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500	[ { "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 Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).\n\nClinical Trial Summary:\n\nThe purpose of the study is to investigate the safety and efficacy of transcatheter aortic\r valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at\r intermediate surgical risk by randomizing patients to either Surgical Aortic Valve\r Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.\r\n\r Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of\r transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic\r Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the\r pivotal clinical trial.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Subject must have co-morbidities such that Heart Team agrees predicted risk of\r operative mortality is ≥3% and <15% at 30 days (Intermediate Clinical Risk\r classification). Heart team evaluation of clinical surgical mortality risk for each\r patient includes the calculated STS score for predicted risk of surgical mortality\r augmented by consideration of the overall clinical status and co-morbidities\r unmeasured by the STS risk calculation;\r\n\r - Heart Team unanimously agree on treatment proposal and eligibility for randomization\r based on their clinical judgement (including anatomy assessment, risk factors, etc.);\r\n\r - Subject has severe aortic stenosis presenting with;\r\n\r 1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or\r aortic valve area index < 0.6cm2/m2 AND\r\n\r 2. Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous\r pressure recordings at cardiac catherization [or with dobutamine stress, if\r subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio <\r 0.25;\r\n\r - Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York\r Heart Association (NYHA) Functional Class II or greater;\r\n\r - Subject and the treating physician agree that the subject will return for all required\r post-procedure follow-up visits;\r\n\r - Subject meets the legal minimum age to provide informed consent based on local\r regulatory requirements;\r\n\r Exclusion Criteria:\r\n\r - Subject has refused surgical aortic valve replacement (SAVR) as a treatment option;\r (not applicable for Single Arm)\r\n\r - Any condition considered a contraindication for placement of a bioprosthetic valve\r (i.e., subject requires a mechanical valve);\r\n\r - A known hypersensitivity or contraindication to all anticoagulation/antiplatelet\r regimens (or inability to be anticoagulated for the index procedure), nitinol, or\r sensitivity to contrast media which cannot be adequately pre-medicated;\r\n\r - Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet\r count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;\r\n\r - Ongoing sepsis, including active endocarditis;\r\n\r - Any condition considered a contraindication to extracorporeal assistance;\r\n\r - Any percutaneous coronary or peripheral interventional procedure performed within 30\r days prior to randomization (Subjects with recent placement of drug eluting stent(s)\r should be assessed for ability to safely proceed with SAVR within the protocol\r timeframe);\r\n\r - Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within six weeks of randomization;\r\n\r - Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or\r mechanical hemodynamic support;\r\n\r - Recent (within 6 months of randomization) cerebrovascular accident (CVA) or transient\r ischemic attack (TIA);\r\n\r - Active gastrointestinal (GI) bleeding that would preclude anticoagulation;\r\n\r - Subject refuses a blood transfusion;\r\n\r - Severe dementia (resulting in either inability to provide informed consent for the\r trial/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits);\r\n\r - Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left\r main coronary artery (Syntax score calculation is not required for patients with\r history of previous revascularization if repeat revascularization is not planned);\r\n\r - Estimated life expectancy of less than 24 months due to associated non-cardiac\r comorbid conditions;\r\n\r - Other medical, social, or psychological conditions that in the opinion of the\r Investigator precludes the subject from appropriate consent or adherence to the\r protocol required follow-up exams;\r\n\r - Currently participating in an investigational drug or another device trial (excluding\r registries);\r\n\r - Evidence of an acute myocardial infarction ≤30 days before the index procedure;\r\n\r - Need for emergency surgery for any reason;\r\n\r - True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);\r\n\r - Extensive mediastinal radiation;\r\n\r - Liver failure (Child-C);\r\n\r - Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as\r measured by resting echocardiogram;\r\n\r - Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);\r\n\r - Pregnancy or intent to become pregnant prior to completion of all protocol follow-up\r requirements;\r\n\r - End stage renal disease requiring chronic dialysis or creatinine clearance < 20\r cc/min;\r\n\r - Pulmonary Hypertension (systolic pressure> 80mmHg);\r\n\r - Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory\r Volume (FEV1) < 750cc;\r\n\r - Frailty assessments identify:\r\n\r 1. Subject is < 80 years of age and three or more of the following apply\r\n\r 2. Subject is ≥ 80 years of age and two or more of the following apply\r\n\r - Wheelchair bound\r\n\r - Resides in an institutional care facility (e.g., nursing home, skilled care\r center)\r\n\r - Body Mass Index < 20 kg/m2\r\n\r - Grip Strength < 16 kg\r\n\r - Katz Index Score ≤ 4\r\n\r - Albumin < 3.5 g/dL;\r\n\r - Marfan syndrome or other known connective tissue disease that would necessitate aortic\r root replacement/intervention; (Not applicable for Single Arm)\r\n\r Note: Additional anatomical and vascular exclusion criteria may apply.\r\n\r Note: * For purposes of the single arm phase of the trial, \"randomization\" will refer to\r trial enrollment.\n\nPatient 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
501	[ { "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 Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial)\n\nClinical Trial Summary:\n\nWe hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and\r decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse\r LV remodeling favorably in patients with asymptomatic moderate to severe AS.\n\nClinical Trial Detailed Description:\n\nAortic stenosis (AS) is common valvular disorder, affecting 2% to 4% of adults older than 65\r years. It is gradually but constantly progressive disease whit a long asymptomatic phase, but\r once symptoms develop, the prognosis is poor.\r\n\r Currently, treatment strategy is focused mainly to watchful monitoring and judicious timing\r of aortic valve replacement (AVR). However, not all patients are proper candidate of\r corrective surgery and the needs of development of medical treatment are increasing. Various\r mechanisms have been suggested in progression of AS and recent observational studies\r suggested not only mechanical stress of \"wear and tear\" but also active inflammatory process\r likewise atherosclerosis may contribute the progression of AS. Through clinical descriptive\r studies, atherosclerotic risk factors, such as hypertension, diabetes mellitus, dyslipidemia,\r obesity, smoking, and metabolic syndrome have been known to facilitate the progression of AS.\r\n\r The renin-angiotensin system (RAS) is activated at an early stage of AS, promoting\r developemtnt of left ventricular hypertrophy (LVH), myocardial fibrosis, and diastolic\r dysfunction. Lipid lowering therapy and RAS blockade have emerged potential medical treatment\r to slow the progression of AS, however, many clinical trials did not show consistent\r beneficial effect of statins.8-10 RAS blockers are perceived as being relative\r contraindication due to concerns about increasing pressure gradient. However, patients with\r AS tolerate RAS blocker well on initiation and the use of angiotensin converting enzyme (ACE)\r inhibitors appears to confer long term survival benefit on patients considered to have a\r contraindication including AS.Pressure overload of LV, activation of RAS, and subsequent\r adverse LV remodeling, myocardial fibrosis, and LV dysfunction may potential therapeutic\r target to retard the progression of AS and to improve exercise capacity, and even long-term\r outcomes. RAS blocker including ACEI or angiotensin receptor blockers (ARBs) have been known\r to improve exercise capacity and long term outcome in patient with hypertension, congestive\r heart failure, or myocardial infarction.\r\n\r We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and\r decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse\r LV remodeling favorably in patients with asymptomatic moderate to severe AS.\r\n\r Prospective, double-blinded, randomized clinical trial with enrollment of normotensive or\r hypertensive patients of age 20 to 75 who require echocardiography for a clinical indication,\r which typically consists of known aortic stenosis or presence of cardiac murmur. Moderate to\r severe aortic stenosis will be defined as a continuous wave Doppler determined peak aortic\r valve jet velocity of 3.0 - 4.5 m/s or mean pressure gradient of 25 - 49 mmHg, or aortic\r valve area of 0.76 - 1.5 cm2. Patients meeting inclusion criteria without any exclusion\r criteria will be randomized 1:1 to angiotensin receptor blocker, Fimasartan, or placebo.\r After 1-year enrollment period, all patients will be followed for 1 year. Cardiopulmonary\r exercise test will be performed at baseline enrollment period, and at the end of follow-up.\r Echocardiographic evaluation will be performed at regular interval of baseline and 6 months\r interval until the end of study.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Male or female\r\n\r - Age: 20-75 years\r\n\r - Moderate to severe aortic stenosis defined as a continuous wave Doppler determined\r peak aortic valve jet velocity of 3.0 - 4.5 m/s, mean pressure gradient of 25 - 49\r mmHg, or aortic valve area of 0.76 - 1.5 cm2.\r\n\r - Asymptomatic aortic stenosis patients, Stationary or minimum dyspnea on exertion (NYHA\r Fc ≤ I or II) will be included.\r\n\r - Patients who were prescribed ACEI or ARBs for treatment of hypertension will be\r enrolled after 2 weeks wash-out period.\r\n\r - SBP 120-140 mmHg with or without medication regardless of presence of hypertension or\r not.\r\n\r - Patients with BP > 140/90 mmHg with or without medication will be included after their\r BP is controlled with anti-hypertensive medication other than ACEI/ARBs.\r\n\r - Patients who are able to perform appropriate cardiopulmonary exercise test with\r treadmill.\r\n\r - The patient agrees to the study protocol and the schedule of clinical, cardiopulmonary\r exercise test, and echocardiographic follow-up, and provides informed, written\r consent, as approved by the appropriate Institutional Review Board/Ethical Committee\r of the respective clinical site.\r\n\r Exclusion Criteria:\r\n\r - Symptomatic aortic stenosis: presence of exertional dyspnea (≥ NYHA Fc III), angina or\r syncope\r\n\r - Very severe aortic stenosis regardless of presence of symptoms. It was defined as a\r critical stenosis in the aortic valve area ≤ 0.75 cm2 accompanied by a peak aortic jet\r velocity ≥4.5 m/s or a mean transaortic pressure gradient ≥50 mm Hg on Doppler\r echocardiography.\r\n\r - Uncontrolled HTN (SBP > 160 or DBP >100) without ACEI or ARBs during 2-weeks wash out\r period in patients who were prescribed ACEI or ARBs for treatment of hypertension.\r\n\r - Patients with known history of coronary artery disease including myocardial\r infarction, regardless of the treatment (medication only, percutaneous coronary\r intervention, or coronary artery bypass grafting).\r\n\r - Planned cardiac surgery or planned major non-cardiac surgery within the study period.\r\n\r - Stroke or resuscitated sudden death in the past 6 months.\r\n\r - Chronic disease requiring treatment with oral, intravenous, or intra-articular\r corticosteroids (use of topical, or nasal corticosteroids is permissible).\r\n\r - Untreated hyperthyroidism or hypothyroidism with TSH levels more than 2 times upper\r limit of normal.\r\n\r - A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in\r the past 3 years or current treatment for the active cancer.\r\n\r - Female of child-bearing potential who do not use adequate contraception and women who\r are pregnant or breast-feeding.\r\n\r - 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.\r\n\r - Evidence of congestive heart failure, or left ventricular ejection fraction < 50%.\r\n\r - Significant renal disease manifested by serum creatinine > 2.0mg/dL\r\n\r - Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation\r (ALT or AST > 3 times upper limit of normal).\r\n\r - Documented bilateral renal artery stenosis or known contraindication of ACEI or ARBs\r\n\r - History of chronic obstructive pulmonary disease or asthma manifested by acute\r aggravation of COPD in the past 6 months, or currently taking bronchodilators\r including long-acting beta2 agonist, anticholinergics, or inhaled steroids.\r\n\r - Other valvular disease : Moderate or severe mitral regurgitation or mitral stenosis,\r Moderate or severe aortic regurgitation\r\n\r - Patients who are unable to perform cardiopulmonary exercise test.\r\n\r - Unwillingness or inability to comply with the procedures described in this protocol.\r\n\r - Patient who have been diagnosed with galactose intolerance, lactase deficiency,\r malabsorption of glucose or galactose which is main ingredient of placebo.\n\nPatient 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
502	[ { "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 Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System\n\nClinical Trial Summary:\n\nTreatment of ischemic heart failure.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nCandidates for this study must meet ALL of the following inclusion criteria:\r\n\r Clinical Inclusion Criteria:\r\n\r - Age ≥ 18 and ≤ 79 years.\r\n\r - Body Mass Index (BMI) ≤ 40.\r\n\r - Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or\r \"ambulatory\" Class IV as determined through the use of the SAS) post Myocardial\r Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior\r to enrollment.\r\n\r - Patient is not hospitalized at the time of enrollment.\r\n\r - Receiving appropriate medical treatment for heart failure according to the current\r American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update\r for the Diagnosis and Management of Chronic Heart Failure in the Adult during the\r three months prior to enrollment.\r\n\r - The patient or the patient'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)/Ethics Committee (EC) of the\r respective clinical site.\r\n\r - The patient and the treating physician agree that the patient will return for all\r required post-procedure follow-up visits.\r\n\r Inclusion Criteria based on Imaging:\r\n\r - 15% ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram\r (TTE).\r\n\r - Post LV MI structural heart dysfunction represented by LV wall motion abnormality\r (WMA) by TTE.\r\n\r - Left ventricle must have appropriate anatomy (size and morphology) for implant\r placement using Cardiac Computed Tomography (CT) and confirmed by LV gram\r\n\r Candidates will be excluded from the study if ANY of the following conditions apply:\r\n\r Clinical Exclusion Criteria:\r\n\r - Untreated clinically significant coronary artery disease requiring revascularization.\r\n\r - Cardiogenic shock within 72 hours of enrollment.\r\n\r - Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or\r Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment.\r\n\r - Excessive wall motion abnormalities outside the anteroapical region.\r\n\r - Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack\r (TIA).\r\n\r - End stage renal disease requiring chronic dialysis.\r\n\r - Obstructive Sleep Apnea (OSA): unless compliant on CPAP therapy or successful surgery.\r\n\r - Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or Creatinine > 2.5mg/dl.\r\n\r - Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable\r states.\r\n\r - Active peptic ulcer or GI bleeding within the past 3 months.\r\n\r - A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium\r and nickel alloy), or sensitivity to contrast media, which cannot be adequately\r pre-medicated.\r\n\r - Ongoing sepsis, including active endocarditis.\r\n\r - Life expectancy < 1 year due to associated non-cardiac co-morbid conditions or\r currently on the heart transplant lists.\r\n\r - Other medical, social, or psychological conditions that in the opinion of an\r Investigator precludes the patient from appropriate consent.\r\n\r - Currently participating in an investigational drug or another device study (prior to\r primary endpoint reached).\r\n\r - Female patients with childbearing potential and a positive urine pregnancy test .\r\n\r Anatomical Exclusion Criteria:\r\n\r - Pre-existing prosthetic heart valve in mitral or aortic position.\r\n\r - Valvular stenosis or regurgitation (tricuspid, aortic or mitral) > 2+.\r\n\r - Presence of anatomic anomalies (including severe calcification) detected by cardiac\r imaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpeded\r deployment and/or operation of the Parachute Implant\n\nPatient 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
503	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nClinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis\n\nClinical Trial Summary:\n\nThe primary objective of the present trial is to demonstrate the safety and effectiveness of\r the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small\r aortic annuli and deemed difficult for surgical operation.\n\nClinical Trial Detailed Description:\n\nThe purpose of this trial is to evaluate the effectiveness and safety of the MDT-2111 TAV\r system in subjects with small annuli and symptomatic severe AS deemed difficult for surgical\r intervention. The primary endpoint is a composite of functional effectiveness as measured by\r improvement of at least 1 New York Heart Association (NYHA) class from baseline to 6 months\r and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6\r months.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Subject must have co-morbidities such that one cardiologist and one cardiac surgeon\r agree that medical factors preclude operation, based on a conclusion that the\r probability of death or serious morbidity exceeds the probability of meaningful\r improvement.\r\n\r 2. Subject has senile degenerative aortic valve stenosis with:\r\n\r mean gradient > 40 mmHg or jet velocity greater than 4.0 m/s by either resting or\r dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac\r catheterization (either resting or dobutamine stress), AND an initial aortic valve\r area of ≤ 0.8 cm² (or aortic valve area index ≤ 0.5 cm²/m²) by resting echocardiogram.\r\n\r 3. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA\r Functional Class Class III or greater. If screening committee agrees the eligibility\r of a patient with class II , based on medical factors, he/she can be enrolled.\r\n\r 4. Patient has been informed of the nature of the trial and has signed an Informed\r Consent Form.\r\n\r 5. Patient agrees to comply with specified follow-up evaluations and to return to the\r same investigational site where the procedure was performed.\r\n\r Exclusion Criteria:\r\n\r 1. Evidence of an acute myocardial infarction ≤ 30 days prior to the intended treatment.\r\n\r 2. Any percutaneous coronary or peripheral interventional procedure performed within 30\r days prior to the procedure.\r\n\r 3. Blood dyscrasias as defined:\r\n\r - Leukopenia (WBC count < 1,000 cells/mm³)\r\n\r - Thrombocytopenia (platelet count <50,000 cells/mm³)\r\n\r - History of bleeding diathesis or coagulopathy\r\n\r - Hypercoagulable states\r\n\r 4. Untreated clinically significant coronary artery disease requiring revascularization.\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. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic\r attack(TIA).\r\n\r 9. End stage renal disease requiring chronic dialysis.\r\n\r 10. GI bleeding within the past 3 months.\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 - Ticlopidine\r\n\r - Heparin\r\n\r - Contrast media\r\n\r - Nitinol (titanium and nickel alloy)\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 co-morbid conditions.\r\n\r 15. Other medical, social, or psychological conditions that in the opinion of an\r Investigator precludes the subject from appropriate consent.\r\n\r 16. Severe dementia (resulting in either inability to provide informed consent for the\r trial/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits).\r\n\r 17. Currently participating in an investigational drug or another device trial. Note:\r Trials requiring extended follow-up for products that were investigational, but have\r since become commercially available, are not considered investigational trials.\r\n\r 18. Symptomatic carotid or vertebral artery disease.\r\n\r 19. Native aortic annulus size < 18 mm or > 20 mm per the screening diagnostic imaging.\r\n\r 20. Pre-existing prosthetic heart valve in any position.\r\n\r 21. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant\r aortic regurgitation).\r\n\r 22. Mitral regurgitation (moderate to severe) or severe tricuspid regurgitation.\r\n\r 23. Moderate to severe mitral stenosis.\r\n\r 24. Hypertrophic obstructive cardiomyopathy.\r\n\r 25. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\r\n\r 26. Severe basal septal hypertrophy with an outflow gradient.\r\n\r 27. Ascending aorta diameter > 34 mm\r\n\r 28. Congenital bicuspid or unicuspid valve verified by echocardiography.\r\n\r 29. For patients with native coronary artery dependent circulation:\r\n\r - Sinus of valsalva width < 25 mm OR\r\n\r - Height of the left or right coronary sinus of valsalva (to the tubular aorta) <\r 15mm.\r\n\r 30. Femoral or iliac artery of the first choice corresponding to any one of the following:\r\n\r - Angle at aortic root (the angle between aortic valve annulus plane and horizontal\r plane/vertebra) exceeds 70°.\r\n\r - Vessel diameter of femoral or iliac artery is less than 6 mm.\r\n\r - Aorta has severe calcification, excess tortuosity or severe atherosclerosis.\r\n\r - Transarterial access not able to accommodate an 18Fr sheath.\r\n\r 31. Subclavian artery of the second choice corresponding to any one of the following:\r\n\r - Angle at aortic root (the angle between aortic valve annulus plane and horizontal\r plane/vertebra) exceeds 70° (in the case of left subclavian artery) and 30° (in\r the case of right subclavian artery).\r\n\r - Vessel diameter of subclavian artery is less than 6 mm.\r\n\r - Transarterial access not able to accommodate an 18Fr sheath.\r\n\r 32. Direct Aortic Artery as third line choice of access. Patients are excluded from Direct\r Aortic access if:\r\n\r - Access site is less than 6 cm from the aortic valve basal plane\r\n\r - Access site has calcification or porcelain aorta\r\n\r - Access site and delivery trajectory contain RIMA or patent RIMA graft\n\nPatient 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
504	[ { "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\nHemodynamic Comparison of Tissue Aortic Valves\n\nClinical Trial Summary:\n\nThe purpose of this study is to:\r\n\r 1. Assess for hemodynamic differences at rest and with exercise between three clinically\r available tissue aortic valves.\r\n\r 2. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV\r hypertrophy, and changes in LV systolic and diastolic function) after aortic valve\r replacement for severe aortic stenosis (AS) between three clinically available aortic\r valve bioprosthesis.\n\nClinical Trial Detailed Description:\n\nVarious aortic valve prostheses have unique hemodynamic characteristics, and there is\r on-going interest in defining those hemodynamic characteristics in the interest of avoiding\r residual LV outflow obstruction and prosthesis-patient mismatch (residual LV outflow\r obstruction despite a normally functioning prosthesis ) after aortic valve replacement.\r Attempts to compare hemodynamics between prostheses have been limited by different sizing\r systems used by various manufacturers (precluding meaningful comparison of valves by valve\r size) and biological variability of in vivo gradients and effective orifice area for any\r valve (making potentially small differences in hemodynamics difficult to detect). Assessment\r of hemodynamics during increased cardiac output associated with exercise testing has been\r used to better define potentially subtle differences in hemodynamics between valve\r prostheses. In addition, assessment for change in LV geometry (notably including LV\r hypertrophy) after aortic valve replacement has been used as a surrogate marker of aortic\r prosthesis hemodynamics.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age ≥ 18 years.\r\n\r - Severe aortic stenosis (AS) based on overall clinical impression, with or without\r aortic valve mean gradient ≥ 40 mm Hg, EOA < 1.0 cm2, or EOA index < 0.6 cm2/m2.\r\n\r - Scheduled for clinically indicated elective aortic valve replacement for a primary\r diagnosis of severe AS.\r\n\r - Less than moderate aortic regurgitation on preoperative testing.\r\n\r - Isolated aortic valve replacement; or aortic valve replacement with concomitant\r coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid\r annuloplasty for functional mitral regurgitation / tricuspid regurgitation.\r\n\r - Left ventricular ejection fraction ≥ 40% on preoperative testing.\r\n\r - Physically able and willing to pedal a recumbent bicycle.\r\n\r - Patient and surgeon agree that the patient will undergo valve replacement with a\r bioprosthesis.\r\n\r - Patient and surgeon agree that the use of one specific bioprosthesis manufacturer /\r model is not indicated based on clinical criteria.\r\n\r - Willing to undergo randomization to have implanted one of three bioprosthesis at the\r time of aortic valve replacement.\r\n\r - Willing and able to undergo preoperative echocardiography/Doppler for purposes of the\r research study.\r\n\r - Willing and able to undergo post-operative exercise stress echocardiography/Doppler 5\r to 7 months after valve replacement for purposes of the research protocol.\r\n\r Exclusion Criteria:\r\n\r - Age < 18 years.\r\n\r - AS felt by overall clinical impression to be less than severe.\r\n\r - Aortic valve replacement is urgent or emergent.\r\n\r - Moderate of more aortic regurgitation on preoperative testing.\r\n\r - Concomitant mitral or tricuspid valve replacement.\r\n\r - Left ventricular ejection fraction < 40% on preoperative testing.\r\n\r - Physically unable or unwilling to pedal a recumbent bicycle.\r\n\r - Planned aortic valve replacement with a mechanical prosthesis.\r\n\r - Operating surgeon believes that any one of the three protocol bioprosthetic devices is\r contraindicated based on clinical criteria.\r\n\r - Not willing to undergo randomization to have implanted one of three bioprosthesis.\r\n\r - Unwilling or unable to undergo preoperative echocardiography/Doppler for purposes of\r the research protocol.\r\n\r - Unwilling or unable to undergo post-operative exercise stress echocardiography/Doppler\r 5 to 7 months after valve replacement for purposes of the research protocol.\n\nPatient 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
505	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nCardiac MRI for Severe Aortic Stenosis\n\nClinical Trial Summary:\n\nThis study will evaluate the importance of arterial stiffness and wave reflections as\r determinants of persistent left ventricular (LV) hypertrophy and fibrosis (assessed using\r cardiac magnetic resonance imaging [MRI]) after correction of severe stenosis of the aortic\r valve. The hypothesis will test whether stiff arteries and increased wave reflections impede\r pumping of blood by the LV after aortic valve replacement (AVR)and precent adequate\r regression (improvement) of hypertrophy and fibrosis of the myocardium despite correction of\r aortic valve stenosis.\n\nClinical Trial Detailed Description:\n\nA total of 80 participants will be enrolled into the study from site with the\r protocol-required technology. The Pennsylvania Department of Health funding for this trial is\r limited to sites in Pennsylvania. Participants will undergo pre- and post-operative cardiac\r MRI, blood draws, a 6-minute walk test, arterial tonometry, medical history assessment, and\r quality-of-life questionnaires to characterize the pathophysiologic factors causing\r variability in regression after AVR. Researchers will evaluate the role of specific\r hemodynamic abnormalities as determinants of post-AVR LV remodeling (LV hypertrophy and LV\r myocardial fibrosis) as seen on contrast-enhanced cardiac MRI. The trial also will evaluate a\r non-contrast-enhanced MRI approach (T1rho) potentially effective in assessing LV myocardial\r fibrosis.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - 18 years of age or older\r\n\r - Severe symptomatic aortic stenosis (estimated aortic valve area <1 cm2) 1,2 as\r documented on a transthoracic echocardiogram (ECG) performed within 4 months prior to\r enrollment\r\n\r - Planned for AVR within 8 weeks after enrollment\r\n\r - Able to have a cardiac MRI within 3 weeks prior to the AVR surgery\r\n\r - A preoperative coronary angiography demonstrating the absence of\r hemodynamically-significant CAD in need of revascularization during AVR surgery\r\n\r - Able to tolerate cardiac MRI with gadolinium contrast as required by protocol, to be\r performed at an ACRIN-qualified facility using an ACRIN-qualified MR scanner\r\n\r - Willing and able to provide a written informed consent\r\n\r Exclusion Criteria:\r\n\r - Not suitable to undergo cardiac MRI or use the contrast agent gadolinium because of:\r\n\r - Claustrophobia\r\n\r - Presence of metallic objects or implanted medical devices in body (i.e.,\r implanted cardiac pacemaker or defibrillator, central nervous system aneurysm\r clips, implanted neural stimulators, cochlear implant, ocular foreign body [e.g.,\r metal shavings], other implanted medical devices [e.g., drug infusion port],\r insulin pump, surgical clips, prostheses, artificial hearts, valves with steel\r parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\r\n\r - Weight greater than that allowable by the MRI table\r\n\r - Known LV ejection fraction <50%\r\n\r - Previous aortic valve surgery\r\n\r - Planned additional valve repair/replacement\r\n\r - Infective endocarditis\r\n\r - Moderate or severe aortic valve regurgitation\r\n\r - Rhythm other than sinus rhythm (i.e., atrial fibrillation) that results in an\r irregular heartbeat, compromising the quality of MRI and tonometry data acquisition,\r as documented on an ECG performed within 8 weeks prior to enrollment\r\n\r - Presence of hemodynamically-significant CAD that would require revascularization\r during the AVR surgery\r\n\r - Myocardial infarction or unstable angina in the previous month\r\n\r - Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 of body surface area\r documented within 4 weeks prior to enrollment\r\n\r NOTE: This threshold has been deemed appropriate for this study, rather than <30\r mL/min/1.73m2, since eGFR is likely to decrease for participants between the baseline and\r 6-month examinations. The protocol calls for gadolinium administration in the 6-month\r evaluation, and gadolinium administration is contraindicated in the presence of an eGFR <30\r mL/min/1.73m2. Therefore, initially excluding patients who have an eGFR < 60 mL/min/1.73m2\r will minimize the presence of an eGFR <30 mL/min/1.73m2 at the time of the 6-month\r evaluation.\r\n\r An eGFR < 30 mL/min/1.73m2 of body surface area or acute kidney injury will be a\r contraindication to gadolinium contrast administration, and participants with insufficient\r kidney function immediately before the 6-month cardiac MRI will undergo an MRI without\r contrast-enhancement and will continue on-study.\r\n\r - Presence of a bicuspid aortic valve, which is associated with an intrinsic aortopathy\r that may affect arterial load in its own right;\r\n\r - Resting heart rate >120 beats per minute, systolic blood pressure >180 mm Hg, or\r diastolic blood pressure > 100 mm Hg\r\n\r - Pregnancy or intent to become pregnant\r\n\r - Conditions that would make the study measurements less accurate or unreliable (i.e.,\r frequent premature beats that may affecting cardiac gating, anatomic neck\r characteristics impeding arterial tonometry, inability to perform an adequate breath\r hold for cardiac MRI acquisitions) or the reliable post-operative follow-up of\r patients (for at least 6 months post-AVR) unlikely\r\n\r - Known peripheral vascular disease, which may limit the ability to exercise\r independently of cardiac status due to claudication\r\n\r - Unwillingness of the patient to undergo a cardiac MRI\r\n\r - Unwillingness of the patient to sign the consent form\r\n\r - Any condition limiting life expectancy to <1 year\n\nPatient 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
506	[ { "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 Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement\n\nClinical Trial Summary:\n\nTo evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of\r symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the\r risk of surgical aortic valve replacement has a predicted operative mortality or serious,\r irreversible morbidity risk of ≥50% at 30 days.\n\nClinical Trial Detailed Description:\n\nThe primary objective of the study is to evaluate the safety and effectiveness of the\r Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk\r Pivotal Trial population due to one or more additional co-morbidities, as measured by a\r composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic\r severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled\r in this study have a predicted operative mortality or serious, irreversible morbidity risk of\r ≥50% at 30 days associated with surgical aortic valve replacement.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Subject must have co-morbidities such that one cardiologist and two cardiac surgeons\r agree that medical factors preclude operation, based on a conclusion that the\r probability of death or serious morbidity exceeds the probability of meaningful\r improvement. Specifically, the predicted operative risk of death or serious,\r irreversible morbidity is ≥ 50% at 30 days.\r\n\r - Subjects must meet all of the criteria under at least one of the sub-groups 2a-c:\r\n\r a. Senile degenerative aortic valve stenosis and i. At least one of the following\r co-morbid conditions:\r\n\r 1. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography\r\n\r 2. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography\r\n\r 3. End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI\r CKD Classification) or creatinine clearance <20cc/min but not requiring renal\r replacement therapy\r\n\r AND\r\n\r ii. mean gradient > 40 mmHg or jet velocity greater than 4.0 m/sec by either\r resting or dobutamine stress echocardiogram (if the LVEF < 50%), or simultaneous\r pressure recordings at cardiac catheterization either resting or with dobutamine\r stress (if the LVEF < 50%) AND iii. an initial aortic valve area of ≤ 0.8 cm2 (or\r aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous\r pressure recordings at cardiac catheterization\r\n\r AND/OR\r\n\r b. Low gradient, low output aortic stenosis as defined by the presence of all\r three of the following i. In the presence of LVEF <50%, absence of contractile\r reserve, a mean gradient ≥25mmHg and <40mmHg AND jet velocity less than 4.0m/sec\r with dobutamine stress echocardiography or simultaneous pressure recordings at\r cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient ≥25mmHg\r and <40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or\r simultaneous pressure recordings at cardiac catheterization AND ii. an initial\r aortic valve area of ≤0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting\r echocardiogram or simultaneous pressure recordings at cardiac catheterization AND\r iii. radiographic evidence of severe aortic valve calcification AND/OR c. Failed\r bioprosthetic surgical aortic valve\r\n\r - Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York\r Heart Association (NYHA) Functional Class II or greater.\r\n\r - 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 IRB of the respective clinical site.\r\n\r - 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 Clinical\r\n\r - Evidence of an acute myocardial infarction ≤30 days before the MCS TAVI procedure.\r\n\r - Any percutaneous coronary or peripheral interventional procedure performed within 30\r days prior to the MCS TAVI procedure\r\n\r - Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet\r count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.\r\n\r - Untreated clinically significant coronary artery disease requiring revascularization.\r\n\r - Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or\r mechanical hemodynamic support.\r\n\r - Need for emergency surgery for any reason.\r\n\r - Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as\r measured by resting echocardiogram.\r\n\r - Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack\r (TIA).\r\n\r - Active Gastrointestinal (GI) bleeding that would preclude anticoagulation.\r\n\r - A known hypersensitivity or contraindication to all anticoagulation/antiplatelet\r regimens (including ability to be anticoagulated for the index procedure), nitinol, or\r [allergic] sensitivity to contrast media which cannot be adequately pre-medicated.\r\n\r - Ongoing sepsis, including active endocarditis.\r\n\r - Subject refuses a blood transfusion.\r\n\r - Life expectancy <12 months due to associated non-cardiac co-morbid conditions.\r\n\r - Other medical, social, or psychological conditions that in the opinion of an\r Investigator precludes the subject from appropriate consent.\r\n\r - Severe dementia (resulting in either inability to provide informed consent for the\r study/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits).\r\n\r - Currently participating in an investigational drug or another device study.\r\n\r - Symptomatic carotid or vertebral artery disease.\r\n\r Anatomical\r\n\r Subject has a:\r\n\r - Native aortic annulus size <18 mm or >29 mm per the baseline diagnostic imaging (not\r applicable for TAV in SAV subjects) OR\r\n\r - Surgical bioprosthetic annulus <17mm or >29mm i. Stented SAV per the manufactured\r labeled inner diameter OR ii. Stentless SAV per the baseline diagnostic imaging\r\n\r - Subject has a pre-existing prosthetic heart valve with a rigid support structure in\r either the mitral or pulmonic position:\r\n\r 1. that could affect the implantation or function of the study valve OR\r\n\r 2. the implantation of the study valve could affect the function of the pre-existing\r prosthetic heart valve\r\n\r - Moderate to severe mitral stenosis.\r\n\r - Mixed aortic valve disease: aortic stenosis and aortic regurgitation with predominant\r aortic regurgitation, (AR is moderate-severe to severe (≥3-4+))(except for failed\r surgical bioprothesis)\r\n\r - Hypertrophic obstructive cardiomyopathy.\r\n\r - Echocardiographic evidence of new or untreated intracardiac mass, thrombus or\r vegetation.\r\n\r - Severe basal septal hypertrophy with an outflow gradient.\r\n\r - Aortic root angulation (angle between plane of aortic valve annulus and horizontal\r plane/vertebrae) >70° (for femoral and left subclavian/axillary access) and >30° (for\r right subclavian/axillary access).\r\n\r - Ascending aorta that exceeds the maximum diameter for any given native or surgical\r bioprosthetic* aortic annulus size (see table below) Aortic Annulus Diameter/\r Ascending Aorta Diameter, 18 mm* - 20 mm/ >34 mm, 20 mm - 23 mm/ >40 mm, 23 mm - 27\r mm/ >43 mm, 27 mm - 29 mm/ >43 mm,\r\n\r * 17mm for surgical bioprosthetic aortic annulus\r\n\r - Congenital bicuspid or unicuspid valve verified by echocardiography (Not applicable\r for TAV in SAV subjects).\r\n\r - Sinus of valsalva anatomy that would prevent adequate coronary perfusion.\r\n\r - Degenerated surgical bioprothesis presents with a significant concomitant perivalvular\r leak (between prothesis and native annulus), is not securely fixed in the native\r annulus, or is not structurally intact (e.g. wireform frame fracture) (ONLY FOR TAV in\r SAV subjects)\r\n\r - Degenerated surgical bioprothesis presents with a partially detached leaflet that in\r the aortic position may obstruct a coronary ostium (ONLY FOR TAV in SAV subjects)\r\n\r Vascular\r\n\r - Transarterial access not able to accommodate an 18Fr sheath.\n\nPatient 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
507	[ { "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\nMetabolic Determinants of the Progression of Aortic Stenosis\n\nClinical Trial Summary:\n\nCalcific aortic stenosis (AS) has become the most common cardiac disease after coronary\r artery disease and hypertension. Unfortunately no medical therapies have been proven to\r decrease either the progression of valve stenosis or the resulting adverse effects on\r myocardial remodeling and function. In light of the studies performed in PROGRESSA, it\r becomes obvious that: i) AS is a complex and actively regulated process that involves the\r interaction of several pathways including lipid infiltration and retention, chronic\r inflammation, osteogenic activation, and active mineralization within the valvular tissues;\r ii) AS is not a disease strictly limited to the aortic valve but rather a systemic disease\r that often involves calcification and stiffening of the aorta and impairment of LV function\r as a consequence of pressure overload. Our findings suggest that the dysmetabolic milieu\r linked to visceral obesity may accelerate the deterioration of the structure and function not\r only of the aortic valve but also of the aorta and of the left ventricle. These findings open\r new avenues of research and provide strong impetus for the elaboration of prospective studies\r focusing on the \"valvulo-metabolic risk\" in AS.\r\n\r The general hypotheses are: The metabolic abnormalities linked to visceral obesity accelerate\r (1) the progression of valvular calcification and stenosis, aortic calcification and\r stiffness; (2) the progression of myocardial fibrosis and dysfunction.\r\n\r The general objectives of the study are to elucidate the mechanisms implicated in the\r pathogenesis of AS and to identify the metabolic factors that determine the progression of:\r i) aortic valve calcification and stenosis; ii) myocardial fibrosis and dysfunction; and iii)\r clinical outcomes.\r\n\r This study will contribute to identifying the key metabolic determinants of AS progression\r and will pave the way for the future development of non surgical therapies for this disease.\r The results of this study would provide strong support to the realization of randomized trial\r to test the efficacy of lifestyle modification program or new pharmacological treatment\r aiming at the reduction of visceral fat and associated metabolic abnormalities in the AS\r population. Furthermore, this study will contribute to the identification of novel blood and\r imaging biomarkers of faster disease progression, which will help to optimize risk\r stratification and timing of AVR in the AS population.\n\nClinical Trial Detailed Description:\n\nThe hypotheses are: (1) The metabolic abnormalities linked to visceral obesity increase: i)\r the progression of aortic valve calcification and stenosis, of aortic calcification and\r stiffness, and thereby of the global hemodynamic load imposed on the LV; ii) the progression\r of myocardial hypertrophy, fibrosis, and dysfunction, iii) the loss in bone mineral density,\r and iv) the occurrence of adverse events in patients with AS. (2) Specifically, insulin\r resistance, the small, dense LDL and HDL phenotypes, enhanced oxidative stress & inflammatory\r state, and activation of the RAS act synergistically to: i) promote infiltration, retention,\r and modification of lipids within the valvular and arterial tissues, ii) enhance the\r inflammatory and osteoblastic response to oxidized lipids, iii) activate apoptosis of VICs\r and apoptosis-mediated calcification of the aortic valve and aorta, iv) promote osteoclastic\r activity and demineralization within the bone tissues (calcification paradox) (Figs. 1&6).\r These mechanisms predominate in the middle-aged patients, whereas imbalance in nuclear\r coregulators, alteration of adipokine system, dysregulation of mineral metabolism, and loss\r calcification inhibitors are the main contributing mechanisms in the elderly (Figs. 1,5,6).\r The contribution of visceral obesity to disease progression is more important in the patients\r with mildly or moderately calcified valves than in those with heavily calcified valves. In\r the latter, further progression of calcification and stenosis is predominantly influenced\r dysregulation of mineral metabolism. (3) The alteration of the myocardial energetic\r substrates and of the protein synthesis/degradation balance associated with visceral obesity\r and insulin resistance amplify the development of myocardial hypertrophy and fibrosis in\r response to pressure overload and accelerates the progression to myocardial dysfunction\r (Figs. 7&8). The adverse LV remodelling and fibrosis resulting from the synergistic effects\r of pressure overload and dysmetabolism predispose to the occurrence of paradoxical low flow\r AS and cardiac events.\r\n\r The general objectives of the study are to elucidate the mechanisms implicated in the\r pathogenesis of AS and to identify the metabolic factors that determine the progression of:\r i) aortic valve calcification and stenosis; ii) aorta calcification and stiffness, iii)\r myocardial remodeling, fibrosis and dysfunction; and iv) clinical outcomes in the AS\r population.\r\n\r The specific aims of the study are:\r\n\r 1. To obtain and analyze: i) the metabolic profile, ii) the progression of aortic valve,\r aorta, and coronary artery calcification measured by CT, iii) the hemodynamic\r progression of valve stenosis by Doppler-echocardiography, iv) the progression of\r myocardial remodeling, fibrosis, and dysfunction by MRI, v) the change in bone mineral\r density by DXA, vi) the occurrence of clinical outcomes (AVR or death), and vii) the\r valvular tissues explanted at the time of AVR in a series of 280 patients with AS.\r\n\r 2. To perform histo-pathologic and genetic/protein expression analyses of valve tissues to\r document the lipid infiltration /retention/modification and the inflammatory and\r osteoblastic activities within the metabolic abnormalities, age, valve phenotype, and\r bone mineral density.\r\n\r 3. To study the relationship between the cardio-metabolic determinants: i) traditional\r cardiovascular risk factors (hypercholesterolemia, hypertension, smoking), ii) amount of\r visceral fat and metabolic abnormalities associated with visceral obesity and the\r outcome variables: i) progression of aortic valve calcification and stenosis, aorta\r calcification and stiffening, bone mineral loss, and myocardial remodelling, fibrosis\r and dysfunction, ii) occurrence of adverse outcomes, iii) lipid infiltration/ retention/\r modification, inflammatory/osteoblastic activities in the valve\r\n\r 4. To determine if the impact of these cardio-metabolic determinants on disease progression\r differ according to age, gender, BAV phenotype, and degree of aortic valve calcification\r at baseline.\r\n\r 5. To examine the relationship between aortic valve/aorta/coronary (i.e. ectopic)\r calcification and bone mineral density and determine the impact of cardio-metabolic and\r mineral metabolism factors on this relationship.\r\n\r 6. To examine the respective contribution of aortic valve calcification/stenosis, aorta\r calcification /stiffness, coronary calcification, bone density, and myocardial fibrosis\r to the occurrence of clinical outcomes in this AS cohort.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age >21 years\r\n\r - Presence of aortic stenosis defined as peak aortic jet velocity ≥2.5 m/s\r\n\r Exclusion Criteria:\r\n\r - Symptomatic aortic stenosis\r\n\r - Very severe aortic stenosis defined as an AVA≤0.6 cm2\r\n\r - Left ventricular ejection fraction < 50%\r\n\r - More than mild aortic or mitral regurgitation, or mitral stenosis\r\n\r - Atrial fibrillation or flutter\r\n\r - Pregnant or lactating women\r\n\r - Contraindications to gadolinium-enhanced MRI\n\nPatient 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
508	[ { "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\nContinuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy\n\nClinical Trial Summary:\n\nObjective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is\r contraindicated in certain patients. An alternative is continuous wound catheter analgesia.\r We will investigate whether ropivacaine, administered through a wound catheter placed by the\r surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult\r patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be\r randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75%\r ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or\r saline at the same scheme of administration. Patients will also benefit from\r patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min),\r paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary\r endpoints will be pain intensity on a visual analog scale at rest and on coughing and side\r effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the\r nurses and caring staff involved in this study will be blinded. Solutions of saline and\r ropivacaine will be prepared identically by the central pharmacy, without any possible\r identification of the product.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Patients scheduled for thoracotomy who presented with contraindications to TEA.\r\n\r Contraindications to TEA are :\r\n\r - Patient's refusal after informations about advantages and risks of the technique\r\n\r - Anti platelets treatment that can't be discontinued\r\n\r - Anticoagulants at a curative dosage\r\n\r - haemostasis and/or coagulation disorders: thrombopenia < 100.000/mm3, ACT > 1,5 /\r control, PTT < 75%\r\n\r - Systemic or local infection of the puncture point\r\n\r - 2 and 3 grade atrio-ventricular heart block without pacing\r\n\r - Severe aortic valve stenosis\r\n\r - Kyphoscoliosis\r\n\r - certain neurological disorders\r\n\r Exclusion Criteria:\r\n\r - Patient's refusal to participate in the study\r\n\r - Psychiatric disorder (impossibility to collect the informed consent)\r\n\r - Patient under juridical protection\r\n\r - On going an other study\r\n\r - Pregnancy, breastfeeding\r\n\r - Non balanced epilepsy\r\n\r - 3 grade auriculo-ventricular heart block without pacing\r\n\r - Severe hepatocellular insufficiency\r\n\r - Anti arrhythmic treatment : class III of the Vaughan William's classification\r\n\r - Skin infection of the puncture point\r\n\r - Allergy to aminoamides local anaesthetic\r\n\r - Surgical difficulties to insert paravertebral catheter\n\nPatient 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
509	[ { "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 Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve\n\nClinical Trial Summary:\n\nThe purpose of the clinical study is to prove that the heart valve device is safe, effective,\r and performs as intended.\n\nClinical Trial Detailed Description:\n\nThis is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be\r enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with\r the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the\r following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of\r five years.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Inclusion Criteria - Subjects will be required to meet all inclusion criteria:\r\n\r 1. Male or female, age 18 years or older\r\n\r 2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a\r planned replace-ment as indicated in the preoperative evaluation\r\n\r 3. Is scheduled to undergo planned aortic valve replacement with or without\r concomitant coronary bypass surgery\r\n\r 4. Provide written informed consent\r\n\r 5. Geographically stable and agrees to attend follow-up assessments until all\r subjects have completed 5 years of follow up\r\n\r Exclusion Criteria:\r\n\r - Exclusion Criteria - Subjects will not be eligible for trial participation if any of the\r following criteria are present:\r\n\r 1. Pure aortic insufficiency\r\n\r 2. Requires emergency surgery\r\n\r 3. Previous aortic valve replacement\r\n\r 4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a\r bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ\r\n\r 5. Requires multiple valve replacement/repair\r\n\r 6. Requires a surgical procedure outside of the cardiac area (e.g., vascular\r endarterectomy, vascular bypass, tumor removal)\r\n\r 7. Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention\r\n\r 8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to\r the scheduled AVR surgery\r\n\r 9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery\r\n\r 10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage\r renal disease requiring chronic dialysis\r\n\r 11. Hyperparathyroidism\r\n\r 12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack\r (TIA) within 6 months (180 days) of the procedure\r\n\r 13. Presence of non-cardiac disease limiting life expectancy to less than 12 months\r\n\r 14. Hypertrophic obstructive cardiomyopathy (HOCM)\r\n\r 15. Left ventricular ejection fraction ≤ 25%\r\n\r 16. Documented history of substance (drug or alcohol) abuse within the last 5 years\r\n\r 17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation\r\n\r 18. Hemodynamic or respiratory instability requiring inotropic support, mechanical\r circulatory support, or mechanical ventilation within 30 days prior to the procedure\r\n\r 19. Pregnancy, lactation, or planning to become pregnant;\r\n\r 20. Currently incarcerated or unable to give voluntary informed consent\r\n\r 21. Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or\r thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or\r coagulopathy\r\n\r 22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)\r\n\r 23. Current or recent participation (within 6 weeks prior to surgery) in an\r investigational drug or device trial\r\n\r - Intra-operative Exclusion Criteria\r\n\r 24. Anatomic variances which contraindicate implant of the trial valve, such as:\r\n\r 1. anomalous coronary arteries\r\n\r 2. annular deformation or extensive calcification of the annulus or aortic root\r which cannot be removed\r\n\r 3. significant calcium on the anterior mitral leaflet\r\n\r 4. pronounced septal calcification\r\n\r 5. position of coronary ostia relative to Model 8300ACD valve that would result in\r obstruction of blood flow\r\n\r 25. Available devices are not suitably sized for the subject's annulus\n\nPatient 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
510	[ { "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 Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS\n\nClinical Trial Summary:\n\nMarfan syndrome (MFS) is an inherited disorder of connective tissue with morbidity and\r mortality from aortic dilatation and dissection. The current standard of care is beta-blocker\r (BB) treatment and therapeutic target is heart rate. The degree of aortic dilatation and\r response to BB vary in adults with MFS. However, aortic stiffness is often present, and can\r be a predictor of aortic dilatation and cardiovascular complications. Aortic stiffness is a\r logical therapeutic target in adults with MFS.\r\n\r Transforming growth factor beta(TGF-beta) mediates disease pathogenesis in MFS and\r contributes to aortic stiffness. Cross-talk between TGF-beta system and renin-angiotensin\r system (RAS) has been demonstrated. The angiotensin receptor blocker (ARB), losartan,\r inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. In a\r small cohort study, the use of ARB therapy (losartan or irbesartan) significantly slowed the\r rate of progressive aortic dilatation in patients with MFS, after BB therapy had failed to\r prevent aortic root dilatation. In another study, angiotensin converting enzyme inhibitor,\r perindopril, reduced both aortic stiffness and aortic root diameter in patients with MFS\r taking standard BB therapy. Renin inhibitor, aliskiren, has not been studied to reduce aortic\r stiffness and attenuate aortic dilatation in patients with MFS.\r\n\r This trial is a randomized, open-label trial of 32 patients with Marfan syndrome, treated\r with 6 months of aliskiren vs. negative controls in patients with MFS under atenolol\r treatment. MRI for aortic pulsed wave velocity (PWV) and distensibility, measurements of\r central BP (CBP) and augmentation index (AIx) will be performed at the beginning and end of\r treatment. A blood drawn for serum markers of TGF-beta, extracellular matrix turnover and\r inflammation will also be performed at 0 and 6 months. We plan to determine whether aliskiren\r decreases aortic stiffness significantly more than negative controls in patients with MFS\r under atenolol treatment.\n\nClinical Trial Detailed Description:\n\nStudy design and study population The study design was a prospective randomized intervention\r study in a single center. A randomization process was performed to assign participants to\r either the aliskiren-treatment group or the negative control group in an open-label design.\r The duration of the study period was 24 weeks as the time frame for treatment. Duration of\r treatment was decided based on previous studies using RAS inhibitor 13,25. Aliskiren was\r administered to patients in the treatment group at an oral dose of 150-300 mg per day.\r Medication administration started after a baseline study with a dose of 150 mg of aliskiren,\r which was escalated to 300 mg of aliskiren at 4 weeks after evaluation of tolerability and\r the presence of adverse effects as angioedema, gastrointestinal symptoms, rash, gout,\r hypotension, and renal stones. The patients stopped taking aliskiren if serious adverse\r events such as angioedema or allergic reactions definitely related to the medication\r developed. Dose reduction was considered in cases with development of hyperkalemia, elevation\r of serum creatinine to twice baseline, symptomatic hypotension, gout, or renal stones. Dose\r reduction to 150 mg after escalation was performed on the decision of the investigators if\r the patient complained of discomfort and side effects that were probably related to the\r medication.\r\n\r MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All\r patients were receiving atenolol as standard β-blocker therapy. All patients gave written\r informed consent to participate in the study, which was approved by the Samsung Medical\r Center Ethics Committee. This trial is registered at ClinicalTrial.gov. (Identifier:\r NCT01715207) Inclusion criteria were age 14 to 55 years, a diagnosis of MFS by Ghent\r criteria, β-blocker treatment for at least 3 months, and no chronic RAS inhibitor therapy\r (i.e., angiotensin II receptor blockers or ACE inhibitors) for 90 days prior to screening.\r Exclusion criteria were previous medical history of aortic surgery and/or dissection,\r significant valve disease requiring surgery, aortic root dimension > 5.0 cm, renal\r dysfunction (creatinine > upper normal limit), pregnancy or planned pregnancy within 12\r months of study entry or current breast feeding, known renal artery stenosis,\r hypersensitivity to aliskiren or any of the excipients, elevation of serum creatinine during\r follow-up (> 30% of baseline), diarrhea resulting in severe dehydration, development of gout\r or ureter stone, symptomatic hypotension (systolic blood pressure <90 mmHg with symptoms),\r hyperkalemia, and concomitant treatment with cyclosporin A.\r\n\r Follow-up and outcomes All included patients were clinically followed to monitor adverse\r effects of angioedema, gastrointestinal symptoms, rash, gout, hypotension, and renal stone at\r initial examination, 1 week, 4 weeks, 8 weeks, 16 weeks, and 24 weeks. The following\r laboratory data were collected during the same period: potassium, electrocardiogram,\r creatinine, uric acid, and urine analysis. Echocardiographic evaluation, peripheral\r tonometric measurements of peripheral PWV, central aortic blood pressure and augmentation\r index, cardiac magnetic resonance imaging (cardiac MRI), and biomarkers were analyzed at\r baseline and after 24 weeks of treatment.\r\n\r Safety information was collected, including all adverse events and all serious adverse\r events. Completion of a serious adverse event form was required for all serious adverse\r events that occurred during the study period. All serious adverse events were assessed by\r investigators and reported to the Novartis safety desk within 24 hours.\r\n\r The primary end point was central aortic distensibility by cardiac MRI at 24 weeks, reported\r as the change over the 24-week period after randomization. The secondary end points were\r central aortic PWV by cardiac MRI, change in central aortic blood pressure (hereafter, aortic\r BP), augmentation index, peripheral PWV by tonometry, aortic root diameter by\r echocardiography, severity of aortic regurgitation by echocardiography, and\r dissection/rupture/operation of aneurysm.\r\n\r Cardiovascular imaging - echocardiography and cardiac MRI Cardiac MRI Cardiac MRI was\r performed using a 1.5-Tesla scanner (Magnetom Avanto, Syngo MR; Siemens Medical Solutions,\r Erlangen, Germany). Aortic diameters were measured at four landmark levels: level 1, the\r ascending aorta at the level of bifurcation of the pulmonary artery; level 2, the upper\r descending thoracic aorta at the level of bifurcation of the pulmonary artery; level 3, the\r lower descending thoracic aorta at the level of the diaphragm; level 4, the abdominal aorta\r just above the iliac bifurcation. Cine imaging was also performed at the same levels to\r measure aortic stiffness.\r\n\r Cardiac MRI analysis - central aortic distensibility and central aortic PWV Analyses of the\r MRIs were performed using commercial software (Argus version 4.02, Siemens Medical Systems,\r Germany) by experienced observers who were blinded to patient information. To measure central\r aortic distensibility, the systolic and diastolic cross-sectional areas were measured by\r manual contouring of the aorta through the cardiac cycle on the cine image. Distensibility at\r the four regions was calculated as the mean of values obtained from the following equation:\r Distensibility = (Amax - Amin)/[Amin × (Pmax - Pmin)](10-3mm/Hg), where Amax is the maximal\r (systolic) aortic area, Amin is the minimal (diastolic) aortic area, Pmax is the systolic\r blood pressure (SBP), and Pmin is the diastolic blood pressure (DBP). Central aortic blood\r pressure measured non-invasively by SphygmoCor was used for systolic and diastolic blood\r pressure.\r\n\r Aortic PWV was measured according to the well-validated method using MRI 19. From the\r velocity-encoded MRIs, aortic contours were automatically detected and manually adjusted in\r each slice area throughout the cardiac cycle. The transit time between the flow curves of\r each region of the aorta was determined from the midpoint of the systolic up-slope on the\r flow versus time curve 26-28. The up-slopes were identified by drawing a line between the\r points of 40% and 60% maximum velocity on the waveform. The distance between each aortic\r level was measured on black blood images using a curved line along the center of the aorta.\r Based on these data, the regional PWV was calculated as the ratio of the distance between\r levels and the time differences between the arrival of the pulse wave at each level. The PWV\r was measured at two regions: the proximal aorta (proximal PWV between level 1 and level 2)\r and the entire aorta (PWV-total between level 1 and level 4).\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Diagnosis of MFS by Ghent criteria and/or genetically proven Fibrillin-1 (FBN1)\r mutation\r\n\r 2. Age between 14 and 55 years\r\n\r 3. Beta-blocker treatment at least 3 months\r\n\r 4. subjects must not have been receiving chronic RAS inhibitor therapy (i.e. ARBs, or ACE\r inhibitors)>= 90days prior to screening\r\n\r 5. Written informed consent from the patients or authorized representatives must be\r obtained\r\n\r Exclusion Criteria:\r\n\r 1. previous medical history of aortic surgery and/or dissection\r\n\r 2. significant valve disease requiring surgery\r\n\r 3. aortic root dimension > 5.5 cm\r\n\r 4. renal dysfunction (creatinine > upper normal limit)\r\n\r 5. pregnancy or planned pregnancy within 12 months of study entry or breast feeding women\r\n\r 6. Known renal artery stenosis\r\n\r 7. Hypersensitivity to the aliskiren or to any of the excipients\r\n\r 8. Elevation of serum creatinine during follow-up (> 30% than baseline)\r\n\r 9. Diarrhea, resulting severe dehydration\r\n\r 10. Development of gout or ureter stone\r\n\r 11. Symptomatic hypotension (SBP<90 with symptom)\r\n\r 12. Hyperkalemia\r\n\r 13. Concomitant use with ciclosporin A\n\nPatient 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
