bioihbjkbjnl/mcl2 huggingface dataset:
Oral Immunotherapy for Peanut Allergy (PMIT)
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity
Intervention: Peanut OIT; Placebo
Intervention description: Defatted peanut flour ingested daily as oral mucosal immunotherapy; Oat flour matched by weight and consistency that is ingested daily as a placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Peanut allergy

Summary:

      The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects
      who have peanut allergy less allergic and induce changes in their immune system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject between 1 and 18 years of age

          -  EITHER history of significant clinical symptoms occurring within 60 minutes after
             ingesting peanuts greater than 6 months ago AND peanut specific IgE >15 kU/L

          -  OR history of significant clinical symptoms occurring within 60 minutes after
             ingesting peanuts within the past 6 months AND peanut specific IgE > 7 kU/L

          -  A family that will be able to be compliant with all study visits

          -  All females of child bearing age must be using appropriate birth control

        Exclusion Criteria:

          -  Subjects with a history of severe, anaphylaxis to peanut

          -  Medical history that would prevent a double blind placebo controlled oral food
             challenge (DBPCFC/OFC) to peanut

          -  Unable to cooperate with challenge procedures or unable to be reached by telephone for
             follow-up

          -  Diagnosed oat allergy

          -  Pregnancy or lactation
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: ACT-541468; Placebo
Intervention description: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg; Capsules for oral administration matching the ACT-541468 capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; elderly; Polysomnography

Summary:

      This study evaluates the dose response of ACT-541468 on the change of wake after sleep onset
      (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure.

          -  Male or female aged ≥ 65 years.

          -  Body mass index (BMI): 18.5 ≤ BMI (kg/m2 ) < 32.0

          -  Insomnia disorder according to DSM-5 criteria.

          -  Self-reported history of insufficient sleep quantity.

          -  Insufficient sleep quantity as collected subjectively in the sleep diary and validated
             objectively by polysomnography.

          -  Insomnia Severity Index score ≥ 15.

        Exclusion Criteria:

          -  Any current history of sleep disorder other than insomnia, or any lifetime history of
             related breathing disorder, periodic limb movement disorder, restless legs syndrome,
             circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.

          -  Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.

          -  Caffeine consumption ≥ 600 mg per day.

          -  Shift work within 2 weeks prior to the screening visit, or planned shift work during
             study.

          -  Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel ≥
             3 time zones during study.

          -  Hematology or biochemistry test results deviating from the normal range to a
             clinically relevant extent as per judgment of the Investigator.

          -  AST and/or ALT > 2 × ULN and/or bilirubin > 1.5 × ULN (except known history of
             Gilbert's syndrome);

          -  Severe renal impairment (known or defined as estimated creatinine clearance < 30
             mL/min);

          -  History or clinical evidence of any disease or medical condition or treatment, which
             may put the subject at risk of participation in the study or may interfere with the
             study assessments.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             the subject's full participation in the study or compliance with the protocol.
Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
Condition: Anorexia Nervosa; Osteoporosis
MeSH terms: Osteoporosis; Anorexia; Anorexia Nervosa
Intervention: estradiol 0.045 mg/levonorgestrel 0.015mg
Intervention MeSH terms: Levonorgestrel; Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Anorexia Nervosa; Osteoporosis; Eating Disorder; Disordered Eating; Estrogen; Bone

Summary:

      Decreased bone strength is a common and serious medical problem present in many women with
      anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones
      than women with normal bone strength.

      This study will investigate whether the use of transdermal estrogen can improve bone mineral
      density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when
      used for 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female; ages 25-50 years

          -  Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) psychiatric
             criteria for AN, including <85% of ideal body weight as defined by the 1983
             Metropolitan Life Insurance Height and Weight Tables, and amenorrhea

          -  T-score of < -1.5 at spine or hip

          -  Treatment team or treatment professional in place for clinical treatment/monitoring
             during the study

        Exclusion Criteria:

          -  Diseases known to affect bone metabolism, including untreated thyroid dysfunction,
             vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency

          -  Personal history of venous or arterial clot

          -  History of stroke or myocardial infarction

          -  History of migraine headaches

          -  History of hypercoagulable disorder

          -  Personal history or history of a first-degree relative with breast cancer

          -  History of hereditary angioedema

          -  Any medication known to affect bone metabolism, including systemic glucocorticoids
             within three months of the baseline visit, depot medroxyprogesterone within 6 months
             of the baseline visit, oral bisphosphonates within one year of the baseline visit or
             intravenous (IV) bisphosphonates within three years of the baseline visit

