araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Melanoma Molecular Profiling Analysis

Summary: There is a significant need to develop new and more effective ways to treat melanoma that will decrease patient morbidity and mortality. This protocol intends to collect and process a portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and appropriate lineage control tissue will be collected. Material only from already-indicated and planned procedures as part of standard medical care will be used. The main goal of this study will be to properly collect and process material to be analyzed and explore the molecular features melanoma biological samples.


Eligibility: Inclusion Criteria:
  -  Primary melanoma with the following Breslow thickness and stage
  -  ≥ 2 mm with ulceration, T3b
  -  ≥ 4 mm without (T4a) or with (T4b) ulceration
  -  Patients with a biopsied tumor that has not been widely resected will also be eligible for study according to the above-specified criteria for tumor thickness and stage.
  -  Age 12 years or older.
  -  Patients must have documented hemoglobin level of 10g/dL or higher. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
  -  Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.
  Exclusion Criteria:
  -  Serious illnesses that may be considered a contraindication to surgery as determined by the physician investigator. If a subject is cleared for surgery as clinically indicated (wide excision of the primary melanoma and sentinel lymph node biopsy), subject would be eligible.
  -  Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
  -  Active infection or antibiotics within one-week prior to study
  -  Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension

Summary: In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.


Eligibility: Inclusion Criteria:
  -  Stage 1 and 2 hypertension without treatment for at least 2 weeks
  -  Women with no risk of becoming pregnant
  Exclusion Criteria:
  -  Study participation could result in risk to health of subject
  -  Cardiovascular disease
  -  Secondary hypertension or stage 3 hypertension
  -  Myocardial infarction within the last 6 months
  -  Congestive heart failure
  -  Pulmonary edema
  -  Valvular alterations or rheumatic cardiopathy
  -  Clinically relevant conduction disorders significant arrhythmias
  -  Alcohol or illicit drug use
  -  Medication abuse
  -  Pregnant or nursing women

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

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: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Acupuncture Versus Placebo Acupuncture During In Vitro Fertilization (IVF) Embryo Transfer

Summary: During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer

Detailed description: Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi treatment. The patients are randomized to receive either acupuncture or sham acupuncture (placebo)around embryo transfer

Eligibility: Inclusion Criteria:
  -  infertility
  -  below 38 years
  -  ivf or icsi treatment
  -  fresh embryo transfer cycle
  -  no more than two earlier embryo transfers with "fresh" embryos
  -  embryo transfer on day 2 or 3 after oocyte aspiration, single or double embryo transfer
  Exclusion Criteria:
  -  Frozen embryo transfer
  -  oocyte donation
  -  other "alternative" treatment during the cycle

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Detect Fluid Early From Intra-thoracic Impedance Monitoring

Summary: To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.


Eligibility: Inclusion Criteria:
  -  Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
  -  Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months
  Exclusion Criteria:
  -  History of kidney disease requiring hemodialysis
  -  Refractory end stage heart failure

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use

Summary: The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual care. Additionally, the investigators will look at whether racial concordance (physician and patient being of the same race) improves satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is that a video in which participants are of the same race as the patient will provide better education and more satisfaction with the treatment decision and may lead to more patients choosing ICD therapy.


Eligibility: Inclusion Criteria:
  -  Class I primary prevention indications for an implantable cardioverter defibrillator (ICD). These include:
  -  Patients with ejection fraction <35% due to prior myocardial infarction (MI) who are at least 40 days post-MI and with New York Heart Association (NYHA) functional class II or III;OR
  -  Patients with nonischemic dilated cardiomyopathy (DCM) who have an LVEF < 35% and who meet criteria for NYHA functional class II or III; OR
  -  Patients with left ventricular dysfunction due to prior MI who are at least 40 days post-MI, have an left ventricular ejection fraction (LVEF) <30% and are in NYHA functional class I-III; OR
  -  Patients with nonsustained ventricular tachycardia (VT) due to prior MI, LVEF <40%, and with inducible ventricular fibrillation (VF) or sustained VT at electrophysiological study; AND
  -  Self identified race as black/African American or white/Caucasian

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial

Summary: Patients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will be randomly assigned to one of four treatment groups:
  I: (Standard of Care at WRAMC): Application of L-M-X topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in normal saline)
  II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate)
  III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine)
  IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate + 1% Lidocaine)
  The primary study outcome is pain, which will be evaluated for each study group before, and after radiocolloid injection utilizing a standardized 10-point Likert scale, the Wong-Baker FACES Pain Rating Scale, and the McGill Pain Questionnaire. Physician appraisal of patient pain (Wong-Baker FACES Pain Rating Scale) will be estimated during the radiocolloid injection and compared with that of the patient.

Detailed description: Null hypothesis: There is no difference in overall pain intensity between standard and pH adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for breast cancer.
  Objectives and scientific aims:
  To compare the intensity of pain (Wong-Baker FACES Pain Rating Scale + McGill Pain Questionnaire) associated with WRAMC's current standard and pH-adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for breast cancer.
  To assess objectively physician appraisal of patient pain during the radiocolloid injection and compare physician interpreted pain score with patient reported pain score.
  Define the success rate of intra-operative SLN identification for each study group.

Eligibility: Inclusion criteria:
  1. Female military healthcare beneficiaries should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy.
  2. Written informed consent must be obtained from each patient prior to entering the study.
  3. Female military healthcare beneficiaries with early breast cancer scheduled to undergo sentinel lymph node mapping and biopsy at WRAMC
  Exclusion criteria:
  1. Female military healthcare beneficiaries with chronic pain syndrome (e.g. fibromyalgia) undergoing active narcotic-based treatment.
  2. Female military healthcare beneficiaries participating in other clinical trials the requirements of which may preclude complete involvement in this study.
  3. Female military healthcare beneficiaries with significant allergy to local anesthetics.
  4. Female military healthcare beneficiaries presenting with large (>4cm), clinically node positive, painful, locally advanced breast cancer.