511	[ { "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\nEnable® Aortic Sutureless Bioprosthesis Evaluation\n\nClinical Trial Summary:\n\nThe EASE Enable study is intended to collect additional data on the clinical outcomes of the\r Medtronic Enable® Aortic Bioprosthesis in \"real world\" patients.\n\nClinical Trial Detailed Description:\n\nThe EASE Enable study is intended to characterize the clinical performance of the Medtronic\r Enable® aortic bioprosthesis in a post-market real-world setting.\r\n\r This is a Non-randomized, prospective, non-interventional multi-center post-market release\r (PMR) study. Up to 800 subjects will be enrolled at up to 40 centers in Europe. After aortic\r valve replacement with the Enable® aortic bioprosthesis, each patient will have routine\r follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant\r or prior to hospital discharge, whatever comes first), within 6 months following\r implantation, 1 year and annually thereafter up to 5 years post-implant.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the\r two.\r\n\r - Patient requires replacement of his/her native aortic valve with a bioprosthesis with\r or without concomitant procedures.\r\n\r - Patient is above the minimum age as required by local regulations to be participating\r in a clinical study.\r\n\r - Patient is willing to return to the implant site for follow-up visits.\r\n\r - Patient has been adequately informed of this clinical study and is willing to sign the\r patient Data Release Form.\r\n\r Exclusion Criteria:\r\n\r - Patient requires replacement of two or more valves.\r\n\r - Patient who underwent previous aortic valve replacement (AVR).\r\n\r - Patient with native bicuspid aortic valve.\r\n\r - Patient with active endocarditis or other systemic infection.\r\n\r - Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or\r ascending aorta geometry as seen via preoperative imaging.\n\nPatient 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
512	[ { "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\nFetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome\n\nClinical Trial Summary:\n\nFor fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve\r fetal growth of left heart structures and thus improve potential for biventricular repair\r strategies after birth.\n\nClinical Trial Detailed Description:\n\nFetal aortic stenosis is an anatomically simple birth defect in which there is partial\r blockage of the aortic valve, limiting blood flow out of the left side of the heart. If the\r blockage becomes severe in fetal life, the left heart structures may stop growing and the\r baby may be born with hypoplastic left heart syndrome (HLHS), a lethal condition without\r neonatal heart surgery or heart transplantation. Standard treatment for babies born with HLHS\r includes three major cardiac operations before the age of 6 years. Postnatal outcomes for\r HLHS are uncertain and vary with patient; however, the few adult survivors are currently\r suffering substantial medical problems, including a high incidence of neurologic problems.\r For fetuses with severe obstruction, fetal intervention may improve outcomes by increasing\r flow through the left heart, thus improving left heart function and encouraging continued\r growth of the left heart structures. If fetal intervention can preserve left heart function\r and growth, this should provide a better prognosis for the baby and allow for biventricular\r repair strategies after birth.\r\n\r This research study is a prospective, non-randomized clinical trial of 30 patients that will\r assess the safety and efficacy of in utero percutaneous balloon dilation of fetal aortic\r valve with severe stenosis. This technique has been successfully used to perform postnatal\r aortic valve dilations for several decades, but has had limited application and study in\r utero.\r\n\r Pregnant women carrying a fetus diagnosed with severe aortic stenosis will be referred to the\r University of California, San Francisco Fetal Treatment Center for evaluation, initial\r screening and counseling. If all fetal and maternal inclusion criteria are met, the balloon\r aortic valvuloplasty operation will be offered to the pregnant woman. Patients who do not\r meet study eligibility or decline prenatal intervention will be offered the option to enroll\r as a study control.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Pregnant woman carrying a fetus with normal cardiac segmental anatomy and severe\r aortic stenosis as defined by:\r\n\r - Dysplastic/stenotic aortic valve with forward flow, with or without gradient, and\r no significant insufficiency\r\n\r - If mitral insufficiency (incomplete closure of the mitral valve)is present, left\r ventricle systolic pressure calculation must be ≥ a normal systemic blood\r pressure (BP) for gestational age\r\n\r - Retrograde aortic arch flow\r\n\r - Left to right atrial shunting\r\n\r - Left ventricle length no less than 90% the length of the right ventricle\r\n\r - Maternal age ≥ 16 years of age;\r\n\r - Gestational age: 17 0/7-30 6/7 weeks' gestation as determined by clinical information\r and evaluation of first ultrasound. (Aortic valve dilation procedure cannot be\r performed until 18 0/7 weeks);\r\n\r - Normal karyotype with written confirmation of results. Results by fluorescence in situ\r hybridization (FISH) for aneuploidy will be acceptable if the patient is at 24 weeks\r or more; non-invasive testing is acceptable (maternal serum testing for cell-free\r fetal DNA, currently commercially available).\r\n\r - Singleton pregnancy;\r\n\r - Able to travel to study site for study evaluation, procedures, and visits;\r\n\r - Support person to travel and stay with patient (support person will be required to\r sign the support person consent form);\r\n\r - Has received pre-authorization for insurance for fetal intervention or has the ability\r to self-pay for study treatment\r\n\r Exclusion Criteria:\r\n\r - Failure to meet all inclusion criteria;\r\n\r - Multi-fetal pregnancy;\r\n\r - Insulin dependent pregestational diabetes;\r\n\r - Fetal anomaly not related to aortic stenosis. A detailed fetal anatomic ultrasound\r will be conducted before consideration for the study and if the finding is abnormal,\r the patient will be excluded;\r\n\r - Current or planned cerclage or documented history of incompetent cervix;\r\n\r - Placenta previa or placental abruption;\r\n\r - Short cervix (< 20mm) measured by cervical ultrasound;\r\n\r - Previous spontaneous delivery prior to 37 weeks of a singleton pregnancy. If the study\r candidate had intact membranes and was induced, this is not considered spontaneous.\r Stillbirths prior to 37 weeks are not exclusionary.\r\n\r - Obesity as defined by body mass index of 35 or greater;\r\n\r - Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal\r alloimmune thrombocytopenia;\r\n\r - Positive maternal HIV status. This is due to the increased risk of transmission to the\r fetus during the maternal-fetal procedure. If the patient's HIV status is unknown, the\r patient must be tested and found to have negative results before she can be entered\r into the fetal treatment group;\r\n\r - Known Hepatitis C positivity. If the patient's Hepatitis C status is unknown, she does\r not need to be screened;\r\n\r - Other maternal medical condition which is a contraindication to surgery or general\r anesthesia, such as asthma, cardiac disease, the refusal of a blood transfusion, or a\r previous hysterotomy in the active segment of the uterus;\r\n\r - Patient does not have a support person (e.g., husband, partner, mother), or that\r support person is unwilling to sign the support person consent form;\r\n\r - Inability to comply with the travel and follow-up requirements of the study;\r\n\r - Patient does not meet other psychosocial criteria to handle the implications of the\r study;\r\n\r - Participation in another intervention study that influences maternal and fetal\r morbidity and mortality;\r\n\r - Maternal hypertension which would increase the risk of preeclampsia or preterm\r delivery (including, but not limited to: uncontrolled hypertension, chronic\r hypertension with end organ damage and new onset hypertension in current pregnancy).\n\nPatient 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
513	[ { "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 (BAV) Registry\n\nClinical Trial Summary:\n\nThe purpose of this registry is to gather information on patients with bicuspid aortic valve\r disease.\n\nClinical Trial Detailed Description:\n\nThe purpose of this registry is to gather information on patients with bicuspid aortic valve\r disease. The data collected in the registry will be used to assess patterns of aortic\r dilation, responses to medical therapy based on serial imaging and to assess for potential\r genetic markers of this disease\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Any patient over the age of 18 who is able/willing to give informed consent with the\r diagnosis of bicuspid aortic valve disease, a family history of this disease or an\r ascending aortic aneurysm that is idiopathic can be included in the registry.\r\n\r Exclusion Criteria:\r\n\r - Patients unable or unwilling to give informed consent.\n\nPatient 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
514	[ { "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\nAortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome\n\nClinical Trial Summary:\n\nThe study aim is:\r\n\r 1. To examine aortic tissue by light microscopy\r\n\r 2. To examine aortic tissue by electron microscopy\r\n\r 3. To study changes in the epigenome and transcriptome of the X chromosome specific to\r aortic tissue.\r\n\r 4. To examine aortic tissue using biochemistry including proteomics.\r\n\r 5. To establish the karyotype of fibroblasts with standard chromosome examination on 10\r meta-phases as well as by fluorescent in situ hybridization (FISH) with probes covering\r the X and Y chromosome. Using the latter 200 meta-phases will be examined.\r\n\r 30 controls who did not die from aortic dissection or dilation will be recruited from The\r Department of Forensic Medicine at Aarhus University Hospital.\r\n\r The investigators will subject samples of aortic tissue from women undergoing prophylactic\r aortic surgery due to either Marfan syndrome or bicuspid aortic valve to the same panel of\r examinations (except karyotyping). Lastly the investigators will compare the results from the\r three groups (Turner syndrome, Marfan syndrome and Bicuspid aortic valve).\n\nClinical Trial Detailed Description:\n\nTurner syndrome is a congenital complete or partial lack of one of the female sex chromosomes\r affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence\r of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and\r autoimmune diseases in general.\n\nClinical Trial Eligibility Criteria:\n\nTurner syndrome (TS).\r\n\r A. Inclusion\r\n\r - TS verified by genotyping\r\n\r - Age > 18 years\r\n\r - Awaiting operation due to aortic dilation\r\n\r B. Exclusion - Previous aortic dissection or operation of the aorta (per-cutaneous or open\r surgery)\r\n\r Marfan syndrome (MS)\r\n\r A. Inclusion\r\n\r - Females with MS verified clinically or by genotyping\r\n\r - Age > 18 years\r\n\r - Awaiting operation due to aortic dilation\r\n\r B. Exclusion\r\n\r - Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery)\r\n\r Bicuspid aortic valve\r\n\r A. Inclusion\r\n\r - Females with Bicuspid aortic valve\r\n\r - Age > 18 years\r\n\r - Awaiting operation due to aortic dilation\r\n\r B. Exclusion - Previous aortic dissection or operation of the aorta (per-cutaneous or open\r surgery)\r\n\r Controls\r\n\r A. Inclusion\r\n\r - Men/females who died from conditions other than aortic dilation or dissection.\r\n\r - Age 20-60 years.\r\n\r B. Exclusion\r\n\r - Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery)\n\nPatient 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
515	[ { "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 Comparison of Advanced Imaging Techniques in Aortic Stenosis\n\nClinical Trial Summary:\n\nIn patients with aortic stenosis the valve through which blood is pumped out of the main\r heart chamber is narrowed. This results in heart muscle working harder to open the valve so\r blood can circulate around the body. The muscle adapts to the increased pressure load to\r maintain efficiency. This can cause long-term muscle damage. To predict when this\r deterioration will require a valve replacement is difficult and untimely operation exposes\r patients to unnecessary risk.\r\n\r We aim to compare all validated techniques looking at different aspects of heart muscle\r strain in these patients. These will be a blood sample measuring a specific hormone (BNP) and\r enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying scarring and\r an exercise echocardiogram that measures heart muscle response and pressure changes across\r the valve. Tests will be performed at recruitment and either after one year or after valve\r replacement, which ever comes first.\r\n\r In comparing these different imaging techniques we aim to identify patients who will benefit\r from an early operation, those whose muscle is likely to recover back to normal and which\r patients it is safe to wait longer for the surgery, avoiding unnecessary risk.\r\n\r The results of the study will benefit patients as it will help doctors more accurately assess\r the timing of valve surgery and improve their prediction of long term heart muscle recovery.\r It may also increase convenience in clinical management by reducing unnecessary tests and\r hospital trips. This would translate into cost savings for the NHS.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r (Group A)\r\n\r - Asymptomatic patients with moderate to severe Aortic Stenosis\r\n\r - Ejection fraction greater than 50%\r\n\r - Not yet being considered for valve surgery\r\n\r (Group B)\r\n\r - Severe Aortic Stenosis (as per ESC guidelines)\r\n\r - Listed for immediate aortic valve replacement\r\n\r Exclusion Criteria: (Group A and B)\r\n\r - Inability to provide informed consent\r\n\r - Concurrent primary valve lesions greater than mild (as defined by ESC criteria)\r\n\r - Previous myocardial infarction (regional wall motion abnormality on resting echo)\r\n\r - Cardiomyopathy\r\n\r - Congenital heart disease\r\n\r - Previous cardiac surgery\r\n\r - Renal failure (CKD stage 3, eGFR >30ml/min/1.73m2)\r\n\r - Pregnancy, risk of pregnancy, breast feeding\n\nPatient 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
516	[ { "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 of Aortic Valve Bioprostheses Established by Catheter\n\nClinical Trial Summary:\n\nRegister multicenter, prospective, open, non-randomized implantation of percutaneous aortic\r bioprostheses through for the treatment of severe degenerative aortic stenosis\r Epidemiological data and the 1-year survival of aortic bioprostheses implanted by\r percutaneous.\n\nClinical Trial Detailed Description:\n\nAortic valve stenosis is a serious chronic life-threatening in the short or medium term since\r the onset of functional symptoms. Aortic valve replacement surgery is currently the treatment\r of choice. It is done by surgery with sternotomy and extracorporeal circulation. However,\r despite the considerable improvement of the conditions of care per and post operative, this\r procedure is sometimes burdened with high mortality, especially in the population with severe\r co-morbidities and / or many. For this reason, some patients are considered against the\r indicated surgery or high surgical risk.\r\n\r The recent development of aortic valve bioprostheses implanted with new approaches (pressure\r or transapical) can be considered for aortic valve replacement in a population that was\r previously excluded.\r\n\r Based on very thorough evaluation of these valves test benches and animal as well as human\r settlements achieved through multiple studies and registries mono or multi patients\r challenged by cardiac surgeons or considered at high surgical risk, it is clear that the\r implementation of these valves could allow, under conditions of optimal implementation and\r monitoring, improve short-and long-term clinical status, quality of life and prognosis of\r patients.\r\n\r FRANCE 2 registry, established in 2010, and whose inclusions ended 30 June 2012 has allowed\r an initial assessment of aortic valve bioprostheses implanted catheter The following registry\r France 2 has been requested by the highest authorities of health, FRANCE register TAVI is\r performed in continuity FRANCE 2. It takes account of the first data FRANCE 2. Data Report\r Form has been reduced, no new item has been added, it will be carried out in all centers\r authorized in France to implement this technique. The collection of data will TAVI France\r under the same conditions as those FRANCE 2, the database will be managed by the French\r Society of Cardiology\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. - Existence of senile degenerative aortic stenosis with a transvalvular gradient by>\r 40 mmHg and / or maximum velocity> 4 m / sec and / or initial valve area <1 cm ²\r (indexed <0.6 cm ² / m²). The initial measurement of valve area must be obtained\r within 30 days prior to valve implantation\r\n\r 2. - Presence of symptoms related to aortic stenosis (dyspnea, angina, syncope effort\r ...) demonstrated by Functional Classification for Congestive Heart Failure functional\r class> 2 or Class I, but with left ventricular dysfunction (ejection fraction <40% )\r\n\r 3. - A Score to \"EuroSCORE\" (Logistic European system for cardiac operative risk\r evaluation) > 20% and / or Society of Thoracic Surgeons' risk Calculator> 10. In case\r the \"EuroSCORE\" <20% or STS <10, confirmed that some comorbidities were not captured\r by these indices will be produced by the surgeon and cardiologist\r\n\r Some patients are in a situation against medical-cardiac surgery indicates heavy\r although this does not appear in the predictive risk assessment through the scores. In\r this regard, patients may be included in the following conditions:\r\n\r 3-1 - ascending aorta very calcified (\"porcelain\") 3-2 - Any other condition\r preventing cannulation for cardiopulmonary bypass, aortic clamping, or access\r mediastinal surgery: History of 3-2-1 against mediastinal irradiation indicating\r open-chest 3-2-2 thoracic deformity or history of mediastinitis-cons indicating the\r opening of the thorax 3-2-3 Other (eg, history of coronary bypass surgery may indicate\r against the opening of the thorax)\r\n\r 4. - The patient accepts the scheduled evaluations at follow-up clinic\r\n\r 5. - The patient or his legal representatives were informed of the nature of valve\r implantation and associated register and accept the conditions.\r\n\r Exclusion Criteria:\r\n\r - none\n\nPatient 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
517	[ { "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\nAlternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis\n\nClinical Trial Summary:\n\nInvestigational study of Edwards Lifesciences, LLC's \"Edwards SAPIEN Transcatheter Heart\r Valve\" for non-femoral delivery, (or alternative access deliver) in patients with severe\r symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be\r inoperable for open aortic valve replacement and in whom existing co-morbidities would not\r preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed\r in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN\r device compare to inoperable patients undergoing alternative access TAVR with the Edwards\r SAPIEN device experience a reasonably similar incidence of 30 day adverse events?\n\nClinical Trial Detailed Description:\n\nTranscatheter aortic valve replacement (TAVR) using the Edwards SAPIEN valve and Retroflex 3\r delivery system provides both a mortality and quality of life benefit for inoperable\r patients. Only the transfemoral (TF) access has been approved in the US. A substantial number\r of patients cannot have a TF approach due to inadequate vessel size, vessel disease, or other\r anatomical considerations. The pivotal study did not include an assessment of safety and\r effectiveness of alternative access approaches in this inoperable patient group.\r\n\r Early approaches to TAVR included a femoral transvenous approach with transseptal access to\r the left side for delivery of the valve. This approach avoided large bore arterial\r catheterization, but it had unacceptable rates of complications and lacked reproducibility.\r Alternative access approaches have been developed because of the risks associated with\r inserting large caliber catheters into small, diseased femoral arteries often associated with\r diffuse vasculopathy. To avoid the vascular complications from femoral access, other\r transcatheter approaches have been developed to include open surgical access to the left\r ventricular apex (TA), ascending aorta, (TAO), subclavian and axillary arteries (TS), and\r retroperitoneal access to the iliac artery (TI) as well as distal aorta. In addition to\r providing TAVR to patients who cannot have TF access, additional advantages include better\r catheter control and safer closure of the access site. Commonly cited disadvantages include\r the need for surgical expertise and additional equipment, along with the potential for longer\r recovery, more incisional pain, greater radiation exposure for operators, unsuitable delivery\r catheters for alternative access sites, and a host of unique alternative access site\r complications.\r\n\r We propose to collectively analyze 30-day safety endpoints as a lumped data group for these\r alternative access approaches. These data are gathered from clinical practice in real-world\r settings and submitted to the TVT Registry. It is expected that centers will choose among the\r various choices for alternative access based the causative factors underlying the need for\r alternative access, as well as local skill sets and experience. For this lumped data group of\r alternative access approaches we will compare 30-day safety results to the TA outcomes\r reported from Cohort A of the PARTNERS 1 trial. We recognize that these TA patients were high\r risk operable patients rather than inoperable patients, but no other direct comparator group\r is available. We reason that the TA data from this published clinical trial are high quality,\r represent an alternative access approach rather than TF, and will provide a frequency of\r safety endpoints that have been found to be acceptable both clinically and from a regulatory\r perspective.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - 18 years or older\r\n\r - Primary indication is symptomatic primary severe aortic stenosis predicted to benefit\r from relief of valvular stenosis\r\n\r - Aortic valve area less than 0.8 centimeters squared\r\n\r - Mean aortic valve gradient greater than or equal to 40 mmHG\r\n\r - Peak aortic jet velocity greater than or equal to 4.0 m per second\r\n\r - Valve sheath access site is femoral, axillary, transapical, transaortic, subclavian or\r subaxillary\r\n\r - Patient is judged by the local heart team to be inoperable for Aortic Valve\r Replacement due to severe chest wall deformities or radiation effects, severe\r peripheral or aortic vascular disease, or severe systemic disease prohibiting the safe\r conduct of Cardiopulmonary Bypass (CPB)\r\n\r Exclusion Criteria:\r\n\r - Aortic valve annulus size is less than 18 mm or greater than 25 mm\r\n\r - Active infectious endocarditis\r\n\r - Valve in prosthetic valve procedure\r\n\r - Patients considered by the heart team to be unlikely to receive meaningful or durable\r clinical benefit from the procedure\n\nPatient 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
518	[ { "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\nGenetic Risks for Bicuspid Aortic Valve Disease\n\nClinical Trial Summary:\n\nBicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but\r very little is known about the genetic causes or risk factors for adverse outcomes.\r Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years\r old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the\r ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to\r use individual genetic information to identify persons with BAV who are at high risk for\r complications and to customize therapies.\n\nClinical Trial Detailed Description:\n\nTo be included in the study, patients must have a bicuspid or unicuspid aortic valve,\r documented by clinical history or imaging studies. If the aortic valve was replaced\r surgically, they may still be eligible. Participants will be asked to donate a single tube of\r blood and fill out a questionnaire. Patients will also be followed up by telephone or email\r about once a year to determine if they experience any medical complications related to\r Bicuspid Aortic Valve (BAV), such as aortic aneurysms, aortic dissections or valve disease.\r Patients may not be included if they are less than 18 years old at the time of recruitment or\r have a recognized genetic syndrome or genetic mutation such as Marfan or Ehlers-Danlos\r syndrome.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - At least 18 years of age\r\n\r - Diagnosis of bicuspid or unicuspid aortic valve\r\n\r Exclusion Criteria:\r\n\r - Less than 18 years of age\r\n\r - Recognized syndrome or identified genetic mutation\n\nPatient 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
519	[ { "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\nAngiogenesis and Fibrosis in Aortic Stenosis\n\nClinical Trial Summary:\n\nAngiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible\r for cardiovascular disease. In this proposal, the investigators intend to build upon a highly\r successful programme of studies exploring the cardiovascular applications of positron\r emission tomography. Specifically, the investigators will explore the potential role of a\r novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and αvβ5\r integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and\r remodelling. This tracer has been successfully used to assess angiogenesis in metastatic\r tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here\r propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases,\r specifically aortic stenosis and aortic atherosclerosis. The investigators will correlate\r 18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis as well as ex vivo\r histological characterisation of tissue. If successful, this novel radiotracer could provide\r an extremely important non-invasive method of assessing in vivo angiogenesis, plaque\r vulnerability, and tissue remodelling as well as potential applications in developing stem\r cell therapies.\n\nClinical Trial Detailed Description:\n\nIntegrins\r\n\r Integrins are a group of molecules responsible for intercellular adhesion and signalling.\r They comprise a superfamily of heterodimeric receptors that are composed of 18 different α\r and β subunits. In combination, they can generate 24 different receptor subtypes with a range\r of physiological and pathophysiological functions. The αvβ3 receptor is an integrin that is\r found at low levels on mature endothelial cells but is markedly up regulated on endothelial\r cells of actively growing blood vessels. It was previously known as the vitronectin receptor\r although it was subsequently found to bind many other ligands including fibrinogen,\r fibronectin, laminin, thrombospondin, von Willebrand factor, and certain collagen subtypes.\r These features are also seen with the αvβ5 integrin receptor, with both receptors recognising\r the arginine-glycine-aspartate (RGD) motif present on these ligands.\r\n\r 1.1.2 Role of αvβ3 and αvβ5 Integrins in Cardiovascular Disease\r\n\r The expression of αvβ3 and αvβ5 receptors is up regulated in a number of diseased states and\r this has been particularly well characterised in the angiogenesis associated with tumour\r growth and metastases. However, there are many potential roles for this integrin pathway in\r cardiovascular disease including myocardial infarction, atherosclerosis, restenosis, aortic\r stenosis and aneurysm disease that have been relatively unexplored.\r\n\r 1.1.2.1 Aortic Stenosis\r\n\r Aortic stenosis is characterized by extensive valvular thickening due to accumulation of\r fibrous tissue and remodeling of the extracellular matrix. In all three layers of the valve,\r abundant fibroblast-like cells are found and are commonly referred to as valvular\r interstitial cells. A sub-population of these cells become activated by the inflammatory\r activity within the valve and differentiate into myofibroblasts. Whilst fibroblasts control\r the synthesis of collagen in the normal valve, myofibroblasts are responsible for the\r accelerated fibrosis observed within stenotic valves. In addition, matrix metalloproteinases\r are secreted by myofibroblasts and inflammatory cells, and have an important and complex role\r in the restructuring of the valve leaflet matrix. As already indicated, activation and\r differentiation of fibroblasts into myofibroblasts are dependent on αvβ3 and αvβ5 receptor\r expression. In addition, mirroring the situation in carotid atherosclerosis, patients with\r severe aortic stenosis have a high incidence (78%) of intraleaflet haemorrhage and this is\r associated with angiogenesis and more rapid disease progression.\r\n\r Histopathological studies have confirmed fibrosis to be an integral part of the left\r ventricular hypertrophic process in aortic stenosis. Myofibroblasts infiltrate the myocardium\r and secrete extracellular matrix proteins including collagen types I and III. Areas of\r fibrosis are observed to co-localize with areas of myocyte apoptosis and it has been\r suggested that fibrosis occurs as a form of scarring after myocyte death and injury. As with\r fibrosis in the valve, the renin-angiotensin system, transforming growth factor-beta and an\r imbalance in matrix metalloproteinase and their tissue inhibitor activity have all been\r implicated in this process. A mid-wall pattern of fibrosis has been observed in the\r myocardium of up to 38% of patients with moderate or severe aortic stenosis and has been\r associated with a more advanced hypertrophic response. Importantly, there is also an 8-fold\r increase in mortality associated with mid-wall fibrosis.\r\n\r 1.1.2.2 Atherosclerosis and Restenosis\r\n\r The development of atherosclerosis is due to a complex interplay of oxidised lipid,\r inflammatory cell infiltration, and smooth muscle cell migration in the arterial wall. Once\r established, atherosclerotic plaques may progress and rupture leading to the clinical\r presentations of acute myocardial infarction and stroke. Features associated with plaque\r rupture include a thin fibrous cap, lipid-rich pool and intraplaque haemorrhage. Indeed,\r plaque rupture is particularly associated with plaque neovascularisation and\r vascular-endothelial growth factor expression suggesting that instability may be induced by\r angiogenesis. Thus, up regulation of αvβ3 and αvβ5 receptors may represent a novel marker of,\r and potential therapeutic target for, plaque vulnerability.\r\n\r 1.1.3 Fluciclatide\r\n\r Fluciclatide is a RGD-containing cyclic peptide that has recently been developed as an\r 18F-radiotracer to detect tumour angiogenesis by positron emission tomography. It is highly\r selective for the αvβ3 and αvβ5 receptors with affinities (EC50) of 11.1 and 0.1 nM\r respectively with minimal cross reactivity with the αIIbβ3 receptor (EC50 281 nM).\r Pre-clinical tumour work has demonstrated that 18F-fluciclatide is taken up by glioblastomas\r and that this is suppressed by the anti-angiogenic tyrosine kinase inhibitor, sunitinib,\r confirming the specificity of fluciclatide for areas of angiogenesis. It has been assessed in\r phase I clinical trials and found to be safe and well tolerated.\r\n\r 1.1.4 Aims\r\n\r To date, there have been many preclinical studies examining the application of radiotracers\r targeting the αvβ3 and αvβ5 integrin receptors. The clinical application of these tracers has\r been largely limited to oncology as a method of assessing angiogenesis within tumours. Here\r we wish to explore the role of the αvβ3 and αvβ5 receptor radiotracer, 18F-fluciclatide, to\r assess angiogenesis and fibrosis in patients with aortic stenosis as a measure of both\r valvular and myocardial fibrosis. This patient group will have co-existent aortic atheroma\r and this will provide us with an opportunistic assessment of tracer uptake in\r atherosclerosis. We feel it is important to assess a range of cardiovascular conditions to\r determine whether αvβ3 and αvβ5 integrin receptor expression is particular to certain disease\r processes. If successful, these preliminary data will permit the more detailed exploration of\r specific disease areas and novel therapeutic interventions. At present, fluciclatide is not\r licensed or approved for clinical use and is being used here as an Investigational Agent to\r explore the pathophysiology of aortic stenosis.\r\n\r 1.2 ORIGINAL HYPOTHESES\r\n\r We hypothesise that 18F-fluciclatide can identify the expression of the αvβ3 and αvβ5\r integrin receptors in vivo in man in two major cardiovascular disease areas: aortic\r atherosclerosis and aortic stenosis. Specifically, we hypothesise that 18F-fluciclatide will:\r\n\r 1. Be taken up into aortic atherosclerotic plaque.\r\n\r 2. Show demonstrable uptake in the aortic valve and myocardium of patients with aortic\r stenosis that will correlate with the degree of active angiogenesis and fibrosis.\r\n\r 6.1 ANGIOGENESIS AND FIBROSIS IN AORTIC STENOSIS\r\n\r Aortic stenosis is associated with substantial left ventricular hypertrophy and consequent\r myocardial fibrosis with the latter predicting prognosis. Left ventricular hypertrophy and\r associated fibrosis is also a major risk factor for adverse cardiovascular events in a number\r of other conditions including essential hypertension. Cardiac magnetic resonance imaging is\r the gold-standard method of assessing for the presence of myocardial fibrosis but it does not\r necessarily indicate the on going activity of the fibrotic process. In this study, we will\r assess the uptake of 18F-fluciclatide in patients with aortic stenosis as a model of pressure\r overload left ventricular hypertrophy. We will also seize the opportunity to determine\r whether there is any uptake of 18F-fluciclatide in the aortic valve given that this has been\r shown to have areas of fibrosis and angiogenesis.\r\n\r All study patients and healthy volunteers will undergo blood sampling, echocardiogram,\r positron emission and computed tomography scans with 18F-fluciclatide as well as cardiac\r magnetic resonance imaging with assessment of gadolinium late enhancement. Following\r injection of 18F-fluciclatide, patients will be monitored using our standard clinical\r approach, including observation of haemodynamic parameters, and this will continue throughout\r their study visit until departure. In patients undergoing aortic valve replacement surgery,\r aortic valve tissue will be retained and a 3-mm tru-cut biopsy of left ventricular myocardium\r obtained with which to compare the findings from the scans.\r\n\r Healthy volunteer patients will not undergo repeat assessment. After a period of one to two\r years from their initial scan, patients with Aortic Stenosis will return for repeat blood\r sampling, cardiac magnetic resonance imaging with assessment of late gadolinium enhancement\r and echocardiogram. Those patients who have undergone an aortic valve replacement will\r undergo repeat positron emission and computed tomography scans with 18F-fluciclatide six\r months after their operation, prior to their second cardiac MRI scan.\r\n\r Blood samples will be assessed using standard clinical biochemical and haematological\r profiles such as full blood count and urea and electrolytes. In addition, markers of cardiac\r ischaemia, fibrosis and angiogenesis will be assessed. Additional serum, plasma and DNA will\r be stored at -80 degrees Celsius for future potential analyses.\r\n\r 6.1.2 Study Interpretation\r\n\r We anticipate that myocardial uptake of 18F-fluciclatide will be increased in patients with\r aortic stenosis and left ventricular hypertrophy. We expect the degree of myocardial uptake\r to correlate with cardiac magnetic resonance imaging assessment of fibrosis as well as the\r histological measures of fibrosis and αvβ3 and αvβ5 integrin receptor expression. We expect\r the degree of myocardial uptake to predict cardiac magnetic resonance imaging assessment of\r fibrosis following a period of one to two years. In exploratory analyses, we will also take\r the opportunity to assess the extent of 18F-fluciclatide uptake within the aortic valve\r itself, and if successful, correlate this with histological measures of angiogenesis and\r fibrosis.\r\n\r 6.2 ANGIOGENESIS IN AORTIC ATHEROSCLEROSIS\r\n\r Patients with aortic stenosis will have a high prevalence of concomitant aortic\r atherosclerosis. In Dr Dweck's Fellowship, we were able to exploit this association and\r undertake secondary analyses of 18F-sodium fluoride uptake in aortic and coronary\r atherosclerosis. This generated some highly innovative findings that informed our\r understanding of atherosclerosis and the role of calcification.\r\n\r 6.2.1 Study Schedule\r\n\r We will use the datasets obtained from the patients above to explore the uptake of\r 18F-fluciclatide within the thoracic aorta. Atherosclerosis will be identified using computed\r tomography and magnetic resonance images obtained of the thorax at the time of the study\r scans. No additional image acquisition will be required. This will provide pilot data to\r inform subsequent dedicated studies focused on acutely inflamed atherosclerotic plaques, such\r as patients with recent transient ischaemic attacks or strokes attributable to carotid\r disease.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria\r\n\r - asymptomatic mild (peak valve velocity of 2-5-3.0 m/s; n=10), moderate (peak valve\r velocity of 3.0-4.0 m/s; n=10) or severe aortic stenosis (peak valve velocity of >4.0\r m/s; n=10) and 10 patients with severe aortic stenosis proceeding to aortic valve\r replacement.\r\n\r - Healthy control subjects (n=10) will have no past medical history of ischaemic heart\r disease or valvular heart disease and have a structurally normal heart on\r echocardiography.\r\n\r Exclusion Criteria:\r\n\r - Atrial fibrillation\r\n\r - Hepatic failure (Childs-Pugh grade B or C)\r\n\r - Renal failure (estimated glomerular filtration rate <25 mL/min)\r\n\r - Women of child-bearing potential\r\n\r - Contraindication to magnetic resonance imaging\r\n\r - Inability to undergo scanning\r\n\r - Ochronosis and those with any form of collagen-vascular disease.\n\nPatient 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
520	[ { "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 Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System\n\nClinical Trial Summary:\n\nThe purpose of this postmarket Registry is to assess the standard of care and clinical\r outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical\r routine according to the approved commercial indications. Procedures and assessments required\r by this registry are generally considered standard of care for Transcatheter Aortic Valve\r Replacement patients.\r\n\r Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical\r performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and angiographic\r imaging.\n\nClinical Trial Detailed Description:\n\nThe patient population will include patients who are candidates for transcatheter aortic\r valve replacement (TAVR). According to routine practice, the heart team (interventional\r cardiologist and cardiothoracic surgeon) makes a choice to use the Direct Flow Medical Aortic\r Valve System, compared to other available TAVR prostheses, on the basis of clinical and\r surgical considerations. Therefore, the valve is implanted when the heart team decides that\r this product is best suited to the specific patient.\r\n\r In order to be enrolled in this Registry, the patient must be a candidate for the\r implantation of the Direct Flow Medical Transcatheter Aortic Valve System, based on the\r commercial indications as stated in the Instructions for Use.\r\n\r Therefore, candidates for this study must meet the following criteria (Indications for Use):\r\n\r 1. Age > 70 years old\r\n\r 2. Severe aortic valve stenosis determined by echocardiogram and Doppler:\r\n\r - mean gradient >40 mmHg or peak jet velocity >4.0 m/s AND\r\n\r - aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2\r\n\r 3. Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional\r Class ≥ II, or syncope).\r\n\r 4. Patient is an extreme risk candidate for open surgical aortic valve repair such that the\r site Investigators (interventional cardiologist and cardiothoracic surgeon) agree that\r medical factors preclude operation, based on the conclusion that the probability of\r death or serious morbidity exceeds the probability of meaningful improvement due to the\r patient's co-morbidities (such as, but not limited to, severe COPD, porcelain aorta,\r previous thorax irradiation) or logistic EuroSCORE ≥ 20.\r\n\r All the Registry clinical evaluations and tests performed are generally considered standard\r of care for TAVR patients. When these recommendations conflict with the standard of care at\r the Registry site, the standard of care should prevail. In addition to the standard of care,\r the Sponsor recommends one brief additional evaluation (the EQ-5D quality of life measure) be\r conducted. Failure to perform this evaluation shall not be considered a protocol deviation.\r\n\r Baseline Clinical Evaluation\r\n\r - Medical History and Physical Exam\r\n\r - 12 lead ECG and Arrhythmia Assessment\r\n\r - Logistic EuroSCORE/STS Score\r\n\r - New York Heart Association (NYHA) functional status\r\n\r - Modified Rankin Score Assessment (mRS)\r\n\r - Current Cardiac Medications Baseline Imaging Studies\r\n\r - Transthoracic Echo (TTE)\r\n\r - CT Scan (ECG triggered, contrast enhanced)\r\n\r - Aorto-Iliac Angiogram:\r\n\r 1. Peripheral Evaluation\r\n\r 2. Coronary Evaluation\r\n\r All patients will have clinical follow-up at hospital discharge, 30 days, 12 months and\r annually to 3 years and undergo the following evaluations:\r\n\r - Physical Exam\r\n\r - 12 lead ECG and Arrhythmia Assessment\r\n\r - New York Heart Association (NYHA) functional status\r\n\r - Modified Rankin Score Assessment (mRS) if symptomatic for stroke\r\n\r - Current Cardiac Medications\r\n\r - Transthoracic echo (TTE) Patients in whom the heart team has planned to use the Direct\r Flow Medical Transcatheter Aortic Valve System valve, are informed of the DISCOVER\r Registry and their consent to participate is required. This study intends to monitor the\r clinical condition of the patient for a period of 3 years after the operation. By\r agreeing to participate, the patient agrees to undergo clinical assessments and specific\r tests at certain intervals (prior to the procedure; during the implantation; at hospital\r discharge, at 30 days after the procedure, and at 1 year, 2 and 3 years later); the\r patient also agrees to the collection of these daThe purpose of this Registry is to\r monitor outcomes data for the Direct Flow Medical Transcatheter Aortic Valve System in\r the Post Market phase. The primary outcome of interest is freedom from all-cause\r mortality at 30 days. The results from the pivotal CE mark study (IP 010) yielded a 30\r day freedom from all-cause mortality rate of 97%. Should the \"true\" rate be 97%, then\r N=250 patients would provide an estimate of the rate with a margin of error of 2%, with\r 95% confidence.\n\nClinical Trial Eligibility Criteria:\n\nCandidates for this study must meet all of the Indications criteria and none of the\r Contraindications.\r\n\r Inclusion Criteria (Indications):\r\n\r 1. Age > 70 years old\r\n\r 2. Severe aortic valve stenosis determined by echocardiogram and Doppler:\r\n\r - mean gradient >40 mmHg or peak jet velocity >4.0 m/s\r\n\r - aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2\r\n\r 3. Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional\r Class ≥ II, or syncope).\r\n\r 4. Patient is an extreme risk candidate for open surgical aortic valve repair such that\r the site Investigators (interventional cardiologist and cardiothoracic surgeon) agree\r that medical factors preclude operation, based on the conclusion that the probability\r of death or serious morbidity exceeds the probability of meaningful improvement due to\r the patient's co-morbidities (such as, but not limited to, severe COPD, porcelain\r aorta, previous thorax irradiation) or logistic EuroSCORE ≥ 20.\r\n\r Exclusion Criteria (Contraindications):\r\n\r The Direct Flow Medical device is contraindicated for post implant balloon valvuloplasty.\n\nPatient 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
521	[ { "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\nType II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.\n\nClinical Trial Summary:\n\nThis project focuses on the physiopathology of left ventricular remodeling associated with\r type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve\r replacement.\r\n\r The main objective is to compare the reverse left ventricular remodeling between patients\r with type II diabetes and case-control patients without diabetes at one(1) year after\r surgical aortic valve replacement.\r\n\r The secondary objectives are :\r\n\r 1. assess the influence of type II diabetes on left ventricular remodeling in patients\r presenting with aortic valve stenosis,\r\n\r 2. assess the predictive value of myocardial fibrosis and other LV characteristics present\r prior to aortic valve surgery on the LV reverse remodeling and their influence on\r cardiovascular events at one (1) year after surgery,\r\n\r 3. assess the influence of type II diabetes on cardiovascular morbidity and mortality post\r aortic valve surgery.\r\n\r The investigators main hypothesis is that patients with type II diabetes and aortic valve\r stenosis requiring aortic valve replacement have poorer LV function and less favorable post\r surgery clinical outcomes than patients without type II diabetes.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age > 18 years\r\n\r - Arm 1: Treated Type II diabetes, Arm 2: absence of type II diabetes\r\n\r - Aortic valve stenosis\r\n\r - LVEF > 50% with no kinetic abnormalities\r\n\r - Non significant obstructive coronary artery disease\r\n\r - Absence of gadolinium enhanced MRI contraindications\r\n\r - Informed consent signed\r\n\r - Patient affiliated to the French Social Security.\r\n\r Exclusion Criteria:\r\n\r - Chronic arrhythmia or absence of sinus rhythm\r\n\r - Past history of cardiomyopathy or coronary insufficiency\r\n\r - Significant coronaropathy seen during the coronary angiography with >50% degree\r stenosis prior to aortic valve replacement\r\n\r - Hemodynamically significant valvular dysfunction other than aortic stenosis (grade 2\r mitral or aortic insufficiency, mitral valve stenosis < 1.5 cm2)\r\n\r - Systemic chronic inflammatory disease leading to cardiac injury (scleroderma)\r\n\r - Renal insufficiency (clearance < 30 ml/min)\r\n\r - Insufficient transthoracic echocardiography echogenicity\r\n\r - Type I diabetes mellitus\r\n\r - Uncontrolled hypertension (> 180/100 mm Hg)\n\nPatient 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
522	[ { "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 Metoprolol on Thalassemia Cardiomyopathy\n\nClinical Trial Summary:\n\neffect of B blocker was first evaluated in patient with cardiomyopathy not induced by\r ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on\r Thalassemia cardiomyopathy was evaluated in this study\n\nClinical Trial Detailed Description:\n\nIn this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to\r receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk\r test was performed at baseline and repeated after 6 months and the values were compared.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - documented LVEF < 50% by echocardiography\r\n\r - B thalassemia\r\n\r - No decompensated heart failure for at least 4 weeks (hospitalization for CHF,\r worsening lower extremity edema, worsening dyspnea on exertion, , and orthopnea)\r\n\r - have no evidence of acute myocarditis and\r\n\r - hemoglobin level above 7 gr⁄dL.\r\n\r Exclusion Criteria:\r\n\r - pulse rate below 60/min\r\n\r - systolic blood pressure less than 90 mmHg\r\n\r - evidence of peripheral vascular disease\r\n\r - major depression, history of asthma, PR interval more than 240 msec, second or third\r degree AV block\r\n\r - major medical diseases including diabetes mellitus requiring insulin injection,\r hypothyroidism, hypoparathyroidism, chronic renal failure (glomerular filtration rate\r below 30 ml/min), hepatic cirrhosis, hepatitis-B and hepatitis-C, positive tests for\r human immunodeficiency virus, and other hemoglobinopathies\n\nPatient 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
523	[ { "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 Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing\n\nClinical Trial Summary:\n\nThe aim of this prospective, randomized and controlled trial is to evaluate the use of the\r ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of\r beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in\r single-chamber or dual chambers ICD recipients HF patients with moderate to severe left\r ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a\r 12-months follow up.\r\n\r Besides the investigators want to assess if the combination of ivabradine to a low-dose of\r beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a\r lower degree of left ventricular dysfunction progression, the reduction of ventricular\r arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of\r life in ICD heart failure patients.\n\nClinical Trial Detailed Description:\n\nBackground\r\n\r High heart rate (HR) represent per se a risk factor for cardiovascular mortality and heart\r failure (HF) progression, despite optimal HF therapy. Beta-blockers remain the therapy of\r choice in all patients with systolic HF, but they may worsen atrioventricular (AV) conduction\r and increase right ventricular (RV) pacing percentage. Several studies have demonstrated\r detrimental effects of RV pacing on cardiac function. Percent RV pacing > 40-50% is an\r independent predictor of death and hospitalization for HF in implantable\r cardioverter-defibrillator(ICD) patients, particularly in those with preexistent left\r ventricular dysfunction.1,2 Cumulative RV pacing > 2% and ejection fraction (EF) < 40% are\r independent predictors for Ventricular Tachycardia(VT)/Ventricular Fibrillation (VF)\r occurrence in ICD patients.3 Therefore reduction of cumulative RV pacing as far as possible\r should be achieved in ICD patients. Ivabradine is a specific inhibitor of the If current of\r the sinus node, that induces a selective and dose dependent HR reduction; it is a pure HR\r lowering agent without effects on AV conduction or contractility.4 In HF patients implanted\r with an ICD ivabradine could act as an heart rate control drug in combination with a\r beta-blocker without increase right ventricular (RV) pacing percentage and may be an option\r to reduce left-ventricular dysfunction progression and ventricular arrhythmias burden and\r appropriate ICD therapy.\r\n\r Aim\r\n\r The aim of this prospective, randomized and controlled trial is to evaluate the use of the\r ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of\r beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in\r single-chamber or dual chambers ICD recipients HF patients with moderate to severe left\r ventricular dysfunction (FE ≤ 40%) and an heart rate ≥70 bpm in sinus rhythm over a 12-months\r follow up.\r\n\r Besides we want to assess if the combination of ivabradine to a low-dose of beta-blocker\r (bisoprolol) versus titration of beta-blocker (bisoprolol) may determine a lower degree of\r left ventricular dysfunction progression, the reduction of ventricular arrhythmias burden and\r ICD appropriate therapy occurrence and the improvement of quality of life in ICD heart\r failure patients.\r\n\r Endpoints of the study\r\n\r Primary endpoints:\r\n\r Right ventricular pacing percentage increase > 50% or Cardiovascular death or Heart failure\r decompensation or Crossover due to worsening heart failure.\r\n\r Secondary endpoints:\r\n\r Ejection fraction decrease < 5% and Left Ventricular End-Systolic Volume decrease <15%.\r\n\r Ventricular arrhythmias and ICD appropriate therapy reduction. Heart rate variability\r improvement NYHA Classification improvement Minnesota Living With Heart Failure Questionnaire\r (MLHFQ) total score reduction.\r\n\r Right ventricular pacing percentage. Composite endpoint: cardiovascular death and\r hospitalization due to worsening heart failure.\r\n\r Crossover rate due to worsening heart failure\r\n\r Study protocol:\r\n\r Baseline assessment:\r\n\r Clinical visit: demographic data, risk factors for cardiovascular disease, primary cause of\r heart failure, NYHA class, comorbidities, echocardiographic parameters, drug therapy,\r cardiovascular hospitalizations in the last year.\r\n\r Rest ECG (for assessment of rest heart rate, presence of sinus rhythm or device-induced\r rhythm, QRS duration); Blood pressure measurement; Electronic device control (for assessment\r of right ventricular stimulation percentage; electrical parameters and arrhythmias diagnostic\r data); Echocardiogram (for assessment of left ventricular end-diastolic and end-systolic\r volumes, left ventricular ejection fraction); MLHFQ\r\n\r Assignment of consecutive patients to treatment with ivabradine plus beta-blocker(bisoprolol)\r or beta-blocker (bisoprolol) titration. Mean Heart Rate Target is 55-70 bpm for both groups.\r\n\r Ivabradine will be administered at a dose of 5 mg twice daily in addition to a low dose of\r beta-blocker (bisoprolol 1,25 or 2,5 mg). After four weeks of treatment ivabradine will be\r eventually lowered up to 2,5 mg twice daily in the presence of side effects (phosphenes,\r diplopia, headache or dizziness).\r\n\r Beta blocker Bisoprolol will be up-titrated biweekly starting from the initial dose of\r 1,25-2,5 mg daily up to the max dose of 10 mg daily or to the maximum tolerated dose.\r\n\r Patients are controlled in office follow-up visits after 3, 6 and 12 months, in addition to a\r Remote Monitoring program for clinical data and trend reviewing at least every 15 days or as\r soon as possible whenever a Remote Monitoring alert notification is received. Besides every\r 15 days patients will receive a telephone contact in order to evaluate their clinical state\r and to uptitrate the beta blocker therapy based on mean heart rate detected trough remote\r control of the ICD.\r\n\r Three months in-office follow-up:\r\n\r Clinical visit: symptoms, NYHA class, drug therapy, cardiovascular hospitalizations in the\r last three months.\r\n\r Rest ECG (for assessment of rest heart rate, presence of sinus rhythm or device-induced\r rhythm, QRS duration); Blood pressure measurement; Echocardiogram (for assessment of left\r ventricular end-diastolic and end-systolic volumes, left ventricular ejection fraction);\r Electronic device control (for assessment of right ventricular stimulation percentage;\r electrical parameters and arrhythmias diagnostic data) .\r\n\r Six months in office follow-up:\r\n\r Clinical visit: NYHA class, comorbidities, echocardiographic parameters, drug therapy,\r cardiovascular hospitalizations in the last three months.\r\n\r Rest ECG (for assessment of rest heart rate, presence of sinus rhythm or device-induced\r rhythm, QRS duration); Echocardiogram (for assessment of left ventricular end-diastolic and\r end-systolic volumes, left ventricular ejection fraction); Electronic device control (for\r assessment of right ventricular stimulation percentage; electrical parameters and arrhythmias\r diagnostic data).\r\n\r MLHFQ\r\n\r One year in office follow-up:\r\n\r Clinical visit: NYHA class, comorbidities, echocardiographic parameters, drug therapy,\r cardiovascular hospitalizations in the last three months.\r\n\r Rest ECG (for assessment of rest heart rate, presence of sinus rhythm or device-induced\r rhythm, QRS duration); Electronic device control (for assessment of right ventricular\r stimulation percentage; electrical parameters and arrhythmias diagnostic data).\r\n\r Echocardiogram (for assessment of left ventricular end-diastolic and end-systolic volumes,\r left ventricular ejection fraction); MLHFQ\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Age ≥ 18 years.\r\n\r Patients with stable chronic heart failure implanted with mono-cameral or bicameral ICD\r with a home monitoring remote control.\r\n\r Moderate to severe left ventricular dysfunction (FE ≤ 40%).\r\n\r Any cause of heart failure was allowed apart congenital heart disease.\r\n\r Bicameral ICD programmed in DDD or AAI/DDD with AV interval < 300 msec.\r\n\r Rest ECG heart rate ≥70 bpm;\r\n\r Sinus rhythm.\r\n\r In therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose\r tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin II\r receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless\r contraindicated.\r\n\r Exclusion Criteria:\r\n\r Inability of providing informed consent;\r\n\r Age < 18 years.\r\n\r State of pregnancy or lactation.\r\n\r Recent (<2 months) myocardial infarction;\r\n\r Contraindications to beta-blockers and ivabradine;\r\n\r Rest ECG heart rate < 70 bpm;\r\n\r No sinus rhythm.\r\n\r Administration of non-dihydropyridinic calcium channels antagonists, digitalis, class I\r antiarrhythmic drugs, strong inhibitors of cytochrome P450 3A4 at the time of enrollment.\n\nPatient 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
524	[ { "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\nC-Pulse® System European Multicenter Study\n\nClinical Trial Summary:\n\nThe study is designed to observe the clinical outcomes of heart failure patients treated with\r C-Pulse® System in the usual manner and according to the approved indications and\r contraindications.\n\nClinical Trial Detailed Description:\n\nEvaluation of the post-market clinical performance and safety of the C-Pulse® System for the\r treatment of Heart Failure in the population of patients who meet the approved clinical\r conditions provided in the indications and contraindications.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patient is 18 years or older\r\n\r - Patients with moderate to severe ambulatory heart failure [American College of\r Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV\r ambulatory], who are refractory to optimal medical therapy\r\n\r - Patients who are non-responders to CRT pacemaker therapy\r\n\r - Patient has signed and dated the investigation informed consent form\r\n\r Exclusion Criteria:\r\n\r - Evidence of significant ascending aortic calcification on postero-anterior chest X-ray\r or CT scan\r\n\r - Moderate or severe atherosclerotic aortic disease\r\n\r - Ascending aorto-coronary artery bypass grafts\r\n\r - Any history of aortic dissection\r\n\r - Connective tissue disorder such as Marfans disease\r\n\r - Aorta not conforming to specified dimensional constraints\r\n\r - Patient has severe mitral valve incompetence, grade 4+\r\n\r - Patient has moderate to severe aortic valve incompetence, grade 2 - 4+\r\n\r - Patient has systolic blood pressure less than 90 or greater than 140mmHg\r\n\r - Presence of active systemic infection\r\n\r - Presence of bleeding or coagulation disorder (relative)\n\nPatient 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
