bioihbjkbjnl/mcl2 huggingface dataset:
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Intervention: AR101 - Peanut protein capsule
Intervention description: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 4 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: Characterized Peanut Allergen; Peanut; OIT; Oral Desensitization; Peanut Allergen; Peanut-Allergic Children; Children; Peanut-Allergic Adults

Summary:

      This is a multi-center, open-label, follow-on study to gather additional information on the
      safety and tolerability of oral desensitization with CPNA in the subjects who participated in
      ARC001.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of ARC001 study

          -  No change in the status of any longitudinally applicable ARC001 inclusion criteria

        Key Exclusion Criteria:

          -  Early termination from ARC001

          -  Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge

          -  A lapse in dosing of more than 10 days from completion of ARC001

          -  Change in the status of any longitudinally applicable ARC001 exclusion criteria
An 8-Week Refractory Chronic Cough Study (MK-7264-021)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Intervention: Gefapixant; Placebo (for gefapixant)
Intervention description: Gefapixant tablets administered by mouth twice daily for 8 weeks; Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant
      (AF-219) in participants with refractory chronic cough.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women and Men between 18 and 80 years of age inclusive

          -  Have refractory chronic cough

          -  Women of child-bearing potential must use 2 forms of acceptable birth control

          -  Have provided written informed consent.

          -  Are willing and able to comply with all aspects of the protocol.

        Exclusion Criteria:

          -  Current smoker

          -  Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%

          -  History of upper respiratory tract infection or recent significant change in pulmonary
             status within 4 weeks of the Baseline

          -  History of opioid use within 1 week of the Baseline Visit

          -  Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2

          -  History of concurrent malignancy or recurrence of malignancy within 2 years prior to
             Screening (not including participants with <3 excised basal cell carcinomas)

          -  Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP)
             >90 mm Hg

          -  Significantly abnormal laboratory tests at Screening

          -  Clinically significant abnormal electrocardiogram (ECG)

          -  Pregnant or Breastfeeding

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results and, in the judgment of the Investigator or Sponsor, would make the
             participants inappropriate for entry into this trial
Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Intervention: Fenofibrate; Placebo
Intervention description: 145mg of fenofibrate; Placebo
Intervention MeSH terms: Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to study the safety and efficacy of fenofibrate, an
      FDA-approved drug for high cholesterol and/or elevated triglycerides (fats), as a treatment
      for Huntington's disease (HD). Subjects who meet the entry criteria will be randomized (3:1)
      to either 145mg of fenofibrate or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An adult of either sex, ages 25-85 inclusive,

          -  Have proficiency with written and spoken English and corrected vision or hearing to
             complete the cognitive testing,

          -  Are able to give informed consent,

          -  Have good overall health status with no known problems anticipated over the course of
             the trial,

          -  Have a diagnosis of HD supported by positive gene test within the past 6 months.

        Exclusion Criteria:

          -  Other major neurological disease [e.g., multiple sclerosis, parkinson's disease,
             cortical stroke, etc]

          -  Clinically significant hepatic or renal disease,

          -  Current or recent (< 1 month) use of dopamine blocking agents such as tetrabenazine,
             anticonvulsants, neuroleptics, HAART, antiemetics, and antipsychotics for any reason,

          -  Current use of Warfarin (Coumadin). Enrollment in another investigational drug study
             within the prior three months.
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
Condition: Uveitis; Macular Edema; Uveitis, Posterior; Uveitis, Anterior; Panuveitis; Uveitis, Intermediate
MeSH terms: Macular Edema; Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior; Edema
Intervention: 4 mg CLS-TA; 0.8 mg CLS-TA
Intervention description: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension); 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uveitis; macular edema; UME; posterior uveitis; anterior uveitis; panuveitis; intermediate uveitis; noninfectious uveitis; triamcinolone acetonide; suprachoroidal space; injection; microneedle; intravitreal injection; corticosteroid; CME; choroid; retina; microinjection; SCS

Summary:

      The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA,
      in subjects with macular edema following non-infectious uveitis. A single suprachoroidal
      injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema
      following non-infectious uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of noninfectious uveitis

          -  diagnosis of macular edema associated with noninfectious uveitis

        Exclusion Criteria:

