validation of morphological markers informative of\r aortic dilatation in order to improve the precision of the risk of aneurysm of the thoracic\r aorta and of acute aortic syndrome for patients with BAV.\r\n\r The primary objective of this study is to demonstrate a correlation between the aortic local\r PWV measured with MRI and the progression of the thoracic aorta diameters measured by MRI\r after a follow-up of 2 years\r\n\r The secondary objectives are:\r\n\r 1. To demonstrate a correlation between the progression of the dilatation of the different\r segments of the thoracic aorta with the following measures:\r\n\r - Aortic distensibility measured in MRI at the Valsalva sinus and at the ascending\r tubular aortic level.\r\n\r - Aortic distensibility measured in TTE of the same segments in TM and in B mode .\r\n\r - Carotid pulse rate measured on carotid arteries by UF.\r\n\r 2. To demonstrate a correlation between the progression of the dilatation of the different\r segments of the thoracic aorta with the following environmental risk factors:\r\n\r - Active Smoking\r\n\r - Diabetes\r\n\r - Hypertension\r\n\r - Familial form of aortic BAV (defined by the presence of a relative, 1st or 2nd\r degree, with BAV or thoracic aortic aneurysm)\r\n\r - Morphological type of BAV\r\n\r - Aortic coarctation\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adults over 18 years of age,\r\n\r - confirmed BAV by TTE computed tomography or MRI.\r\n\r - Adults benefiting from a social security scheme,\r\n\r - having received information on the research\r\n\r - having signed the consent form\r\n\r Exclusion Criteria:\r\n\r - Patient with a syndromic form of BAV:\r\n\r - Loeys-Dietz syndrome,\r\n\r - Turner syndrome\r\n\r - Williams-Beuren syndrome\r\n\r - Shone syndrome\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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677
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[
{
"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\nBIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.\n\n**Clinical Trial Summary:**\n\nProspective non interventional, observational registry of 150 patients undergoing TAVI with\r Evolut platform for bicuspid aortic stenosis.\n\n**Clinical Trial Detailed Description:**\n\nStudy Design Study Design: prospective non-interventional multicenter registry Screening:\r MSCT submitted to core lab & sizing strategy pre-declared (annular sizing, supra-annular\r sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab\r\n\r TAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and\r Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators'\r discretion Study Population All consecutive patients presenting with severe and symptomatic\r bicuspid aortic valve stenosis or mixed disease\r\n\r Inclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient\r judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for\r transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.\r\n\r 5. Estimated life-expectancy>1 year.\r\n\r Exclusion Criteria 1. Age <18 years 2. Asymptomatic patients 3. Estimated life expectancy<1\r year 4. Pure aortic regurgitation. 5. LVEF<20% 6. No baseline MSCT evaluation. 7. Unsuitable\r aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for\r transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day\r and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30\r days: physical examination, ECG, TTE /MSCT upon operators' judgement\r\n\r 1 year: physical examination, ECG, TTE.\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-TAVI with Evolut Pro or Evolut R XL, based on\r MSCT assessment.\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. Asymptomatic patients\r\n\r 3. Estimated life expectancy<1 year\r\n\r 4. Pure aortic regurgitation.\r\n\r 5. LVEF<20%\r\n\r 6. No baseline MSCT evaluation.\r\n\r 7. Unsuitable aortic root anatomy for Evolut Pro or XL.\r\n\r 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL.\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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678
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"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 Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles\n\n**Clinical Trial Summary:**\n\nEvaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan\r procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low\r preoperative risk profiles in prospective study\n\n**Clinical Trial Detailed Description:**\n\nStudy Population:\r\n\r This study will include all patients referred for an elective Fontan procedure at the period\r of the study, who demonstrated a standard risk profile. An Informed consent will be obtained\r from the guardians before enrollment in the investigation. All procedures followed will be in\r accordance with institutional guidelines.\r\n\r Randomization Technique:\r\n\r Patients will be assigned to undergo either a fenestrated or non-fenestrated Extra-cardiac\r Fontan, based on a table of randomly generated numbers. Preoperative clinical data will be\r collected and compared to ensure appropriate randomization.\r\n\r Preoperative Evaluation:\r\n\r Enrolment Criteria:\r\n\r Preoperative evaluation consists of ECG, transthoracic echocardiogram, and complete cardiac\r catheterization.\r\n\r Patients with the following parameters will be eligible for enrollment in the study:\r\n\r Sinus Rhythm Atriovnetricular valve regurgitation not more than mild Aortic (neoaortic) valve\r regurgitation not more than mild Normal systolic dominant ventricle function Mean pulmonary\r artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge\r pressure) Pulmonary vascular resistance not more than 2 woods unit End diastolic ventricular\r filling pressure not more than 8 mm Hg\r\n\r Patient with the following will not be eligible for inclusion:\r\n\r Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or\r interventional additional procedures before or during the Fontan operation. Pacemaker\r insertion before or during Fontan operation. Significant pulmonary arteriovenous\r malformations (AVMs) rendering fenestration potentially a cause of excessive cyanosis.\r Patients for whom the cardiology/cardiac surgery case conference decision is strongly in\r favor of fenestration for any other cause.\r\n\r Ventricular filling pressure will be directly measured as the end-diastolic pressure in the\r dominant systemic ventricle. The degree of systemic atrioventricular valve regurgitation will\r be assessed semi-quantitatively by echocardiographic color Doppler, primarily based on width\r of jet origin. The regurgitation jet will be graded as none, mild, moderate, or severe.\r Rhythm is assessed with preoperative ECG or Holter monitor (if required). Coil occlusion of\r aortopulmonary collaterals is not an exclusion criterion and is recommended before the Fontan\r operation.\r\n\r Operative Technique and postoperative management:\r\n\r Treatment Patients underwent an extracardiac Fontan operation. The extracardiac Fontan\r channel will be constructed with a Polytetrafluoroethylene (PTFE) tube graft from the\r inferior vena cava to the pulmonary artery. The size if the graft is determined by the\r surgeon and ranged from 16 to 22 mm in diameter. The fenestration consists of a single 3- to\r 6-mm communication between the Fontan channel and the common atrium.\r\n\r Postoperative treatment will include administration of captopril, and aggressive use of\r diuretics. All patients will receive aspirin (81 mg per day) and warfarin with a target\r International Normalized Ration INR of 2-2.5 beginning on the first postoperative day. To\r maximize caloric intake, patients ill not be fluid restricted after the initial postoperative\r period. All patients will be placed on fat free diet for 6 weeks. Chest tubes will be left in\r place until drainage is less than 5 mL/kg in a 24-hour period. A chest tube will be\r reinserted only if a symptomatic pleural effusion is diagnosed. Steroids and Octreotide will\r be started after 2 weeks of persistent drainage or immediately if Chylothorax is diagnosed\r biochemically.\r\n\r The attending cardiologist and surgeon determined the need for and timing of postoperative\r cardiac catheterization. Patients will be discharged from the intensive care unit when\r hemodynamic and respiratory stability is ensured and a stable heart rhythm is maintained. The\r patients will be discharged from hospital after all chest tubes are removed and when the\r clinical status permits.\r\n\r Assessment of Outcomes:\r\n\r The primary end is the total length of chest tube drainage in days. If chest tube reinsertion\r is required during the same admission, this time will be added to the primary outcome. Other\r outcome variables include length of stay in the intensive care unit, total hospital stay in\r days, total amount of chest tube drainage, occurrence of stroke,readmissions, reoperation, or\r death within 90 days of discharge. All end points are defined a priori. The day of surgery\r counted as day 1 for all variables. All reoperations will be assessed including returning to\r the operating room for bleeding or poor hemodynamics, replacement of chest tubes, cardiac\r catheterization, and late fenestration.\r\n\r Statistical Analysis:\r\n\r Sample size estimates is based on a retrospective analysis of the last 100 patients who\r underwent the Fontan procedure at out institutionwith 80% power to avoid a type II\r statistical error. A reduction in total chest tube drainage days of 15% is considered\r clinically significant. The median length of chest tube drainage (estimated as one day less\r than the median postoperative length of hospitalization) was 19 days. Given a clinically\r significant difference of 15%, the calculated days of difference were 19 X 0.15 = 2.85. We\r set the relevant difference to be 3 days. Using a modified Lehr's equation for sample size in\r count data, we estimate the number in each group to be, n=4/〖(√(γ_1 )-√(γ_2 ))〗^2\r =4/〖(√19-√16)〗^2 =31patients.\r\n\r Descriptive statistics will be calculated for all variables. Medians and ranges describe\r continuous variables. Categorical variables will be summarized as frequencies. The Mann\r Whitney U test will be used for all continuous variables; analysis and Fisher's exact test\r will be applied for all dichotomous variables.\r\n\r Count data for hospital length of stay, intensive care unit length of stay, and length of\r chest tube drainage will be compared by means of Poisson regression or Cox proportional\r hazards models. A probability value of 0.05 will indicate statistical significance. All\r calculations were performed with R-project statistical software (www.r-project.org).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - This study will includeall patients referred for an elective TCPC procedure at the\r period of the study, who demonstrated a standard risk profile\r\n\r - Preoperative evaluation consisted of ECG, transthoracic echocardiogram, and complete\r cardiac catheterization.\r\n\r Patients with the following parameters will be eligible for enrollment in the study:\r\n\r - Sinus Rhythm\r\n\r - Atriovnetricular valve regurgitation not more than mild\r\n\r - Aortic (neoaortic) valve regurgitation not more than mild\r\n\r - Normal systolic dominant ventricle function\r\n\r - Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated\r by pulmonary vein wedge pressure)\r\n\r - Pulmonary vascular resistance not more than 2 woods unit\r\n\r - End diastolic ventricular filling pressure not more than 8 mm Hg\r\n\r Patient with the following will not be eligible for inclusion:\r\n\r - Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or\r interventional additional procedures before or during the Fontan operation.\r\n\r - Pacemaker insertion before or during Fontan operation.\r\n\r - Significant pulmonary arteriovenous malformations (AVMs) rendering fenestration\r potentially a cause of excessive cyanosis.\r\n\r - Patients for whom the cardiology/cardiac surgery case conference decision is strongly\r in favor of fenestration for any other cause.\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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679
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[
{
"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\nBifocal Right Ventricular PAcing in Right Bundle Branch blocK and Heart Failure With Reduced Ejection Fraction. The Study Tests the Superiority of Right Ventricular Bifocal Stimulation Over VVI Implantable Defibrillator in Right Bundle Branch Block and Heart Failure.\n\n**Clinical Trial Summary:**\n\nRATIONALE:\r\n\r Cardiac resynchronization therapy (CRT) is known to improve cardiac performance and to reduce\r morbidity and mortality in reduced-ejection fraction heart failure (HFrEF) despite optimal\r medical therapy (OMT). Several studies have shown that patients with with left bundle branch\r block (LBBB) respond favourably to CRT, whereas there is less certainty about non-LBBB\r morphology.\r\n\r Specifically, whether patients with right bundle branch block (RBBB) and HFrEF benefit from\r CRT is unclear. Some studies suggest lack of favourable outcomes. It follows from this that\r VVI implantable defibrillator are implanted in most RBBB patients.On the other hand right\r ventricular bifocal stimulation could be useful as an alternative approach in patient with\r RBBB. It consists of two endocardial leads implanted in right ventricle. The first lead is\r implanted in His bundle area, and the second lead is in the right ventricle apex. In this way\r bifocal pacing could decrease the inter- and intraventricular delays, thus improving left\r ventricular hemodynamics. However no specifically randomized studies are designed to date.\r\n\r PURPOSE:\r\n\r To demonstrate the superiority of right ventricular bifocal stimulation over placebo (VVI\r implantable defibrillator) in RBBB and HFrEF despite OMT.\r\n\r DESIGN Multicenter prospective randomized, double blind cross-over study. MASKING\r Investigator responsible for device programming is masked from having knowledge about\r clinical, functional, and echocardiographic data. On the other hand echocardiographist is\r masked from having knowledge about stimulation mode. Patients are masked from having\r knowledge about their clinical, functional, and device data.\r\n\r POPULATION At least fifty patients would be enrolled. The enrollment period should be one\r year. Study overall duration should be two years.\r\n\r ELIGIBILITY CRITERIA RBBB and HFrEF (left ventricular ejection fraction ≤35%) in sinus\r rhythm, in NYHA class II-III or ambulatory IV despite OMT.\r\n\r EXCLUSION CRITERIA\r\n\r -Refusal or withdrawal of informed consent.Renal failure (glomerular filtration rate ≤ 60\r ml/min).Life expectancy < 12 months.Active neoplasm.Permanent atrial fibrillation.40 days\r following acute coronary syndrome.Atrio-ventricular block (from second degree AV\r block).Valvular heart disease with surgery indications.\r\n\r PROTOCOL Each patient undergoes baseline assessment. Pharmacological therapy,\r hospitalization,NYHA functional class, QRS complex informations, type of heart disease and\r comorbidities are collected. Quality of life (QOL) is defined by Minnesota Living with Heart\r Failure questionnaire. Functional capacity is assessed by 6MWT (optionally by cardiopulmonary\r exercise test). Trans-thoracic echocardiogram is performed, analyzing: left-ventricle\r diameters and volumes, left-ventricle ejection fraction (LVEF), left atrial diameter and\r area, TAPSE,valvulopathy,systolic pulmonary artery pressure. All patients undergo bifocal\r right ventricular resynchronization therapy: right atrial lead is implanted, whereas the\r first ventricular lead is placed in His bundle area, and the second ventricular lead in the\r right ventricle apex. Then the leads are connected to the respective channels of a CRT-D\r generator.After the implant, all devices are programmed in VVI mode. After the first 40±10\r days (first f-up) patients are 1:1 randomized to VVI mode 40 beats/minute (placebo arm) or\r bifocal DDD-mode 60 beats/minute (with VV delay 0 msec and optimal AV delay). After six\r months (second f-up) a clinical and instrumental assessment equal to baseline is performed,\r as well as devices electrical parameters control. Then arms cross-over is performed (from\r VVI-mode to bifocal DDD-mode and vice versa). At 12 months (end of follow-up) an evaluation\r equal to that performed at 6 months is assessed. Echocardiographic data are unravelled to the\r investigator responsible for device programming. In this way the stimulation mode able to\r determine the best clinical improved (VVI or bifocal DDD mode) is programmed and the study\r closes.\r\n\r PRIMARY ENDPOINT The main assumption is that bifocal stimulation can increase of at least 20%\r the distance walked during 6MWT in respect of baseline and VVI-mode.The primary endpoint is\r the distance walked (expressed by meters) during 6MWT, as assessed at baseline, 6-months\r follow-up and 12 months follow up. Specifically changes in 6MWT observed during bifocal\r DDD-mode compared to baseline and to VVI mode would be significative if there is an increase\r of at least 20%.\r\n\r SECONDARY ENDPOINT\r\n\r Secondary endpoint is bifocal stimulation therapy response, defined by at least one of the\r following criteria, evaluated at baseline, 6-months follow-up and 12 months-follow-up in\r comparison to baseline and VVI mode:\r\n\r NYHA functional class improvement; changes in 6MWT, defined by an increase in distance walked\r major or equal to 30%; LVEF improvement major or equal to 25%;Left ventricular telesystolic\r volume reduction major or equal to 15%\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with RBBB and HFrEF (defined by left ventricular ejection fraction ≤35%) in\r sinus rhythm, who remain in NYHA class II-III or ambulatory NYHA class IV despite OMT.\r\n\r Exclusion Criteria:\r\n\r - Refusal or withdrawal of informed consent.\r\n\r - Renal failure (defined by an estimated glomerular filtration rate ≤ 60 ml/min)\r\n\r - Life expectancy < 12 months\r\n\r - Active neoplasm\r\n\r - Permanent atrial fibrillation\r\n\r - 40 days following acute coronary syndrome\r\n\r - Atrio-ventricular block (from second degree AV block)\r\n\r - Valvular heart disease with surgery indications\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"
