bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Condition: Non Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
Intervention: Tropifexor; Licogliflozin; Placebo
Intervention description: 100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day; 30mg tablet of licoglifozin taken orally every day; licogliflozin placebo + tropifexor placebo
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NASH; Non alcoholic steatohepatitis; Tropifexor; LJN452; Licogliflozin; LIK066; Placebo

Summary:

      Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and
      tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy,
      compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis
      (NASH) and liver fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy
        obtained no more than 6 months before randomization as demonstrated by the following:

          1. NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation
             and ballooning and

          2. Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at
             screening

          -  HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or
             sulfonylureas

          -  Clinical evidence of liver impairment as defined by the presence of any of the
             following abnormalities:

               -  Platelet count < LLN (see Central laboratory manual).

               -  Serum albumin < LLN (see Central laboratory manual).

               -  International Normalized Ratio (INR) > ULN (see Central laboratory manual).

               -  ALT or AST > 5× ULN (confirmed by 2 values during screening).

               -  Total bilirubin > ULN (see Central laboratory manual) (confirmed by 2 values
                  during screening), including Gilbert's syndrome.

               -  Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening).

               -  History of esophageal varices, ascites or hepatic encephalopathy

               -  Splenomegaly

               -  MELD score >12
Trial of Sertraline to Treat Children With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: Sertraline; Placebo
Intervention description: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.; The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 24 Months
Maximum age: 68 Months
Healthy volunteers: No
Keywords: Fragile X Syndrome; Pediatrics; sertraline; autism

Summary:

      This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2
      years to 5 years 8 months old. The trial is six months long, and each participant will
      receive a series of tests at both the beginning and end of the study. The researchers hope to
      show improvements in language and a decrease in autistic symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fragile X Syndrome

        Exclusion Criteria:

          -  Current or past SSRI treatment

          -  Current or past MAOI (monoamine oxidase inhibitor ) treatment

          -  Serious co-morbid medical disorder affecting brain function and behavior (not
             including fragile X syndrome).

          -  Uncontrolled seizure disorder or epilepsy

          -  Bipolar disorder

          -  Latex allergies
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Clazakizumab; Placebo (Matching with Clazakizumab)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to identify an appropriate dose of study medication.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American
             Rheumatism association (ARA) [1987] or American College of Rheumatology/European
             League Against Rheumatism (ACR/EULAR) [2010]) at least 16 weeks prior to screening

          -  ACR global functional status class of 1 to 3

          -  Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors

          -  All subjects must have been receiving treatment with a minimum dose of 15 mg per week
             of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to
             screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be
             reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per
             week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is
             permitted, if it is at a dose approved for the treatment of RA and the dose has been
             stable for at least 28 days prior to screening

          -  Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at
             baseline (Day 1)

          -  Elevated High-sensitivity (hs) CRP and/or ESR

        Exclusion Criteria:

          -  Active serious infection

          -  History of or active tuberculosis (TB)

          -  Elevated liver function tests (LFTs)
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Intervention: THN102 Dosage A; THN102 Dosage B; THN102 Dosage C
Intervention description: THN102 Dosages A: placebo; THN102 Dosage B : 200mg/2mg; THN102 Dosage C: 200mg/18mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Complete 3 way-Crossover
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose
      levels of THN102 to placebo in patients suffering from Parkinson's disease associated with
      excessive daytime sleepiness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement
             Disorders Society (MDS).

          -  Subjects with Hoehn and Yahr scale score ≤ 4.

          -  Body mass index > 18 kg/m2 and < 35 kg/m2.

          -  Subjects should have a complaint of daytime sleepiness impacting their quality of life
             and/or daytime functioning (e.g. falling asleep while reading or watching television,
             while eating or talking with other people).

          -  Epworth Sleepiness Scale (ESS) score ≥ 14.

        Exclusion Criteria:

          -  Subjects with known or with a suspected sleep apnea syndrome or who have any other
             cause of excessive daytime sleepiness, such as shift work sleep disorder.

