araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Effect of Beta-blocker Therapy on QTc Response in Exercise and Recovery in Normal Subjects

Summary: Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia are usually triggered by exercise and can be prevented in most patients by beta-blocker therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by the abnormal QT response to exercise testing (failure of the QT interval to shorten normally). Preliminary data from our laboratory show that the exercise QT intervals of patients with LQT1 are partially normalized by beta-blocker therapy. It is still currently not known if beta-blockers modify the QT/heart rate relationship (a primary effect on repolarization) or if the "normalizing" effect is due to the inability of subjects on beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for prolongation to occur. Moreover, the physiologic response of the exercise QT interval to beta-blockers in healthy control subjects is not known.
  Objective. The objective of this study is to define the impact of beta-blocker therapy on the QT response to exercise and recovery in normal subjects.
  Methods. Approximately 36 healthy adult subjects age-matched to previously studied LQT1 subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an exercise test, and 3) two weeks of placebo therapy ending in an exercise test. Beta blocker and placebo will be given in random order in a double-blind fashion. The QT response to exercise and recovery will be compared between drug-free and beta-blocker-treated states. These data will be compared to those previously collected for LQT1 subjects.
  Implications. These results will provide new information about the effect of beta-blocker therapy on repolarization parameters in normal subjects, and will provide a context in which to interpret the previous findings that beta-blocker administration modifies the QT response to exercise in LQT1 subjects.


Eligibility: Inclusion Criteria:
  -  Healthy normal adults, age- and gender-matched to previously studied LQT1 subjects
  Exclusion Criteria:
  -  Cardiac disease
  -  Diabetes
  -  Hypertension
  -  Severe allergic reaction
  -  Asthma requiring treatment
  -  Use of medications other than oral contraceptives, acetaminophen, nonsteroidal anti-inflammatory drugs, or synthroid or other thyroid medications
  -  Pregnancy (subjects will be asked if they are pregnant)
  -  Inability to sign informed consent

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

Summary: To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.
  To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

Detailed description: The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

Eligibility: Inclusion Criteria:
  -  Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion.
  -  Informed consent form signed.
  -  Able to attend both scheduled visits and to comply with all trial procedures.
  -  For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.
  Exclusion Criteria:
  -  Subject currently breast-feeding.
  -  Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.
  -  Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.
  -  Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  -  Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
  -  Personal history of Guillain-Barre syndrome.
  -  Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures.
  -  Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral).
  -  Influenza vaccination received this season (2007-2008).

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

Summary: To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.


Eligibility: Inclusion Criteria:
  -  Symptomatic atrial fibrillation
  -  Atrial fibrillation documented by ECG
  -  Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.
  Exclusion Criteria:
  -  Systolic blood pressure <100 mmHg
  -  Heart rate <50 bpm
  -  Temperature >38°C
  -  QT or QTcB >440 ms
  -  QRS >140 ms
  -  Paced atrial or ventricular rhythm on ECG
  -  Serum potassium <3.5 meq/L
  -  History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
  -  History of amiodarone in last 6 months.
  -  Clinical evidence of acute coronary syndrome
  -  Acute pulmonary edema or embolism
  -  Hyperthyroidism
  -  Acute pericarditis
  -  History of failed electrical cardioversion at any time
  -  History of torsades des pointes
  -  History of familial long QT interval syndrome
  -  History of ventricular tachycardia requiring drug or device therapy
  -  History of NYHA Heart Failure Class 3 or 4.

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Explorative Study of AZD1305 in Atrial Fibrillation Patients

Summary: Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state


Eligibility: Inclusion Criteria:
  -  Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
  -  Sinus rhythm at randomisation
  Exclusion Criteria:
  -  Haemodynamically unstable condition as judged by the Investigator, systolic BP <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation
  -  Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
  -  Sinus bradycardia (<50 beats per minute (bpm)) at randomisation
  -  QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
  -  Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
  -  QRS duration >120 ms at randomisation
  -  Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John's Worth

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer

Summary: Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.

Detailed description: The standard of care in breast cancer surgery includes identification and assessment of the sentinel lymph node (SLN). At the present time, SLN mapping utilizes a gamma ray-emitting radiotracer and/or a blue dye. Radiotracers provide sensitive detection of SLNs, but require involvement of a nuclear medicine physician, vary widely in transit time depending on the agent employed, can be difficult to localize with a handheld gamma probe, and expose both patient and caregivers to ionizing radiation. Blue dyes, such as isosulfan blue, cannot be seen easily through skin and fat, but can aid in definitive identification of the SLN when the handheld gamma probe gives ambiguous results. Finally, the learning curve associated with expertise in the SLN procedure is quite long using currently available techniques.
  In this 12-patient pilot study, we are testing a new intraoperative imaging system that we developed for image-guided surgery. The imaging system uses invisible, near-infrared (NIR) light to visualize lymphatic flow and to identify the SLN. The imaging system makes no contact with the patient and can display surgical anatomy simultaneously with NIR fluorescence.
  All patients will receive the standard of care for SLN mapping, namely technetium-99m sulfur colloid lymphoscintigraphy. In addition, patients will be injected with indocyanine green (ICG) diluted in human serum albumin (HSA). ICG is already FDA approved for other indications and is used in this study at 400-fold to 2000-fold lower than the typical clinical dose. Dilution into HSA improves the brightness of ICG by over 3-fold, making it an excellent tracer for lymphatic flow.
  The purpose of this pilot study is to determine whether the ergonomics of the imaging system interfere with typical clinical workflow during breast cancer surgery. A secondary goal is to optimize the imaging parameters (light levels, exposure time, etc.) associated with identification of the SLN.

Eligibility: Inclusion Criteria:
  -  Women or men above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
  Exclusion Criteria:
  -  Pregnant women,
  -  Significant renal, cardiac, or pulmonary disease,
  -  History of iodine allergy.

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)

Summary: Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week.


Eligibility: Inclusion Criteria:
  -  Be male or female between 19 and 78 years of age, inclusive
  -  Have a diagnosis of SBS and 1 or more of the following characteristics:
  -  Dependent upon TPN and/or IV fluids
  -  Unable to receive TPN because of a documented history of complications associated with the long-term parenteral infusions (e.g. lack of venous access, multiple septic events, progressive liver dysfunction while on TPN, etc)
  -  A documented remnant bowel anatomy that is inconsistent with adequately supporting life without parenteral support (e.g. < 70 cm of healthy small intestine and a portion of colon, or less than 150 cm in patients with no colon)
  -  A documented history of diarrhea and/or malabsorption that has significantly compromised the patient's nutritional and hydration status (e.g. significant weight loss - 5% over 1 month or 10% over 6 months, or a serum albumin < 3.5 g/dl, documented nutrient deficiencies, documented episodes of dehydration, etc).
  -  Is able to eat at least some (>500 calories) of solid food on a regular basis or tolerate at least some (>500 calories) of an enteral feeding formula
  -  Have stable liver and renal function
  -  For patients with known hypertension and other cardiovascular disorders, be both compensated and stabilized on a regular therapeutic regimen
  -  For women participating in the study, manifest or give assent to 1 of the following criteria to ensure that the patient does not become pregnant during the study:
  -  The patient must be surgically sterile or demonstrably postmenopausal.
  -  Any patient capable of becoming pregnant must have a negative urine pregnancy test and must agree to practice a method of contraception documented to have at least 90% reliability throughout the treatment period.
  -  Have the ability to understand the requirements of the study, to provide written Informed Consent, and to abide by the study restrictions and agree to complete the required assessments in the Follow-up Period
  Exclusion Criteria:
  -  Be pregnant or lactating
  -  Have a history of mental deficiency or illness that might compromise compliance with the requirements of the study
  -  Have clinically serious neurological dysfunction
  -  Have hypoxemic pulmonary diseases (i.e., resting pAO2 < 75 torr)
  -  Have unstable ischemic heart disease or uncompensated cardiac failure
  -  Have participated in any study involving an investigations drug within 30 days prior to entry into this trial.

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

Summary: The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.


Eligibility: Inclusion Criteria:
  Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease demonstrated by two PCR positive tests 3 months apart both during the past 6 months.
  Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No other current or planned anti-leukemia therapies
  Exclusion Criteria:
  Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months) Patient has received another investigational agent within last 6 months or tyrosine kinase inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation
  Impaired cardiac function including any one of the following:
  Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known family history of long QT syndrome. Clinically significant resting brachycardia (<50 beats per minute) QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) History of or presence of clinically significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

Summary: The main objective is to research for genetic factors involved in the extreme modifications of the QT interval of the electrocardiogram in answer to a pharmacological stimulation (sotalol) and physiological stimulation in the apparently normal general population.
  The phenotypic characterization, based on the ventricular repolarisation dynamics will be used aiming at term of the predictive genetic factors of the acquired long QT syndrome

Detailed description: Study of 1000 apparently healthy subjects which will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA.

Eligibility: Inclusion Criteria:
  -  Both sexes
  -  Age between 18 and 60 years
  -  European or North African Origin
  -  Body mass index between 19 and 29 kg / m ²
  -  Obtaining informed and written consent
  Exclusion Criteria:
  -  Asthma
  -  Heart rate < 50 bpm
  -  Systolic blood pressure < 100 mm Hg
  -  Atrioventricular block
  -  Known chronic illness with chronic treatment
  -  Raynaud phenomenon
  -  QT prolonging drug
  -  Family or personal history of the congenital long QT syndrome
  -  QT/QTc Fridericia (QTcf) > 450 ms
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: AVAI: Atrial Ventricular Arrythmia Incidence

Summary: The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

Detailed description: The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.

Eligibility: Inclusion Criteria:
  -  Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
  -  Patient has signed the study specific Informed consent document.
  -  Patient is older than 18 years of age
  Exclusion Criteria:
  -  Patient has a permanent Atrial Fibrillation
  -  Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
  -  Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
  -  Patient requires cardiac resynchronization
  -  Patient has Brugada Syndrome
  -  Patient has long QT Syndrome
  -  Patient has a device replacement;
  -  Patient is pregnant or nursing
  -  Patient is unable to attend the follow-up visits

Relevance to patient case: not relevant
Patient case: 19-year-old female with long QT syndrome; genetic feature: KCNH2

Clinical trial: A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects

Summary: This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.


Eligibility: Inclusion Criteria:
  -  Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice adequate (double barrier) non-hormonal contraceptive methods to prevent pregnancies.
  -  Body Mass Index (BMI) ≥ 18.5 and < 30 kg/m2, inclusive
  Exclusion Criteria:
  -  Female who is pregnant
  -  Any of the liver function tests (i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Alkaline Phosphatase (AP)) above the upper limit of normal (ULN)
  -  Any clinically significant history of disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
  -  Abnormal pulse and/or blood pressure measurements and the pre-study as follows: Pulse < 40 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (blood measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically
  -  A marked baseline prolongation of QT/QTc interval after repeated measurements of >450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
  -  Use of any prescribed or OTC (over-the counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for paracetamol (up to 3 g/day)
  -  Any use of drugs of abuse within 3 months prior to admission to the clinical unit
  -  History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit
  -  History of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or 40 ml of spirits or 1 glass of wine) (> 14 units of alcohol for female subjects) within 3 months prior to admission to the clinical unit
  -  Donation of blood or blood products within 3 months prior to admission to the clinical unit

Relevance to patient case: not relevant