bioihbjkbjnl/mcl2 huggingface dataset:
Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
Condition: Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Intervention: ondansetron; placebo ondansetron; Ondansetron
Intervention description: ondansetron 0.2 mg bid, oral preparation, 16 weeks; Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.; Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Intervention MeSH terms: Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous
      drinking, HIV-infected men and women, using the serotonin receptor (5-HT3) antagonist
      ondansetron. The investigators predict that participants who are treated with active doses of
      ondansetron will reduce their drinking more and show better HIV treatment participation and
      progress compared to participants who are treated with placebo. This study will provide
      important new safety and efficacy results on drinking and HIV outcomes following alcohol
      pharmacotherapy in HIV-infected persons.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be at least 18 years old and HIV-infected

          -  All subjects will be actively drinking at hazardous levels (1) AUDIT score => 4 for
             women or =>8 for men, or 2) => 2 binge drinking episodes/month, or 3) >7 drinks/week
             for women or >14 drinks/week for men)

        Exclusion Criteria:

          -  Liver Function Tests (LFTs) > 5 X normal

          -  Magnesium or potassium > 3 X normal

          -  Qtc => .460 and or a family history of long QT syndrome (LQT)

          -  Inability to read and comprehend English

          -  Actively psychotic or other severe mental health symptoms that would prevent
             appropriate participation

          -  Current enrollment in alcoholism treatment program

          -  Pregnancy; Ondansetron is currently a category B drug. While animal data have not
             identified any harmful effects to mother or fetus, there have not been adequate human
             controlled trials to recommend routine use in this population
Canakinumab in Patients With Active Hyper-IgD Syndrome
Condition: Mevalonate Kinase Deficiency
MeSH terms: Mevalonate Kinase Deficiency
Intervention: Canakinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 24 Months
Healthy volunteers: No
Keywords: Hyper IgD syndrome; canakinumab; HIDS; mevalonate kinase deficiency; MKD

Summary:

      This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics
      (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a diagnosis of HIDS proven by DNA analysis and/or enzymatic studies.

          2. At time of start of drug treatment: active HIDS as evidenced by a physician global
             assessment of HIDS flare severity ≥ 2 and CRP values >10 mg/L (normal CRP < or = 10
             mg/L).

          3. Patients who have a history of > or = 3 febrile acute HIDS flares in a 6-month period
             when not receiving prophylaxis treatment (e.g. anakinra daily treatment) with a
             duration of each flare lasting > or = 4 days and limiting the normal daily activities.

        Exclusion Criteria:

          1. Pregnant or nursing (lactating) women.

          2. History of being immunocompromised, including a positive HIV at screening (ELISA and
             Western blot) test result.

          3. Positive Hepatitis B or Hepatitis C.

          4. Live vaccinations within 3 months prior to the start of the trial

          5. Positive tuberculosis screening test.

        Other protocol-defined inclusion/exclusion criteria may apply
IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
Condition: Von Willebrand Disease
MeSH terms: Menorrhagia; Von Willebrand Diseases
Intervention: Oprelvekin, Interleukin 11, IL-11
Intervention description: 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
Intervention MeSH terms: Oprelvekin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: IL-11; von Willebrand disease; von Willebrand factor; VWFmRNA; menorrhagia

Summary:

      The purpose of this study is to determine the efficacy and safety of rhIL-11, when given
      subcutaneously for six consecutive months, in reducing menstrual blood loss in women with
      type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by
      subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by
      the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias,
      fluid retention, or edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females 18-45 years of age

          -  Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
             normal VWF multimers

          -  Menorrhagia refractory to estrogens, hormones, hemostatic agents

          -  Willingness to have blood drawn

        Exclusion Criteria:

          -  Use of immunomodulatory or experimental drugs, or diuretics

          -  Pregnant or lactating women or those unwilling to use contraception during study

          -  Previous cardiac disease, congestive failure, arrhythmia (e.g., atrial fibrillation,
             atrial flutter), hypertension, MI, stroke, or thrombosis