525	[ { "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\nMetformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease\n\nClinical Trial Summary:\n\nCardiovascular disease is the most common cause of death in the world. Most of the attention\r in treating ischemic heart disease (IHD) is understandably directed toward treating coronary\r artery disease. However there are other treatable culprits in these patients.\r\n\r Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of\r hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In\r one study, the presence of LVH was a stronger predictor of mortality than either multivessel\r cor-onary disease or impaired LV function.\r\n\r Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes.\r In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39%\r lower risk of myocardial infarction compared with conventional therapy. Metformin also\r offered dual benefits of improving vascular function and lessening ischemia in nondiabetic\r patients.\r\n\r Hence, the main aim of this study was to assess whether metformin could regress LVM in\r patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and\r endothelial function in this patient group.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - They had to have normal glucose tolerance.\r\n\r - They had to have either angiographically documented coronary artery disease or a\r previous history of myocardial infarction.\r\n\r - They were required to have an office BP < 130/80 mm Hg\r\n\r - The presence of LVH on echocardiography (American Society of Echocardiography criteria\r LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women).\r\n\r Exclusion Criteria:\r\n\r - They were currently prescribed metformin.\r\n\r - They had renal and liver dysfunction, heart failure, or malignancy, or were unable to\r give informed consent.\r\n\r - Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers,\r claustrophobia) were also excluded, as were pregnant or lactating women.\n\nPatient 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
526	[ { "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\nHealth Impacts of Sustainable Ingredient Selection in the Food and Drink Industry - ALTERNATIVE PROTEIN STUDY\n\nClinical Trial Summary:\n\nSummary\r\n\r This research will examine the nutritional effects of supplementing diets with alternative\r plant sources of protein with potential to be grown in Scotland. In particular, we will\r assess the potential of these plant protein sources to complement diets in which the\r predominant source of protein is meat. These protein sources will include plants from the\r Fabaceae, Cannabaceae and Polygonaceae families, which could be used as the basis for the\r development of new foods. The research will assess if these plant proteins can deliver a\r comparable alternative to meat based diets.\r\n\r It is anticipated that the results could encourage increased consumption of plant products\r which would be favorable for consumers shifting away from animal-derived proteins for health\r and/or environmental reasons.\r\n\r Hypothesis: Consumption of protein rich plants could be a sustainable and healthy choice for\r partial replacement in predominantly meat based diets.\r\n\r Objective: The objective of this acute study is to assess satiety, postprandial effects,\r metabolite bioavailability and metabolism of single alternative proteins from a shortlist\r including buckwheat, fava beans, lupin, pea, and hemp in comparison with red meat.\r\n\r Study protocol\r\n\r Aims: To assess the impact of a pea, fava bean, lupin, hemp, buckwheat in comparison with\r meat in healthy people on:\r\n\r - Biomarkers of satiety as measured by gut-related hormones and subjective appetite using\r visual analogue scales, specifically to be collected during the meal over a three hour\r period, every 30 minutes. The energy intake measured for each volunteer after an ad\r libitum lunch (five hours after test meal).\r\n\r - Biomarkers of CVD risk including total cholesterol, low density lipoproteins (LDL), high\r density lipoproteins (HDL), triglycerides and non-esterified fatty acids (NEFA).\r\n\r - Assessment of peripheral glycaemic control, fasting glucose, area under the curve\r combined with insulin data.\r\n\r - Plasma and urine markers of important phytochemical and protein metabolites will be\r quantitatively analysed to determine the systemic availability, in vivo concentrations\r and excretion times.\r\n\r - Volunteer views towards diets rich in plant proteins will be assessed.\n\nClinical Trial Detailed Description:\n\nBackground\r\n\r Recent scientific evidence suggests that diets largely based on plant foods, such as\r well-balanced vegetarian diets, have potential to improve health, in contrast with\r predominantly meat-based diets. However, many consumers may not wish to exclude meat from the\r diet, despite current advice to reduce, in particular, processed meat. One way to achieve\r this is to increase consumption of plant-based protein components in the diet.\r\n\r Making a comparison of the nutritional content of high protein plants (i.e. those with > 20 g\r protein/100 g dry weight), several candidate sources were identified. In particular, these\r belong to the Fabaceae family and include pulses (green peas, fava beans, lupin seeds) and\r certain common bean species. Species from plant families other than the Fabaceae generally\r have less protein. An exception is hemp seed (Cannabaceae family), which can have a protein\r content around 40g protein /100g dry weight, is a source of fibre, and has favourable fatty\r acid and amino acid profiles. Other families of interest include the Amaranthaceae species\r (Quinoa), Polygonaceae (Buckwheat) and the Poaceae (Wheat, Barley and Oats). Protein content\r of these pseudocereal and cereal crops ranges from 12-20 g protein /100 g dry weight.\r Although lower in protein content compared with the Fabaceae species, they are generally rich\r in fibre and consequently will impart additional benefits to a high-protein plant based diet.\r\n\r According to the Scottish Health Survey (2009), nearly two-thirds of men (66.3%) and\r approximately half of women (58.4%) were overweight. Obesity is a major risk factor for\r metabolic syndrome, which is linked to conditions such as type II diabetes mellitus (T2DM).\r Having impaired glucose tolerance doubles the chance of morbidity and mortality from\r cardiovascular disease (CVD). CVD is the leading cause of death and accounts for nearly 30%\r of deaths worldwide each year. Clinical studies have shown that regular consumption of pulses\r can reduce blood levels of total cholesterol and low density lipoprotein (LDL).\r\n\r The recent meta-analysis of randomized controlled trials provides the strongest evidence to\r date that non-soya legume consumption lowers serum total and LDL cholesterol and therefore,\r may lower the risk of CVD. Eating pulses regularly may also lower CVD risk via favorable\r effects on blood pressure, blood glucose and insulin levels and by satisfying hunger and\r helping manage body weight. Higher legume intakes were associated with lower body mass index\r (BMI), blood pressure, serum total cholesterol (TC) and a lower incidence of T2DM, compared\r with lower legume intakes. In addition to achieving energy balance and improving the overall\r diet, the World Health Organization (WHO) recommends that people increase consumption of\r legumes (pulses), as well as vegetables, wholegrain and nuts to prevent obesity. There does\r not seem to be differential effects of pea-protein as compared to other meat and dairy\r proteins when fed at similar amounts as a pre-load.\r\n\r Technically a nut, hempseed typically contains over 30% oil and about 25% protein, with\r considerable amounts of dietary fibre, vitamins and minerals. The two main proteins in\r hempseed are edestin and albumin (high-quality storage proteins are easily digested and\r contain nutritionally significant amounts of all essential amino acids); hempseed has\r exceptionally high levels of the amino acid arginine. Hempseed is an excellent source of\r nutrition and has been used to treat various disorders for thousands of years in traditional\r medicine. Animal studies and only few humans study (on hemp seeds oil) agree as well that\r hempseed has health promoting properties; supported by results from nutritional analyses of\r the seed, oil and seed meal. Being a rich source of polyunsaturated fatty acids and proteins\r which contain all of the essential amino acids in nutritionally sufficient amounts as\r detailed by the FAO/WHO (Food and Agriculture Organization of the United Nations/World Health\r Organization) suggested requirements for infants or children. Hemp proteins have a Protein\r Digestibility Corrected Amino Acid Score (PDCAAS) equal to or greater than certain grains,\r other nuts, and some pulses. Hempseed, in addition to its nutritional value, has demonstrated\r positive health benefits, including the lowering of cholesterol and high blood pressure.\r\n\r Buckwheat has attracted increasing attention from food scientists for its potential\r beneficial effects in chronic diseases. In the early 1970's the nutritional properties of\r buckwheat were first demonstrated. The cholesterol lowering effects of buckwheat protein\r extracts in rats with cholesterol-enriched diets has been reported.\r\n\r There has been much research conducted on the functionalities and properties of buckwheat\r proteins and other phytochemicals in buckwheat seeds. Among them, the most promising are the\r flavones, flavonoids, phytosterols, fagopyrins, and the thiamin-binding proteins. Buckwheat\r proteins have unique amino acid compositions Experiments, both in animal models and with\r human studies revealed that buckwheat flour can improve T2DM, obesity, hypertension,\r hypercholesterolemia and constipation.\r\n\r For the social science element of the project, the proposed study will employ qualitative\r research methods which emphasise the importance of 'lay' knowledge and the subjective\r experience of research participants. Within the field of nutrition research, qualitative\r methods and techniques still remain comparatively rare. This is partly because of the\r privileged status of quantitative research, but also because of the length of time and amount\r of effort that goes into each qualitative study and the small pool of qualified researchers\r in this field .As qualitative research efforts require that researchers seek to understand\r people and the social and cultural contexts in which they live from the participants' points\r of view, this type of knowledge has much to contribute to our understanding of why people eat\r what they do. For the purposes of this study, qualitative methods will enhance our\r understanding of the acceptability, to consumers in Scotland, of foods based on sustainable,\r plant-based protein. It will also tell us much about any barrier that exist to the uptake of\r such foods, from a consumer perspective.\r\n\r Planned work for the study\r\n\r From a health perspective it is essential to establish the bioavailability and metabolism of\r plant proteins and other dietary constituents in humans. Certain metabolites are absorbed\r early in the gastrointestinal tract, whereas others are transported to the colon where they\r are extensively metabolized by the gut microbiota. In this acute study, we will characterise\r the bioactive metabolites present in the urine and plasma samples obtained. This will inform\r on their availability to the systemic circulation, as well as their excretion profiles. We\r will employ targeted quantitative analysis using both LC-MS and GC-MS which will provide the\r identity of metabolites and their in vivo concentrations. We will focus on metabolites that\r are considered to impact on human health. The principal metabolites analysed will be those\r produced by the phenylpropanoid pathway and products of protein and carbohydrate metabolism.\r These will include derivatives and metabolites of the simple phenols, benzoic acids, phenolic\r acids, phenylacetic acids, phenypropionic acids, phenylpyruvic acids, phenyllactic acids,\r mandellic acids, phenolic dimers, acetophenones, benzaldehydes, cinnamaldehydes, benzyl\r alcohols, cinnamyl alcohols, indoles, isoflavones, coumarins, chalcones, flavanones,\r flavones, flavonols, anthocyanidins. We have also shown that many of these compounds are\r bioactive and exhibit anti-oxidant and anti-inflammatory activity at in vivo concentrations.\r These studies will provide important information on bioavailability and metabolism, but will\r also allow us to correlate the indices with biomarkers of health. In this study we will also\r examine the effect of different protein sources on post-prandial effects, endocrine responses\r (e.g. PYY (peptide YY) levels) and hunger ratings. The energy intake for each volunteer will\r be measured after lunch (ad libitum) on the intervention day. Volunteer views and\r acceptability towards diets rich in plant protein will be assessed. Some components in pulses\r may contribute to weight control by inhibiting intestinal absorption of carbohydrates and\r other energy yielding nutrients such as protein. Correlating the metabolic profiles with\r biomarkers of health will provide information that will be fed back into agricultural\r practice to optimise crop breeding strategies for benefits on human health.\r\n\r With regard to the social science component of the project, in-depth semi-structured\r interviews will be used. The term 'semi-structured' reflects the intrinsic flexibility of\r qualitative interview approaches, which often use an aide-memoire or interview guide rather\r than a formal schedule. In addition, the form and content of the research questions is likely\r to vary, in response to each particular interview context. This type of built-in design can\r strengthen qualitative research because of its attentiveness to context.\r\n\r All interviews will be digitally recorded and fully transcribed. The qualitative analytical\r techniques applied will look for and examine the themes and patterns of meaning within the\r kinds of data generated by this research mode. The interviews and conversations that take\r place as part of qualitative inquiry will generate responses, perceptions, opinions and so on\r from research participants. These can be understood as constituting a 'discourse' (or set of\r ideas) derived from the focus of the inquiry that lends itself particularly well to thematic\r analysis. Themes are derived by the process known as 'coding' (or labelling) specific chunks\r of text according to the ideas which they seem to represent. This interpretative work\r involves the creation of analytical themes by the researcher and is particularly useful in\r bringing together the 'insider' or 'emic' perspective derived from the research participant's\r knowledge and experience, with the 'outsider' or 'etic' perspective of the researcher and the\r relevant literature. Patterns in the data are thus identified through the intellectual work\r of bringing together components or fragments of ideas, perceptions or experiences which might\r be meaningless when considered in isolation. The researcher engaged in thematic analysis\r seeks to understand how different ideas or components fit together in a meaningful way, in\r order to produce a coherent analytical account.\r\n\r The analysis will be validated by referring back to the relevant literature, which may\r support (or counter) inferences drawn by the researcher. The interweaving of research\r findings with extant research literature will help strengthen the interpretive account\r provided by the researcher. Research participants will also be engaged in this process in\r that their feedback on emerging patterns will be sought. This process of member checking will\r be conducted during the course of each interview. Through an analytical framework that\r focuses on discourse and acknowledges the importance of participants' own perspectives and\r experiences, analysis will present a contextualised exploration of the ways in which\r consumers perceive plant-based proteins as alternatives or supplements to meat.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Healthy males and females, non-vegetarians, non-smokers, age 18-65 with BMI 18-35 kg m-2,\r taking no exclusion criteria medication.\r\n\r Exclusion Criteria:\r\n\r Diabetes Severe gastrointestinal disorders Kidney disease Thromboembolic or coagulation\r disease Hepatic disease Alcohol or any other substance abuse Gout Eating disorders Allergy\r Unregulated thyroid disease Asthma Eczema Hay fever Gluten/wheat intolerance Psychiatric\r disorder resulting in a perceived inability to give informed consent (including severe\r depression, lithium treatment, schizophrenia, severe behavioral disorders)\r\n\r Medication exclusion criteria (Confirmed with GP) Orlistat (Xenical) Oral antidiabetics,\r insulin Digoxin, anti-arrhythmics Anti-inflammatories/anti-pyretics Tricyclic\r antidepressants, neuroleptics Antihistamines\n\nPatient 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
527	[ { "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 Valve Aortopathy Feasibility Study\n\nClinical Trial Summary:\n\nIn order to determine the effectiveness of medical therapy options to prevent enlargement of\r the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This\r feasibility study will gather accurate data on number needed to screen, changes in medication\r use over time, and variance of the intended study endpoint.\n\nClinical Trial Detailed Description:\n\nThe study will consider all patients with a bicuspid aortic valve and 1) determine the number\r of patients needed to be screened for a clinical trial, based on patient eligibility\r percentages applying specific inclusion and exclusion criteria, 2) for those meeting these\r criteria, follow changes in and compliance with medical therapy over two years, and 3) in a\r limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the\r change in aortic area over time.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Bicuspid aortic valve\r\n\r - Aortic measurement of 35 - 49 mm on prior imaging study\r\n\r Exclusion Criteria:\r\n\r - Prior aortic valve or thoracic aortic surgery\r\n\r - Prior aortic dissection\r\n\r - Other condition associated with enlarged aorta including Coarctation, Marfans, Turner\r syndrome, Loeys-Dietz, etc.\r\n\r - Severe aortic stenosis or regurgitation\r\n\r - Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator\r\n\r - Anticipated pregnancy, surgery, or move outside the area within 2 years\n\nPatient 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
528	[ { "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\nIntensive Statin Therapy in Patients With AMI\n\nClinical Trial Summary:\n\nObjective: Statins have been shown to have beneficial pleiotropic effects besides being lipid\r lowering. The investigators hypothesized that early and intensive statin treatment was\r associated with improved left ventricular (LV) function and with a stabilization of the\r coronary atherosclerotic plaques in patients with acute myocardial infarction (AMI) Method:\r In a prospective randomized blinded endpoint trial patients with ST segment elevation or non\r ST segment elevation AMI were randomized to either intensive statin-therapy (loading dose\r rosuvastatin 80 mg immediately after randomization followed by 40 mg daily) or usual statin\r therapy (simvastatin 40 mg daily). Patients were followed 12 month and the investigators\r performed echocardiography at randomization, after 30 days and after 12 month. The\r investigators used 2D Speckle Tracking for the assessment of LV-function. Coronary plaque\r assessment was done with Cardiac-CT (MSCT) at baseline and after 12 month.\r\n\r Primary outcome for this study was assessment of LV function with global and regional\r myocardial strain. Secondary outcomes can be divided in 4 groups:\r\n\r 1. Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume,\r atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate.\r\n\r 2. Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM,\r E-selection and Nitrate/Nitrite ratio.\r\n\r 3. Coronary plaque assessment by MSCT: Plaque volume and plaque stability.\r\n\r 4. Long term follow-up: Mortality and cardiovascular events\n\nClinical Trial Detailed Description:\n\nIntroduction Coronary heart disease (CHD) remains the leading cause of mortality in the\r western world. In Europe, CHD accounts for one fifth of all deaths annually. Acute myocardial\r infarction (AMI) is caused primarily by plaque rupture and it has been demonstrated that the\r pathogenesis of AMI involves interplay of the endothelium, the inflammatory cells and the\r thrombogenicity of the blood. Following an acute myocardial infarction (AMI), profound\r structural changes can be encountered, resulting in left ventricular (LV) remodeling and\r development of depressed cardiac function.\r\n\r Heart failure (HF) is a significant cause of morbidity and mortality worldwide with an\r estimated prevalence of 1% to 2% in the western world and AMI remains the predominant cause.\r\n\r Statins were first developed to improve the lipid profile and reduce the development of CVD.\r Several large randomized controlled trials have shown that statin therapy is beneficial in\r both primary and secondary prevention of atherothrombosis. Results from two large, acute\r coronary syndrome trials suggested further clinical benefit of statins in addition to their\r lipid lowering effect. This stemmed from the observation of a cardiovascular event-rate\r reduction in patients with AMI only weeks after initiation of statin treatment. Several\r experimental studies have demonstrated that statins, apart from their LDL lowering effect,\r exert beneficial pleiotropic effects on inflammation, endothelial function, thrombosis,\r plaque stability and ischaemic-reperfusion injury.Other experimental studies in animals have\r reported beneficial effects of statins on LV function after AMI. In clinical settings statins\r have been shown to prevent periprocedural myocardial damage in patients treated with\r percutaneous coronary intervention (PCI) and the ARMYDA-ACS trial demonstrated a protective\r effect of statin loading on the myocardium before PCI in patients with ACS. Only a few\r clinical studies have directly investigated the acute effect of statins on LV function in\r patients with AMI and the results are inconclusive.\r\n\r All previous studies have concentrated on patients with STEMI and disregarded those with\r NSTEMI; moreover, no studies have investigated the effect of an early statin loading dose in\r patients with AMI. The investigators hypothesized that early and intensive statin treatment\r was associated with improved left ventricular (LV) function and with a stabilization of the\r coronary atherosclerotic plaques in patients with acute myocardial infarction (AMI) Thus, the\r primary aim of the Intensify trial was to examine the effect of early intensive statin\r treatment on LV function with strain echocardiography in patients with AMI after 30 days.\r\n\r Methods Study population This study was a prospective randomized controlled (RCT) trial with\r a blinded endpoint design. The trial was approved by the Regional Scientific Ethics Committee\r for Southern Denmark and the Danish Data Protection Agency. Patients with AMI defined by\r current guidelines were consecutively collected from a single coronary care unit from April\r 2010-august 2012. Inclusion criteria were all patients with NSTEMI and STEMI, and the\r exclusion criteria were prior intensive statin treatment, contraindication to intensive\r statin therapy and a time limit above 24 hours from hospital admission.\r\n\r Patients were randomized to either intensive statin treatment with rosuvastatin 40 mg or\r usual care with simvastatin 40 mg. The intensive care group was given a loading dose of\r rosuvastatin 80 mg as soon as possible followed by 40 mg daily. The usual care group was\r treated with simvastatin 40 mg daily. Apart from the different statin treatment, all patients\r were treated the same according to current national guidelines.\r\n\r Patients were followed for 12 month and examined immediately after randomization, after 1\r month and after 12 month.\r\n\r Coronary angiography and Culprit vessel Culprit vessel and infarct location was identified\r from the coronary angiography. In patients with single vessel disease (lumen stenosis < 50%)\r the diseased vessel was identified as culprit. In patients with multi-vessel disease, the\r culprit vessel was identified by a combination of angiographic and electrocardiographic\r criteria. In patients with normal CAG we used electrocardiographic and multi-slice computer\r tomography to identify the culprit lesion. If the culprit lesion could not be found, the\r patient was excluded from the study. The investigators used the AHA scientific statement of\r myocardial segmentation and nomenclature for tomographic imaging from 2002 to define the\r coronary arteries supply area of the myocardium.\r\n\r Echocardiography Echocardiography was performed at randomization and after 30 days using the\r GE Vivid 7 ultrasound system (GE Medical System Inc., Horten, Norway) with a standard 3.5 MHz\r ultrasound probe. A standardized protocol was followed at each examination and all\r examinations were performed by one operator. Consecutive heartbeats were recorded at a sweep\r speed of 25 mm/s and digitally stored, blinded to patient identity. Examinations were\r analyzed off-line by one experienced observer using EchoPAC version 1.12.0 (GE, Vingmed). All\r analysis was done with a sweep speed of 67 mm/s and recordings were measured and averaged\r from 3 consecutive heartbeats. Examinations with poor image quality and patients with atrial\r fibrillation were excluded from the analyses. Left ventricular- and atrial volumes were\r estimated using the Simpsons biplane method of discs in the 4- and 2 chamber views and\r ejection fraction was calculated. Mitral inflow pattern was estimated in the apical four\r chamber view and pattern of peak early (E) and peak atrial (A) velocities were measured. E/A\r ratio was calculated by dividing E by A. Mitral annular velocities were estimated in the\r apical 4- and 2 chamber view using pulsed wave tissue Doppler imaging. A pulsed wave Doppler\r sample volume was placed at the level of the mitral annulus first in the lateral wall, then\r in the septum and finally in the anterior- and posterior wall. Using tissue Doppler imaging\r peak early (E´), peak systolic (S´) mitral annular velocities were estimated. E/E´ ratio was\r obtained by dividing E by E´.\r\n\r Strain analyses Longitudinal systolic strain was measured by speckle tracking\r echocardiography. This was obtained from 2D gray scale images of the apical 4-chamber,\r 2-chamber and long-axis view with optimized focus on the left ventricle and frame rate ≥ 69\r frames/sec. Duration of systole was defined in the 5-chamber apical view by marking aorta\r valve opening and closure from the continuous wave Doppler curve.\r\n\r Strain analyses were done in EchoPAC version 1.12.0 (GE, Vingmed) with the Q-analysis\r software. The left ventricular borderline was manually traced in each apical plane and\r tracking of motion was automatically done by the software. Peak systolic strain was\r determined in all 18 segments from the three apical views. Global strain for the left\r ventricle was provided by the software as the average value of the peak systolic longitudinal\r strain of the three apical views. Strain of the infarct zone was calculated as the mean value\r of the segments supplied by the culprit vessel\r\n\r Time to intensive statin bolus:\r\n\r Patients randomized to the intensive care group were given a loading bolus of rosuvastatin 80\r mg as soon as possible after admission and continued intensive treatment with 40 mg daily.\r Patients randomized to the usual care group were treated after current guidelines with\r simvastatin 40 mg daily and started statin therapy before discharge from the hospital.\r Patients treated intensively were divided in two groups. A very early statin group receiving\r statin treatment before 12 hours after admission and an early statin group receiving statin\r after 12 hours but before 24 hours from admission to the hospital.\r\n\r MSCT:\r\n\r The investigators performed a contrast enhanced Cardiac CT (MSCT) at randomization and after\r 12 month. The investigators used a standardized protocol at every examination and detailed\r method description can be seen elsewhere.\r\n\r Biochemistry:\r\n\r Blood was drawn at baseline before randomization and after 30 days. The investigators\r measured lipid-profile HBA1C, Creatinin, ALAT and CK.\r\n\r Statistical analyses Continuous outcome variables are presented as mean ± standard deviation\r (SD). Changes in outcome variables from baseline to follow-up are presented as Delta (∆)\r values (follow-up values - baseline values) Differences between groups are analyzed with an\r unpaired Students t-test with unequal variance. The investigators used multiple linear\r regressions in order to adjust for potential confounders. The investigators defined the\r confounders to be: Baseline left ventricular output variable, diabetes, hypertension,\r hypercholesterolemia, prior statin treatment, history of ACS, type of infarction, type of\r invasive treatment, culprit vessel, beta-blockers, ACE/ARB-inhibitors and time from symptoms\r to invasive treatment.\r\n\r Continuous exposure variables are presented as median and lower and upper quartiles and\r categorical data as frequencies and percentages. Difference in exposure variables were tested\r with Krushal-Wallis test for continuous variables and for categorical variables with\r Fischer's exact test. Statistical tests were two-sided, and a P-value < 0.05 was considered\r to be statistically significant. All statistical analyses were performed using STATA version\r 12 (StataCorp LP, Collage Station, TX, USA)\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - All patients with NSTEMI and STEMI\r\n\r Exclusion Criteria:\r\n\r - prior intensive statin treatment\r\n\r - contraindication to intensive statin therapy\r\n\r - Time limit above 24 hours from hospital admission.\n\nPatient 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
529	[ { "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\nReal World Expanded Multicenter Study of the MitraClip® System (REALISM)\n\nClinical Trial Summary:\n\nProspective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve\r Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day,\r 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms:\r a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did\r not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for\r consideration for either Emergency Use (EU) or Compassionate Use (CU).\n\nClinical Trial Detailed Description:\n\nThe EVEREST II REALISM study (REALISM study) is a continued access registry designed for\r continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip®\r Device) under more \"real world\" conditions. After the completion of enrollment in the pivotal\r EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry\r Study NCT01940120, continued access to the technology was warranted to collect additional\r safety and effectiveness data on the MitraClip® Device. This continued access study was\r approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High\r Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk\r eligibility criteria were evaluated for consideration for either Emergency Use (EU) or\r Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April\r 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013.\r\n\r REALISM is a prospective, multi-center, study of the safety and effectiveness of an\r endovascular approach to the treatment of mitral valve regurgitation using the Evalve\r Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe\r (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic\r echocardiogram (TTE), were considered for enrollment in this study. The TTE and a\r transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity,\r valve anatomy and left ventricular parameters.\n\nClinical Trial Eligibility Criteria:\n\nPatients screened in EVEREST II REALISM Study will first be screened for high risk (HR)\r status and enrolled into the HR arm if they meet eligibility for this arm of the study. If\r they do not meet eligibility for the HR arm, patients will be further screened for\r eligibility for enrollment into the non-high risk (NHR) arm.\r\n\r Key Inclusion Criteria:\r\n\r - The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of\r the mitral valve (MV)\r\n\r - Male or non-pregnant female\r\n\r - Trans-septal catheterization is determined to be feasible by the treating physician\r\n\r High Risk Arm:\r\n\r - Predicted procedural mortality risk calculated using the STS surgical risk calculator\r of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR\r surgical candidate due to the presence of one of the following indications:\r\n\r 1. Porcelain aorta or mobile ascending aortic atheroma\r\n\r 2. Post-radiation mediastinum\r\n\r 3. Previous mediastinitis\r\n\r 4. Functional MR with EF <40\r\n\r 5. Over 75 years old with EF<40\r\n\r 6. Re-operation with patent grafts\r\n\r 7. Two or more prior chest surgeries\r\n\r 8. Hepatic cirrhosis\r\n\r 9. Three or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL\r 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35\r\n\r - Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of\r the investigator intervention to reduce MR is likely to provide symptomatic relief for\r the patient\r\n\r - American Society of Anesthesiologists (ASA) physical status classification of ASA IV\r or lower\r\n\r Non-High Risk Arm:\r\n\r - Moderate to severe (3+) or severe (4+) chronic MV regurgitation and:\r\n\r 1. Symptomatic with >25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of\r the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left\r Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation\r (AFib) iv. Pulmonary arterial systolic pressure (PASP) >50 mmHg at rest or >60 mmHg\r with exercise\r\n\r - Candidate for MV repair or replacement surgery, including cardiopulmonary bypass\r\n\r Key Exclusion Criteria:\r\n\r - Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended\r treatment\r\n\r - In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French\r scale (F) catheter or the presence of an inferior vena cava (IVC) filter would\r interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT)\r is present\r\n\r - MV orifice area <4.0 cm2\r\n\r - If leaflet flail is present:\r\n\r 1. Flail Width ≥15 mm, or\r\n\r 2. Flail Gap ≥10 mm.\r\n\r - If leaflet tethering is present:\r\n\r 1. Vertical coaptation length <2 mm\r\n\r - Leaflet anatomy which may preclude clip implantation, proper clip positioning on the\r leaflets or sufficient reduction in MR. This may include:\r\n\r 1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops\r\n\r 2. Presence of a significant cleft of A2 or P2 scallops\r\n\r 3. More than one anatomic criteria dimensionally near the exclusion limits\r\n\r 4. Bileaflet flail or severe bileaflet prolapse\r\n\r 5. Lack of both primary and secondary chordal support\r\n\r - Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or\r cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).\r\n\r - Need for emergency surgery for any reason\r\n\r - Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic\r valve or currently implanted Ventricular assist device (VAD)\r\n\r - Echocardiographic evidence of intracardiac mass, thrombus or vegetation\r\n\r - Active endocarditis or active rheumatic heart disease or leaflets degenerated from\r either endocarditis or rheumatic disease (i.e. noncompliant, perforated)\r\n\r - History of bleeding diathesis or coagulopathy or subject will refuse blood\r transfusions\r\n\r - Life expectancy <12 months\r\n\r - Active infections requiring current antibiotic therapy\r\n\r - Patients in whom transesophageal echocardiography (TEE) is contraindicated\r\n\r High Risk Arm:\r\n\r - EF <20%, and/or LVESD >60 mm\r\n\r Non-High Risk Arm:\r\n\r - The need for any other cardiac surgery\r\n\r - Any endovascular therapeutic interventional or surgical procedure performed within 30\r days prior to the index procedure\r\n\r - Severe Left Ventricular (LV) dysfunction (EF <25% and/or LVESD >55mm)\r\n\r - Severe mitral annular calcification\r\n\r - Systolic anterior motion of the MV leaflet\r\n\r - Hypertrophic cardiomyopathy\r\n\r - History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6\r months\r\n\r - Upper GI bleeding within the prior 6 months\r\n\r - Platelet count <75,000 cells/mm³\r\n\r - Creatinine >2.5mg/dL\n\nPatient 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
530	[ { "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\nHsTnT in Stable Coronary Artery Disease\n\nClinical Trial Summary:\n\nCoronary artery disease (CAD) is one of the leading causes of morbidity and mortality\r worldwide. Life threatening manifestations such as acute myocardial infarction (AMI) and\r sudden cardiac death are the most important causes of death in many countries. Cardiac\r troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for\r diagnosis of acute myocardial infarction by the Universal definition of myocardial\r infarction. Since a new generation of high-sensitivity cardiac troponin assays has become\r commercially available a few years ago, myocardial infarction can be detected earlier and\r even small AMIs, that were classified as unstable angina pectoris (UAP) with the less\r sensitive assays, are detectable now. On the other side, more patients with acute or chronic\r myocardial damage not due to AMI are identified now. Thereby, the reason for elevated\r troponin levels should be sought actively, because high troponin levels were associated with\r adverse outcome - independent of the underlying pathomechanism. The reasons for troponin\r elevations in patients with stable CAD are not clear yet. Associations with extensive\r atherosclerosis, carotid lesions and complex coronary plaques in coronary CT scans were\r reported. Therefore, patients with elevated troponin levels represent a risk population and\r might profit from intensified secondary prevention. In this context, ticagrelor might be part\r of a prevention strategy as currently tested in the PEGASUS trial.\r\n\r We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of\r our outpatient clinic, because data regarding prevalence, causes and prognosis of elevated\r troponin values in unselected cohorts is sparse. Therefore, all patients (n=910) that\r presented to our outpatient clinic 12 months after introduction of the high-sensitivity\r troponin T assay (june 2009) and were free of complaints or presented with UAP are being\r enrolled. All patients are characterized by demographic, laboratory and clinical\r characteristics (including medication) and all available imaging data (exercise-ecg,\r echocardiography, stress-echocardiography, computed tomography, cardiac MRI and coronary\r angiography) in order to compare baseline characteristics of troponin positive and troponin\r negative patients. In addition, the Framingham- and PROCAM-Score representing established\r calculators of long-term risk prediction are calculated.\r\n\r Prognostic endpoints are defined as severe cardiovascular events and progress of the\r initially diagnosed disease. Those endpoints are associated with the initial hs-cTnT value\r and serial changes.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients of outpatient clinic presenting 12 months after introduction of the hs-TnT\r test in june 2009\r\n\r Exclusion Criteria:\r\n\r - none\n\nPatient 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
531	[ { "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\nInternational Bicuspid Aortic Valve Consortium (BAVCon)\n\nClinical Trial Summary:\n\nBicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation,\r occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign\r abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection\r in 20-30% of those with BAV. BAV is strongly associated with early development of aortic\r valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the\r >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of\r the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve\r disease and we still do not understand the genetic cause(s) of BAV despite evidence for its\r high heritability.\r\n\r The Specific Aims of this study are:\r\n\r 1. To identify the genetic causes of bicuspid aortic valve disease and its associated\r thoracic aortic disease.\r\n\r 2. To identify potential pathways to predict the clinical course of BAV disease and for\r treating human BAV disease.\r\n\r To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium\r (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to\r fulfill the performance of these aims.\n\nClinical Trial Detailed Description:\n\nThe International Bicuspid Aortic Valve Consortium (BAVCon) Registry is the data collection\r arm of the International Bicuspid Aortic Valve Consortium, a 16 institution international\r consortium of investigators with interests in the genetics, molecular biology, imaging,\r surgery and natural history of bicuspid aortic valve disease.\r\n\r The BAVCon Registry is a longitudinal cohort study, which is observational by design. The\r cohort will consist of patients with BAV. Consideration will be given to eventual inclusion\r of a disease-free control or comparison group. The study will compare genetic risk factors,\r cross-sectional and longitudinal data on risk factors related to the diagnosis, treatment and\r outcomes among groups of enrolled patients. As part of the natural course of clinical care,\r the patients and their physicians will determine the approach to treatment and the study will\r record the observed related outcomes. The study will not attempt to interfere with the\r outcomes through any type of planned intervention; therefore, there are no anticipated\r adverse events as a result of study participation.\r\n\r Study Design\r\n\r The Registry is designed to capture information on patients with bicuspid aortic valve\r disease. The BAVCon Registry population will be comprised of patients from sixteen BAVCon\r Clinical Centers. The participating BAVCon Clinical Centers are:\r\n\r - Harvard University / Partners Healthcare, Boston (Dr. Simon Robson, Consortium PI)\r\n\r - GenTAC Consortium (Dr. Kim Eagle, PI)\r\n\r - Hospital Vall d'Hebron, Barcelona, Spain (Dr. Arturo Evangelista, PI)\r\n\r - Monaldi Hospital, Naples, Italy (Dr. Giuseppe Limongelli, PI)\r\n\r - Mayo Clinic, Rochester (Dr. Hector Michelena, PI)\r\n\r - Oxford University, Oxford, England (Dr. Malenka Bissell, PI)\r\n\r - Saarland University Medical Center, Saarland, Germany (Dr. Hans-Joachim Schäfers, PI)\r\n\r - San Donato Hospital IRCCS, Milan, Italy (PI: Dr. Alessandro Frigiola)\r\n\r - Tufts University, Boston (Dr. Gordon Huggins, PI)\r\n\r - Université de Liège, Liege, Belgium (Dr. Patrizio Lancelotti, PI)\r\n\r - Université Laval, Quebec (Dr. Yohan Bossé, PI)\r\n\r - University of Michigan, Ann Arbor (Dr. Anna Booher, PI)\r\n\r - University of Pennsylvania, Philadelphia (Dr. Joseph Bavaria, PI)\r\n\r - University of Salerno, Salerno, Italy (Dr. Eduardo Bossone, PI)\r\n\r - University of Texas Medical School, Houston (Dr. Dianna Milewicz, PI) One center with\r specific expertise, but not enrolling patients, is University of Ottawa (Dr. Mona Nemer,\r PI).\r\n\r The data supplied by each participating center are collected from the following sources:\r\n\r Patient interview or questionnaire Hospital medical records Surgical records Imaging studies\r\n\r Enrollment Information about the Registry will be disseminated to potential study subjects\r using a number of sources. The principal means of enrollment will be from the Cardiology and\r Surgical Clinics of each Hospital. In addition, collaborations with the patient advocacy\r groups such as the Bicuspid Aortic Valve Foundation. These organizations have well\r established resources for providing information to patients such as websites, newsletters,\r and national conferences. A recruitment brochure has been developed to explain the goals and\r basic procedures of the Registry. Finally, the study website, http://www.bavcon.org, will\r inform potential subjects about the Registry. All recruitment materials will be approved by\r the DCC and BCC IRBs, as appropriate, prior to dissemination.\r\n\r BCC study staff will identify eligible patients using the eligibility criteria developed and\r approved by the Steering Committee. They will both screen their current patient population as\r well as identify new patients that attend the clinic. Eligible patients will be solicited\r during clinic visits according to protocols approved by the local IRB.\r\n\r Initially, a care provider will introduce the Registry to the patient or the parent or\r guardian of the patient, and ask if they are interested in talking further with the research\r coordinator. If the patient (or parent or guardian) agrees, the research coordinator will\r meet with the patient for a more comprehensive explanation of the Registry. If there is\r continued agreement, the research coordinator will proceed with the consent and enrollment\r process. Signed informed consent will be obtained prior to any data or sample collection.\r Patients will receive a hard-copy of the consent form to keep. Patients will be able to ask\r questions at any time. One parent or guardian may provide signed consent for a minor child or\r other person with a physical or mental condition that prevents them from doing so themselves.\r Literacy in the native language of the country (English and Spanish in the USA) will be\r required of the consenting patient or parent/guardian. Child assent will be obtained from\r children at least 8 years of age, or as determined by the local IRB. Across all the sites, we\r anticipate total enrollment of up to 10,000 patients.\r\n\r Eligibility Criteria\r\n\r Inclusion criteria for entry into the Registry are:\r\n\r - Patients diagnosed with bicuspid aortic valve\r\n\r - All ages ≥8 years\r\n\r - Able to provide fully informed consent\r\n\r Local Site Restrictions Some sites will not be collecting tissue from patients, therefore\r information on tissue collection will be absent. Some sites do not routinely perform CT or\r MRI on their patients, so these data will also be absent.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients diagnosed as having a bicuspid aortic valve\r\n\r - All ages ≥8 years\r\n\r - Able to provide fully informed consent\r\n\r Exclusion Criteria:\r\n\r - None\n\nPatient 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
532	[ { "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\nVentricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction\n\nClinical Trial Summary:\n\nHeart failure with preserved ejection fraction (HFPEF) is a large medical problem, for which\r no drug or device has a recommendation in current heart failure guidelines. Sudden cardiac\r death is suggested as the most common cause of death in HFPEF patients, although data is\r sparse. Use of an Implantable Loop Recorder (ILR) may be useful in patients with HFPEF to\r evaluate the incidence of sustained ventricular tachyarrhythmias. If ventricular\r tachyarrhythmias are seem frequently, treatment with an Implantable Cardioverter\r Defibrillator (ICD) may be an option in the future.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Clinical criteria:\r\n\r 1. Age >18 years\r\n\r 2. Written informed consent\r\n\r 3. HF with moderate to severe symptoms NYHA II or III\r\n\r 4. Hospitalization or emergency room visit for HF or symptom relief with diuretics within\r 12 months\r\n\r 5. Sinus rhythm or AF\r\n\r Echocardiographic criteria:\r\n\r 1. LVEF >40%\r\n\r 2. Left atrial size (volume ≥34 mL/m2 or LA parasternal diameter ≥45), or left\r ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV\r diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall <9 cm/s).\r\n\r Biomarker criteria:\r\n\r 1. BNP >100ng/L or NT-pro-BNP>400ng/L if sinus rhythm\r\n\r 2. BNP >300ng/L or NT-pro-BNP>1200ng/L if atrial fibrillation\r\n\r Exclusion Criteria:\r\n\r 1. Patients unwilling or unable to sign informed consent\r\n\r 2. Patients with a pacemaker or ICD\r\n\r 3. Indication for ICD therapy according to the ESC guidelines\r\n\r 4. Life expectancy of less than one year\r\n\r 5. Significant coronary artery disease or myocardial infarction < 3 months\r\n\r 6. Complex congenital heart disease\r\n\r 7. Pregnancy\n\nPatient 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
533	[ { "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\nFludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia\n\nClinical Trial Summary:\n\nThe goal of this research is to test if the conditioning regimen, fludarabine and total body\r irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment\r regimen for ALL patients older than 40 years of age and/or younger patients with high risk\r medical conditions. The primary objective is to establish the efficacy of allo HCT in older\r ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also\r assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative\r FluTBI conditioning regimen.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Disease Criteria:\r\n\r - ALL in complete remission (CR) at the time of transplant. Remission is defined as\r \"less than 5.0% bone marrow lymphoblasts by morphology,\" as determined by a bone\r marrow aspirate obtained within 2 weeks of study registration.\r\n\r - Philadelphia chromosome positive ALL is allowed.\r\n\r - Lymphoid blastic crisis of CML will be included (provided that patients achieve\r CR).\r\n\r - Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must\r be comorbidities which preclude the patient to undergo CyTBI conditioning regimen.\r\n\r - Organ Function Criteria: All organ function testing should be done within 28 days of\r study registration.\r\n\r - Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated\r Acquisition) scan or echocardiogram.\r\n\r - Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity)\r ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for\r hemoglobin) ≥ 50% of predicted.\r\n\r - Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60\r mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:\r\n\r CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL).\r\n\r - Hepatic:\r\n\r - Serum bilirubin 2.0 g/dL\r\n\r - Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN\r\n\r - Alkaline phosphatase 2.5 ULN\r\n\r - Performance status: Karnofsky ≥ 70%\r\n\r - Consent: Patient must be informed of the investigational nature of this study in\r accordance with institutional and federal guidelines and have the ability to provide\r written informed consent prior to initiation of any study-related procedures, and\r ability,in the opinion of the principal investigator, to comply with all the\r requirements of the study.\r\n\r - Presence of a willing adult HLA-matched sibling (excluding identical twin) or\r HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors\r will be evaluated for eligibility and suitability per the standard of care according\r to the FACT and NMDP guidelines.\r\n\r Exclusion Criteria:\r\n\r - Non-compliant to medications.\r\n\r - No appropriate caregivers identified.\r\n\r - HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive\r\n\r - Active life-threatening cancer requiring treatment other than ALL\r\n\r - Uncontrolled medical or psychiatric disorders.\r\n\r - Uncontrolled infections, defined as positive blood cultures within 72 hours of study\r entry, or evidence of progressive infection by imaging studies such as chest CT scan\r within 14 days of registration.\r\n\r - Active central nervous system (CNS) leukemia\r\n\r - Preceding allogeneic HSCT\r\n\r - Receiving intensive chemotherapy within 21 days of registration. Maintenance type of\r chemotherapy will be allowed.\n\nPatient 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
534	[ { "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\nBreast Cancer Toxicity\n\nClinical Trial Summary:\n\nThe aims of the cohort will be to quantify impact of cancer treatments toxicities , and to\r generate predictors of chronic toxicity in patients with non-metastatic breast cancer.\r\n\r The project will include four specific aims :\r\n\r 1. To develop a database of chronic treatment related toxicity in a cohort of 13250 women\r with stage I-III breast cancer (= non metastatic), whatever these treatments are\r (surgery; radiation therapy; chemotherapy …)\r\n\r 2. To describe incidence, clinical presentation, and outcome of chronic toxicities over a\r maximum of 8 years.\r\n\r 3. To describe the psychological, the social and the economic impacts of chronic\r toxicities.\r\n\r 4. To generate predictors for chronic toxicities in order to prevent them, based upon\r biological criteria.\r\n\r The expected impact of these toxicities, when identified, will be to improve quality of life\r and to decrease health cost, by the early identification of patients at high risk of\r toxicity. Such early identification could lead to prevent toxic effect by: a. developing\r prevention strategies, b. substituting toxic treatment by a non (less) toxic one.\r\n\r Also, such cohort will offer a quantification of the impact of treatment toxicity, that could\r be further used to quantify medical usefulness of strategies that aim at decreasing treatment\r toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen\r etc…)\n\nClinical Trial Detailed Description:\n\nSPECIFIC AIM I: TO DEVELOP A TOXICITY DATABASE ON A COHORT OF 20,000 WOMEN WITH STAGE I-III\r (NON METASTATIC) BREAST CANCER\r\n\r Selection criteria The cohort will include female patients with non-metastatic breast cancer\r (stage I-III) without any selection based on their characteristics (except stage) or\r treatment. They may be included in other concomitant clinical studies.\r\n\r Patients will have to sign informed consent and will have to benefit from social security.\r\n\r The lack of selection criteria is related to the fact that the cohort aims at investigating\r toxicity in the whole population of breast cancer from a public health perspective.\r\n\r Sample size The cohort plans to include 13250 women in 13 years. A cohort of 13250 patients\r will allow to detect a two fold increased in the risk of a specific toxicity in a homogenous\r subgroup.\r\n\r As illustration, the study present a 90% power to detect whether a variable (age as example)\r observed in 50% of patients is associated with an increased risk of toxicity (heart toxicity)\r in a specific subgroup (Her2+++).\r\n\r Development of the cohort The13250 patients will be recruited in 20 cancer centers, maximum\r in France. The project will start with 14 centers and will further be expanded to 6\r additional centers. These patients will be followed for at least 5 years in the context of\r the cohort. After 5 years, additional specific data will then be captured each year.\r\n\r Patients will be included at the time of diagnosis, before any cancer specific treatment.\r After having signed informed consent, the patient will fill a first questionnaire for\r demographics (adapted from French DREES reference study) and living conditions, and a set of\r validated questionnaires related to QoL (BR 23) and special psychological dimensions. In\r addition, blood samples will be collected at baseline.\r\n\r The toxicities (events) will start to be collected 3 months after the end of \"acute\"\r treatment (surgery/adjuvant/chemotherapy/radiation therapy). Toxicity data will also be\r collected at the time of the last chemotherapy. Toxicities will be collected each 6 months,\r alternatively by a dedicated nurse and by the patient herself. Three sets of toxicities will\r be collected.\r\n\r - First, predefined and previously described toxicities will be collected on dedicated\r items in the case report form.\r\n\r - Second, unknown toxicities will be captured by the use of a patient's notebook where\r each patient will collect events and doctor' visits (general practitioner or organ\r specialist). This will allow capturing events that have not previously been associated\r with cancer treatment toxicities.\r\n\r - Finally, objective measurements by paraclinic exams will be done. This includes yearly\r blood tests and a heart ultrasonography at 1 and 5 years.\r\n\r In addition to the data collection, a baseline blood sample for genetic analyses will be\r done, and serum samples will be collected at baseline and yearly during 5 years (serum).\r\n\r Outcome data will also be collected and will include metastatic relapse (+ site),\r locoregional relapse (+ site) and death.\r\n\r SPECIFIC AIM II: TO DESCRIBE INCIDENCE, CLINICAL PRESENTATION, BIOLOGICAL CHARACTERISTICS AND\r OUTCOME OF CHRONIC TOXIC EVENTS\r\n\r This specific aim will follow three goals :\r\n\r - First, the investigators will describe the incidence of predefined chronic toxicities\r according to the treatment received.\r\n\r - Second, the investigators will aim at identifying new treatment-related toxicities. This\r information will be captured through a dedicated notebook where each patient will report\r all health and social related events.\r\n\r - Finally, the investigators will also assess the outcome of each adverse event, and try\r to develop some hypotheses to be addressed in further clinical trials.\r\n\r SPECIFIC AIM III: TO DESCRIBE THE PSYCHOLOGICAL AND THE SOCIAL IMPACTS OF TOXIC EVENTS This\r specific aim will be split in two parts: a. to describe the psychological and the social\r impact to the patient, b. to describe the impact at the population level.\r\n\r To describe psychological and social impact for the patient\r\n\r Using robust well validated methods, subjective and objective dimensions of wellbeing will be\r investigated, that is: a. Quality of life b. Living conditions c. Psychosocial issues.\r\n\r Quality of life Global perception of quality of life will be assessed through both SF-36,\r QLQ-C30 and BR 23.\r\n\r Social impact Living conditions will be assessed through a questionnaire derived from the\r French DRESS reference study on living conditions. The initial questionnaire was designed by\r DRESS to investigate the social, economical, professional condition two years after the\r diagnosis of cancer: back or abandonment of the initial professional/social activity,\r conversion, income trends, etc.\r\n\r Psychological impact This part will focus on psychological functioning, including\r psychological impact of chronic toxicities and psychological impact of cancer itself.\r Psychological impact is mainly expected on emotional issues, cognitive disorders, body image\r and sexual disorders.\r\n\r To describe the impact on the society This sub-aim will mainly focus on medico-economics and\r will assess the global impact of treatment toxicity on health economy. The quantification of\r costs related to toxicities is a major challenge since it could allow to identify avoidable\r major source of expenses and could allow better tailoring treatment accordingly. Specific\r partnerships are being developed with the French social security and other public/private\r partners in order to accurately quantify toxicity-related cost.\r\n\r SPECIFIC AIM IV TO DEVELOP PREDICTORS FOR CHRONIC TOXICITIES In the present specific aim, the\r goal will be to develop molecular/biologic predictors for toxic events. In as many cases as\r possible, the investigators will split the cohort into a discovery set and a test set, or\r will identify a cross-validating series before doing analyses.\r\n\r Ultimately, the goal is to develop multiparametric scores to predict the occurrence of\r toxicity.\r\n\r Regarding molecular predictors, it is planned that 20 ml blood will be collected yearly. One\r sample at baseline will be dedicated to single nucleotide polymorphism (SNP) arrays and\r validation of candidate genetic variants.\r\n\r A number of tests are already planned. First, we will investigate conventional biological\r parameters including endocrine tests (cortisolemia, TSH, estradiol levels, mullerian\r hormone…), metabolic test (including lipidemia), hematologic tests, liver function, immune\r function (assessed by lymphocyte counts). Second, more recent and under investigation tests\r will be added including troponin (heart failure), mullerian hormone, bone resorption markers\r (bone loss), RANK / RANKL, osteoprotegerin (bone loss).\r\n\r Finally, it is planned to use the baseline sample for the discovery of genetic tests and to\r use the serum for the discovery of biochemical predictors.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Women,\r\n\r - Aged 18 years and over,\r\n\r - With an invasive breast cancer diagnosed by cytology or histology,\r\n\r - Tumors cT0 to cT3, CN0-3,\r\n\r - No clinical evidence of metastasis at the time of inclusion,\r\n\r - Untreated including scored for breast cancer surgery in progress,\r\n\r - Patient receiving a social security system,\r\n\r - Patient mastering the French language,\r\n\r - Free and informed consent for additional biological samples, different questionnaires\r and collecting information on resource usage.\r\n\r Exclusion Criteria:\r\n\r - Metastatic breast cancer,\r\n\r - Local recurrence of breast cancer,\r\n\r - History of cancer within 5 years prior to entry into the trial other than basal cell\r skin or carcinoma in situ of the cervix,\r\n\r - Already received treatment for breast cancer ongoing,\r\n\r - Blood transfusion performed for less than six months,\r\n\r - Persons deprived of liberty or under supervision (including guardianship).\n\nPatient 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
