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

Clinical trial: A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Summary: Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. It has been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.

Detailed description: Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. The main mechanism of action of Ranolazine is the inhibition of late I(Na) thus decreasing the Ca++ load in the cardiomyocites. Consequently oxygen consumption also decreases. It has also been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.
  Primary end-point: To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy.
  Secondary end-points: To determine wheather Ranolazine improves patients' NYHA functional class, excercise capacity, LV systolic and diastolic function and weather ranolazine affects supraventricular and ventricular arrhythmia occurance/frequency.

Eligibility: Inclusion Criteria:
  -  established diagnosis of non-ischemic dilated cardiomyopathy
  -  EF < 35%
  -  NYHA f.c. II - IV
  -  Optimal medical management > 6 months
  -  Age < 75 years and > 18 years
  Exclusion Criteria:
  -  known hypersensitivity to the medication
  -  age > 75 years or < 18 years
  -  EF > 35%
  -  renal insufficiency (GF < 30)
  -  liver dysfunction (liver tests > 3x the upper normal limit))
  -  LQT syndrome
  -  drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.)
  -  dementia
  -  active hemathological or malignant disease

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

Clinical trial: Arrhythmia Prediction Trial

Summary: Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden Cardiac Death Prediction.

Detailed description: Sudden Cardiac Death (SCD) threatens survival of Coronary Artery Disease and Dilated Cardiomyopathy patients with Heart Failure. Discovering efficient SCD risk stratification markers is of high importance. In this study, heart failure patients will be risk stratified with indices from the Myocardial substrate (QRS, fragmented QRS, Late potentials, LVEF), indices from the Repolarization status (QT duration, QT rate corrected , QT dispersion, QT/RR, T wave Amplitude Variability, T wave alternans, QT Variability Index), indices from the Autonomic Nervous System function [ Heart Rate variability, Heart rate Turbulence, Deceleration Capacity (DC) , DC sign of fraction, Beat to Beat DC, Non linear indices of Heart Rate Dynamics], the Non sustained ventricular tachycardia and Ventricular extrasystolic activity and the Circadian Properties of Heart Rate observed during Ambulatory Monitoring. Furthermore Programmed Ventricular Stimulation will be used. High resolution 30 min ECG recordings will performed for further indices research and development. All the Arrhythmic Risk Stratifiers will be analysed and their performance for Sudden Cardiac Death Prediction and for Total Mortality will be estimated according the follow up.

Eligibility: Inclusion Criteria:
  -  Myocardial Infarction
  -  Dilated Cardiomyopathy
  -  Sinus rhythm
  Exclusion Criteria:
  -  Malignant diseases seriously affecting the survival
  -  Conditions/diseases affecting the Autonomic Nervous System's function
  -  Dementia
  -  Alcoholism
  -  Psychiatric diseases
  -  Addiction

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

Clinical trial: Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)

Summary: The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is (1) on repetitive administration of cell therapy that would allow for long-lasting improvements in heart function and outcome in this patient population. In parallel, the investigators aim to (2) develop a standardized patient-specific stem cell product that could be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for therapeutic application when clinically indicated. By using a unique multimodality imaging platform, the goal of this project is also to (3) define standardized clinical criteria that would serve as a guideline for evaluation of the effects of stem cell therapy in future clinical trials and everyday clinical settings. Finally, to improve the clinical implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery technique that could be used to treat both left and right and ventricular failure and could be implemented in a standardized fashion designed for a widespread clinical use.


Eligibility: Inclusion Criteria:
  -  Age 18-70 years old
  -  Diagnosis of DCM according to European Society of Cardiology position statement
  -  Left ventricular ejection fraction (LVEF) by echocardiography 20-40%,
  -  New York Heart Association (NYHA) functional class heart failure II or III for at least 3 months before referral.
  Exclusion Criteria:
  -  Acute multi-organ failure
  -  History of any malignant disease within 5 years
  -  Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
  -  Pregnancy

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

Clinical trial: Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

Summary: The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions.
  The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.


Eligibility: Inclusion Criteria:
  -  Male or female aged ≥ 18 years
  -  Histological or cytological confirmed metastatic colorectal cancer
  -  Written documentation of KRAS wild-type status and BRAFV600-mutation with RNF43 mutation and/or RSPO fusion
  -  Progression of disease after at least one prior standard of care regimen or intolerant to irinotecan based regimens
  -  Availability of a representative tumor specimen (primary or metastatic, archival or newly obtained)
  -  Measurable disease as per RECIST v1.1
  -  Eastern cooperative oncology group (ECOG) performance status ≤ 2
  Exclusion Criteria:
  -  Phase II only: Prior treatment with RAF inhibitors, Wnt pathway inhibitors, cetuximab, panitumumab, and/or other EGFR inhibitors
  -  Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enroll
  -  Current treatment with medications or consuming foods that are strong inhibitors or inducers of CYP3A4/5 or herbal medications and that cannot be discontinued at least one week prior to the start of treatment.
  -  Symptomatic or untreated leptomeningeal disease
  -  Acute or chronic pancreatitis
  -  Clinically significant cardiac disease
  -  Patients with any of the following laboratory values at Screening/baseline
  -  Absolute neutrophil count (ANC) <1,500/mm3
  -  Platelets < 100,000/mm3
  -  Hemoglobin < 9.0 g/dL
  -  Serum creatinine >1.5 x ULN or calculated or directly measured CrCl < 50% lower limit of normal
  -  Serum total bilirubin >1.5 x ULN
  -  AST/SGOT and/or ALT/SGPT > 2.5 x ULN, (> 5 x ULN if liver metastases present)
  -  Patients with impaired hepatic function as defined by Childs-Pugh class B or C
  -  Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral WNT974/LGX818
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy Patients

Summary: Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated cardiomyopathy patients with heart failure.
  Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy ( cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from May 2012 to April 2014. These 30 cases were treated under the recommendations of normal diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the experimental interferences were avoided and patients were divided into the experimental group and the placebo group. The patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. Then the investigators get the venous blood centrifugalization and cryopreservation. The patients take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. Three and six month later，electrocardiogram and echocardiography were taken and the determination of the NT - proBNP was done. The placebo group was followed up in the same way.


Eligibility: Inclusion Criteria:
  -  Congetive heart failure
  Exclusion Criteria:
  -  Valvular heart diseases

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

Clinical trial: Effects of HTEA ON Heart Failure Secondary to Idiopathic Dilated Cardiomyopathy or Post-myocardial Infarction

Summary: The investigators would evaluate the effects of the novel method, HTEA on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction.

Detailed description: The investigators would evaluate the effects of the novel method, HTEA on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction. The specific index is 6 miniutes walk distance, echocardiography, NYHA, NTproBNP level, peripherial WBC, RBC, PLT, Cre, UA, K+, Na+ upon entrance to hospital and 4 weeks after HTEA treatment, and 3 months after discharge. The morbidity and re-hospitalization would also calculated 3 months after discharge.

Eligibility: Inclusion Criteria:
  -  90 chronic cardiac failure patients in our hospital were selected and divided into two groups.
  Exclusion Criteria:
  -  Vavular diseases

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

Clinical trial: A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy

Summary: This is a rollover study designed to investigate the safety and effectiveness of investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and may, in the Investigator's opinion, derive benefit from continued treatment.


Eligibility: Key Inclusion Criteria:
  -  Received ARRY-371797 as treatment for a genetic dilated cardiomyopathy secondary to LMNA mutations in a clinical study sponsored by Array BioPharma.
  -  May, in the opinion of the Investigator, benefit from continued ARRY-371797 treatment.
  -  Additional criteria exist.
  Key Exclusion Criteria:
  -  Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
  -  Additional criteria exist.

Relevance to patient case: definitely relevant
Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy

Summary: : Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.
  Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.
  Methods: 330 patients are planned to be included and followed for 2 years


Eligibility: Inclusion Criteria:
  -  patient with dilated cardiomyopathy and typical symptoms of cardiac insufficiency at the time of the diagnosis: oedemas of lower limbs, dyspnoea, asthenia.
  -  and of a reduction in the fraction of ventricular ejection left (awkward) 45 % measured in echocardiography ( modified Simpson biplane) and associated with a volume télédiastolic volume superior to the normal in echocardiography: > 90ml / m2 ( modified Simpson biplane).
  Exclusion Criteria:
  -  Patients to whom the dysfunction VG is secondary or in a secondary overload of pressures in a HTA or a severe valvulopathie is in a coronary infringement(achievement), proved by histories of infarct or gestures(movements) of revascularisation (bypass(decking), stent) and or coronary hurts at least bi tronculaires significant the severity of which can explain the ventriculaire failure.

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

Clinical trial: Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

Summary: To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)


Eligibility: Inclusion Criteria:
  -  All subjects must be >/= 18 years at the first screening examination / visit
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  -  Subjects with advanced, histologically or cytologically confirmed solid tumors described to express fibroblast growth factor receptor 2 (FGFR2) that are refractory to any standard therapy
  -  For maximum tolerated dose (MTD) Dose Expansion: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer who had undergone within 4 lines of systemic anti-cancer treatment and not eligible for standard therapy anymore.
  -  Subjects need to have evaluable disease (measurable or not measurable).
  -  Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment
  Exclusion Criteria:
  -  History of allergic reactions to monoclonal antibody therapy (or excipients in the formulation)
  -  Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
  -  Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
  -  History of symptomatic metastatic brain or meningeal tumors unless the subject is longer than 3 months from the end of definitive therapy before the first dose of the investigational drug and has clinically or radiologically no evidence of tumor growth.
  -  History of clinically significant cardiac disease
  -  Congenital coagulation abnormalities
  -  Subjects who are pregnant or are breast-feeding

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

Clinical trial: Myocardial Metabolism in Patients With Dilated Cardiomyopathy

Summary: Dilated cardiomyopathy (DCM) is characterized by a metabolic shift from fat to carbohydrates and failure to increase myocardial glucose uptake in response to workload increments. The investigators aimed at verifying whether this pattern is influenced by the presence of abnormal glucose tolerance (AGT).

Detailed description: A catheter is advanced into the coronary sinus by fluoroscopy to withdraw venous blood. A unipolar pacing catheter is positioned into the right atrium. Arterial sampling is done from the femoral artery introducer catheter.
  The study protocol consisted of 3 steps (Rest, Pacing and Recovery), during which timed blood samples are collected to measure plasma NEFA and glucose. After the instrumentation is completed, Rest arterio-venous sampling is performed at time -15 min and 0 min. After the 0 min, heart rate is increased by atrial pacing to 110 bpm for 3 minutes and to 130 bpm for 3 additional minutes and arterio-venous sampling is repeated at the end of each step (at time 3 and 6 min). Pacing is then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.

Eligibility: Inclusion Criteria:
  For patients with dilated cardiomyopathy:
  -  Myocardial left ventricular ejection fraction (LVEF) <40%
  -  left ventricular end-diastolic diameter (LVEDD) >56 mm
  For patients without dilated cardiomyopathy:
  -  LVEF >50%
  -  LVEDD <56 mm.
  Exclusion Criteria:
  -  NYHA class IV
  -  Atrial fibrillation
  -  Previous myocardial infarction
  -  Valvular heart disease
  -  Myocarditis
  -  Pericarditis
  -  Severe to moderate systemic arterial hypertension
  -  Fasting hyperglycaemia (>7.0 mmol/l)
  -  Treated diabetes, autoimmune diseases, neoplasia, kidney, liver or respiratory failure

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

Clinical trial: Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Summary: Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.

Detailed description: Registry will include all patients who underwent intracoronary or intramyocardial cell therapy as a part of clinical trials performed at UMC Ljubljana from January 2005 until January 2018. Patients will be followed on regular basis in a dedicated heart failure outpatient clinic, clinical data will be collected and stored in a secure central database. Data will be analyzed in periodic intervals by an independent Data monitoring board in an attempt to better define the predictors of clinical response to cell therapy in this patient population.

Eligibility: Inclusion Criteria:
  -  Patient inclusion criteria consisted of the following: age 18-65 years old, diagnosis of DCM according to the European Society of Cardiology position statement (9), optimal medical management for at least 6 months, left ventricular ejection fraction (LVEF) <40%, and New York Heart Association functional Class III on stable medical therapy for at least 3 months before referral.
  Exclusion Criteria:
  -  Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.

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

Clinical trial: Acute Dietary Nitrate in Dilated Cardiomyopathy

Summary: Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice.

Detailed description: Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice. This study is a randomized, double-blind placebo-controlled, crossover trial. Resting blood pressure, phlebotomy and ISWT will be performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.

Eligibility: Inclusion Criteria:
  -  Clinically stable,
  -  Confirmed non-ischemic, dilated cardiomyopathy
  Exclusion Criteria:
  -  Active musculo-skeletal conditions
  -  Ischemic heart disease
  -  Pulmonary hypertension
  -  COPD
  -  Taking vasodilators
  -  Diabetes mellitus

Relevance to patient case: not relevant