bioihbjkbjnl/mcl2 huggingface dataset:
L-arginine in Severe Asthma Patients Grouped by Exhaled Nitric Oxide Levels
Condition: Asthma; Inflammation
MeSH terms: Asthma; Inflammation
Intervention: L-Arginine; Placebo
Intervention description: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.; Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Asthma; Severe Asthma

Summary:

      The major impact of this study will be to identify the adult severe asthma cohort that will
      benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of
      adult severe asthma patients will respond to supplemental L-arginine and derive clinical
      benefit from the addition of this therapy to standard-of-care asthma medications. The
      investigators hypothesize that the patients that benefit most will have low exhaled nitric
      oxide concentrations (< 20 ppb) at baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults >18 yrs of age

          -  Diagnosis of severe asthma based on American Thoracic Society Workshop definition (Am
             J Respir Crit Care Med 2000; 162:2341)

          -  Active asthma medications of high dose inhaled corticosteroids plus long-acting beta
             agonist

          -  History of recent asthma exacerbations or Asthma control test score < 20/25

        Exclusion Criteria:

          -  <19 yrs of age

          -  Forced expiratory volume 1sec <30% predicted

          -  Pregnant or nursing women

          -  Current smokers or smoking history > 15 pack years

          -  Actively taking or known intolerance to L-arginine
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Bilastine 0.2%; Bilastine 0.4%; Bilastine 0.6%; Bilastine 0%
Intervention description: 1 drop in each eye at 3 separate times during a 25 day period.; 1 drop in each eye at 3 separate times during a 25 day period.; 1 drop in each eye at 3 separate times during a 25 day period.; 1 drop in each eye at 3 separate times during a 25 day period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to
      vehicle for the treatment of the signs and symptoms of allergic conjunctivitis
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  be at least 18 years old

          -  be willing and able to avoid all disallowed medications and contact lenses

          -  must have a pregnancy test if of childbearing potential

          -  must be able to read an eye chart from 10 feet away

        Key Exclusion Criteria:

          -  must not have any allergies to the study medications

          -  must not have any ocular or non ocular condition that investigator feels will
             interfere with study parameters

          -  must not have used immunotherapy in the last 2 years

          -  must not have used an investigational drug or device in the past 30 days or
             concurrently enrolled in another investigational trial
Extension Study for Patients Who Have Participated in a BMN 701 Study
Condition: Pompe Disease
MeSH terms: Glycogen Storage Disease Type II
Intervention: BMN 701
Intervention description: GILT-tagged recombinant human GAA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion
      every 2 weeks (qow) to patients with late-onset Pompe disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed a prior BMN 701 clinical development study;

          -  Have provided written informed consent after the nature of the study has been
             explained prior to performance of any study-related procedures. Minors may participate
             as long as they provide written assent after the nature of the study has been
             explained to them and after their parent, or legal guardian has provided written
             informed consent, prior to the performance of any study-related procedures;

          -  Have been diagnosed with late-onset Pompe Disease, based on the entry criteria of a
             prior BMN 701 study;

          -  If sexually active, be willing to use 2 known effective methods of contraception from
             Screening until 4 months after the last dose of study-drug;

          -  If female, and not considered to be of childbearing potential, be at least 2 years
             post-menopausal, or have had tubal ligation at least 1 year prior to screening, or
             have had a total hysterectomy;

          -  If female, and of childbearing potential, have a negative pregnancy test during the
             Screening Period and at the Baseline visit, and be willing to have additional
             pregnancy tests during the study;

          -  Have the ability to comply with the protocol requirements, in the opinion of the
             Investigator.