535	[ { "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\nDeveloping and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients\n\nClinical Trial Summary:\n\nWhile thyroid cancer is generally associated with a favourable prognosis, there is a\r discrepancy with how important if not traumatic its impact can be on patients. Quality of\r life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an\r optimal period for a preventive intervention. The goal of this study is to evaluate the\r impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid\r cancer patients, including a dedicated nurse who will provide important psychoeducational\r elements identified in previous focus group studies of thyroid cancer patients, i.e.,\r information on: the physical illness; the emotional impact of being newly diagnosed with\r thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine\r treatments and its associated safety precautions, nutrition and dietary considerations; and\r how the cancer diagnosis can be an opportunity to make important lifestyle changes and\r establish new life-priorities.\n\nClinical Trial Detailed Description:\n\nThe investigators will conduct a 2-arm Randomized Controlled Trial comparing an\r Interdisciplinary Team-Based Care Approach to usual care.\r\n\r The primary research question will be: Does adding the Interdisciplinary Team-Based Care\r Approach (ITCA-ThyCa) to usual care (EG) increase levels of overall QoL among newly diagnosed\r thyroid cancer patients, compared with those receiving usual care (UC), at 9 months\r post-randomization (i.e., after all of the dedicated-nurse meetings are administered) as\r judged by scores on the Functional Assessment of Chronic Illness Therapy-General (FACT-G)?\r Primary hypothesis: The EG will report higher scores of overall QoL on the FACT-G than the UC\r at 9 months post-randomization.\r\n\r Secondary research questions: The investigators plan to evaluate ITCA-ThyCa effects on\r secondary outcomes such as level of: physical health (SF-36 Physical Health subscale), mental\r health (SF-36 Mental Health subscale), fatigue (Functional Assessment of Chronic Illness\r Therapy-Fatigue; FACIT-F), anxiety and depression (Hospital Anxiety and Depression Scale;\r HADS), and negative illness perception (Illness Perception Questionnaire - Revised (IPQ-R).\r The investigators also plan to explore ITCA-ThyCa effects on satisfaction with care (16\r questions of the NRC Picker satisfaction survey measuring patient satisfaction with care) and\r healthcare service use (types of professionals consulted, frequency of visits, and time\r elapsed between referral and first consultation). Hypotheses: The EG will report a higher\r level of physical and mental health on the SF-Physical and Mental Health subscales,\r respectively; and a lower level of fatigue on the FACIT-F, anxiety and depression on the\r HADS, and negative illness perception on the IPQ-R; compared with the UC at 9 months\r post-randomization.\r\n\r All of the abovementioned changes will be present throughout the treatment, namely at 7-10\r days and 5 months post-randomization (i.e., immediately after each of the meetings planned\r with the dedicated nurse).\r\n\r All of the abovementioned changes will persist at 12 months post-randomization (i.e.,\r corresponding to 6 months after all anti-cancer treatments are completed and 3 months after\r all dedicated-nurse meetings have been administered).\r\n\r Feasibility and acceptability (9 first months of the trial):\r\n\r The investigators plan on testing the feasibility and acceptability of the 2-arm RCT of\r ITCA-ThyCa during the first 9 months of the trial (once the investigators start recruiting,\r after the first 3-6 months dedicated to hiring our personnel and developing the manual of our\r approach). During this phase, the investigators will aim to address the following research\r questions:\r\n\r 1. Can the investigators recruit a sufficient number of patients (i.e., a minimum of 60\r patients over 6 months or 10/month) and retain a sufficient proportion of thyroid cancer\r patients (i.e., at least 80% at 7-10 days, 5 months or 9 months post-randomization) in\r both trial arms?\r\n\r 2. Is ITCA-ThyCa acceptable to at least 80% of EG thyroid cancer patients? Secondary pilot\r study questions\r\n\r 3. Which evaluation time should be primary post-randomization, based on an acceptable\r retention rate of 80%?\r\n\r 4. What variance estimates can be used to inform calculation of sample size for the full\r study?\r\n\r If the design remains the same following this pilot, the investigators aim to roll in the\r pilot data in the full trial.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis\r (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary\r type; TNM classification system);\r\n\r - Willing to participate in the EG meetings;\r\n\r - >18 years;\r\n\r - Alert and capable of giving free and informed consent;\r\n\r - Able to speak and read English or French.\r\n\r Exclusion Criteria:\r\n\r - Anaplastic thyroid cancer;\r\n\r - Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC)\r or referring physician) or expected survival <6 months according to clinical judgment.\n\nPatient 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
536	[ { "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\nPain in Women With Chronic Pelvic Pain\n\nClinical Trial Summary:\n\nChronic pelvis pain is very common between adult women. Significant progress is made in\r clarifying the multifactorial model of chronic pain pathogenesis, but a more complete\r assessment is important in order to improve the therapeutic approach. The purpose of this\r study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.\n\nClinical Trial Detailed Description:\n\nChronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at\r least 6 months. This pain interfere with habitual activities and requires clinical or\r surgical treatment. It is a complex interaction between the gastrointestinal, urinary,\r gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological\r factors. Its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14\r to 24% among women of reproductive age. It is very important a multidimensional approach in\r order to stablish a more specific profile.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Women.\r\n\r - Clinical diagnosis of chronic pelvic pain.\r\n\r - More than eighteen years.\r\n\r - Non-menstrual or noncyclic pelvic pain.\r\n\r - Duration of pain of at least 6 months.\r\n\r Exclusion Criteria:\r\n\r - Duration of pain less than 6 months.\r\n\r - Women who were pregnant in the last 12 months\n\nPatient 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
537	[ { "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\nAngiography Study of BioNIR Drug Eluting Stent System (NIREUS)\n\nClinical Trial Summary:\n\nThe NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR\r Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison\r to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute).\r\n\r The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary\r endpoint of angiographic in-stent late loss at 6 months.\n\nClinical Trial Detailed Description:\n\nThis is a prospective, multi-center, single-blind, two-arm, 2:1 randomized clinical trial.\r\n\r Randomization will be stratified by the presence of medically treated diabetes vs. no\r medically treated diabetes and by site. Lesions planned to be treated must be declared and\r recorded at time of randomization.\r\n\r Angiographic follow-up will be performed at 6 months. Clinical follow-up will be performed at\r 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization.\r\n\r The Primary Endpoint is in-stent late loss at 6 months as measured by the angiographic core\r laboratory.\r\n\r Angiographic Secondary Endpoints to be evaluated at 6 months are:\r\n\r - In-segment late loss\r\n\r - Follow-up percent diameter stenosis (in-stent and in-segment)\r\n\r - Binary restenosis (in-stent and in-segment)\r\n\r - Length and patterns of angiographic restenosis (Mehran classification)\r\n\r Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5\r years, except as noted, are:\r\n\r - Device, Lesion, and Procedure Success at time of baseline procedure\r\n\r - Target lesion failure (TLF; the composite of cardiac death, target vessel-related MI, or\r ischemia-driven TLR)\r\n\r - Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or\r ischemia-driven TLR)\r\n\r - Target vessel failure (TVF; the composite rate of death, target vessel-related MI, or\r ischemia-driven TVR)\r\n\r - Overall Mortality\r\n\r - Cardiac Death\r\n\r - Myocardial Infarction\r\n\r - Target Vessel Related MI\r\n\r - Ischemia-driven TLR\r\n\r - Ischemia-driven TVR\r\n\r - Stent Thrombosis (ARC definite and probable)\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age ≥ 18 years\r\n\r - Patient with an indication for PCI including angina (stable or unstable), silent\r ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis\r of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI,\r or recent STEMI. For STEMI the time of presentation to the first treating hospital,\r whether a transfer facility or the study hospital, must be >24 hours prior to\r randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both\r enzyme levels have peaked.\r\n\r - Non-target vessel PCI are allowed prior to randomization depending on the time\r interval and conditions as follows:\r\n\r a. During Baseline Procedure: i. PCI of non-target vessels performed during the\r baseline procedure itself immediately prior to randomization if successful and\r uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI\r Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment\r changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.\r\n\r b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see exclusion\r criteria #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target\r vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as\r defined above.\r\n\r ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the\r baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12\r hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above\r the local laboratory upper limit of normal, serial measurements must demonstrate that the\r biomarkers are falling.\r\n\r d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed\r greater than 30 days prior to procedure whether or not successful and uncomplicated.\r\n\r - Patient or legal guardian is willing and able to provide informed written consent and\r comply with follow-up visits and testing schedule.\r\n\r Angiographic inclusion criteria (visual estimate):\r\n\r - Treatment of up to three de novo target lesions, maximum of one de novo target lesion\r per vessel\r\n\r - Target lesion(s) must be located in a native coronary artery with visually estimated\r diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100%.\r\n\r - Lesion must be ≤28 mm long and can be covered by a single study stent with maximum\r length of 33 mm (note: multiple focal stenoses may be considered as a single lesion\r and be enrolled if they can be completely covered with one stent).\r\n\r - TIMI flow 2 or 3\r\n\r - If more than one target lesion will be treated, the RVD and lesion length of each must\r meet the above criteria.\r\n\r Exclusion Criteria:\r\n\r - Planned procedures after the baseline procedure in either the target or non-target\r vessels.\r\n\r - STEMI within 24 hours of initial time of presentation to the first treating hospital,\r whether at a transfer facility or the study hospital or in whom enzyme levels (either\r CK-MB or Troponin)have not peaked.\r\n\r - PCI within the 24 hours preceding the baseline procedure and randomization.\r\n\r - Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.\r\n\r - History of stent thrombosis.\r\n\r - Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90\r mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support,\r including IABP.\r\n\r - Known LVEF <30%.\r\n\r - Subject is intubated.\r\n\r - Relative or absolute contraindication to DAPT for 12 months (including planned\r surgeries that cannot be delayed, or subject is indicated for chronic oral\r anticoagulant treatment).\r\n\r - Hemoglobin <10 g/dL.\r\n\r - Platelet count <100,000 cells/mm3 or >700,000 cells/mm3.\r\n\r - White blood cell (WBC) count <3,000 cells/mm3.\r\n\r - Clinically significant liver disease.\r\n\r - Renal disease as defined by an estimated creatinine clearance <40 mL/min using\r Cockcroft-Gault equation.\r\n\r - Active peptic ulcer or active bleeding from any site.\r\n\r - Bleeding from any site within the prior 8 weeks requiring active medical or surgical\r attention.\r\n\r - History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions.\r\n\r - If femoral access is planned, significant peripheral arterial disease which precludes\r safe insertion of a 6F sheath.\r\n\r - Cerebrovascular accident or transient ischemic attack within the past 6 months, or any\r permanent neurologic defect attributed to CVA.\r\n\r - Known allergy to the study stent components, whether in the BioNIR or Resolute, e.g.\r cobalt, nickel, chromium, molybdenum, Carbosil®, PBMA, Biolinx polymer, or limus drugs\r (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or\r any other analogue or derivative or similar compounds).\r\n\r - Known allergy to protocol-required concomitant medications such as aspirin, or DAPT\r (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated\r contrast that cannot be adequately pre-medicated.\r\n\r - Any co-morbid condition that may cause non-compliance with the protocol (e.g.\r dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g.\r cancer, severe heart failure, severe lung disease).\r\n\r - Patient is participating in or plans to participate in any other investigational drug\r or device clinical trial that has not reached its primary endpoint.\r\n\r - Women who are pregnant or breastfeeding (women of child-bearing potential must have a\r negative pregnancy test within one week before treatment).\r\n\r - Women who intend to become pregnant within 12 months after the baseline procedure\r (women of child-bearing potential who are sexually active must agree to use a reliable\r method of contraception from the time of screening through 12 months after the\r baseline procedure).\r\n\r - Patient has received an organ transplant or is on a waiting list for an organ\r transplant.\r\n\r - Patient is receiving or scheduled to receive chemotherapy within 30 days before or any\r time after the baseline procedure.\r\n\r - Patient is receiving oral or intravenous immunosuppressive therapy or has known\r life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are\r allowed.\r\n\r Angiographic Exclusion Criteria (visual estimate):\r\n\r - Unprotected left main lesions ≥30%, or planned left main intervention.\r\n\r - Stenting of ostial LAD or LCX lesions (stenting of any diseased segment within 5 mm of\r the unprotected left main coronary artery).\r\n\r - Lesions located within an arterial or saphenous vein graft or distal to a diseased\r arterial or saphenous vein graft.\r\n\r - Moderately or heavily calcified lesions.\r\n\r - Moderately or heavily tortuous or angulated lesions or vessels.\r\n\r - Bifurcation lesions in the presence of a side branch ≥2.0 mm in diameter.\r\n\r - Lesions containing thrombus.\r\n\r - Total occlusions.\r\n\r - In-stent restenotic lesions or lesions present within 10 mm of a previously implanted\r stent.\r\n\r - Lesions requiring pre-dilatation with any device other than simple balloon angioplasty\r (e.g. atherectomy or cutting/scoring balloons).\r\n\r - Another lesion in the target vessel is present that requires or has a high probability\r of requiring PCI during the baseline procedure or within 6 months after the baseline\r procedure.\n\nPatient 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
538	[ { "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\nNon-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation\n\nClinical Trial Summary:\n\nThe overall objective of this proposal is to examine the feasibility and accuracy of\r non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals\r referred for transcatheter aortic valve implantation (TAVI).\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Adults with severe aortic stenosis referred for possible transcatheter aortic valve\r implantation with clinically indicated computed tomography imaging\r\n\r Exclusion Criteria:\r\n\r - Inability or unwillingness to consent\r\n\r - Inability to complete magnetic resonance imaging (MRI) study\r\n\r - Contraindication to MRI\r\n\r - Participation in another research study\r\n\r - Non-diagnostic computed tomography scan\n\nPatient 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
539	[ { "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 Outcome of Patients With Low-gradient Severe Aortic Stenosis\n\nClinical Trial Summary:\n\nTo assess the ability of baseline clinical parameters and imaging modalities to predict short\r and long term left ventricular function and clinical outcome of subjects with low-gradient,\r severe aortic stenosis.\r\n\r To assess the impact of aortic valve replacement as compared to medical therapy on clinical\r outcome of patients with low-gradient, severe aortic stenosis.\r\n\r To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities\r on the assessment of AS severity and definition of low gradient severe aortic stenosis.\n\nClinical Trial Detailed Description:\n\nTo assess the ability of baseline clinical parameters and imaging modalities to predict short\r and long term left ventricular function and clinical outcome of subjects with impaired left\r ventricular function and / or low-gradient, severe aortic stenosis.\r\n\r To assess the impact of aortic valve replacement as compared to medical therapy on clinical\r outcome of patients with impaired left ventricular function and / or low-gradient, severe\r aortic stenosis.\r\n\r To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities\r on the assessment of AS severity and definition of low gradient severe aortic stenosis.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area\r of 0.6 cm2/m2 and low gradient (mean gradient across the aortic valve <40 mmHg) by\r echocardiography\r\n\r 2. Symptomatic patients with aortic stenosis referred for medically indicated AVR\r\n\r 3. Signed informed consent to participate in the study.\r\n\r Exclusion Criteria:\r\n\r 1. Pregnancy or breast feeding (women of childbearing potential will have a serum or\r urine pregnancy test).\r\n\r 2. Need for emergency surgery for any reason.\r\n\r 3. Any case in which the practicing physician asserts that enrollment in the protocol\r will adversely affect the patient treatment course.\n\nPatient 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
540	[ { "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\nExercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.\n\nClinical Trial Summary:\n\nDetecting abnormalities in the left ventricular mechanical and hemodynamic response to the\r stress of exercise may offer early diagnostic indicators in patients suffering from valvular\r disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining\r importance in providing prognosis among those patients. However, decreased signal to noise\r ratio in the images and increased motion-related artifacts during exercise stress\r echocardiography have been reported, with a lack of reproducibility of results and a the\r limitation of its availability only in reference centers. In our laboratory, we are able to\r perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end\r of the patient table, previously described in healthy volunteers.\r\n\r The first aim of our study is to demonstrate the safety and the feasibility of our MRI\r protocol in selected patients with asymptomatic severe organic mitral regurgitation, to\r assess left ventricular volumes and function, and regurgitant volume in comparison to\r exercise cardiac echography.\r\n\r Besides, few recent studies sustain the relevance of novel markers of central aortic function\r (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore\r vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the\r premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic\r stiffness would be useful for risk assessment and preventive follow-up strategies in young\r asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and\r non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore,\r this technique should be able to evaluate the effect of drugs on aortic stiffness change in\r trials, before and after drug therapy, more relevant than the classic change in aortic\r diameter measurement.\r\n\r The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate\r local and regional heterogeneity in aortic functional parameters (distensibility, compliance\r and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by\r MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and\r to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave\r velocity estimation by applanation tonometry.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Autonomous ADULT patient,\r\n\r patient Marfan:\r\n\r - under their usual treatment(processing) (including ß blocking)\r\n\r - diagnosis confirmed by the molecular biology (transfer(transformation) of the gene\r FBN1)\r\n\r - Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta on an\r echocardiography or an imaging in cups(cuttings) dating less than 6 months.\r\n\r PATIENT Aortic bicuspid :\r\n\r - Diagnosis confirmed by cardiac echography and/or imaging in cups(cuttings)\r\n\r - Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta, and absence of\r valvulopathy aortic significant (IA of rank I in II, absence of significant RA), on\r the echocardiography or the imaging in cups(cuttings) dating less than 6 months.\r\n\r patients Insufficiency mitral organic moderated in severe asymptomatic:\r\n\r - SOR > 30 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than\r 6 months\r\n\r - Absence of ischemic or functional cause\r\n\r - Patient recovering from a functional evaluation by echography of effort\r\n\r patients Insufficiency mitral organic severe surgical\r\n\r - SOR > 40 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than\r 6 months\r\n\r - Absence of ischemic or functional cause\r\n\r - Status functional: stage(stadium) II of the NYHA\r\n\r - Patient recovering from a functional evaluation by echography of effort\r\n\r Volunteer healthy :\r\n\r - affiliated to the Social Security\r\n\r - having given its agreement by signed consent\r\n\r - not presenting contraindication to the realization of a MRI\r\n\r Exclusion Criteria:\r\n\r - Patient claustrophobic,\r\n\r - patient refusing the protocol or the examination\n\nPatient 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
541	[ { "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\nFinding Early Predictors of Myocardial Dysfunction\n\nClinical Trial Summary:\n\nThe study objective is to clarify the grounds of heart exertional dyspnoea stenocardia in\r patients with well-controlled stage I or II hypertension according to European Society of\r Hypertension, without changes in epicardial coronary arteries in CT coronary angiography and\r normal resting echocardiography result, and to assess of potential early markers of heart\r hypertrophy and failure in patients with hypertension.\n\nClinical Trial Detailed Description:\n\nThe study is to allow for identification of patients with hypertension, in whom an early\r introduction of pharmacological treatment of heart failure HF should be considered.\r Evaluation in the detection of asymptomatic myocardial dysfunction will include potential\r heart failure markers such as: cardiotrophin 1, cystatin C, serum syndecan-4, collagen III\r N-terminal propeptide [PIIINP], NT-proBNP, IL1RL1 and modern echocardiography methods in\r order to increase the effectiveness of prevention, diagnosis and treatment optimalization.\r\n\r Material and study plan about 100 persons (age 30-70 years old) will be included in the\r study, patients with stage I or II primary hypertension according to the European Society of\r Hypertension: Group A- 15 patients without symptoms of heart failure Group B- 30 patients\r with exertional dyspnoea Group C - 40 patients with overt heart failure\r\n\r In group B (patients with exertional dyspnea/stenocardia) we will include only patients who\r have undergone CT coronary angiography without any identified changes in the epicardial\r coronary arteries, which will facilitate answering the presented purpose of research.\r Patients in groups A and B with normal resting echocardiography and treated with a maximum of\r 2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base), according to the\r following regimen:\r\n\r ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance\r with the standards for heart failure. Each patient will be informed about the objectives of\r the study and give written consent to participate.\r\n\r After signing informed consent patients will have performed the following tests:\r\n\r - Interview and documentation analysis,\r\n\r - Physical examination,\r\n\r - Electrocardiogram\r\n\r - Echocardiography at rest and during submaximal exercise on a bicycle ergometer\r\n\r - Levels of markers: cystatin C, cardiotrophin-1, Procollagen III N-Terminal Propeptide\r (PIIINP), Syndecan 4 (SDC4) and NT-proBNP, IL1RL1. Each patient will be informed about\r the objectives of the study and give written consent to participate.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - persons (age 30-70 years old) will be included in the study, patients with stage I or\r II primary hypertension according to the European Society of Hypertension\r\n\r Exclusion Criteria:\r\n\r - with coronary artery disease or a history of coronary artery disease (A, B)\r\n\r - with unstable hypertension\r\n\r - with a positive stress test\r\n\r - with NYHA class III-IV heart failure\r\n\r - after percutaneous or surgical revascularization\r\n\r - with diabetes\r\n\r - with GFR < 60\r\n\r - with hyperthyroidism and hypothyroidism\r\n\r - active smokers\r\n\r - with an implanted pacemaker\r\n\r - with obesity level II and III\r\n\r - with ECG-arrhythmia\r\n\r - pregnant and lactating\r\n\r - with congenital heart disease\r\n\r - with hemodynamically significant acquired heart defects\r\n\r - with cardiomyopathies (A,B)\r\n\r - with cancer\r\n\r - with anemia\r\n\r - abusing alcohol or drugs\r\n\r - with chronic inflammatory and other diseases\r\n\r - or who have not given their informed consent to participate in the study\n\nPatient 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
542	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nThe Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease\n\nClinical Trial Summary:\n\nObstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous\r study has suggested that OSA significantly increases cardiovascular morbidity and mortality,\r especially in patients with pre-existing cardiovascular disease.The standardized treatment of\r moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term trials\r indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies have a\r relative short duration with only but few more than one year. In our opinion, they are not\r sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact of OSA\r on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could\r reduce blood pressure and improve metabolic disorder in patients with coronary heart disease\r (CHD)and OSA.\n\nClinical Trial Detailed Description:\n\nObstructive sleep apnea (OSA) is a common disorder characterized by repetitive partial\r (hypopnea) or complete (apnea) occlusion of the upper airway during sleep caused by collapse\r of the pharyngeal airway, resulting in sleep fragmentation and oxyhemoglobin desaturation.\r Kiely and colleague's study showed that over 20% of hypertensive patients exhibit OSA,\r whereas prevalence of hypertension in the setting of OSA exceeds 50%. One study confirmed\r that OSA is an important identifiable cause of hypertension. OSA is considered as one of the\r most common risk factors of resistant hypertension. Previous study has suggested that OSA\r significantly increases cardiovascular morbidity and mortality, especially in patients with\r pre-existing cardiovascular disease. Several studies confirmed that CPAP reduced systolic\r blood pressure (SBP) and diastolic blood pressure (DBP) in patients with OSA. Additionally,\r some papers reported that there was a protective effect of CPAP therapy against death from\r cardiovascular disease in patients with severe OSA. Other researches regarding the\r antihypertensive effect of CPAP therapy, however, showed that CPAP had no antihypertensive\r effect. But relevant studies have a relative short duration with only but few more than one\r year. In our opinion, they are not sufficient to detect the real effect of CPAP on reduction\r in BP. According to our knowledge, there is no report about long-term effect of CPAP on BP in\r hypertensive patients with coronary revascularization (CRV) and OSA under conventional\r antihypertensive medications. Therefore, we conducted a long-term, prospective controlled\r study to investigate the effects of CPAP on BP, metabolic disorder, clinical symptoms,\r cardiovascular and cerebrovascular events in patients with CHD and OSA on conventional\r treatment.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - men and women, aged 45 to 75 years old\r\n\r - verified diagnosis of hypertension by medical history or receiving antihypertensive\r drugs\r\n\r - established diagnosis of CHD\r\n\r - at least 3-month optimal treatment for hypertension\r\n\r - moderate or severe OSA\r\n\r Exclusion Criteria:\r\n\r - if they had secondary hypertension\r\n\r - central sleep apneas\r\n\r - history of significant chronic renal, or hepatic failure or severe pulmonary disease\r\n\r - diagnosed with malignant cancer with a life expectancy of less than 2years\r\n\r - regular use of medications that can affect BP(including corticosteroids or sedative\r drugs)\r\n\r - severe psychiatric disease\r\n\r - sustained excessive alcohol use\r\n\r - current use of CPAP treatment for OSA or pharyngeal surgery for OSA\r\n\r - New York Heart Association Class III-IV degree\r\n\r - declined to participate or were unable to give informed consent\n\nPatient 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
543	[ { "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\nEndothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity\n\nClinical Trial Summary:\n\nThere is a correlation between endothelial progenitor cells (stem cells) and stenosis of the\r aortic valve.\n\nClinical Trial Detailed Description:\n\nDegenerative aortic valve (AV) stenosis (AS) is the most common valvular disease and\r increases in prevalence with age. Severe aortic valve stenosis accounts for considerable\r disease and death, especially in older patients. Aortic valve stenosis is the primary\r indication for valve replacement in western countries, and the number will only increase as\r elderly people are a growing subpopulation. Measures to identify AV disease earlier, to\r identify factors that influence disease progression and treat AV disease pharmacologically or\r with less invasive approaches would be a significant improvement over the current standard of\r care. These advances will only be possible with a better understanding the mechanisms\r underlying valve development and disease. Preliminary data suggest a novel pathophysiological\r concept for impaired valvular endothelial cells regeneration, leading to the progression of\r age-associated calcific AV disease and a potential treatment target is the disrupted\r endothelial cell layer of the valve leaflet.\r\n\r The research objectives are:\r\n\r 1. To assess the number and function of endothelial progenitor cellss and apoptotic\r endothelial progenitor cellss in patients with mild, moderate and severe aortic\r stenosis.\r\n\r 2. To study the association between aortic stenosis progression, severity, symptoms and\r left ventricular function and the number and function of circulating endothelia\r progenitor cells. By understanding the correlation between valve severity, left\r ventricular longitudinal function and endothelial progenitor cells we will indentify\r high risk patients population that need early intervention. We hope to add new\r information on the pathogenesis of aortic stenosis and to indentify factors that predict\r disease progression.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients with Aortic stenosis\r\n\r - Control with aortic stenosis\r\n\r Exclusion Criteria:\r\n\r - No\n\nPatient 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
544	[ { "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\nEfficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation\n\nClinical Trial Summary:\n\nA prospective, non-randomized, multi-center clinical study of the Venus P-valve for the\r treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart\r defect.\n\nClinical Trial Detailed Description:\n\nThe aim of this protocol is to assess the efficacy, safety and performance of Venus P-valve.\r\n\r Patients between 18-60 years with RVOT stenosis and moderate to severe pulmonary\r regurgitation (≥3+) who have undergone trans-annular patch repair of their RVOT, cardiac\r magnetic resonance (CMR) screening right ventricular end-diastolic volume index (RVEDVI)\r between 130-160mL/m2.\r\n\r Post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - RVOT stenosis who have undergone transannular patch repair with moderate to severe\r pulmonary regurgitation\r\n\r - Isotopic or CMR criteria of RVEDVI≥130mL/m2 and ≤160mL/m2\r\n\r - Age≥18 years and ≤60 years (Zhongshan Hospital age≥18 years and ≤60 years\r\n\r - Body weight≥18 kg\r\n\r - Pulmonary annular diameter between 14mm to 31mm\r\n\r - RVOT length≥20mm\r\n\r - The subject or his/her legal representative has provided written informed consent\r\n\r - Subject will comply with protocol required follow-ups\r\n\r Add any of the following conditions:\r\n\r - Subject is symptomatic\r\n\r - Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI\r\n\r - ≥3+ pulmonary regurgitation by echocardiograms\r\n\r - Deteriorating RVEF%\r\n\r - Progressive tricuspid valve regurgitation (at least moderate degree)\r\n\r - Complicated with RVOT obstruction (RV systolic pressure>80mmHg)\r\n\r - Persistent arrhythmias\r\n\r Exclusion Criteria:\r\n\r Candidates will be excluded from the study if any of the following conditions are present:\r\n\r - Existing pulmonary artery branch stenosis or artificial pulmonary valve\r\n\r - Severe chest wall deformity\r\n\r - ADHF\r\n\r - Active infection or endocarditis requiring antibiotic therapy\r\n\r - Leukopenia (WBC<3000mm3)\r\n\r - Acute or chronic anemia (Hb<9g/L)\r\n\r - Platelet account <100,000 cells/mm3\r\n\r - In the judgment of the investigator, percutaneous introduction and delivery of the\r valve is not feasible\r\n\r - A known hypersensitivity to aspirin or heparin\r\n\r - Positive urine or serum pregnancy test in female subjects\r\n\r - Ileofemoral vessel characteristics that would preclude safe placement of introducer\r sheath\n\nPatient 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
545	[ { "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\nHAART 200 Aortic Valve Annuloplasty Trial\n\nClinical Trial Summary:\n\nThe HAART 200 \"Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction\" Trial is a\r prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of\r the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve\r annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic\r insufficiency (AI).\n\nClinical Trial Detailed Description:\n\nAortic valve disease is the most common valvular heart disease with approximately 200,000\r patients per year undergoing conventional aortic valve replacement in North America and\r Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency,\r which is the failure of the aortic valve to close completely during diastole, causing blood\r to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in\r a fourth to a third of patients coming to surgical intervention, and constitutes a very\r important subset. Several conditions are associated with bicuspid disease, including\r ascending aortic or root aneurysms in up to a third.\r\n\r Traditional management of aortic valve and root disease has been with aortic valve\r replacement, with or without root replacement (Bentall Procedure). However, as has been\r observed in patients with mitral valve repair, the option of maintaining one's reconstructed\r native valve versus a replacement, either bioprosthetic or mechanical, can have multiple\r benefits. The advantages of repair include: the avoidance of prosthetic valve related\r complications and structural degeneration with bioprosthetic valves over 10-15 years and\r elimination of the need for anticoagulation and related problems with mechanical valves in\r younger patients. The significantly lower rate of endocarditis after repair is a major\r impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently\r is established as an excellent option for patients with BAV. However, with connective tissue\r disorders being an inherent feature of BAV, outcomes have been less stable long-term than for\r trileaflet repair, primarily because of late annular redilatation in BAV disease.\r\n\r Therefore, this study is designed to evaluate the safety and effectiveness of annular\r stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid\r aortic valve for predominant aortic insufficiency.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. The subject is 18 years of age or older\r\n\r 2. The subject has bi-leaflet aortic valve morphology\r\n\r 3. The subject has documented aortic valve disease which may or may not include:\r\n\r - Aortic valve insufficiency\r\n\r - Ascending aortic or aortic root pathology\r\n\r - Other pathology of the ascending aorta that requires elective aortic replacement\r\n\r - Associated stable one or two vessel coronary disease requiring concomitant\r coronary bypass\r\n\r - Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who\r are undergoing re-repair because of annular re-dilatation\r\n\r - All bicuspid annular and leaflet configurations will be included\r\n\r 4. The subject needs:\r\n\r - correction of BAV annular dilatation in patients with chronic AI and dilated\r annulus\r\n\r - restoration of a circular annular shape in patients with bicuspid valve and\r expansion of sinus to sinus dimensions\r\n\r - stabilization of annular geometry long-term in rare bicuspid valve patients with\r severe AI and minimal annular dilatation\r\n\r 5. The is willing to comply with specified follow-up evaluations, including\r transesophageal echocardiography (TEE) if there are inadequate images by transthoracic\r echocardiography (TTE) to assess the aortic valve\r\n\r 6. The subject has reviewed and signed the written informed consent form\r\n\r 7. The subject agrees to return for all follow-up evaluations for the duration of the\r study (i.e. geographically stable)\r\n\r Exclusion Criteria:\r\n\r 1. All patients will be excluded who require emergency surgery for any reason.\r\n\r 2. All the patients who have had a prior heart valve replacement\r\n\r 3. The subject's aortic valve morphology is not bicuspid.\r\n\r 4. The subject has active endocarditis\r\n\r 5. The subject has mixed stenosis and regurgitation of the aortic valve with predominant\r stenosis\r\n\r 6. Heavily calcified BAV valves, calcified aortic roots, or \"porcelain aortas\"\r\n\r 7. Leukopenia with a White Blood Cell (WBC) of less than 3000\r\n\r 8. Acute anemia with a Hgb less than 9mg%\r\n\r 9. Platelet count less than 100,000 cells/mm3\r\n\r 10. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood\r transfusions\r\n\r 11. Active infection requiring antibiotic therapy (if temporary illness, subjects may\r enroll 2-4 weeks after discontinuation of antibiotics)\r\n\r 12. Subjects in whom transesophageal echocardiography (TEE) is contraindicated\r\n\r 13. Low Ejection Fraction (EF) < 35%\r\n\r 14. Life expectancy < 1 year, or severe comorbidities, such as dialysis or severe Chronic\r Obstructive Pulmonary Disease (COPD)\r\n\r 15. The subject is or will be participating in a concomitant research study of an\r investigational product or has participated in such a study within the 30 days prior\r to screening\r\n\r 16. The subject is a minor, an illicit drug user, alcohol abuser, prisoner,\r institutionalized, or is unable to give informed consent\r\n\r 17. The subject is pregnant or lactating\r\n\r 18. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack\r (TIA)\r\n\r 19. Myocardial Infarction (MI) within one month of trial inclusion\r\n\r 20. The subject has a known intolerance to titanium or polyester\r\n\r 21. The subject has documented unstable or > 2 vessel coronary disease\r\n\r 22. The subject requires additional valve replacement or valve repair\n\nPatient 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
546	[ { "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\nChina National Heart Failure Registry\n\nClinical Trial Summary:\n\nThe purpose of CN-HF is to establish the national registration of hospitalized heart failure\r patients, evaluate and compare the clinical features and prognosis of diastolic and systolic\r heart failure, and find out the status of treatment and implementation of guidelines on heart\r failure in China.\n\nClinical Trial Detailed Description:\n\nThe CN-HF is a national, multi-centered, prospective and observational registry study, led by\r Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital (head unit) with 50 to 100\r secondary and tertiary hospitals involved. The study planed to consecutively enroll 10 000\r heart failure patients fulfilling the inclusion criteria. Each center will register all\r patients with heart failure involved in the discharge or death diagnosis in consecutive 6\r months, and each registered patient will be followed up for at least 3 years. The study\r consists 3 phases: the screening phase, the baseline registry phase, and the follow-up\r registry phase.\r\n\r The data collecting and reporting will employ the combination of paper-based case report form\r (CRF) and web-based electronic CRF. The handwriting paper CRF are provided by the head unit\r as raw data. Investigators in each center should input the raw data into the web-based CRF\r using the login name and password provided by the head unit.\r\n\r The data management center specified by the head unit is responsible for the establishment\r and maintenance of CRF and the central database, the regular check of data submitted and the\r updating of the database. During the data collection, the data management center will also\r regularly check and report errors in the CRF and feedback to each centers and supervise to\r correct errors.\r\n\r At the end of the study, the database will be locked after all data being checked and\r updated. Each participating center will preserve their own copy of paper-based CRF and\r electronic CRF, the head unit will preserve all paper-based CRFs and electronic CRFs.\r\n\r Statistical analysis will be performed by independent statisticians in the head unit\r (Shanghai Institute of Cardiovascular Diseases) using the SAS software. The Student t test or\r chi-square test will be used for comparison between two groups. The Cox proportional hazard\r model will be used to investigate the risk factors for adverse cardiovascular events.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients discharged from the department of cardiology;\r\n\r - Discharge or death diagnosis involves diseases with I50 as the beginning of the\r International Classification of Diseases (ICD)-10 code, including congestive heart\r failure, congestive heart disease, cardiac failure, right side heart failure, right\r side ventricular failure, acute left side heart failure, chronic left side cardiac\r dysfunction, cardiac asthma, left side heart failure, left side heart failure with\r acute pulmonary edema, low cardiac output syndrome, cardiac dysfunction, acute heart\r failure, chronic heart failure, grade Ⅱ cardiac function class, grade Ⅲ cardiac\r function class, grade Ⅱ-Ⅲ cardiac function class, grade Ⅳ cardiac function class,\r heart failure, cardiac-renal failure, circulatory failure, and grade Ⅰcardiac function\r class (I51.903), pregnancy with heart failure (O99.408), pregnancy with cardiac\r dysfunction (O99.429), postpartum cardiac dysfunction (O99.434), post-operative heart\r failure with pulmonary edema (I97.104), and heart failure after cardiac surgery\r (I97.106);\r\n\r - Agree to sign an informed consent form.\r\n\r Exclusion Criteria:\r\n\r - Refuse to sign an informed consent form;\r\n\r - Already involved in this study during previous hospitalization.\n\nPatient 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
547	[ { "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\nProtection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation\n\nClinical Trial Summary:\n\nTranscatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical\r practice, but concerns have been raised regarding periprocedural complications like e.g.\r myocardial injury, stroke or acute kidney injury. Remote ischemic preconditioning (RIPC) with\r upper limb ischemia/reperfusion provides perioperative myocardial protection in patients\r undergoing elective coronary artery bypass surgery. The present study assesses protection of\r heart, brain and kidney by RIPC in patients undergoing TAVI. The study also addresses safety\r and clinical outcome.\n\nClinical Trial Detailed Description:\n\n- On the assumption of our recent data (Thielmann et al, Lancet 2013, 382(9892):597-604),\r we performed a power analysis, revealing an estimated enrollment of 189 patients per\r group. But since no true data exist regarding RIPC and TAVI, interim analysis will be\r performed after 50 patients per group.\r\n\r - After induction of conscious sedation or general anaesthesia, RIPC is accomplished by 3\r cycles of 5 min inflation/5 min deflation of a blood pressure cuff around the left arm\r to 200 mm Hg. In the placebo group, the blood pressure cuff remains uninflated for 30\r min.\r\n\r - Blind: study coordinators, outcome assessors, operators and treating physicians except\r for the attending anaesthetist.\r\n\r - Drugs used for conscious sedation: midazolam, remifentanil.\r\n\r - Drugs used for general anaesthesia: sufentanil, etomidate, rocuronium, isoflurane.\r\n\r - TAVI is performed by standard techniques using the balloon-expandable Sapien XT (Edwards\r Lifesciences Inc., Irvine, California, USA) and the next-generation Sapien 3 stent-valve\r bioprosthesis which replaces the Sapien XT prosthesis, when CE-approved.\r\n\r - Arterial blood samples are obtained prior to and after RIPC-maneuver/Placebo, after\r aortic valve implantation and after access site closure, for biochemical analyses\r focussing on ligands that have been previously implicated in conditioning protocols at\r various organs. A bioassay system, consisting of a Langendorff-perfused isolated heart\r with ischemia and reperfusion will be used. This bioassay system will be exposed to the\r obtained arterial plasma of the patients.\r\n\r - Venous blood samples are drawn before TAVI and at 1, 6, 12, 24, 48 and 72 hours after\r the procedure.\r\n\r - Cardiac and cerebral MRI is performed in selected patients at baseline and within the\r first week after TAVI.\r\n\r - On-site follow-up at 3±3 months, 12±3 months and yearly thereafter.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Adult patients with severe symptomatic native aortic valve stenosis scheduled for\r elective TAVI due to a prohibitive or high risk for surgical aortic valve replacement\r as judged by the institutional heart team based on risk scores and comorbidity\r assessment\r\n\r - Written informed consent\r\n\r Exclusion Criteria:\r\n\r - Life expectancy < 1 year\r\n\r - Patients who are unlikely to gain improvement in their quality of life by TAVI\r procedure\r\n\r - Unfavorable anatomy for TAVI (e.g. inadequate annulus size)\r\n\r - Left-ventricular thrombus\r\n\r - Active endocarditis\r\n\r - Active infection\r\n\r - Acute ST-segment elevation myocardial infarction\r\n\r - Hemodynamic instability\r\n\r - Preoperative troponin I concentration above the upper normal limit of 0.1 ng/ml\r\n\r - Stroke within the last 6 weeks\r\n\r - Acute or chronic hemodialysis\n\nPatient 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
548	[ { "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 Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection\n\nClinical Trial Summary:\n\nAcute aortic dissection (AD) is a deadly, difficult to diagnose disease presenting with an\r array of common and unspecific symptoms. Aortic dissection detection (ADD) risk score is a\r bedside clinical tool to estimate the risk of AD. D-dimer has been evaluated in several\r studies as a biomarker of AD and has showed a pooled diagnostic sensitivity of 97%. However,\r considering the severe morbidity and mortality of AD, a negative d-dimer per se is considered\r insufficient to rule-out AD in unselected patients.\r\n\r The aim of the present study is to evaluate whether the diagnostic performance of d-dimer\r differs in patients at different clinical risk of AD, and in particular whether a negative\r d-dimer test may allow safe rule-out of AD in any patient subgroup without necessity to\r perform urgent aortic imaging.\r\n\r Consecutive adult patients with suspected AD presenting to Emergency Department will be\r enrolled before the establishment of a final diagnosis; a standardized clinical form\r comprehensive of presence/absence of 12 risk markers allowing ADD risk score fulfilled and\r d-dimer levels measured at presentation.\r\n\r The aortic imaging exam used to confirm or refuse of AD will be computed tomography\r angiography or transesophageal echocardiography and final diagnosis established after\r reviewing of all available data.\r\n\r The accuracy, failure rate and efficiency of a diagnostic strategy combining standardized\r clinical stratification via the ADD risk score with d-dimer testing will therefore be\r assessed.\n\nClinical Trial Detailed Description:\n\nAcute AD will include the following etiological entities, also known as acute aortic\r syndromes: acute aortic dissection, intramural aortic hematoma, penetrating aortic ulcer and\r spontaneous aortic rupture.\r\n\r A pre-specified secondary sub-analysis will evaluate the diagnostic accuracy of focus cardiac\r ultrasound (FoCUS) and chest x ray for suspected AD.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age >18 years\r\n\r - Presentation to the ED with any of the following symptoms: chest pain, back pain,\r abdominal pain, syncope or symptoms of perfusion deficit (central nervous system,\r mesenteric, myocardial, or limb ischemia)\r\n\r - Aortic dissection considered among the differential diagnosis by the attending\r physician. Enrollment in the study will be decided by the attending physician during\r evaluation in the ED and before the establishment of a final diagnosis.\r\n\r Exclusion Criteria:\r\n\r - An alternative diagnosis to AD objectively established by the attending physician\r after the initial medical evaluation\r\n\r - Clinical severity or other conditions not allowing complete evaluation/proper\r enrollment\r\n\r - Lack of consent to participate to the study\n\nPatient 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
549	[ { "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 III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol\n\nClinical Trial Summary:\n\nThe objective of this investigation is to compare the cardioprotective effects and safety of\r two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients\r undergoing aortic valve surgery. The study design is a prospective, double blind,\r multicenter, randomized, Phase III comparison study intended to demonstrate superiority in\r surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24\r hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement\r (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively\r (e.g., myocardial infarction).\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients >/= 30 and </= 85 years of age\r\n\r - Male or female with aortic valve disease\r\n\r - Able to understand character and individual consequences of the clinical trial and to\r provide written informed consent to participate in the study\r\n\r - Women of childbearing potential (ie, those who have not undergone a hysterectomy or\r who have not been post-menopausal for at least 12 consecutive months) must test\r negative for pregnancy prior to bypass surgery.\r\n\r Exclusion Criteria:\r\n\r - History of recent (< 6 weeks) Q-wave myocardial infarction\r\n\r - Left ventricular ejection fraction < 25% (as assessed by any one of the following:\r contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)\r\n\r - Patients on intra-aortic balloon devices or with history of previous coronary artery\r bypass surgery\r\n\r - Pregnant or lactating patients\r\n\r - Patients who have participated in any other investigational studies within 30 days\r previous to enrollment\r\n\r - Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour\r despite inotropic and chronotropic support)\r\n\r - Patients with severe chronic obstructive lung disease (FEV1 < 50%)\r\n\r - Previous cardiac valvular disease (clinical relevant)\r\n\r - GFR <60 ml/min\r\n\r - Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double\r valve surgery, other concomitant operations excluding coronary artery bypass surgery\r or closing a patent foramen ovale\r\n\r - Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by\r history or physical examination\r\n\r - History of alcohol abuse, illicit drug use, significant mental illness, physical\r dependence to any opioid, or any history of drug abuse or addiction within 12 months\r of study enrollment.\n\nPatient 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
550	[ { "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\nEfficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia\n\nClinical Trial Summary:\n\nThe purpose of this study is to investigate the efficacy and safety of dietary supplements\r (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic\r smokers having mild to moderate hyperlipidemia after 30 days of intervention.\n\nClinical Trial Detailed Description:\n\nIn a randomized, double-blind, placebo control trial, the efficacy and safety of dietary\r supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers\r having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive\r the dietary supplements and placebo for 30 days. The efficacy of the supplements will be\r measured by estimating cotinine and malondialdehyde level.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Men > 20 years\r\n\r Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to\r moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC >200 mg/dL and/or HDL-C <40 mg/dL)\r\n\r Being mentally competent and able to understand all study requirements and sign the\r informed consent form.\r\n\r Exclusion Criteria:\r\n\r Patients with Chronic obstructive pulmonary disease (COPD)\r\n\r Women\r\n\r Patients with severe liver, renal, cardiac or brain diseases.\r\n\r Unable to complete follow up.\r\n\r Subjects on any medication like diuretics.\r\n\r Allergic to any medication.\r\n\r With a history of alcohol and/or drug abuse.\n\nPatient 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
551	[ { "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\nFarming, Personal Protective Equipment, Nepal\n\nClinical Trial Summary:\n\nAccording to the World Health Organization pesticide poisoning is a major health problem due\r to the millions of cases annually occurring worldwide. Farmers have a particularly high risk\r of pesticide poisoning because of their work involving pesticide use to protect crops. The\r majority of pesticide poisonings occur in developing countries. On a short term it is not\r realistic to reduce farmers' use of pesticides significantly because it would require that\r secure and cost-effective alternatives are introduced. This is a lengthy process, which\r should undoubtedly be supported. However, it becomes as important to make sure that farmers\r can protect themselves from pesticide exposure meanwhile. Use of personal protective\r equipment can minimize pesticide exposure on farmers' bodies and consequently reduce their\r risk of pesticide poisoning. However, the sparse research identified through a systematic\r literature review shows that we are not in a position to give recommendations on what\r personal protective equipment farmers should protect themselves with against pesticide\r exposure suitable to their specific conditions. The purpose of the present study is to\r examine factors that influence farmers' use of personal protective equipment during their\r work with organophosphates and, based on this examine the ability of locally adapted personal\r protective equipment to reduce their organophosphate exposure. The hypothesis is that farmers\r working in locally adapted personal protective equipment have less acute organophosphate\r poisoning symptoms, a higher plasma cholinesterase level and find it to be a more feasible\r solution than farmers working in their daily practice wearing. Examining how locally adapted\r personal protective equipment (onwards referred to as the LAPPE solution) performs in\r practice implies testing it in an intervention study. A randomized crossover experiment\r design is chosen partly because fewer farmers have to be recruited since each farmer will act\r as his own control and partly because the between farmer variation is strongly reduced. The\r performance of the LAPPE solution will be tested in one experiment and compared to the\r performance of the same farmers' daily practice wearing (onwards referred to as the DP\r solution) in another experiment. The LAPPE solution is expected to have a superior\r performance. The participation sequence (LAPPE/DP or DP/LAPPE) will be randomized. The study\r will be conducted among farmers in Chitwan, Nepal.\n\nClinical Trial Detailed Description:\n\nLITERATURE SEARCH STRATEGY:\r\n\r Based on recommendations from information specialists in the field of health, agriculture and\r technology the following databases were chosen to search for scientific literature about the\r present study's purpose: Pubmed, Embase, SveMed, CAB abstracts (Centre for Agriculture and\r Biosciences International), Agris, DADS (Denmark's Technical University's Digital Library),\r Scopus and Ebsco. The key search terms for the literature search were: personal protective\r equipment, farmers, pesticides, developing countries and tropical climate. Synonyms for each\r of these search terms were identified by means of Gyldendals Dictionary and previous\r international literature. In Pubmed, SveMed, Embase, CAB abstracts and Agris the synonyms\r were applied to find subject headings which the main search was based on. However, in DADS,\r Scopus, Ebsco searches on subject headings was not an option and therefore the main search\r was based on the synonyms.\r\n\r - Pubmed: 3349 hits, subject headings for key terms personal protective equipment and\r pesticides with no limitations.\r\n\r - Embase: 399 hits, subject headings for key terms personal protective equipment and\r pesticides with the limitation human.\r\n\r - SveMed: 24 hits, subject headings for key terms personal protective equipment and\r pesticides.\r\n\r - CAB abstracts: 607 hits, subject headings for key terms personal protective equipment\r and pesticides.\r\n\r - Agris: 681 hits, subject headings for key terms personal protective equipment and\r pesticides.\r\n\r - DADS 8650 hits, subject headings for key terms personal protective equipment and\r pesticides.\r\n\r - Scopus: 1988 hits, synonyms for key terms personal protective equipment and pesticides\r and developing countries and tropical climate with the limitation to human.\r\n\r - EBSCO: 722 hits, synonyms for key terms personal protective equipment and pesticides.\r\n\r Firstly, the relevance of titles was evaluated, secondly the relevance of abstracts from hits\r with relevant titles was evaluated and thirdly the relevance of full texts from hits with\r relevant abstracts was evaluated. A search was made based on the function 'related studies'\r for each relevant study in each database. The reference list of each relevant study was\r viewed and searched in Web of Science for citations. Finally each accessible relevant study\r was read carefully (5 hits). Exclusion criteria were studies on closed farming, mechanized\r farming, non-tropical conditions, and farming in industrialized countries or laboratory\r performance testing of personal protective equipment seeing that these criteria would not\r represent typical farming conditions in developing countries. Grey literature was searched in\r databases of the International Labor Organization, World Health Organization and Food and\r Agricultural Organization.\r\n\r STUDY AREA:\r\n\r Nepal is divided into 75 administrative districts. Pesticide consumption data show that\r excessive use of pesticides is common in different crops such as rice, maize, wheat and\r vegetables production areas. Chitwan District is selected purposively for three reasons:\r\n\r - One of the highest vegetable growing districts of Nepal is Chitwan.\r\n\r - An excessive pesticide use is documented in Chitwan.\r\n\r - An unpublished study being the first of its kind in Nepal known to the research group\r documents the seriousness of the problem in Chitwan. A comparative cross-sectional study\r was conducted among 90 vegetable farmers using hand pressured backpack sprayers and 90\r blood donors. Fifty %, 15 % and 13 % of the pesticides used by the vegetable farmers\r could be categorized as moderately, highly and slightly hazardous, respectively,\r according to the World Health Organization Hazard Classification. Organophosphates were\r one of the most common pesticides used by the vegetable farmers; the moderately\r hazardous chlorpyrifos and imidacloprid as well as the highly hazardous dichlorvos. Poor\r working practices without adequate safety precautions were common among the vegetable\r farmers. The vegetable farmers reported a higher number of acute organophosphate\r poisoning symptoms and had lower levels of acetyl cholinesterase than blood donors.\r Chitwan has a total population of around 566,661 and was a largely uncultivated dense\r forest before the Nepali government started spraying with the insecticide\r dichlorodiphenyltrichloroethane for a Malaria Eradication Project in the 1950s.\r Immediately, Chitwan became a major farming region and services and infrastructure\r expanded across the area. Out of a total 46,894 hectare of arable land, 44,291 hectare\r is used for agricultural purpose (maize, rice, wheat, beans, lentils, mustard and\r vegetables). Agriculture is the primary source of income for 75 % of the population.\r Around 4000-5000 people of the working population is engaged in vegetable farming.\r Chitwan has 40 village district committees and the District Agricultural Office\r considers 10 of these as pocket areas in terms of vegetable farming based on their own\r observations, experiments, monitoring and personal communication with vegetable farmers.\r The ten pocket areas are Mangalpur, Jagatpur, Shukranagar, Chainpur, Bhandara,\r Gitanagar, Sibanagar, Jutpani, Kumroj and Padampur. To the extent that it is possible\r farmers fulfilling the inclusion and exclusion criteria of the present study in these\r pocket areas will be recruited:\r\n\r RECRUITMENT STRATEGY:\r\n\r Non-probability.\r\n\r SAMPLE SIZE DETERMINATION:\r\n\r The sample size calculations are based on a quasi-experimental unpublished study of 25\r vegetable farmers from Chitwan whose acute organophosphate poisoning symptoms and plasma\r cholinesterase levels were measured pre and post an organophosphate spraying session on the\r same day during daily practice conditions.\r\n\r - Mean number of acute organophosphate poisoning symptoms 1.08±1.32 (Pre spraying\r measurement) 2.4±1.87 (Post spraying measurement) 0.0003 (P-value)\r\n\r - Mean U/ml level of plasma cholinesterase 1.41±0.59 (Pre spraying measurement) 1.29±0.54\r (Post spraying measurement) 0.0548 (P-value)\r\n\r The pre and post organophosphate spraying measurements are considered to represent the\r \"healthiest\" and \"unhealthiest\" condition that the vegetable farmers can be expected to be\r in, respectively. Thus, for the present study the pre and post organophosphate spraying\r measurements are expected to resemble the results among the farmers after having worked with\r organophosphates wearing the LAPPE solution and DP solution, respectively. A sample size\r suitable to the study resources was gained when applying the pre and post results of the\r number of acute organophosphate poisoning symptoms.\r\n\r - Paired means = 1.08, 2.4\r\n\r - Paired standard deviations = 1.320,1.870\r\n\r - Correlation = 0\r\n\r - Sides = 1, 2\r\n\r - Alpha = 0.05\r\n\r - Power = 0.9\r\n\r Taking into consideration dropouts, technical problems leading to invalid measurements,\r refusals and co-variables for multivariate analyses 33 % of the sample size (34 pairs) is\r added, the result being rounded up to 50 pairs of farmers needed for the present study.\r\n\r DATA ANALYSES:\r\n\r Descriptive:\r\n\r - Frequency, proportion categorical variables\r\n\r - Mean, minimum, maximum and standard deviation of numeric variables\r\n\r - Table crossing background, explanatory and feasibility variables with LAPPE/DP\r experiment\r\n\r - Table crossing number of acute organophosphate poisoning symptoms with plasma\r cholinesterase levels U/ml\r\n\r Unadjusted (paired t-test and McNemar test):\r\n\r - Mean difference in number of acute organophosphate poisoning symptoms after both\r experiments\r\n\r - Mean difference in plasma cholinesterase level U/ml after both experiments\r\n\r Adjusted (mixed model):\r\n\r - Number of acute organophosphate poisoning symptoms after the LAPPE experiment is\r compared to the number of acute organophosphate poisoning symptoms after the DP\r experiment adjusted for baseline values, period effect, experiment sequence and\r explanatory variables.\r\n\r - Plasma cholinesterase level U/ml after the LAPPE experiment is compared to the plasma\r cholinesterase level U/ml after the DP experiment adjusted for baseline values, period\r effect, experiment sequence and explanatory variables.\r\n\r Sensitivity:\r\n\r To allow confidence in the main finding its robustness will be assessed by repeating the\r analyses with more rigid health outcome definitions if possible such as:\r\n\r - Farmers with acute organophosphate poisoning symptoms before the LAPPE and DP experiment\r are excluded.\r\n\r - Farmers with more abnormal plasma cholinesterase levels U/ml before the LAPPE and DP\r experiment are excluded.\r\n\r - Farmers with chronic illness are excluded.\r\n\r - Farmers who respond to the \"fake\" symptoms are excluded.\r\n\r ETHICAL CONSIDERATIONS:\r\n\r Informal recognition and encouragement in Chitwan will be obtained from the District\r Agricultural Office and District Public Health Office. An advisory opinion from the Danish\r Ethics Committee will be obtained. Informed consents will be retrieved from farmers\r participating in the pre-testing and experiments.\r\n\r The plasma cholinesterase measurement will make it possible to identify farmers with abnormal\r levels. If such cases occur the farmer will be excluded from the study and given advice on\r how to proceed. The small amount of blood required is not considered as damaging to the\r farmers' health. However, the finger stick may have minor risks such as momentary pain when\r the lancet goes into the finger, bruise, visible and sore puncture site for a short period,\r feeling of dizziness or light headedness. Disposable finger stick lancets will be used to\r avoid any infectious transmission.\r\n\r The LAPPE solution will be provided to the farmers after their participation with an\r information folder and oral explanation on how to store the LAPPE. Despite the results of the\r study, the LAPPE solution is an improvement in farmers' current practice which is that they\r basically do not protect themselves according to the recommendations of World Health\r Organization or Food and Agricultural Organization.\r\n\r The choice of organophosphates for the experiments will be based on the type of\r organophosphates that the farmers already use. In other words, the farmers will not be\r exposed to less or more dangerous pesticides than what they usually expose themselves to.\r During the data collection the organophosphates will be stored according to their safety\r label recommendations. In case, the remaining organophosphates cannot be used in other\r studies they will be disposed by taking safety precautions as recommended by the World Health\r Organization.\r\n\r During all study activities a first aid kit will be accessible and the data collectors will\r wear basic personal protective equipment during the experiments and informed about a safe\r handling of organophosphates.\r\n\r During data entry, data is stored on two external hard disks and the principal investigator's\r computer in the control of the principal investigator. Data on the Test Mate ChE\r Cholinesterase System is automatically deleted when the power is switched off. Every week a\r full backup of the data file will be saved on a USB stick placed outside research\r establishments under the principal investigator's control until the data entry is complete.\r Data editing and analysis will be based on a data file without sensitive information (like\r name, address and phone number). The data file will be saved on an external hard disk, USB\r stick and the principal investigator's computer drop box on a daily basis and kept under\r secure conditions and with only access to the principal investigator.\r\n\r The following data will be stored in a locked safe under research establishments in the sole\r control of the principal investigator:\r\n\r - Original data\r\n\r - File with raw data\r\n\r - File with analyzable and anonymized data\r\n\r - File linking farmers' sensitive information with their study identification number\r\n\r The following data will be stored in a locked safe outside research establishments in the\r sole control of the principal investigator and safe owners:\r\n\r • File with analyzable data excluding sensitive information\r\n\r If necessary, during analysis and interpretation of results the research group can get access\r to the file with analyzable and anonymized data through e-mail. However, the e-mail will not\r contain the file linking sensitive information with study identification numbers and is\r therefore considered as being manually encrypted.\r\n\r Upon completion of the research study the original data will be cut into pieces, placed in a\r sealable bag which can be tightly tied, fill the bag with water and then transfer the bag to\r a waste container. Blood tests and materials used in this regard will be given to Nepal Red\r Cross Society. Data stored outside research establishments will be retrieved. Two independent\r data files; one file with analyzable data excluding sensitive information and another file\r with farmers' sensitive information linking to their study identification number and scanned\r copies of informed consents will be stored in Nepal for up to five years. Potential\r permission to store data in Denmark will be seeked from the Danish Data Protection Agency.\r Upon approval data will be sent to the Danish Data Archive for indefinite storage time with\r data documentation. The condition for data access to the Danish Data Archive is that only the\r principal investigator will have access to the data and full control of giving permission for\r sharing data with others in the future. If sharing of data occurs the new researcher will\r have to seek approval from the Danish Data Protection Agency and then consult the Danish Data\r Archive.\n\nClinical Trial Eligibility Criteria:\n\nInclusion\r\n\r - Male (females usually wear national dresses considered to provide adequate protection\r (43).\r\n\r - Age min. 18 years (implies being a legal worker).\r\n\r - Grows crops in knee and abdomen height in given data collection period.\r\n\r - Willing to spend 1.5-3 hours working with organophosphates under normal working\r conditions.\r\n\r - Involved in farming minimum two years (implies being active).\r\n\r - Usually sprays at least once in two weeks with organophosphates on average (implies\r being active).\r\n\r - Uses a hand pressured backpack sprayer placed at home (necessary to complete\r non-intervention).\r\n\r - Works with crops in 5-10 katha land (sufficient to apply organophosphates for given\r time).\r\n\r - Has a mobile/landline number (necessary for easy contact).\r\n\r Exclusion\r\n\r - Has a helper during work with organophosphates (organophosphate exposure reduced).\r\n\r - Is unwilling to stay organophosphate free one week prior to each of two experiment\r days (necessary for comparable measurements).\r\n\r - Has any of the following conditions: liver disease/damage, alcoholic/viral hepatitis,\r acute infection, chronic malnutrition, heart attack, metastasis, obstructive jaundice,\r inflammation, uses pyridostigmine drugs (decreases or increases plasma cholinesterase)\r (44-46).\n\nPatient 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
552	[ { "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\nImproving Echo Measurements in the Diagnosis of Aortic Stenosis\n\nClinical Trial Summary:\n\nAortic stenosis is a common valvular heart disease, affecting mainly people over age 60. It\r is characterized by years to decades of slow progression followed by rapid clinical\r deterioration and a high death rate once symptoms develop. The onset of symptoms confers a\r poor prognosis: patients die within an average of five years after the onset of angina, three\r years after the onset of syncope, and two years after the onset of heart failure symptoms.\r The overall mortality rate is 75% at three years without surgery. Drug therapy for it remains\r ineffective, and aortic valve replacement is the only recommended long-term treatment.\n\nClinical Trial Detailed Description:\n\nOBJECTIVES Primary Objective The primary objective of this study is to review the current\r practice of transthoracic echocardiogram (TTE) imaging measurements in conjunction with\r computerized tomography (CT) and to standardize these measurements in order to improve the\r accuracy of the diagnosis of aortic stenosis (AS).\r\n\r Secondary Objective The secondary objective of the study is to define the true incidence of\r low flow, low gradient severe aortic stenosis with a normal ejection fraction (EF).\r\n\r BACKGROUND In recent years, the advancement of medical technology has allowed certain\r patients to undergo less invasive approaches for aortic valve replacement such as\r transcatheter aortic valve replacement (TAVR). In order to appropriately select treatment\r options, anatomical measurements must be accurately obtained utilizing TTE and CT.\r\n\r According to the American College of Cardiology/American Heart Association Practice\r Guidelines, the severity o f aortic stenosis is determined by definitions of aortic jet\r velocity, mean pressure gradient, and aortic valve area (AVA) (Bonow, 2008).\r\n\r Mild Moderate Severe AVA (cm2) 1.5 1.0 - 1.5 < 1.0 Mean gradient (mmHg) < 25 25 - 40 > 40 Jet\r velocity (m/s) < 3.0 3.0 - 4.0 > 4.0\r\n\r Rationale for study\r\n\r Of greatest interest to this study is the calculation of the AVA in the diagnosis of the\r severity of aortic stenosis. Since the area cannot be directly measured from\r echocardiographic images, it is calculated based on the diameter across the left ventricular\r outflow tract (LVOT) as measured via TTE. The preferred modality for measuring AVA is the\r continuity equation:\r\n\r AVA=((〖Area〗_LVOT ×〖VTI〗_LVOT))/〖VTI〗_AS Where LVOT = Left Ventricular Outflow Tract, VTI =\r Doppler velocity-time interval.\r\n\r Using TTE, the stroke volume at the LVOT is obtained by measuring the diameter across the\r LVOT. The continuity equation assumes the aortic valve annulus is a perfect circle; because\r of this, any error in measuring the LVOT results in an under calculation of the aortic valve\r area. It is also important to consider that the anatomy of the aortic annulus is not\r circular, which also contributes to an inaccurate calculated AVA.\r\n\r An underestimated valve area could lead to a diagnosis of severe aortic stenosis when not\r appropriate. Recently, there has been an increase in literature published on the diagnosis of\r severe aortic stenosis with a low mean gradient and preserved left ventricular function as\r measured by ejection fraction (EF). It is possible that many of these patients do not have\r severe AS but are misclassified as such because underestimation of the LVOT diameter leads to\r underestimation of aortic valve area as calculated by the continuity equation. This study\r aims to define the true incidence of these patients by ensuring the aortic valve area is\r measured as accurately as possible based on current imaging procedures.\r\n\r In order to determine the accuracy of TTE measurements in current practice, this study would\r compare the LVOT diameter from TTE to the LVOT diameter on CT scans, which is inherently\r three-dimensional and therefore more accurate.\r\n\r The AVA of all subjects will be re-calculated using the continuity equation and the LVOT\r diameter measured with CT. These re-calculated AVA will be compared to the original AVA\r obtained via TTE. In subjects whose newly calculated AVA, utilizing CT measurements, varies\r greatly from their TTE calculated AVA, the original TTE images will be re-evaluated for\r correct measurements. Additionally, any subject with a TTE-measured LVOT diameter less than 2\r cm will also be re-evaluated for correct measurement.\r\n\r The figure below illustrates an underestimated LVOT diameter using 2D echocardiography.\r\n\r Anumeha Tandon, Paul A. Grayburn, Imaging of Low-Gradient Severe Aortic Stenosis, JACC:\r Cardiovascular Imaging, Volume 6, Issue 2, February 2013, Pages 184-195, ISSN 1936-878X,\r http://dx.doi.org/10.1016/j.jcmg.2012.11.005.\r\n\r (http://www.sciencedirect.com/science/article/pii/S1936878X12009497)\r\n\r PATIENT POPULATION\r\n\r This study is an observational, retrospective review of data collected as standard of care.\r The study intends to review the charts of up to 400 patients over the last 5 years who\r underwent both CT and TTE within a one-week timeframe as a workup for aortic valve stenosis\r at The Heart Hospital Baylor Plano (THHBP) or Baylor University Medical Center (BUMC).\r\n\r SUMMARY Enrollment Up to 400 patients at THHBP and BUMC Design This study is a retrospective\r chart review of previously collected standard of care data.\r\n\r METHODS, STATISTICAL ANALYSIS & DATA MANAGEMENT Patients will be classified as severe or\r non-severe AS based on aortic valve area calculation as per ACC/AHA guidelines. Thus,\r patients with AVA ≤ 1.0 cm2 will be considered severe AS. This will also be evaluated using\r two other widely used criteria for aortic valve area indexed for body surface area. Severe AS\r will be considered as AVAi ≤ 0.6 cm2 (guidelines) or ≤ 0.5 cm2 (Braunwald's text, Grayburn).\r Using these three definitions, any patient who also has a peak velocity ≥ 4.0 m/s or a mean\r gradient ≥ 40 mmHg will be considered to definitely have severe AS. Patients with values <\r 4.0 m/s or < 50 mmHg will be further classified by stroke volume index < 35 mL/m2 to have low\r flow, low gradient severe AS. Further classification will be based on LVEF ≥ 50% or <50%. The\r former will be considered to have paradoxical low flow, low gradient severe AS with preserved\r LVEF (Hachicha, Circ 2007) or traditional low flow, low gradient severe AS (Tandon, Grayburn\r JACC Imaging 20130> The above criteria will be used to reclassify patients when LVOT\r cross-sectional area is determined by CT scan instead of echocardiography. Reclassification\r will occur with CT measurements of LVOT for AVA and SVI, both of which are dependent on LVOT\r area, generalized linear mixed model (GLMM) with a logistic link function will be used to\r assess whether differences in classification exist.\r\n\r The same multivariable model stratified by gender will be used to perform a pre-specified\r subgroup analysis (re-measuring the echocardiographic LVOT diameter on all subjects who are\r \"re-classified\" by CT). This will be done by remeasuring at the traditional LVOT diameter\r located 5-10 mm below the aortic annulus and also by measuring at the juncture of the aortic\r leaflets and LVOT in mid-systole (Mayo clinic way). The purpose of this analysis is to\r determine if the Mayo clinic method of LVOT measurement reduces the number of\r misclassifications compared to the traditional method. Finally, the investigators will also\r examine the CT data for threshold values which suggest erroneous or outlier values for\r echocardiography. Men and women will be assessed separately. For example, a value of 1.6 cm\r is often found on echocardiography but rarely on CT scanning in their subjective clinical\r experience.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria\r\n\r - Adults over the age of 18.\r\n\r - Any patient undergoing both TTE and CT scans within a one-week timeframe as a workup\r for aortic stenosis.\r\n\r Exclusion Criteria\r\n\r - There are no specific exclusion criteria for this retrospective review.\n\nPatient 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
553	[ { "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\nEngager Align Post-market Clinical Study\n\nClinical Trial Summary:\n\nPurpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic\r Valve Implantation System in a real world environment.\r\n\r Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market\r study.\r\n\r 250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1\r month, 6 months, and 12 months after the procedure. The recruitment period will be\r approximately 12 months, so the total study duration will be 24 months.\n\nClinical Trial Detailed Description:\n\nThe study objective is to characterize the safety and clinical benefit of the Engager\r Transcatheter Aortic Valve Implantation System in a real world setting.\r\n\r The primary endpoint of this study is all-cause mortality at 30 days or during index\r hospitalization.\r\n\r Secondary endpoints of this study are:\r\n\r - Device success according to VARC2 is defined as:\r\n\r - absence of procedural mortality (all-cause mortality at discharge, 30 days or during\r index hospitalization), AND\r\n\r - correct positioning of the Engager bioprosthesis in the proper anatomic location, AND\r\n\r - Engager bioprosthesis performing as intended (no prosthesis-patient mismatch and mean\r aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe\r regurgitation).\r\n\r - Composite early safety (at 30 days) according to VARC2 includes the following\r components:\r\n\r - all-cause mortality\r\n\r - all stroke\r\n\r - life-threatening bleeding\r\n\r - acute kidney injury (stage 2-3)\r\n\r - coronary artery obstruction requiring intervention\r\n\r - major vascular complication\r\n\r - valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)\r\n\r - Clinical efficacy according to VARC2 at 6 months and 1 year is defined as:\r\n\r - all-cause mortality\r\n\r - all stroke\r\n\r - hospitalizations for valve-related symptoms or worsening congestive heart failure (CHF)\r\n\r - NYHA class III or IV\r\n\r - valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area\r (EOA) ≤0.9-1.1 cm² and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or\r severe prosthetic valve regurgitation)\r\n\r - Time-related valve safety accordingly to VARC2 at 6 months and 1 year is defined as:\r\n\r - Structural valve deterioration\r\n\r - Valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, (EOA) ≤0.9-1.1 cm²\r and/or (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)\r\n\r - Requiring repeat procedure (TAVI or SAVR)\r\n\r - Prosthetic valve endocarditis\r\n\r - Prosthetic valve thrombosis\r\n\r - Thrombo-embolic events (e.g. stroke)\r\n\r - VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)\r\n\r - All-cause mortality at 6 months and 1 year\r\n\r - Cardiovascular mortality at 30 days, 6 months and 1 year\r\n\r - Incidence of TAVI-related complications at 30 days, 6 months and 1 year:\r\n\r - Myocardial infarction\r\n\r - Periprocedural and spontaneous stroke\r\n\r - Life-threatening, major and minor bleedings\r\n\r - Acute kidney injury state 1, 2 and 3\r\n\r - Apical and vascular complications\r\n\r - Conduction disturbances\r\n\r - Conversion to open-heart surgery\r\n\r - Unplanned use of cardiopulmonary bypass\r\n\r - Coronary obstruction and dissection\r\n\r - Ventricular septal perforation\r\n\r - Mitral valve apparatus damage or dysfunction\r\n\r - Cardiac tamponade\r\n\r - Endocarditis\r\n\r - Valve thrombus\r\n\r - Valve migration, embolization or ectopic valve deployment\r\n\r - Valve in valve deployment\r\n\r - Total, transvalvular and paravalvular regurgitation as measured by TTE at 30 days\r and 1 year\r\n\r - Mean aortic valve gradient, peak velocity and effective orifice area as measured by\r TTE at 30 days and 1 year\r\n\r - Engager implant depth as measured by standard of care angiography at the end of\r implant procedure\r\n\r - Incidence and rationale for permanent pacemaker implantation after Engager implant\r procedure\r\n\r - Changes in Quality of Life as measured by the EQ5D questionnaire at baseline,\r discharge, 30 days, 6 months and 1 year\r\n\r - Length of stay during index hospitalization (ICU and general ward)\r\n\r - Incidence of re-hospitalization at 30 days, 6 months and 1 year\r\n\r Subject population All patients with severe aortic stenosis requiring treatment, who are\r selected by a heart team to be treated electively with the Engager Transcatheter Aortic Valve\r Implantation System are eligible to be included in this study.\r\n\r Treatment The Engager Transcatheter Aortic Bioprosthesis will be implanted using the Engager\r Transcatheter Delivery System. The bioprosthesis is delivered transapically on a catheter\r during a beating heart procedure.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Patient can be included if ALL of the following criteria are met:\r\n\r - Patient with severe aortic valve stenosis requiring treatment;\r\n\r - Patient is an acceptable candidate for elective treatment with the Medtronic Engager\r Transcatheter Aortic Valve Implantation System and in conformity with the local\r regulatory requirements;\r\n\r - Patient is above the minimum age as required by local regulations to be participating\r in a clinical study;\r\n\r - The patient has been informed of the nature of the study and has consented to\r participate, and has authorized the collection and release of his/her medical\r information by signing a consent form (Patient Informed Consent Form or Data Release\r Form).\r\n\r Exclusion Criteria:\r\n\r Patient will not be included if any of the following conditions exist:\r\n\r - Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine,\r clopidogrel, Nitinol of contrast medium that cannot be adequately controlled with\r pre-medication;\r\n\r - Intracardiac mass, thrombus, or vegetation;\r\n\r - Aortic aneurysm;\r\n\r - Sepsis or acute endocarditis;\r\n\r - Bleeding diathesis, or coagulopathy;\r\n\r - Cardiogenic shock, suspected cardiogenic shock;\r\n\r - Unicuspid or bicuspid aortic valve;\r\n\r - Pre-existing prosthetic heart valve in aortic position;\r\n\r - Patient is currently enrolled in another investigational device or drug trial;\r\n\r - Patients with life expectancy less than 12 months after TAVI.\n\nPatient 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
554	[ { "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\nMyocardial Injury and Postoperative Complications\n\nClinical Trial Summary:\n\nTo determine whether perioperative myocardial injury is associated with adverse outcome in\r patients scheduled for major abdominal surgery.\n\nClinical Trial Detailed Description:\n\nStudy design\r\n\r The MICOLON study is a prospective, single-centre, observational cohort study on the\r association between 5th generation high sensitive cardiac troponin T levels and non-cardiac\r outcome after major abdominal surgery in patients at risk for coronary artery disease.\r\n\r Patient eligibility\r\n\r Patients are eligible to enter the study if they are scheduled to undergo elective major\r abdominal surgery with an expected postoperative mortality rate >3%, are aged 45 years or\r older and have at least one of the following major cardiac risk factors: diabetes mellitus,\r peripheral artery disease (i.e. intermittent claudication or history of vascular surgery\r except arteriovenous shunt and vein stripping procedures), history of hospitalization for\r congestive heart failure, history of myocardial infarction, stable angina pectoris, history\r of coronary artery bypass grafting or percutaneous coronary angioplasty, renal insufficiency\r (defined as preoperative creatinine >150 μmol/L), history of cerebral vascular event, aortic\r valve stenosis (defined as aortic valve area <1 cm2), atrial fibrillation, moderate or poor\r left ventricular function (defined as left ventricular ejection fraction <55%), or two of the\r following minor risk factors for coronary artery disease: age >70 years, hypertension,\r hypercholesterolemia, history of transient ischemic attack, chronic obstructive pulmonary\r disease, smoking or low functional capacity (capable of physical activity of 4 metabolic\r equivalents or less). Patients are excluded from study participation if they have no signed\r informed consent.\r\n\r Study procedure\r\n\r Patients eligible for the study are identified at the outpatient preoperative anesthesiology\r clinic. Patients are examined and screened for cardiac risk factors by an anesthesiology\r resident or a dedicated screening nurse. Results of preoperative laboratory tests, data on\r patient characteristics and preoperative use of cardiovascular drugs (i.e. statin,\r ß--blocker, platelet inhibitor, calcium antagonists, angiotensin-converting enzyme inhibitor\r and angiotensine receptor blocker) were noted. Prior to any study procedure written informed\r consent is obtained from all patients. During the study period blood is collected for plasma\r troponin T measurements after induction of general anesthesia (baseline) and on the 1st, 3rd\r and 7th postoperative day. All plasma samples are frozen and stored at -20°C at the\r hospital's laboratory until analysis. Cardiac troponin T batch analysis is performed every 3\r weeks with the use of 5th generation Elecsys Troponin T high sensitive assay on an automated\r Cobas 6000 platform (Roche Diagnostics, Germany). The limit of detection of this high\r sensitive assay was determined at 3 ng/L with a 99th percentile upper reference limit of 14\r ng/L. In addition, plasma creatinine levels are measured in each sample with an enzymatic\r method on the same automated platform (Roche Diagnostics, Germany). An estimated glomerular\r filtration rate is calculated from plasma creatinine values using the Modification of Diet in\r Renal Disease formula. During the entire study period daily routine quality control samples\r for troponin and creatinine ensure comparable patient data across different reagent lots.\r After analysis the samples are stored at -80°C.\r\n\r Surgical procedures are performed under general anesthesia or a combination of general and\r epidural anesthesia. Anesthesia management is left to the discretion of the attending\r anesthesiologist. According to hospital protocol, patients scheduled for gastric-esophageal,\r pancreatic or hepatic surgery and patients aged ≥80 or with an American Association of\r Anesthesiologists physical status classification system ≥3 will be admitted to an intensive\r care unit postoperatively for at least 24 hours. To improve postoperative recovery all\r patients are treated according to the current Enhanced Recovery After Surgery guidelines.\r\n\r During the postoperative period research personnel performs patient visits, reviews medical\r charts and notes complications. At thirty days after surgery troponin results are reported to\r the researchers and a follow-up telephone interview is performed if patients are discharged\r from the hospital at that time. Patients will be asked if a medical complication has occurred\r since their discharge from the hospital. If so, medical details are retrieved from their\r treating physicians. Information from routine postoperative clinic visits is used if patients\r can not be reached by telephone. Noted endpoints are judged by an event committee, that is\r blinded for troponin results.\r\n\r Endpoint definition\r\n\r Primary parameter of the study is postoperative myocardial injury at day 1, 3 or 7. Secondary\r parameters are met by the occurrence of any of the following non-cardiac events within 30\r days after surgery: mortality - defined as death without cardiovascular origin; sepsis -\r defined as systemic inflammatory response syndrome (SIRS) in response to a proven or\r suspected microbial infection; pneumonia - defined as purulent sputum or isolation of a\r pathogen from sputum culture or blood culture and clinical symptoms (e.g. dyspnea, fever,\r cough) or a consolidation or pleural effusion on chest radiograph; respiratory failure -\r defined as non-cardiac hypoxia or hypercapnia leading to ICU (re)admission for respiratory\r support (e.g. (non)invasive ventilation or high concentration oxygen therapy); anastomotic\r dehiscence - defined as presence of luminal contents through drain or wound site causing\r local inflammation or SIRS, or leak detected on imaging studies in combination with clinical\r signs of SIRS; intestinal ischemia - defined as signs of superficial or transmural bowel\r ischemia on imaging studies and clinical symptoms (e.g. abdominal pain or tenderness) or\r SIRS; wound infection - purulent drainage from superficial incision or deliberate opening of\r superficial incision by surgeon and clinical signs of local inflammation (e.g. pain,\r tenderness, swelling, redness); bleeding - defined as abnormal postoperative bleeding needing\r surgical (i.e. re-operation) or endovascular (i.e. coiling) treatment. Other study parameters\r were length of hospital stay and in-hospital mortality.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients > 45 years of age with 1 or more major cardiovascular risk factors:\r Congestive heart failure, peripheral artery disease (intermittent claudication,\r history of vascular surgery etc), diabetes mellitus type I or II, coronary artery\r disease (history of myocardial infarction, stable angina pectoris, history of ischemia\r or coronary artery disease on cardiac tests (electrocardiogram, scintigraphy,\r echocardiogram, coronary angiogram etc), cerebrovascular accident, renal insufficiency\r (creatinine > 150umol/l), aortic valve stenosis (valve area < 1 cm2) OR 2 or more\r minor cardiovascular risk factors: Age > 70, hypertension, high cholesterol, low\r functional capacity (4 metabolic equivalents or less), transient ischemic attack,\r chronic obstructive pulmonary disease AND undergoing abdominal surgery with an\r expected 30-day mortality rate > 2-3%: colorectal, gastric, pancreatic and liver\r surgery.\r\n\r Exclusion Criteria:\r\n\r - Age < 45 years of age, not scheduled for higher risk abdominal surgery, low\r cardiovascular risk profile.\n\nPatient 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
555	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nHLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA\n\nClinical 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\nClinical Trial Detailed Description:\n\nProspective, non-randomized, single arm, single-center first-in-man feasibility trial.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. 75 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 a New York Heart Association (NYHA)\r Functional Classification of II or greater\r\n\r 4. Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT\r\n\r 5. An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one\r cardiovascular surgeon and one cardiologist that the co-morbidities not captured by\r the STS or EuroScore expected to increase the operative mortality risk to > 15%.\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. Pre-existing prosthetic heart valve in any position, or prosthetic ring\r\n\r 3. Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation\r\n\r 4. Moderate to severe mitral stenosis\r\n\r 5. Myocardial infarction within the past 30 days\r\n\r 6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\r\n\r 7. LVEF < 30%\r\n\r 8. Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic ; or in\r the opinion of the investigator cannot be controlled by medical therapy).\r\n\r 9. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds\r of systemic pressure\r\n\r 10. Hemodynamic instability requiring inotropic drug therapy within the past 14 days or\r mechanical support within the past 6 months\r\n\r 11. Untreated clinically significant coronary artery disease requiring revascularization\r\n\r 12. 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 13. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia,\r history of bleeding diathesis or coagulopathy\r\n\r 14. Patient ineligible for or refuses blood transfusions\r\n\r 15. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive\r calcification, severe tortuosity or small vessels) that would preclude passage of\r catheters from the femoral arterial access to the aorta as evidenced by peripheral\r MSCT\r\n\r 16. Active peptic ulcer or gastrointestinal bleeding within the past 90 days\r\n\r 17. Stroke or transient ischemic attack within past 6 months\r\n\r 18. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage\r renal disease requiring chronic dialysis\r\n\r 19. Active infection requiring ongoing treatment\r\n\r 20. Need for emergent surgery or intervention other than the investigational procedure\r\n\r 21. Any therapeutic invasive cardiac procedure performed or planned to perform within 30\r days of the index procedure, (or 6 months for drug eluting coronary stent or\r biventricular pacemaker implantation)\r\n\r 22. Hypersensitivity or contraindication to procedural medication and device materials\r (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated\r\n\r 23. Life expectancy < 1 year due to non-cardiac co-morbid conditions\r\n\r 24. Currently participating in any investigational drug or device studies that may\r confound the results of this study\r\n\r 25. 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\nPatient 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
556	[ { "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 a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients\n\nClinical Trial Summary:\n\nThe study is a prospective, randomized, open-label comparison of a multimodal regimen and a\r standard, narcotic-based regimen for postoperative pain control in patients undergoing\r surgery for an operatively indicated, isolated extremity fracture. The investigators will be\r measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse\r events and fracture union. The investigators hypothesize that this multimodal regimen will\r lead to improved pain, less narcotic use and improved satisfaction as compared to the\r standard regimen.\n\nClinical Trial Detailed Description:\n\nPatients will be assessed for inclusion or exclusion during admission to the hospital or\r during evaluation in the clinic or emergency room for an isolated extremity fracture for\r which surgery is indicated. Once enrolled in the study and consent obtained, patients will be\r randomized into either the standard therapy group or the multimodal therapy group using\r permuted block randomization based on injury site. The sites of fracture are as follows:\r\n\r - wrist/hand/forearm\r\n\r - elbow/upper arm/shoulder\r\n\r - acetabulum/pelvis\r\n\r - foot/ankle\r\n\r - patella/tibia (shaft, proximal)\r\n\r - femur (proximal to distal)\r\n\r The investigators have assumed that these distinct areas result in a similar amount of\r disability and pain as compared to the other sites. This is an attempt to mitigate the\r possible confounder of disproportionate numbers of more painful or more debilitating injuries\r falling in one study group compared to another.\r\n\r Pre-operatively, patient demographic data will be recording including age, gender, BMI, hand\r dominance, occupation, use of tobacco/alcohol/illicit drugs, use of assistive devices,\r relevant comorbidities (i.e., diabetes), site of injury, mechanism and energy (high or low).\r If there is to be a delay between initial presentation and surgery, as is often the case for\r distal radius or ankle fractures, among others, multimodal patients will begin their therapy\r immediately after evaluation. Thus, they will be started on scheduled 1000mg acetaminophen\r and 100mg gabapentin both three times daily. They will also be provided an 5mg oxycodone\r prescription with instructions to take 1-3 tablets every 4 hours as needed for pain. Standard\r therapy patients will be prescribed oxycodone alone, using the same parameters, with the\r ability to take acetaminophen on an as needed basis.\r\n\r Pre-operatively, multimodal patients will receive 1000mg IV acetaminophen, 100mg PO\r gabapentin and 400mg PO celecoxib. All patients will have a peripheral nerve block placed\r when indicated, to confirm to the investigators standard of care. Patients will then undergo\r surgery with the investigators standardized anesthesia protocol as described in the protocol.\r Intraoperatively, multimodal patients will receive 8mg of IV dexamethasone. Post-operatively,\r multimodal patients will be given 1000mg acetaminophen three times daily for the duration of\r their narcotic use and 100mg Gabapentin three times daily for 1 week, which will be titrated\r to 200mg three times daily for 1 additional week. They will also receive an oxycodone\r prescription as described previously. Standard therapy patients will be given an oxycodone\r prescription alone with the advice to take tylenol on an as needed basis not to exceed\r 4000mg/day. No placebo medications will be used as this is an open label study.\r\n\r Patients will be instructed to avoid all anti-inflammatory medications. All patients across\r groups will be given aspirin 81mg for deep vein thrombosis prophylaxis if they suffered a\r lower extremity fracture. Should a patient require an alternative deep vein thrombosis\r prophylaxis regimen due to an allergy to aspirin or a personal history of deep vein\r thromboses, low molecular weight heparin will be used.\r\n\r Patients will be given a diary to record their daily narcotic use, daily minimum, maximum and\r average pain scores using a visual analog scale and any side effects. Patients will be\r provided the contact information of the attending surgeon's nurse to report any serious\r allergies or adverse effects of the study medications. A case by case decision will be made\r to either continue the protocol or to drop the patient from the study and make needed\r medications changes.\r\n\r Patients will be followed at defined time points after surgery including, 2 wks, 6wks, 3mo\r and 6mo.\r\n\r At their 2 wk follow up visit they will fill out the Short Musculoskeletal Function\r Assessment for their preoperative functional state as well as the American Pain Society\r Patient Satisfaction Questionnaire. These will again be filled out at their 3 and 6 month\r visits. Union will be assessed at their 3 and 6 month visits by a third party, blinded\r observed. It will be defined as three cortices of bridging callus on 2 orthogonal views. Once\r fracture union occurs or nonunion is identified control patients will be allowed to use non\r steroidal anti-inflammatories as needed. Time to return to work/normal activity, total\r narcotic usage and duration of narcotic use will also be recorded.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Bone fracture\r\n\r - Isolated injury\r\n\r - Requires operative intervention\r\n\r Exclusion Criteria:\r\n\r - pathological fractures\r\n\r - inability to personally consent to participation due to cognitive impairment,\r intoxication or sedation\r\n\r - severe head injury\r\n\r - polytrauma patients with multiple fractures or other injuries\r\n\r - pregnancy\r\n\r - open fractures\r\n\r - metabolic bone disease\r\n\r - allergies or contraindications to the study medications, including sulfa medications.\r\n\r - prior or current drug or alcohol dependence or abuse\r\n\r - liver or kidney disease\r\n\r - physician directed narcotic use\n\nPatient 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
557	[ { "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 Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate the efficacy and safety of combination of\r Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with\r essential hypertension and dyslipidemia.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Patients who voluntarily signed informed consent for participating in this clinical\r trial\r\n\r 2. Male and female between 20 and 75 years old\r\n\r 3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening\r visit (Visit1)\r\n\r 4. Patients who meet the following criteria of fasting LDL-C and blood pressure at\r Baseline visit (Visit3) assessment after undergoing the therapeutic lifestyle change.\r\n\r - Low risk group: the case that does not have any other risk factor apart from\r hypertension / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180\r\n\r - Moderate risk group: the case that has more than or equal to one risk factor\r apart from hypertension and has the 10-year risk of less than 10% / LDL-C\r (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180\r\n\r - Moderate high risk group: the case that has more than or equal to one risk factor\r apart from hypertension and has the 10-year risk between 10% and 20% / LDL-C\r (mg/dL): ≥130, ≤250, Mean SiSBP(mmHg): ≥140, <180\r\n\r - High risk group: the case of CHD (Coronary heart disease) or CHD risk equivalents\r\n\r - Risk factors include cigarette smoking, hypertension (BP≥140/90 mmHg or on\r antihypertensive medication), low HDL cholesterol (<40mg/dL), family history\r of premature CHD(CHD in male first-degree relative <55 years of age; CHD in\r female first-degree relative < 65 years of age), and age (men≥45 years;\r women ≥55 years). in case of HDL-C ≥60mg/dL, reduce 1 from the total number\r of risk factors.\r\n\r - Electronic 10 year risk calculators are available at\r www.nhlbi.nih.gov/guidelines/cholesterol\r\n\r - CHD includes history of myocardial infarction, unstable angina, coronary\r artery procedures (angioplasty or bypass surgery), or evidence of clinically\r significant myocardial ischemia.\r\n\r - CHD risk equivalents include atherosclerotic disease (peripheral arterial\r disease, abdominal aortic aneurysm and carotid artery disease [transient\r ischemic attacks or stroke of carotid origin or >50% obstruction of a\r carotid artery]), diabetes and 2+ risk factors with 10 year risk of over 20%\r\n\r 5. Subject must be able to understand the trial procedures and be willing to cooperate\r and complete the trial.\r\n\r Exclusion Criteria:\r\n\r 1. Severe hypertension patients with mean siSBP ≥ 180mmHg and/or SiDBP ≥110mmHg at the\r assessment of Screening visit (Visit1) and/or Baseline visit (Visit3). Or patients\r with postural hypotension with manifestation.\r\n\r 2. Patients with the mean SiSBP from 3 times of measurement of over 20mmHg.\r\n\r 3. Secondary hypertension patients, but not limited to the following disease (example:\r renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of\r the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis,\r Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc)\r\n\r 4. Secondary dyslipidemia: nephrotic syndrome, dysproteinemia, obstructive hepatopathy or\r Cushing's syndrome.\r\n\r 5. Patients with fasting TG ≥ 400mg/dL at Pre-Baseline visit (Visit2) assessment\r\n\r 6. History of myopathy, rhabdomyolysis or/and CK ≥ 2 times upper normal limit.\r\n\r 7. Use of lipid modifying drug within 4 weeks prior to Pre-Baseline visit (Visit2) and/or\r antihypertensive drug within 2 weeks prior to Pre-Baseline visit(Visit2)\r\n\r 8. Clinically significant renal function abnormality in the laboratory results at\r Pre-Baseline visit (i.e. serum creatinine ≥ 1.5 times upper normal limit), liver\r function abnormality (ALT, AST ≥ 2 times upper normal limit), severe fatty liver\r disease that requires medication.\r\n\r 9. Clinically significant hypokalemia(less than 3.5 mmol/L) or hyperkalemia (exceeded 5.5\r mmol/L) measured at Pre-Baseline visit (Visit2)\r\n\r 10. Subjects with following surgical and internal disease that may affect absorption,\r distribution, metabolism or excretion of drugs and have conditions which include the\r following (but are not limited to): history of major gastrointestinal surgeries\r including gastrectomy, gastro-enterostomy or bowel resection, gastrointestinal bypass\r graft and stabling; current active gastritis, ulcer, gastrointestinal and rectal\r bleeding, presence of active inflammatory bowel syndrome or biliary obstruction with\r the past 12 months.\r\n\r 11. Subjects with depletion of body fluid or sodium ion not able to correct\r\n\r 12. Subjects with sever insulin-dependent Diabetes Mellitus(DM) or Chronic DM (HbA1c > 9%\r at Pre-Baseline visit, dosage of an oral hypoglycemic agent was modified within 12\r weeks prior to screening visit , or currently use of active insulin treatment) or with\r hypothyroidism not able to correct.( TSH ≥ 1.5 times upper normal limit)\r\n\r 13. Subjects with severe heart disease (Heart failure New York Heart Association(NYHA)\r class 3 and 4), or history of any of the followings within the past 6 months; ischemic\r heart disease (e.g. angina pectoris, myocardial infarction), peripheral vascular\r disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass\r graft.\r\n\r 14. Subjects with clinically significant ventricular tachycardia, atrial fibrillation,\r atrial flutter or any other clinical significant arrhythmia conditions at discretion\r of investigator\r\n\r 15. Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary\r artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or\r mitral valve stenosis.\r\n\r 16. Subjects with severe cerebrovascular disorder (e.g. stroke, cerebral infarction or\r cerebral hemorrhage within the past 6 months)\r\n\r 17. Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory\r therapy, past or current medical history with wasting disease, autoimmune diseases\r (e.g. rheumatoid arthritis, systemic lupus erythematosus) or connective tissue\r disease.\r\n\r 18. Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual\r disturbance or retinal microaneurysm in the past 6 months)\r\n\r 19. Subjects with hepatitis B (including positive test for HBsAg), hepatitis C-positive\r\n\r 20. Subjects with history or evidence of abusing drugs or alcohol within the past 2 years.\r\n\r 21. Medical history with hypersensitivity to angiotensin II antagonist based drugs or\r HMG-CoA reductase inhibitor based drugs or any ingredient contained in these 2 drugs.\r\n\r 22. Medical history with clinically significant hypersensitivity to any components or\r other drugs on the investigational product or additives (yellow 5)\r\n\r 23. Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency\r or glucose-galactose malabsorption.\r\n\r 24. Pregnant women and lactating female.\r\n\r 25. Subjects planning pregnancy or childbearing potential who are not using effective\r contraceptive methods (surgical sterilized, intrauterine (contraceptive) device/condom\r or the combination of diaphragm and spermicidal agents)\r\n\r 26. Subjects who are participating in another trial or took other investigational product\r within 12 weeks prior to Screening visit\r\n\r 27. Medical history of all kinds of malignant tumor including leukemia and lymphoma in the\r past 5 years\r\n\r 28. A subject with other reasons not specified above that, ineligible to participate in\r this clinical trial at discretion of study investigators.\n\nPatient 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
558	[ { "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 Hand Osteoarthritis on Arterial Stiffness\n\nClinical Trial Summary:\n\nPatients affected by osteoarthritis (OA) have an increase overall mortality compared to the\r general population, mainly due to cardiovascular diseases. OA patients without cardiovascular\r risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular\r mechanisms are still not well known, the structure and function of the vessel wall can be\r affected by several inflammatory and metabolic parameters during OA.These functional and\r structural changes of the arterial wall leads to arterial stiffness, measured by the\r pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness\r and has been shown to have predictive value for morbidity and mortality. In our study, we\r planned to compare arterial stiffness in OA patients with healthy subjects.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients with clinical hand OA defined according to the ACR (American College of\r Rheumatology) criteria.\r\n\r - Patients with radiographic hand OA defined according to the Kellgren\r\n\r - Lawrence criteria (≥ 2).\r\n\r - Steady dose of statins for at least one month.\r\n\r - Subject affiliated to a social security scheme\r\n\r - Written informed consent\r\n\r Exclusion Criteria:\r\n\r - Rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis diseases.\r\n\r - History of arterial hypertension treated and / or uncontrolled (SBP > 140 mmHg and DBP\r (diastolic blood pressure) > 90 mmHg)\r\n\r - Diabetes (fasting blood glucose > 7 mmol/L)\r\n\r - Obesity (BMI > 35 kg/m²)\r\n\r - Chronic renal failure defined by a glomerular filtration rate <60 ml/min/1,73m ².\r\n\r - Patient with uncontrolled cardiovascular disease or a personal history of\r cardiovascular events (myocardial infarction and angina, occlusive arterial disease,\r stroke)\r\n\r - Pregnant or breastfeeding, or premenopausal and not taking an effective contraception\n\nPatient 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
559	[ { "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\nRegression of Myocardial Fibrosis After Aortic Valve Replacement\n\nClinical Trial Summary:\n\nAortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and\r the Western world. Surgery for severe AS prior to symptom onset is controversial.\r Conventionally changes in valve area and gradient are used to time intervention but\r myocardial changes may be more predictive of surgical need.\r\n\r This study aims to elucidate the role of diffuse myocardial fibrosis as a prognostic marker,\r implementing a novel, non-invasive MRI technique to measure it.\r\n\r Design: The investigators will measure diffuse myocardial fibrosis in 150 patients with\r severe narrowing of the aortic valve before and one year after valve replacement. Expected\r outcomes: Diffuse myocardial fibrosis measured by MRI scanning will predict outcome after\r surgery in aortic stenosis. Anticipated Health Benefits: Identify patients with higher post\r operative morbidity and mortality, who may benefit from earlier valve replacement.\n\nClinical Trial Detailed Description:\n\nSurgery for severe aortic stenosis (AS) prior to symptom onset is controversial.\r Conventionally changes in valve area and gradient are used to time intervention but\r myocardial changes may be more predictive of surgical need. This study aims to elucidate the\r role of diffuse myocardial fibrosis as a prognostic marker, implementing a novel,\r non-invasive technique to measure it.\r\n\r AS is the most common valvular heart condition in the United Kingdom and the Western world.\r Its prevalence rises with age - about 3% aged over 75 have severe AS. During a period of\r progressive valve narrowing, the left ventricle (LV) adapts to the increased pressure with\r increasing concentric muscle hypertrophy. However, eventually this remodelling becomes\r maladaptive and the LV less compliant, leading to symptoms (breathlessness, chest pain, and\r loss of consciousness). This heralds a significant increase in morbidity and mortality.\r Consequently aortic valve replacement (AVR) in symptomatic patients is a Class I indication.\r In most asymptomatic patients however, prophylactic surgery is controversial: the risk of\r surgery is thought to be greater than watchful waiting, although there is no randomised data\r to support this approach. Conversely, diffuse myocardial fibrosis is thought to play a key\r role in functional deterioration, symptom development and possibly outcome in AS.\r Unfortunately, assessment of AS severity, including hemodynamic parameters such as peak\r velocity and mean gradient, poorly predict symptom development and/or optimal timing of\r surgery.\r\n\r A non-invasive technique to quantify diffuse myocardial fibrosis against the gold standard of\r myocardial biopsy has been developed and validated in patients with AS: Cardiovascular\r magnetic resonance (CMR) with T1 mapping uses the extracellular tracer gadolinium to measure\r the extracellular volume (ECV), which closely reflects the degree of diffuse fibrosis. An\r important observation in a previous cohort (Flett et al European Heart Journal Cardiovascular\r Imaging 2012) was the fate of patients with severe fibrosis: they were more symptomatic at\r baseline, improved the most post-operatively and yet carried a trend towards increased\r mortality at six months. To unravel this, this study aims to track diffuse fibrosis in the\r RELIEF-AS study with a larger cohort (n=150) and for longer (12 months) to understand how to\r use diffuse fibrosis as a prognostic marker.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Severe aortic stenosis (1 or more of: aortic valve area < 1.0cm2, peak pressure\r gradient >64mmHg, or mean pressure gradient > 40mmHg).\r\n\r - Symptomatic.\r\n\r - Age > 18 years and < 90 years.\r\n\r Exclusion Criteria:\r\n\r - Severe valvular disease other than AS.\r\n\r - Previous Valve surgery\r\n\r - Severe renal impairment eGFR < 30ml/min.\r\n\r - Any absolute contraindication to CMR\r\n\r - Other medical condition that limits life expectancy or precludes AVR.\r\n\r - Pregnancy\n\nPatient 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
560	[ { "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\nEfficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia\n\nClinical Trial Summary:\n\nThe purpose of this study is to investigate the efficacy and safety of dietary supplements\r (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic\r smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.\n\nClinical Trial Detailed Description:\n\nIn a randomized, double-blind, placebo control trial, the efficacy and safety of dietary\r supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers\r having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive\r the dietary supplements and placebo for 60 days. The efficacy of the supplements will be\r measured by estimating cotinine and malondialdehyde level.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Men > 20 years\r\n\r - Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild\r to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC >200 mg/dL and/or HDL-C <40\r mg/dL)\r\n\r - Being mentally competent and able to understand all study requirements and sign the\r informed consent form.\r\n\r Exclusion Criteria:\r\n\r - Patients with Chronic obstructive pulmonary disease (COPD)\r\n\r - Women\r\n\r - Patients with severe liver, renal, cardiac or brain diseases.\r\n\r - Unable to complete follow up.\r\n\r - Subjects on any medication like diuretics.\r\n\r - Allergic to any medication.\r\n\r - With a history of alcohol and/or drug abuse.\n\nPatient 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
561	[ { "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\nCerebral Protection in Transcatheter Aortic Valve Replacement\n\nClinical Trial Summary:\n\nThe Sentinel System will be a safe and effective method for capturing and removing embolic\r material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce\r the ischemic burden in the cerebral anterior circulation.\n\nClinical Trial Detailed Description:\n\nThe Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and\r retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation\r while performing transcatheter aortic valve replacement.\r\n\r The objective of this study is to assess the safety and efficacy of the Claret Medical\r Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic\r Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection).\r\n\r The study population is comprised of subjects with severe symptomatic calcified native aortic\r valve stenosis who meet the commercially approved indications for TAVR with the Edwards\r SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Approved indications for commercially available Edwards SAPIEN Transcatheter Heart\r Valve, model 9000TFX or SAPIEN XT, model 9300TFX meeting one of the three sub-criteria\r below:\r\n\r SAPIEN\r\n\r 1. transfemoral delivery in subjects with severe symptomatic calcified native aortic\r valve stenosis without severe aortic insufficiency and with ejection fraction\r >20% who have been examined by a heart team including an experienced cardiac\r surgeon and a cardiologist and found to either be:\r\n\r 1. inoperable and in whom existing co-morbidities would not preclude the\r expected benefit from correction of the aortic stenosis; or\r\n\r 2. be operative candidates for aortic valve replacement but who have a Society\r of Thoracic Surgeons predicted operative risk score >8% or are judged by the\r heart team to be at a 15% risk of mortality for surgical aortic valve\r replacement.\r\n\r or\r\n\r 2. transapical delivery in subjects with severe symptomatic calcified native aortic\r valve stenosis without severe aortic insufficiency and with ejection fraction >\r 20% who have been examined by a heart team including an experienced cardiac\r surgeon and a cardiologist and found to be operative candidates for aortic valve\r replacement but who have a Society of Thoracic Surgeons operative risk score 8%\r or are judged by the heart team to be at a 15% risk of mortality for surgical\r aortic valve replacement.\r\n\r SAPIEN XT (Transfemoral or Transapical only)\r\n\r 3. in patients with symptomatic heart disease due to severe native calcific aortic\r stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a\r mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0\r m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system,\r who are judged by a heart team, including a cardiac surgeon, to be at high or\r greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons\r operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).\r\n\r 2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15\r mm) diameters without significant stenosis (> 70%) as determined by Multi-Slice\r Computed Tomography (MSCT) scan or equivalent imaging modality\r\n\r 3. The subject and the treating physician agree that the subject will return for all\r required post-procedure follow-up visit\r\n\r 4. The subject or the subject's legal representative has been informed of the nature of\r the trial, agrees to its provisions and has provided written informed consent as\r approved by the IRB of the respective clinical site\r\n\r Exclusion Criteria:\r\n\r General\r\n\r 1. Vasculature in the right extremity precluding 6Fr sheath radial or brachial access\r\n\r 2. Inadequate circulation to the right extremity as evidenced by signs of artery\r occlusion (modified Allen's test) or absence of radial/brachial pulse\r\n\r 3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity\r vasculature\r\n\r 4. Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment\r\n\r 5. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified\r\n\r 6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant\r aortic regurgitation >3+)\r\n\r 7. 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 8. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe\r (greater than 3+) mitral insufficiency\r\n\r 9. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of\r bleeding diathesis or coagulopathy\r\n\r 10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.\r\n\r 11. Need for emergency surgery for any reason\r\n\r 12. Hypertrophic cardiomyopathy with or without obstruction\r\n\r 13. Severe ventricular dysfunction with LVEF ≤20%\r\n\r 14. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation\r\n\r 15. Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant\r CEA/stenting\r\n\r 16. Subject has undergone carotid stenting or carotid endarterectomy within the previous 6\r weeks\r\n\r 17. Active peptic ulcer or upper GI bleeding within the prior 3 months\r\n\r 18. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or\r clopidogrel, or sensitivity to contrast media, which cannot be adequately\r pre-medicated\r\n\r 19. Recent (within 6 months) CVA or a TIA\r\n\r 20. Renal insufficiency (creatinine > 3.0 mg/dL or GFR < 30) and/or renal replacement\r therapy at the time of screening\r\n\r 21. Life expectancy < 12 months due to non-cardiac co-morbid conditions\r\n\r 22. Subjects in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who\r will refuse transfusion\r\n\r 23. Subjects who have active bacterial endocarditis or other active infections\r\n\r 24. Currently participating in an investigational drug or another device study\r\n\r 25. Subjects who have a planned treatment with any other investigational device or\r procedure during the study follow-up period (90 days)\r\n\r 26. Subject with planned concomitant surgical or transcatheter ablation for Atrial\r Fibrillation during the study follow-up period (90 days)\r\n\r 27. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure\r\n\r Neurologic\r\n\r 28. Subject had active major psychiatric disease\r\n\r 29. Subject has severe visual, auditory, or learning impairment and who are unable to\r comprehend English and therefore unable to be consented for the study\r\n\r 30. Subjects with neurodegenerative or other progressive neurological disease or history\r of significant head trauma followed by persistent neurologic defaults or known\r structural brain abnormalities\r\n\r Angiographic\r\n\r 31. Excessive tortuosity in the right radial/brachial/subclavian artery preventing\r Sentinel System access and insertion\r\n\r 32. Subject whose brachiocephalic or left carotid artery reveals significant stenosis,\r calcification, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the\r ostium\r\n\r Magnetic Resonance Imaging\r\n\r 33. Subject Body Mass Index (BMI) precluding imaging in scanner\r\n\r 34. Contraindications to MRI (subjects with any implantable temporary or permanent\r pacemaker or defibrillator, metal implants in field of view, metallic fragments,\r clips, or devices in the brain or eye before TAVR procedure)\r\n\r 35. Planned implantation of a pacemaker or defibrillator implantation after TAVR\r\n\r 36. Claustrophobia\r\n\r 37. Known allergy to gadolinium or contrast agent\n\nPatient 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
