araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Infliximab for the Prevention of Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation

Summary: This study will evaluate the efficacy of infliximab in reducing the incidence of grade II-IV acute graft versus host disease by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplant.

Detailed description: Rationale: Acute graft host disease (GvHD) remains a barrier to successful hematopoietic stem cell transplantation (HCT) used for the treatment of cancers in some patients. GvHD can result from a lack of compatibility between the donor and recipient. Research suggests another primary cause of GvHD comes from cytokines, or a substance produced by cells of the immune system that affect the immune response in both positive and negative ways. Infliximab is an antibody that directly targets the cytokine associated with GvHD. This study is building upon previous research to assess infliximab's ability to prevent GvHD after HCT.
  Purpose: This study is evaluating the efficacy of infliximab in reducing the incidence of GvHD after HCT. The safety of this approach, along with changes to specific cytokines from this treatment, will also be measured.
  Treatment: Patients in this study will receive infliximab through intravenous infusion. Infliximab will be administered in six doses, including one day before chemotherapy or radiotherapy, after the stem cell infusion, and then on days 7, 14, 28 and 42. Standard post-transplant treatments of cyclosporine (Neoral) and methotrexate (Methotrexate) will also be given through intravenous infusion. Cyclosporine will be given on day 1, and the subsequent schedule will be determined on an individual basis. Methotrexate will be administered on days 1, 3, 6, and 11. Several tests and exams will be given throughout the study to closely monitor patients.

Eligibility: Inclusion Criteria:
  -  Patients undergoing allogeneic HCT for the following disorders:
  -  Acute myelogenous leukemia
  -  Acute lymphoblastic leukemia
  -  Non-Hodgkin's lymphoma
  -  Hodgkin's disease
  -  Multiple myeloma
  -  Chronic lymphocytic leukemia
  -  Chronic myeloid leukemia in accelerated or blast crisis at time of transplant.
  -  Age >20 yrs
  Exclusion Criteria:
  -  Patients undergoing allogeneic stem cell transplantation for chronic myelogenous leukemia and aplastic anemia are excluded.
  -  Pregnant or breast-feeding females.

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: BiPAP for Cardiomyopathy With Central Sleep Apnea

Summary: We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would improve LV function.


Eligibility: Inclusion Criteria:
  -  Idiopathic dilated cardiomyopathy
  Exclusion Criteria:
  -  a history of alcohol abuse, diabetes mellitus, endocrine disorders, hypertension, obstructive sleep apnea syndrome, and chronic obstructive pulmonary disease

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Progenitor Cell Therapy in Dilative Cardiomyopathy

Summary: Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.

Detailed description: Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (BMC) may enhance left ventricular functional recovery in patients with acute myocardial infarction. It is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to regionally improve left ventricular contractility by selective infusion of BMC into the left anterior descending coronary artery.
  Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy

Eligibility: Inclusion Criteria:
  -  Age 8-80
  -  Dilated Cardiomyopathy, Ejection fraction < 40%
  -  LVEDD > 60mm
  -  Stable clinical condition within last 6 months
  -  Written informed consent
  Exclusion Criteria:
  -  Myocardial infarction or coronary intervention in the past
  -  Change of medical therapy within the last 6 weeks prior to cell therapy
  -  Tumor within last 5 years or incomplete remission
  -  Active infection
  -  Active bleeding
  -  Stroke within last 2 years
  -  Surgery or trauma within last 2 months
  -  Uncontrolled hypertension
  -  HIV infection
  -  Chronic inflammatory disease
  -  Liver disease (GOT > 2x upper normal limit)
  -  Renal dysfunction (creatinin > 2.0mg/dl)
  -  Thrombopenia < 100.000
  -  Anemia (hemoglobin < 8.5 g/dl)
  -  Mental retardation

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

Summary: The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations


Eligibility: -  Genders eligible for Study: Both
  -  Age: between 18 and 55 years
  -  Healthy volunteers are accepted
  Inclusion Criteria:
  -  Subjects tested positive for HIV-1 infection (HIV-infected subjects).
  -  Subjects that are tested negative for HIV (Healthy subjects).
  -  Either on stable antiretroviral therapy or not on antiretroviral therapy.
  -  CD4 cells > = 200 - 750/µl.
  -  Subjects must be in good general health except for HIV infection.
  -  Women must not be pregnant and use an acceptable method of contraception.
  Exclusion Criteria:
  -  Impairment of immunologic function (other than HIV infection).
  -  History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
  -  Uncontrolled serious infection.
  -  History of or active autoimmune disease.
  -  History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  -  History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
  -  High risk of developing a myocardial infarction or coronary death.
  -  History of intravenous drug abuse (within the last 12 months).
  -  Known allergy to egg or aminoglycoside (gentamicin).
  -  History of anaphylaxis or severe allergic reaction.
  -  Subjects undergoing treatment for tuberculosis infection or disease.
  -  Chronic administration of systemic immuno-suppressants.