}
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possibly relevant
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680
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[
{
"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 Echo Assessment in Mitral Valve Replacement\n\n**Clinical Trial Summary:**\n\nRheumatic heart disease remains a major health problem in developing countries. It is the\r most important sequel of rheumatic fever and occurs in about 30% of patients with rheumatic\r fever.Rheumatic heart disease presents with different degrees of pancarditis and associated\r valve failure. Involvement of the mitral leaflets can cause mitral regurgitation (MR) or\r stenosis and eventually can lead to heart failure. Mitral repair or replacement is therefore\r recommended before left ventricular (LV) dysfunction develops.\r\n\r Study Objectives/Specific Aims Overall Goal: To determine the benefit the patient with\r pulmonary hypertension will get from mitral valve replacement as regard function improvement\r and remodeling of the right ventricle.\r\n\r - Objective1: Identify risk factors that are predictive of outcomes.(Type and severity of\r Mitral valve pathology , severity of pulmonary hypertension, tricuspid regurge,\r preoperative RV dysfunction)\r\n\r - Objective2: Determine the value of management strategies (Mitral valve replacement in\r pulmonary hypertension i.e. : decrease RV pressure overload and enhance RV remodeling)\r\n\r - Objective3: Assessment of the outcomes clinically & Echocardiographically :\r postoperative results during hospital stay and follow up (short term up to 3 months).\n\n**Clinical Trial Detailed Description:**\n\nIn 1994, it was estimated that 12 million individuals had RF and RHD worldwide , and at least\r 3 million had congestive heart failure (CHF) that required repeated hospital admissions. A\r large section of the individuals with CHF required cardiac valve surgery within 5-10 years .\r The mortality rate for RHD varied from 0.5 per 100 000 population in Denmark, to 8.2 per 100\r 000 population in China , and the estimated annual number of deaths from RHD for 2000 was\r 332000 worldwide . The mortality rate per 100 000 population varied from 1.8 in the WHO\r Region of the Americas, to 7.6 in WHO South-East Asia Region. The disability-adjusted life\r years (DALYs)1 lost to RHD ranged from 27.4 DALYs per 100 000 population in the WHO Region of\r the Americas, to 173.4 per 100 000 population in the WHO South-East Asia Region. An estimated\r 6.6 million DALYs are lost per year worldwide.\r\n\r THE PATHOLOGY OF RHEUMATIC MITRAL VALVE DISEASE Rheumatic mitral valves shows a different set\r of lesions by comparison with degenerative valves, because of the characteristic inflammatory\r process, which results in thickening of the leaflets and other components of the mitral valve\r apparatus, of variable degrees, and distorts and impairs the movements of the valve. So, the\r disease appears here in two forms - stenosis and regurgitation, or a combination of both.\r\n\r In the case of valve regurge, the most frequent lesion is prolapse of the anterior leaflet,\r which is present in more than 90% of young patients and is most often caused by elongated\r chordae to its central and medial areas (A2 and A3). In contrast to degenerative disease,\r posterior leaflet prolapse is practically not found, except in cases with ruptured chordae\r due to infective endocarditis. On the contrary, this leaflet is often shortened in its width,\r sometimes resumed to a very narrow and thick strip of tissue. In more complicated cases, the\r chordae may be thick and retracted, as may also be the papillary muscles, and the commissures\r may be fused in varying degrees. Often, the leaflets and subvalvular apparatus are a\r continuous mass of fibrous tissue. Lastly, the annulus is dilated in 95% of the patients. It\r is widely accepted that dilatation occurs essentially in the posterior segment of the\r annulus, although there is some evidence that it may also occur in the anterior segment,\r especially in dilated cardiomyopathy.\r\n\r Pulmonary hypertension and valvular heart disease Valvular Heart Disease VHD is a common\r etiology of pulmonary hypertension, which may result from many mechanisms as an increase in\r pulmonary vascular resistance, pulmonary blood flow, or pulmonary venous pressure. The\r chronic rise in pulmonary arterial pressure (PAP) often leads to right ventricular (RV)\r pressure overload and subsequent RV failure. When present, PH is a marker of poor outcome in\r VHD. Assessment of the presence and severity of Pulmonary hypertension thus has an important\r role in the risk stratification and therapeutic management of VHD.\r\n\r The sure diagnosis of PH related to VHD is based on the following criteria: mean PAP 25 mm Hg\r together with an abnormally high pulmonary capillary wedge pressure (PCWP) >15 mm Hg or left\r ventricular (LV) end-diastolic pressure >18 mm Hg in the context of significant VHD. When\r pulmonary venous congestion is the main determinant of PH, PH is named isolated\r post-capillary PH or pulmonary venous hypertension.\r\n\r PATHOPHYSIOLOGY Increase in LV filling pressure and left atrial (LA) pressure leads to a\r passive rise in backward pressure of the pulmonary vein. Persistently elevated pulmonary\r venous pressure can favor fragmentation of the structure and result in \"alveolar capillary\r stress failure,\" accompanied by capillary leakage and acute alveolar edema. This acute phase\r is reversible, but long-term persistence of high pulmonary venous pressure may provocate some\r degree of irreversible remodeling of the alveolar capillary membrane, with excessive\r deposition of type IV collagen. Plus, chronic elevated pulmonary venous pressure\r progressively and passively increases PAP and concomitantly produces pathological changes in\r pulmonary veins. and arteries, leading to increased pulmonary vascular resistance . The\r pathophysiology of PH in VHD thus involves progressive structural alteration of the pulmonary\r vascular bed mediated by the potent vasoconstrictor endothelin-1 . An increase in\r pulmonary-arterial vasoconstriction and systolic PAP results into RV dilation and\r hypertrophy. The RV failure is associated with tricuspid annulus dilation and an increase in\r tricuspid regurgitation severity, which further acerbates RV dysfunction. At the\r decompensated phase, systolic PAP can decrease despite the increase in pulmonary vascular\r resistance, due to the fall in RV stroke volume related to advanced RV failure.\r\n\r After treatment, the reversibility of PH depends on the type, severity, and chronicity of\r VHD, as well as the underlying pathophysiological adaptations. For instance, in mitral\r stenosis (MS), a rapid decrease in PAP is observed after relief of the stenosis, whereas a\r longer time could be required in other VHDs, especially when PH is linked to volume overload,\r as in mitral regurgitation (MR). Right ventricular function assessment The right ventricle\r has long been neglected, yet it is RV function that is strongly associated with clinical\r outcomes in many conditions. Although the left ventricle has been studied extensively, with\r established normal values for dimensions, volumes, mass, and function, measures of RV size\r and function are lacking. The relatively predictable left ventricular (LV) shape and\r standardized imaging planes have helped establish norms in LV assessment. There are, however,\r limited data regarding the normal dimensions of the right ventricle, in part because of its\r complex shape. The right ventricle is composed of 3 distinct portions: the smooth muscular\r inflow (body), the outflow region, and the trabecular apical region. Volumetric\r quantification of RV function is challenging because of the many assumptions required. As a\r result, many physicians rely on visual estimation to assess RV size and function.\r\n\r The basics of RV dimensions and function were included as part of the ASE and European\r Association of Echocardiography recommendations for chamber quantification published in 2005.\r This document, however, focused on the left heart, with only a small section covering the\r right-sided chambers. Since this publication, there have been significant advances in the\r echocardiographic assessment of the right heart. In addition, there is a need for greater\r dissemination of details regarding the standardization of the RV echocardiographic\r examination .\r\n\r PERIOPERATIVE ASSESSMENT OF THE RV In cardiac surgery, right heart catheterization and\r echocardiography play an essential and complementary role in the assessment of RV structure\r and function. Both provide useful information that may help tailor the anesthetic and\r surgical approach and provide guidance in the management of hemodynamically unstable\r patients. Hemodynamically, Right ventricular dysfunction or failure is usually recognized in\r the presence of a right atrial pressure (RAP) _8-10 mm Hg or a RAP to pulmonary capillary\r wedge pressure _0.8 (isolated RV failure) and/or a low cardiac index (_2.2 L _ min_1 _ m_2).\r Increasing RAP may also be a sign of impeding RV failure. echocardiography also provides\r useful information on RV and pulmonary structure, valvular function and pericardial\r physiology.\r\n\r The echocardiographic evaluation of the RV is more challenging than that of the left\r ventricle. The main difficulties encountered may be explained by 1) the complex shape of the\r RV, 2) heavy apical trabeculations of the RV, which limits endocardial surface recognition,\r and 3) the marked load dependence of several indices of RV function. Despite these\r limitations, a comprehensive assessment of the RV may provide important data into its\r contractility, preload, and afterload.\r\n\r Lastly and as recommended by the American society of Echocardiography Endorsed by the\r European Association of Echocardiography, a registered branch of the European Society of\r Cardiology, and the Canadian Society of Echocardiography in 2010 guidelines all studies, the\r sonographer and physician should examine the right heart using multiple acoustic windows, and\r the report should represent an assessment based on qualitative and quantitative parameters.\r The parameters to be performed and reported should include a measure of right ventricular\r (RV) size, right atrial (RA) size, RV systolic function (at least one of the following:\r fractional area change [FAC], S', and tricuspid annular plane systolic excursion [TAPSE];\r with or without RV index of myocardial performance [RIMP]), and systolic pulmonary artery\r (PA) pressure (SPAP) with estimate of RA pressure on the basis of inferior vena cava (IVC)\r size and collapse.\r\n\r So in this study we will focus on right ventricular function and performance after performing\r Mitral valve replacement to the rheumatic heart disease patients associated with pulmonary\r hypertension either mild or severe, to put a hand on the extent of benefit the patient who\r developed pulmonary hypertension will get from mitral valve replacement as regard function\r improvement and remodeling of the right ventricle and the proper timing of surgery.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All ages will be accepted.\r\n\r - Isolated mitral valve lesion either stenosis or regurge.\r\n\r - Good LV function (EF <45%).\r\n\r - Any degree of tricuspid valve regurge..\r\n\r Exclusion Criteria:\r\n\r - Concomitant Aortic valve lesion needs replacement.\r\n\r - Poor LV function (Low EF> 45%).\r\n\r - Other causes of pulmonary hypertension i.e.: (Chronic obstructive or restrictive\r pulmonary disease, connective tissue disease and chronic thromboembolism).\r\n\r - Emergency and Redo 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:** possibly relevant"
}
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possibly relevant
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681
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[
{
"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\nImaging Histone Deacetylase in the Heart\n\n**Clinical Trial Summary:**\n\nThe overall goal of this PET-MR imaging trial is to evaluate 11C-Martinostat, a histone\r deacetylase targeted radioligand, in patients with aortic stenosis, individuals with\r diabetes, and healthy volunteers.\n\n**Clinical Trial Detailed Description:**\n\nHistone deacetylases (HDACs), a class of epigenetic enzymes, play an important role in the\r pathophysiology of heart failure, including development of left ventricular hypertrophy and\r myocardial fibrosis. Preclinical data demonstrate the importance of HDAC inhibition in\r attenuating these pathological processes and maintaining the integrity of the myocardium.\r However, the role of HDACs in the human heart, and the utility of HDAC inhibition remains\r unknown. Therefore, a noninvasive method to detect HDAC activity in the human heart in\r healthy individuals and patients with heart disease may be of major medical and public health\r value to help determine prognosis, direct therapy, and guide the development of novel\r therapies for heart failure. The investigators have recently developed a novel radiotracer,\r 11C-Martinostat, which binds with high affinity to class I HDACs. The objective of this\r protocol is to assess the utility of 11C-Martinostat PET-MR to detect HDAC expression in the\r hearts of healthy individuals and patients with severe aortic stenosis or diabetes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Group 1: Healthy Volunteers (n = 30)\r\n\r - Healthy adults with no known history of medical disease\r\n\r - Age 18-85 years\r\n\r - No history cardiovascular disease\r\n\r - Ability to provide informed consent\r\n\r Group 2: Patients with Diabetes (n = 16)\r\n\r - Age 18-85 years\r\n\r - Diagnosis of diabetes\r\n\r - Echocardiogram within last 12 months showing no evidence of left ventricular\r hypertrophy or hemodynamic findings consistent with heart failure with preserved\r ejection fraction\r\n\r - Ability to provide informed consent\r\n\r Group 3: Patients with Aortic Stenosis (n = 50)\r\n\r - Age 18-85 years\r\n\r - Echocardiogram or cardiac MRI scan within last 12 months documenting left ventricular\r hypertrophy and degenerative calcific aortic stenosis\r\n\r - Ability to provide informed consent\r\n\r Exclusion Criteria:\r\n\r - Known contraindication to 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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682
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[
{