          -  any ocular trauma within the immediate 6 months prior to treatment

          -  any photocoagulation or cryotherapy in the 6 months prior to treatment

          -  any IVT injection of anti-VEGF treatment in the 2 months prior to treatment

          -  any eye diseases other than uveitis and ME that could compromise central visual acuity

          -  any previous suprachoroidal injection of triamcinolone acetonide in the study eye
Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: somatostatin
Intervention description: Somatostatin may be used to suppress endogenous insulin secretion
Intervention MeSH terms: Somatostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 1 diabetes; Hypoglycemia unawareness

Summary:

      The long-range goal of this project is to determine the effects of diabetes and the
      hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans.
      We will measure brain glycogen turnover and content in normal controls and subjects with
      diabetes under conditions of modest hyper-and hypoglycemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65

          -  Healthy control

          -  Must be able to provide informed consent

          -  Type 1 diabetes with hypoglycemia unawareness with hemoglobin A1c < 7.5%

          -  Poorly controlled diabetics with hemoglobin A1c > 7.5%

          -  Subjects with hypoglycemia unawareness must report an inability to recognize at least
             some blood glucose values <58 mg/dL during the 3 months prior to the study.

        Exclusion Criteria:

          -  Over 300 pounds

          -  Claustrophobic

          -  History of ischemic heart disease, arrhythmia, of seizure disorder

          -  Pregnant

          -  On medications known to alter blood flow or carbohydrate metabolism

          -  Have internally located pieces of metal
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Condition: Colonoscopy
Intervention: BLI800 - Dose 1; BLI800 - Dose 2
Intervention description: BLI800 oral solution; BLI800 oral solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: colonoscopy; pediatric

Summary:

      The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a
      bowel preparation prior to colonoscopy in pediatric patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female between the ages of 12 to 17

          -  Weight more than 40kg

          -  Undergoing colonoscopy for routinely accepted indications

          -  If female, and of child-bearing potential, subject must use an acceptable form of
             birth control or remain abstinent for the duration of the study.

          -  Negative pregnancy test at screening, if applicable

          -  In the Investigator's judgment, caregiver is mentally competent to provide informed
             consent for their child to participate in the study.

        Exclusion Criteria:

          -  Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute
             peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel
             perforation, toxic colitis or megacolon.

          -  Subjects who had previous significant gastrointestinal surgeries.

          -  Subjects with increased risk of bowel perforation, including connective tissue
             disorders, toxic dilation of the bowel or recent bowel surgery.

          -  Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with
             clinically significant electrolyte abnormalities based on Visit 1 laboratory results

          -  Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.

          -  Subjects with a prior history of renal, liver or cardiac insufficiency

          -  Subjects required to take any other oral medication within 3 hours of dosing until
             completion of both doses.

          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          -  Subjects with tendency for nausea and/or vomiting, or that have known swallowing
             disorders.

          -  Subjects for whom intake of substances is likely to affect gastrointestinal motility
             or urinary flow rate.

          -  Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Dutasteride; Prednisone
Intervention MeSH terms: Prednisone; Abiraterone Acetate; Dutasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate; metastatic; castrate resistant

Summary:

      The purpose of this research study is to determine if the addition of dutasteride to a
      regimen with abiraterone acetate and prednisone will improve on therapy in patients with
      castrate-resistant prostate cancer and metastatic disease. This study will also help
      determine the side effects of the study treatment and how often they occur.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of adenocarcinoma of the prostate

          -  Castrate resistant disease

          -  Metastatic disease

          -  Normal organ and marrow function

          -  Subjects with partners of childbearing potential must be willing to use adequate
             methods of birth control

        Exclusion Criteria:

          -  Uncontrolled intercurrent illness

          -  Uncontrolled hypertension

          -  Active or symptomatic viral hepatitis or chronic liver disease

          -  History of pituitary or adrenal dysfunction

          -  Clinically significant heart disease

          -  History of a different malignancy unless disease-free for at least 5 years

          -  Known brain metastasis

          -  History of gastrointestinal disorders

          -  Prior therapy with abiraterone acetate

          -  HIV-positive individuals on antiretroviral therapy

          -  Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily

          -  Atrial fibrillation or other cardiac arrhythmia requiring therapy

          -  Thromboembolism in the last 6 months
Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: 18F-fluoroestradiol
Intervention description: Patients will receive the FES tracer during a PET/MRI scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Purpose: The primary objective is to evaluate the sensitivity and specificity of
      18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis.