          -  Bone fracture within the prior 12 months

          -  Serum potassium < 3.0 meq/L or serum alanine aminotransferase (ALT) > 3 times the
             upper limit of normal

          -  Fasting serum triglyceride level > 150 mg/dL

          -  Pregnant or breastfeeding

          -  Active substance abuse
Nevanimibe HCl for the Treatment of Classic CAH
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Hyperplasia
Intervention: Nevanimibe hydrochloride
Intervention description: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CAH; nevanimibe

Summary:

      This is a multicenter, intra-subject dose-titration open-label study of nevanimibe
      hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH).
      Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a
      Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is
      anticipated that the overall duration of the study per subject will range from 24-42 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency and/or
             historical documentation of elevated 17-OHP

          -  Chronic glucocorticoid replacement therapy for at least 6 consecutive months prior to
             screening

          -  Stable glucocorticoid and mineralocorticoid regimen for at least 4 weeks prior to
             screening and throughout the treatment period of the study

        Exclusion Criteria:

          -  Nonclassic CAH

          -  Other causes of adrenal insufficiency

          -  HIV, hepatitis B, or hepatitis C

          -  AST or ALT >2x ULN, bilirubin or serum creatinine >1.5x ULN
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Condition: Acute Ischemic Stroke; Transient Ischemic Attack (TIA)
MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia
Intervention: BMS-986177; Placebo; Clopidogrel; Aspirin
Intervention description: Oral administration; Oral Administration; Oral administration; Oral administration
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2366.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to determine whether the addition of an oral Factor XIa
      Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary
      stroke prevention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female ≥40 years of age

          -  Acute Ischemic Stroke or Transient Ischemic Attack

          -  Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain
             area

        Exclusion Criteria:

          -  Predicted inability to swallow study medication

          -  Any condition that, in the opinion of the Investigator, contraindicates anticoagulant
             therapy or would have an unacceptable risk of bleeding

          -  Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke

        Other protocol defined inclusion/exclusion criteria could apply
18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 18F-DCFPyL
Intervention description: 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an interventional, single group assignment, prospective nonrandomized, open label
      Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate
      cancer with increasing prostate-specific antigen (PSA) levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of prostate cancer

          -  Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6
             weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following
             radiation therapy (ASTRO Phoenix consensus definition)

          -  Age ≥ 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

          -  Ability to understand and willingness to sign a written informed consent document

          -  Willing to comply with clinical trial instructions and requirements

        Exclusion Criteria:

          -  History of another active malignancy within 3 years, other than basal cell and
             squamous cell carcinoma of the skin

          -  Presence of prostate brachytherapy implants unless approved by the PI

          -  Administration of another radioisotope within five physical half-lives of trial
             enrollment

          -  Radiation or chemotherapy within 2 weeks prior to trial enrollment

          -  Estimated glomerular filtration rate (eGFR) < 15 ml/mmol

          -  Serum total bilirubin > 3 times the upper limit of normal

          -  Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 5 times the upper
             limit of normal

          -  Inadequate venous access

          -  Claustrophobia or any other condition that would preclude PET imaging

          -  Patients must not be receiving ADT except per criteria directly below. Patients who
             received in the past must have a serum testosterone that is recovered to at least 100
             ng/dL.

          -  Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC
Metoclopramide Versus Placebo for GJ Placement
Condition: Radiation Exposure; Enteral Nutrition
Intervention: Metoclopramide 5 MG/ML Injectable Solution; Saline
Intervention description: A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement.; A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.
Intervention MeSH terms: Metoclopramide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interventional Radiology; Metoclopramide; Gastrojejenostomy

Summary:

      The goal of this study is to determine whether use of promotility agents to stimulate gastric
      peristalsis can reduce fluoroscopy time and procedure time during gastrojejunostomy (GJ)
      tubes placement in interventional radiology (IR). The investigators hypothesize that
      increased gastric peristalsis will aid in advancing a guidewire through the pylorus, a time
      consuming and tedious step required during GJ tube placement. In order to maximize scientific
      rigor and clinical practice impact, the investigators aim to answer this question through a
      blinded, randomized, placebo controlled trial.

      Specific Aim 1: To test the hypothesis that a single dose of IV metoclopramide immediately
      prior to GJ tube placement reduces the fluoroscopy time required to advance a guidewire
      through the pylorus.

      Specific Aim 2: To determine whether a single dose of IV metoclopramide immediately prior to
      GJ tube placement reduces total procedure fluoroscopy time, air kerma and total procedure
      time.

      Specific Aim 3: To assess the safety of a single dose of promotility agent prior to GJ tube
      placement by assessing rates of adverse events in the periprocedural period in patients
      receiving IV metoclopramide versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years old or older

          -  undergoing de novo GJ placement as part of their routine clinical care

        Exclusion Criteria:

          -  Patient pregnant

          -  Contraindications to metoclopramide including:

               -  allergic reaction

               -  pheochromocytoma

               -  QTc prolongation

               -  history of seizure disorder

               -  extrapyramidal symptoms
Atrasentan Spermatogenesis and Testicular Function
Condition: Nephropathy; Diabetes
MeSH terms: Kidney Diseases
Intervention: Atrasentan
Intervention description: Atrasentan
Intervention MeSH terms: Atrasentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetic Nephropathies; Kidney Diseases; Urologic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Summary:

      This study is being conducted to evaluate the effects of Atrasentan on sperm production and
      testicular function in male subjects with Type 1 or 2 Diabetes and Nephropathy.

      This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an
      Observational Period (up to an additional 52 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males 30 to 75 years of age

          -  Type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic
             medication and angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor
             blockers (ARB) (renin-angiotensin system [RAS] inhibitor)

          -  Estimated Glomerular Filtration Rate (eGFR) equal to or greater than 35 mL/min/1.73
             m^2 with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula and
             Urine Albumin-to-Creatinine Ratio (UACR) equal to or greater than 30 and less than
             5,000 mg/g creatinine.

          -  Able to provide a semen specimen at the required intervals.

          -  Baseline sperm concentration equal to or greater than 30 million per mL.

        Exclusion Criteria:

          -  Treatment with hormone suppressive agents or cancer chemotherapy within the 6 months
             prior to the initial screening visit or planned during the study.

          -  History of severe peripheral edema or facial edema unrelated to trauma or history of
             myxedema in the prior 4 weeks prior to screening.

          -  History of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring
             oxygen therapy.

          -  Documented diagnosis of heart failure, previous hospitalization for heart failure or
             current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea,
             paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not
             explained by other causes, and for which there was a change in medication or other
             management directed at heart failure.

          -  Currently receiving or has received hormone replacement therapy within 6 months prior
             to screening.
Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Selinexor (KPT-330)
Intervention description: Oral tablet or suspension at 60, 80, 100 or 120 mg per patient-specific body surface area category. Dosing will occur twice weekly in 28-days cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous; SCC; Carcinoma; KPT-330; SINE; Selinexor; Karyopharm; Karyopharm Therapeutics; Lung; Head; Neck; Esophageal

Summary:

      Open-label, multi-center, single-arm, Phase 2 study of oral selinexor in patients with SCC of
      the head and neck (HN-SCC; Cohort 1), lung (L-SCC; Cohort 2), or esophagus (E-SCC; Cohort 3)
      who have relapsed or have metastasis following chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  confirmed SCC of the head and neck, lung, or esophagus

          -  1 to 2 prior therapies

          -  measurable disease at screening and documented progression within the past 6 weeks

        Exclusion Criteria:

          -  patients requiring total parenteral nutrition

          -  unstable cardiovascular function

          -  substantially impaired gastrointestinal function

          -  Symptomatic brain metastases

          -  another malignancy within 3 years except adequately treated in situ carcinoma of any
             type, basal or non-melanomatous skin cancer
Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: Lanraplenib; Filgotinib; Tirabrutinib; Lanraplenib placebo; Filgotinib placebo; Tirabrutinib placebo
Intervention description: 1 x 30 mg tablet administered orally once daily; 1 x 200 mg tablet administered orally once daily; 1 x 40 mg tablet administered orally once daily; 1 x tablet administered orally once daily; 1 x tablet administered orally once daily; 1 x tablet administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and
      tirabrutinib in adults with active Sjogren's Syndrome (SjS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosed with primary or secondary SjS according to the 2002 American European
             Consensus Group (AECG) classification

          -  Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's
             syndrome disease activity index (ESSDAI) ≥ 5

          -  Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or
             anti-SSB)

        Key Exclusion Criteria:

          -  Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD)
             (prior bDMARD treatment allowed with appropriate washout as per study protocol)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.