"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\nProlonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation\n\n**Clinical Trial Summary:**\n\nPatients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of\r silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the\r investigators to implement specific therapeutic measures that may improve patient outcomes\r and reduce hospitalization length post-TAVI.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective registry including patients accepted by the heart team for a TAVI\r procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT®\r device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring\r will be of 1 week. There will be no restriction regarding the type of valve and approach used\r for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the\r specific therapeutic measures implemented upon the occurrence of the arrhythmic event.\r Following the TAVI procedure, the patients will be monitored (telemetry) until hospital\r discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical\r follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to\r 5-year follow-up.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.\r\n\r Exclusion Criteria:\r\n\r - Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1\r week within the 3 months prior to the TAVI procedure.\r\n\r - Prior permanent pacemaker.\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
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683
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[
{
"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\nRegistry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)\n\n**Clinical Trial Summary:**\n\nProspective, multicenter registry in patients undergoing commercially available balloon\r expandable valve implantation. The registry will consist of 3 phases:\r\n\r Prospective determination of baseline Status Quo (3 months):\r\n\r Documentation of treatment pathways and endpoints of \"routine\" patients without educational\r program\r\n\r Dedicated reflection and training (1 day):\r\n\r One training session after the observational period to reflect on treatment pathways,\r exchange between valve coordinators involved, and develop improvements.\r\n\r Implementation of tailored changes (2 months):\r\n\r Implementation of the changes developed in the training.\r\n\r Determination of the effect (3 months):\r\n\r Coordinator measures optimization changes and determines effects.\n\n**Clinical Trial Detailed Description:**\n\nAlong the severe aortic stenosis (sAS) treatment pathway there are delays that may impact\r quality management and hospital efficiency. A dedicated valve coordinator, interfering with\r all stages of patient handling throughout the hospital may increase the efficiency of the sAS\r patient flow, accelerate decision making and clinical outcomes while at the same time\r decreasing resource consumption.\r\n\r The hypothesis is that the implementation of a dedicated valve coordinator will improve the\r patient flow of sAS patients scheduled to undergo TAVI, their outcome, patient and physician\r satisfaction and will optimize costs.\r\n\r In total, three centers across Germany (Munich, Düsseldorf, Bad Bevensen) will participate.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted\r for TAVI\r\n\r Exclusion Criteria:\r\n\r - patients not providing 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:** definitely relevant"
}
] |
definitely relevant
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684
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[
{
"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\nEvaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation\n\n**Clinical Trial Summary:**\n\nThis study is to evaluate the efficacy and safety of transcatheter aortic valve replacement\r (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic,\r Minneapolis, MN).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients must have co-morbidities such that the principal investigator and\r co-investigator concur that the predicted risk of operative mortality is ≥15% (STS\r score ≥10 OR Logistic EuroSCORE ≥20%).\r\n\r A candidate who does not meet [the STS score criteria ≥ 10 OR Logistic EuroSCORE ≥20%]\r can be included in the study if a peer review by at least two investigators concluded\r and documented that the patient's predicted risk of operative mortality is ≥15% from\r old age, severe frailty or STS score ≥8. In this case, all evidence must be documented\r in the study case report form as well as in the patient medical record.\r\n\r 2. There is a formal agreement by a cardiac surgeon, echo part cardiologist and\r interventional cardiologist according to the relevant guideline.\r\n\r 3. The subject does not have severe degenerative aortic stenosis and do have severe\r aortic regurgitation.\r\n\r 4. The subject or the subject's legal representative has been informed of the nature of\r the study, agrees to its provisions and has provided written informed consent as\r approved by the Institutional Review Board (IRB) of the respective clinical site.\r\n\r 5. The subject agrees that the subject will keep in touch with study team for all\r required post-procedures like angiography or transesophageal echography.\r\n\r 6. The subject agrees that the subject will cooperate with study team for all required\r post-procedure visits.\r\n\r 7. The subject's age is 20 or more.\r\n\r Exclusion Criteria:\r\n\r 1. Evidence of an acute myocardial infarction ≤ 1 month 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 2. Any therapeutic invasive cardiac procedure performed within 30 days of the index\r procedure, (or 6 months if the procedure was a drug-eluting coronary stent\r implantation).\r\n\r 3. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg%),\r thrombocytopenia (platelet count <50,000 cells/mm³), history of bleeding diathesis or\r coagulopathy.\r\n\r 4. Untreated clinically significant coronary artery disease requiring revascularization.\r\n\r 5. Need for emergency surgery for any reason.\r\n\r 6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\r\n\r 7. Active bacterial endocarditis or other active infections.\r\n\r 8. Active peptic ulcer or upper GI bleeding within the prior 3 months.\r\n\r 9. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine\r (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be\r adequately pre-medicated.\r\n\r 10. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack\r (TIA).\r\n\r 11. Life expectancy < 12 months due to non-cardiac comorbid conditions.\r\n\r 12. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as\r maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend or angle\r of aortic arch ≥200 degree),aortic arch atheroma (especially if thick [> 5mm],\r protruding or ulcerated) or narrowing (especially with calcification and surface\r irregularities) of the abdominal or thoracic aorta, severe \"unfolding\" and tortuosity\r of the thoracic aorta (applicable for transfemoral patients only).\r\n\r 13. Root disease including annuloaortic ectasia or aneurysm of root or sinus.\r\n\r 14. Iliofemoral vessel characteristics that would preclude safe placement of introducer\r sheath such as severe obstructive calcification, severe tortuosity(with moderate or\r severe calcification and two or more severe curve (angle ≥90°) (applicable for\r transfemoral patients only).\r\n\r 15. Pregnant(positive result from pregnancy test conducted during screening visit and\r within prior 2 weeks of valve replacement) or lactating 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:** possibly relevant"
}
] |
possibly relevant
|
685
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[
{
"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."
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"content": "**Clinical Trial Title:**\n\nInflammatory Biomarkers of Pediatric Pulmonary Hypertension\n\n**Clinical Trial Summary:**\n\nTo investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with\r other inflammatory mediators, is elevated in pediatric patients with congenital heart disease\r (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy\r controls.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r -patients of any age with congenital cardiac disease coming for catheterization of the\r right heart, or both the right and left heart.\r\n\r Exclusion Criteria:\r\n\r - active systemic infection\r\n\r - current active cancer\r\n\r - active cancer treatment\r\n\r - prior bone marrow transplant\r\n\r - prior solid 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\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"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."
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"content": "**Clinical Trial Title:**\n\nTrial of Cardiac CT in Acute Chest Patients With Intermediate Level Initial High-sensitivity Cardiac Troponin\n\n**Clinical Trial Summary:**\n\nPatients who present to the emergency department (ED) with acute chest pain (ACP) possibly\r due to Coronary artery disease (CAD), with a normal heart tracing (ECG), need to have further\r troponin blood tests to confirm or exclude a heart attack. After initial troponin testing, a\r significant 50-85% of patients are said to be in an \"observational zone\" as one cannot\r confirm or exclude a diagnosis of a heart attack. Even after repeat blood testing, 22-33%\r remain in this \"observational zone\". These patients can be challenging to manage as they are\r not safe to be discharged home, but they also cannot be treated as a heart attack. This\r contributes to ED overcrowding and uncertainty in treatment plans.\n\n**Clinical Trial Detailed Description:**\n\n1. Background Coronary artery disease (CAD) remains the most common cause of mortality in the\r world according to the World Health Organisation (WHO). Chest pain accounts for a significant\r healthcare burden representing approximately 700,000 annual visits to the emergency\r department in England and Wales [1]. Patients with acute chest pain (ACP) of possible cardiac\r origin account for approximately 17% of all emergency department (ED) consultations, but less\r than 10% of these are eventually diagnosed with acute myocardial infarction (AMI).\r\n\r Hence a means of evaluating these patients in the ED in an efficient manner, whilst ensuring\r high sensitivity and specificity, is of paramount importance. Cardiac biomarkers e.g. cardiac\r Troponin (cTn) I or T along with electrocardiogram (ECG) remain the cornerstone in the\r evaluation of patients with suspected acute coronary syndrome (ACS).\r\n\r 1.1 Performance of high-sensitivity cardiac troponins High-sensitivity cardiac troponin\r (hs-cTn) assays enable the measurement of cTn at concentrations not detected with the former\r generation conventional cTn assays. In September 2015 hs-cTn assays were adopted in the\r European Society of Cardiology (ESC) guidelines for the management of patients with acute\r coronary syndrome (ACS) without persistent ST elevation. The proposed algorithms advocate\r either a single hs-cTn at ED presentation or repeat measurements after 1 or 2 hours thus\r enabling a more rapid \"rule-in\" and \"rule out\" of AMI compared with conventional cTn assays.\r The cut off values for the different hs-cTn assays are assay specific [2].\r\n\r The performance of these algorithms (involving hs-cTn) has been evaluated in multiple\r studies. A prospective multicentre study by Gimenez et al looked at ruling out AMI using\r undetectable levels of hs-cTn (I and T) at presentation. With hs-cTnT, AMI was ruled out in\r 26.5% of cases with a negative predictive value (NPV) of 98.6%. Among three different hs-cTnI\r assays which were studied, the NPV ranged from 98.8% to 100%. No patient with undetectable\r levels of hs-cTnT died during the first 30 days and only 0.4% had died (2 patients not due to\r AMI) at 24 months' follow-up. Among the three hsc-TnI assays, mortality at 24 months ranged\r from 0 to 2.4% with only one death due to AMI (which occurred in the first 30 days) [3].\r\n\r Although the more rapid risk-stratification with these algorithms (on the first sample of\r hs-cTn) helps in reduced time to rule-in or rule-out AMI there remains, however, (between the\r initial \"rule-in\" and \"rule-out\" categories) an intermediate \"observational zone\" category of\r patients, who do require a serial troponin test at 1 hour for further risk-stratification.\r Recent pilot data by Marjot et al have shown that, after initial hs-cTnT testing on\r presentation, there are a significant proportion of patients (54%) who would require further\r troponin testing after 1 hour as they were stratified in the observational zone on the\r initial troponin test. Despite the mandated repeated troponin at 1 hour, Marjot et al also\r showed that in real world practice, the mean time to repeat troponin was still 2.9 hours and\r that after training and implementation of the algorithm for 3 months, over 65% of patients\r still had their troponin taken at least 90 minutes after the first [4]. Similarly, in a\r sub-study of the ROMICAT II trial, Ferencik et al also found that a substantial 86.9% of\r patients had intermediate hs-cTn levels on initial testing and the addition of a second or\r third hs-cTn level did not improve risk stratification [5]. A study involving hs-cTnI (in a 2\r hour algorithm) by Lindahl et al showed that, 47.1% remained in the observational zone on\r initial troponin. After a repeat troponin 2 hours later, 25.5% of patients, remained in the\r observational zone [6]. This presents an opportunity for a possible alternative means of\r further evaluating the initial observational zone cohort of patients in a more efficient\r manner.\r\n\r Furthermore, multiple studies also showed that, even after repeat serial 1-hour troponin, a\r significant proportion of patients remains in the intermediate \"observational zone\" category\r and this is associated with mortality and adverse cardiac event risks. Suggestions for\r further management of these patients is not standardised and is guided by possible further\r repeat troponin and/or invasive or non-invasive cardiac imaging [2]. In a prospective\r international multicentre trial, Mueller et al found that 22.5% of patients remained in the\r observational zone and cumulative mortality for this cohort was 0.7% at 30 days but increased\r substantially to 9.6% at 365 days [7]. Similarly, Reichlin et al found that 24.1% of patients\r were found to be in the observational zone. In this cohort, the prevalence of acute MI was\r 18.6% and the cumulative mortality was 1.6% at 30 days, rising to to 16.5% at 2 years\r follow-up [8]. Mokhtari et al evaluated major adverse cardiac events (MACE) at 30 days in an\r observational study where the 1-hour hs-cTnT algorithm supplemented by patient history and\r ECG (\"extended algorithm\") was compared with an algorithm using hs-cTnT alone (troponin\r algorithm). Despite the addition of patient history and ECG, the proportion of patients\r remaining in the observation zone was not significantly different between the two algorithms\r and was found to be of the order of 25-27%. In the extended algorithm the 30 day MACE event\r rate including unstable angina was 10.1% in the observational zone cohort [9]. A study by\r Jaeger et al showed that 33% of patients still remained in the observational zone and that\r the cumulative mortality was found to be 0.6% at 30 days and 3.55 at 360 days [10]. These\r studies aptly demonstrate the presence of a significant cohort of patients who remain in the\r observational zone despite second troponin testing. Thus, again there is a pressing need to\r clarify risk stratification and further clinical management to reduce the proportion of\r patients in the observational zone.\r\n\r 1.2 Possible role for computed tomography coronary angiography The use of computed tomography\r coronary angiography (CTCA) in patients with acute chest pain has been shown to be safe [11],\r with high sensitivity and negative predictive value for coronary artery disease [12-15] and\r cost-effective with decreased time to diagnosis and earlier discharge from the ED [11, 16].\r The finding of coronary artery disease on CTCA has been shown to predict prognosis, with\r significantly worse MACE for patients with >50% stenoses, compared to those with <50%\r [17-19]. Historically 10% of patients with clinical Non-ST-elevation myocardial infarction\r (NSTEMI) on conventional troponin analysis were found to have unobstructed (<50% stenosis)\r coronary arteries on invasive coronary angiography. Subsequently it has been shown that\r approximately 10% of these have actual evidence of subendocardial infarction when\r investigated on late-gadolinium enhanced cardiac MRI (CMR) [20]. Therefore, in the era of\r high-sensitivity troponin assays, the percentage of patients with actual evidence of\r infarction would be even less in the ruled in group. Hence in our proposed research clinical\r pathway (detailed in section Experimental details and design of proposed investigation), the\r investigators have selected the conservative value of <25% stenosis to rule out AMI.\r\n\r Very few studies have examined the possible role of CTCA in the era of hs-cTn's. A sub-study\r of the ROMICAT II trial by Ferencik et al, showed that CTCA, with advanced plaque assessment\r and hs-cTn, significantly decreased the proportion of patients who had been classified in the\r intermediate category on initial hs-cTn from 43.8% to 24.4% when compared with conventional\r slow release troponin and traditional CTCA assessment (based on luminal stenosis alone).