        Exclusion Criteria:

          -  Have received any experimental or approved therapy for Pompe disease, other than BMN
             701, subsequent to completion of a BMN 701 study and prior to entry into POM-002;

          -  Have received, or are anticipated to receive, any investigational medication, other
             than BMN 701, within 30 days prior to the first dose of study-drug;

          -  Are breastfeeding at screening or planning to become pregnant (self or partner) at any
             time during the study;

          -  Have a medical condition or extenuating circumstance that, in the opinion of the
             Investigator, might compromise the patient's ability to comply with the protocol
             requirements or compromise the patient's well being or safety.
Fexofenadine Use in Gastroesophageal Reflux Symptoms
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Fexofenadine; Placebo - Cap
Intervention description: Fexofenadine 180 mg in the morning; Placebo cap in the morning
Intervention MeSH terms: Fexofenadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The investigators wish to study the effectiveness of Fexofenadine (an over the counter
      allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still
      have symptoms despite being on a proton pump inhibitor. The investigators will do this by
      giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill)
      for 2 weeks. The participants will not know which drug they are getting at a particular time.
      This will help the investigators better assess the true effectiveness of Fexofenadine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A minimum 6-month history of heartburn and regurgitation, as their main symptom

          -  Experience at least 3-4 days with episodes of heartburn or regurgitation per week

          -  Female patients who are postmenopausal or using acceptable methods of birth control.

        Exclusion Criteria (selected)

          -  Esophageal stricture

          -  Primary esophageal motility disorder

          -  Systemic sclerosis

          -  Active inflammatory bowel disease

          -  Zollinger-Ellison syndrome

          -  Active gastric or duodenal ulcer

          -  Active infectious or inflammatory conditions of the small or large intestine

          -  Malabsorption syndromes of the intestine

          -  History of gastrointestinal cancer

          -  Current active cancer

          -  Prior gastric or intestinal surgery

          -  Pregnant or breast feeding

          -  Other serious psychiatric or medical disease
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: BMS-986165; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will investigate BMS-986165 to assess its effects in participants with systemic
      lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening
             visit

          -  Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification
             criteria for SLE

          -  One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti-
             double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate
             results) or positive anti-Smith (anti-Sm) as determined by the central laboratory

          -  Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6
             points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash
             [score must be confirmed by Central Review Services (CRS)]

          -  Men and women must agree to follow specific methods of contraception, if applicable

        Exclusion Criteria:

          -  Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus
             nephritis

          -  SLE overlap syndromes such as scleroderma and mixed connective tissue disease

          -  Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)

          -  History of any significant drug allergy

        Other protocol defined inclusion/exclusion criteria apply
Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Condition: Alcohol Reactivity
MeSH terms: Alcoholism
Intervention: varenicline; placebo
Intervention description: 1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.; placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: alcohol; reactivity; smoking cessation medications

Summary:

      The purpose of this study is the examine the effect of varenicline on cognition to a high
      dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of
      the blood alcohol curve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 years old or older

          -  Able to read and write in English

          -  Smokers and nonsmokers

          -  Meet criteria for alcohol use disorders

          -  Currently enrolled in NCT00580645

        Exclusion Criteria:

          -  Any significant current medical or psychiatric conditions that would contraindicate
             the consumption of alcohol

          -  Significant hepatocellular injury

          -  Positive test results at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal, or evidence of severe mental illness

          -  Prescription of any psychotropic drug in the 30 days prior to study enrollment

          -  Blood donation within the past 8 weeks

          -  Individuals who are seeking treatment for drinking or smoking or who have attempted to
             quit drinking or smoking within the past 3 months

          -  Known allergy to varenicline or taking H2blockers

          -  Participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current protocol

          -  Subjects likely to exhibit clinically significant alcohol withdrawal during the study
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Condition: Dementia With Lewy Bodies; REM Sleep Behavior Disorder; Parkinson's Disease Dementia
MeSH terms: Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease; REM Sleep Behavior Disorder; Mental Disorders
Intervention: Nelotanserin; Placebo
Intervention description: once daily, oral, 20-mg tablets; once daily, oral, matching tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Dementia with Lewy bodies; Lewy bodies; REM sleep behavior disorder; Parkinson's disease dementia

Summary:

      This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of
      Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy
      bodies (DLB) or Parkinson's disease dementia (PDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based
             on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)
             diagnostic criteria

          -  Presence of frequent REM sleep behavior episodes

          -  Mini Mental State Examination score ≥ 18

        Exclusion Criteria:

