bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ER OROS paliperidone; Placebo; Olanzapine
Intervention description: Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.; Form= tablet, route= oral use. Two tablets once daily for 6 weeks.; Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.
Intervention MeSH terms: Olanzapine; Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Schizophrenia; JNS007ER; Positive and Negative Syndrome Scale (PANSS); Paliperidone; Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of Extended Release
      Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in
      patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have given their own consent in writing to participate in the study

          -  Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
             (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20,
             295.90, 295.60)

          -  Patients who have acute symptoms of schizophrenia

          -  Both inpatients and outpatients are acceptable

        Exclusion Criteria:

          -  A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease
             diagnosis other than schizophrenia

          -  A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and
             caffeine dependence) within 180 days before the screening test

          -  Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or
             >120

          -  Patients treated with three or more types of antipsychotic within 28 days before the
             screening test

          -  Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)

          -  Patients with a complication of or a past history of cerebrovascular accident

          -  Patients with a complication of or a past history of diabetes mellitus
Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Formoterol Turbuhaler® 4.5mg; Formoterol Turbuhaler® 9 mg; Turbuhaler® placebo
Intervention description: 4.5 mg inhaled twice daily; 9 mg inhaled twice daily; placebo inhaled twice daily
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 613.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD

Summary:

      The purpose of this study is to show the efficacy and safety of formoterol for the
      maintenance treatment of patients with COPD compared with placebo in patients in Japan and in
      European countries during 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged above 40 with a clinical diagnosis of COPD and current COPD
             symptoms

          -  Current or previous smoker with a smoking history of 10 or more pack years

          -  Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator
             FEV1 < 80% of predicted normal value

        Exclusion Criteria:

          -  History and/or current clinical diagnosis of asthma or atopic diseases such as
             allergic rhinitis

          -  Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2

          -  Any relevant cardiovascular disorder as judged by the investigator or any current
             respiratory tract disorder other than COPD.
Comparison of Cross-cylinder and Conventional Photorefractive Keratectomy(PRK) in Correcting Medium-high Astigmatism
Condition: Astigmatism
MeSH terms: Astigmatism
Intervention: photorefractive keratectomy (PRK)
Intervention description: comparison of PRK by cross-cylinder approach in one eye and conventional (single) method in the other eye for laser correction of astigmatism
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Excimer Laser; photorefractive keratectomy; astigmatism

Summary:

      The purpose of this study is to determine whether cross-cylinder approach is more effective
      than routine method in laser correction of astigmatism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >20 years of age

          -  refractive stability for at least one year

          -  regular and symmetric astigmatism of >1.5 diopters

        Exclusion Criteria:

          -  corneal thickness<470 microns

          -  keratoconus or suspected keratoconus

          -  active ocular disease and systemic collagen disease
A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
Condition: Osteoarthritis, Hip; Osteoarthritis, Knee; Lower Back Pain; Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Back Pain; Chronic Pain; Low Back Pain
Intervention: Oxycodone CR; Tapentadol (CG5503) ER
Intervention description: Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.; Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Pain; Low Back Pain; Hip Pain; Knee Pain; Backache; Tapentadol

Summary:

      The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at
      doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients
      with at least a 3-month history of low back pain, or pain caused by knee or hip
      osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference
             joint for at least 3 months or clinical diagnosis of low back pain of benign origin
             for at least 3 months

          -  Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal
             anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen

          -  Have a pain intensity >4 on Numerical Rating Scale

        Exclusion Criteria:

          -  Life-long history of seizure disorder or epilepsy

          -  Any of the following within one year: mild/moderate traumatic brain injury, stroke,
             transient ischemic attack, and brain neoplasm

          -  Severe traumatic brain injury within 15 years (consisting of more than one of the
             following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma,
             unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual
             sequelae suggesting transient changes in consciousness

          -  History of malignancy within past 2 years, with exception of a successfully treated
             basal cell carcinoma

          -  Presence of significant pain associated with conditions other than osteoarthritis or
             low back pain that could confound the assessment or self-evaluation of pain
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod 1.25 mg; Fingolimod 0.5 mg; Interferon β-1a 30 µg
Intervention description: Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.; Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.; Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Fingolimod Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 1292.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: FTY720; Interferon; RRMS; Multiple Sclerosis; Efficacy

Summary:

      This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod
      versus interferon β-1a to reduce the frequency of relapses in patients with
      relapsing-remitting multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
             (MS)

          -  Patients with a relapsing-remitting disease course

          -  Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5

        Exclusion Criteria:

          -  Patients with other chronic disease of the immune system, malignancies, acute
             pulmonary disease, cardiac failure, etc

          -  Pregnant or nursing women

          -  Patients who cannot tolerate treatment with an interferon

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Nivolumab; Ipilimumab; Pemetrexed; Cisplatin; Carboplatin
Intervention MeSH terms: Carboplatin; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 605.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effectiveness and tolerability of the combination of
      Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with
      unresectable pleural mesothelioma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females at least 18 years of age

          -  Histologically confirmed pleural malignant mesothelioma not eligible for curative
             surgery

          -  ECOG Performance status of 0 or 1

          -  Available tumor sample for testing

          -  Acceptable blood work

        Exclusion Criteria:

          -  Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas

          -  Prior chemotherapy for pleural mesothelioma

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody

          -  History of other malignancy unless the subject has been disease-free for at least 3
             years

          -  Active, untreated central nervous system (CNS) metastasis

        Other protocol defined inclusion/exclusion criteria could apply
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; TEZ/IVA; IVA; Placebo; Placebo
Intervention description: Participants received VX-659/TEZ/IVA orally once daily in the morning.; Participants received TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening.; Participants received placebo matched TEZ/IVA orally once daily in the morning.; Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the
      F508del mutation (F/F).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation (F/F)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
Condition: Smoking Cessation; Alcohol-Related Disorders
MeSH terms: Alcohol-Related Disorders
Intervention: Bupropion; placebo
Intervention description: 300 mg QD; placebo
Intervention MeSH terms: Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment
      for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate
      the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving
      treatment for alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry

          -  Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at
             time of study entry

          -  Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry

        Exclusion Criteria:

          -  History of seizures, head trauma and/or severe hepatic cirrhosis

          -  Current use of medications known to affect smoking behavior and/or cessation

          -  Use of tricyclic antidepressant medication and monoamine oxidase inhibitors

          -  Major depressive disorder within the month prior to study entry

          -  Eating disorder within the year prior to study entry

          -  History of bipolar or psychotic disorder

          -  Pregnant or breastfeeding

          -  Unstable serious medical disorder

          -  History of migraines

          -  Currently using smokeless tobacco, pipes, or cigars
Efficacy of TAK-085 in Participants With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Omega-3-acid ethyl esters 90 (TAK-085); Eicosapentaenoic acid-ethyl (EPA-E)
Intervention description: Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.; EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 611.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study was to determine the efficacy and safety of TAK-085, once daily
      (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily
      (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit
             3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference
             between these 2 values is within 30% of the higher one.

          2. Participants with differences between 2 values of fasting Low density lipoprotein -
             cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25%
             of the higher one.

        Exclusion Criteria:

          1. Participants who have coronary artery diseases (eg, confirmed myocardial infarction
             and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a
             history of revascularization.

          2. Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm
             within 6 months prior to Visit 1 (Week -8).

          3. Participants who have a history or complication of a clinically significant
             hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract
             ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within
             6 months prior to Visit 1 (Week -8).

          4. Participants who have been diagnosed with pancreatitis.

          5. Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency,
             apolipoprotein C-II deficiency or type III familial hyperlipidemia.

          6. Participants with complication of Cushing's syndrome, uremia, systemic lupus
             erythematosus (SLE) or serum dysproteinemia.
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Condition: Inflammation; Pain
MeSH terms: Inflammation
Intervention: Vehicle of Loteprednol Etabonate; Loteprednol Etabonate
Intervention description: 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.; 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to compare the safety and efficacy of loteprednol etabonate
      compared to vehicle for the treatment of postoperative inflammation and pain following
      cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are at least 18 years of age.

          -  Subjects who are candidates for routine, uncomplicated cataract surgery.

          -  Subjects who, in the Investigator's opinion, have potential postoperative pinholed
             Snellen visual acuity (VA) of at least 20/200 in the study eye.

        Exclusion Criteria:

          -  Subjects who have known hypersensitivity or contraindication to the study drug or
             components.

          -  Subjects with a severe/serious ocular condition, or any other unstable medical
             condition, that in the investigator's opinion may preclude study treatment or
             follow-up.

          -  Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or
             being treated for glaucoma in the study eye.

          -  Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the
             non-study eye.
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
Condition: Chronic Hepatitis C; Liver Fibrosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: peginterferon alfa-2b (SCH 54031)
Intervention description: 0.5 µg/kg Weekly QW SC for 36 months
Intervention MeSH terms: Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 540.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no
      treatment for the prevention of fibrosis progression in adult participants with moderate to
      severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol
      treatment in protocol P02370 (NCT00039871).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at entry in study P02370 (NCT00039871) 18-65 years;

          -  Nonresponder to PEG-Intron plus Rebetol in study P02370

        Exclusion Criteria:

          -  Participants who did not participate in the P02370 study.

          -  Any medical condition, including but not limited to decompensated liver disease,
             malignancy or substance abuse, that developed during the P02370 study which could
             interfere with the participant's participation in and completion of this study.