bioihbjkbjnl/mcl2 huggingface dataset:
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Glimepiride; Canagliflozin (JNJ-28431754); Metformin
Intervention description: Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.; Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.; Metformin will be given orally at the protocol-specified dose for 104 weeks.
Intervention MeSH terms: Metformin; Glimepiride; Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1452.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes; Metformin; Glimepiride; Hemoglobin A1c; Type 2 diabetes mellitus; Canagliflozin

Summary:

      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of
      canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes
      mellitus with inadequate control despite treatment with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of type 2 diabetes

          -  Body mass index (BMI) >=22 to <=45 kg/m2, at screening

          -  Patients must be taking a stable dosage of metformin as monotherapy at screening

          -  Patients must have a HbA1c between >=7% and <=9.5% at Week 2

          -  Patients must have a fasting plasma glucose (FPG) <=270 mg/dL (15 mmol/L) at Week -2

        Exclusion Criteria:

          -  Patients having prior exposure or known contraindication or suspected hypersensitivity
             to JNJ-28431754, glimepiride, or metformin

          -  History of diabetic ketoacidosis or type 1 diabetes mellitus

          -  History of pancreas or beta-cell transplantation

          -  History of active proliferative diabetic retinopathy

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Renal disease requiring treatment with immunosuppressive therapy within the past 12
             months before screening or a history of dialysis or renal transplant

          -  Taken thiazolidinedione therapy in the past 16 weeks before screening
Efficacy of Nalmefene in Patients With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Placebo; Nalmefene
Intervention description: as-needed use, tablets, orally, 6 months; 18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Intervention MeSH terms: Nalmefene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol-Related Disorders; Alcoholism; Mental Disorders; Central Nervous System Agents

Summary:

      The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in
      the treatment of alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

        In- and outpatients who:

          -  had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical
             Manual of Mental Disorders - Text revision (DSM-IV-TR) criteria

          -  had had ≥6 HDDs in the 4 weeks preceding the Screening Visit

          -  had had an average alcohol consumption at WHO medium risk level or above in the 4
             weeks preceding the Screening Visit

        Exclusion Criteria:

        The patient:

          -  had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence

          -  had an antisocial personality disorder

          -  had risk of suicide evaluated by the suicidality module of the Mini-International
             Neuropsychiatric Interview (MINI)

          -  had a history of delirium tremens or alcohol withdrawal seizures

          -  reported current or recent (within 3 months preceding screening) treatment with
             disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid
             antagonists

          -  reported current or recent treatment with antipsychotics or antidepressants

          -  was pregnant or breast-feeding

        Other protocol-defined inclusion and exclusion criteria may apply.
Trial of Linaclotide in Patients With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Intervention: Matching Placebo; Linaclotide
Intervention description: Oral, once daily; Oral, once daily
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 643.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to determine the efficacy and safety of linaclotide
      administered to patients with chronic constipation (CC). The primary efficacy parameter is
      the percentage of patients in each dosing group that meet the protocol definition for
      Complete Spontaneous Bowel Movement (CSBM) Overall Responder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has completed a colonoscopy according to the AGA criteria, with no clinically
             significant findings

          -  Patient has successfully completed protocol procedures (with no clinically significant
             findings): physical exam, 12-lead ECG, or clinical laboratory tests

          -  Patient meets protocol criteria for CC: reports < 3 bowel movements per week and
             reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation
             during > 25% of BMs

          -  Patient demonstrates continued chronic constipation through Pretreatment Period

          -  Patient is compliant with IVRS

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
Condition: Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Dyslipidemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Dyslipidemias; Hyperphosphatemia
Intervention: MCI-196; Placebo
Intervention description: 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study; 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 642.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Dyslipidemia; Phosphate binder

Summary:

      This is a phase III multi-centre study in two periods: the first period is a phosphate binder
      and lipid lowering drugs washout for 8 weeks, the second period is a double-blind,
      randomised, parallel group, fixed dose, for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or over

          -  Clinically stable haemodialysis or peritoneal dialysis

          -  Stable phosphate control

          -  On a stabilised phosphorus diet

          -  Female and of child-bearing potential have a negative serum pregnancy test

          -  Male subjects must agree to use appropriate contraception

        Exclusion Criteria:

          -  Current clinically significant medical comorbidities, which may substantially
             compromise subject safety, or expose them to undue risk, or interfere significantly
             with study procedures and which, in the opinion of the Investigator, makes the subject
             unsuitable for inclusion in the study.

          -  A a serum albumin level<30.0g/L

          -  A PTH level >1000pg/mL

          -  A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡

          -  A serum LDL-C level >4.94mmol/L(190mg/dL)

          -  A serum triglycerides level >6.76mmol/L (600mg/dL)

          -  A History of significant gastrointestinal motility problems

          -  A positive test for HIV 1 and 2 antibodies

          -  A history of substance or alcohol abuse within the last year

          -  Seizure disorders

          -  A history of drug or other allergy

          -  A temporary catheter as a vascular access

          -  Participated in a clinical study with any experimental medication in the last 30 days
             or an experimental biological product within the last 90 days prior to signing of
             informed consent
D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Cognition Disorders; Cognitive Dysfunction
Intervention: D-serine; Cognitive Retraining (CRT); Placebo; Cognitive Retraining Placebo
Intervention description: D-serine (30 mg/kg); Cognitive retraining therapy (CRT); Placebo D-serine Drug; Cognitive retraining therapy (CRT) control
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA)
      receptor function in the brain and thereby increasing the capacity of the brain to both form
      new connections and strengthen existing connections, schizophrenic patients may derive both
      greater and sustained benefit from cognitive retraining.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia or schizoaffective disorder

        Exclusion

          -  Pregnant or lactating
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Abatacept
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of Abatacept after intravenous
      administration in Japanese children and adolescents with active juvenile idiopathic arthritis
      who have a history of an inadequate response or intolerance to Methotrexate or biologics
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a history of an inadequate therapeutic response or intolerance in
             the opinion of the examining physician to at least one biologics or Methotrexate
             (MTX).

          -  Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of
             Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular
             Rheumatoid Factor (RF+), polyarticular (RF-), or systemic with a polyarticular-course.

          -  Men and women, ages 4 to 17 years, inclusive at enrollment.

          -  Subjects must have a history of at least 5 joints with active disease and must have
             currently active articular disease as defined by:

               1. ≥2 active joints (e.g. presence of swelling, or if no swelling is present,
                  limitation of motion (LOM) accompanied by pain, tenderness, or both) at screening
                  and at Week 0 (Day 1).

               2. ≥2 joints with LOM at screening and at Week 0 (Day 1).

        Exclusion Criteria:

          -  Systemic onset JIA with any of the following manifestations within the last 6 months
             prior to enrollment: intermittent fever due to JIA, rheumatoid rash,
             hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.

          -  Presence of any other rheumatic disease or major chronic
             infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease,
             psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus
             erythematosus, etc.)
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 520.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylactic

Summary:

      The reason for this study is to see if the drug galcanezumab is safe and effective in
      participants with episodic migraine. The study will last about 53 weeks and may include up to
      12 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a diagnosis of migraine as defined by International Headache
             Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2)
             (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and
             migraine onset prior to age 50

          -  Prior to screening, participants must have a history of 4-14 migraine headache days
             and at least 2 migraine attacks per month on average within the past 3 months

        Exclusion Criteria:

          -  Are currently enrolled in any other clinical trial involving an investigational
             product or any other type of medical research judged not to be scientifically or
             medically compatible with this study

          -  Current use or prior exposure to galcanezumab or another calcitonin gene-related
             peptide (CGRP) antibody, including those who have previously completed or withdrawn
             from this study or any other study investigating a CGRP antibody

          -  Participants who are taking, or are expected to take, therapeutic antibodies during
             the course of the study (for example, adalimumab, infliximab, trastuzumab,
             bevacizumab, etc.)

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab

          -  Women who are pregnant or nursing

          -  History of chronic migraine, daily persistent headache, cluster headache, medication
             overuse headache, migraine with brainstem aura, or hemiplegic migraine
Long Term Safety Study of NVA237 vs QAB149 in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Long-acting beta 2-agonist (LABA); Placebo
Intervention description: NVA237 will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI; QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI; Placebo to match QAB149
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, NVA237, QAB149, glycopyrronium bromide

Summary:

      The purpose of the study is to provide long term safety data of NVA237. This study will
      assess the safety and tolerability of a single dose strength of NVA237.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients with COPD according to GOLD 2011 who have signed informed
             consent.

          2. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.

          3. Current or ex-smokers with a smoking history of at least 10 pack years

          4. Patients with a mMRC score of at least 2 at run-in.

        Exclusion Criteria:

          1. Patients contraindicated for muscarinic antagonist agents and beta-2 agonists

          2. Patients with a history of malignancy of any organ system, treated or untreated,
             within the last five years

          3. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or
             moderate-severe renal impairment or urinary retention

          4. Patients who had a COPD exacerbation within 6 weeks prior to screening.

          5. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.

          6. Patients with a history of asthma.

          7. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40
             years of age.

          8. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in

          9. Patients with concomitant pulmonary disease

         10. Patients with a history of certain cardiovascular co-morbid conditions

         11. Patients with a diagnosis of alpha-1 anti-trypsin deficiency

         12. Patients with active pulmonary tuberculosis

         13. Patients in the active phase of a pulmonary rehabilitation programme

         14. Other protocol-defined inclusion / exclusion criteria may apply
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: nivolumab; ipilimumab
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1844.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an investigational immunotherapy Nivolumab,
      when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the
      return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or
      stage IV Melanoma
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of
             participation in study.

          -  Must have full activity or, if limited, must be able to walk and carry out activities
             such as light house work or office work

          -  No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s)
             and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for
             central nervous system (CNS) lesions)

        Exclusion Criteria:

          -  History of uveal melanoma

          -  Patients with active, known or suspected autoimmune disease

          -  Prior treatment with interferon (if complete < 6 months prior to participation in
             study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any
             other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
             pathways

        Other protocol defined inclusion/exclusion criteria could apply
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Condition: Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
MeSH terms: Infections; Cystic Fibrosis; Fibrosis
Intervention: TOBI; Placebo
Intervention description: TOBI (tobramycin inhaled solution); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 3 Months
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Tobramycin Inhalation solution; Cystic fibrosis; Lung disease; anti-bacterial agents

Summary:

      This study investigated the efficacy of inhaled TOBI treatment for early infections of P.
      aeruginosa in paediatric patients with cystic fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cystic fibrosis

          -  Early lower respiratory tract infection with P. aeruginosa,

        Exclusion Criteria:

          -  Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

          -  Administration of loop diuretics within 7 days prior to study drug administration.

          -  Other protocol-defined inclusion/exclusion criteria may apply