          -  Subjects have a current diagnosis of significant psychotic disorders including, but
             not limited to, schizophrenia or bipolar disorder

          -  Subjects' RBD symptoms are secondary to or better accounted for by another medical
             condition, psychiatric disorder, or substance abuse

          -  Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid,
             gastrointestinal, renal, hematologic or other medical disorder
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate (containing 300 mg T)
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Primary hypogonadism; Secondary hypogonadism

Summary:

      The purpose of the study is to determine the effect of food with various amounts of fat on
      the absorption of an oral testosterone undecanoate formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male

          -  Age 18-65

          -  Morning serum testosterone (T) <300 ng/dL on two occasions

        Exclusion Criteria:

          -  Significant intercurrent disease

          -  Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history
             of prostate cancer.

          -  Serum transaminases >2 times upper limit of normal

          -  Serum bilirubin >2.0 mg/dL

          -  Hematocrit <35% or >50%

          -  BMI >36

          -  Untreated, obstructive sleep apnea.
Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Metformin
Intervention description: 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Breast Cancer; Metformin

Summary:

      The purpose of this pilot study is to use a pre surgical intervention model to evaluate the
      biologic effects of metformin in women with newly diagnosed early invasive breast cancer.
      Metformin is a drug commonly used to treat patients with diabetes. This model will be used to
      evaluate the effects of metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ
             (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks
             after enrollment

          -  Body mass index > 25

          -  Age ≥ 21 years

          -  No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry

          -  Signed informed consent

        Exclusion Criteria:

          -  History of diabetes mellitus requiring medical therapy

          -  Treatment with other investigational drugs within 6 months of study entry

          -  Significant renal impairment with a creatinine > 1.4 mg/dl

          -  Other serious intercurrent medical illness
Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM/IVA; Placebo
Intervention description: LUM 400 mg/IVA 250 mg every 12 hours (q12h); No Active Drug
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study
      that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who
      have at least one A455E mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with confirmed diagnosis of CF

          -  All subjects must have an A455E mutation on at least 1 CFTR allele; no more than 10
             subjects may have an F508del mutation on 1 CFTR allele.

          -  Forced expiratory volume in one second (FEV1) ≥30% of predicted and ≤90% of predicted
             at the Screening Visit, based on the Global Lung Function Initiative (GLI)-2012 multi
             ethnic all-age reference equations.

          -  Stable CF disease as judged by the investigator.

          -  Willing to remain on a stable medication regimen for CF from 4 weeks before Day 1
             through the Follow up Visit.

        Exclusion Criteria:

          -  History of any comorbidity reviewed at the Screening Visit that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject.

          -  A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation
             on at least one CFTR allele.

          -  Pregnant or breastfeeding.

          -  Any abnormal laboratory values at the Screening Visit.

          -  History of cataract/lens opacity, or evidence of cataract/lens opacity determined to
             be clinically significant by the ophthalmologist or optometrist during the
             ophthalmologic examination at the Screening Visit.

          -  Use of strong inhibitors or strong inducers of CYP3A, including consumption of certain
             herbal medications and certain fruit and fruit juices, within 14 days before Day 1

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements
Vision Response to Dopamine Replacement
Condition: Albinism; Oculocutaneous Albinism
MeSH terms: Albinism; Albinism, Oculocutaneous
Intervention: Levodopa/carbidopa
Intervention description: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
Intervention MeSH terms: Levodopa; Carbidopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No
Keywords: levodopa; Albinism; dopamine; oculocutaneous albinism; vision; retina function

Summary:

      The purpose of the study is to evaluate and document physiologic and functional changes in
      visual performance and retinal function of patients diagnosed with albinism (a dopamine
      deficiency state) following a trial of oral Levodopa/carbidopa treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of oculocutaneous albinism

          -  age over 3 and weight over 25 lbs.

        Exclusion Criteria:

          -  ocular only albinism

          -  ocular pathology other than albinism

          -  neurologic disease, history of myocardial infarction, history of clinical depression,
             pregnancy