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

Clinical trial: Cardiac Sarcoidosis and FDG-PET

Summary: Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. Its cardiac involvement may be potentially fatal. Although endomyocardial biopsy is required for deﬁnitive diagnosis of cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis patients. However, to our knowledge, no investigations have been published with regard to FDG quantification for the diagnosis and management of cardiac sarcoidosis by PET.

Detailed description: Fasting FDG-PET will be performed in all subjects. Serum calcium, C-reactive protein (CRP), angiotensin converting enzyme (ACE), lysozyme, and B-type natriuretic peptide (BNP) levels will be measured in all patients. All patients will undergo chest X-ray, resting 12-lead ECG, transthoracic echocardiography, and 3 types of radionucleotide imaging using Tc-99m sestamibi for myocardial perfusion, Ga and FDG for whole-body evaluation. All assessments will be conducted within 2 weeks and no sign indicated any change in disease activity of sarcoidosis. The patients with cardiac involvement will be treated with 30 mg/day of prednisolone orally for the first 4 weeks, then will decrease to a dose of 20 mg/day for the next 4 weeks, and will maintain to a dose of 10 mg/day afterwards.

Eligibility: Inclusion Criteria:
  -  Subjects between the ages of 35 and 85 years
  -  Subjects with systemic sarcoidosis
  -  Subjects with idiopathic sarcoidosis
  Exclusion Criteria:
  -  Subjects with active inflammatory diseases not related to sarcoidosis
  -  Subjects with coronary artery disease and primary valvular heart diseases
  -  Subjects with uncontrolled diabetes mellitus or insulin treatment
  -  Subjects with use of the corticosteroid
  -  Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease

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

Clinical trial: Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

Summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


Eligibility: Inclusion Criteria:
  1. Female presenting with metastatic breast cancer.
  2. Tumor must have been tested by FISH/CISH for FGFR1 amplification.
  3. HER2 and HR status must have been determined.
  4. Patients must have HER2 negative breast cancer.
  5. Patients must have a documented disease progression as define by RECIST at baseline.
  6. Patients with HR+ disease:
  -  Must have received at least one prior endocrine therapy in the metastatic setting.
  -  Must have received no more than three lines of chemotherapy in the metastatic setting.
  7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
  Exclusion Criteria:
  1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
  2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  -  History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
  -  Clinically significant resting bradycardia (< 50 beats per minute).
  -  LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
  3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
  4. Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
  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: The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle

Summary: The aim of the study was to assess of the influence of atorvastatin on selected indicators of an inflammatory condition, function of the left ventricle and factors affecting the occurrence of undesired events like rehospitalizations and mortality in patients with dilated cardiomyopathy.


Eligibility: Inclusion Criteria:
  -  patients 18 years old or older
  -  patients who signed informed consent
  -  patients with dilated cardiomyopathy (according ESC 2007)
  -  patients who had no significant coronary artery stenoses >30% on cardiac catheterization
  Exclusion Criteria:
  -  BP ≥140/90 lub <90/60
  -  congenital heart disease
  -  acquired valvular disease except for mitral incompetence secondary to left ventricular dilatation
  -  New York Heart Association (NYHA) functional class IV
  -  statin treatment
  -  preserved hyperactivity of aminotransferases with unexplained etiology,
  -  muscle disorders which might cause drug-induced myopathy,
  -  uncontrolled diabetes,
  -  liver diseases,
  -  creatinine level > 2 mg/dl and/or GFR<30ml/min,
  -  abuse of alcohol or drugs,
  -  chronic inflammatory diseases,
  -  pregnancy or lactation,
  -  severe hypothyroidism,
  -  immunosuppressive treatment,
  -  operation or severe injury during last month
  -  vaccination during last 3 months
  -  heart stimulation device or implantable cardioverter defibrillator
  -  or who didn't write conscious consent

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

Clinical trial: Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor

Summary: MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.


Eligibility: Inclusion Criteria:
  -  Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.
  -  Documented positive BRAF mutation (V600E, V600K, or V600D).
  -  Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment.
  -  The subject must have a radiographically measurable tumor.
  -  The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
  -  Able to swallow and retain oral medication.
  -  Sexually active subjects must use acceptable methods of contraception during the course of the study.
  -  Adequate organ system function and blood cell counts.
  Exclusion Criteria:
  -  The subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study.
  -  Previous treatment with a MEK inhibitor.
  -  Current use of a prohibited medication listed in the protocol.
  -  Uncontrolled glaucoma.
  -  Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment.
  -  Current severe or uncontrolled systemic disease.
  -  History of clinically significant heart, lung, or eye/vision problems.
  -  Significant unresolved side effects from previous anti-cancer therapy.
  -  The subject is pregnant or breastfeeding.

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

Clinical trial: Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial

Summary: Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.


Eligibility: Inclusion Criteria:
  -  Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
  -  Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)
  Exclusion Criteria:
  -  Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
  -  Need for use of PPV for perinatal depression or other indications
  -  Presence of any of the following
  -  congenital malformations (diagnosed prenatally)
  -  chromosomal anomalies (diagnosed prenatally)
  -  congenital heart disease diagnosed by fetal echocardiography.

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

Clinical trial: Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF)

Summary: Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (CHF). Recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. It results in increased peripheral resistance that may influence limb blood flow, muscle fitness and activities of daily.The purposes of this study are
  1. to compare muscular strength, endurance, and perfusion of quadriceps between CHF patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS) and difference in activities of daily living
  2. to compare endothelium function between CHF patients and healthy control subjects
  3. the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.