          -  Past allergic reaction to Neumega or DDAVP

          -  Surgery within the past 8 weeks

          -  Inability to comply with study protocol requirements

          -  Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs

          -  Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
             containing substantial quantities of FVIII and/or VWF within five days of study
An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
Condition: Cardiac Failure; Myocardial Failure; Congestive Heart Failure; Heart Decompensation
MeSH terms: Heart Failure
Intervention: BMS-986231; Furosemide; Placebo
Intervention description: Intravenous administration; Intravenous administration; Intravenous administration
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in
      participants with heart failure and weakened heart function given a standard dose of
      diuretic.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Left ventricular ejection fraction <45%, as assessed by echocardiography, a multigated
             acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan within 18 months

          -  On stable chronic guideline-directed therapy for HF including chronic loop diuretics,
             ACEi, ARBs, MRAs, ARNI or / and β-blockers as tolerated, with no changes of these
             medications in the past 2 weeks

          -  At least an oral dose of 40 mg of furosemide/day or equivalent (20 mg torsemide, 1 mg
             bumetamide)

        Exclusion Criteria:

          -  SBP < 115 mm Hg or > 180 mm Hg at screening or pre-randomization

          -  Heart rate < 50 beats per minute (bpm) or > 120 bpm at screening or pre-randomization

          -  Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy,
             idiopathic hypertrophic or uncorrected severe valvular disease

        Other protocol defined inclusion/exclusion criteria could apply
Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543; CTP-543 matching placebo
Intervention description: Administered as tablets.; Administered as tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with
      chronic, moderate to severe alopecia areata.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definitive diagnosis of alopecia areata with a current episode lasting at least 6
             months and not exceeding 10 years at the time of Screening. Total disease duration
             greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

          -  Clinical lab results within the normal range

        Exclusion Criteria:

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or untreated actinic
             keratosis on the scalp.

          -  Treatment with systemic immunosuppressive medications or biologics.

          -  Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening
             or during the study
A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: Placebo Cream; Ruxolitinib Phosphate Cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hair loss; alopecia areata; alopecia totalis; alopecia universalis; JAK inhibitors; topical hair growth

Summary:

      A phase 2 study to find out if the drug ruxolitinib Phosphate Cream is safe and has
      beneficial effects in people who have alopecia areata (partial or complete hair loss) when
      applied to the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AA

          -  Duration and extent of current episode of AA

          -  Evidence of active hair loss

        Exclusion Criteria:

          -  Evidence of diffuse, spontaneous terminal hair regrowth

          -  Receipt of treatment known to potentially affect the course of AA within last month
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: diazepam nasal spray
Intervention MeSH terms: Diazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cluster Seizures; Seizures; Clusters; Acute repetitive seizures

Summary:

      This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray
      in adolescents and adults with cluster seizures, with a focus on potential local effects
      (changes in nasal mucosa, olfaction, and taste).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of drug-resistant epilepsy

          -  Patients who experience multiple episodes of acute repetitive seizures requiring at
             least one concomitant antiepileptic drug (AED)

          -  Occurrence of at least 3 seizure clusters within the past 12 months, including at
             least one cluster in the 4 months prior to the Screening Visit

          -  A caregiver must consent to participate together with the subject for purposes of
             observation and data collection

          -  The caregiver must be present when the investigational product is administered

          -  Screening body weight between 26 to 111 kg, inclusive

        Exclusion Criteria:

          -  Female subject who is pregnant, breastfeeding, or planning to become pregnant

          -  Presence or history of any abnormality or illness that may affect the absorption,
             distribution, metabolism or elimination of diazepam

          -  Known allergy or hypersensitivity to diazepam, related drugs, or any of the
             formulation components

          -  Positive screening test for ethanol or other drugs of abuse

          -  Unable to receive medications intranasally
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: SB218352_15; SB218352_8; SB218352_4; SB218352_2; SB218352_8AL; SB218352_4AL; SB218352_2AL
Intervention description: Non-adjuvanted pandemic influenza A formulation 1 vaccine; Non-adjuvanted pandemic influenza A formulation 2 vaccine; Non-adjuvanted pandemic influenza A formulation 3 vaccine; Non-adjuvanted pandemic influenza A formulation 4 vaccine; Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine; Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine; Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 385.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: prophylaxis of pandemic influenza

Summary:

      Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which
      most of the population lacks immunity. If such virus is pathogenic to human and demonstrates
      the ability to transmit from person to person, the result is a global outbreak of disease
      that affects a high percentage of individuals in a short period of time and is likely to
      cause substantially increased mortality and morbidity in all countries of the world.
      Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have
      been directly transmitted to humans, raising concern over the possibility of a new influenza
      pandemic among the world's immunologically naive populations. In order to face this kind of
      situation, a pandemic influenza vaccine has to be developed.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol

          -  A male or female aged over 60 years at the time of vaccination.

          -  Written informed consent obtained from the subject.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the administration of the study vaccine, or
             planned use during the study period.

          -  Participation in an earlier study with a candidate pandemic H9N2 vaccine.

          -  Acute disease at the time of enrolment.

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Drug and/or alcohol dependency.
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: ASC-J9 cream; placebo
Intervention description: Topical application to the face twice daily for 12 weeks.; vehicle control applied topically twice daily for 12 weeks
Intervention MeSH terms: Androgens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 186.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: acne

Summary:

      The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating
      acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 12 years of age.

          -  Facial acne, with:

             20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more
             than 2 nodules/cysts on the face

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Skin diseases other than acne vulgaris

          -  Use of oral retinoids within 6 months of Baseline Visit

          -  Unwilling to discontinue all other treatments for facial acne

          -  Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
Condition: NAFLD; NASH
MeSH terms: Non-alcoholic Fatty Liver Disease
Intervention: Elobixibat; Placebo oral tablet
Intervention description: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).; Placebo identical in appearance to active drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Randomized, Placebo-Controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of
      elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or
      NASH (nonalcoholic steatohepatitis)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a current biopsy-confirmed NASH within 6 months of screening or a suspected
             diagnosis of NAFLD/NASH

          -  Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10%
             liver steatosis

          -  Fasting serum low density lipoprotein-cholesterol (LDL-C) >130 mg/dL at Screening,
             >110 mg/dL on lipid-lowering medications

        Key Exclusion Criteria:

          -  Body mass index (BMI) <25 kg/m2

          -  Fibrosis-4 index (Fib-4) >2.6

          -  Any of the following laboratory abnormalities:

               1. alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate
                  aminotransferase (AST) >5 × ULN

               2. International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy

               3. Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome

               4. Platelet count less than the lower limit of normal (LLN)

               5. Creatinine clearance as calculated by the modification of diet in renal disease
                  (MDRD) estimated glomerular filtration rate (eGFR) equation <60 mL/min

          -  Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >9.5%

          -  Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to
             thyroid dysfunction.

          -  Uncontrolled hypertension

          -  Participants with known intolerance to MRI or with conditions contraindicated for MRI
             procedures
Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
Condition: Pulmonary Hypertension; Sickle Cell Disease; Thalassemia
MeSH terms: Hypertension, Pulmonary; Hypertension; Anemia, Sickle Cell; Thalassemia; Hemolysis
Intervention: L-Glutamine
Intervention description: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pulmonary Hypertension; Sickle Cell Disease; Thalassemia

Summary:

      The primary hypothesis of this study is that glutamine supplementation will improve the
      erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and
      pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with
      PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography >
      2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and
      subsequently alter sickle red cell endothelial interaction that can be identified using
      endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological
      markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will
      decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced
      arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine
      bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD
      and Thal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of SCD (Hb SS, SC or SBeta- thalassemia) or Thal

          -  PH documented by echocardiography, defined as at TRV greater than 2.5 m/s

          -  Age greater than or equal to 4 years

        Exclusion Criteria:

          -  Inability to take or tolerate oral medication

          -  Acute crisis or hospitalization within 1 month of enrollment

          -  Hepatic dysfunction (SGPT greater than 3X normal)

          -  Renal dysfunction (Creatinine greater than 2X normal)

          -  Allergy to glutamine

          -  Pregnancy or breastfeeding

          -  Patients on sildenafil (Viagra), calcium channel blockers, or amino acid/protein
             supplements (other therapies acceptable if stable more than 3 months)