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

Clinical trial: Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment

Summary: A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

Detailed description: In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.
  The primary endpoint is the antiretroviral effect over 48 weeks.
  The secondary endpoints are;
  1. The immunologic effects from baseline at the 48th and 144th week
  2. Reasons of treatment failure by 144th week
  3. Adverse events and their rate of incidence by 144th week
  4. Serum concentration of tenofovir in selected patients
  5. Serum concentration of atazanavir in selected patients
  6. Renal complication in tenofovir arm

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of HIV infection,
  -  Antiretroviral initiation is recommended by current clinical guidelines,
  -  Treatment naïve,
  -  Age over 20 years old Japanese,
  -  Able to obtain written informed consent
  Exclusion Criteria:
  -  Current malabsorption condition,
  -  Prior use of lamivudine for hepatitis B treatment,
  -  Positive serology of Hepatitis B surface antigen,
  -  Patients who have following abnormal laboratory results within 6 weeks prior enrollment;
  1. alanine aminotransferase is more than 2.5 times higher of upper normal limit
  2. estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
  3. serum phosphate level is less than 2.0mg/dl
  -  Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
  -  Patients in pregnancy or breat feeding
  -  Patients who are taking medications contraindicated combine use of study medicine
  -  Patients whose primary care physicians consider inadequate to be enroll the study

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

Clinical trial: Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children

Summary: This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.
  This is a crossover, controlled, clinical trial in which children with esophageal stricture will be randomized in two groups to receive either topical mitomycin or no additional treatment during standard esophageal dilation session.

Detailed description: Topical mitomycin C has been used as an adjunct drug to endoscopic treatment of aero-digestive strictures. There has been some case reports and case series of this application in esophageal strictures in children, with good results. Nevertheless, it lacks a controlled clinical trial to access the efficacy of the mitomycin C in this context.
  This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.
  This is a crossover placebo-controlled single-blind clinical trial.
  Patients: Subjects up to 18 year-old, with esophageal stricture requiring endoscopic dilation, either due to dysphagia or by stricture preventing passage of the endoscope.
  Inclusion criteria:
  -  peptic esophageal stricture
  -  post-surgical esophageal stricture
  -  caustic esophageal stricture
  The patient will be randomized by one treatment group, either A or B.
  -  A. during the first endoscopic procedure it will be applied of topical mitomycin C over the esophageal mucosa after dilation, then the second procedure (in two weeks) will be performed as a standard dilation, without mitomycin C.
  -  B. the first procedure will be performed in a standard way, and after two weeks, in the second procedure mytomicin-C will be spread over the esophageal mucosa.
  The allocation will not be informed to the patient. At the end of the study protocol, the patients will be clinically evaluated and the dilation program will continue on discretion of the assistant doctor. The target esophageal bore is 11 mm (or 12.8 mm if age above 5 yrs).
  Mitomycin C will be applied over the esophageal mucosa in the site of stricture after dilation with a cotton pledget soaked in solution (0.4mg/ml) by three minutes. The pledget will he held over the mucosa with a biopsy forceps.
  Clinical evaluation. Dysphagia will be evaluated by a structured questionnaire, using a Likert scale. The patient will answer the questionnaire daily.
  Main outcome measure: Number of days with improved symptom (dysphagia) after a session.

Eligibility: Inclusion Criteria:
  -  children with esophageal strictures
  -  and dysphagia
  -  or stricture preventing endoscope to pass over it.
  Exclusion Criteria:
  -  congenital esophageal stricture
  -  stricture associated to eosinophilic esophagitis

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

Clinical trial: Safety Study of CD-NP in Heart Failure

Summary: An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.


Eligibility: Key Inclusion Criteria:
  -  Male or female ≥18 years of age diagnosed with NYHA class III or IV heart failure in the last six months
  -  Female patients must be post-menopausal or surgically sterile
  -  Diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload
  Key Exclusion Criteria:
  -  Women who are pregnant, breast-feeding or of child-bearing potential
  -  Clinically unstable patients
  -  Major surgical procedures within 30 days of entry
  -  Febrile temp > 100 degrees F)
  -  Symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
  -  Currently on IV vasoactive support (e.g., heart transplant candidate)
  -  History of unexplained syncope within the past 3 months
  -  History of organ transplantation
  -  Comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the Investigator, would prevent a patient's participation in the study.
  -  Participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
  -  Treatment with nesiritide within 14 days prior to dosing.
  -  Inability to effectively communicate with study personnel.

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: Observational Study

Summary: Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy

Detailed description: Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction <35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months

Eligibility: Inclusion Criteria:
  -  Diagnosis of idiopathic dilated cardiomyopathy
  -  Optimized therapy and for idiopathic dilated cardiomyopathy
  -  Left ventricular ejection fraction (Simpson) < 35%
  -  Peak oxygen consumption (VO2 peak) < 16 mL.kg-1min-1
  -  Functional classes II-IV of the NYHA
  Exclusion Criteria:
  -  dilated cardiopathies of ischemic or chagasic origin
  -  primary valve disease
  -  excessive use of alcohol or illicit drugs
  -  pregnancy
  -  ventricular arrhythmias
  -  any co-morbidity with impact on survival

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

Clinical trial: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

Summary: Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.