562	[ { "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 Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI\n\nClinical Trial Summary:\n\nThe objective of this study is to evaluate the safety and effectiveness of the MicroPort's\r Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic\r stenosis who are considered unsuitable for Surgical Valve Replacement.\n\nClinical Trial Detailed Description:\n\n1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve\r prosthesis and delivery system in intervention by peripheral artery.\r\n\r 2. The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients\r are recruited in the study with native aortic valve stenosis which are considered\r unsuitable for Surgical Valve Replacement.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - 18 years or older, male or non pregnant women;\r\n\r - Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean\r gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 1.0\r cm2 (or AVA index < 0.6 cm2/m2)\r\n\r - Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart\r Association) Functional Class ≥ II\r\n\r - Expectation of life>12 months\r\n\r - Calcific aortic stenosis, which is suitable for transcatheter aortic valve\r implantation anatomically\r\n\r - is evaluated by at least two cardiovascular physicians, and they agreed that medical\r factors precluding operation suitable for surgery (the probability of death or\r serious, irreversible morbidity exceeded 50%)\r\n\r - The subject agreed to comply follow-up evaluation\r\n\r Exclusion Criteria:\r\n\r - Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment\r\n\r - aortic valve is a congenital unicuspid valve, or is non-calcified.\r\n\r - Any therapeutic invasive cardiac procedure resulting in a permanent implant that is\r performed within 30 days\r\n\r - Implanted any heart valve prosthesis, prosthetic valve ring, severe（>3＋）mitral valve\r insufficiency\r\n\r - Blood dyscrasia such as leukopenia (WBC < 3×109/L), acute anemia (Hgb < 90 g/L),\r thrombocytopenia (PLT < 50×109/L), bleeding diathesis, or history of coagulopathy.\r\n\r - Untreated clinically significant coronary artery disease requiring revascularization\r\n\r - Hemodynamic instability requiring mechanical cardiac assist or mechanical hemodynamic\r support devices\r\n\r - Need for emergency surgery for any reason\r\n\r - Hypertrophic cardiomyopathy with or without obstruction\r\n\r - Severe ventricular dysfunction with LVEF (Left ventricular ejection fraction) < 20%\r\n\r - Echocardiographic evidence of intracardiac mass, thrombus or vegetation\r\n\r - Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months\r\n\r - A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine,\r clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately\r pre-medicated.\r\n\r - Native aortic annulus size < 17 mm or> 29 mm.\r\n\r - Patient refuses aortic valve replacement surgery.\r\n\r - Cerebrovascular Accident (CVA) within 6 months, including TIA (transient ischemic\r attack).\r\n\r - Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring\r chronic dialysis.\r\n\r - Life expectancy < 12 months\r\n\r - Significant abdominal or thoracic aorta disease, including aneurysm, marked tortuosity\r (hyperacute bend), aortic arch atheroma, narrowing of the abdominal aorta (especially\r with calcification and surface irregularities), or severe \"unfolding\" and tortuosity\r of the thoracic aorta\r\n\r - Iliofemoral vessel characteristics that would preclude safe placement of 16F to 19F\r introducer sheath such as severe obstructive calcification, severe tortuosity\r\n\r - Active bacterial endocarditis or other active infections.\r\n\r - Bulky calcified aortic valve leaflets in close proximity to coronary ostia\r\n\r - severe incapacitating dementia.\r\n\r - Currently participating in an investigational drug or another device study that has\r not reached its primary endpoint.\r\n\r - Researchers identify that the patients with poor compliance who cannot be completed in\r accordance.\n\nPatient 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
563	[ { "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\nPredicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity\n\nClinical Trial Summary:\n\nAortic stenosis is the most common valvular heart disease and an important public-health\r problem. Surgical or interventional aortic valve replacement are based on symptoms and\r measures of valvular and ventricular function using echocardiography.There is no uniform\r pattern of progression. Instead, marked differences not only between individuals, but also\r during the time course of the disease can be observed.\r\n\r Several prospective studies have been performed to enhance the predictability of disease\r behavior. Individually it is still prone to large errors and hard to predict aortic stenosis\r progression. Therefore, in patients with aortic sclerosis without severe stenosis, it is\r desirable to find a strong predictor of rapid disease progression. This would allow\r anticipating cardiovascular deterioration by identifying individuals at particular risk.\r\n\r Study Hypothesis\r\n\r In patients with aortic sclerosis, increased serum calcification propensity, as measured by\r the T50-Test, is related to the amount of stenosis progression in one year.\n\nClinical Trial Detailed Description:\n\nBackground\r\n\r Clinical Background\r\n\r Aortic stenosis is the most common valvular heart disease and an important public-health\r problem. It is present in approximately 25% of all adults aged >65 years. Decisions about\r surgical or interventional aortic valve replacement are based on symptoms and measures of\r valvular and ventricular function using echocardiography. Such valvular affections are the\r result of a chronic progressive disease, usually starting with hemodynamically\r non-significant aortic sclerosis, and then progressing to severe stenosis over years. There\r is no uniform pattern of progression. Instead, marked differences not only between\r individuals, but also during the time course of the disease can be observed. Aortic sclerosis\r progresses to mild aortic stenosis in <15% of patients over 2 to 7 years. Once moderate\r stenosis is present (jet velocity >3 m/s), the average progression is 0.3 m/s per year, but\r still highly variable. When peak jet velocity exceeds 4 m/s, survival free from symptoms and\r valve replacement is significantly reduced.\r\n\r In the past, several prospective studies have been performed to enhance the predictability of\r disease behavior. Some determinants of rapid progression and adverse outcome have been\r identified, such as: age, gender, cardiovascular risk factors, B-natriuretic peptide,\r stenosis severity, degree of valvular calcification and others. Although it appears that\r progression is more rapid in degenerative calcific disease than congenital or rheumatic\r disease, predicting progression individually is still prone to large errors even when\r considering these determinants. Therefore, regular clinical follow-up is mandatory in\r patients with asymptomatic aortic valve affections. In patients with aortic sclerosis without\r severe stenosis, it is desirable to find a strong predictor of rapid disease progression.\r This would allow anticipating cardiovascular deterioration by identifying individuals at\r particular risk.\r\n\r Background of Tissue Calcification\r\n\r From a biochemical and histological point of view, aortic sclerosis is a valvular disease\r characterized by focal plaque-like lesions containing microscopic calcifications. Because\r calcium and phosphate concentrations in serum are near supersaturation, the balance of\r inhibitors and promoters critically influences the development of calcification. The serum\r protein fetuin-A is a major systemic inhibitor of calcification. Together with additional\r blood components, fetuin-A prevents the supersaturated calcium and phosphate from\r precipitating by forming soluble colloidal protein-mineral nanoparticles and is therefore an\r integral part of the defense system preventing calcifications. Low serum concentrations of\r fetuin-A are associated with a reduced capacity to inhibit calcification in vitro.\r Calcification takes place when this humoral line of defense is overwhelmed.\r\n\r Koos et al. showed that serum levels of the calcification inhibitor fetuin-A are associated\r with the progression of aortic valve calcifications and major adverse clinical events,\r independent of the renal function and inflammation.\r\n\r A novel in vitro blood test developed by Pasch et al. provides an overall measure of\r calcification propensity by monitoring the maturation time (T50) of calciprotein particles.\r First published clinical data indicate that the T50 test is a helpful biomarker for the\r prediction of future vascular calcifications.\r\n\r Study Endpoints\r\n\r - Index test (parameter to be evaluated): T50-Test\r\n\r - Comparator tests (tests to define disease status):\r\n\r Primary:\r\n\r Progression of peak aortic jet velocity over one year (m/s per year)\r\n\r Secondary:\r\n\r Progression of peak aortic jet velocity >20% in one year (dichotomized primary comparator)\r Combined endpoint: death, hospitalizations, aortic-valve replacement, heart failure, angina,\r syncope\r\n\r Inclusion Criteria\r\n\r - Patient referred to routine clinical echocardiography at the Department of Cardiology,\r Inselspital Bern\r\n\r - Aortic sclerosis with or without stenosis\r\n\r - Written informed consent\r\n\r Exclusion Criteria\r\n\r The goal is to recruit a population comprising a large variety of clinical conditions.\r Exclusion criteria are:\r\n\r - Age <18 years\r\n\r - Aortic valve replacement scheduled within 1 year after inclusion\r\n\r - Any aortic valvular disease other than degenerative sclerotic, bi- or unicuspid valves\r\n\r - Known disease with expected survival <1 year\r\n\r - Known malignant tumor\r\n\r - Subvalvular obstruction (in LVOT) with mean pressure gradient >10mmHg\r\n\r Echocardiography\r\n\r Patients will be examined by standard echocardiography including a comprehensive assessment\r of cavity and wall dimensions, ventricular and valvular function, morphologic appraisal and\r pressure predictions. In particular, peak aortic jet velocity will be recorded using CW\r Doppler from the window yielding the highest velocity signal. Aortic stenosis severity will\r be measured using peak flow velocity (m/s). Progression will be expressed as peak flow\r velocity change per year (m/s per year). Aortic valve sclerosis will be assessed visually\r from a short axis according to Rosenhek: 1, no calcification; 2, mildly calcified (small\r isolated spots); 3, moderately calcified (multiple larger spots); and 4, heavily calcified\r (extensive thickening and calcification of all cusps).\r\n\r T50-Test The addition of calcium and phosphate to serum triggers the formation of primary\r calciprotein particles (CPP, see figures 2 and 3). As nano-suspension of calcium-phosphate,\r these particles represent a defense mechanism of the serum against calcification. Primary\r CPPs undergo spontaneous transition to secondary CPPs. The formation of these particles\r represents calcification. In the T50-Test, the time elapsed for the transformation of 50% of\r the particles is measured and is specific for individual sera.\r\n\r The blood-sample will be taken immediately after completion of the echocardiographic exam.\r\n\r Objective\r\n\r The purpose of this study in patients with aortic sclerosis with and without stenosis is to\r establish an independent predictor of progression of aortic valve obstruction using a new\r calcification propensity measure in the serum.\r\n\r Methods\r\n\r Recruitment 200 consecutive patients referred for a routine clinical echocardiographic exam\r showing varying degrees of aortic sclerosis will be included.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patient referred to routine clinical echocardiography\r\n\r - Aortic sclerosis with or without stenosis\r\n\r - Written informed consent\r\n\r Exclusion Criteria\r\n\r - Age <18 years\r\n\r - Aortic valve replacement scheduled within 1 year after inclusion\r\n\r - Any aortic valvular disease other than degenerative sclerotic, bi- or unicuspid valves\r\n\r - Known disease with expected survival <1 year\r\n\r - Known malignant tumor\r\n\r - Subvalvular obstruction (in left ventricular outflow tract) with mean pressure\r gradient >10mmHg\n\nPatient 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
564	[ { "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\nDiuretic Versus Placebo in Pulmonary Embolism\n\nClinical Trial Summary:\n\nPulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about\r 75000 cases in France and a short-term mortality rate of about 10%. Death is usually related\r to an acute right ventricular (RV) failure due to the increase in right ventricular\r afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in\r case of shock. However several studies suggest that fluid expansion may worsen acute RV\r failure by increasing RV dilatation and ischemia and left ventricular compression by RV\r dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of\r fluid expansion. In a preliminary study published by our group, we showed that diuretic\r treatment in the setting of PE with RV dilatation is safe and is associated with an increase\r in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients\r with oliguria. This may be related to the decrease of ventricular interdependence and\r enhancement of both LV and RV function.\r\n\r The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in\r patients referred for acute PE with RV dilatation compared to placebo. The combination of\r urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it\r indicates the disappearance of pre-shock symptoms and is therefore associated with a lower\r event risk. Thus, it allows early discharge of the patients from the intensive care unit.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Patients aged 18 years and over with\r\n\r 1. Symptomatic acute pulmonary embolism with first clinical symptoms within 15 days, and\r objectively confirmed by CT scan\r\n\r 2. RV dysfunction (≥1 criterion) confirmed by elevated BNP value or echocardiography or\r spiral computed tomography of the chest:\r\n\r - Echocardiography\r\n\r o Right/Left ventricular end diastolic diameter > 1(apical or subcostal 4-chamber\r view)\r\n\r - Computed tomography\r\n\r o Right/Left short-axis diameter ratio>0.9 (transverse plane)\r\n\r - Positive Nt-proBNP (>600) or BNP>200 pg/mL\r\n\r 3. One abnormal following PESI criteria\r\n\r - Heart Rate>110/min\r\n\r - Systolic blood pressure<100mmHg\r\n\r - Arterial oxyhemoglobin level<90% on room air or after 5 minutes of oxygen\r withdrawal.\r\n\r Exclusion Criteria:\r\n\r - Cardiogenic shock requiring thrombolysis\r\n\r - Previous significant left ventricular insufficiency (LVEF<45%)\r\n\r - Systolic blood pressure<90mmHg at admission\r\n\r - Age ≤ 18 years\r\n\r - Pregnancy\r\n\r - No health insurance\r\n\r - Patients deprived of liberty or under legal protection\r\n\r - Creatinin clearance <30mL/min/m²\r\n\r - hypersensibility to furosemide or its excipients\r\n\r - functional renal insufficiency\r\n\r - Hepatic encephalopathy\r\n\r - Urinary tracks obstruction\r\n\r - Hypovolemia or dehydration.\r\n\r - Sever hypokalemia (K+ < 3mmol/L)\r\n\r - Severe hyponatremia (Na+ < 125mmol/L)\r\n\r - Ongoing hepatitis and hepatic insufficiency severe in patients with renal\r insufficiency or dialysis\n\nPatient 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
565	[ { "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\nAcupuncture and Moxibustion for Hyperlipemia\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate the effect of 12 weeks of acupuncture and\r moxibustion compared with active control, on absolute and percent change from baseline in\r low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Subject signed the informed consent\r\n\r - Male or female ≥18 to ≤75 years of age\r\n\r - Fasting TG ≤400 mg/dL\r\n\r - Fasting LDL-C as determined by central laboratory on admission and meeting the\r following LDL-C values based on risk factor status:\r\n\r - 0-1 Risk Factor Group: LDL-C ≥160 mg/dL\r\n\r - 2+ Risk Factor Group: LDL-C ≥130 mg/dL\r\n\r - CHD or CHD risk equivalents: LDL-C ≥100 mg/dL\r\n\r - Major Risk factors: （1）Cigarette smoking;（2）Hypertension (BP ≥140/90 mmHg or on\r anti-hypertensive medication);（3）Low HDL cholesterol (HDL-C <40 mg/dL);（4）Family\r history of premature CHD (CHD in male first degree relative <55 years; CHD in\r female first degree relative <65 years);（5）Age (men ≥45 years; women ≥55 years)\r\n\r - CHD and CHD equivalents:（1）Other clinical forms of atherosclerotic disease\r (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid\r artery disease);（2）Diabetes;（3）Multiple risk factors that confer a 10-year risk\r for CHD >20%\r\n\r Exclusion Criteria:\r\n\r - CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening\r ≤99 mg/dL\r\n\r - NYHA II, III or IV heart failure, or last known left ventricular ejection fraction\r <30%\r\n\r - Uncontrolled cardiac arrhythmia, atrial fibrillation with rapid ventricular response,\r or not controlled supraventricular tachycardia in the past 3 months prior to\r randomization\r\n\r - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),\r coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization\r\n\r - Planned cardiac surgery or revascularization\r\n\r - Type 1 diabetes or newly diagnosed type 2 diabetes or poorly controlled type 2\r diabetes\r\n\r - Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) >160 mmHg\r or diastolic BP (DBP) >100 mmHg\r\n\r - Subjects taken red yeast rice, niacin >200 mg/d, or omega-3 fatty acids >1000 mg/d or\r prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates\r and derivatives, or bile-acid sequestering resins in the last 6 weeks prior to LDL-C\r screening\r\n\r - Subjects taken systemic cyclosporine, systemic steroids, vitamin A derivatives and\r retinol derivatives for the treatment of dermatologic conditions in the last 3 months\r prior to LDL-C screening\r\n\r - Hyperthyroidism or hypothyroidism\r\n\r - Moderate to severe renal dysfunction\r\n\r - Active liver disease or hepatic dysfunction\r\n\r - CK >3 times the ULN at screening or at end of lipid stabilization period, confirmed by\r a repeat measurement at least 1 week apart\r\n\r - Known active infection or major hematologic, renal, metabolic, gastrointestinal or\r endocrine dysfunction in the judgment of the investigator\r\n\r - Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization\r\n\r - Current therapeutic anticoagulation with vitamin K antagonist, heparin, low-molecular\r weight heparin, direct thrombin inhibitor\r\n\r - Currently enrolled in another investigational device or drug study\r\n\r - Female subject during pregnant or breast feeding period\r\n\r - History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma,\r breast ductal carcinoma in situ, or stage 1 prostate carcinoma)\r\n\r - Known sensitivity to any of the products to be administered during dosing\r\n\r - Subjects couldn't provide the written informed consent and/or comply with all required\r study procedures\n\nPatient 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
566	[ { "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\nInvestigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)\n\nClinical Trial Summary:\n\nProspective longitudinal study on four small groups of surgical patients affected by: BAV\r with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with\r isolated stenosis in over 60 year-old patients.\r\n\r The aim of the study is to select homogeneous small groups of surgical patients with the same\r subtype of BAV and same aortic behaviour and identify markers/predictors of\r favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more\r likely to be considered at high risk for aortic degeneration.\n\nClinical Trial Detailed Description:\n\nThe aim of the study is to select homogeneous small groups of surgical patients with the same\r subtype of BAV and same aortic behaviour and identify markers/predictors of\r favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more\r likely to be considered at high risk for aortic degeneration. The study will focus on\r multiple aspects of BAV disease. What follows will be considered and combined:\r\n\r Aortic valve, aorta root and ascending aorta morphology The use of two- (2DE) and\r three-dimensional (3DE) trans-thoracic (TTE) and/or transoesophageal (TOE) echocardiography\r can identify all kind of BAV morphology (leaflet position and coronary ostia displacement).\r It also gives quali- quantitative information about root and ascending aorta morphology and\r size.\r\n\r BAV genetics Recently, missense mutations in the NOTCH1 gene have been shown to be associated\r with calcific aortic valve disease plus BAV. However mutations in the NOTCH1 gene only\r partially explain the presence of BAV in the absence of other syndromic diseases (i.e. Marfan\r Syndrome, Loeys Dietz Syndrome type I and II and Ehlers Danlos type IV Syndrome).\r\n\r BAV Histology In all enrolled patients, during operation, tissue samples will be collected\r from valve cusps (in case of valve involvement), aortic wall (aortic root, concavity or\r convexity of ascending aorta) or from both of them. Samples will be analyzed in order to\r classify medial and intimal disruption and changes.\r\n\r Study Design and Setting of the Study The first step will consist in enrolling patients with\r echocardiographic diagnosis of BAV and indication for surgery. From the echo data, aortic\r valve, as well as aortic root and ascending aorta morphology will be assessed in order to\r classify patients in each phenotypic pattern. The echo images from participating centres will\r be sent to an echo core lab for quali- quantitative analysis (see below) and all data will be\r recorded in a specific database.\r\n\r The second step will consider first-degree relatives of each enrolled patient. The\r investigators will ask every first degree relative to perform a screening TTE in order to\r find out, according to familiar aetiology of BAV, the presence of BAV and/or associated\r disease (aortic root or ascending aorta enlargement or coronary ostia displacement).\r\n\r The third step will consist in collecting blood samples from each patient and from any of\r first-degree relatives with BAV diagnosis. BAV-specific genetic tests will be performed and\r all data will be recorder in a specific database.\r\n\r The fourth intraoperative step will consist in :\r\n\r 1. performing a 3D TOE in order to study the geometry and the dynamic behaviour of the\r aortic valve and root and\r\n\r 2. in collecting surgical tissue samples: during operation there will be described\r precisely the anatomy of the valve and the aorta in detail; then, from the usual site of\r surgery, there will be collected valve and aortic wall samples in order to perform\r histological, immunohistochemical and genetics tests.\r\n\r Blood and surgical samples will be stored in a bio-bank for future analysis related to this\r protocol.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Men and women over 18 years-old and under the age of 60 (age selection will prevent\r from enrolling patient with age-related valve and aortic wall degeneration). For the\r BAV stenosis group there will be considered patients over 60 years-old: including the\r most frequent form of BAV disease and the commonest age, this group could be used as a\r control group compared to the outlier ones.\r\n\r - Echo diagnosis of BAV and indication to surgery:\r\n\r BAV with isolated regurgitation, BAV with normal valvular function but associated aorta\r dilatation, BAV with both valve regurgitation and aortic dilatation BAV with isolated\r stenosis\r\n\r - Signed informed consent\r\n\r Exclusion Criteria:\r\n\r - Patient with a previous cardiac or great vessels surgery\r\n\r - coexistent coarctation of the aorta\r\n\r - non-associated cardiac diseases: valve disease (other than aortic), ischemic disease,\r congenital heart disease.\r\n\r - Marfan syndrome or other connective tissue disorders involving aortic valve and aortic\r wall disease (history of disease or clinical signs).\r\n\r - Other conditions/circumstances likely to lead to poor study adherence (e.g.\r psychological or organizational reasons).\r\n\r - Serious disease other than aortic, severely limiting life expectancy.\r\n\r - Patients who refuse to give informed consent\n\nPatient 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
567	[ { "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 Myocardial Fibrosis in Aortic STenosis\n\nClinical Trial Summary:\n\nThis observational cohort study studies the impact myocardial fibrosis has on patients with\r severe aortic stenosis undergoing aortic valve replacement.\n\nClinical Trial Detailed Description:\n\nAortic stenosis is the most common valvular disease in the Western World. It is a slow\r evolving degenerative disease caused by gradual accumulation of calcium in the valve.\r Untreated it is fatal. Reduced opening area of the valve increases afterload on the left\r ventricle (LV), which leads to raised end-diastolic pressure in the LV. Increased wall stress\r leads to LV hypertrophy and expansion of the extracellular matrix. An abnormally high\r extracellular volume fraction is called myocardial fibrosis (MF), which causes increased LV\r stiffness, diastolic dysfunction, dilatation of the left atrium and in the end heart failure.\r\n\r The standard of treatment for aortic stenosis is an operation, aortic valve repair (AVR),\r where a mechanical or biological valve replaces the old one. The operation involves a\r substantial risk of postoperative mortality, and is therefore delayed until the patient\r develops symptoms such as shortness of breath, chest pains or syncope. For most patients AVR\r causes significant symptom reduction and reduced mortality. Recent studies have indicated\r that patient with severe MF, which may account for up to one third of the patients treated,\r have little or no symptom improvement and an increased mortality after AVR. This raises\r concern that their LV is so severely fibrotic that it is beyond repair. These patients may\r not benefit from an operation, or should possibly have had AVR performed at an earlier stage\r of the disease.\r\n\r Today, cardiac fibrosis can be detected by a biopsy which is invasive. Late Gadolinium and\r T1-mapping cardiac Magnetic Resonance imaging (MRi) has recently been evaluated as a new\r method to detect MF, but this method is costly and contraindicated for some patients. Cardiac\r Computerized Tomography (CT) has been proposed as a method to evaluate MF, but has not been\r properly validated yet.\r\n\r In this study we compare different methods (biopsy, MRi, CT, echocardiography and different\r biomarkers) to evaluate the extent of MF in 130 patients with severe aortic stenosis\r undergoing AVR. We will focus on their symptom improvement and survival rate one year after\r the operation. Our main thesis is that patients with severe fibrosis before the operation\r have little or no symptom improvement and reduced survival after the operation. If this\r thesis is correct, it will question which patients to offer AVR. Some patients we operate\r today may have no benefit from the operation because the left ventricle is damaged from\r severe fibrosis, and some patients from who we withhold the operation today because they are\r asymptomatic may benefit from AVR before they develop severe fibrosis.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Severe aortic valve stenosis (AVA ≤1cm2).\r\n\r - Scheduled for aortic valve replacement.\r\n\r - Signed consent\r\n\r Exclusion Criteria:\r\n\r - At least moderate mitral regurgitation or stenosis.\r\n\r - Primary aortic insufficiency.\r\n\r - Persistent or permanent atrial fibrillation/flutter.\r\n\r - CKD with e-GFR < 40 ml/kg/min.\r\n\r - Pacemaker or Implantable Cardioverter Defibrillator (ICD).\n\nPatient 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
568	[ { "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\nQuantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients\n\nClinical Trial Summary:\n\nIt is a common understanding that patients with coronary heart disease are suffering, among\r others, from reduced myocardial perfusion. In order to increase (normalize) the reduced\r perfusion, when a conventional approach failed, coronary bypass surgery, coronary vessel\r dilatation or stenting are performed. The similar situation with reduced myocardial perfusion\r may be found in patients with stenosis of the aortic valve, where aortic valve replacement\r may increase myocardial perfusion by left-ventricular remodelling. However, there is\r presently no method established to measure myocardial perfusion quantitatively and\r noninvasively before and after a therapeutic intervention.\r\n\r Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in\r ml/100g/min would strengthen the indication for specific therapeutic approach and enable an\r objective control of effectiveness of the applied therapy.\r\n\r Hypothesis:\r\n\r There is a measureable difference in quantitative myocardial perfusion values before (lower)\r and after (higher) interventional or surgical procedure.\r\n\r The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT\r 256 Brilliance ) quantitatively in ml/100g/min in three groups of patients:\r\n\r 1. Before and after coronary bypass surgery\r\n\r 2. Before and after coronary vessel dilatation/stenting\r\n\r 3. Before and after aortic valve replacement.\r\n\r The investigators will not assign specific interventions to the subjects of these three\r groups. Therefore, the research is strictly observational.\r\n\r Design:\r\n\r Prospective study to measure quantitatively myocardial perfusion in the above mentioned three\r groups of patients with simultaneous control and registration of all essential, physiological\r determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial\r perfusion measurements will be performed directly after the indication for intervention or\r surgery and on the last day before discharge from hospital.\r\n\r All the collected data (determinants) inclusively the CT-studies will be anonymised and\r archived on a local server. The investigators of the University of Medical Computed Sciences\r and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion\r measurements and all statistical analysis independently of the CT-studies performing\r physicians.\n\nClinical Trial Detailed Description:\n\nReliability of the hypothesis:\r\n\r On phantom studies simulating myocardial perfusion measurements and in animal studies we\r could confirm that using advanced CT technology (as e.g. \"iCT 256 Brilliance\") it is possible\r to measure myocardial perfusion in absolute values - in ml/100g/min. These myocardial\r perfusion measurements did not differ from those received by EBCT (Electron Beam Computed\r Tomography). Based on these experimental results and based on the quantitative measurements\r of myocardial perfusion in 1500 patients studied by EBCT at the Medical University of Graz\r the hypothesis may be done that using the above mentioned iCT 256 technology, it should be\r possible to measure myocardial perfusion quantitatively in a daily clinical practice.\r\n\r Ethical aspects:\r\n\r The study will be performed according to the international regulations (ISO 14144:212-01) and\r in agreement with the \"Declaration of Helsinki\". After oral and written explanation of the\r planned study and by signing the study agreement by patient and by responsible physician,\r patients participation is voluntary. The patients participating can leave the study any time\r without negative sequels for him or her. There is no financial restitution for the patients.\r\n\r Patients will be informed about (very rare) possible allergoid-toxic reactions during and\r after intravenous contrast agent application. For possible emergency well trained medical\r staff and equipment is present. About renal insufficiency: renal failure (creatinin clearance\r <60ml/min [GFR (Glomerulo Filtration Rate)will be calculated according the\r Cockroft-Gault-Formula, GFR {ml/min}=((40-age)weight{kg}0,85{only for women}]/serum\r creatinin [mg/dl]72) above.\r\n\r The applied X-ray dose (CT) may and will be reduced by:\r\n\r reduction of KV (kilovoltage) from 120 to 100 or 80 in dependance of patients weight,\r reduction of MA (milliamper)by using iterative image reconstruction allgorithm (iDOSE). These\r technical approaches represent the best possibility to reduce X-ray dose for the patient. As\r the coronary heart disease with stenotic lesions above 50% is a disease mainly of an elderly\r men (in female mostly after menopause and in male after 50 years of age) the risk for X-Ray\r dose related genetic defects is very low. The expected applied X-Ray doses by the above\r mentioned approach will be very low and therefore the risk of X-Ray induced malignancy may be\r regarded as very low too.\r\n\r Design:\r\n\r Prospective study to measure quantitatively myocardial perfusion in the above mentioned three\r groups of patients with simultaneous control and registration of all essential, physiological\r determinants of myocardial perfusion immediately before the CT study. The CT myocardial\r perfusion measurements will be performed directly after the indication for intervention or\r surgery and on the last day before discharge from hospital.\r\n\r All the collected data (determinants) including the CT-studies will be anonymised and\r archived on a local server. These anonymised data may be approached only by members of Graz\r University of Technology, Institute of Health Care Engineering who will perform the\r evaluation of the myocardial perfusion measurements and the statistical analysis\r independently of the CT-studies performing physicians.\r\n\r Practical procedure:\r\n\r 1. In supine position on CT table the blood pressure and the heart rate will be measured\r and registered.\r\n\r 2. In all patients a standard native cardiac CT for evaluation of coronary calcification by\r Agatston score will be performed.\r\n\r 3. In all patients myocardial perfusion will be measured in inspiration and contrast agent\r application where by the amount of contrast agent and the applied dose is related to\r patient weights as shown below:\r\n\r Patient Perfusion 210mg Iodine/ml Expected dose weight [kg] / [kV/mAs] / [ml] / per\r shoot [mSv](milli Sievert)\r\n\r <60 80/80 40 0.21/ 60-70 80/100 50 0.25/ 70-90 80/120 60 0.30/ 90-100 100/90 70 0.40/\r >100 100/100 80 0.43\r\n\r 4. Standard cardiac CT will be performed to evaluate coronary arteries and left ventricular\r volumes.\r\n\r 5. In supine position on CT table the blood pressure and the heart rate will be measured\r and registered.\r\n\r Quantitative evaluation:\r\n\r The calculation of the myocardial perfusion succeeds in all slices with visible left\r ventricular myocardium using a modification of the formula described by K.Miles and model\r based approaches.\r\n\r The calculation of the left ventricular volumes succeeds by use of the vendors software.\r\n\r Statistic:\r\n\r All personal and measured data will be anonymised, tested, analysed and evaluated in Graz\r University of Technology.\r\n\r The numerical values will be expressed as mean +/- SD (min, max, 95% CI). p-values of 0.05\r will be regarded statistically significant. Paired test and or Wilcoxon signed-rank tests\r will be used. X² analyses will be used to compare categoric variables. Additionally\r correlation analyses (Pearson, Spearman) will be performed and method of classification (pre-\r vs. postoperative) will be applied. All calculation will be done by SPSS 21.0 (SPSS, Chicago,\r Il, USA) or by Matlab statistic toolbox or R.\r\n\r The neccessary number of studied patients is based on the results of 64 patients studied\r before and after aortic valve replacement in whom the myocardial perfusion was measured\r before and four months after surgery.\r\n\r Pre-operative: Mean=74 (SD=21) ml/100g/min Post 4 Months: Mean=78 (SD=20) ml/100g/min.\r Difference= +4ml/100g/min. With 0.5 supposed correlation of the measured values the standard\r deviation of the differences may be estimated as 20ml/100g/min.\r\n\r By alpha=0.05, 1-beta=0.80, n=209 patients is needed.\r\n\r In addition to the pre- and post surgery evaluation, statistical models explaining the\r influence of collected data on the quantitaitve myocardial perfusion will be computed.\r\n\r As a drop-out quote of 10% may be expected it is neccessary to study in each group of\r patients 230 patients. This means total 690 patients.\r\n\r All data will be registered in database and tested for plausibility.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r in cohort: Coronary Bypass Surgery:\r\n\r o presence of at least one coronary stenotic lesion above 50% with clinical indication for\r coronary bypass surgery\r\n\r in cohort: Coronary Stenting: o presence of at least one coronary stenotic lesion above 50%\r with indication for coronary vessel dilatation/stenting\r\n\r in cohort: Aortic Valve Replacement\r\n\r o presence of aortic valve disease (stenosis) with clinical indication for aortic valve\r replacement without coronary vessel stenosis above 50%\r\n\r for all three cohorts:\r\n\r - list of medication timely related to the procedure\r\n\r - signed informed consent\r\n\r Exclusion Criteria:\r\n\r for all three cohorts:\r\n\r - intolerance to contrast agent\r\n\r - multiple myeloma, pheochromocytoma, thyroid dysfunction, acute infection\r\n\r - renal failure\r\n\r - severe arrhythmia\r\n\r - pregnancy\r\n\r - reduction of cognitive capabilities to understand the purpose and the extent of the\r study\r\n\r - participation in a medical-scientific study using X-rays in the last ten years\r\n\r - lack of Russian knowledge to fill the forms\r\n\r - lack of signed study agreement -\n\nPatient 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
569	[ { "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\nStatins at the Primary Care Level\n\nClinical Trial Summary:\n\nHypercholesterolemia, a major cause of disease burden in both the developed and developing\r world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third\r of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the\r prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%,\r whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was\r 37.3 % and the proportion of those who are under pharmacological treatment was dismally low:\r only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of\r coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on\r statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and\r low-dose aspirin were available free-of-charge at the primary care clinics of the public\r sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg)\r were incorporated into the package of drugs provided free-of-charge for patients with high\r cholesterol, according to CVD risk stratification. The goal of this study is to test whether\r a multifaceted educational intervention targeting physicians and pharmacist assistants,\r improves detection, treatment and control of hypercholesterolemia among uninsured patients\r with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will\r test whether a multifaceted educational intervention program lowers LDL-cholesterol levels\r and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance\r with clinical practice guidelines, and improves patient care management and adherence to\r medication. A cost-effectiveness study will be conducted to compare the intervention to the\r usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public\r primary care clinics who will be assigned to receive either the intervention or the usual\r care. This study is timely and will generate urgently needed data on effective and, practical\r and sustainable intervention programs aimed at the prevention and control of CVD risk that\r can be directly used in other primary care settings and health care systems in LMICs.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Arteriosclerotic cardiovascular disease: defined as acute coronary syndrome; history\r of myocardial infarction, stable or unstable angina, coronary revascularization,\r stroke, or transient ischemic attack presumed to be of atherosclerotic origin and\r revascularization.\r\n\r - Moderate-High CVD risk according to the WHO charts adapted by the National MoH\r (estimated 10-year CVD risk ≥ 20%)\r\n\r - LDL-C level ≥ 190 mg/dL\r\n\r - Type 2 diabetes in patients between 40 and 75 years of age\r\n\r Exclusion Criteria:\r\n\r - Patients that are already receiving statins, pregnant women, bed-bound, and patients\r who cannot give informed consent.\r\n\r - End stage chronics kidney disease receiving dialysis ,HIV/AIDS, tuberculosis, alcohol\r or drugs abuse.\n\nPatient 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
570	[ { "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 Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve\r replacement (TAVR) in patients with bicuspid aortic valve stenosis.\n\nClinical Trial Detailed Description:\n\nThis registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry\r changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and\r continue to 10-year follow-up.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients with bicuspid aortic valve stenosis who are not candidates for surgical\r aortic valve replacement because of coexisting illnesses.\r\n\r - The patient or guardian agrees to the study protocol and the schedule of clinical\r follow-up, and provides informed, written consent, as approved by the appropriate\r Institutional Review Board/Ethics Committee of the respective clinical site.\n\nPatient 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
571	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nLeft Atrial Volume Index in Asymptomatic Aortic Stenosis\n\nClinical Trial Summary:\n\nAortic stenosis results in increased filling pressures of the heart. Size and function of the\r left atrium may be a marker for more advanced heart disease (heart failure) in patients with\r severe aortic stenosis, not presenting any apparent symptoms.\r\n\r The goal of this study is to establish the importance and possible implications of left\r atrial dilation in asymptomatic patients with aortic valve stenosis.\n\nClinical Trial Detailed Description:\n\nAortic valve stenosis (AS) is the most common valvular disease in the western world. Mild and\r moderate AS generally is well tolerated severe AS is associated with considerable morbidity\r and mortality.\r\n\r The consequence of AS is increased pressure load on the left ventricle, which causes changes\r in the ventricular function and structure (Left ventricular remodeling, hypertrophy,\r fibrosis).\r\n\r With longstanding elevated filling pressures the left atrium will dilate and heart failure\r symptoms will develop.\r\n\r When apparent, symptoms of heart failure, in AS are associated with high mortality rate and\r aortic valve replacement (AVR) is recommended.\r\n\r The clinical assessment of heart failure symptoms in AS is however challenging particularly\r in the elderly, as symptoms progress slowly and may mimic age related fragility.\r\n\r In this observational study, the goal is to investigate the importance and possible\r implications of left atrial dilation and heart failure among 100 patients with asymptomatic\r severe aortic stenosis. Participants undergo echocardiographic evaluation for diastolic heart\r failure and we assess myocardial fibrosis using magnetic resonance imaging and exercise\r testing with invasive hemodynamic monitoring (right heart catheterization).\r\n\r LA dilatation may potentially identify patients likely benefiting of early surgery. The\r importance and possible implications of LA dilatation in asymptomatic AS patients has however\r not yet been established.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Asymptomatic severe aortic stenosis (Vmax > 3.5 m/sec and aortic valve area < 1 cm2).\r\n\r Exclusion Criteria:\r\n\r - Moderate LV systolic dysfunction (LVEF < 50%)\r\n\r - Concomitant moderate-severe aortic valve regurgitation\r\n\r - Concomitant moderate-severe mitral valve regurgitation\r\n\r - Moderate to severe nephropathy\r\n\r - Chronic or persistent atrial fibrillation\r\n\r - Implanted pacemaker or cardio defibrillator\r\n\r - Disability to exercise testing.\n\nPatient 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
572	[ { "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\nChanges in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.\n\nClinical Trial Summary:\n\nThe investigators want to compare the effects of two drugs, levosimendan and milrinone, on\r cardiac muscle, both in terms of contractility and relaxation. Half of the participants will\r be randomized to each drug. The effects will be measured through echocardiographic\r deformation analyses.\r\n\r Since deformation analyses could be dependent on different loading conditions of the heart, a\r second purpose of the study is to investigate the changes on deformation parameters after\r applied changes in preload and afterload, but also heart rate.\n\nClinical Trial Detailed Description:\n\nAortic stenosis is associated with myocardial hypertrophy and diastolic dysfunction. In\r patients undergoing open aortic valve replacement surgery due to stenosis, the investigators\r want to compare the effect on myocardial relaxation between two commonly used drugs,\r levosimendan and milrinone, using catheter-based measurements in combination with\r echocardiographic evaluation.\r\n\r Standard anaesthesia and surgical care for these patients is performed. After surgery is\r completed and the participant is transferred to the intensive care unit, the studies are\r performed during general anaesthesia and the participants still connected to a respirator\r with controlled ventilation.\r\n\r Echocardiographic data will be collected simultaneously with hemodynamic parameters - first\r at two control measurements, then after each of two different doses of the drug. Preload,\r afterload and heart rate will be kept stable during this intervention. The echocardiographic\r data is later analyzed offline for strain and strain rate.\r\n\r To further investigate the dependency of strain and strain rate on changes in preload,\r afterload, and heart rate, these variables are consecutively changed prior to drug\r administration. For this purpose, all patients first have their baseline data recorded,\r thereafter are paced at two different rates, then preload and afterload is altered by passive\r leg elevation and phenylephrine, respectively. Hemodynamic and echocardiographic data are\r collected simultaneously at baseline and after each intervention. Before administration of\r the drugs, baseline conditions are restored.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Subject has aortic valve stenosis\r\n\r - Subject is scheduled for open heart aortic valve replacement with or without\r simultaneous coronary artery bypass grafting\r\n\r Exclusion Criteria:\r\n\r - Less than normal systolic function, defined as ejection fraction less than 0,5\r\n\r - Non-sinus rhythm\r\n\r - Any major surgical complication\r\n\r - Problems understanding the informed consent\n\nPatient 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
573	[ { "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\nHigh-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)\n\nClinical Trial Summary:\n\nTASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of\r minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic\r aortic stenosis.\n\nClinical Trial Detailed Description:\n\nDevelopment of symptoms such as heart failure, syncope or angina pectoris is the\r well-established indication for valve operation in patients with severe aortic stenosis.\r However, many patients tend to misinterpretate or even ignore symptom onset, and irreversible\r myocardial dysfunction may occur. Measurement of aortic valve area by transthoracic\r echocardiography using the continuity equation is prone to methological mistakes, whereas\r transvalvular gradients are usually easy to quantify but may underestimate hemodynamic\r effects in the presence of low flow (stroke volume index below 35 ml/m2). All these\r shortcomings in clinical routine may be overcome by objectively and easily assessable\r parameters indicating advanced aortic stenosis. Severe aortic valve calcification is such a\r risk factor for worse prognosis. However, assessment of valve calcification by\r echocardiography is a subjective measurement and highly operator-dependent. Quantification of\r valve calcification by multi detector computed tomography is limited by exposure to\r radiation, availibilty and cost.\r\n\r A laboratory parameter already used in clinical routine would fullfill the requirements for\r such a risk stratification much better. Natriuretic peptides may be of interest in this\r context, but their plasma levels are strongly influenced by age, sex, concomitant arterial\r hypertension and/or renal dysfunction and volume status. Recently, high-sensitivity troponin\r plasma levels have been suggested to indicate ongoing myocardial fibrosis in aortic stenosis.\r A small study with 60 patients suggested that hs-TnT predicte the operative outcome of AS. We\r therefore set out to characterize the clinical value of minimally elevated troponin T plasma\r levels both in patients with asymptomatic and symtomatic aortic stenosis.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - aortic stenosis detected by echocardiography / invasively\r\n\r Exclusion Criteria:\r\n\r - acute coronary syndrome\r\n\r - endocarditis\n\nPatient 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
574	[ { "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 preDIlatation in tRanscathEter aortiC Valve implanTation Trial\n\nClinical Trial Summary:\n\nThis is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV)\r on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI)\r procedure. Patients will undergo a physical exam, coronary angiography and computed\r tomography angiography before TAVI. The randomization for direct or non-direct TAVI ( with\r BAV or without BAV) will take place 24 hours prior to the procedure by the core lab at\r Hippokration Hospital in Athens. The same lab will analyze in blind fashion the results of\r all the imaging modalities for each patient. The patients will be followed during the\r hospital stay and at 30 days and 1 year thereafter by echocardiography. The procedure of\r predilatation will be at the operator's discretion.\n\nClinical Trial Detailed Description:\n\nBackground: Balloon aortic valvuloplasty (BAV) is a vital part of the transcatheter aortic\r valve implantation (TAVI) procedure. There is a lack of long-term evidence in patients\r undergoing direct TAVI without predilatation.\r\n\r Trial: This is a prospective multi-center randomized trial.\r\n\r Participating medical centers:\r\n\r 1. 1st Department of Cardiology, Hippokration Hospital/Athens Medical School, Athens,\r Greece\r\n\r 2. Heart Institute, Hadassah Hebrew University Medical Center, POB 12000, Jerusalem 91120,\r Israel.\r\n\r 3. Department of Cardiology, Division of Internal Medicine, University Medical Centre\r Ljubljana, Zaloška 7, SI-1525 Ljubljana, Slovenia.\r\n\r 4. Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece\r\n\r 5. Second Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece\r\n\r Description: Patients will undergo a physical exam, coronary angiography and computed\r tomography angiography before TAVI. The randomization for direct or non-direct TAVI will take\r place 24 hours prior to the procedure by the core lab at Hippokration Hospital in Athens. The\r same lab will analyze in blind fashion the results of all the imaging modalities for each\r patient. The patients will be followed during the hospital stay and at 30 days and 1 year\r thereafter by echocardiography. The procedure of predilatation will be at the operator's\r discretion. Access sites for TAVI are: transfemoral, subclavian and transaortic.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Diameter of >5mm for Evolut R and >6mm for CoreValve of the vessel.\r\n\r 2. Aortic valve diameter of ≥20mm and ≤29mm as measured by echo.\r\n\r 3. Ascending aorta diameter ≤ 43mm at the sinotubular junction.\r\n\r 4. Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve\r area 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 5. STS score of ≥ 8 OR LogEuroSCORE> 20%, OR\r\n\r - 80 years old OR\r\n\r - 65 years old with 1 or 2 (but not more than two) from the following criteria:\r\n\r - Liver cirrhosis (Class A or B).\r\n\r - Pulmonary insufficiency: VMS<1 liter.\r\n\r - Previous heart surgery (CABG, vascular surgery).\r\n\r - Porcelain aorta.\r\n\r - Pulmonary artery systolic pressure >60 mmHg and high risk for heart surgery.\r\n\r - Relapsing pulmonary embolism.\r\n\r - Right ventricular insufficiency.\r\n\r - Thoracic wall injuries that contraindicate an open heart surgery.\r\n\r - History of radiation therapy of the mediastinum.\r\n\r - Connective tissue disease that contraindicates an open heart surgery.\r\n\r - Frailty/cachexia.\r\n\r 6. Patients will be informed on the nature of the study and provide written consent.\r\n\r Exclusion Criteria:\r\n\r 1. A known hypersensitivity or contraindication to any of the following which cannot be\r adequately pre-medicated: aspirin or heparin and bivalirudin, ticlopidine and\r clopidogrel, nitinol (titanium or nickel), contrast media\r\n\r 2. Ongoing sepsis, including active endocarditis.\r\n\r 3. Any percutaneous coronary or peripheral interventional procedure with a bare metal or\r drug eluting stent performed within 30 days prior to Heart Team assessment.\r\n\r 4. Echocardiographic evidence of LV or LA thrombus.\r\n\r 5. Mitral or tricuspid valve insufficiency (> grade II).\r\n\r 6. Previous aortic valve replacement (mechanical or bioprosthetic).\r\n\r 7. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or\r transient ischemic attack (TIA).\r\n\r 8. Patients with:\r\n\r Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion\r of a transcatheter sheath.\r\n\r OR Symptomatic carotid or vertebral artery disease (> 70% stenosis).\r\n\r 9. The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.\r\n\r 10. Estimated life expectancy of less than 12 months due to associated non-cardiac\r co-morbid conditions.\r\n\r 11. Creatinine clearance < 20 ml/min.\r\n\r 12. Active gastritis or ulcer.\r\n\r 13. Pregnancy.\r\n\r 14. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <\r 20%.\r\n\r 15. Unicuspid or bicuspid aortic valve.\r\n\r 16. Mixed aortic valve disease (aortic stenosis and aortic regurgitation> 2+).\r\n\r 17. Liver failure (Child-Pugh class C).\r\n\r 18. 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 19. Extreme aortic valve calcification and calcific asymmetry (if semiquantitively\r measured: grade 4, Agatston score: grade 4 AgS>5000 AU).\r\n\r 20. Aortic valve area of < 0.4 cm2.\n\nPatient 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
575	[ { "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\nSupporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)\n\nClinical Trial Summary:\n\nThe HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for\r use during high-risk percutaneous coronary interventions (PCI) performed electively or\r urgently in hemodynamically stable patients with severe coronary artery disease, when a heart\r team, including a cardiac surgeon, has determined high-risk PCI is the appropriate\r therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent\r hemodynamic instability, which can result from repeat episodes of reversible myocardial\r ischemia that occur during planned temporary coronary occlusions and may reduce peri-and\r post-procedural adverse events.\n\nClinical Trial Detailed Description:\n\nProspective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120\r sites in the US and Europe. Control device will be any Abiomed Impella device approved for\r use in high-risk PCI.\r\n\r This clinical investigation is divided into two phases, a feasibility phase and a pivotal\r phase.\r\n\r - Feasibility Phase: Includes 75 roll-in and 120 randomized subjects registered under the\r CIP versions 2-4 at 48 sites in the United States (U.S.) prior to January 30, 2017\r\n\r - Pivotal Phase: Includes subjects to be registered under Version F or a later version of\r the CIP at up to 120 sites in the U.S. and Europe\r\n\r Non-randomized Roll-in Cohort: Up to 480 subjects with the HeartMate PHP.\r\n\r Randomized Cohort: A minimum of 473 and a maximum of 716 subjects will be randomized in a 2:1\r ratio to the HeartMate PHP and Impella.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - At least 18 years of age\r\n\r - Subject is undergoing elective or urgent high risk PCI procedure and is\r hemodynamically stable\r\n\r - Subject is indicated for a revascularization of at least one de novo or restenotic\r lesion in a native coronary vessel or bypass graft\r\n\r - A heart team, including a cardiac surgeon, has determined high risk PCI is an\r acceptable therapeutic option\r\n\r - Subject must provide written informed consent prior to any clinical investigation\r related procedure\r\n\r Imaging Inclusion Criteria:\r\n\r • The presence of complex coronary artery disease (CAD) makes hemodynamic instability\r resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex\r CAD is defined as an ejection fraction of <50% by echocardiographic assessment AND at least\r one of the following:\r\n\r - intervention of the last patent coronary conduit, OR\r\n\r - intervention of an unprotected left main artery, OR\r\n\r - intervention on patient presenting with triple vessel disease defined as at least one\r significant stenosis (at least 50% diameter stenosis on visual assessment) in all\r three major epicardial territories\r\n\r Exclusion Criteria:\r\n\r - Emergency PCI\r\n\r - Any prior coronary revascularization within the last 6 months\r\n\r - Any MI with elevated cardiac biomarker (creatinine kinase-MB (CK-MB) or troponin >1X\r upper limit of normal (ULN)) and no evidence of at least 1 consecutive CKMB or\r troponin value trending downward from previous value (at least 4 hours apart) OR ST\r Elevation MI (STEMI) within 72 hours prior to the index procedure regardless of the\r level of cardiac biomarker\r\n\r - Cardiac arrest within 24 hours of procedure requiring cardiopulmonary resuscitation\r (CPR) or defibrillation\r\n\r - Any use of a mechanical circulatory support device within 14 days prior to the index\r procedure (Note: Subjects must be hemodynamically stable without any hemodynamic\r support to be eligible for this clinical investigation.)\r\n\r - Hemodynamic support with a mechanical circulatory support device (e.g.the HeartMate\r PHP, Impella, intra-aortic balloon pump (IABP), or extra-corporeal membrane\r oxygenation (ECMO)) post-PCI is anticipated.\r\n\r - Any condition that requires discontinuation of antiplatelet and/or anticoagulant\r therapy within 90 days following the index procedure (e.g. planned noncardiac surgery)\r\n\r - Any use of vasopressors or inotropes within 24 hours prior to the index procedure\r\n\r - Staged PCI is planned within 90 days following device removal.\r\n\r - Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria\r OR altered sensorium AND cardiac index <2.2 L/min/m2)\r\n\r - History of aortic valve replacement or repair\r\n\r - Severe peripheral vascular disease that will preclude the use of a 14F access sheath,\r which is required for the insertion of the HeartMate PHP catheter\r\n\r - Known abnormalities of the aorta that would preclude surgery, including aneurysms and\r significant tortuosity or calcifications\r\n\r - Subject is on hemodialysis.\r\n\r - Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X ULN or\r Internationalized Normalized Ratio (INR) ≥1.6 or lactate dehydrogenase (LDH) > 2.5X\r ULN\r\n\r - Abnormal coagulation parameters (platelet count ≤75000/mm3 or INR ≥1.6 or fibrinogen\r ≤1.5 g/l)\r\n\r - Active systemic infection requiring treatment with antibiotics\r\n\r - Stroke or transient ischemic attack (TIA) within 6 months of procedure\r\n\r - Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants\r (including heparin), or antiplatelet therapy drugs that cannot be adequately\r premedicated\r\n\r - Subject is pregnant (For a female subject of childbearing potential, a pregnancy test\r must be performed within 14 days (≤14 days) prior to the index procedure per site\r standard test).\r\n\r - Participation in another clinical study of an investigational drug or device that has\r not met its primary endpoint\r\n\r - Presence of other anatomic or comorbid conditions, or other medical, social, or\r psychological conditions that, in the investigator's opinion, could limit the\r subject's ability to participate in the clinical investigation or to comply with\r followup requirements, or impact the scientific soundness of the clinical\r investigation results\r\n\r - Life expectancy <1 year\r\n\r Imaging Exclusion Criteria:\r\n\r - Mural thrombus in the left ventricle\r\n\r - Documented present of aortic stenosis (orifice area of 1.52 cm^2 or less)\r\n\r - Moderate to severe aortic insufficiency by echocardiographic assessment\n\nPatient 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