          -  Psychiatric and neurological disorders (other than Parkinson's disease),

          -  Cardiovascular disorders such as - but not limited to

          -  Uncontrolled moderate to severe hypertension

          -  History or current diagnosis of electrocardiogram (ECG) abnormalities indicating
             significant risk of safety for patients participating in the study

          -  Recent myocardial infarction

          -  Stable or unstable angina pectoris

          -  Cardiac insufficiency or history of heart failure

          -  Previous history of cardiac valvular surgery

          -  Subjects with current impulse control disorder.

          -  Subjects showing dementia or with MoCA < 23.

          -  Subjects with current suicidal risk

          -  Current or recent (within one year) history of substance abuse or dependence disorder

          -  Other active clinically significant illness

          -  Subjects with hepatic or renal impairment
Allopregnanolone for the Treatment of Traumatic Brain Injury
Condition: Traumatic Brain Injury; Posttraumatic Epilepsy
MeSH terms: Brain Injuries; Epilepsy; Brain Injuries, Traumatic; Epilepsy, Post-Traumatic; Wounds and Injuries
Intervention: Allopregnanolone injection; Placebo injection
Intervention description: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium; Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
Intervention MeSH terms: Pregnanolone; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Brain Injuries; Pregnanolone; Epilepsy

Summary:

      This study will provide initial data on the safety and effectiveness of allopregnanolone in
      improving neurobehavioral outcome and reducing mortality in adults with moderate and severe
      traumatic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaking person

          -  Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow
             Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12]

          -  Less than 8 hours from injury to study initiation

          -  Able to participate for the full term of the study

        Exclusion Criteria:

          -  Subjects with life expectancy of less than 24 hours

          -  Isolated epidural hematoma

          -  Hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment)

          -  Hypotension (systolic blood pressure ≤90 mm Hg on 2 or more reliable measurements
             before enrollment)

          -  Cardiopulmonary arrest prior to randomization

          -  Spinal cord injury with motor deficits

          -  Bilateral non-reactive pupils with Glasgow Coma Scale 3

          -  Body weight >120 kg

          -  Pregnancy

          -  Active breast or reproductive organ cancer

          -  Allergy to progesterone

          -  History of thromboembolic events

          -  Receipt of activated Factor VII before enrollment

          -  Any disease that is unstable or which could jeopardize the safety of the subject
             including severe renal impairment (creatinine clearance <50 ml/min)

          -  Prisoner/ward of the state

          -  Known treatment with another investigational drug therapy or procedure within 30 days
             of injury
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment
Condition: Hazardous Drinking; Cigarette Smoking
Intervention: Naltrexone; Placebo
Intervention description: Daily 50 mg naltrexone; Matched naltrexone placebo
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking
      cessation outcomes in heavy drinkers seeking smoking cessation treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1.) be at least 18 years of age, 2.) drink heavily at least once per month on average
             (≥4 drinks per occasion for women; ≥5 drinks for men), 3.) have smoked cigarettes
             regularly for at least one year, 4.) currently smoke at least 5 cigarettes a day, 5.)
             currently be using no other tobacco products or nicotine replacement therapy

        Exclusion Criteria:

          -  1.) meet criteria for current substance dependence (excluding nicotine and alcohol);
             2.) report opiate use in the past month, have a drug screen positive for opiates, or
             require opiate containing medications for pain management; 3.) meet criteria for a
             current major depressive or manic episode; 4.) are currently psychotic or suicidal;
             5.) have an unstable or serious medical condition that would preclude use of the
             nicotine patch or naltrexone (e.g., unstable angina pectoris, severe arrhythmia,
             recent congestive heart failure); 6.) have aspartate aminotransferase or alanine
             aminotransferase levels of more than 3 times the reference range or elevated bilirubin
             levels; or 7.) are currently pregnant or lactating, intend to become pregnant, or are
             not using a reliable means of birth control.
Vortioxetine for Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: Vortioxetine; Placebo
Intervention description: Medication currently approved for major depression.
Intervention MeSH terms: Vortioxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of the present study is to examine the efficacy and safety of vortioxetine vs placebo
      in adults with moderate to severe Binge eating disorder, as indicated by at least 3 binge
      eating days per week for the 2 weeks before the baseline visit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women age 18-65;

          2. Primary diagnosis of Binge eating disorder;

          3. At least 3 binge eating days per week for the 2 weeks before the baseline visit;

          4. Ability to understand and sign the consent form.

        Exclusion Criteria:

          1. Unstable medical illness based on history or clinically significant abnormalities on
             baseline physical examination (history of medical illness which is currently stable is
             allowed such as diabetes well controlled, treated hypothyroidism, hypertension, etc)

          2. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity
             rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

          4. Past 12-month DSM-5 major psychiatric disorder (psychotic disorder, bipolar disorder,
             major depressive disorder)

          5. Past 6-month alcohol or substance use disorders

          6. Illegal substance use based on urine toxicology screening

          7. Initiation of psychological or weight-loss interventions within 3 months of screening

          8. Use of any other prescription psychotropic medication (except an as needed hypnotic or
             as needed benzodiazepine)

          9. Previous treatment with Vortioxetine

         10. Currently taking over the counter weight loss medications. If willing to stop these
             medications, the participant will not be excluded based on this criterion.

        10) Cognitive impairment that interferes with the capacity to understand and
        self-administer medication or provide written informed consent
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: LCI699; Eplerenone; LCI699-matching Placebo; Eplerenone-matching Placebo
Intervention description: LCI699 oral capsules; Eplerenone oral capsules; LCI699-matching placebo oral capsules; Eplerenone-matching placebo oral capsules
Intervention MeSH terms: Eplerenone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Blood Pressure; Hypertension; Resistant Hypertension

Summary:

      This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to
      placebo and eplerenone in participants with resistant hypertension.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140
             millimeters of mercury (mmHg) and <180 mmHg

          -  Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the
             treatment of resistant hypertension

          -  Male and female participants 18 to 75 years of age

        Exclusion criteria:

          -  Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary
             artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,
             cerebrovascular accident, or transient ischemic attack

          -  Clinically significant electrocardiography (ECG) findings related to cardiac
             conduction defects

          -  Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] >9%)

          -  Malignancies within the last 5 years (excluding basal cell skin cancer)

        Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF; RBV
Intervention description: SOF administered orally once daily; RBV oral solution or capsules will be administered orally in a divided daily dose based on weight
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will have two parts as follows:

      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and
      confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric
      participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days
      of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.

      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF
      dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the
      Treatment Phase with no interruption of study drug administration. The Treatment Phase will
      evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in
      pediatric participants with genotype 2 or 3 HCV infection, respectively.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Consent of parent or legal guardian required

          -  Chronic HCV infection genotype 2 or 3

          -  Screening laboratory values within defined thresholds

          -  PK Lead-in only: all individuals must be treatment naive

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus

          -  Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)

          -  Pregnant or nursing females

          -  Known hypersensitivity to study medication

          -  Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of LL-BMT1 in Patients With Elevated Intraocular Pressure
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: LL-BMT1
Intervention description: Drug-printed contact lens in both eyes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, non-comparative
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Prostaglandin; Intraocular pressure

Summary:

      This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle
      glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single
      dose of LL-BMT1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age at the Screening Visit

          -  Diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes

          -  At least one eye (called the study eye) must have an untreated intraocular pressure
             between 22 mmHg and 34 mmHg (inclusive) as measured at 9 am during the Baseline Visit.

          -  Best corrected visual acuity of Early Treatment Diabetic Retinopathy Study of 50
             letters or better

        Exclusion Criteria:

          -  Glaucoma or optic neuropathy due to anything other than above noted reasons
             Cup-to-disc ratio of >0.8 in either eye

          -  Corneal thickness <480 or >620 μm