Eligibility: Inclusion Criteria:
  -  diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
  -  left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
  -  age below 60 years
  -  absence of neoplasm
  -  absence of hematologic disease or systemic disease
  -  no previous cardiac intervention
  Exclusion Criteria:
  -  episodes of tachycardia or ventricular fibrillation
  -  severe or moderated mitral insufficiency
  -  any other valvulopathies

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

Clinical trial: Study to Demonstrate the Non-inferiority of Olmesartan Medoxomil Versus Candesartan Cilexetil in Reducing Blood B-type (or Brain) Natriuretic Peptide Levels at Week 24

Summary: This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24


Eligibility: Inclusion Criteria:
  -  Male or female, adult, out-patients aged between 18 and 85 years
  -  Patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of CHF
  -  Patients with functional NYHA class II-IV with LVEF < 40% assessed within the last 3 months
  -  Patients with blood BNP levels > 400 pg/ml or NT-ProBNP levels > 1500 pg/ml
  -  Patients with CHF due to ischemic heart disease, idiopathic dilated cardiomyopathy (IDC), mitral or aortic insufficiency or hypertension
  -  Patients with stable conventional treatment with diuretics, ACEI and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance
  Exclusion Criteria:
  -  Females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. If a female becomes pregnant during the study, she has to be withdrawn immediately
  -  Patients with current hospitalisation due to heart failure
  -  Patients with stroke or transient ischemic attack (TIA) within the last 3 months
  -  Patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months
  -  Planned cardiac surgery, revascularization or resynchronization within the study period
  -  Patients with operable valvular disease or significant obstructive cardiomyopathy
  -  Patients with bradycardia [heart rate (HR) < 50 bpm]
  -  Patients with hypotension [systolic blood pressure (SBP) < 90 mmHg]
  -  Patients with obstructive pneumopathy
  -  Patients with clinical significant renal failure (creatininemia > 200 micromol/l)

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

Clinical trial: Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid

Summary: We suggest treating the Hutchinson-Gilford Progeria Syndrome by two molecules (zoledronic acid and pravastatin).The therapeutic approach which we propose has for objectives to reduce, to prevent or to delay the gravest infringements of the disease, to prolong the life of the children, and in a more general way, aim at improving their living conditions.


Eligibility: Inclusion Criteria:
  -  Molecularly characterised patients with a known mutation of their LMNA gene leading to the production of a farnesylated prelamin A, whether truncated or not
  -  Patients must be able to travel and consult in Marseille, France for necessary explorations planned at the inclusion step, then following the protocol flow
  -  chart for zoledronic acid injections and follow-up visits
  -  Patient older than 3 years
  -  Patients affiliated or beneficiary of a legal medical insurance
  -  Adult patients certifying they have been properly informed about the protocol, and they signed a written consent form. Children and/or disabled patients whose parents/legal tutor have been informed and have signed a written consent form
  Exclusion Criteria:
  -  Known hypersensitivity to pravastatin or zoledronic acid
  -  Seric transaminase levels higher than 3 times of normal value
  -  CPK level higher than 5 times of normal value
  -  Creatininemia higher than 0.5mg/dl or 44mM, or creatinin clearance lower than 70ml/min/1.73m3
  -  Presence of dental troubles, or recent dental trouble
  -  Maxillary osteonecrosis or bone nakedness antecedent
  -  Congenital galacosemia, glucose or galactose maladsorption syndrome, lactase deficiency
  -  Every other pathology thought to be incompatible with proposed treatment by the investigator
  -  Under treatment that can interfere with pravastatin and/or zoledronate metabolisms

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

Clinical trial: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

Summary: This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.


Eligibility: Inclusion Criteria:
  -  Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
  -  Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram
  -  Age below 70 years
  -  Absence of neoplasm
  -  Abscence of hematologic disease or systemic disease
  -  No previous cardiac intervention
  Exclusion Criteria:
  -  Episodes of tachycardia or ventricular fibrillation
  -  Severe or moderated mitral insufficiency
  -  Any other valvulopathies
  -  Previous cardiac surgery

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

Clinical trial: Retrospective Study Evaluating IGF1R And p95HER2 as Prognostic Factors in Non Small Cell Lung Cancer (NSCLC)

Summary: Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically resected non small cell lung cancer patients
  The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.


Eligibility: Inclusion Criteria:
  -  Radically resected non small cell lung cancer patients with tumor tissue available
  Exclusion Criteria:
  -  Tumor tissue not available
  -  Clinical data not available

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

Clinical trial: Stem Cells and Resynchronization Cardiac

Summary: Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.