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Cell Therapy In Dilated Cardiomyopathy

Summary: The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Detailed description: This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.
  The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.
  Hypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.

Eligibility: Inclusion Criteria:
  -  Diagnosis of dilated cardiomyopathy according to WHO criteria
  -  Syndromic heart failure in functional class III or IV of the NYHA
  -  Enrollment and continuous follow-up in cardiac out-patient clinic
  -  Adequate medical therapy after optimization therapy
  -  Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule
  Exclusion Criteria:
  -  Valvular diseases, except functional mitral or tricuspid reflow
  -  Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
  -  Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
  -  Sustained ventricular tachycardia
  -  Abusive use of alcohol or illicit drugs
  -  Pregnancy
  -  Use of cardio toxic drugs
  -  Any co-morbidity with impact in life expectancy in 2 years
  -  Renal function compromised (creatinine above 2 mg/dl)

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Cell Therapy in Chagas Cardiomyopathy

Summary: The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Detailed description: This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.
  The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.

Eligibility: Inclusion Criteria:
  -  Diagnosis of dilated cardiomyopathy according to WHO criteria
  -  Syndromic heart failure in functional class III or IV of the NYHA
  -  Enrollment and continuous follow-up in cardiac out-patient clinic
  -  Adequate medical therapy after optimization therapy
  -  Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule
  Exclusion Criteria:
  -  Valvular diseases, except functional mitral or tricuspid reflow
  -  Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
  -  Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
  -  Sustained ventricular tachycardia
  -  Abusive use of alcohol or illicit drugs
  -  Pregnancy
  -  Use of cardio toxic drugs
  -  Any co-morbidity with impact in life expectancy in 2 years
  -  Renal function compromised (creatinine above 2 mg/dl)
  -  Definitive implant of pace-makers, resynchronizers and CDIs
  -  Heart failure with symptoms initiating less than 1 year ago
  -  Active systemic arterial hypertension or history of hypertension

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Blood Collection From Individuals With Lung Disease for Genetic Studies

Summary: This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung cancer.

Detailed description: The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease. The investigators aim to collect blood samples from 300 people with lung disease and 300 controls over 5 years.

Eligibility: Inclusion Criteria:
  -  Must provide informed consent
  -  Males and females, age 18 years and older
  -  Lung disease proven by at least one of the following:
  -  symptoms consistent with pulmonary disease
  -  chest X-rays consistent with lung disease
  -  pulmonary function tests consistent with lung disease
  -  lung biopsy consistent with lung disease
  -  family history of lung disease
  -  disease of organs with know associated with lung disease
  -  individuals suspected of history of lung disease based on history and/or physical examination
  -  normal controls (individuals without history of lung disease) to be sampled to provide a comparison to the lung disease cohort.
  Exclusion Criteria:
  -  Drug and/or alcohol abuse within the past six months
  -  Females who are pregnant or nursing

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy

Summary: This study will investigate the effects of rosiglitazone, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. The primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the heart's ability to metabolize glucose (sugar).

Detailed description: Nondiabetic patients with nonischemic cardiomyopathy who are insulin-resistance or insulin-sensitive based on a fasting homeostasis model assessment (HOMA) value are eligible for the trial. At baseline, a 6-minute walk test is performed, followed by assessment of coronary flow reserve with ammonia-PET imaging before/after adenosine infusion. Subjects are then given an oral glucose load (75g), followed by PET imaging with F-18-fluoro-2-deoxyglucose (FDG). Subjects then begin taking rosiglitazone 4 mg qd x 12 weeks, after which the 6-minute walk test & PET imaging is repeated.

Eligibility: Inclusion Criteria:
  -  Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-II congestive heart failure
  -  History of Stage C-D heart failure with EF ≤ 40% during the course of the disease
  -  Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
  -  Age > 18 yrs
  Exclusion Criteria:
  -  Cardiomyopathy due to one of the following:
  -  Ischemic heart disease
  -  Primary valvular lesion
  -  Hypertrophic cardiomyopathy
  -  Cardiac resynchronization within the last 3 months
  -  Transaminase values > 2.5 x upper limit of normal or history of liver disease
  -  Diagnosis of diabetes mellitus by:
  -  Diabetes previously diagnosed per patient history
  -  2 or more fasting glucose values > 125 mg/dl
  -  Current NYHA class III or IV heart failure
  -  Serum creatinine > 1.6 mg/dl
  -  History of heart transplantation
  -  Pregnancy or active breast feeding
  -  Hospitalization for decompensated heart failure within 30 days prior to enrollment.

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

Summary: The purpose of the study is to evaluate the influence of cardiovascular risk factors, heart failure and cardiovascular drug therapy on erectile function in cardiovascular high-risk patients.