\r However, significant drawbacks of the study included the observational design and the\r unlimited time for CT interpretation. [5].\r\n\r The prospective randomised BEACON study compared the use of CTCA in addition to hs-cTn with a\r conventional management strategy involving hs-cTn alone. The authors concluded that the CTCA\r supplemented strategy did not meet the primary endpoint of identifying more patients with\r significant CAD requiring revascularisation. The use of CTCA also did not shorten hospital\r stay nor allow for more direct discharge from the ED, despite 42% of patients having no\r identifiable CAD and serial troponin testing being carried out at 3-6 hours. The main\r benefits of CTCA included significantly lower direct medical costs and less out-patient\r testing. However, duration of hospital stay was not the primary endpoint and the exclusion\r criteria did not include a specified lower limit for hs-cTn for ruling out AMI and only\r patients with no coronary disease were deemed to be suitable for A&E discharge [21]. Given\r the drawbacks of these studies, there is a compelling need to compare the performance of a\r management strategy involving hs-cTn supplemented by CTCA in a direct prospective randomised\r fashion, with usual standard of care involving serial hs-cTn alone, in the cohort of acute\r chest pain patients deemed to be in the intermediate observational zone according to the\r initial hs-cTn result.\r\n\r 2. Study Objectives and Design 2.1 Aim of the study In patients with ACP requiring serial\r hs-cTn testing, to perform a head-to-head comparison of a management strategy involving\r serial hs-cTn supplemented by CTCA versus the conventional standard of care management guided\r by serial second hs-cTn alone in a randomised prospective trial. To the best of the author's\r knowledge this study will provide the first prospective and randomised data pertaining to\r hospital length of stay as a primary outcome in the use of CTCA on this ACP cohort (with an\r intermediate observational zone category) on initial hs-cTn results presenting to the ED in a\r tertiary hospital (see Study 1 below).\r\n\r It will also provide further data on the influence of traditional and more advanced CTCA\r diagnostics (e.g. traditional CT stenosis assessment, advanced plaque characterisation) in\r clinical decision making, incremental to that provided by hs-cTn based care alone in patients\r with acute chest pain (see Study 2 below).\r\n\r 2.2 Original hypothesis The use of CTCA will lead to improvements in hospital length of stay\r and risk stratification and clinical management of patients in the intermediate/observational\r zone category on initial hs-cTn when compared with standard of care involving serial hs-cTn\r alone.\r\n\r 2.3 Experimental Details and Design of the Proposed Investigation\r\n\r The proposed work is divided into two clinical studies:\r\n\r Study 1: Prospective, randomised single-centre trial to compare hospital length of stay,\r patient clinical management and outcomes between standard of care supplemented by CTCA versus\r standard of care alone, in ACP patients found to be in the intermediate observational zone\r category on initial hs-cTn in an acute hospital setting.\r\n\r The times for recruitment will be from 8am to 4pm, Mondays to Fridays (inclusive). If\r recruited, the patients will be randomised to either (Arm A): undergo early CTCA along with a\r serial second hs-cTnT; or (Arm B): undergo standard of care involving serial hs-cTnT alone.\r Patients in both arms will be consented to have CTCA. However, Arm B (standard of care arm)\r will be blinded from CTCA findings and will have standard of care based clinical management\r according to serial hs-cTn. The CTCA data in Arm B will be used for Study 2 (see below).\r\n\r Arm A: CTCA assessment will be carried out in Arm A while the patient would normally be\r waiting to have their repeat serial hs-cTn taken or waiting for the blood test result.\r\n\r Patients with <25% stenosis on CTCA will have AMI ruled-out and may be considered for\r discharge or alternative reasons for their clinical presentation may be investigated. The\r results of these CTCA scans will be made available to the patients' clinical care team and\r further management decisions will be left to their discretion.\r\n\r Arm B: Patients in this arm will be managed according to standard of care, which includes\r serial hs-cTn testing. These patients will also have CTCA carried out, but the CTCA\r assessment will not form part of the patients' clinical management as clinicians will be\r blinded to CTCA findings. Furthermore, unlike Arm A, CTCA image interpretation will not take\r place in the acute hospital setting. It will be carried out in the following days. The whole\r CTCA procedure will be carried out after the patient has had their hs-cTn taken and while the\r patient is waiting for their hs-cTn result (as the investigators would not like the CTCA to\r delay the staff members from taking the blood test).\r\n\r Study 2: Sub-analysis of CTCA + biomarkers arm (Arm B): Analysis of the CTCA data-sets will\r be carried out including luminal stenosis, and plaque characterisation. Thereafter this\r information will be revealed to a select group of clinicians, who will be asked (in a virtual\r setting) to comment on possible changes to their original (hs-cTn based) clinical management\r plans in the light of the information gleaned from the existing CTCA datasets. From existing\r CTCA stenosis data, the cardiology clinicians will be asked to comment on any changes to\r their clinical management plan if they were given the following information:\r\n\r (i) hs-cTn + CTCA stenosis (ii) CTCA stenosis + CT plaque characterisation (iii) A\r combination of the above. The investigators will also make a comparison between these virtual\r plans of action and actual course of action among patients who undergo invasive coronary\r angiogram +/- invasive FFR assessment as part of their routine care.\r\n\r CT-Plaque Characterisation AMI results from sudden coronary luminal thrombosis, which can\r occur from any of three underlying pathological lesions: plaque rupture, plaque erosion and\r calcified nodules. Plaque rupture represents most of the underlying pathologies for AMI and\r the precursor coronary lesion is known as thin capped fibroatheroma (TCFA). These tend to be\r composed of a large lipid-rich necrotic core, thin and intact fibrous cap, spotty calcium,\r inflammation due to infiltration by macrophages and some smooth muscle cells [24].\r\n\r High risk morphological features of TCFA that can be identified on CTCA plaque assessment\r include: (a) napkin ring sign (b) positive remodelling (c) spotty calcification and (d) low\r attenuation.\r\n\r 2.6 Study Statistics The investigators will first inspect the normality of the distribution\r of the outcome variable. If it appears as though the distribution is not normal as expected,\r then the investigators will use non-parametric tests (Mann-Whitney U test); differences\r between groups will be constructed using 10,000 bootstrap simulations on the difference in\r medians, and derive associated confidence intervals and p-values. If there are any\r significant imbalances in any covariate(s) between the two groups, then the investigators\r will also perform quantile (specifically median) regression analysis on the difference\r between median length of stay between the two groups, adjusted for these covariate(s). To\r estimate the standard errors for the difference in medians, 10,000 bootstrap simulations of\r this quantile regression will be performed. If there are any significant imbalances, then the\r adjusted analysis will be considered the main analysis, otherwise the univariate analysis\r will be taken to be the main analysis. If the data are Normally distributed then standard\r regression techniques will be used.\r\n\r 2.7 Cost and Economic Analysis The cost and cost-effectiveness analyses will assess whether\r the addition of CTCA within the ED setting to the conventional clinical pathway without acute\r imaging will produce any changes in terms of total costs and/or cost-effectiveness analyses.\r For the purposes of the secondary objectives of cost analyses and economic evaluations\r (consistent with secondary outcomes) quality of life and symptoms will be measured using the\r EQ-5D-5L questionnaire at baseline after the ED episode and then monthly for the first three\r months and three monthly thereafter. All relevant costs from an NHS and Personal Services\r perspective will be considered using a top-down costing strategy (consistent with GSTFT\r finance data). Cost-effectiveness will be estimated in terms of the incremental cost per\r quality-adjusted life year (QALY) of comparing both clinical pathways (with and without the\r use of CTCA in acute setting). This ratio will be calculated using the area under the curve\r for health utility using the EQ-5D-5L and health service costs up to one year. Sensitivity\r analyses will explore the potential impact of major adverse events upon lifetime costs and\r QALYs as well as the adoption of a societal perspective. Existing published models will\r constitute the base for long-term modelling of both clinical pathways. Lifetime QALYs and\r costs of surviving patients will be estimated from published sources of life expectancy,\r annual costs and corresponding annual utilities. It is hypothesised that patients in whom\r coronary artery disease is identified, will adhere better to strategies that include primary\r and secondary prevention. This means that the early use of CTCA might hold benefits in the\r short-term) as well in the medium and long-term.\r\n\r 2.8 Timeline In our internal audit, patients who presented with acute chest pain to the ED at\r GSTFT, and were found to be in an intermediate grey zone on initial troponin analysis and who\r required a second troponin amounted to 26 patients per week. As the investigators aim to\r recruit patients Monday to Friday from 8am to 4 pm, it is anticipated that it may be possible\r to recruit 5 patients per week in total. Given the target of 250 patients in the study,\r recruitment is likely to take approximately 52 weeks to achieve.\r\n\r Follow up Procedures Patients will be followed up at 1, 2, 3, 6, 9 and 12 months following\r the hospital visit, to capture all relevant costs and outcomes.\r\n\r It is estimated that 30% of participants enrolled in the study may be lost to follow-up.\r\n\r Data collection General and study specific data Data will be collected by the research team\r from routinely collected NHS records and will include several categories, such as: baseline\r demographics, co-morbidities, ECG results, admission and discharge diagnoses, cardiology and\r other relevant investigations or interventions, repeat hospitalisations and adverse events.\r\n\r Patient questionnaires Patients will receive a call (at 1, 2, 3, 6, 9 and 12 months) to\r collect key information around resource use, patient quality of life and patient\r satisfaction. During this contact, participants will be asked: i) about the presence and\r degree of pain/discomfort, their level of concern and patient satisfaction using a scale of\r 0-10; ii) EQ-5D-5L questionnaire, with five questions; iii) NHS resource use, due to the\r participant's ACP episode; and iv) the presence of any Major Adverse Cardiac Events (MACE).\r This information above will be required to achieve secondary objectives of the study.\r\n\r 3. CTCA Procedures and findings 3.1 CTCA Procedure The CTCA exam will be performed on a new\r generation a multi-detector dual-source CT scanner.\r\n\r The investigators will try to ensure optimum CTCA images by attempting to minimise coronary\r and chest wall motion artefact through reducing heart rate to below 63 beats per minute (bpm)\r and by getting the patients to hold their breath for 10 - 12 seconds. If the heart rate is\r above 63 bpm and the systolic blood pressure (BP) is above 100 mmHg, intravenous\r beta-blockers) will be given to achieve the target heart rate. To further optimise coronary\r images, sublingual glyceryl trinitrate (GTN) will be given if the systolic BP is above 90\r mmHg. Pre-CTCA renal function will be available from routine bloods samples that are taken as\r part of standard of care work-up of patients presenting to the ED with acute chest pain.\r Female patients of potential child bearing age will be screened for the possibility of\r pregnancy according to the local Guy's and St. Thomas' Radiology protocols.\r\n\r 3.2 CTCA Image Interpretation and Reporting\r\n\r The CTCA will be interpreted and reported by an experienced Radiologist or Cardiologist with\r a minimum of Level II certification in cardiac CT angiography. Angiograms will be reported\r using the standard 15 segment model [22]. A stenosis will be graded in severity according to\r the following classification [23]:\r\n\r 1. Minimal: 0-24%\r\n\r 2. Mild: 25-49%\r\n\r 3. Moderate: 50-70%\r\n\r 4. Severe: >70%\r\n\r 5. Total Occlusion: 100% As discussed previously, patients with <25% stenosis will have AMI\r ruled-out.\r\n\r 3.3 CTCA Results For Arm A, CTCA image interpretation and reporting will be carried out\r as early as possible in the acute hospital setting, while the patient is an in-patient.\r The results will be made available to the patients' clinical care team and further\r management decisions will be left to their discretion.\r\n\r Patients in Arm B will also have CTCA carried out but the CTCA assessment will not form\r part of the patients' clinical management as this arm will be blinded to CTCA findings.\r Furthermore, unlike Arm A, CTCA interpretation followed by reporting will not take place\r in the acute hospital setting. Should the CTCA be found to have significant high risk\r CAD e.g. >50% stenosis in the left main (LM) coronary artery, and/or >50% stenosis in\r the proximal left anterior descending (LAD) coronary artery, they will be un-blinded and\r kept in a separate registry. Their results will be discussed with the hospital care team\r and if required, an urgent cardiology out-patient referral will be made to enable\r further clinical management.\r\n\r 3.4 CTCA Incidental Findings Pooled studies show: (i) an incidental extra-cardiac\r finding in 44% of patients undergoing CTCA; and (ii) the diagnosis of a major finding in\r 16% of the CTCA exams [25]. Incidental findings on CTCA will be documented in the CTCA\r report. In the case of Arm A (Study 1), the clinical care team will be made aware of the\r finding through the report. In Arm B any clinically significant findings e.g. cancers\r and/or prognostically significant coronary artery disease will be notified as a\r Radiology alert to the clinical care team and the patient's general practitioner.\r\n\r 4. Sample Size, Selection and Withdrawal of Subjects 4.1 Sample Size Waiting times often\r exhibit a skewed distribution, and so the sample size calculation was based on the\r difference in median waiting time.\r\n\r To estimate the sample size needed to observe a one-hour reduction in median hospital\r length of stay, normal techniques based on standard deviation estimates are not valid.\r The investigators therefore used a random sample of 49 patients undergoing the current\r pathway as the control 'population', and created an equivalent treatment 'population' by\r multiplying the waiting times of the 49 sampled patients by a constant such that the\r median was reduced by one hour; this constant was found to be 0.799.\r\n\r For a given sample size n, 10,000 Monte Carlo simulations were performed by sampling n\r patients with replacement from each of the two groups, and the p-value from a\r Mann-Whitney U test was calculated for each simulation. The proportion of these 10,000\r simulations with a p-value below 0.05 was recorded as the power for that sample size n.\r The sample size was varied until a power of 0.8 was obtained, and was found to be 250\r patients in total (125 patients in each arm of the study).\r\n\r Patient drop-out is anticipated to be minimal as all patients, by definition of the\r primary outcome, will be in hospital for the length of their hospital stay, and\r therefore their length of stay will be recorded.\r\n\r 5. Study Procedures 5.1 Screening Procedures Patients with suspected ACS eligible for\r the study will enter GSTFT via the ED at St Thomas' Hospital. If the initial ECG shows\r no ischaemic changes and the initial hs-cTn result cannot rule in or rule out AMI, the\r patient will be identified as a potential recruit to the study by the clinical care\r team.\r\n\r A screening log will be maintained by the site and kept in the Investigator Site File.\r This will record all potentially eligible patients approached about the study and the\r reasons why they were not registered in the study if this is the case.\r\n\r 5.2 Consenting Participants Once a potential participant is identified by the clinical\r team, and if the patient meets the inclusion criteria (and none of the exclusion\r criteria), a trained member of research team will obtain signed informed consent from\r the patient.\r\n\r This procedure will be supported by a patient information sheet that appropriately\r explains the aims, methods, anticipated benefits and potential hazards of the study.\r\n\r It is anticipated that the consent process will take no longer than 15 minutes. It will\r be explained to the patient that it is his/her right to ask to be withdrawn from the\r study at any point in time.\r\n\r Written informed consent on the current approved version of the consent form for the\r study will be obtained before any study-specific procedures are conducted, and a copy\r will be given to the patient and kept in the patient's medical notes. The discussion and\r consent process will be documented in the patient notes.\r\n\r The patient's capacity will be assessed by trained and delegated clinical/research staff\r who have completed study specific training and have been delegated this responsibility\r by the Principal Investigator (PI).\r\n\r Research staff are responsible for:\r\n\r - Assessing the patient's capacity to provide informed consent.\r\n\r - Checking that the current approved version of the information sheet and consent\r form are used.\r\n\r - Checking that information on the consent form is complete and legible and the\r patient has completed/initialled all relevant sections and signed and dated the\r form.\r\n\r - Checking that an appropriate member of staff has countersigned and dated the\r consent form to confirm that they provided information to the patient.\r\n\r - Checking that an appropriate member of staff has made dated entries in the\r patient's medical notes relating to the informed consent process (i.e. information\r given, consent signed etc.).\r\n\r - Following registration:\r\n\r - Adding the patient study number to all copies of the consent form, which\r should be filed in the patient's medical notes and investigator site file.\r\n\r - Giving the patient a copy of their signed consent form and patient information\r sheet.\r\n\r - Respecting the right of the patient to refuse to participate in the study without\r giving reason as all patients are free to withdraw at any time.\r\n\r 5.3 Randomisation Procedures Once patients consent to participate in the study, they\r will be randomised into the intervention group (i.e. with CTCA) or the control group\r (i.e. hs-cTn based standard of care) on a 1:1 ratio.\r\n\r Randomisation will be carried out via the use of opaque sealed envelope block\r randomisation method. Both the block randomisation list and the sealed envelopes will be\r produced by the statistician. Each block will contain 5 envelopes, which would translate\r to 50 blocks. 25 blocks will contain 3 envelopes for Arm A and 2 envelopes for Arm B.\r The remaining 25 blocks will contain 3 envelopes for Arm B and 2 envelopes for Arm A.\r Each block will also be randomly arranged. The sealed opaque envelopes/blocks used to\r assign patients to either arm will be prepared by an individual external to the study.\r The recruiter will not be able to identify which arm a potential participant is going to\r be randomised to until after he/she has received informed signed consent from the\r potential participant.\r\n\r Once randomised onto the study, the patient will be given a study number. This will be\r documented in the enrolment log.\r\n\r 5.4 Radiation assessment The proposed study includes only one scan per patient covering\r approximately the cardiac anatomy from the aortic root/pulmonary arteries level down to\r below the inferior border of the heart. The CT scan protocol will use standard\r prospective ECG gating. If necessary intravenous beta-blockers will be given to achieve\r the target heart rate (below 63 beats per minute). If for clinical reasons (e.g.\r elevated heart rate despite the use of oral and/or intravenous beta-blockers) it is not\r possible to use the prospective CTCA scanning protocol, the patient will not undergo the\r CTCA examination and therefore will not take part in the study. The typical Dose-Length\r Product (DLP) for the prospective CTCA scan is expected to be in the region of 350\r mGy.cm. This leads to an estimate cardiac CT dose of approximately 9mSv per scan. To\r provide an upper estimate of dose that is not expected to be exceeded, the 95th\r percentile plus 20% is taken. This gives a DLP of 640mGycm which corresponds to an\r effective dose of 16mSv. These effective doses estimates are based on a previous dose\r (DLP) audit of 30 CTCA scans performed on adult patients between 02/03/2017 and\r 20/03/2017 on the Siemens Force scanner at St Thomas' Hospital using the 'CaScore Turbo\r Flash' or the 'Coronaries Prospective' protocol. The total research protocol dose (TRPD)\r for this study is set at 16mSv all of which is due to the CTCA imaging research\r procedure, i.e. additional to standard care. It is noted that some patients involved in\r this study may go on to have other procedures involving radiation as part of their\r standard care. These are difficult to fully characterise and are not included in this\r dose calculation. The total risk expressed as the total detriment (cancer incidence\r weighted for lethality and life impairment and the probability over two succeeding\r generations of severe hereditary disease) is estimated at approximately 1 in 1100 for\r the full TRPD dose. The TRPD value corresponds to approximately 7 years of natural\r background radiation exposure, where the average natural background radiation per capita\r is 2.2 mSv in the UK.\r\n\r 6. Assessment of Safety\r\n\r A serious adverse event is any untoward medical occurrence that:\r\n\r - Results in death;\r\n\r - Is life-threatening;\r\n\r - Requires in-patient hospitalisation or prolongation of existing hospitalisation;\r\n\r - Results in persistent or significant disability/incapacity; or\r\n\r - Other important medical events. 6.1 Ethics reporting A serious adverse event (SAE)\r occurring to participant would be reported to the REC that gave a favourable\r opinion of the study where in the opinion of the Chief Investigator the event was:\r 'related' - that is, it resulted from administration of any of the research\r procedures; and 'unexpected' - that is, the type of event is not listed in the\r protocol as an expected occurrence. Reports of related and unexpected SAEs would be\r submitted within 15 days of the Chief Investigator becoming aware of the event,\r using the NRES report of serious adverse event form.\r\n\r All related AEs that result in a patient's withdrawal from the study or are present at\r the end of the study, should be followed up until a satisfactory resolution occurs. A\r patient may also voluntarily withdraw from treatment due to what he, or she, perceives\r as an intolerable AE. If either of these occurs, the patient would undergo an end of\r study assessment and be given appropriate care under medical supervision until symptoms\r cease or the condition becomes stable.\r\n\r 7. Study Steering Committee The Study Steering Group will meet at fixed points during\r the study and will include patient representatives.\r\n\r Data Monitoring and Ethics Committee (DMEC) functions will be embedded in the Study\r Steering Committee. The Study Steering Committee will have access to unblinded\r comparative data. The committee will monitor data collection methods and make\r recommendations regarding whether there are any ethical or safety reasons why the study\r should not continue.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients above 18 years of age with ischaemic sounding chest pain prompting visit to\r the emergency department (suspected ACS).\r\n\r 2. No-ischaemic ECG changes (i.e. no ST-segment elevation or depression 1mm in 2 or more\r contiguous leads, and/or T-wave inversions).\r\n\r 3. Episode of chest pain within last 12 hours.\r\n\r 4. Initial troponin in the intermediate range (5-50ng/L).\r\n\r Exclusion Criteria:\r\n\r 1. STEMI.\r\n\r 2. Signs and symptoms of acute heart failure and/or haemodynamic instability.\r\n\r 3. Dynamic ischaemic ECG changes.\r\n\r 4. Patient not suitable to undergo CTCA\r\n\r 1. Inability to breath hold for 10 seconds\r\n\r 2. Severe renal impairment (eGFR <30 mL/min)\r\n\r 3. Contraindication to beta-blockers (not relevant for patients with baseline sinus\r rhythm at rate of <63bpm)\r\n\r 5. Atrial Fibrillation on ECG.\r\n\r 6. Patients with known significant obstructive coronary artery disease (>50% stenosis) on\r previous invasive or CT coronary angiogram.\r\n\r 7. Patients with previous PCI/CABG revascularisation.\r\n\r 8. Patients with a history of congenital heart disease.\r\n\r 9. Patients with known coronary artery anomalies.\r\n\r 10. Patients who lack capacity to give consent or participate in the study.\r\n\r 11. Previous recruitment to the present study.\r\n\r 12. Known pregnancy or patients who are currently breast feeding.\r\n\r 13. Prisoners.\r\n\r 14. Patients involved in current or a recent (within the last 4 months) CTIMP 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:** not relevant"
}
] |
not relevant
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687
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[
{
"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 Myocardial Fibrosis in Severe Aortic Valve Stenosis\n\n**Clinical Trial Summary:**\n\nDegenerative aortic valve stenosis (AS) is the most common valve heart disease in the\r developed Western countries. The hemodynamic progression of AS occurs over time and leads to\r LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as\r increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS\r patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction\r and, consequently, to with AS related symptoms. When symptoms associated with AS appear,\r patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter\r aortic valve implantation (TAVI) is not performed.\r\n\r Primary hypothesis of the research: fibrotic changes in the myocardium are related to\r immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients\r with severe AS.\r\n\r The goal of the study is to determine the prognostic implications of focal as well as diffuse\r myocardial fibrosis in patients with severe aortic valve stenosis.\n\n**Clinical Trial Detailed Description:**\n\nAS is the most common valvular heart condition in the Western world. In response to increased\r afterload imposed by AS adaptive left ventricular (LV) remodelling occurs which in a course\r of a disease transitions from LV hypertrophy to maladaptive changes in the myocardium leading\r to cardiac decompensation and symptoms development. This transition is predominantly driven\r by myocardial fibrosis and myocyte cell death. Increasing evidence have demonstrated that\r presence of myocardial fibrosis, detected by cardiovascular magnetic resonance (CMR), could\r serve as an early marker of LV decompensation and predict adverse outcomes in patients with\r aortic stenosis. Currently, the indications for valvular replacement are based on the\r stenosis severity evaluated by echocardiography and the presence of symptoms.\r\n\r The objective of the project is to identify parameters of non-invasive imaging modalities\r (two-dimensional echocardiography with an extended myocardial deformation analysis, 1.5 T CMR\r with T1 parametric map and late gadolinium enhancement (LGE) predictive of cardiac\r decompensation and to evaluate the prognostic significance of myocardial fibrotic changes in\r patients with severe degenerative AS. In patients with suspicion of cardiac amyloidosis,\r 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy will be performed.\r\n\r Study design: a prospective, open, case-driven, multicentre study (Lithuania, Denmark).\r\n\r Investigators will assess LV structural and functional alterations before and 12 months after\r aortic valve intervention. Cardiac imaging data will be aligned with histopathological data\r from myocardial tissue samples collected at the time of aortic valve replacement in SAVR\r group. In patients with suspicion of cardiac amyloidosis, DPD scintigraphy and further\r evaluation regarding amyloidosis will be performed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Severe aortic stenosis (aortic valve area <1.0cm2 or aortic valve area index <0.6\r cm2/m2\r\n\r - Age ≥18 years.\r\n\r - Signed informed patient consent form.\r\n\r Exclusion Criteria:\r\n\r - Severe valvular disease other than AS.\r\n\r - Significant coronary heart disease requiring revascularisation.\r\n\r - History of myocardial infarction.\r\n\r - Previous cardiac surgery.\r\n\r - Severe renal impairment eGFR <30ml/min/1.73m2.\r\n\r - Any absolute contraindication to CMR.\r\n\r - Inherited or acquired cardiomyopathy.\r\n\r - Other medical conditions that limits life expectancy or precludes SAVR or TAVI.\r\n\r - Pregnant or nursing women\r\n\r - Mental condition rendering the patient unable to understand the nature, scope and\r possible consequences of the study or to follow the protocol\r\n\r - Patients in permanent atrial fibrillation.\r\n\r - Significant chronic obstructive pulmonary disease (FEV1 <70% of predicted value)\r\n\r - Patient with implanted devices (pacemaker, ICD)\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"
}
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definitely relevant
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688
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[
{
"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\nCerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.\n\n**Clinical Trial Summary:**\n\nThe aim of this collaborative analysis is to evaluate stroke rates and mortality in patients\r undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES\r valve. In the absence of large randomized controlled trials, we will conduct a large\r collaborative patient-pooled meta-analysis on 30-day stroke and mortality in patients\r undergoing primary transfemoral TAVI with either MCV or ES valve.\n\n**Clinical Trial Detailed Description:**\n\nThe main aim of this patient-pooled analyses is to compare stroke rates and mortality in\r patients undergoing TAVI with the self-expandable MCV prosthesis compared to the\r balloon-expandable ES valve. However, this collaboration may also be used to compare various\r outcomes.\r\n\r Studies were included if they complied with the following requirements: original prospective\r studies, including patients with aortic valve stenosis treated with transfemoral TAVI of\r native valves and reporting of 30 day stroke outcomes according to VARC criteria or other\r specified corresponding criteria . Moreover, to be included studies had to report both the\r use of self-expandable MCV prosthesis and the balloon-expandable ES valve in more than 50\r patients in each arm to ensure experience in use of the valves. Studies were excluded if they\r only addressed patients undergoing valve-in-valve and re-do procedures or bicuspid valves or\r included the same study population. Principal Investigators of these studies were approached\r for collaboration.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients undergoing transfemoral transcatheter aortic valve procedures\r\n\r Exclusion Criteria:\r\n\r - valve-in-valve procedures, other acces routes than transfemoral\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
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689
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[
{
"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\nAutomated Phonocardiography Analysis in Adults\n\n**Clinical Trial Summary:**\n\nBackground: Computer aided auscultation in the differentiation of pathologic (AHA class I)\r from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be\r a useful tool to assist healthcare providers in identifying pathological heart murmurs and\r may avoid unnecessary referrals to medical specialists.\r\n\r Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously\r detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent\r (AHA class III).\r\n\r Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart\r murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity\r compared to medical specialist.\r\n\r Methods: Each patient is auscultated and diagnosed independently by a medical specialist by\r means of standard auscultation. Auscultation findings are verified via gold-standard\r echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of\r the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The\r algorithm results are compared to the findings of the medical professionals as well as to the\r echocardiogram findings.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adults with a heart defect verified by echocardiography\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
|
690
|
[
{
"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 Root Enlargement in Aortic Valve Replacement\n\n**Clinical Trial Summary:**\n\nAortic valve disease is a progressive illness that varies from minor valve thickening lacking\r obstruction of blood stream to severe calcification and alteration of the valve leading to\r weakened leaflet motion. Aortic valve replacement is a usual operation but can be complicated\r by a small aortic annulus requiring the insertion of an aortic valve prosthesis.\r Prosthesis-patient discrepancy results in worse outcomes.\n\n**Clinical Trial Detailed Description:**\n\nProsthesis-patient discrepancy results in worse outcomes, including elevated left ventricular\r work, decreased left ventricular mass regression, and has also been linked with high\r mortality. Therefore, Aortic root posterior enlargement by autologous fixed pericardium to\r insert an Aortic valve prosthesis with size suitable to patient body surface area to avoid\r the previous worse outcome of patient prosthesis mismatch. In this study the investigators\r will try to identify the benefits of Aortic Root Enlargement in management of Small Aortic\r Annulus in Patients with severe valvular aortic stenosis\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 17-75 years old\r\n\r - patients with sever aortic valve stenosis undergoing valve replacement surgery\r\n\r - informed consent has been obtained\r\n\r Exclusion Criteria:\r\n\r - Planned off-pump cardiac surgery\r\n\r - Patients required intra-aortic balloon pump\r\n\r - under 17 years of age\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
|
691
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[
{
"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\nVenTouch OUS Feasibility Study\n\n**Clinical Trial Summary:**\n\nThis is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the\r VenTouch System for treatment of subjects with functional MR.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the\r VenTouch System for treatment of subjects with functional MR enrolling up to 15 subjects who\r have been diagnosed with Grade 3-4 functional mitral valve regurgitation and deemed eligible\r per assessment by the inclusion/exclusion criteria. The duration of the study follow-up is 36\r months from the time of therapy adjustment. Data from this trial may be utilized in support\r of a CE study in Europe and/or a pilot IDE study in the U.S. Follow-up testing will be\r performed at 1, 3, 6, 12, 24, and 36 months post-therapy adjustment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Adults ≥18 years of age\r\n\r 2. Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic\r or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by\r echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2)\r\n\r 3. NYHA Class II to IV\r\n\r 4. Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography\r\n\r 5. Treatment and compliance with optimal guideline-directed medical therapy for heart\r failure for at least 30 days\r\n\r 6. Subjects with a Class I indication for CRT implant according to current guidelines\r should have CRT implant prior to entry into the study. Subjects who have existing CRT\r implants may be included in the study if the implant has been in place for at least 90\r days; reprogramming of an implanted CRT that results in increased biventricular pacing\r (from <92% to ≥92%) must be in place for at least 30 days.\r\n\r 7. Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by\r echocardiography\r\n\r 8. Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where\r LVEDDi is calculated by LVEDD/Body Surface Area (BSA))\r\n\r 9. Subject is willing and available to return for study follow-up\r\n\r 10. Subject or legal representative understands and provides signed informed consent for\r participation in study\r\n\r 11. Acceptance of subject for trial enrollment after review of all subject baseline data\r by Study Selection Committee\r\n\r Exclusion Criteria:\r\n\r 1. Life expectancy of less than 12 months due to conditions other than cardiac status\r\n\r 2. Anticipated need for LVAD or transplant within 12 months\r\n\r 3. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy\r or chronic outpatient oral steroid use\r\n\r 4. American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart\r failure\r\n\r 5. Six-minute walk distance < 150 meters\r\n\r 6. Identified need for any cardiovascular surgery\r\n\r 7. STS score that suggests prohibitive surgical risk as determined by Subject Selection\r Committee\r\n\r 8. Untreated clinically significant coronary artery disease\r\n\r 9. Any procedure, condition or cardiac anatomy that may impact or compromise the\r pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads,\r pericarditis, or other procedure involving pericardial access)\r\n\r 10. Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI\r myocardial infarction, unstable angina) or clinically significant cardiac events (e.g.\r hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any\r hospitalization) within 30 days of enrollment\r\n\r 11. Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress,\r endocarditis, myocarditis, pericarditis)\r\n\r 12. Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured\r or elongated chordae, prolapsed valve, perforated valve leaflets, significant\r calcification in the annulus, or calcification in the leaflets that restricts motion)\r\n\r 13. Severe symptomatic carotid stenosis\r\n\r 14. Severe or sustained pulmonary hypertension, defined by resting pulmonary artery\r systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart\r catheterization\r\n\r 15. Physical evidence of right-sided congestive heart failure with echocardiographic\r evidence of moderate or severe right ventricular dysfunction or moderate to severe TR\r\n\r 16. Hypotension (systolic pressure <90 mmHg)\r\n\r 17. Hemodynamic instability requiring inotropic support or mechanical heart assistance\r within 30 days\r\n\r 18. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart\r disease causing heart failure other than dilated cardiomyopathy\r\n\r 19. UNOS status 1 heart transplantation\r\n\r 20. Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis\r\n\r 21. Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of\r enrollment\r\n\r 22. Active systemic infection or bleeding\r\n\r 23. Autoimmune disorders and/or the use of immune suppression therapy\r\n\r 24. Females who are pregnant (as documented by HCG beta pregnancy test in females of\r child-bearing age) or lactating\r\n\r 25. Currently enrolled in another investigational drug or device study\r\n\r Intra-Operative Exclusion Criteria:\r\n\r 1. Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured\r or elongated chordae, prolapsed valve, perforated valve leaflets, significant\r calcification in the annulus, or calcification in the leaflets that restricts motion)\r\n\r 2. Signs/indications of ischemia\r\n\r 3. Intra-operative coronary angiography demonstrates that there is compression of the\r coronary arteries or reduction in coronary blood flow due to the VenTouch implant\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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692
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[
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"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\nREPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects\n\n**Clinical Trial Summary:**\n\nREPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through\r Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects\n\n**Clinical Trial Detailed Description:**\n\nTo evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the\r Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in\r symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for\r surgical valve replacement including those who have a bicuspid native valve.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject has documented severe aortic stenosis defined as initial AVA ≤1.0 cm2 (or AVA\r index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mm Hg OR maximal aortic valve\r velocity ≥4.0 m/s OR Doppler velocity index ≤0.25 as measured by echocardiography\r and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis\r with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to\r assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min\r recommended)c; the subject may be enrolled if echocardiographic criteria are met with\r this augmentation. (IC1)\r\n\r - A subject in the Bicuspid Aortic Valve Nested Registry cohort must have a documented\r Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and\r confirmed by the CT core lab with hemodynamic parameters that meet the criteria in\r IC1.\r\n\r - Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the\r center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case\r Review Committee [CRC]).\r\n\r - Subject has symptomatic aortic valve stenosis per IC1 definition above with NYHA\r Functional Class ≥ II.\r\n\r - Heart team (which must include an experienced cardiac interventionalist and an\r experienced cardiac surgeon) agrees that the subject is at intermediate risk of\r operative mortality (≥3% and <8% at 30 days based on the Society of Thoracic Surgeons\r [STS] risk score and other clinical comorbidities unmeasured by the risk calculator)\r and TAVR is appropriate. Note: Risk of operative mortality must be assessed via an\r in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC\r (which must include an experienced cardiac surgeon).\r\n\r - Heart team agrees that the subject is likely to benefit from valve replacement. IC7.\r Subject (or legal representative) has been informed of the study requirements and the\r treatment procedures, and provides written informed consent.\r\n\r - Subject, family member, and/or legal representative agree(s) and subject is capable of\r returning to the study hospital for all required scheduled follow-up visits.\r\n\r - Subject is expected to be able to take the protocol-required adjunctive pharmacologic\r therapy.\r\n\r Exclusion Criteria:\r\n\r - Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the\r Bicuspid Nested Registry cohort).\r\n\r - Subjects in the Bicuspid Nested Registry cohort will have a documented Sievers Type 0\r or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT\r core lab. Subjects are not eligible for inclusion in the Bicuspid Nested Registry\r cohort if the maximum diameter of the ascending aorta is >45 mm or if the subject has\r another indication for aortic root replacement. Subjects with a Sievers Type 2\r bicuspid valve are not eligible for enrollment in any study cohort.\r\n\r - Subject has had an acute myocardial infarction within 30 days prior to the index\r procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice\r normal in the presence of CK-MB elevation and/or troponin elevation).\r\n\r - Subject has had a cerebrovascular accident or transient ischemic attack clinically\r confirmed by a neurologist or neuroimaging within the past 6 months prior to study\r enrollment.\r\n\r - Subject is on renal replacement therapy or has GFR <20 (based on hospital preferred\r method). See AEC1 below if subject is in the CT Imaging Substudy.\r\n\r - Subject has a pre-existing prosthetic aortic or mitral valve.\r\n\r - Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.\r\n\r - Subject has moderate to severe mitral stenosis (mitral valve area ≤1.5 cm2 and\r diastolic pressure half-time ≥150 ms, Stage C or Dc).\r\n\r - Subject has a need for emergency surgery for any reason.\r\n\r - Subject has a history of endocarditis within 6 months of index procedure or evidence\r of an active systemic infection or sepsis.\r\n\r - Subject has echocardiographic evidence of new intra-cardiac vegetation or\r intraventricular or paravalvular thrombus requiring intervention.\r\n\r - Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood\r cell count <1,000 cells/mm3.\r\n\r - Subject will refuse transfusions or has had a gastrointestinal bleed requiring\r hospitalization or transfusion within the past 3 months, or has other clinically\r significant bleeding diathesis or coagulopathy that would preclude treatment with\r required antiplatelet regimen.\r\n\r - Subject has known hypersensitivity to contrast agents that cannot be adequately\r pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors,\r heparin, nickel, tantalum, titanium, or polyurethanes.\r\n\r - Subject has a life expectancy of less than 24 months due to non-cardiac, comorbid\r conditions based on the assessment of the investigator at the time of enrollment.\r\n\r - Subject has hypertrophic cardiomyopathy.\r\n\r - Subject has any therapeutic invasive cardiac or vascular procedure within 30 days\r prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker or\r implantable cardioverter defibrillator implantation, which are allowed).\r\n\r - Subject has multivessel coronary artery disease with a Syntax score >22, and/or an\r unprotected left main coronary artery.\r\n\r - Subject has severe left ventricular dysfunction with ejection fraction <20%.\r\n\r - Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic\r support or mechanical support devices.\r\n\r - Subject has arterial access that is not acceptable for the study device delivery\r system as defined in the device Instructions For Use.\r\n\r - Subject has severe vascular disease that would preclude safe access (e.g., aneurysm\r with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing\r of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding,\r ulcerated atheroma in the aortic arch).\r\n\r - Subject has current problems with substance abuse (e.g., alcohol, etc.) that may\r interfere with the subject's participation in this study.\r\n\r - Subject is participating in another investigational drug or device study that has not\r reached its primary endpoint.\r\n\r - Subject has untreated conduction system disorder (e.g., Type II second degree\r atrioventricular block) that in the opinion of the treating physician is clinically\r significant and requires a pacemaker implantation. Enrollment is permissible after\r permanent pacemaker implantation.\r\n\r - Subject has severe incapacitating dementia.\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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693
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[
{
"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\nValvular Aortic Stenosis Prognosis Study\n\n**Clinical Trial Summary:**\n\nAortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is\r the reference method for assessment of aortic stenosis and provides prognostic elements.\r However, it is imperfect with many inconsistencies between measures. On the other hand, the\r prognosis of patients with low flow and low gradient aortic retraction is discussed.\r\n\r The main objective of this work is to study the prognosis of asymptomatic and symptomatic\r aortic retraction.\n\n**Clinical Trial Detailed Description:**\n\nAortic stenosis is an attack most often acquired from the aortic valve corresponding to a\r defect of opening of this valve. Its prevalence increases with age and approaches 2% at age\r 65 and 25% at age 85 . It is in the majority of cases degenerative due to the development of\r calcifications on the aortic sigmoid valves by a process close to atherosclerosis (Otto CM,\r Circulation, 1994). It is associated with cardiovascular risk factors (age, male sex,\r smoking, high blood pressure and associated high LDL cholesterol). Aortic stenosis may also\r frequently be the consequence of aortic bicuspid (congenital) or more rarely rheumatic fever.\r\n\r Aortic stenosis is responsible for an obstacle to ejection of the left ventricle with\r increased afterload and thus left ventricular work. After a long asymptomatic period when the\r obstacle to ejection is compensated by the induction of an adaptive left ventricular\r hypertrophy, symptoms appear initially of effort (dyspnea, angina, lipothymia see syncope)\r then clinical signs of insufficiency heart. The occurrence of symptoms should cause aortic\r valve replacement because at this stage the prognosis becomes unfavorable with a risk of\r death by cardiac decompensation or sudden death.\r\n\r The two pillars of the diagnosis of severity are the evaluation of functional aortic valve\r area and the average transvalvular gradient. The tight aortic stenosis is defined for a\r functional aortic area <1cm² or 0.6cm² / m² and a mean tranvular gradient> 40 mmHg.\r\n\r Patient survival data and / or a possible complication or indication for surgery will be\r evaluated periodically either during a standard follow-up consultation if patients are\r followed in the referral center or by telephone contact with the attending physician or\r cardiologist. . In case of death, the cause and date will be collected.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Retrospectively, all patients examined from January 1, 2000 to November 2014 will be\r included in the echocardiography laboratory whose objective examination is a narrowing\r of the aortic valve (maximum transaortic velocity ≥2.5 m / s).\r\n\r - Aortic stenosis may be known in the past.\r\n\r Exclusion Criteria:\r\n\r - Refusal of the patient to participate in the study.\r\n\r - Patients who have previously had aortic valve surgery before being examined in the\r echocardiography laboratory.\r\n\r - Patients who can not be contacted or who do not respond will not be included in the\r database.\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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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694