576	[ { "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 Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery\n\nClinical Trial Summary:\n\nFractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary\r angiography to assess the potential of a coronary stenosis to induce myocardial ischemia.\r Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress\r imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional\r manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of\r FFR for all angiographically significant stenoses would add considerable time, cost, and\r complexity to each PCI procedure and might also increase the risk of catheter-related\r complications such as coronary dissection and perforation. Although the guideline mentioned\r that FFR may not be useful in very high grade lesions (angiographically >90%) which always\r have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80\r obtained by angiographic parameters including degree of stenosis, lesion location and vessel\r size. It would be valuable to find more precise criteria available by conventional\r angiography for discrimination of functional stenosis in way to reduce the risk of additional\r procedure. For the purpose, the investigators will perform FFR in the lesions with\r significant stenosis (>70% diameter stenosis by visual estimation) and compare the\r angiographic parameters and FFR values in the study.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients ≥ 19 years old\r\n\r - Typical angina\r\n\r - Stable or unstable angina pectoris\r\n\r - At least one or more major epicardial coronary arteries with significant stenosis\r (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal\r portion of left anterior descending artery, left circumflex artery, or right coronary\r artery\r\n\r - Reference vessel diameter of target lesion ≥3.0 mm\r\n\r - Normal LV ejection fraction (≥50%) without wall motion abnormality by echocardiography\r\n\r Exclusion Criteria:\r\n\r - Previous myocardial infarction\r\n\r - Previous coronary bypass graft surgery\r\n\r - Cardiogenic shock\r\n\r - Multiple lesions in the vessel of interest\r\n\r - Contraindication or hypersensitivity to adenosine or contrast media\r\n\r - Reduced coronary blood flow (TIMI flow grade <3) in the vessel of interest\r\n\r - Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous\r lesions\r\n\r - Pregnant women or women with potential childbearing\r\n\r - Inability to understand or read the informed content\n\nPatient 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
577	[ { "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\nAAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft\n\nClinical Trial Summary:\n\nThe ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective,\r registry designed to collect \"on-label\" data in real world clinical settings on patients\r undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft\r System. Registry data will augment existing data from ongoing and prospective Aorfix™\r clinical trials for the purposes of publication, general product development and quality\r measures.\n\nClinical Trial Detailed Description:\n\nThe ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective,\r registry established by Lombard Medical Ltd. (Lombard) to collect \"on-label\" data in real\r world clinical settings on patients undergoing endovascular repair with the latest generation\r Aorfix™ AAA Flexible Stent Graft System, for treatment of abdominal aortic and aorto-iliac\r aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0°\r and 90°. This indication for Aorfix™ is approved in all territories where this Registry is\r being operated and this Registry does not seek to collect data on any use of the implant for\r which full commercial approval does not already exist.\r\n\r The ARCHYTAS Registry data will augment existing data from ongoing and prospective clinical\r trials with Aorfix™ for the purposes of publication, general product development and quality\r measures.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.\r\n\r 2. Intention to electively implant the Aorfix™ Stent Graft System.\r\n\r Exclusion Criteria:\r\n\r 1. Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).\r\n\r 2. Unwillingness or inability to comply with the recommended follow-up assessments\r according to the standards of care at the investigative site.\r\n\r 3. Unwillingness or inability to provide informed consent to both the Registry and the\r EVAR procedure.\r\n\r 4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous\r surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.\n\nPatient 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
578	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nStudy of Hypertrophic Cardiomyopathy Under Stress Conditions. Concordance Between Two Complementary Tests: Stress MRI and Exercice Stress Echocardiography\n\nClinical Trial Summary:\n\nHypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic\r cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the\r left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an\r important heterogeneity of prognosis and clinical expression going from a asymptomatic state\r until the devastating sudden death occurring in a young person.The diagnosis of HCM is\r definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial\r history).This hypertrophy is often accompanied by other abnormalities detected by\r echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral\r regurgitation …Now, the current challenge is to determine the prognosis factors of the\r disease that could help to identify the patients with high risk of sudden death. Some\r prognosis factors are knowed and used in the calculation of a new risk score. This risk score\r allows to estimate the risk of sudden death at 5 years and propose depending on the result,\r the implantation of a defibrillator for primary prevention.The physiopathological mechanism\r of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major\r mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where\r ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be\r the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart\r failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an\r important mechanism of the disease evolution. Acute ischemic events could be a trigger of\r malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is\r long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis\r appears at a very advanced stage of the disease. Exercice stress echocardiography permits to\r detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis\r apparition. Moreover the investigators suggest to study the deformation parameters by speckle\r tracking or 2D strain witness of a contractile LV dysfunction before the apparition of\r segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more\r sensible technique to identify focal myocardial fibrosis resulting in areas of late\r gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the\r severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by\r hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of\r hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible\r hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful\r sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies\r show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without\r LGE which reflects the presence of new fibrosis.The objective of study is to compare these\r two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually\r used in the diagnosis or the monitoring of the disease. The investigators propose to realize\r an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle\r and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1\r mapping.Actually the investigators consider that LGE is a risk factor of the disease\r (although not yet involved in the calculation of the risk of sudden death) and need to be\r study in each MRI realized for HCM. From the same way, the investigators suggest to follow\r patients to determine if the abnormalities detected by these two techniques and particularly\r 2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are\r prognosis factors of the disease and appear more precociously than LGE.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - The patient is adult (> or = 18 years) and informed.\r\n\r - He's agree for a 24-month follow-up.\r\n\r - The patient must be member or beneficiary of a health insurance system.\r\n\r - He must have a clear diagnosis of HCM defined by a left ventricular hypertrophy in\r tranthoracic echocardiography (superior to 15mm or 13mm if there is a familial\r history) without other causes of hypertrophy (severe hypertension, aortic stenosis,\r amyloidosis or fabry disease, ..)\r\n\r Exclusion Criteria:\r\n\r - The patient is under safeguarding justice, tutorship or curatorship.\r\n\r - The patient formalizes his opposition.\r\n\r - It's impossible to give enlightened information.\r\n\r - The patient doesn't read French.\r\n\r - The patient is pregnant or breastfeeding.\r\n\r - Contraindication to the realization of a MRI (defibrillator, no-MRI compatible PMK,\r claustrophobia,..)\r\n\r - Contraindication to the Persantine° injection (asthma, high degree block, ..)\r\n\r - Contraindication or impossibility to realize a stress echocardiography.\r\n\r - Comorbidity that can be responsible of the studied anomalies: coronaropathy,\r myomectomy, multicomplicated diabetes, …\n\nPatient 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
579	[ { "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\nRIGENERA 2.0 Trial\n\nClinical Trial Summary:\n\nStudy Objectives: To determine whether, in patients with large acute myocardial infarction\r undergoing primary or rescue angioplasty, the administration of subcutaneous Lenograstim\r [recombinant human Granulocyte-Colony Stimulating Factor (rhu G-CSF), Myelostim 34,\r Italfarmaco] associated with Myocardial Contrast Echocardiography and the intravenous\r infusion of sulphur hexafluoride (Sonovue, Bracco) determines an improvement:\r\n\r - in regional and global contractile function, myocardial perfusion and infarct size\r assessed by cardiovascular magnetic resonance.\r\n\r - Echocardiographic parameters of LV function\r\n\r - in the serum profile of inflammatory and mobilizing cytokines and of biomarkers of\r myocardial damage and wall stress\n\nClinical Trial Detailed Description:\n\n1. INTRODUCTION 1.1. BACKGROUND AND RATIONALE OF THE STUDY The long term prognosis of\r patients suffering from acute myocardial infarction (AMI) has progressively improved\r since the introduction of reperfusion therapies and in particular primary angioplasty\r [1]. In the setting of ST-elevation myocardial infarction (STEMI), the immediate\r reopening of acutely occluded coronary arteries via primary angioplasty is the treatment\r of choice to salvage ischemic myocardium. However, the sudden re-initiation of blood\r flow can lead to a local acute inflammatory response with further endothelial and\r myocardial damage. This phenomenon, described as 'reperfusion injury', may explain why,\r despite optimum myocardial reperfusion, the short-term mortality after AMI approaches 7%\r [1] and the incidence of heart failure approaches 15-20% [2][3]. Despite the use of full\r conventional treatment, including ACE inhibitors, beta-blockers, aldosterone inhibitors\r and diuretics, in the context of randomised controlled trials yearly mortality rates of\r patients with post-infarction heart failure are still in the range of 10-13% and\r rehospitalisation for worsening of heart failure occurs at a yearly rate of 6-8 % [4].\r Registry data indicate a more dismal outcome in real world clinical experience. A major\r reason for the high morbidity and mortality is that the heart has an inadequate\r regenerative response to the myocardial necrosis sustained following AMI; cell death\r from the ischemic damage can lead to progressive ventricular dilation and dysfunction\r through the processes of adverse left ventricular remodelling. However, the discovery of\r tissue resident cardiac stem cells in the mammalian heart [5] has challenged the long\r held belief that the heart is a terminally-differentiated organ and opens up the\r possibility of using bone marrow derived stem cells to repair the heart. Indeed, recent\r experimental studies documented that bone marrow-derived cell (BMC) injection into the\r infarcted heart stimulates the formation of newly formed cardiac myocytes, although the\r origin of these myocytes is still a matter of debate[6]. Numerous pre-clinical studies\r provided high degree of evidence that bone marrow derived cells do contribute to cardiac\r repair after acute myocardial injury, limit infarct expansion and improve cardiac\r function most likely via a paracrine mechanism of action. Pre-clinical evidence is\r corroborated by several small to intermediate size clinical trials demonstrating\r beneficial effects of bone marrow derived cells on top of the state-of-the-art\r reperfusion treatment [7]. For this reason, European Community has recently funded\r within FP-7 \"The effect of intracoronary reinfusion of bone marrow derived mononuclear\r cells (BM-MNC) on all cause-mortality in acute myocardial infarction (BAMI)\" project\r aimed to definitively demonstrate the efficacy of BM-MNC in patients with myocardial\r infarction.\r\n\r Considering that recovery of post-infarction LV function is favourably correlated to\r bone marrow derived stem cell mobilization induced by endogenous Granulocyte-Colony\r Stimulating Factor (G-CSF) [8-9], therapeutic stem cell mobilization was proposed as an\r alternative method to ameliorate post-infarction LV function. Several basic studies have\r supported this notion suggesting that stem cell mobilization might improve LV function\r by increasing stem cell homing in the damaged myocardium in addition to a favourable\r direct effect of G-CSF on LV myocardium [10-12].\r\n\r On these bases several studies have evaluated the effect of G-CSF on LV function in\r patients with myocardial result with mixed results [13]. In general, G-CSF was proven\r safe but the effect appeared modest. However, in patients with large myocardial\r infarction the effect was significant and clinically relevant approaching a 5% increase\r in LVEF. In particular in the Rigenera Trial conducted at the Catholic University of the\r Sacred Heart of Rome 41 patients with large anterior wall AMI at high risk of\r unfavorable remodeling were randomized 1:2 to Lenograstim (rhu G-CSF, Myelostim 34,\r Italfarmaco) (10 μg/kg/day for 5 days) or to conventional therapy. After a median\r follow-up of 5 months patients treated with Lenograstim exhibited improvement of 5% in\r LVEF, in the absence of LV dilation. In contrast, patients treated conventionally\r exhibited significant LV dilation in the absence of an improvement in LVEF [14]. In the\r present study, a subgroup of 8 patients randomized to Lenograstim received also the\r administration of a second-generation ultrasound contrast agent containing sulphur\r hexafluoride (SonoVue®, Bracco, Milan, Italy) administered intravenously (5 ml at 1\r ml/min) for myocardial opacification to collect diagnostic images by Myocardial Contrast\r Echocardiography. Interestingly, a post hoc analysis, revealed that only patients\r receiving Sonovue® showed a significant benefit on LV function [unpublished data]. This\r could be due to an increased homing effect of mobilized bone marrow derived stem cells\r due to the myocardial destruction of contrast medium-microbubbles by 3.5 MHz ultrasounds\r produced by the Echo machine. As this regard, two basic studies demonstrated that the\r highly focused ultrasound-mediated stimulation of microbubbles increased the migration\r of stem cells across the myocardial endothelium into the post-ischemic myocardium in\r vivo [15-16]. Moreover, long term (10 years) follow up data of the RIGENERA trial have\r been recently collected, confirming the safety of the procedure and a significant\r improvement of the quality of life assessed by NYHA functional class, Seattle Heart\r Failure Model, Minnesota Living with Heart Failure Questionnaire (p<0.005) when\r compairing patients treated with G-CSF versus standard therapy. Data regarding efficacy,\r in terms of LVEF, end-diastolic volume and end-systolic volume are currently under\r analysis.\r\n\r On the basis of the previous results, The Recupero dall'Infarto miocardico con G-CSF E\r Nuovi Esempi di Rigenerazione Avanzata (RIGENERA 2.0) trial will specifically test the\r efficacy of the combined effect of subcutaneous Granulocyte - Colony Stimulating Factor\r and sulphur hexafluoride on post-infarction left ventricular function.\r\n\r 1.2 BENEFIT-RISK ASSESSMENT In every clinical trial, anticipated benefits need to be\r weighed against the study associated risks. In previous investigations where G-CSF has\r been used, no G-CSF associated adverse reactions were reported. Only the MAGIC trial was\r prematurely stopped due to possible safety concerns in treated patients in terms of an\r unexpectedly high restenosis rate in stented vessels [17]. However, only three patients\r in the G-CSF group received angiographic follow-up, thus no clear conclusion about the\r incidence of restenosis should have reasonably be drawn from this study. In all other\r studies using G-CSF adverse events were comparable between patients and controls [13].\r Nevertheless G-CSF is largely used in oncology for treatment of febrile neutropenia and\r in hematology for this indication and for mobilization of stem cells for\r transplantation. As this regard G-CSF is considered reasonably safe without any\r association with a documented increase in malignancies [18].\r\n\r SonoVue has been shown to be safe and well tolerated with minimal risk to patients. In\r clinical trials, the overall incidence of adverse events was relatively low (10.7%\r overall, 5.2% investigational product-related) in subjects receiving SonoVue. The most\r frequently reported adverse events were headache (2.1%), nausea (0.9%), chest pain\r (0.8%), and chest discomfort (0.5%). All other adverse events occurred at a frequency of\r <0.5%. Most adverse events were mild and resolved spontaneously within a short time\r without sequelae. Serious adverse events occurred in 0.43% of patients and only 0.08% of\r events were considered to be of some relationship to the administration of SonoVue\r (probable, possible, or unlikely). No product- related deaths were reported within\r MAH-sponsored trials.\r\n\r The anticipated benefits of RIGENERA 2.0 trial for study participants are expected\r better LV function, a parameter that is well-known to influence long-term outcome.\r Nevertheless, chiefs of the different Units involved in the present study will form a\r Data Monitoring Committee that will stop the study in case of an observed increase in\r the rate of adverse events.\r\n\r 2. STUDY OBJECTIVES 2.1. PRIMARY OBJECTIVE Primary efficacy endpoint\r\n\r • Left ventricular ejection fraction (LVEF) at 6 months assessed by Cardiac Magnetic\r Resonance and centrally reviewed\r\n\r Secondary efficacy endpoints:\r\n\r - Left ventricular end-diastolic volume (LVEDV) assessed by Cardiac Magnetic\r Resonance at 6 months at 6 months and centrally reviewed\r\n\r - Left ventricular end-systolic volume (LVEDV) assessed by Cardiac Magnetic Resonance\r at 6 months and centrally reviewed\r\n\r - Left ventricular ejection fraction (LVEF) assessed by 2D Echocardiography at 6\r months and centrally reviewed\r\n\r - Left ventricular end-diastolic volume (LVEDV) assessed by 2D Echocardiography at 6\r months and centrally reviewed\r\n\r - Left ventricular end-systolic volume (LVEDV) assessed by 2D Echocardiography at 6\r months and centrally reviewed\r\n\r - Incidence of clinical major adverse events (death, myocardial infarction, sustained\r cardiac arrhythmias, cardiogenic shock, stroke and rehospitalization due to heart\r failure at 1 year).\r\n\r Safety endpoints:\r\n\r • Incidence of new neoplastic and hematological diseases\r\n\r 3. OVERALL DESIGN AND PLAN OF THE STUDY 3.1. OVERVIEW OF STUDY FLOW The RIGENERA 2.0 trial\r is a phase II placebo-controlled, randomized, open label, with Blinded Evaluation of\r end-points. One hundred and twenty STEMI patients are planned to be enrolled in 4\r Italian centers (Rome - Catholic University of the Sacred Heart, Ferrara, Pisa and\r Padua). Patients with an acute ST-elevation myocardial infarction as defined by the\r universal definition of AMI undergoing acute revascularization (i.e. either acute PCI\r within 24 hours of symptom onset or thrombolysis within 12 hours followed by acute PCI\r within 24 hours of symptom onset) will be screened at investigational sites. Patients\r who had acute PCI at institutions different from the investigational sites (recruiting\r centers) can also be included: interested patients may be referred for screening to any\r of the participating study sites within 3 to 4 days. Informed consent and assessment of\r eligibility of patients with respect to in- and exclusion criteria will be done at the\r recruiting centers. If all other eligibility criteria are met, echocardiography will be\r performed 3 to 6 days after the acute PCI and ejection fraction will be quantified. In\r case of LVEF≤45% the patient will be 1:1 electronically randomized to G-CSF and MCE or\r placebo and MCE according to site. Patients will be randomized to receive either\r subcutaneous Granulocyte - Colony Stimulating Factor (group 1) or Placebo (group 2) both\r added on top of optimal standard of care and Myocardial Contrast Echocardiography with\r intravenous infusion of sulphur hexafluoride.\r\n\r Lenograstim (rhu G-CSF, Myelostim 34, Italfarmaco) (5 µg/kg twice daily for 5 days,\r subcutaneously) or placebo (saline solution twice daily for 5 days, subcutaneously) will be\r administered at least 5 days after admission.\r\n\r Both in patients treated with Lenograstim (rhu G-CSF, Myelostim 34, Italfarmaco) and in\r patients treated with placebo, immediately before the first dose of Lenograstim (rhu G-CSF,\r Myelostim 34, Italfarmaco) or placebo and in the morning of the last day of treatment in\r which the peak of BMSC mobilization is expected, an echocardiogram using an echocardiographic\r contrast agent (Sonovue, Bracco) will be performed. In the days of administration of the drug\r or placebo, ECG, blood pressure, blood count and coagulation analyses will be monitored.\r\n\r In the case of muscle and bone pain or severe headache patients will be treated with\r paracetamol.\r\n\r In the case of leukocytosis (> 40000/mcl) dose of G-CSF in 24 hours will be halved and in the\r case of leukocytosis (> 70000/mcl) completely stopped.\r\n\r After hospital discharge, all study patients will return to the clinical centre for a follow\r up visit after 30 days. Six months after randomization all the patients will undergo\r outpatient Cardiac Magnetic Resonance and Conventional Echocardiography. At the same time,\r all patients will undergo Myocardial Contrast Echocardiography. At 1 year all patients will\r attend a final site visit at the clinical centers collecting any clinical event. However, all\r clinical endpoints will be reported as occurring throughout the follow up. Clinical Major\r adverse cardio-cerebrovascular events (death, myocardial infarction, stroke and\r re-hospitalization due to heart failure) at 1 year will be adjudicated by a clinical event\r committee blinded to the patient treatment allocation. This will ensure a consistent and\r unbiased adjudication of events across all investigational sites.\r\n\r 3.2. STUDY POPULATION 3.2.1. Number of patients A total of approximately 120 male and female\r patients are planned to be enrolled in the RIGENERA 2.0 trial. Enrolment will involve 4\r Italian centres (Roma, Pisa, Ferrara, Padua). Recruiting centres will keep a log of all\r patients proposed to be included.\r\n\r 3.2.2. Inclusion criteria\r\n\r 1. Signed and dated informed consent\r\n\r 2. Men and women of any ethnic origin aged ≥ 18 years\r\n\r 3. Patients with acute ST-elevation myocardial infarction as defined by the universal\r definition of AMI.\r\n\r 4. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2)\r within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset\r followed by successful percutaneous coronary intervention (PCI) within 24 hours after\r thrombolysis\r\n\r 5. Left ventricular ejection fraction ≤ 45% with significant regional wall motion\r abnormality assessed by quantitative echocardiography 3 to 6 days after reperfusion\r therapy\r\n\r 3.3.3. Exclusion criteria\r\n\r 1. Participation in another clinical trial within 30 days prior to randomization\r\n\r 2. Pregnant or nursing women or women in childbearing age not able to esclude the\r possibility of a pregnancy\r\n\r 3. 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 4. Necessity to revascularize additional vessels, outside the target coronary artery after\r investigational therapy/placebo administration (additional revascularizations after\r primary PCI and before investigational therapy/placebo administration are allowed)\r\n\r 5. Persistent cardiogenic shock\r\n\r 6. Known hematologic and neoplastic diseases\r\n\r 7. Severe impaired renal function, i.e. eGFR<30 ml/min\r\n\r 8. Persistent fever or diarrhoea not responsive to treatment within 4 weeks prior screening\r or severe infection\r\n\r 9. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)\r\n\r 10. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease\r\n\r 4. STUDY CONDUCT 4.1. SCHEDULE OF PROCEDURES The schedule of study assessment is listed in\r Table 1. Screening Days -6 to - 3 Randomization Treatment Day 0 to 5 Recovery Day 5 to 10 1\r month 4-6 Months Informed Consent X Demographics X Medical History X Killip Class X X X NYHA\r Class X X X Physical Examination X X X Vital Signs (BP and HR) X X X ECG X X X Safety\r Laboratory X X (daily) X X X Concomitant Medications X X X Adverse Event / Endpoint\r Collection X X X X Echocardiography+ X X Magnetic Resonance X X Recommended but optional\r Bloods (see below) X X X Urine Pregnancy test(where applicable) X X X Investigational therapy\r X X\r\n\r ♦Recommended but optional Bloods Screening:\r\n\r Hematology: Red blood count, white blood count Biochemistry and enzymes: serum urea, serum\r uric acid, glutamic-oxaloacetic transaminase (GOT), glutamic-pyruvate transaminase (GPT),\r lactate dehydrogenase (LDH), total cholesterol, low density lipoprotein cholesterol (LDL),\r high density lipoprotein cholesterol (HDL), triglycerides, glycosylated hemoglobin (HbA1c)\r Electrolytes: sodium, potassium Cardiac marker: Creatine kinase (CK), Creatine kinase\r muscle-brain (CK-MB), (high sensitive) troponin T or I Coagulation: International Normalised\r Ratio (INR) Hematology: hemoglobin, hematocrit, red blood count, white blood count, platelets\r Biochemistry and enzymes: serum urea, serum uric acid, GOT, GPT, LDH, total cholesterol,\r LDL-cholesterol., HDL-cholesterol, triglycerides, HbA1C Electrolytes: sodium, potassium\r Cardiac marker: CK, CK-MB, (high sensitive) troponin T or I Coagulation: INR\r\n\r 4.2. PATIENT SCREENING AND RANDOMISATION Patients will be recruited based on the existing\r medical information from the pool of AMI patients at the clinical centres. Patients who had\r the primary PCI performed at clinical centres that are different from the recruiting centre\r can also be included: interested patients may be referred for screening to any of the\r participating study sites within 3 to 4 days. Informed consent and assessment of eligibility\r of patients with respect to inclusion and exclusion criteria will be done at the recruiting\r centre. Written informed consent must be obtained from patients prior to any study specific\r procedures. After consenting, patients undergo the procedures listed for the screening visit.\r After ensuring that a patient meets all other eligibility criteria, the investigator will\r perform the echocardiography and an electronic record of the echocardiography will be kept\r and transferred to the central Echocardiography Core Laboratory for following analyses. After\r local quantification of left ventricular ejection fraction, randomisation will be allowed for\r all patients with LVEF ≤ 45%. At randomization a patient number that will be used as the key\r identifier for the entire study period, will be supplied. Patients will be randomised to\r investigational therapy or placebo in a 1:1 ratio. Patients with a LVEF > 45% will not be\r randomised, but will be classified as screening failures. Patients randomised but not treated\r will be replaced. Patients who discontinue the study after treatment, will not be replaced.\r\n\r 4.3. DESCRIPTION OF STUDY ASSESSMENTS 4.3.1. Medical history / demographics A complete\r medical history will be obtained from each patient at the screening visit. Demographics,\r including gender, age and ethnic origin, and the smoking status will be recorded.\r\n\r 4.3.2. Killip Class\r\n\r Patients will be ranked according to the Killip Class status. Definitions of the grading\r system are as follows:\r\n\r Class I: Absence of rales over the lung fields and absence of S3. No heart failure. No\r clinical signs of decompensation.\r\n\r Class II: Rales over 50% or less of the lung fields or the presence of an S3. Heart failure.\r Diagnostic criteria include rales, S3 gallop and venous hypertension.\r\n\r Class III: Rales over more than 50% of the lung fields. Severe heart failure. Frank pulmonary\r edema.\r\n\r Class IV: Cardiogenic shock. Hypotension (a systolic blood pressure of less than 90 mmHg for\r at least 30 minutes or the need for supportive measures to maintain a systolic blood pressure\r of greater than or equal to 90 mmHg), end-organ hypoperfusion (cool extremities or a urine\r output of less than 30 ml/h, and a heart rate of greater than or equal to 60 beats per\r minute). The hemodynamic criteria are a cardiac index of no more than 2.2 l/min per square\r meter of body-surface area and a pulmonary capillary wedge pressure of at least 15 mmHg.\r Signs include hypotension (systolic pressure < 90 mm Hg) and evidence of peripheral\r vasoconstriction such as oliguria, cyanosis and diaphoresis. Heart failure, often with\r pulmonary oedema, has also been present in the majority of these patients.\r\n\r 4.3.3. Physical examination All patients will undergo standard or abbreviated physical\r examinations. The standard examination is based on the following body systems: body\r temperature, HEENT (head, eyes, ears, nose, throat), respiratory system, cardiovascular\r system, abdomen, extremities, neurological system. The abbreviated physical examination\r consists of body temperature, respiratory system, cardiovascular system, and lymph nodes. The\r body weight will be determined at each physical examination. The body height will be obtained\r at screening only.\r\n\r 4.3.4. Vital signs Blood pressure and heart rate at rest will be determined using a standard\r method.\r\n\r 4.3.5. Electrocardiography A 12 lead electrocardiogram (ECG) will be recorded. ECGs will be\r recorded while the patient is resting in supine position. Abnormal findings in ECG recordings\r will be documented and the clinical relevance will be judged. A de-identified copy of the\r baseline ECG will be digitally stored.\r\n\r 4.3.6. Clinical laboratory Blood sampling and sample analysis will be performed at the\r clinical centre. The local investigator is responsible for proper judgment of abnormal blood\r test results, and is responsible for appropriate patient care following clinically\r significant pathological results. Please refer to section 6.4.5 to determine whether an\r abnormal laboratory value may constitute an adverse event.\r\n\r The following analysis will be obtained at screening, daily during the five days of treatment\r (from day 0 to day 5) and at 5, 30 and 180 days:\r\n\r Screening:\r\n\r Hematology: Hemoglobin, hematocrit, Red blood count, white blood count, platelets\r Biochemistry: Serum creatinine, serum urea, serum uric acid, glutamic-oxaloacetic\r transaminase (GOT), glutamic-pyruvate transaminase (GPT), lactate dehydrogenase (LDH), total\r cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol\r (HDL), triglycerides, glycosylated hemoglobin(HbA1c), Creatine kinase (CK), Creatine kinase\r muscle-brain(CK-MB), high sensitive troponin T hs-TnT, Vascular Endothelial Growth Factor\r (VEGF), Insulin Growth Factor 1 (IGF-1), hepatocyte Growth Factor (HGF), Stromal Derived\r Factor 1 alpha (SDF-1 alpha) Urine: Pregnancy test for woman of childbearing potential\r Coagulation: Prothrombin Time (PT), International Normalised Ratio (INR), activated partial\r thromboplastin time (aPTT) 4.3.7. Concomitant medications All patients participating in the\r trial should receive treatment according to evidence based guidelines. Concomitant\r medications will be recorded throughout the study.\r\n\r 4.3.8. Standard Echocardiography A resting echocardiogram at enrollment and at 4-6 months\r will be recorded and digitally stored. See details in 5.3.1 Only if the patient qualifies\r with LVEF ≤ 45% in the local reading, the patients will be randomised\r\n\r 4.3.9. Investigational therapy/placebo Lenograstim (rhu G-CSF, Myelostim 34, Italfarmaco) (5\r µg/kg twice daily for 5 days, subcutaneously) or placebo (saline solution twice daily for 5\r days, subcutaneously) will be administered at least 5 days after admission.\r\n\r Both in patients treated with Lenograstim (rhu G-CSF, Myelostim 34, Italfarmaco) and in\r patients treated with placebo, immediately before the first dose of Lenograstim (rhu G-CSF,\r Myelostim 34, Italfarmaco) or placebo and in the morning of the last day of treatment in\r which the peak of BMSC mobilization is expected, an echocardiogram using an echocardiographic\r contrast agent (Sonovue, Bracco) will be performed in the days of administration of the drug\r or placebo, ECG, blood pressure, blood count and coagulation analyses will be monitored.\r\n\r In the case of muscle and bone pain or severe headache patients will be treated with\r paracetamol.\r\n\r In the case of leukocytosis (> 40000/mcl) dose of G-CSF in 24 hours will be halved and in the\r case of leukocytosis (> 70000/mcl) completely stopped.\r\n\r Patients will be safely discharged on the basis of laboratory data.\r\n\r 4.4. DURATION OF THE STUDY 4.4.1. Study duration for study patients Each enrolled patient\r will remain in the study throughout the entire study duration, with a minimum follow-up of 1\r year for each patient. A study patient's participation may be terminated early for reasonable\r cause, such as the investigator's medical decision. At any time, the patient has the right to\r withdraw consent without a negative impact on her/his medical treatment. However, the\r investigators are encouraged to ask for the patient's permission for further follow-up\r telephone contacts from those whose decision for discontinuation was based on the need for\r further outpatient visits.\r\n\r 4.4.2. Duration of the whole study Patients will be enrolled during a recruitment phase of\r approximately 2 years. Since minimum study duration for one patient is one year, the overall\r study duration is approximately 3 years. The Data Monitoring Committee may terminate the\r study earlier based on safety concerns at any time, or based on the interim efficacy\r analysis. Competent authorities/ethics committees retain the right for premature termination\r of the study according to applicable regulations. At an individual study centre, the study\r may be terminated early if the work performed is not compliant with Good Clinical Practice\r (GCP).\n\nClinical Trial Eligibility Criteria:\n\nPopulation Adult male or female patients aged < 80 years with acute myocardial infarction\r undergoing successful primary or rescue percutaneous recanalization of the infarct-related\r coronary artery, defined as TIMI 3 flow and residual stenosis <20%) within 24 hours of\r symptom onset and Left Ventricular Ejection Fraction (LVEF) ≤ 45% at 3-6 after\r revascularization, as documented by a two-dimensional echocardiogram.\r\n\r Inclusion Criteria:\r\n\r 1. Signed and dated informed consent\r\n\r 2. Men and women of any ethnic origin aged ≥ 18 years\r\n\r 3. Patients with acute ST-elevation myocardial infarction as defined by the universal\r definition of AMI.\r\n\r 4. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow\r ≥2) within 24 hours of symptom onset by successful percutaneous coronary intervention\r (PCI) or thrombolysis within 12 hours of symptom onset followed by successful PCI\r within 24 hours after thrombolysis\r\n\r 5. Left ventricular ejection fraction ≤ 45% at 24 hours after revascularization, as\r documented by a two-dimensional echocardiogram.\r\n\r Exclusion Criteria:\r\n\r 1. Participation in another clinical trial within 30 days prior to randomisation\r\n\r 2. Pregnant or nursing women or women in childbearing age not able to esclude the\r possibility of a pregnancy\r\n\r 3. 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 4. Necessity to revascularise additional vessels, outside the target coronary artery\r after investigational therapy/placebo administration (additional revascularisations\r after primary PCI and before investigational therapy/placebo administration are\r allowed)\r\n\r 5. Persistent cardiogenic shock\r\n\r 6. Known hematologic and neoplastic diseases\r\n\r 7. Severe impaired renal function, i.e. GFR<30 ml/min\r\n\r 8. Persistent fever or diarrhoea not responsive to treatment within 4 weeks prior\r screening or severe infection\r\n\r 9. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)\r\n\r 10. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease\n\nPatient 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
580	[ { "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\nHYbrid CoronAry Revascularization in DiabeticS\n\nClinical Trial Summary:\n\nTo evaluate whether an HCR strategy is more or less effective than conventional coronary\r artery bypass grafting (cCABG), in diabetic patients with multivessel CAD involving the left\r anterior descending artery (LAD), who do not present in the context of acute ST-elevation\r myocardial infarction (STEMI).\n\nClinical Trial Detailed Description:\n\nGlobally, diabetes mellitus has become a major threat to human health. An increase in the\r prevalence of diabetes has been observed, which in part can be attributed to the aging of the\r population, as well as to an increase in the rate of obesity and sedentary lifestyle in\r Canada and the United States.1 Diabetes mellitus is an emerging epidemic with an estimate,\r currently, of almost 18 million confirmed cases and another 20 million patients with impaired\r glucose tolerance at risk to diabetes, in the United States alone.2,3\r\n\r Diabetes mellitus, either Type-I or Type-II, is a very strong risk factor for the development\r of coronary artery disease (CAD) and stroke. Eighty percent of all deaths among diabetic\r patients are due to atherosclerosis, compared to about 30% among non-diabetic patients.2 A\r large NIH cohort study, the First National Health and Nutrition Examination Survey, revealed\r that heart disease mortality in the general population is declining at a much greater rate\r than in diabetic patients. In fact, diabetic women suffered an increase in heart disease\r mortality over the same time period.4,5 Furthermore, despite recent reductions in\r cardiovascular events amongst adults with diabetes, the absolute risk of cardiovascular\r events remains 2- fold greater than amongst non-diabetic individuals.6\r\n\r There are various methods by which we can treat multivessel CAD in diabetic patients.\r Although conventional bypass (cCABG) is more beneficial than percutaneous coronary\r intervention (PCI) with drug eluting stents (DES) for myocardial revascularization in\r diabetics with multivessel CAD, diabetics are also the patients who experience the most\r complications, infections, and highest costs with cCABG through a sternotomy. Recently, we\r developed and diffused MICS CABG, which can be combined with PCI/DES to vessels other than\r the one at the front of the heart in order to constitute hybrid coronary revascularization\r (HCR). The safety and efficacy of MICS CABG was recently validated in a multicentre study\r from our research team, with 100% patency of the left internal thoracic artery (LITA)-LAD\r axis on angiography7. Potential advantages of an HCR approach in diabetics include the\r avoidance of a sternotomy and the potential for earlier recovery, less bleeding and\r transfusions, fewer infections, decreased costs, increased patient acceptance, while\r potentially maintaining the benefits of cCABG due to the LITA-LAD axis in a diabetic\r population.\r\n\r Despite HCR's theoretical advantages as outlined above, it is a novel innovative approach\r that has not been studied in a randomized setting, nor in the context of diabetic patients.\r Its rationale and main research question stem from MICS CABG work by the principal\r investigator, as well as his recent, collaborative Lancet meta-analysis which revealed that\r diabetic patients with multivessel coronary disease (CAD) have better much survival with\r bypass surgery than with stents8. However, diabetics are also the patients who experience the\r most complications and infections from cCABG with incision of the breastbone. The\r investigators main hypothesis is therefore that a HCR strategy in diabetics with multivessel\r CAD will combine the benefits of bypass surgery on the artery at the front of the heart (the\r LAD), nearly eliminate the risk of complications and wound infection, and allow for faster\r recovery and improved quality of life when compared to cCABG. Other blockages would be\r treated with a PCI/DES to reduce the invasiveness of the procedure.\r\n\r Overall, the investigators believe that the equipoise as to whether HCR is better than cCABG\r in diabetic patients with multivessel CAD constitutes the next important question in the\r diabetes/CAD field. The investigators propose to evaluate the feasibility of a definitive\r trial examining this question by conducting the present pilot trial.\r\n\r Upon study approval, the time frame will be one year of recruitment, followed by 1 year of\r follow-up. Since this is a pilot trial, the investigators are assessing the feasibility of\r conducting this trial on diabetic patients with multivessel coronary artery disease. Should\r this trial be feasible, the investigators will extend the study to a full-scale study. At\r that time, an application will be submitted to conduct the study.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Male or Female, aged 18 years or older;\r\n\r 2. Diabetes Mellitus (Type 1 or Type 2) undergoing treatment;\r\n\r 3. Multivessel disease involving the LAD + at least one other coronary territory\r (stenosis ≥ 70% in a 1.5 mm artery) in a patient referred for cCABG;\r\n\r 4. Angiographic lesion characteristics amenable to both PCI/DES and MICS CABG;\r\n\r 5. Indication for revascularization based upon objective ischemia.\r\n\r Exclusion Criteria:\r\n\r 1. Severe congestive heart failure (class III or IV NYHA) at enrollment;\r\n\r 2. Left ventricular ejection fraction less than 20%;\r\n\r 3. Prior CABG surgery;\r\n\r 4. Prior heart valve surgery;\r\n\r 5. Prior PCI within the previous 6 months;\r\n\r 6. Previous tuberculosis or trauma to the chest that may have caused adhesions or LITA\r damage;\r\n\r 7. Previous stroke within 6 months or patients with stroke at more than 6 months with\r significant residual neurologic involvement, as reflected by a Rankin Score > 1;\r\n\r 8. Prior history of significant bleeding that might be expected to recur with MICS CABG\r or PCI/DES related anticoagulation;\r\n\r 9. STEMI or Q-wave MI within 72 hours prior to enrollment;\r\n\r 10. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g.\r valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting);\r\n\r 11. Contraindication to either cCABG, MICS CABG, or PCI/DES because of a coexisting\r clinical condition;\r\n\r 12. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding\r diathesis;\r\n\r 13. Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor;\r\n\r 14. Dementia with a Mini Mental Status Examination (MMSE) score of < 20;\r\n\r 15. Extra-cardiac illness that is expected to limit survival to less than 5 years;\r\n\r 16. Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all\r women not clearly menopausal;\r\n\r 17. Concurrent enrollment in another clinical trial;\r\n\r 18. Geographic inaccessibility for the follow-up visits required by protocol.\n\nPatient 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
581	[ { "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\nBiological Variation of Cardiac Biomarkers in Aortic Valve Stenosis\n\nClinical Trial Summary:\n\nCalcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the cornerstone\r in diagnostics and follow-up is echocardiography. Cardiac biomarkers (such as cardiac\r troponins T and I and NT-pro-BNP) hold promise to fulfil a role in early recognition of\r complications concerning the aortic valve and decompensation. For this purpose, it is\r important to assess the normal biological variation (BV) of cardiac biomarkers in CAVS. The\r assessment of biological variation will contribute to a better understanding of fluctuation\r of cardiac biomarkers in subjects with stable CAVS. These data will improve monitoring of\r CAVS using cardiac biomarkers.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Clinically stable moderate aortic valve stenosis\r\n\r - No evidence of acute cardiovascular disease\r\n\r Exclusion Criteria:\r\n\r - Acute myocardial infarction in the last six months\r\n\r - Pulmonary embolism in the last six months\r\n\r - Hospitalisation for heart failure in the last six months\r\n\r - Chronic kidney disease\n\nPatient 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
582	[ { "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\nIntra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy\n\nClinical Trial Summary:\n\nThe purpose of this study is to determine whether intraoperative (during surgery) morphine\r and clonidine hip injections are effective in postoperative pain management for patients\r undergoing hip arthroscopy.\n\nClinical Trial Detailed Description:\n\nBackground:\r\n\r Over the last few decades, the use and safety of arthroscopic hip surgery has considerably\r improved though the evolution and development of arthroscopic imaging and instrumentation\r (Lynch et al., 2013). There is still a considerable amount of room for growth and research in\r comparison to arthroscopic knee and shoulder surgery, which have been around much longer. One\r area which needs attention is postoperative pain management for patients undergoing hip\r arthroscopy. The benefits to controlling postoperative pain range from improved patient\r comfort and decreased time of recovery to decreased narcotic medication usage and reduced\r cost of care (Ramsay 2000).\r\n\r Many studies on the use of morphine injections into the joint after arthroscopic knee surgery\r have demonstrated effectiveness in reducing both patient reported pain and narcotic\r medication usage after surgery (Stein et al., 1991; Yari et al., 2013; Zeng et al., 2014).\r Furthermore, studies have shown that joint injections of clonidine improve the pain relieving\r effect of morphine when the two are used in combination (Joshi et al., 2000). While there is\r considerable evidence supporting the use of joint injections of morphine for knee surgery,\r very little has been cited for such use in hip arthroscopy (Lavelle et al., 2007). The\r purpose of our study is to better assess the effectiveness of morphine and clonidine joint\r injections in reducing patient reported pain and narcotic medication usage after hip\r arthroscopy.\r\n\r Protocol:\r\n\r Participants in this study will be part of a trial for the use of a morphine and clonidine\r joint injection during hip surgery. Participants will be randomly selected to either receive\r a standard dose of morphine and clonidine or normal saline solution through a joint\r injection. The normal saline will have no active drug ingredients. In either case the\r injection will occur at the conclusion of surgery. The joint injection is the only change to\r the medical care that will occur for patients who decide to participate in this study. Pain\r levels will be monitored and treated after surgery, and all pain management after surgery\r will follow the normal standard of care. Additionally, participants will be asked to fill out\r a brief questionnaire before and after surgery. All patients will be sent home with a short\r diary that will allow them to record their medication usage, pain scores, and potential side\r effects in the week following surgery. The diary with this information will be returned when\r the patients come back for their standard-of-care two week follow-up appointment.\r\n\r No additional visits or appointments beyond what the procedure already entails are needed to\r participate in this study.\r\n\r The treatment (morphine/clonidine or normal saline injection) will be chosen by chance, like\r flipping a coin. Neither the participant nor the study doctor will choose which treatment the\r patient gets. There will be an equal chance of being given either treatment. Neither the\r participant nor the study doctor will know which treatment is assigned.\r\n\r Morphine and clonidine are FDA-approved drugs being used in a non-approved context (hip\r injection). All standard of care procedures will take place to ensure patient safety during\r and after surgery, while the patients are in the outpatient surgical center. All adverse\r events will be properly documented and reported to the IRB.\r\n\r Data Management:\r\n\r Data points include age, sex, height, weight, tobacco use, VAS pain scores, discharge times,\r duration of surgery, discharge criteria score, medication use, and scores from the QoR-15\r survey. All information that includes personally identifying information, such as name or\r medical record number, is not entered into the database with the medical information.\r Identifying information is only entered into a separate database that links the patient to an\r arbitrary study number.\r\n\r Statistical analysis of the data will include a Student's T-Test, non-parametric Mann Whitney\r test, and chi-square test. If there is substantial data missing for a subject, which would be\r otherwise essential for analysis, the subject's information for that particular analysis will\r be excluded. To the best extent possible, data that can be interpolated will be utilized.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Any patient undergoing a hip arthroscopy procedure for femoracetabular impingement by\r the senior surgeon (M.T.)\r\n\r Exclusion Criteria:\r\n\r - Morphine contraindication\r\n\r - Clonidine contraindication\r\n\r - Pregnant women\r\n\r - Prisoners\r\n\r - Adults unable to consent\n\nPatient 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
583	[ { "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\nRenal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA)\n\nClinical Trial Summary:\n\nThe ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded\r endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting +\r standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration\r in patients with confirmed resistant hypertension (RH) and angiographically proven grade III\r unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.\n\nClinical Trial Detailed Description:\n\nAll eligible patients diagnosed with RH on office BP measurements and unilateral or bilateral\r ARAS ≥60% on a non-invasive test (CT-angiogram or MR-angiogram) will receive a standardized\r optimized triple antihypertensive treatment for 4 weeks. After 4 weeks, patients with\r confirmed RH by ABPM (daytime ABPM ≥ 135 or 85 mmHg) and no clinically significant increase\r in plasma creatinine from baseline (< 30%) will undergo a renal angiogram to confirm the\r degree of ARAS ≥60% in diameter.\r\n\r Immediately after the renal angiography, all patients will undergo flow fractional reserve\r (FFR) measurements. Once FFR measurements have been done and all criteria are met, patients\r will be randomized in the angiography room to either renal artery stenting + SOMT (stenting\r group) versus SOMT (control group) whatever the results of the FFR in a 1:1 ratio. Both\r groups will continue the SOMT during follow-up.\r\n\r The SOMT will be prescribed from the inclusion visit until the 6 month-visit after\r randomization. After randomization, the antihypertensive treatment will be adapted according\r to the results of home BP (HBP) at monthly visits starting 2 months after randomization.\r After the 6-month visit, the antihypertensive treatment adaptation will be left at the\r discretion of the physician in charge of the patient.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age: 40 to 80 Years\r\n\r - Men or women\r\n\r - Supine office BP ≥ 140 and/or 90 mmHg at screening despite a stable medication regimen\r including full tolerated doses of 3 or more anti-hypertensive treatments of different\r classes, including a diuretic.\r\n\r - Unilateral or bilateral ARAS of a main renal artery ≥60% diagnosed by renal CT-\r angiogram (or MR-angiogram if there is a contraindication to perform CT) performed in\r the year before\r\n\r - One or two functional kidney(s) ≥ 70 mm in pole-to-pole length\r\n\r - eGFR ≥ 20 ml/min/1.73 m² (MDRD formula)\r\n\r - Signed informed consent\r\n\r - Social insurance coverage\r\n\r Inclusion criteria for the renal angiogram procedure:\r\n\r - RH confirmed by daytime ABPM ≥ 135 or 85 mmHg after 1 month treatment with SOMT at Visit\r V1.\r\n\r Inclusion criteria for the randomization:\r\n\r - Unilateral or bilateral ARAS of a main renal artery ≥ 60% confirmed on renal angiogram\r by Quantitative Vascular Analysis (QVA)\r\n\r - Increase in plasma creatinine < 30% after 4-week SOMT\r\n\r Exclusion Criteria:\r\n\r - Fibromuscular dysplasia of renal artery or other non-atherosclerotic renal artery\r stenosis\r\n\r - Other secondary form of hypertension excluded on the basis of a clinical,\r hormonological and/or imaging work-up\r\n\r - Restenosis after a previous renal angioplasty or stenting\r\n\r - Only a stenosis of an accessory renal artery supplying <1/2 of the ipsilateral renal\r parenchyma\r\n\r - Additional indication of ARAS stenting (Malignant hypertension, ≥ 30% increase in\r plasma creatinine after renin angiotensin system (RAS) blocker or after RAS blocker\r and diuretic administration, flash pulmonary edema)\r\n\r - Kidney pole-to-pole length < 70 mm\r\n\r - Vascular disease precluding access for stenting\r\n\r - Abrupt vessel closure or dissection after diagnostic angiography\r\n\r - Contraindication to renal artery stenting according the notice for use of the stents\r\n\r - eGFR < 20 ml/min/1.73 m² (MDRD)\r\n\r - History of transient ischemic accident (TIA) or cerebrovascular accident (CVA) during\r the 3 months prior to visit 1\r\n\r - History of acute heart failure or heart failure (NYHA class III-IV) within the 3\r months prior to visit 1\r\n\r - History of myocardial infarction, unstable angina, coronary bypass or percutaneous\r coronary angioplasty during the 3 months prior to visit 1\r\n\r - Abdominal aortic aneurysm with indication for surgery or EVAR (Endovascular Aneurysm\r Repair)\r\n\r - Known history of cholesterol embolism\r\n\r - Brachial circumference of ≥ 42 cm\r\n\r - Severe contrast media allergy, not amenable to pre-treatment\r\n\r - Allergy to aspirin or clopidogrel\r\n\r - Atrial fibrillation\r\n\r - Comorbid condition causing life expectancy ≤ 3 years\r\n\r - Unlikely to co-operate in the study and/or poor compliance anticipated by the\r investigator\r\n\r - Participant not affiliated to the French social security\r\n\r - Pregnancy or breastfeeding\r\n\r - Guardianship for incapacity\n\nPatient 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
584	[ { "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 Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients\n\nClinical Trial Summary:\n\nIntroduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which\r are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme\r Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor\r Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless,\r dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration\r of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety.\r Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( %\r relative to target doses) in the intervention group (HF nurse) and in the control group (\r cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart\r Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and\r mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New\r (\"de novo\") HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17\r Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and,\r driven by protocol, the HF nurse implements the up-titration. In the control group doses are\r decided by the cardiologist clinical support and education being provided by nurses.\r Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF),\r NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP),\r 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin,\r Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour\r Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality\r of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be\r provided on the effectiveness of this healthcare management, that could be economically\r evaluated in future studies. A qualitative study also will be undertaken to explore barriers\r and facilitators to implementation\n\nClinical Trial Detailed Description:\n\nNo apply\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patient with \"de novo\" heart Failure and LVEF <= 40% admitted in hospital, without\r contraindications for BB prescription with cardiologist up-titration prescription and\r without having achieved BB target dose previous discharge and signing informed\r consent.\r\n\r Exclusion Criteria:\r\n\r - Contraindications for BB.\r\n\r - Living in a nursing home.\r\n\r - Life expectancy < 6 months.\r\n\r - Unable to self-care or mental disease without caregiver.\r\n\r - Unable to weight\r\n\r - Without phone\r\n\r - Unable to go to clinic visit.\n\nPatient 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
585	[ { "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 Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device\n\nClinical Trial Summary:\n\nTranscatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive\r treatment option in patients with symptomatic severe aortic valve (AV) stenosis at\r prohibitive or increased risk for conventional open-heart surgery. Recent randomized clinical\r trials reported a large treatment effect of TAVI over medical treatment among inoperable\r patients and similar or superior outcomes compared with surgical aortic valve replacement in\r high to intermediate risk patients. However, atrio-ventricular conduction disturbances and\r arrhythmias (in particular atrial fibrillation) before, during or after TAVI remain a matter\r of concern as they have important consequences.\r\n\r The objective of this study is to investigate the incidence, nature and prognostic\r significance of AV-conduction disturbances and arrhythmias among patients with severe,\r symptomatic aortic stenosis undergoing TAVI before, during and after the procedure using a\r small implantable cardiac monitoring system (ICM; Medtronic REVEAL LinQTM).\r\n\r One hundred patients will be enrolled in this study. Prior to TAVI (at least 4 weeks), at the\r time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted under\r the skin of the chest under local anesthesia. The device will be interrogated just prior to\r readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of\r symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on\r medical and device treatment as well as clinical outcomes analyzed.\r\n\r The present study will provide information about the actual incidence and impact of\r symptomatic and silent arrhythmias and AV-conduction disturbances among patients with severe,\r symptomatic aortic stenosis undergoing TAVI. Specifically, the study estimate the burden of\r arrhythmias before TAVI and to accurately determine the incidence of new onset atrial\r fibrillation and complete AV-block within 12 months after the procedure. Identifying patients\r at risk for AV- conduction abnormalities, atrial fibrillation (AF), and non-sustained or\r sustained ventricular arrhythmias may guide future preventive measures, medical treatment and\r improve patients outcomes after TAVI.\n\nClinical Trial Detailed Description:\n\nBackground\r\n\r TAVI has emerged as a valuable minimal-invasive treatment option in patients with symptomatic\r severe aortic valve stenosis at prohibitive or increased risk for conventional open-heart\r surgery. AV conduction disturbances and arrhythmias before, during or after TAVI remain a\r matter of concern as they have consequences.\r\n\r Prior to TAVI the ICM will be inserted under the skin of the chest under local anesthesia.\r The device will be interrogated just prior to readmission for TAVI and thereafter at 1, 3, 6,\r and 12 months of follow-up. The incidence of symptomatic as well as silent brady- and\r tachyarrhythmias will be recorded, and its impact on medical and device treatment as well as\r clinical outcomes analyzed.\r\n\r All patients with severe, symptomatic aortic stenosis undergoing TAVI at the institution\r irrespective selected bioprosthesis will be included in the study. Final decision on\r eligibility will be made by the local Heart Team.\r\n\r Objective\r\n\r To investigate the incidence, nature and prognostic significance of AV-conduction\r disturbances and arrhythmias among patients with severe, symptomatic aortic stenosis\r undergoing TAVI before, during and after the procedure using a small implantable cardiac\r monitoring system (ICM; Medtronic REVEAL LinQTM). The primary endpoint of the study is to\r establish the incidence of new onset atrial fibrillation and complete AV-block within 12\r months after TAVI.\r\n\r Methods\r\n\r One hundred patients with severe, symptomatic aortic stenosis undergoing TAVI will be\r enrolled in this prospective, observational study. Prior to TAVI (at least 4 weeks), at the\r time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted under\r the skin of the chest under local anesthesia. The device will be interrogated just prior to\r readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of\r symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on\r medical and device treatment as well as clinical outcomes analyzed.\r\n\r The study is observational: the patients will not be assigned to a specific intervention.\r Patients consenting will be monitored using a specific device that has been approved for\r market release. The objective of the study is to use the information obtained with this\r monitoring device to assess the incidence, nature and prognostic significance of\r atrioventricular conduction disturbances and arrhythmias among patients with severe,\r symptomatic aortic stenosis undergoing Transcatheter Aortic Valve Implantation before, during\r and after the procedure. The objective of the study is not to investigate the performance of\r the monitoring device.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Severe symptomatic aortic valve stenosis undergoing TAVI\r\n\r Exclusion Criteria\r\n\r - Missing IC\r\n\r - Pacemaker, internal cardioverter-defibrillator or cardiac resynchronization therapy\r (CRT) device at the time of screening\r\n\r - Anatomic or clinical contraindications for TAVI or REVEAL insertion\r\n\r - Patient currently participating in another study evaluating a new transcatheter valve\r prosthesis or a new drug\n\nPatient 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