      Participants: A total of 12 participants will be recruited from individuals with clinically
      suspected endometriosis who are scheduled for planned operative laparoscopy at the University
      of North Carolina at Chapel Hill (UNC).

      Procedures (methods): This is a prospective, one arm, single center study of 12 subjects with
      clinically suspected endometriosis to demonstrate FES PET/MR's clinical utility for diagnosis
      of endometriosis. This study will be an evaluation of the radiotracer, FES, which binds to
      estrogen receptors and has previously been used to study estrogen receptor expression in
      tumors, to detect endometriosis. Participants will undergo one FES PET/MR scan within 4 weeks
      prior to their scheduled surgery. Participants will also complete questionnaires regarding
      their condition, pain, and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Female of childbearing age

          -  Clinically suspected (symptomatic) endometriosis.

          -  Scheduled for planned operative laparoscopy with no hormone treatment for at least two
             cycles

          -  Able to provide informed consent or assent

        Exclusion Criteria:

          -  Male

          -  Institutionalized subject (prisoner or nursing home patient)

          -  Known history of breast, ovarian or endometrial cancer.

          -  Pregnant or breast-feeding women
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: glycopyrrolate, 1.0%; glycopyrrolate, 2.0%; glycopyrrolate, 3.0%; glycopyrrolate, 4.0%; Vehicle
Intervention description: glycopyrrolate Topical Wipes, 1.0%; glycopyrrolate Topical Wipes, 2.0%; glycopyrrolate Topical Wipes, 3.0%; glycopyrrolate Topical Wipes, 4.0%; Vehicle Topical Wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared
      to vehicle for the treatment of axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or older.

          -  Primary, axillary hyperhidrosis of at least 6 months duration.

          -  A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.

          -  A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each
             axilla (total of 100 mg) while at rest at room temperature.

          -  Male or non-pregnant, non-lactating females.

        Exclusion Criteria:

          -  Prior surgical procedure for hyperhidrosis.

          -  Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or
             investigational)

          -  Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.

          -  Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists
             thought to relieve antidepressant-induced hyperhidrosis. Treatment with
             psychotherapeutic medications for less than 4 months prior to study enrollment. -
             Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine),
             or beta-blockers within 4 weeks prior to enrollment.

          -  Prior axillary treatment with axillary iontophoresis within 4 weeks.

          -  Axillary use of nonprescription or prescription antiperspirants within 2 weeks of
             study enrollment.

          -  Known history of a condition that may cause secondary hyperhidrosis.

          -  Known history of Sjögren's syndrome or Sicca syndrome.

          -  Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Gulf War Illness: Evaluation of an Innovative Detoxification Program
Condition: Gulf War Illness
Intervention: plain crystalline niacin, exercise, sauna
Intervention description: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
Intervention MeSH terms: Niacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Healthy volunteers: No
Keywords: Hubbard detoxification; Exercise; Sauna therapy; Niacin; Gulf War illness

Summary:

      Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is
      characterized by persistent memory and concentration problems, headaches, fatigue and muscle
      and joint pain. It is not known what causes the illness, but exposure to chemicals is
      suspected. The Hubbard detoxification program consists of exercise and sauna therapy together
      with administration of several dietary supplements, particularly crystalline niacin used at
      increasing concentrations over a period of about four weeks. The investigators hypothesize
      that this program will reduce symptoms, as tested by administration of cognitive and quality
      of life tests and serum clinical chemistry tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case
             definition.

        Exclusion Criteria:

          -  Veterans who meet the inclusion criteria but have been diagnosed by a physician with
             (1) chronic conditions (eg., cancer, heart disease, diabetes, liver disease, multiple
             sclerosis, etc.) that are not associated with Gulf War service but can produce diverse
             symptoms similar to Gulf War Illness; (2) conditions that might interfere with
             respondents' ability to report symptoms (eg., psychiatric conditions or history of
             hospitalization for depression, alcohol or drug dependence; (3) pregnancy or
             unwillingness to use contraception.