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[
{
"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 Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis\n\n**Clinical Trial Summary:**\n\nTAVI is still a relatively new technique that is emerging with advance in the percutaneous\r and implantable valve technology. Despite its safe use in inoperable and high risk patients\r with severe symptomatic aortic valve stenosis, minimizing complications, predictors of\r outcomes and approach preference is still an area of study. Here we decided to study the\r outcomes of patients undergoing TAVI, different approaches used and their subsequent results\r and complications.\n\n**Clinical Trial Detailed Description:**\n\nSevere symptomatic aortic stenosis in elderly patients represents a surgical challenge for\r cardiac surgeons due to heavy calcifications and associated comorbidities. Such conditions\r usually are associated with dramatic intra and postoperative complications leading to many\r cases being declined for open surgical replacement. Many treatment modalities were described\r including trans-catheter valvotomy but with only temporary improvements and high rates of\r recurrence.\r\n\r Transcatheter Aortic Valve Implantation (TAVI) has offered an alternative solution to such\r cases in which open surgery is deemed too risky or prohibited. Percutaneous Heart Valves\r (PHV) implantations have been experimented on animals since the early 1990s. Yet the first\r human case was not reported till 2002, in which a percutaneously implanted heart valve (PHV)\r composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was\r developed and implanted through the antegrade trans-septal approach in a patient presenting\r with severe calcific aortic stenosis associated with many noncardiac comorbidities including\r leg ischaemia. Despite Patient's death after 17 weeks due to noncardiac causes, his follow-up\r showed significant improvement of left ventricle (LV) function and aortic valve area after\r implantation of the percutaneous valve.\r\n\r This case was followed by several single-center and small multicenter registries and series\r that included inoperable or very-high-risk patients, which were associated with promising\r results that confirmed the feasibility of TAVI.\r\n\r Many approaches are used for TAVI with the transfemoral approach being the primary option.\r Abnormalities of the iliofemoral anatomy have led to the emergence of other approaches\r including transapical, subclavian, axillary, and transaortic routes. Potential advantages of\r such approaches would be the avoidance of using large catheters though the iliofemoral\r system, aortic arch, ascending aorta, and aortic valve. Yet, their main disadvantage would be\r the need for general anaesthesia.\r\n\r As any surgical procedure, TAVI carries some risk of complications, major vascular injuries,\r stroke, conduction abnormalities, myocardial infarction, coronary obstruction and acute\r kidney injury have been reported. Although, careful planning, patient selection,\r perioperative workup and individualised approach choice play an important role in avoiding\r such problems.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with severe symptomatic aortic stenosis undergoing TAVI.\r\n\r Exclusion Criteria:\r\n\r - Patients with concomitant valvular heart 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
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695
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[
{
"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 Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study\n\n**Clinical Trial Summary:**\n\nThe objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic\r TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk\r for SAVR\n\n**Clinical Trial Detailed Description:**\n\nMulti-center, prospective, single arm\r\n\r All subjects will be treated with a Medtronic TAVR system. Subject follow-ups will be\r conducted at pre and post-procedure, discharge, 30 days, 1 year, and annually through 10\r years\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Severe aortic stenosis, defined as follows:\r\n\r 1. For symptomatic patients:\r\n\r Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean\r gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic\r echocardiography at rest\r\n\r 2. For asymptomatic patients:\r\n\r Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve\r area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient\r ≥60 mmHg by transthoracic echocardiography at rest, OR\r\n\r Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean\r gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic\r echocardiography at rest, AND an exercise tolerance test that demonstrates a limited\r exercise capacity, abnormal BP response, or arrhythmia OR\r\n\r Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean\r gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic\r echocardiography at rest, AND a left ventricular ejection fraction <50%.\r\n\r 2. Patient is considered low risk for SAVR, where low risk is defined as predicted risk\r of mortality for SAVR <3% at 30 days per multidisciplinary local heart team\r assessment.\r\n\r 3. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.\r\n\r 4. 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. Any condition considered a contraindication for placement of a bioprosthetic valve\r (eg, subject is indicated for mechanical prosthetic valve).\r\n\r 2. Age less than 60 years\r\n\r 3. A known hypersensitivity or contraindication to any of the following that cannot be\r adequately pre-medicated:\r\n\r 1. aspirin or heparin (HIT/HITTS) and bivalirudin\r\n\r 2. ticlopidine and clopidogrel\r\n\r 3. Nitinol (titanium or nickel)\r\n\r 4. contrast media\r\n\r 4. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet\r count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or\r hypercoagulable states.\r\n\r 5. Ongoing sepsis, including active endocarditis.\r\n\r 6. Any percutaneous coronary or peripheral interventional procedure with a bare metal\r stent or drug eluting stent performed within 30 days prior to screening committee\r approval.\r\n\r 7. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left\r main coronary artery.\r\n\r 8. Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within 10 weeks of Heart Team assessment.\r\n\r 9. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or\r mechanical hemodynamic support.\r\n\r 10. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or\r transient ischemic attack (TIA).\r\n\r 11. Gastrointestinal (GI) bleeding that would preclude anticoagulation.\r\n\r 12. Subject refuses a blood transfusion.\r\n\r 13. 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 14. Estimated life expectancy of less than 24 months due to associated non-cardiac\r co-morbid conditions.\r\n\r 15. 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 16. Currently participating in an investigational drug or another device study (excluding\r registries).\r\n\r 17. Evidence of an acute myocardial infarction ≤30 days before the study procedure due to\r unstable coronary artery disease (WHO criteria).\r\n\r 18. Need for emergency surgery for any reason.\r\n\r 19. Subject is pregnant or breast feeding.\r\n\r 20. Subject is legally incompetent, or otherwise vulnerable\r\n\r Anatomical exclusion criteria:\r\n\r 21. Pre-existing prosthetic heart valve in any position.\r\n\r 22. Severe mitral regurgitation amenable to surgical replacement or repair.\r\n\r 23. Severe tricuspid regurgitation amenable to surgical replacement or repair.\r\n\r 24. Moderate or severe mitral stenosis amenable to surgical replacement or repair.\r\n\r 25. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.\r\n\r 26. Prohibitive left ventricular outflow tract calcification.\r\n\r 27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding\r bioprosthesis\r\n\r 28. Aortic annulus diameter of <18 or >30 mm.\r\n\r 29. Significant ascending aortopathy requiring surgical repair\r\n\r 30. Ascending aorta diameter > 4.5 cm\r\n\r For transfemoral or transaxillary (subclavian) access:\r\n\r 31. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access\r vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV.\r However, for transaxillary (subclavian) access in patients with a patent LIMA, access\r vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean\r diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.\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
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696
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[
{
"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 Function in Heart Failure\n\n**Clinical Trial Summary:**\n\nOnly a few studies evaluated the RV systolic function in the three categories of HF,\r regarding the importance of understanding changes in RV function on clinical presentation and\r outcome; it was essential to understand the prevalence and severity of RV dysfunction among\r the three groups and the degree of correlation between RV with LV systolic function.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r -\r\n\r Adult patients of both gender who have the followiong criteria :\r\n\r (i) symptoms with or without signs of HF (ii) elevated natriuretic peptides (BNP ≥35pg/ mL\r or NT-proBNP≥125pg/mL) (iii) relevant structural heart disease: left ventricle hypertrophy\r (left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or left atrial\r enlargement (>34 mL/m2) or diastolic dysfunction (E/e'≥13 and a mean e' septal and lateral\r wall <9 cm/s) were included.\r\n\r Then patients were classified according to EF into HFpEF>50%, HFrEF<40% and HFmrEF >40% and\r <50%\r\n\r Exclusion Criteria:\r\n\r Patients with chronic obstructive pulmonary disease history of pulmonary embolism patients\r with respiratory 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:** definitely relevant"
}
] |
definitely relevant
|
697
|
[
{
"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 to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease\n\n**Clinical Trial Summary:**\n\nTo compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation\r between the intensive care group and the usual care group for patients with hypertension\r accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on\r improvement of left ventricular hypertrophy and its safety\n\n**Clinical Trial Detailed Description:**\n\n1.Primary objectives\r\n\r - To evaluate changes from baseline in LVM at V5 (24M)\r\n\r 2.Secondary objectives\r\n\r 1. To evaluate changes from baseline in LV global longitudinal strain at V5 (24M)\r\n\r 2. To evaluate changes from baseline in E/E' (E: early diastolic LV inflow velocity, E':\r early diastolic mitral annulus velocity) at V5 (24M)\r\n\r 3. To evaluate changes from baseline in LV volumes, a stroke volume index and LV ejection\r fraction at V5 (24M)\r\n\r 4. To evaluate a rate of disease progression\r\n\r - In case of Aortic stenosis (AS), to evaluate changes from baseline in Aortic Valve\r Area (AVA), Vmax, Mean Pressure Gradient (PG) and Valvulo-arterial impedance (Zva)\r at V5 (24M)\r\n\r - In case of Aortic regurgitation (AR), to evaluate changes from baseline in Vena\r contracta at V5 (24M)\r\n\r 5. To evaluate changes from baseline in blood pressure at V2(6M), V3(12M), V4(18M) and\r V5(24M)\r\n\r 6. To evaluate a cumulative incidence rate for each visit time point\r\n\r - Death, Cardiovascular(CV) death, Heart Failure(HF), Myocardial Infarction(MI),\r Hospitalization, Aortic Valve Replacement(AVR)\r\n\r 7. To evaluate outcomes of adverse events, physical examination, vital signs (pulse) and\r laboratory tests (hematological examination, blood biochemical examination, urine test\r and pregnancy test)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male or female aged ≥ 19 years and < 80 years\r\n\r 2. Diagnosis of mild-moderate AS or mild-moderate AR\r\n\r 3. Applicable to 2.0~3.9 m/s of aortic jet velocity for mild-moderate AS or to 0.2~0.6 cm\r of Vena contracta for mild-moderate AR\r\n\r 4. Diagnosis of hypertension (SBP > 130 mmHg if being treated or SBP > 140 mmHg if being\r untreated)\r\n\r 5. For females of childbearing potential; negative pregnancy test results during the\r screening period and prior to administration of the investigational product, and\r agreement on use of medically allowable contraceptive measures (condom, oral\r contraceptive pills, injectable or implantable contraceptives, intrauterine devices,\r birth control patches, etc.) during the study period\r\n\r 6. Voluntary written consent to taking part in the clinical study and willingness to\r comply with requirements of the study\r\n\r Exclusion Criteria:\r\n\r 1. History of a cardiac valve replacement surgery (replacement surgery of mitral valve,\r aortic valve or tricuspid valve)\r\n\r 2. Accompanied by severe mitral regurgitation\r\n\r 3. Admitted to needing a surgery by the current treatment guidelines\r\n\r 4. Accompanied by symptoms such as angina pectoris, exertional dyspnea, syncope, etc.\r\n\r 5. < 50% of left ventricular ejection fraction\r\n\r 6. History of hypersensitivity reaction to active ingredients of the investigational\r product (Amlodipine, Losartan and Chlorthalidone), dihydropyridine derivatives,\r thiazide drugs and other sulfonamide derivatives or their compositions\r\n\r 7. Pregnant or breastfeeding\r\n\r 8. Symptomatic orthostatic hypotension\r\n\r 9. Severe liver failure or renal failure (< 30 mL/min of creatinine clearance)\r\n\r 10. Hereditary angioedema or history of angioedema at treatment with ACE inhibitors or\r angiotensin II receptor blockers\r\n\r 11. Primary hyperaldosteronism\r\n\r 12. Genetic problems such as galactose intolerance, Lapp Lapp lactase deficiency or\r glucose-galactose malabsorption\r\n\r 13. Anuria\r\n\r 14. Refractory hypokalemia\r\n\r 15. Hyponatremia or hypercalcemia\r\n\r 16. Symptomatic hyperuricemia (history of gout or uric acid lithiasis)\r\n\r 17. Untreated Addison's disease\r\n\r 18. Appropriately uncontrolled diabetes\r\n\r 19. Congenital or incurable hypertension\r\n\r 20. Diagnosis of severe cerebrovascular disorders (stroke, cerebral infarction, cerebral\r hemorrhage, etc.) within six months prior to the date of ICF obtainment\r\n\r 21. Wasting disease, autoimmune disease or connective tissue disease\r\n\r 22. Diagnosis of malignant tumor within five years prior to the date of ICF obtainment\r\n\r 23. Administration of another investigational product within four weeks prior to the date\r of ICF obtainment\r\n\r 24. For a patient who is taking anticoagulants and thrombolytic agents; considered\r difficult to keep a stable dosage/regimen by the investigator.\r\n\r 25. Considered unsuitable to be a subject 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:** possibly relevant"
}
] |
possibly relevant
|
698
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[
{