586	[ { "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\nCoronary Artery Aneurysm Registry\n\nClinical Trial Summary:\n\nInternational registry gathering patients with angiographically confirmed coronary aneurysm.\n\nClinical Trial Detailed Description:\n\nINTRODUCTION AND RATIONALE:\r\n\r Coronary artery aneurysm is defined as coronary dilatation which exceeds the diameter of\r normal adjacent segments or the diameter of the patient's largest coronary vessel by 1.5\r times. Described by Bourgon, it is an uncommon disease which has been diagnosed with\r increasing frequency since the advent of coronary angiography. The incidence varies from 1.5%\r to 5% with male dominance and a predilection for the right coronary artery.\r\n\r Although several causes have been reported, atherosclerosis accounts for 50% of coronary\r aneurysms in adults. Reported complications include thrombosis and distal embolization,\r rupture and vasospasm, causing ischemia, heart failure or arrhythmias. The natural history\r and prognosis remains obscure, since definitive data are scarce. Controversies persist\r regarding the use of medical management (antithrombotic) or interventional/surgical\r procedures.\r\n\r OBJECTIVES.\r\n\r Taking into account the classical coronary aneurysm definition, the investigators propose:\r\n\r - ANATOMIC OBJECTIVES.\r\n\r - To characterize coronary aneurysms frequency over all cause invasive coronary\r angiography.\r\n\r - To describe anatomy, location and aneurysms features.\r\n\r - To assess intracoronary imaging data if available.\r\n\r - To describe the natural history, when evolutive chats were available\r\n\r - CLINICAL OBJECTIVES.\r\n\r - Cause for the diagnostic catheterization and aneurysms symptoms, if present.\r\n\r - Patient´s clinical features.\r\n\r - Long-term outcomes.\r\n\r - THERAPEUTIC OBJECTIVES.\r\n\r - To assess management strategies, conservative, interventional or surgical and its\r short and long term results.\r\n\r - Outcomes regarding management.\r\n\r DESIGN:\r\n\r - Retrospective recruitment, prospective follow-up registry.\r\n\r - Multicentric/international.\r\n\r - Anonymized.\r\n\r - Electronic database. Centralized analysis (core) at Hospital Clínico San Carlos.\r\n\r - Recruitment: 1/january/2002-1/december/2015.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria (angiographic diagnosis):\r\n\r - Coronary aneurysm: focal coronary dilatation which exceeds the diameter of normal\r adjacent segments or the diameter of the patient's largest coronary vessel by 1.5\r times.\r\n\r Exclusion Criteria:\r\n\r - Patient ´s refusal to participate.\n\nPatient 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
587	[ { "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\nHypertrophic Cardiomyopathy Symptom Release by BX1514M\n\nClinical Trial Summary:\n\nHypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized\r by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is\r observed within the left ventricle which is named left ventricular outflow tract obstruction\r (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms\r such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To\r now, medical or interventional treatments such as betablocacker, calcium blockers or septal\r alcoholisation or surgery present with a limited efficiency. Recent studies from\r investigators group revealed new concepts about the role of venous return to the LVOTO.\r Therefore the investigators hypothesis that BX1514M generating a venous vascular\r constriction, could improve symptoms of HCM patients by reducing LVOTO.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients with a typical or atypical hypertrophic cardiomyopathy (HCM) confirmed by\r imaging modalities (echo and MRI) and/or genetic tests or a relative history of HCM\r\n\r - Left ventricular obstruction during exercise on treadmill (above 50 mmHg)\r\n\r - Positive response to leg lifting test (obstruction reduction above 20 mmHg) at rest or\r in early recovery phase\r\n\r - Daily symptoms as shortness of breath during exercise (NYHA2-3), non coronary chest\r pain, dizziness\r\n\r - Correct ultrasound windows quality\r\n\r - Sinus rhythm\r\n\r - Optimal medical treatment\r\n\r - For women, pregnancy test or contraception\r\n\r - Written consent form obtained\r\n\r Exclusion Criteria:\r\n\r - Previous treatment by BX1514M\r\n\r - Extra-cardiac pathology with life expectancy below than 1 year\r\n\r - No capability of consent form written\r\n\r - Pregnancy women\r\n\r - Secondary hypertension hypertrophy, secondary valvular disease hypertrophy\r\n\r - Permanent atrial fibrillation\r\n\r - Severe ventricular arrhythmia without Implantable Cardioverter Defibrillator (ICD)\r\n\r - Severe coronary disease\r\n\r - Severe non stabilized hypertension\r\n\r - Severe cardiopathy (ejection fraction below 40% or demonstrated elevated end diastolic\r pressure or pulmonary pressure above 60 mmHg)\r\n\r - Bradycardia\r\n\r - Narrow angle glaucoma\r\n\r - Vascular prethrombotic diseases\r\n\r - Vascular spams\r\n\r - Thyrotoxicosis\r\n\r - Pheochromocytoma\r\n\r - Severe renal failure (<30ml/mn)\r\n\r - Patients at risk of urinary retention secondary to prostatic severe disease\r\n\r - Raynaud's disease\r\n\r - Non selective Monoamine Oxidase Inhibitors (MAOIs), iproniazid, nialamide or\r ephedrine, methylphenidate, phenylephrine, pseudoephedrine or digitalic\r\n\r - Procedures modifying the peripheral venous return\r\n\r - Participation to other research protocol\n\nPatient 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
588	[ { "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\nCoreValve™ Evolut R™ FORWARD Study\n\nClinical Trial Summary:\n\nProspective, single arm, multi-center, observational, post market study to document the\r clinical and device performance outcomes of the Evolut R system used in routine hospital\r practice in a large patient cohort for the treatment of symptomatic native aortic valve\r stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure\r necessitating valve replacement.\n\nClinical Trial Detailed Description:\n\nThe study objective is to document the clinical and device performance outcomes of the Evolut\r R system used in routine hospital practice in a large patient cohort for the treatment of\r symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical\r bioprosthetic valve failure necessitating valve replacement.\r\n\r Prospective, single arm, multi-center, observational, post market study. In Australia and\r Canada it is a prospective, single arm, multi-center pre-market study.\r\n\r Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and\r Africa, Latin America and Canada.\r\n\r Approximately 1000 implanted subjects, consented for follow-up through three years.\r\n\r For each subject, data will be collected preoperatively, intra-operatively, at hospital\r discharge, 30 days, 1, 2 and 3 years.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined\r surgical bioprosthetic valve failure necessitating valve replacement\r\n\r - Acceptable candidate for elective treatment with the Evolut R System and in conformity\r with the local regulatory and medico economic context\r\n\r - Age ≥80 years OR considered to be at high or greater risk for surgical aortic valve\r replacement (AVR) where high risk is defined as:\r\n\r - Society of Thoracic Surgeons (STS) predicted risk of mortality ≥8% OR\r\n\r - Documented heart team agreement of risk for AVR due to frailty or comorbidities.\r\n\r - Geographically stable and willing to return to the implanting site for all follow-up\r visits\r\n\r - Of legal age to provide informed consent (patient Informed Consent or Data Release\r Form) in the country where they enroll in the trial\r\n\r - The patient has been informed of the nature of the study, is able and willing to\r provide consent without assistance from a legal representative and has consented to\r participate, and has authorized the collection and release of his/her medical\r information by signing a Patient Informed Consent or Data Release Form.\r\n\r Exclusion Criteria:\r\n\r - Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and\r bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to\r contrast media, which cannot be adequately premedicated\r\n\r - Preexisting mechanical heart valve in aortic position\r\n\r - Ongoing sepsis, including active endocarditis\r\n\r - Anatomically not suitable for the Evolut R system\r\n\r - Estimated life expectancy of less than 1 year\r\n\r - Participating in another trial that may influence the outcome of this trial\r\n\r - Need for emergency surgery for any reason\n\nPatient 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
589	[ { "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\nREDUCE LAP-HF RANDOMIZED TRIAL I\n\nClinical Trial Summary:\n\nA study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial\r Pressure in Patients with Heart Failure.\n\nClinical Trial Detailed Description:\n\nThe primary objective of this randomized controlled clinical study is to evaluate the\r peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the\r IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left\r sided filling pressures, and who remain symptomatic despite optimal Guideline Directed\r Medical Therapy (GDMT). Clinical outcomes will also be evaluated.\n\nClinical Trial Eligibility Criteria:\n\nKey Inclusion Criteria:\r\n\r - Chronic symptomatic Heart Failure\r\n\r - Ongoing stable GDMT HF management and management of potential comorbidities\r\n\r - Age ≥ 40 years old\r\n\r - LV ejection fraction ≥ 40% within the past 3 months, without previously documented\r ejection fraction <30%.\r\n\r - Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP)\r documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and\r greater than RAP by ≥ 5 mm Hg\r\n\r Key Exclusion Criteria:\r\n\r - MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3\r months, or current indication for coronary revascularization\r\n\r - Cardiac Resynchronization Therapy initiated within the past 6 months\r\n\r - Severe heart failure\r\n\r - Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test >\r 600m\r\n\r - History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or\r pulmonary emboli within the past 6 months\r\n\r - Presence of significant valve disease\r\n\r - Known clinically significant untreated carotid artery stenosis\r\n\r - Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation\n\nPatient 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
590	[ { "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\nAnnular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System\n\nClinical Trial Summary:\n\nMulti center evaluation of the Millipede IRIS for treatment of clinically significant mitral\r regurgitation in subjects determined appropriate for mitral valve surgery.\n\nClinical Trial Detailed Description:\n\nMulti center evaluation of the Millipede IRIS for treatment of clinically significant mitral\r regurgitation in subjects determined appropriate for mitral valve surgery.\r\n\r This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart\r disease, and the consensus statement of MVARC 2015.\r\n\r Subjects will undergo transcatheter implantation of the Millipede IRIS implant.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Presence of symptomatic severe MR (effective regurgitant orifice (ERO) ≥0.2 cm2 for\r Secondary MR, ERO ≥0.4 cm2 for Primary MR)\r\n\r - The New York Heart Association Functional Class II, III or ambulatory IV.\r\n\r - Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%\r\n\r - Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory -Upper\r Limit of Normal (ULN).\r\n\r - Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by TTE obtained\r within 90 days Exclusion Criteria: -Untreated clinically significant coronary artery\r disease requiring revascularization.\r\n\r Presence of any of the following:\r\n\r - Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based\r on echocardiography or right heart catheterization\r\n\r - Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or\r any other structural heart disease causing heart failure other than dilated\r cardiomyopathy of either ischemic or non-ischemic etiology\r\n\r - Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)\r\n\r - Hemodynamic instability requiring inotropic support or mechanical heart assistance.\r\n\r - Hemodynamic instability defined as systolic pressure < 90 mmHg with or without\r afterload reduction, cardiogenic shock or the need for inotropic support or\r intra-aortic balloon pump or other hemodynamic support device.\r\n\r - Physical evidence of right-sided congestive heart failure with echocardiographic\r evidence of moderate or severe right ventricular dysfunction.\r\n\r - Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent.\r\n\r - Percutaneous coronary intervention within 30 days prior to subject's consent.\r\n\r - Tricuspid valve disease requiring surgery.\r\n\r - Aortic valve disease requiring surgery or TAVI.\r\n\r - Carotid surgery within 30 days prior to subject registration.\r\n\r - Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac -Resynchronization\r Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to\r subject registration.\r\n\r - Need for emergent or urgent surgery for any reason or any planned cardiac surgery\r within the next 12 months.\r\n\r - Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve,\r or any prior transcatheter mitral valve procedure.\r\n\r - Status 1 heart transplant or prior orthotopic heart transplantation.\r\n\r - Chronic Kidney Disease.\r\n\r - Chronic Steroid Therapy.\r\n\r - Cerebrovascular accident within 30 days prior to subject's consent.\r\n\r - Severe symptomatic carotid stenosis (> 70% by ultrasound).Life expectancy < 12 months\r due to non-cardiac conditions.\r\n\r - Active infections requiring current antibiotic therapy.\r\n\r - Pregnant or planning pregnancy within next 12 months.\r\n\r - Currently participating in an investigational drug or another device study.\r\n\r - Severe organic lesions with mitral chords retraction, severely fibrotic and immobile\r leaflets, severely deformed subvalvular apparatus.\r\n\r - endocarditis or active endocarditis in the last 3 months.\r\n\r - Heavily calcified annulus or leaflets, mitral valve stenosis.\r\n\r - Congenital malformation with limited valvular tissue\r\n\r - Patient requires mitral valve replacement\r\n\r - Previously implanted prosthetic mitral valve or annuloplasty ring/band.\r\n\r - Evidence of LV or LA thrombus, vegetation or mass\r\n\r - Left Ventricular Ejection Fraction <20%\r\n\r - Left Ventricular End Diastolic Diameter >65 mm\r\n\r - Severe tricuspid regurgitation or severe RV dysfunction\r\n\r - Condition that prevents transatrial access or transfemoral access\r\n\r - Anatomical ineligibility to the investigational device\r\n\r - Known hypersensitivity or contraindication to procedural or post procedural medication\r (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or\r titanium.\n\nPatient 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
591	[ { "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 Left Ventricular Remodeling of Aortic Stenosis\n\nClinical Trial Summary:\n\nAortic stenosis is a major cause of morbidity around the world. Progressive aortic stenosis\r leads to cardiac hypertrophy as a compensatory response. A maladaptive response may lead to\r heart failure at varying degrees of severity of aortic stenosis in individual patients. The\r predicting factors for the occurrence of a maladaptive response are not well defined.\r Therefore current medical therapy for aortic stenosis is considered insufficient and may\r actually cause harm. The only effective therapy for severe, symptomatic aortic stenosis is\r aortic valve replacement. It has been found in an experimental study that Podocan determines\r the degree of cardiac hypertrophy in response to pressure overload via the Wnt-pathway. The\r possible prognostic role of secreted circulating Wnt modulators in aortic stenosis has also\r recently gained attention. This project will attempt to establish the prognostic role of\r circulatory Podocan and Wnt modulators for maladaptive left ventricular response to aortic\r stenosis. This may help identify patients at particular risk to develop left ventricular\r dysfunction with aortic stenosis and improve understanding of the mechanisms of left\r ventricular remodeling in aortic stenosis. Hence, this may also later act as an important\r background in finding more effective therapies to prevent or delay maladaptive left\r ventricular response in aortic stenosis.\n\nClinical Trial Detailed Description:\n\nValvular heart disease is a common clinical indication to assess patients with cardiac MRI.\r Cardiac MRI is comprehensive study that uses multiple imaging sequences.Cardiac MRI is\r indicated to image native and prosthetic aortic valves. Planimetry of the aortic valve is\r valuable for determination of the severity of aortic stenosis. Cardiac MRI is the most\r accurate and reproducible imaging modality to assess left ventricular function and mass. Left\r ventricular (LV) function is a primary determinant of outcomes following aortic valve\r replacement. LV mass is increased in severe aortic stenosis. Variations in the morphology of\r hypertrophy in response to aortic stenosis have been detected by cardiac MRI. Cardiac MRI is\r commonly used to assess aortic stenosis in the context of discordant information from\r alternative imaging modalities and low gradient aortic stenosis.\r\n\r It is expected that 100 participants will be enrolled in the study over 24 months. This is\r sample size was agreed upon after discussion with the statistics team.\r\n\r Patients who agree to participate will provide informed consent prior to their cardiac MRI. A\r 6 minute walk test to measure baseline functional status will be done after consent,\r preferably just prior to reporting to the MRI suite for their scheduled test. Standard\r cardiac MRI will be obtained. All patients having a cardiac MRI have an IV line placed as\r normal procedure. When the line has been placed, prior to contrast infusion (if applicable)or\r other medication administration, blood samples will be collected to test for circulatory\r Podocan and Wnt pathway molecules. Approximately 20 cc will be drawn in total. All specimens\r will be sent to the experimental lab of Dr. Paul Klotman at Baylor Medical Center. All of the\r Podocan & Wnt pathway effectory molecules assays will be completed by Dr. Klotman's lab.\r\n\r The following measurements will be collected from the cardiac MRI:\r\n\r LV end diastolic (ED) volume: ml LV ED index: ml/m2 LV end systolic (ES) volume: ml LV ES\r index: ml/m2 LV ejection fraction (EF): % LV Stroke Volume: ml LV Stroke Index: ml/m2 LV\r Cardiac Output: L/min LV Cardiac Index: L/min/M2 LV Mass: g LV Mass index: g/m2\r\n\r At 12 months post procedure the following information will be collected from the\r participants' charts for endpoint analysis:\r\n\r All cause mortality Cardiac mortality Hospital admissions for valvular disease related\r clinical events such as congestive heart failure, angina, syncope Valve replacement surgery\r\n\r Patients who do undergo valve replacement surgery during the 12 month follow up period and\r are scheduled to undergo a post-op follow up cardiac MRI (expected to be at 9-12 months\r post-op) will be asked to provide additional blood samples to test for circulatory Podocan\r and Wnt pathway molecules at the time of the MRI.\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, gender, ethnicity, Most recent Ht, Wt, BP, Heart Rate BMI Tobacco use/history Alcohol\r use/ history Comorbidities\r\n\r - Hypertension\r\n\r - Hyperlipidemia\r\n\r - Diabetes\r\n\r - Chronic Kidney Disease\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 & 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 - Left Ventricular Hypertrophy Medications\r\n\r Laboratory data:\r\n\r - Lipids\r\n\r - Chemistries\r\n\r - Complete Blood Count\r\n\r - Hemoglobin A1C\r\n\r - Troponin\r\n\r - B-type Natriuretic Peptide\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age 18 or greater\r\n\r - Scheduled for Cardiac MRI\r\n\r - Patients with known aortic valve area of less than 1 cm² on echocardiogram\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 - Other significant (moderate or severe) valvular heart disease\r\n\r - Unable to complete 6 minute walk test (ex. Wheelchair bound)\n\nPatient 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
592	[ { "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\nFeasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis\n\nClinical Trial Summary:\n\nTo assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with\r commercially available bioprostheses in patients with severe, symptomatic aortic stenosis\r (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).\n\nClinical Trial Detailed Description:\n\nTrial Objectives: To assess the safety and feasibility of Transcatheter Aortic Valve\r Replacement (TAVR) with commercially available bioprostheses in patients with severe,\r symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve\r replacement (SAVR).\r\n\r Methodology: This is a multicenter, prospective trial of TAVR in low-risk patients at up to\r twelve sites in the United States. The trial will have three arms. The first will comprise\r 200 patients undergoing transfemoral TAVR. The second arm will comprise200 closely matched\r historical controls who underwent isolated bioprosthetic SAVR.\r\n\r Historical controls will be selected from among patients at the same site who have undergone\r isolated bioprosthetic SAVR within the previous 36 months. TAVR patients will then be matched\r to SAVR patients using STS database variables to perform propensity matching, including (but\r not limited to) age, gender, race, ethnicity, STS score, and valve prosthesis size. Once the\r historical matched controls are identified, detailed chart review will abstract in-hospital\r and 30-day outcomes for the SAVR cohort.\r\n\r The third arm of the trial will comprise a registry of TAVR in up to 100 low-risk patients\r with bicuspid aortic valve. The results from the registry arm will be analyzed independently.\r\n\r Primary Efficacy Endpoint: All-cause mortality at 30 days following transfemoral TAVR vs.\r bioprosthetic SAVR.\r\n\r Primary Safety Endpoint: Defined as the composite of major adverse events at 30 days:\r\n\r a. all-cause mortality c. spontaneous myocardial infarction (MI) d. reintervention: defined\r as any cardiac surgery or percutaneous reintervention that repairs, alters, or replaces a\r previously implanted aortic valve e. VARC life-threatening bleeding f. Increase in serum\r creatinine to ≥300% (>3x increase compared to baseline) OR serum creatinine ≥4.0 mg/dL with\r an acute increase ≥0.5 mg/dL OR new requirement for dialysis g. coronary artery obstruction\r requiring percutaneous or surgical intervention h. VARC major vascular complication i.\r cardiac tamponade j. cardiac perforation k. pericarditis l. mediastinitis m. hemolysis n.\r infective endocarditis o. moderate or severe aortic insufficiency p. significant aortic\r stenosis q. permanent pacemaker implantation r. new-onset atrial fibrillation\r\n\r Secondary Endpoints (TAVR Cohort):\r\n\r 1. Major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, 12\r months, and 2, 3, 4 and 5 years, defined as the composite of:\r\n\r 1. all-cause mortality\r\n\r 2. stroke\r\n\r 3. spontaneous MI\r\n\r 4. reintervention\r\n\r 2. The occurrence of the individual components of MACCE at 30 days, 6 months, 12 months,\r and 2, 3, 4, and 5 years (including stoke).\r\n\r 3. The composite of major adverse device events post-procedure, and at 6 months, 1 year,\r and 2, 3, 4, 5 years\r\n\r 4. VARC major vascular complications, at 30 days and 1 year\r\n\r 5. VARC life-threatening or disabling bleeding, at 30 days and 1 year\r\n\r 6. Technical success upon exit from the operating room or catheterization laboratory,\r defined as all of the following:\r\n\r 1. alive\r\n\r 2. successful access, delivery, and retrieval of the device and/or delivery system\r\n\r 3. correct positioning and successful deployment of the valve\r\n\r 4. no need for unplanned or emergency surgery or reintervention related to the device\r or access procedure, including reinstitution of cardiopulmonary bypass post-weaning\r for SAVR patients\r\n\r 7. Device success at 30 days and 1 year, defined as all of the following:\r\n\r 1. absence of procedural mortality\r\n\r 2. correct positioning of a single prosthetic heart valve in the proper anatomical\r location\r\n\r 3. device performing as intended:\r\n\r 1. No migration, erosion, embolization, detachment, fracture, hemolysis requiring\r transfusion, thrombosis, or endocarditis 2. Intended performance of the heart valve: no\r prosthesis-patient mismatch, mean aortic valve gradient <20 mm Hg OR peak velocity <3 m/s,\r AND no moderate or severe bioprosthetic valve regurgitation 8. Procedural success at 30 days,\r defined as device success AND no major adverse device events 9. Bioprosthetic valve\r regurgitation, defined as either moderate or severe aortic regurgitation OR moderate or\r severe paravalvular leak, at hospital discharge, 12 months, and 2, 3, 4, and 5 years 10.\r Incidence of new-onset atrial fibrillation at hospital discharge, and at 30 days, 12 months,\r and 2, 3, 4, and 5 years.\r\n\r 11. Conduction disturbance requiring permanent pacemaker implantation at hospital discharge,\r 12 months, and 2, 3, 4, and 5 years.\r\n\r 12. Change in NYHA class from baseline to 30 days, baseline to 6 months, baseline to 12\r months, and baseline to 2-5 years.\r\n\r 13. Change in distance walked during 6-minute walk test from baseline to 12 months.\r\n\r 14. Change in responses to the short form Kansas City Cardiomyopathy Questionnaire (KCCQ-12)\r from baseline to 12 months.\r\n\r 15. Echocardiographic assessment of the bioprosthetic valve post-procedure, at 12 months, and\r at years 2-5, including (but not limited to):\r\n\r a. aortic valve mean gradient, maximum gradient, and peak velocity b. calculated aortic valve\r area c. degree of bioprosthetic valve regurgitation 16. Assessment for subclinical leaflet\r thrombosis with multislice computed tomography, or transesophageal echocardiography if GFR\r <50 mL/min/m2, at 1 to 2 months.\r\n\r 17. Individual patient level Success all of the following and device success:\r\n\r 1. No re-hospitalizations or re-interventions for the underlying condition (e.g., HF)\r\n\r 2. Return to prior living arrangement (or equivalent)\r\n\r 3. Improvement vs. baseline in symptoms (NYHA Class decrease ≥ 1)\r\n\r 4. Improvement vs. baseline in functional status (6MWT increase ≥ 50 meters)\r\n\r 5. Improvement vs. baseline in QoL (KCCQ increase ≥ 10)\r\n\r Number of Trial Sites: 12\r\n\r Sample Size: 200 consecutive patients and 200 historical controls, and an additional 100 (up\r to) patients with bicuspid aortic valve\r\n\r Patient Population: Patients with severe, symptomatic AS who are determined by the Heart Team\r to be at low surgical risk (STS score ≤3%).\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Severe, degenerative AS, defined as:\r\n\r 1. mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND\r\n\r 2. calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2\r\n\r 2. Symptomatic AS, defined as a history of at least one of the following:\r\n\r 1. dyspnea that qualifies at New York Heart Association (NYHA) class II or greater\r\n\r 2. angina pectoris\r\n\r 3. cardiac syncope\r\n\r 3. The Heart Team, including at least one cardiothoracic surgeon and one interventional\r cardiologist, deem the patient to be reasonable for transfemoral TAVR with a\r commercially available bioprosthetic valve\r\n\r 4. The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of\r ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that\r SAVR would be an appropriate therapy if offered.\r\n\r 5. The Heart Team agrees that transfemoral TAVR is anatomically feasible, based upon\r multislice CT measurements\r\n\r 6. Procedure status is elective\r\n\r 7. Expected survival is at least 24 months\r\n\r For the bicuspid cohort only:\r\n\r 8. Aortic Stenosis of a bicuspid aortic valve\r\n\r Exclusion Criteria:\r\n\r 1. Concomitant disease of another heart valve or the aorta that requires either\r transcatheter or surgical intervention\r\n\r 2. Any condition that is considered a contraindication for placement of a bioprosthetic\r aortic valve (e.g. patient requires a mechanical aortic valve)\r\n\r 3. Aortic stenosis secondary to a bicuspid aortic valve (except for the bicuspid valve\r cohort)\r\n\r 4. Prior bioprosthetic surgical aortic valve replacement\r\n\r 5. Mechanical heart valve in another position\r\n\r 6. End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine\r clearance <20 cc/min\r\n\r 7. Left ventricular ejection fraction <20%\r\n\r 8. Recent (<6 months) history of stroke or transient ischemic attack\r\n\r 9. Symptomatic carotid or vertebral artery disease, or recent (<6 weeks) surgical or\r endovascular treatment of carotid stenosis\r\n\r 10. Any contraindication to oral antiplatelet or anticoagulation therapy following the\r procedure, including recent or ongoing bleeding, or HASBLED score >3\r\n\r 11. Severe coronary artery disease that is unrevascularized\r\n\r 12. Recent (<30 days) acute myocardial infarction\r\n\r 13. Patient cannot undergo transfemoral TAVR for anatomic reasons (as determined by\r supplemental imaging studies); this would include inadequate size of iliofemoral\r access vessels or an aortic annulus size that is not accommodated by the commercially\r available valves\r\n\r 14. Any comorbidity not captured by the STS score that would make SAVR high risk, as\r determined by a cardiothoracic surgeon who is a member of the heart team; this\r includes:\r\n\r 1. porcelain or severely atherosclerotic aorta\r\n\r 2. frailty\r\n\r 3. hostile chest\r\n\r 4. IMA or other conduit either crosses midline of sternum or is adherent to sternum\r\n\r 5. severe pulmonary hypertension (PA systolic pressure > 2/3 of systemic pressure)\r\n\r 6. severe right ventricular dysfunction\r\n\r 15. Ongoing sepsis or infective endocarditis\r\n\r 16. Recent (<30 days) or ongoing bleeding that would preclude treatment with anticoagulant\r or antiplatelet therapy, including recent gastrointestinal bleeding\r\n\r 17. Uncontrolled atrial fibrillation (resting heart rate >120 beats per minute)\r\n\r 18. Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory\r volume (FEV1) <750 cc\r\n\r 19. Liver failure with Childs class C or D\r\n\r 20. Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest\r\n\r 21. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up\r procedures\r\n\r 22. Known allergy to warfarin or aspirin\n\nPatient 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
593	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nTranscatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)\n\nClinical Trial Summary:\n\nThe objective of this study is to determine the safety and efficacy of transcatheter aortic\r valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as\r compared with OHFT.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria\r\n\r All candidates for this study must meet all of the following inclusion criteria:\r\n\r 1. Age ≥18 years\r\n\r 2. NYHA class ≥ 2\r\n\r 3. NT-proBNP > 900pg/mL (or BNP > 200 pg/mL) or hospitalization for HF within the 2\r years;\r\n\r Note: To account for the decrease in natriuretic peptide levels with\r overweight/obesity, NT-proBNP and BNP levels cutoff will be reduced by 4% for every\r increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).\r\n\r 4. Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month. o\r Patients are expected to be on appropriate pharmacologic therapy and if indicated CRT\r for heart failure. (12, 13) Patients with aortic stenosis may not be able to tolerate\r maximal doses of heart failure medications and no specific guidelines exist for the\r medical treatment of heart failure in the setting of aortic stenosis. It is expected\r that the heart failure PI will review the medical therapy and confirm that it is\r appropriate for the patient's condition.\r\n\r 5. Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve\r area (AVA) >1.0 cm2 and ≤1.5 cm2 on rest echo or if ≤1.0 cm2 at rest and low-flow AS\r is suspected when the an AVA > 1.0 cm2 with low dose dobutamine stress echo (DSE).\r Patients with AVA<1.0 cm2 but with an indexed AVA of >0.6 cm2/m2 on either rest or DSE\r are also eligible. Similarly, patients with AVA >1.5 cm2 but with indexed AVA<0.9\r cm2/m2 on either rest of DSE are also eligible.\r\n\r Note: Typically such cases will demonstrate,\r\n\r • • Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg at rest and aortic valve\r area (AVA) > 1.0 cm2 and ≤1.5 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) at rest\r\n\r OR\r\n\r - Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg and aortic valve area\r (AVA) ≤1.0 cm2 at rest AND MG < 40 mmHg and aortic valve area (AVA)\r\n\r - >1.0 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) with low dose dobutamine\r stress echo (DSE).\r\n\r In atypical cases (for example mean gradient is below 20 mmHg but valve area is\r consistent with moderate AS, the final eligibility determination in regards to\r diagnosis of moderate AS will be made by the echocardiographic core lab.\r\n\r 6. Left ventricular (LV) ejection fraction (EF) < 50% at rest\r\n\r 7. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV\r\n\r 8. Able to provide independent informed consent (i.e., not requiring a legally authorized\r representative)\r\n\r Exclusion Criteria\r\n\r Candidates are excluded from the study if any of the following conditions are present:\r\n\r 1. LVEF < 20% or persistent need for intravenous inotropic support\r\n\r 2. Hospitalization for acute decompensated HF within 2 weeks prior to randomization\r\n\r 3. Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to\r randomization\r\n\r 4. Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization\r\n\r 5. In need and suitable for revascularization per heart team consensus\r\n\r 6. Severe aortic and/or mitral regurgitation\r\n\r 7. Congenital unicuspid or congenital bicuspid aortic valve\r\n\r 8. Concomitant non-aortic valvular disease with a formal indication for valve surgery per\r established guidelines (ESC/ACC/AHA)\r\n\r 9. Previous aortic valve replacement (mechanical or bioprosthetic)\r\n\r 10. Severe RV dysfunction\r\n\r 11. Previous stroke with permanent disability (modified Rankin score ≥ 2)\r\n\r 12. Severe lung disease as indicated by FEV1 <30% predicted or need for chronic daytime\r supplemental oxygen therapy\r\n\r 13. Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or\r need for renal replacement therapy\r\n\r 14. Gastrointestinal (GI) bleeding within the past 3 months\r\n\r 15. Liver cirrhosis Child-Pugh C\r\n\r 16. Active systemic infection, including active endocarditis\r\n\r 17. Unwilling to accept blood transfusion\r\n\r 18. Evidence of intracardiac mass, thrombus or vegetation\r\n\r 19. Absence of minimum amount of aortic valve calcification necessary for TAVR with the\r SAPIEN 3 or SAPIEN 3 Ultra THV\r\n\r 20. Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral\r anticoagulation if indicated (e.g. subject in atrial fibrillation)\r\n\r 21. Sensitivity to contrast media which cannot be adequately pre-medicated\r\n\r 22. Women of child-bearing potential\r\n\r 23. Clinical signs of dementia\r\n\r 24. Other medical, social, or psychological conditions that precludes appropriate consent\r and follow-up\r\n\r 25. Life expectancy < 2 years due to cancer or other non-cardiac chronic diseases\r\n\r 26. Unwillingness to undergo follow-up investigations\r\n\r 27. Currently participating in an investigational drug or another device trial that has\r not reached its primary endpoint (excluding registries)\n\nPatient 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
594	[ { "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\nREMODEL: Hypertensive Heart Disease\n\nClinical Trial Summary:\n\nHypertension and aortic stenosis are the two leading conditions that cause thickening of the\r heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially\r adaptive to maintain optimal heart function. Ultimately, heart failure occurs as a result of\r progressive muscle cell death and scarring (myocardial fibrosis). Dedicated techniques using\r cardiovascular magnetic resonance imaging (MRI) and novel high-sensitivity cardiac troponin\r blood assays are potential markers to detect myocardial fibrosis. Although\r hypertension-related heart disease is very common in Singapore, the significance of\r myocardial fibrosis is not well understood. In this study, the significance of myocardial\r fibrosis in 500 patients with hypertension would be investigated. This will be the largest\r study using state-of-the-art MRI to examine the importance of myocardial fibrosis in\r hypertensive heart disease.\n\nClinical Trial Detailed Description:\n\nAccording to the National Health Survey in 2010, more than 50% of adults between 60-69 years\r old in Singapore had hypertension. As the population ages and life expectancy continues to\r increase, an increasing incidence of hypertensive heart disease would be expected. Similar to\r aortic stenosis, left ventricular hypertrophy in patients with hypertension was associated\r with adverse cardiovascular outcome, independent of traditional risk factors including\r peripheral blood pressure. Unlike aortic stenosis (a condition with fixed obstruction),\r arterial hypertension is dynamic and with effective medical therapy, left ventricular\r hypertrophy can regress and outcome will improve. As such, contemporary guidelines recommend\r more aggressive blood pressure control in patients with hypertension and left ventricular\r hypertrophy. However, the correlation between arterial pressure and left ventricular mass is\r weak, particularly in treated individuals. Coupled with the inherent limitations of measuring\r peripheral blood pressure, it is clear that using arterial pressure to monitor progression or\r assess treatment response in patients with hypertensive heart disease is not optimal.\r\n\r Without timely and appropriate therapies, left ventricular hypertrophy will become\r progressively maladaptive and ultimately the heart fails. Whilst heart failure is more\r commonly known by the signs and symptoms related to impaired systolic ejection fraction,\r heart failure with preserved ejection fraction is an increasingly recognized complex entity\r characterized by signs and symptoms of heart failure in the presence of preserved ejection\r fraction. To date, therapies that improve outcomes in heart failure with reduced ejection\r fraction have not shown similar benefits in patients with heart failure and preserved\r ejection fraction. There is no single explanation for these negative findings, but one\r potential reason may relate to the heterogeneity of patients recruited into these trials, and\r thus supporting a more targeted approach to specific phenotypes rather than a standard\r treatment strategy for all patients.\r\n\r Therefore, a focus on the transition from compensatory left ventricular hypertrophy to\r ventricular decompensation is crucial not only in furthering our understanding of the\r pathophysiology of hypertensive heart disease, but also instrumental in designing future\r trials. Small studies had reported replacement myocardial fibrosis in patients with\r hypertension. But these studies were small and unable to establish determinants associated\r with myocardial fibrosis. Unlike the increasing evidence of myocardial fibrosis in aortic\r stenosis, the prognosis associated with myocardial fibrosis in patients with hypertension is\r currently not known. Although there is promising data suggesting regression in myocardial\r fibrosis with certain antihypertensive therapies, the effects of myocardial fibrosis\r regression on long-term outcome is not known. As discussed earlier, other than relying on\r peripheral blood pressure, there are no biomarkers to monitor response of antihypertensive\r therapy on regression of left ventricular mass and myocardial fibrosis.\r\n\r Our investigators would establish a paradigm to demonstrate the significance of myocardial\r fibrosis in hypertensive heart disease; and examine other biomarkers associated with\r myocardial fibrosis and myocyte death that have high potential of translating into clinical\r application to monitor treatment response.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. 21 years and over\r\n\r 2. Physician diagnosed essential hypertension, on at least 1 medication for blood\r pressure control\r\n\r 3. Newly diagnosed hypertension: systolic blood pressure 140mmHg or greater (diastolic\r blood pressure 90mmHg or greater) on at least 2 office visits (Weber 2013) and not\r started on any anti hypertensive medications at time of ambulatory blood pressure\r monitoring\r\n\r 4. Resistant hypertension: persistent systolic blood pressure 140mmHg or greater\r (diastolic blood pressure 90mmHg or greater) despite on at least 3 anti-hypertensive\r medications (Jennings 2013; Weber 2013)\r\n\r Exclusion Criteria:\r\n\r 1. Known secondary hypertension: renal causes (renal artery stenosis, chronic renal\r failure); endocrine causes (aldosterone excess, pheochromocytoma, cushing's syndrome,\r hyperthyroidism); cardiac causes (coarctation of the aorta)\r\n\r 2. Contraindications to cardiovascular magnetic resonance: implantable devices, cerebral\r aneurysm clips, cochlear implants, renal impairment (GRF <30ml/min/1.73m2),\r claustrophobia and women who are pregnant or breast-feeding\r\n\r 3. Limited life expectancy\r\n\r 4. On-going unstable medical conditions: hypertensive crisis, acute coronary syndromes or\r acute heart failure\r\n\r 5. History of coronary artery disease, ischemic heart disease\r\n\r 6. History of transient ischemic attacks or cerebrovascular events\r\n\r 7. History of atrial fibrillation\r\n\r 8. History of heart failure\n\nPatient 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
595	[ { "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\nEDWARDS INTUITY Valve System CADENCE-MIS Study\n\nClinical Trial Summary:\n\nThe study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive\r surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full\r sternotomy surgical approach.\n\nClinical Trial Detailed Description:\n\nThis is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass\r time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach\r (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy\r surgical approach, in patients with logistic EuroScore < 20 undergoing elective isolated\r aortic valve replacement (AVR) surgery.\r\n\r Additionally, the aim is to gather sufficient data to quantify the effect size of short term\r patient benefit outcomes previously identified from literature and to explore additional\r healthcare resource utilization endpoints.\n\nClinical Trial Eligibility Criteria:\n\nInclusion:\r\n\r 1. adult male or female ≥18 years of age\r\n\r 2. symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency\r disease for which isolated surgical aortic valve replacement without concomitant\r procedures is planned\r\n\r 3. EuroSCORE <20\r\n\r 4. NYHA Class ≥II\r\n\r 5. Subject has signed and dated the investigation informed consent form prior to study\r specific procedures are performed\r\n\r 6. Subject is geographically stable and agrees to participate in follow-up assessments as\r specified in the protocol and informed consent\r\n\r Exclusion (i.a.):\r\n\r 1. pure aortic insufficiency\r\n\r 2. previous cardiac surgery (involved FS or MIS approach)\r\n\r 3. congenital true bicuspid / unicuspid aortic valve\r\n\r 4. requires emergency surgery or has had emergency surgery for any reason\r\n\r ≤ 1 month before the intended treatment\r\n\r 5. LVEF <25%\r\n\r 6. active endocarditis ≤ 6 months before the intended treatment\r\n\r 7. acute MI ≤ 90 days before the intended treatment\r\n\r 8. had a stroke or transient ischemic attack within six months prior to scheduled aortic\r valve replacement surgery\r\n\r 9. oxygen or ventilator dependent\r\n\r 10. life expectancy < 12 months\r\n\r 11. substance abuser\r\n\r 12. Female subject is pregnant or lactating\r\n\r 13. documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2\r mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding\r diathesis or coagulopathy\r\n\r 14. hemodynamic or respiratory instability requiring inotropic support, mechanical\r circulatory support, or mechanical ventilation within 30 days of procedure\r\n\r 15. documented echocardiographic evidence of intracardiac mass, thrombus or vegetation\r\n\r 16. renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at\r screening or end-stage renal disease requiring chronic dialysis\r\n\r 17. documented hyperparathyroidism\r\n\r 18. currently participating in an investigational drug or device trial for which follow-up\r has not yet been completed\r\n\r 19. Minimally Invasive access to the heart is not possible due to anatomical constraints\r or any other pre-existing condition\r\n\r Intra-operative Exclusion:\r\n\r 1. has calcium on the anterior mitral leaflet which cannot be removed\r\n\r 2. has extensive calcification of the aortic root\r\n\r 3. Annular deformation which may or may not be caused by too extensive decalcification of\r the aortic annulus\r\n\r 4. has left atrial thrombus\r\n\r 5. The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result\r in obstruction of blood flow\r\n\r 6. hemodynamically unstable during the procedure requiring the procedure to be aborted\r prior to insertion of the study bioprosthesis and delivery system\r\n\r 7. Study device is not available in the correct size for the subject\n\nPatient 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
596	[ { "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\nPARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis\n\nClinical Trial Summary:\n\nTo establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve\r in patients with severe, calcific aortic stenosis who are at low operative risk for standard\r aortic valve replacement (AVR).\n\nClinical Trial Detailed Description:\n\nProspective, randomized, controlled, multi-center trial. Patients having an operative\r mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized\r 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3\r or aortic valve replacement with a commercially available surgical bioprosthetic valve.\r Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually\r through 10 years.\r\n\r A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional\r patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations\r Registry (UPR) or the Alternative Access Registry.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Severe, calcific aortic stenosis\r\n\r 2. NYHA Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited\r exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with LVEF <50%\r\n\r 3. Heart team agrees the patient has a risk of operative mortality and has an STS <4\r\n\r 4. The study patient has been informed of the nature of the study, agrees to its\r provisions and has provided written informed consent.\r\n\r Exclusion Criteria:\r\n\r 1. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV\r\n\r 2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer\r sheath\r\n\r 3. Evidence of an acute myocardial infarction ≤ 30 days before randomization\r\n\r 4. Aortic valve is unicuspid, bicuspid, or non-calcified\r\n\r 5. Severe aortic regurgitation (>3+)\r\n\r 6. Severe mitral regurgitation (>3+) ≥ moderate stenosis\r\n\r 7. Pre-existing mechanical or bioprosthetic valve in any position\r\n\r 8. 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 9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within 30 days of randomization\r\n\r 10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy,\r or hypercoagulable states\r\n\r 11. Hemodynamic or respiratory instability requiring inotropic support, mechanical\r ventilation or mechanical heart assistance within 30 days of randomization\r\n\r 12. Hypertrophic cardiomyopathy with obstruction\r\n\r 13. Ventricular dysfunction with LVEF < 30%\r\n\r 14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\r\n\r 15. Inability to tolerate or condition precluding treatment with\r antithrombotic/anticoagulation therapy during or after the valve implant procedure\r\n\r 16. Stroke or transient ischemic attack within 90 days of randomization\r\n\r 17. Renal insufficiency and/or renal replacement therapy at the time of screening.\r\n\r 18. Active bacterial endocarditis within 180 days of randomization\r\n\r 19. Severe lung disease or currently on home oxygen\r\n\r 20. Severe pulmonary hypertension\r\n\r 21. History of cirrhosis or any active liver disease\r\n\r 22. Significant frailty as determined by the Heart Team\r\n\r 23. Significant abdominal or thoracic aortic disease that would preclude safe passage of\r the delivery system or cannulation and aortotomy for surgical AVR\r\n\r 24. Hostile chest or conditions or complications from prior surgery that would preclude\r safe reoperation\r\n\r 25. Patient refuses blood products\r\n\r 26. BMI > 50 kg/m2\r\n\r 27. Estimated life expectancy < 24 months\r\n\r 28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately\r treated with pre-medication\r\n\r 29. Immobility that would prevent completion of study procedures\r\n\r 30. Patient is not a candidate for both arms of the study\r\n\r 31. Currently participating in an investigational drug or another device study.\n\nPatient 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
597	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nEvaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve\n\nClinical Trial Summary:\n\nBicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of the\r population. The aortic dilation and aortic valve degeneration are common complications in\r patients with BAV. Statins have shown a reduction in the expression of metalloproteinases of\r the extracellular matrix observed in aortic aneurisms. Several retrospective studies have\r suggested the benefit of the statins to reduce aortic dilation in patients with BAV.\r Moreover, although statins did not show to be useful in the progression of aortic stenosis,\r different studies have suggested a higher profit when the valve affection is not severe. The\r objective of this study is to determine whether atorvastatin is effective at reducing the\r progression of aortic dilation in patients with BAV.\n\nClinical Trial Detailed Description:\n\nBICATOR is a multicentre (8 centres), randomised, double-blind and placebo-controlled\r clinical trial aimed at evaluating the effect of atorvastatin in reducing progression of\r aortic dilation in patients with BAV. The primary outcome is to determine whether\r atorvastatin is effective in reducing aortic dilation in BAV and secondary outcome is to\r define if atorvastatin treatment slows the progression of aortic valve degeneration (valve\r calcification) in a 3 year follow-up period. 220 patients will be included (110 atorvastatin\r - 110 placebo).\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patients ≥ 18 years old with BAV confirmed by transthoracic echocardiography (in case\r of doubts other techniques will be required: transesophageal echocardiography or CT to\r confirm diagnosis).\r\n\r - Valve dysfunction only moderate: in case of aortic stenosis with average gradient < 30\r mmHg and in case of aortic regurgitation a vena contracta < 7 mm or a jet with < 10\r mm.\r\n\r - Aortic valve not show severe calcification by transthoracic echocardiography.\r\n\r - Ascending aortic diameter (Valsalva sinus or tubular ascending aorta) ≤ 50 mm.\r\n\r - The patient must give the consent form signed.\r\n\r Exclusion Criteria:\r\n\r - Patients younger than 18.\r\n\r - Patients with uncontrolled hypertension and a history or risk of diabetes mellitus.\r\n\r - Patients who receive statins treatment or other lipid lowering drug or if they have\r indication to be treated according to the current clinical practice guidelines.\r\n\r - Previous cardiac surgery or any surgery of other segments of the aorta.\r\n\r - Previous aortic dissection and/or aortic coarctation.\r\n\r - NYHA functional class III or IV.\r\n\r - Presence or antecedent of liver failure (transaminase > 2 fold the superior limit of\r normal levels according to local laboratory), renal failure (creatinine clearance <\r 30ml/min or creatinine > 2.5mg/dl), myopathy or creatine kinase levels > 5 fold the\r superior limit of normality, or other gastrointestinal, hematologic or endocrine\r diseases or any other situation that according to the investigator criteria could\r affect the study treatment evaluation.\r\n\r - Hypersensitivity, intolerance or contraindication to any component of the study drug\r or to the contrast used in CT.\r\n\r - Pregnancy, breastfeeding or desire for pregnancy during the study period. A negative\r pregnancy test (negative gonadotropin) will be required in all fertile women to\r participate in the study.\r\n\r - Participation in another drug study.\n\nPatient 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
598	[ { "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\nEDWARDS INTUITY Valve System CADENCE Study\n\nClinical Trial Summary:\n\nThe study purpose is to compare the EDWARDS INTUITY valve system with commercially available\r stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with\r coronary artery bypass.\n\nClinical Trial Detailed Description:\n\nThis is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass\r time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented\r aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical\r aortic valve replacement surgery with concomitant coronary bypass grafts.\r\n\r Additionally, the aim is to gather sufficient data to quantify the effect size of short term\r patient benefit outcomes previously identified from literature and finally to explore\r additional healthcare resource utilization or health economic endpoints.\n\nClinical Trial Eligibility Criteria:\n\nInclusion:\r\n\r - ≥18 years of age\r\n\r - aortic stenosis / mixed aortic stenosis and aortic insufficiency\r\n\r - SAVR+CABG (1-4 distal anastomoses)\r\n\r - Log. EuroSCORE ≥6\r\n\r - NYHA Class ≥II\r\n\r Exclusion (i.a.):\r\n\r - pure aortic insufficiency\r\n\r - pre-existing prosthetic heart valve or ring\r\n\r - congenital true bicuspid / unicuspid aortic valve\r\n\r - LVEF <20%\n\nPatient 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
599	[ { "role": "system", "content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the Clinical Trial Title:, Clinical Trial Summary:, Clinical Trial Detailed Description:, Clinical Trial Eligibility Criteria:, and finally the Patient Description:.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The Patient Description: includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by Answer:: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation." }, { "role": "user", "content": "Clinical Trial Title:\n\nMedtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients\n\nClinical Trial Summary:\n\nThe study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR\r system as measured by rates of all-cause mortality or disabling stroke at two years is\r noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low\r predicted risk of operative mortality for SAVR.\r\n\r The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial\r protocol is to conclude the randomized phase of the trial and initiate the single-arm,\r non-randomized, continued access phase of the trial.\n\nClinical Trial Detailed Description:\n\nMulti-center, international, prospective, randomized, interventional, pre-market.\r\n\r Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to\r SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year,\r 18 months, and annually through 10 years.\r\n\r The expanded use addendum is a multi-center, prospective, non-randomized continued access\r trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR\r system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually\r through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United\r States.\n\nClinical 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\r valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec ,\r or mean gradient ≥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),\r AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by\r transthoracic echocardiography at rest, AND an exercise tolerance test that\r demonstrates a limited exercise capacity, abnormal BP response, or\r arrhythmia OR\r\n\r - Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2),\r AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by\r transthoracic echocardiography at rest, AND a left ventricular ejection\r fraction <50%.\r\n\r 2. Documented heart team agreement of low risk for SAVR, where low risk is defined as\r predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart\r team assessment.\r\n\r 3. 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 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 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. Ongoing sepsis, including active endocarditis.\r\n\r 5. Any percutaneous coronary or peripheral interventional procedure with a bare metal\r stent within 30 days prior to randomization, or drug eluting stent performed within\r 180 days prior to randomization.\r\n\r 6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left\r main coronary artery.\r\n\r 7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid\r stenosis within 10 weeks of Heart Team assessment.\r\n\r 8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or\r mechanical hemodynamic support.\r\n\r 9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or\r transient ischemic attack (TIA).\r\n\r 10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.\r\n\r 11. Subject refuses a blood transfusion.\r\n\r 12. Severe dementia (resulting in either inability to provide informed consent for the\r trial/procedure, prevents independent lifestyle outside of a chronic care facility, or\r will fundamentally complicate rehabilitation from the procedure or compliance with\r follow-up visits).\r\n\r 13. Estimated life expectancy of less than 24 months due to associated non-cardiac\r co-morbid conditions.\r\n\r 14. 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 15. Currently participating in an investigational drug or another device trial (excluding\r registries).\r\n\r 16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to\r unstable coronary artery disease (WHO criteria).\r\n\r 17. Need for emergency surgery for any reason.\r\n\r 18. Subject is pregnant or breast feeding.\r\n\r 19. Subject is less than legal age of consent, legally incompetent, or otherwise\r vulnerable\r\n\r 20. Pre-existing prosthetic heart valve in any position.\r\n\r 21. Severe mitral regurgitation amenable to surgical replacement or repair.\r\n\r 22. Severe tricuspid regurgitation amenable to surgical replacement or repair.\r\n\r 23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.\r\n\r 24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.\r\n\r 25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.\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 aortopathy requiring ascending aortic replacement.\r\n\r For transfemoral or transaxillary (subclavian) access:\r\n\r 30. 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 TAV. However, for\r transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean\r diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter\r <6.0 mm for the Evolut 34R or Evolut PRO TAV.\n\nPatient 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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