Detailed description: Association of cardiovascular risk factors and ED is likely due to an impairment of endothelial function resulting in a decreased activity of endothelial NO-synthase, which plays a major role in physiology of erection. Heart failure is also known to further contribute to endothelial dysfunction and hence, this could lead to erectile dysfunction.
  Study Objectives
  1. Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients.
  2. Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men.
  3. Long-term effects of cardiovascular drug therapy and cardiovascular diseases on erectile function.
  Study Design Male patients across Europe with cardiovascular diseases (CHD, PAD and heart failure) will be evaluated with a standardized questionnaire. Grade of erectile dysfunction will be assessed using an ED-score, generated from two different questionnaires.
  1. IIEF-5 - (International Index of Erectile Function)
  2. KEED - (Cologne Evaluation of Erectile Dysfunction)
  Primary Endpoint The primary endpoint is the sum score of the ED rating scale of the KEED (Kölner Erhebungsbogen zur Erektilen Dysfunktion, see Appendix 1). Erectile dysfunction is defined as reaching more than 17 points in the sum score.
  Secondary Endpoint The first secondary endpoint is the frequency of sexual activity and sexual desire. Another secondary endpoint contains satisfaction with sex life and general well-being. Men are defined as dissatisfied by answering "mixed" or "worse".
  Follow-Up: after 1 year, after 2 years.

Eligibility: Inclusion Criteria:
  -  Male patients with two or more cardiovascular risk factors or
  -  Male patients with a manifestation of atherosclerosis or
  -  Male patients with an ischemic or dilated cardiomyopathy
  -  Written informed consent
  Exclusion Criteria:
  -  Impairment of hormonal status
  -  Refusal of written informed consent
  -  Inability to complete the questionnaires

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair

Summary: -  Chronic severe mitral regurgitation can lead to symptoms and left ventricular dysfunction.
  -  The purpose of this study is to prospectively follow patients with non-ischaemic cardiomyopathy who are eligible for mitral valve repair surgery and primarily measure the quality of life through the Minnesota Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire.

Detailed description: -  Chronic mitral regurgitation (MR) usually spirals into a vicious cycle of left ventricular (LV) volume overload, LV dilatation, mitral annular dilatation and more MR. "MR begets MR". Eventually symptoms and LV dysfunction ensue. However, it can often be treated medically or surgically. Medical therapy is primarily afterload reduction and diuretics. Surgically, there are two options, either mitral valve repair or replacement.
  -  A number of retrospective studies have demonstrated improved LV function and survival in patients undergoing valve repair compared to valve replacement with or without subvalvular preservation. In one report, for example, patients who underwent valve repair were compared to patients who underwent valve replacement. The report found that the former group had lower operative mortality, a greater increase in LV ejection fraction and higher overall ten year survival.
  -  The bulk of the literature at present addresses left ventricular dimensions, ejection fraction, geometry and New York Heart Association functional class, but few have addressed quality of life measures. In addition, most of these studies were retrospective and the majority of patients had concomitant ischaemic heart disease.
  -  Even though the studies concerning quality of life after mitral valve surgery have been few, nevertheless, some have addressed isolated valve surgery without concomitant bypass surgery and have shown improved quality of life, though follow up in some was limited to 3 months. We will follow our population for 12 months after surgical repair.
  -  We will primarily look at subjective measures for quality of life such as the Minnesota Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire, as subjective measures are becoming more and more important following cardiac surgery. Patients will serve as their own controls and all study parameters will be compared pre- and post surgery.

Eligibility: Inclusion Criteria:
  -  Patients that fulfill surgical criteria set by the 2006 ACC/AHA guidelines for the management of patients with valvular heart disease.
  -  Symptomatic mitral regurgitation with left ventricular dysfunction (LVEF < or = 40%) on maximal medical therapy
  Exclusion Criteria:
  -  Mitral valve replacement
  -  Concomitant coronary artery bypass surgery
  -  Patient unable to give informed consent

Relevance to patient case: not relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study

Summary: Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases are of unclear cause, often occuring in families. We believe that mutations in specific already-identified genes contribute to DCM in Quebec and that certain mutations may account for a significant proportion of cases due to the well-documented "founder effect". Two hundred patients with DCM followed in our Heart Function Clinic will be approached for one blood sample at their routine clinic visit to test this hypothesis. The samples will be tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.


Eligibility: Inclusion Criteria:
  -  Followed at MUHC Heart Function Centre
  -  Documented EF of less than or equal to 35% and an enlarged heart with a left ventricular end-diastolic size of greater than 6 cm.
  -  Patient's written consent
  Exclusion Criteria:
  -  Patients with a known underlying condition that results in a weakened and enlarged heart
  -  Patients unable to read and understand the consent form
  -  Patients who do not wish to participate

Relevance to patient case: not relevant