"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\nSAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects\n\n**Clinical Trial Summary:**\n\nThis is a Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of\r AR-501 (gallium citrate) solution, administered via inhalation, in healthy adult and P.\r aeruginosa infected cystic fibrosis (CF) subjects. Phase 1 of the study in HV subjects will\r consist of a single-ascending-dose (SAD) cohort, followed by the HV multiple-ascending-dose\r (MAD) cohort. Phase 2a of the study in CF subjects will consist of a MAD study design. The\r study will evaluate the safety and pharmacokinetic (PK) profile of single and repeat\r administrations of inhaled AR-501 solution in healthy adults, and the safety, PK and efficacy\r of repeat administrations of inhaled AR-501 solution in P. aeruginosa infected CF subjects.\n\n**Clinical Trial Detailed Description:**\n\nThree dose levels (low, medium and high) will be assessed in succession, first in healthy\r volunteer (HV) subjects, then in cystic fibrosis (CF) subjects. The study will be performed\r in 2 parts: Phase 1 part of the study in HV subjects will consist of a single-ascending-dose\r (SAD) cohort, followed by the HV multiple-ascending-dose (MAD) cohort. Phase 2a part of the\r study in CF subjects will consist of a MAD study design.\r\n\r The HV cohort will include up to 48 subjects. The CF cohort will have 42 subjects. Thus, the\r total number of subjects is 90.\r\n\r The Phase 1 HV study will be performed at a Phase 1 Clinical Study Unit and the Phase 2a will\r be performed at approximately 24 clinical trial sites located in the United States and\r possibly in Europe, some of which may be part of the Cystic Fibrosis Foundation\r (CFF)-accredited Therapeutic Development Network (TDN) or the European Cystic Fibrosis\r Society Clinical Trial Network (ECFS-CTN). Subjects who meet all eligibility criteria,\r including giving informed consent, will be enrolled and undergo a screening period of 28\r days.\r\n\r The HV cohort will include up to 24 adult subjects in 3 dose groups (8 per dose group [Low,\r Medium and High]) for the SAD phase of the study. In each dose group, subjects will be\r randomly assigned in a 3:1 ratio to the active drug or placebo, resulting in 6 subjects\r receiving inhaled AR-501 and 2 receiving inhaled placebo in a double-blind manner. The HV MAD\r phase of the study will include 24 adult subjects in 3 dose groups (8 per dose group [Low,\r Medium and High]). In each dose group, subjects will be randomly assigned in a 3:1 ratio to\r active study drug or placebo, resulting in 6 subjects receiving inhaled AR-501 and 2\r receiving inhaled placebo in a double-blind manner. All subjects in HV MAD cohorts will\r receive once weekly inhaled study drug (either AR-501 or matching placebo) for 4 weeks for a\r total of 5 doses.\r\n\r The CF MAD cohort will evaluate 3 different dose levels for a total of 42 adult CF. Of the 42\r subjects, 30 will be randomized to receive one of the three ascending doses of AR-501, while\r 12 will be randomized to receive placebo. All subjects in CF cohorts will receive once weekly\r inhaled study drug (either AR-501 or matching placebo) for 2 weeks for a total of 3 doses.\r\n\r The primary purpose of this study is to assess preliminary clinical safety of inhaled AR-501.\r The true frequency of AEs is unknown, and the sample size cannot be estimated accurately. For\r unknown AEs, the probabilities of observing at least 1 AE among 36 total healthy adult\r subjects and 30 adult CF subjects receiving any AR-501 dose are ≥ 80% if the true rate of\r such events are at least 4.4% and 4.8% respectively.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria (HV Subjects):\r\n\r 1. Written informed consent given by the subject.\r\n\r 2. At least ≥ 18 years old and < 50 years of age.\r\n\r 3. Healthy with no acute medical condition for ≥ 2 weeks prior to screening and no known\r chronic medical condition requiring regular medical follow up and care.\r\n\r 4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.\r\n\r 5. Currently nonsmoking and no history of using nicotine/tobacco-containing products for\r ≥ 5 years prior to screening.\r\n\r 6. Normal chest X-ray, per opinion of the Investigator.\r\n\r 7. FEV1 ≥ 80% of predicted values.\r\n\r 8. No history or current illicit, pharmaceutical drug or alcohol abuse within ≤ 5 years\r prior to screening.\r\n\r 9. A female subject must meet one of the following criteria:\r\n\r If of childbearing potential - agrees to use one of the accepted contraceptive\r regimens from at least 30 days prior to the first administration of the study\r medication, during the study, and for at least 90 days after the last dose of the\r study medication. An acceptable method of contraception includes one of the following:\r\n\r - Abstinence from heterosexual intercourse\r\n\r - Hormonal contraceptives (birth control pills, injectable/implant/insertable\r hormonal birth control products, transdermal patch)\r\n\r - Intrauterine device (with or without hormones), OR\r\n\r - Agrees to use a double barrier method (e.g., condom and spermicide) during the\r study and for at least 90 days after the last dose of the study medication\r\n\r If a female of non-childbearing potential, the subject should be surgically sterile\r (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation)\r or in a menopausal state (at least 1 year without menses), as confirmed by follicle\r stimulating hormone (FSH) levels.\r\n\r 10. A male subject must agree to use a double barrier method (e.g., condom and spermicide)\r during the study and for at least 90 days after the last dose of the study medication.\r\n\r Inclusion Criteria (CF Subjects):\r\n\r 1. Written informed consent given by the subject.\r\n\r 2. At least18 years old\r\n\r 3. Documentation of a CF diagnosis as evidenced by one or more clinical features\r consistent with the CF phenotype and one or more of the following criteria:\r\n\r - Sweat chloride equal to or greater than 60 mmol/liter by quantitative pilocarpine\r iontophoresis test (QPIT)\r\n\r - Two well-characterized, disease-causing mutations in the cystic fibrosis\r transmembrane conductance regulator (CFTR) gene.\r\n\r 4. Confirmation of prior and current colonization/infection with P. aeruginosa defined\r as:\r\n\r at least 2 positive cultures for PA in the last 12 months and a positive culture at\r screening.\r\n\r 5. Respiratory symptoms and CF status are stable with no acute exacerbation at the time\r of randomization.\r\n\r 6. Subject either using 1 alternating monthly suppressive inhaled antimicrobial therapy\r (at the time of randomization) OR using no suppressive inhaled antimicrobial therapy.\r\n\r 7. BMI between 18 and 30 kg/m2, inclusive.\r\n\r 8. Currently non-smoking and no history of using nicotine/tobacco-containing products or\r smoking/vaping (inhaled tobacco products or other inhaled substances) for ≥ 1 year\r prior to screening.\r\n\r 9. 1st 3 sentinels subjects in each dose group must have a FEV1 ≥ 60% of predicted\r values. The remaining 3 sentinel subjects and expanded dosing cohort in each dose\r group must have a FEV1 ≥ 45% of predicted values.\r\n\r 10. Serum creatinine and total bilirubin are both < 1.5 x upper limit of normal (ULN)\r range (isolated bilirubin > 1.5 x ULN range is acceptable if bilirubin is fractionated\r and direct bilirubin is < 35%).\r\n\r 11. A female subject must meet one of the following criteria:\r\n\r - If of childbearing potential - agrees to use one of the accepted contraceptive\r regimens from at least 21 days prior to the first administration of the study\r medication, during the study, and for at least 28 days after the last dose of the\r study medication. An acceptable method of contraception includes one of the\r following:\r\n\r - Abstinence from heterosexual intercourse\r\n\r - Hormonal contraceptives (birth control pills, injectable/implant/insertable\r hormonal birth control products, transdermal patch)\r\n\r - Intrauterine device (with or without hormones), OR\r\n\r - Agrees to use a double barrier method (e.g., condom and spermicide) during\r the study and for at least 28 days after the last dose of the study\r medication\r\n\r - If a female of non-childbearing potential, the subject should be surgically\r sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or\r tubal ligation) or in a menopausal state (at least 1 year without menses), as\r confirmed by FSH levels.\r\n\r 12. A male subject must agree to use a double barrier method (e.g., condom and spermicide)\r during the study and for at least 28 days after the last dose of the study medication.\r\n\r 13. Ability to produce/expectorate sputum sample.\r\n\r Exclusion Criteria (HV Subjects):\r\n\r None of the following criteria can be met.\r\n\r 1. Female subjects who are currently pregnant or lactating.\r\n\r 2. Oral temperature above 37.5ºC at the time of screening or prior to randomization.\r\n\r 3. Clinically abnormal renal function, evidenced by serum creatinine > 1.5 mg/dL.\r\n\r 4. Need for using any nephrotoxic agents during the study.\r\n\r 5. Known allergy or hypersensitivity to albuterol.\r\n\r 6. Significantly abnormal liver function:\r\n\r 1. Total bilirubin >1.5 x upper limit of the normal range (ULN),\r\n\r 2. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 x ULN\r and alkaline phosphatase (ALP) > 2 x ULN\r\n\r 7. Hemoglobin <10 g/dL\r\n\r 8. Abnormal corrected serum calcium concentration prior to enrollment.\r\n\r 9. History or current use of illicit, pharmaceutical drug or alcohol abuse within 5 years\r prior to screening.\r\n\r 10. Positive urine screen for alcohol, cotinine and/or drugs of abuse at screening and\r admission.\r\n\r 11. Positive test results for Human Immunodeficiency Virus (HIV)-1/HIV-2 antibodies,\r Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb).\r\n\r 12. Inability to comply with any study requirements based on judgement of the\r Investigator.\r\n\r 13. Any medical, psychological, cognitive, social or legal conditions that would interfere\r in the ability to give an informed consent and/or participate fully in the study.\r\n\r 14. Participation in another clinical trial involving receipt of an investigative product\r within 30 days before screening.\r\n\r 15. Any other reason as determined by an Investigator.\r\n\r Exclusion Criteria (CF Subjects):\r\n\r None of the following criteria can be met.\r\n\r 1. Female subjects who are currently pregnant or lactating.\r\n\r 2. Oral temperature above 37.5ºC at the time of screening or prior to randomization.\r\n\r 3. Serum creatinine > 1.5 mg/dL or known significant kidney disease.\r\n\r 4. Significantly abnormal liver function:\r\n\r 1. Total bilirubin > 1.5 x ULN range,\r\n\r 2. ALT and/or AST > 3 x ULN range and ALP > 2 x ULN range.\r\n\r 5. History of medically attended hemoptysis, requiring hospitalization (small amount of\r blood streaking in sputum is acceptable).\r\n\r 6. Pulmonary exacerbations within 3 months prior to randomization.\r\n\r 7. Hemoglobin < 10 g/dL.\r\n\r 8. Abnormal corrected serum calcium concentration prior to randomization (normal range is\r typically 8.5-10.2 mg/dL).\r\n\r 9. Any change (initiation, change in type of drug, dose modification, schedule\r modification, interruption, discontinuation, or re-initiation) in a chronic\r treatment/prophylaxis regimen for CF or CF-related conditions within 2 weeks prior to\r randomization.\r\n\r 10. Known allergy or hypersensitivity to albuterol or any component of the study drug or\r placebo\r\n\r 11. History or current use of illicit, pharmaceutical drug or alcohol abuse within 5 years\r prior to screening.\r\n\r 12. Positive urine screen for alcohol, cotinine and/or drugs of abuse at screening\r (positive results for a subject on Orkambi should have a confirmatory test for\r cannabinoids performed, e.g., reflex testing, to rule out cross reaction with Orkambi)\r\n\r 13. History of positive test result for human immunodeficiency virus (HIV) HIV-1/HIV-2\r antibodies, HBsAg or chronic hepatitis C virus infection.\r\n\r 14. Inability to comply with any study requirements based on judgement of the\r Investigator.\r\n\r 15. Any medical, psychological, cognitive, social or legal conditions that would interfere\r in the ability to give an informed consent and/or participate fully in the study.\r\n\r 16. Participation in another clinical trial involving receipt of an investigative product\r within 30 days before randomization.\r\n\r 17. Suspected or confirmed acute respiratory infection (Examples: bacterial pneumonia,\r influenza, COVID-19).\r\n\r 18. Any other reason as determined 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:** not relevant"
}
] |
not relevant
|
699
|
[
{
"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\nPhase Contrast in Valvular Heart Disease\n\n**Clinical Trial Summary:**\n\nThe ability to quantify flow directly using through-plane phase contrast velocity mapping is\r a unique advantage of cardiovascular magnetic resonance and does not rely on the calculation\r from complex equations as echocardiography.\r\n\r The aim s is to study the role of cardiac MRI in the evaluation of valvular heart disease\r through quantification of the impact of valvular lesions upon cardiac function by accurate\r estimation of the left ventricular ejection fraction\n\n**Clinical Trial Detailed Description:**\n\nValvular heart disease is common and increases with age. In the past, valvular heart disease\r was typically caused by rheumatic heart disease, which remains a significant public health\r burden in developing countries. In industrialized nations, however, the rheumatic diseases\r has fallen substantially and valvular heart disease is now mainly degenerative in origin.\r\n\r Valvular heart disease encompasses a number of common cardiovascular conditions that account\r for 10% to 20% of all cardiac surgical procedures.\r\n\r Clinical examination is not a reliable guide to diagnosis or severity. This gap in the\r clinical valvular heart disease and the late presentation of many with severe disease\r emphasizes the importance of quantitative, high-quality cardiac imaging.\r\n\r Imaging needs to assess: 1) valve morphology to determine the etiology and suitability for\r invasive intervention; 2) hemodynamic severity; 3) remodeling of the left ventricle and right\r ventricle; 4) involvement of the aorta and 5) the prediction of adverse cardiovascular\r events.\r\n\r A number of imaging modalities are currently available to evaluate valvular heart disease in\r a comprehensive manner allowing correct assessment of both valve morphology and function.\r Doppler-echocardiography is the most frequently used tool for this purpose because it is\r cost-effective, widely available and, in the majority of the cases, provides sufficient\r information for clinical patient management and possible surgical planning.\r\n\r For a long time, cardiac catheterization and invasive angiography have been regarded as the\r \"gold standard\". However, this invasive approach exposes patients to radiation and iodinated\r contrast media, carrying the non-negligible risk of life-threatening complications but\r nonetheless far from optimal especially regarding the precise quantification of valvular\r regurgitation.\r\n\r Due to considerable improvements in hard- and software design in the last decade, magnetic\r resonance imaging has claimed its role as a central player in a large variety of cardiac\r diseases offering unique information about the mechanism of valve disease, quantifying the\r severity of disease, and discerning the consequences of the lesions including the effects on\r left ventricular volume, left ventricular systolic function, and left atrial volumes. Because\r of both its high accuracy and reproducibility, magnetic resonance imaging has become the\r preferred imaging modality in an increasing number of clinical trials. Also in the field of\r valvular heart disease, considerable progress has been achieved.\r\n\r Today, cardiovascular magnetic resonance has a number of unique advantages over other imaging\r modalities. It provides a view of the entire heart without limitations from inadequate\r imaging windows or body habitus. Additionally, in some patients, information from clinical\r history and physical examination or other diagnostic tests may be discordant with\r echocardiographic findings where there is a significant clinical role for cardiovascular\r magnetic resonance. cardiovascular magnetic resonance also can obtain imaging data in any\r imaging plane prescribed by the scan operator, which makes it ideal for accurate\r investigation of all cardiac valves: aortic, mitral, pulmonic, and tricuspid. It can be\r considered an excellent adjunct to echocardiography for investigating patients with valve\r disease.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with clinically diagnosed valvular heart disease and confirmed by\r echocardiography\r\n\r Exclusion Criteria:\r\n\r - Patients with known contraindication to MRI including the presence of paramagnetic\r\n\r - Surgical clips, or pacemakers\r\n\r - Severely ill patients\r\n\r - Claustrophobic or restless subjects\r\n\r - Patients with arrhythmia\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
|
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