Detailed description: About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.

Eligibility: -  Dilated Cardiomyopathy
  -  Heart Failure
  -  Optimized Therapeutics
  -  Ventricular Desynchrony
  -  Functional Class III or IV
  -  Ejection Fraction(Echo/ Sympson) < 35%

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

Clinical trial: Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis

Summary: The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression and activities of mitochondrium and expression of ubiquitin.


Eligibility: Inclusion Criteria:
  -  idiopatic dilated cardiomyopathy, NYHA I, II, III, IV
  -  dilated left ventricle
  -  ejection fraction below 45%
  Exclusion Criteria:
  -  diabetes mellitus
  -  kidney failure (GFR < 30, creatinine below 2,5 mg/dl

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

Clinical trial: Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107

Summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at biomarkers of angiogenesis and disease in patients with unresectable malignant mesothelioma treated on clinical trial CALGB-30107.

Detailed description: OBJECTIVES:
  -  Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin portend a poor prognosis in patients with unresectable malignant mesothelioma treated with vatalanib on protocol CALGB-30107.
  -  Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin correlate with response or stable disease in these patients.
  OUTLINE: Serum samples previously obtained from patients on protocol CALGB-30107 are tested for levels of thrombospondin I serum, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin using enzyme-linked immunosorbent assays (ELISA).
  PROJECTED ACCRUAL: A total of 47 specimens will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of malignant mesothelioma
  -  Unresectable disease
  -  Must have received treatment with vatalanib on protocol CALGB-30107
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Early Detection of Graft-Versus-Host Disease in Patients Undergoing a Donor Bone Marrow Transplant

Summary: RATIONALE: Studying samples of blood in the laboratory from patients who have undergone a donor bone marrow transplant may help doctors learn more about changes that occur in DNA and identify biomarkers related to graft-versus-host disease. It may also help doctors predict how patients will respond to a donor bone marrow transplant.
  PURPOSE: This laboratory study is looking at early detection of graft-versus-host disease in patients undergoing a donor bone marrow transplant.

Detailed description: OBJECTIVES:
  Primary
  -  Identify detectable changes in the transcriptomic or proteomic expression prior to clinical manifestations of graft-versus-host disease (GVHD) in blood samples from at-risk patients who have undergone allogeneic bone marrow transplantation.
  Secondary
  -  Characterize changes in the transcriptome or proteome expression pattern which are predictive of clinically significant GVHD in these patients.
  -  Develop reliable tests which enable early intervention for these patients.
  OUTLINE: Blood samples are collected prior to and just after typical onset of clinical graft-vs-host disease (GVHD) on days 1, 7-10, 20-23, 30-33, and 60 after allogeneic bone marrow transplantation. RNA is quantified and assessed by microarray analysis to identify changes to transcriptome or proteome expression and markers predictive of the onset of clinical GVHD. Samples are also stored for future analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Any patient undergoing an allogeneic bone marrow transplantation at one of the participating Mayo Clinic sites
  PATIENT CHARACTERISTICS:
  -  Body weight ≥ 15 kg
  -  Not pregnant
  -  Not a prisoner
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.
  PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

Detailed description: OBJECTIVES:
  -  To determine and define the biological basis of different subtypes of chronic graft-vs-host disease using a targeted single nucleotide polymorphisms approach in patients who have undergone allogeneic stem cell transplantation.
  OUTLINE: Two important aspects of the methodologies that will be employed for the analysis of SNPs associated with GVHD are throughput efficiency to be able to perform the assays on a reasonable number of samples as well as having the ability to add or remove SNPs to the assay panel. While a genome-wide association study to identify variants associated with GVHD would offer an unbiased approach, our patient cohort size would not allow significant statistical power in the study. Therefore, a more targeted approach using two established technologies is proposed.
  The Sequenome assay uses the unique combination of a single-base primer extension assay incorporating one of four modified nucleotides. The four modified nucleotides each have a unique mass that allows them to be distinguished from one another using mass spectrometry. Each SNP is determined analyzing the primer extension product from a PCR amplicon that surrounds the SNP of interest. The development of each assay involves designing flanking PCR primers and an internal extension assay using web-based software provided by Sequenome. The assays can be designed to analyze up to 30 SNPs in a single reaction, providing a customizable, efficient and high-throughput assay for SNPs of interest.

Eligibility: DISEASE CHARACTERISTICS:
  -  Underwent prior matched related or unrelated allogeneic stem cell transplantation (SCT)
  -  Presence OR absence of chronic graft-vs-host disease after day 100 and alive after day 180 post-transplantation
  -  No T-cell depleted SCT, cord blood transplantation, mismatched allogeneic transplantation, or autologous transplantation
  -  Available recipient and donor DNA (samples collected from the Vanderbilt University or the Fred Hutchinson Cancer Center tissue bank)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant