bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine; Placebo
Intervention description: Cariprazine capsules, oral administration, once daily.; Matching placebo capsules, oral administration, once daily.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 587.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per
           day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia

        2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared
           with placebo in prevention of relapse in patients with schizophrenia who were initially
           stabilized on a target dose of 4.5 mg/d
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).

          -  Ability to follow study instructions, complete study assessment tools with minimal
             assistance and no alteration to the assessment tools, and likely to complete all
             required visits.

          -  Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
             (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for
             DSM-5 (SCID-5).

          -  Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1
             and Visit 2 (Day 1).

          -  Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive
             symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour;
             P6: suspiciousness/persecution at Visit 1 and Visit 2.

        Exclusion Criteria:

          -  Currently meeting DSM-5 criteria for any of the following:

          -  Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

          -  Bipolar I and II disorder

          -  Autism spectrum disorder, intellectual development disorder, delirium, major/minor
             neurocognitive disorder

          -  History of meeting DSM-5 criteria for substance-related disorders (excluding
             caffeine-related and tobacco-related disorders) within the prior 3 months before Visit
             1.

          -  Prior participation in any clinical trials involving experimental or investigational
             drugs within 6 months before Visit 1 or planned during the study.

          -  Female Participants who are pregnant, planning to become pregnant during the course of
             the study, or are currently lactating.
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Refresh Optive® Gel Drops; REFRESH LIQUIGEL®
Intervention description: Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.; REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Intervention MeSH terms: Carboxymethylcellulose Sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients
      with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current use of an artificial tear product

          -  Visual acuity of at least 20/32 (while wearing glasses, if necessary).

        Exclusion Criteria:

          -  Use of contact lenses in the last 3 months, or anticipated use of contact lenses
             during the study

          -  Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive
             keratectomy, within the last 6 months

          -  Current eye infection or inflammation
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Condition: Rosacea
MeSH terms: Rosacea; Erythema
Intervention: CD07805/47 Gel; Placebo
Intervention description: applied topically once daily; applied topically once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rosacea

Summary:

      This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial
      erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied
      topically once daily is more efficacious than vehicle and provides an acceptable safety
      profile in the treatment of facial erythema associated with rosacea.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female who is at least 18 years of age or older.

          2. A clinical diagnosis of facial rosacea.

          3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
             and at Baseline/Day 1 (prior to the study drug application).

          4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and
             at Baseline/Day 1 (prior to the study drug application).

        Key Exclusion Criteria:

          1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
             rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
             that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
             keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
             telangiectasia.

          2. Presence of three (3) or more facial inflammatory lesions of rosacea.

          3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
             sedatives, systemic anesthetics, or alpha agonists.

          4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac
             glycosides, beta blockers or other antihypertensive agents.

          5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
             or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Intervention: SOF; RBV
Intervention description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action; HCV genotype 4 (GT-4); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; Ribavirin; Open Label; Sofosbuvir; Additional relevant MeSH terms:; Hepatitis; Hepatitis, Chronic; Hepatitis C; Hepatitis C, Chronic

Summary:

      This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus
      ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment experienced and naïve subjects

          -  Chronic genotype 4 HCV-infection

          -  Not co-infected with HIV

          -  Screening laboratory values within defined thresholds

          -  Use of highly effective contraception methods

          -  Subject must be able to comply with the dosing instructions for study drug
             administration and able to complete the study schedule of assessments.

        Exclusion Criteria:

          -  History of any other clinically significant chronic liver disease

          -  Pregnant or nursing female or male with pregnant female partner

          -  History of clinically-significant illness or any other major medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Excessive alcohol ingestion or significant drug abuse
A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium; Comparator: placebo; hydrochlorothiazide (HCTZ)
Intervention description: losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks; placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks; open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the magnitude and durations of the antihypertensive
      effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the
      safety of losartan 50 and 100 mg doses compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-black men and women with mild to moderate hypertension and within 30% of their
             ideal body weight

          -  Patient is in good general health

          -  Blood pressure at time of randomization is 95-115 mm Hg

        Exclusion Criteria:

          -  Secondary Hypertension or history of malignant hypertension

          -  History of stroke

          -  History of myocardial infarction

          -  Atrial flutter or atrial fibrillation

          -  History of congestive Heart failure

          -  Patient taking major psychotropic agent or anti-depressant

          -  Patient regularly uses NSAIDS or high dose aspirin

          -  Known positive test for HIV/AIDS or Hepatitis B

          -  Patient is being treated for acute ulcer disease

          -  Prior exposure to losartan

          -  Actively treated diabetes mellitus

          -  History of chronic liver disease

          -  Actively treated diabetes mellitus

          -  Any known bleeding or platelet disorder

          -  Absence of one kidney

          -  Women of childbearing potential

          -  Alcoholism or drug addiction
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: TMC435; Placebo; Peginterferon alpha-2a (PegIFN alpha-2a); Ribavirin (RBV)
Intervention description: 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks; 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 48 weeks; One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.; 200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; TMC435; HCV; Hep C; Genotype 1

Summary:

      The purpose of this study is to investigate the effectiveness and safety of TMC435 compared
      with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed
      after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and
      ribavirin as part of their treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1 hepatitis C infection (confirmed at screening)

          -  Have previously received peginterferon-based therapy for at least 24 weeks with
             documented HCV RNA at last measurement and relapsed within 1 year of last taking
             medication

          -  Liver biopsy within 3 years before screening (or between the screening and baseline
             visit) showing chronic hepatitis C infection

          -  Must agree to use 2 forms of effective contraception throughout study (both males and
             females)

        Exclusion Criteria:

          -  Infection with HIV or non-genotype 1 hepatitis C

          -  Liver disease not related to hepatitic C infection

          -  Hepatic decompensation

          -  Significant laboratory abnormalities or other active diseases

          -  Pregnant or planning to become pregnant
A Study of Degarelix in Taiwanese Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix
Intervention description: Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Male
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      A phase III trial investigating the efficacy and safety of degarelix one-month depot in
      Taiwanese patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 years or older

          -  Has a histological confirmed prostate cancer

          -  Has a screening serum testosterone above 1.5 ng/mL

          -  Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2

          -  Has a screening PSA value of ≥2 ng/mL

          -  Has a life expectancy of at least 168 days

        Exclusion Criteria:

          -  Current or previous hormone therapy

          -  Is currently treated with 5-α-reductase inhibitor

          -  Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria
             and/or angioedema

          -  Is considered to be a candidate for curative therapy, i.e radical prostatectomy or
             radiotherapy

          -  Has had cancer within the last five years except prostate cancer and surgically
             removed basal or squamous cell carcinoma of the skin.

          -  Has a clinically significant disorder (other than prostate cancer) or any other
             condition , including alcohol or drug abuse, which may interfere with trial
             participation or which may affect the conclusion of the trial as judged by the
             investigator

          -  Has received an investigational drug within the last 28 days preceding Screening Visit
             or longer if considered to possibly influence the outcome of the current trial
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: lurasidone; lurasidone; Placebo
Intervention description: lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day; lurasidone 20 mg/day for Days 1-7; Placebo Comparator
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 505.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar I, Depression

Summary:

      This clinical study is designed to test the hypothesis that lurasidone is effective,
      tolerable, and safe for the treatment of patients with bipolar I depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is diagnosed with bipolar I disorder, most resent episode depressed

          -  Subject must have a lifetime history of at least one bipolar manic or mixed episode

        Exclusion Criteria:

          -  History of nonresponse to an adequate (6-week) trial of three or more antidepressants
             (with or without mood stabilizers) during the current episode

          -  Subject has been hospitalized for a manic or mixed episode within 60 days prior to
             randomization

          -  Imminent risk of suicide or injury to self, others, or property
Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention description: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.; Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanoprost.
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 705.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-angle glaucoma; ocular hypertension

Summary:

      The purpose of the study is to compare two ophthalmic solutions in patients with open-angle
      glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older.

          -  Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as
             specified in protocol.

          -  Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.

          -  Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least
             one continuous month prior to Visit 1.

          -  Willing and able to discontinue use of any topical ocular medicine other than the
             study medication for the duration of the study, including artificial tears.

          -  Best corrected visual acuity of -0.6 logMAR or better in each eye.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Any medical condition (systemic or ophthalmic) that may preclude safe administration
             of the test article.

          -  Use of contact lenses within 30 days of Visit 1.

          -  Use of contact lenses during the study.

          -  Participation in an investigational drug or device study within 30 days of entering
             this study.

          -  Other protocol-defined exclusion criteria may apply.
Individualized Obesity Pharmacotherapy
Condition: Obesity
MeSH terms: Obesity
Intervention: Phentermine-Topiramate; Liraglutide; Naltrexone/bupropion; Phentermine
Intervention description: Extended Release at dose of 7.5/46 mg oral daily; dose of 3 mg subcutaneous daily; Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening); 15-37.5 mg oral daily
Intervention MeSH terms: Liraglutide; Topiramate; Phentermine; Naltrexone; Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pharmacological; Obesity Management; Individualized

Summary:

      The researchers are trying to identify the specific characteristics (phenotypes) that may be
      useful to help select the right medication for weight loss.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adults with obesity (BMI >30 Kg/m2); these will be otherwise healthy individuals with
             no unstable psychiatric disease and controlled comorbidities or other diseases.

          -  Gender: Men or women. Women of childbearing potential will have negative pregnancy
             tests within 48 hours of enrollment and before each radiation exposure.

        Exclusion criteria

          -  Abdominal bariatric surgery

          -  Positive history of chronic gastrointestinal diseases, or systemic disease that could
             affect gastrointestinal motility, or use of medications that may alter
             gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6
             months.

          -  Significant untreated psychiatric dysfunction based upon screening with the Hospital
             Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight
             Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by
             an anxiety or depression score >11 or difficulties with substance or eating disorders,
             the participant will be excluded and given a referral letter to his/her primary care
             doctor for further appraisal and follow-up.

          -  Hypersensitivity to any of the study medications.

          -  No contraindications to all FDA-approved medications