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients

Summary: Breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent CT scan to locate the sentinel lymph node (SLN) before SLN biopsy (SLNB) at the same day of surgery. When CT examination performed, those patients were in supine position, with the arms stretched upward but bent at the elbow with the hands at the side of the cranium which similar to the surgical position. After local anesthesia, 2mL of iopamidol was injected subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about 1 minute. Contiguous 2-mm-thick CT images that included the breast and axilla were obtained prior to administration of the contrast agent. After 3D CT reconstruction, the SLN was identified as the most inferiorly visible nodule in the axilla connected to the lymphatic vessel on the CT imaging monitor. A professional intervention doctor punctured the defined lymph node guided by the CT monitor using the Breast Lesion Localization Needles (interv). The needle would stay in the patient's axilla until the surgery. All the lymph nodes including the CT defined one and which marked by methylene blue dye or 99mTc-sulfur colloid tracers were removed, which then would be tested by touch imprint cytology for the intraoperative diagnosis. Patients who had positive SLN would receive axillary dissection. The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.


Eligibility: Inclusion Criteria:
  -  Breast cancer patients（T1-T2N0）
  -  Age 18-70
  -  Accept of SLNB
  -  Accept our protocol in the informed consent
  Exclusion Criteria:
  -  LABC patients
  -  Age < 18
  -  History of epilepsy
  -  History of thyrotoxicosis
  -  Pregnant women

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

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
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Safety and Clinical Performance of the Protecta ICD and CRT-D

Summary: The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.

Detailed description: The PainFree SST study was a prospective, multicenter clinical trial, which was conducted in two consecutive phases. Phase I assessed safety as determined by assessment of delays in ventricular fibrillation (VF) arrhythmia detection time using new algorithms. Phase II assessed the influence of new algorithms on inappropriate and unnecessary shocks at 1 year of follow-up. Subjects enrolled in Phase I continued in Phase II of the study and data from all enrolled subjects contributed to the analysis of Phase II objectives. A sub-study of Phase II randomized secondary prevention subjects to either 18/24 NID or 30/40 NID in order to assess the safety of prolonged detection in these patients.

Eligibility: Inclusion Criteria:
  -  Patients meeting one of the following criteria can be included in Phase I of the study:
  -  Patients indicated (per local indications) for a dual chamber implantable cardioverter defibrillator (DR-ICD)/cardiac resynchronization therapy defibrillator (CRT-D)
  -  Patients undergoing a device replacement or upgrade to DR-ICD or CRT-D and with the protocol required leads (patients must be enrolled prior to implant)
  -  Patients meeting one of the following criteria can be included in Phase II of the study:
  -  Patients indicated for a DR-ICD/VR-ICD/CRT-D device and intended to receive a Protecta device
  -  Patients undergoing a DR-ICD/VR-ICD/CRT-D device replacement or an upgrade to a Protecta DR-ICD/VR-ICD or CRT-D
  -  Patients indicated for a DR-ICD/VR-ICD/CRT-D already implanted with a Protecta device and the protocol required leads, who have not yet been discharged after implant
  Exclusion Criteria:
  -  Patients with a mechanical tricuspid heart valve
  -  Patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
  -  Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
  -  Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc)
  -  Patients anticipated not being able to complete the study
  -  Patients unwilling to provide written informed consent

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine

Summary: Hypothesis: Combined treatment with valproic acid and ATRA can be used to achieve disease stabilization for a subset of patients with acute myelogenous leukemia (AML), and this effect can be improved without serious toxicity by adding low-dose cytarabine to this treatment.
  Adult patients >18 years of age who can be included:
  Elderly patients who cannot achieve standard chemotherapy, patients with relapsed or resistant AML.
  Treatment: Combined therapy with:
  Valproic acid, continuous therapy until disease progression ATRA, oral therapy for 14 days every three months Low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3, repeated every 3 months.

Detailed description: Patients to be included:
  1. Elderly patients (>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML).
  2. Adult patients of any age (>18 years of age) with relapsed or resistant AML who cannot receive conventional therapy.
  Treatment:
  Valproic acid to be started on day 1 as continuous therapy until disease progression.
  ATRA administered from day 8 orally as 22.5 mg/m2 twice daily for 14 days, repeated every third month.
  Low-dose cytarabine 10 mg/m2 from day 14 and continued as daily injections for up to 10 days, repeated every third month.
  Supportive therapy is given according to the hospitals general guidelines.
  Followup: The first 2 days treatment in hospital, later regular out-patient treatment. Controls will include clinical examination, peripheral blood parameters (including serum valproic acid levels), bone marrow samples.

Eligibility: Inclusion Criteria:
  -  Recently diagnosed AML in patients unfit for intensive chemotherapy
  -  Patients with relapsed or refractory AML
  Exclusion Criteria:
  -  No informed consent
  -  Intolerance to study drugs
  -  Serious liver disease

Relevance to patient case: not relevant
Patient case: 36-year-old female with Brugada syndrome; genetic feature: SCN5A

Clinical trial: Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety

Summary: Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.

Detailed description: ICD therapy with DC shock is associated with impaired quality of life and development of anxiety and depression. In a selected group of patients with ICD the intervention with organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed interventions by the ICD and psychological profile is assessed. In addition a qualitative evaluation using interviews is performed.

Eligibility: Inclusion Criteria:
  -  Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD
  Exclusion Criteria:
  -  Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,

Relevance to patient case: not relevant