Eligibility: Inclusion Criteria:
  -  Age 40-75 years
  -  Chronic heart failure: ejection fraction<40% and at stable condition
  -  Coronary Disease and dilated cardiomyopathy without heart failure
  -  Control group without diagnosis of any heart disease
  Exclusion Criteria:
  -  Clinical diagnosis of neuromusculoskeletal , pulmonary, or other systemic diseases that may affect the testing of the study

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

Clinical trial: Spanish Atrial Fibrillation And Resynchronization Study

Summary: The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.

Detailed description: Cardiac resynchronization therapy (CRT) improves the functional capacity and the quality of life and reduces the mortality of patients with dilated cardiomyopathy, low ejection fraction and wide QRS.
  Only 2% of patients included in CRT randomized trials were in AF.
  To obtain a good response to CRT, percentage >90% of ventricular pacing must be obtained.
  Based on observational studies, current guidelines of CRT recommend the atrio ventricular junction (AVJ) ablation in those patients with permanent atrial fibrillation.

Eligibility: Inclusion Criteria:
  -  Dilated cardiomyopathy (LVEDD >56 mm)
  -  wide QRS (> 120 msec)
  -  NYHA III-IV
  -  EF<35%
  -  Permanent AF

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

Clinical trial: Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants

Summary: The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.


Eligibility: Inclusion Criteria:
  -  Women between 34 0/7- 36 6/7 weeks of gestation
  -  High risk of preterm birth
  Exclusion Criteria:
  -  Multiple births
  -  Fetal congenital malformations
  -  A course of steroids within 2 weeks of randomization
  -  Multiple courses of steroids
  -  Chorioamnionitis
  -  Non reassuring fetal heart rate
  -  Obstetrical indication of delivery
  -  Active bleeding
  -  Pregnancy related hypertensive disorders
  -  Uncontrolled diabetes

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

Clinical trial: Optimized Biventricular Pacing Allograft Recipients

Summary: This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.

Detailed description: This study is designed to increase the benefit of biventricular pacing (BiVP), which is an established therapy for advanced heart failure. The investigators will test 6 left ventricular (LV) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. Pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. Pacing by previously implanted pacemakers will be suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP), left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. Care will not be altered otherwise. Results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. Benefits of this study should include: improved patient selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.

Eligibility: Inclusion Criteria:
  -  New York Heart Association (NYHA) heart failure class III/IV
  -  Left Ventricular Ejection Fraction (LVEF) <36%
  -  QRS >120 msec
  Exclusion Criteria:
  -  Intracardiac shunts
  -  Sinus tachycardia >120 bpm
  -  Second or third degree heart block
  -  Previous cardiac surgery
  -  Mechanical circulatory assistance
  -  Atrial fibrillation

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

Clinical trial: Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

Summary: The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in patients with DCM, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo under the standard treatment of DCM.


Eligibility: Inclusion Criteria:
  -  Dilated Cardiomyopathy (LVEF ≤ 45%)
  Exclusion Criteria:
  -  Secondary dilated cardiomyopathy (such as ischemic cardiomyopathy, valvular cardiomyopathy, hyperthyroid cardiomyopathy, diabetic cardiomyopathy, anemia cardiomyopathy, and etc.)
  -  Coronary heart disease
  -  Rheumatic heart disease
  -  Pulmonary heart disease
  -  Continuous dysarteriotony: hypertension(systolic blood pressure [SBP] ≥ 60mmHg/diastolic blood pressure [DBP] ≥ 100mmHg); hypotension(SBP < 90mmHg/DBP < 60mmHg)
  -  Resting heart rate ≤ 50bpm
  -  Atrioventricular block patients without permanent pacemaker

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

Clinical trial: Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy

Summary: A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with Dilated Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo injection


Eligibility: Inclusion Criteria:
  -  Symptomatic patients with a confirmed diagnosis of dilated cardiomyopathy (NYHA II-III) attending their local 'Heart Failure clinic' who are on optimal heart failure treatment, under supervision from their physician or heart failure nurse specialist, and have no other treatment options
  -  Patients who are NYHA II that have been hospitalised with a dilated cardiomyopathy related condition
  -  Coronary angiography will be performed where necessary to confirm the diagnosis and ensure no other conventional treatment options are indicated
  -  Prior to recruitment to the study patients at risk of ventricular arrhythmia will have undergone electrophysiological assessment and appropriate clinical management (including implantable defibrillator insertion) where indicated (as per NICE guidelines)
  Exclusion Criteria:
  -  NYHA I
  -  Referral hospitals most recent documented ejection fraction of >45% (any imaging modality)
  -  The presence of cardiogenic shock
  -  The presence of acute left and/or right sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
  -  Known severe pre-existent left ventricular dysfunction (with a documented ejection fraction of <10% from referral hospital) prior to randomisation
  -  Congenital cardiac disease
  -  Cardiomyopathy secondary to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia
  -  Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
  -  Previous cardiac surgery
  -  Contra-indication for bone marrow aspiration
  -  Known active infection
  -  Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), HTLV or syphilis.
  -  Chronic inflammatory disease requiring ongoing medication
  -  Serious known concomitant disease with a life expectancy of less than one year
  -  Follow-up impossible (no fixed abode, etc)
  -  Patients with an irregular heart rhythm (AF allowed if paced in a regular rhythm)
  -  Patients with renal impairment (Creatinine >200mmol/L)
  -  Neoplastic disease without documented remission within the past 5 years
  -  Weight>140kg
  -  Subjects of childbearing potential

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

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
  Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  histologically/cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant