bioihbjkbjnl/mcl2 huggingface dataset:
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Condition: Diabetes; Pregnancy
MeSH terms: Pregnancy Complications; Diabetes Mellitus
Intervention: Metformin; Placebo
Intervention description: 1000 mg twice a day; Delivered to match active drug
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 831.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Metformin; Glucophage; Riomet; Glumetza; Fortamet; Glucophage XR

Summary:

      Purpose: The objective of this proposal is to study the safety and efficacy of metformin
      added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.

      Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.
      clinical centers

      Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a
      singleton fetus will be randomized to double-blinded insulin/placebo versus
      insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant
      hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits
      monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at
      less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Maternal age 18-45 years

          -  Singleton pregnancy with no known fetal anomalies

          -  Gestational age between 10weeks 0 days and 22 weeks 6 days by menstrual dating
             confirmed by ultrasound, or ultrasound alone

          -  Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or
             insulin)

          -  Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days
             gestation

          -  Willing to start insulin therapy and discontinue oral hypoglycemic pills other than
             study pills

          -  Able to swallow pills

        Exclusion Criteria:

          -  Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL

          -  Clinical history of lactic acidosis

          -  Known allergy to metformin

          -  Participation in another study that could affect primary outcome

          -  Delivery planned at non-MOMPOD study locations

          -  Unwillingness to use insulin treatment or follow prenatal care doctor's instructions
             for insulin and blood glucose monitoring
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: asenapine; olanzapine
Intervention description: 5-10 mg sublingually twice daily for 26 weeks; 5-20 mg by mouth once daily for 26 weeks
Intervention MeSH terms: Olanzapine; Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an extension study to further test

      the efficacy and safety of asenapine compared with a

      marketed agent (olanzapine) in the treatment of patients with

      persistent negative symptoms of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Continue to meet all demographic and procedural

        inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into

        this extension trial.

          -  Have demonstrated an acceptable

        degree of compliance and completed the 25543

        trial, and would benefit from continued treatment

        according to the investigator.

        Exclusion Criteria:

          -  Have an uncontrolled, unstable clinically significant

        medical condition.

          -  Have been judged to be medically

        noncompliant in the management of their disease.
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Wilate
Intervention description: von Willebrand factor / Factor VIII (plasma derived)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      A prospective, non-controlled, international, multi-centre phase 3 study to investigate the
      pharmacokinetics, efficacy, safety, and immunogenicity of Wilate in previously treated
      children with severe haemophilia A
    

Eligibility criteria:

        Inclusion Criteria:

          1. Severe haemophilia A (<1% FVIII:C) according to medical history

          2. Male patients aged 1 to <12 years

          3. Previous treatment with a FVIII concentrate for at least 50 exposure days (EDs)

          4. Immunocompetence (CD4+ count >200/μL)

          5. Voluntarily given, fully informed written and signed consent obtained by the patient's
             parent(s) or legal guardian and, depending on the children's developmental stage and
             intellectual capacity, informed assent by the patients before any study-related
             procedures are performed

        The interval between the Screening Visit and the PK Visit should not exceed 30 days. If the
        30-day interval is exceeded, determination of the CD4+ count is to be repeated and must be
        >200/μL for patients to be enrolled (i.e., inclusion criterion no. 4).

        Exclusion Criteria:

          1. Any coagulation disorders other than haemophilia A

          2. History of FVIII inhibitor activity (≥0.6 BU) or detectable FVIII inhibitory
             antibodies (≥0.6 BU using the Nijmegen modification of the Bethesda assay) at
             screening, as determined by the central laboratory

          3. Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate
             transaminase [ASAT] levels >5 times of upper limit of normal, creatinine >120 μmol/L)

          4. Patients receiving or scheduled to receive immunomodulating drugs (other than
             antiretroviral chemotherapy), such as alpha-interferon, prednisone (equivalent to >10
             mg/day), or similar drugs
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Condition: Pulmonary Embolism; Thromboembolism; Thrombosis; Venous Thrombosis; Venous Thromboembolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: BAY 59-7939; BAY 59-7939; ASA
Intervention description: 10 mg tablet once daily for 12 months; 20 mg tablet once daily for 12 months; 100 mg tablet once daily for 12 months
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3365.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: deep vein thrombosis; pulmonary embolism; long-term prevention of recurrent symptomatic VTE

Summary:

      This is a multicenter, randomized, double-blind, event-driven, superiority study for
      efficacy.

      Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who
      completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12
             months and did not interrupt anticoagulation for longer than 1 week

        Exclusion Criteria:

          -  Legal lower age limitations (country specific) Indication for therapeutic-dosed
             anticoagulants Indication for antiplatelet therapy or a conventional non-steroid
             anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy
             leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30
             mL/min
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Bimatoprost 0.01%; Bimatoprost 0.03%
Intervention description: Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.; Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Intervention MeSH terms: Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 466.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or
      ocular hypertension (OHT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of glaucoma or ocular hypertension

        Exclusion Criteria:

          -  Active ocular disease other than glaucoma or ocular hypertension

          -  Require chronic use of ocular medications other than the study medication during the
             study (intermittent use of artificial tear solution will be permitted)
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib; Placebo to match filgotinib; Adalimumab; Placebo to match adalimumab; MTX
Intervention description: 200 mg or 100 mg tablet(s) administered orally once daily; Tablet(s) administered orally once daily; 40 mg administered via subcutaneous injection once every two weeks; Administered via subcutaneous injection once every two weeks; Commercially sourced tablet(s) administered orally
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1759.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effects of filgotinib versus placebo
      for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the
      percentage of participants achieving an American College of Rheumatology 20% improvement
      response (ACR20) at Week 12.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a diagnosis of rheumatoid arthritis (RA) [2010 American College of Rheumatology
             (ACR)/European League Against Rheumatism (EULAR) criteria] , and are ACR functional
             class I-III.

          -  Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥
             6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both
             screening and Day 1.

          -  Ongoing treatment with a stable dose of MTX

        Key Exclusion Criteria:

          -  Previous treatment with any janus kinase (JAK) inhibitor

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Dysport® Adult Lower Limb Spasticity Follow-on Study
Condition: Post-stroke Spasticity; Spasticity Post-Traumatic Brain Injury
MeSH terms: Muscle Spasticity; Brain Injuries; Brain Injuries, Traumatic
Intervention: Botulinum toxin type A
Intervention description: I.M. (intramuscular) injection on day 1 of each treatment cycle.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 352.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to assess the long term safety of Dysport® in
      hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over
      repeated treatment cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140
             (NCT01249404)

        Exclusion Criteria:

          -  Fixed contractures in lower limb
Phase 3 Study of Sofosbuvir and Ribavirin
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: Sofosbuvir; PEG; RBV
Intervention description: Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose
Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
Dose of PEG+RBV group: 800 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: 527.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 2 (GT-2); HCV genotype 3 (GT-3)

Summary:

      This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in
      combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon
      (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV)
      genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks
      after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if
      non-inferiority was demonstrated, the study was then allowed to test for superiority.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic Genotype 2 or 3 HCV-infection

          -  Naive to all HCV antiviral treatment(s)

        Exclusion Criteria:

          -  Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody
             (anti-HBc IgM Ab), or anti-HIV Ab

          -  History of any other clinically significant chronic liver disease

          -  A history consistent with decompensated liver disease

          -  History or current evidence of psychiatric illness, immunologic disorder,
             hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant
             use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the
             subject unsuitable for the study.

          -  Participation in a clinical study within 3 months prior to first dose
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Condition: Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago
MeSH terms: Stomach Ulcer; Duodenal Ulcer; Ulcer
Intervention: Esomeprazole 20 mg
Intervention description: Esomeprazole 20 mg once daily
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 395.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: gastrointestinal; GI; NSAID; Japan; Japanese; Gastric ulcer; duodenal ulcer

Summary:

      The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20
      mg once daily for up to 52 weeks of treatment involving patients with a history of gastric
      and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by
      evaluating AE, clinical laboratory value and vital signs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical history of gastric and/or duodenal ulcer

          -  A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc)
             that requires daily NSAID use,at least 20 years of age

        Exclusion Criteria:

          -  Having gastric or duodenal ulcer in active or healing stage according to the
             Sakita/Miwa classification

          -  History of esophageal, gastric or duodenal surgery

          -  Having severe liver disease or chronic renal disease
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: RVT-101; Placebo
Intervention description: once daily, oral, 35 mg tablets; once daily, oral, pill manufactured to match RVT-101 35 mg tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1315.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; RVT-101; donepezil; intepirdine; dementia

Summary:

      This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an
      adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject with AD

          -  Ongoing donepezil therapy for AD

          -  An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline

          -  Hachinski Ischaemia score less than or equal to 4 at Screening.

          -  If female, subject must be: a. of non-childbearing potential or surgically sterile;
             or, b. willing to use an adequate methods of birth control. Male subjects who are
             sexually active will also be required to use an adequate form of birth control.

          -  Subject has the ability to comply with procedures for cognitive and other testing in
             the opinion of the investigator.

          -  Subject has a reliable caregiver who is willing to report on subject's status
             throughout the study.

        Exclusion Criteria:

        Other Causes for Dementia

          -  Diagnosis of vascular dementia

          -  Atypical clinical features or clinical course of dementia that would lead the
             investigator to conclude symptoms are more likely due to an alternate dementia
             diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia,
             or others.

        Confounding Medical Conditions

          -  History of significant psychiatric illness such as schizophrenia or bipolar affective
             disorder or any other significant psychiatric illness that in the opinion of the
             investigator would interfere with participation in the study;

          -  Any clinically relevant concomitant disease, which, in the opinion of the
             investigator, makes the subject unsuitable for inclusion in the study.
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Condition: Intercritical Gout
MeSH terms: Gout
Intervention: Placebo; Rilonacept 80 mg; Rilonacept 160 mg
Intervention description: Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.; Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.; Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.
Intervention MeSH terms: Rilonacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Metabolism, Inborn Errors; Allopurinol; Metabolic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine-Pyrimidine Metabolism, Inborn Errors; Gout

Summary:

      The purpose of this clinical research study was to determine the safety and effectiveness of
      an experimental drug called rilonacept in subjects with gout who are beginning allopurinol
      treatment for gout. Subjects will participate in this study for approximately 22 weeks.
      Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 to 80 years of age;

          -  Previously met the preliminary criteria of the American Rheumatism Association (ARA)
             for the classification; of the acute arthritis of primary gout;

          -  At least 2 gout flares in the year prior to the screening visit;

          -  Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;

        Exclusion Criteria:

          -  Acute gout flare within 2 weeks of the screening visit or during screening;

          -  Persistent chronic or active infections;

          -  History of an allergic reaction to allopurinol;

          -  History or presence of cancer within 5 years of the screening visit;

          -  Previous exposure to Rilonacept;

          -  Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3
             months prior to the screening visit.
(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: coronary intervention
Intervention description: elective coronary intervention
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: percutaneous coronary intervention; low dose intracoronary heparin

Summary:

      The hypothesis:

      Low dose intracoronary unfractionated heparin is as effective and safe as standard dose
      intravenous unfractionated heparin on patients with elective percutaneous coronary
      intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patients; who have planned elective PCI and have had written informed consent for
             participation to study.

          -  The native coronary artery;

               -  lesion with narrowing >=70%,

               -  lesion without thrombus

               -  no left main coronary artery (LMCA) lesion

               -  no chronic total occlusion lesion

        Exclusion Criteria:

          -  Patients have allergy for acetylsalicylic acid (ASA), Clopidogrel and heparin

          -  Patients who performed primary PCI

          -  Patients with acute coronary syndrome

          -  Patients with have a history of myocardial infarction (MI) for two weeks

          -  Patients who were use UFH or low molecular weight heparin (LMWH) for 24 hours

          -  Patients on warfarin therapy

          -  Patients who have bleeding diathesis, or have high risk for bleeding.