bioihbjkbjnl/mcl2 huggingface dataset:
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
Condition: Parkinson's Disease; Dyskinesia
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: Sarizotan; Placebo
Intervention description: Sarizotan will be administered twice daily.; Placebo matching to sarizotan will be administered twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 398.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Dyskinesia; Dyskinesia associated with dopaminergic treatment

Summary:

      The purpose of this study is to test multiple doses of sarizotan to establish a dose with
      maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's
      disease participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant is an out-patient

          -  The participant presents with a diagnosis of idiopathic Parkinson's disease

          -  Prior therapy with all registered Parkinsonian medication is allowed

        Exclusion Criteria:

          -  (For female participants) The participant is pregnant or lactating

          -  The participant is participating in another clinical study or has done so within the
             past 30 days

          -  The participant has received neurosurgical intervention related to Parkinson's disease

          -  The participant has relevant renal impairment

          -  The participant has relevant hepatic impairment

          -  The participant is suffering from any dementia or psychiatric illness

          -  The participant has a history of allergic asthma
Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: 210 mg brodalumab; 140 mg brodalumab; placebo
Intervention description: 210 mg brodalumab administered subcutaneous (SC); 140 mg brodalumab administered subcutaneous (SC); Placebo administered subcutaneous (SC)
Intervention MeSH terms: Brodalumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 661.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: psoriasis, brodalumab (AMG 827)

Summary:

      The purpose of this study is to assess the safety and efficacy of brodalumab taken every two
      weeks at two different doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months

          -  Subject must be considered, in the opinion of the investigator, to be a suitable
             candidate for treatment with a biologic per regional labeling

          -  Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at
             screening and at baseline

        Exclusion Criteria:

          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication-induced psoriasis, or other skin conditions at (eg, eczema) that would
             interfere with study evaluations

          -  Subject has known history of Crohn's disease

          -  Subject has any other significant concurrent medical condition or laboratory
             abnormalities, as defined in the study protocol

          -  Subject has stopped using certain psoriasis therapies as defined in the study protocol

          -  Subject has previously used any anti-IL-17 biologic therapy
A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Symbicort Turbuhaler (Budesonide/formoterol); Drug: any available COPD treatment; investigator to decide
Intervention description: 2 x 160/4.5 microgram, inhalation, bid, 52 weeks; According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 328.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Symbicort; Safety; Efficacy; COPD; Japanese

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler
      compared to standard COPD treatment during one year in Japanese patients with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)

          -  Documented COPD symptoms for more than 2 years

          -  Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator
             FEV1/FVC<70%

        Exclusion Criteria:

          -  History and/or current clinical diagnosis of asthma and atopic diseases such as
             allergic rhinitis

          -  Subjects with significant or unstable ischemic heart disease, arrhythmia,
             cardiomyopathy, heart failure, uncontrolled hypertension as defined by the
             investigator, or any other relevant cardiovascular disorder as judged by the
             investigator

          -  COPD exacerbation during the run-in period or within 4 weeks prior to registration,
             requiring hospitalization and/or treatment with systemic steroids.
Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Placebo Nasal Aerosol; Prednisone capsules; Placebo Prednisone Capsules; Beclomethasone dipropionate
Intervention description: Placebo nasal aerosol administered daily for 42 days of treatment; Prednisone 10 mg capsule taken each day on the last 7 days of treatment; Placebo prednisone capsule taken each day on the last 7 days of treatment; Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.
Intervention MeSH terms: Prednisone; Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis
      function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent

          -  Male or female subjects 12-45 years of age

          -  Documented history of perennial allergic rhinitis

          -  General good health

          -  Other criteria apply

        Exclusion Criteria:

          -  History of physical findings of nasal pathology (within 60 days prior to Screening
             Visit 1)

          -  Participation in any investigational drug study 30 days preceding Screening Visit 1

          -  History of respiratory infection/disorder with 14 days preceding Screening Visit 1

          -  Use of any prohibited concomitant medications
Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel
Intervention description: Rapastinel pre-filled syringes for IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 617.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive
      to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Screening

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Screening

          -  Lifetime history of meeting DSM-5 criteria for:

          -  Schizophrenia spectrum or other psychotic disorder

          -  Bipolar or related disorder

          -  Major neurocognitive disorder

          -  Neurodevelopmental disorder of greater than mild severity or of a severity that
             impacts the participant's ability to consent, follow study directions, or otherwise
             safely participate in the study

          -  Dissociative disorder

          -  Posttraumatic stress disorder

          -  MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo; Linagliptin
Intervention description: Placebo matching linagliptin tablets once daily; Linagliptin tablets once daily
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to
      metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with
      insufficient glycaemic control.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of diabetes mellitus prior to informed consent

          2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12
             weeks)

          3. Glycosylated haemoglobin A1 >= 7.5% and <= 10%

          4. Age between 18 and less than 80

          5. - Body Mass index less or equal to 45

        Exclusion criteria:

          1. Uncontrolled hyperglycaemia during run in period

          2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to
             informed consent

          3. Impaired hepatic function

          4. Gastric by pass surgery

          5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3
             months prior to informed consent

          6. Treatment with anti-obesity drugs

          7. Current treatment with systemic steroids at the time of informed consent or change in
             dosage of thyroid hormones within 6 weeks prior to informed consent

          8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and
             are not practicing an acceptable method of birth control or do not plan to continue
             using this method during the trial
Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BI 1744 (Olodaterol) Low Dose; BI 1744 (Olodaterol) Medium Dose; Placebo; Foradil
Intervention description: BI1744 Respimat low dose once daily and placebo Foradil; BI1744 Respimat medium dose once daily and placebo Foradil; Placebo Respimat once daily and placebo Foradil; 12 mcg twice daily and placebo Respimat
Intervention MeSH terms: Olodaterol; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 100.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study is intended to characterize the lung function profile of BI1744 in COPD patients
      where patients will perform pulmonary function tests at regular intervals for 24 hours at the
      end of a 6 week treatment period. Each patient will receive all four treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients willing to participate with confirmed diagnosis of COPD

          -  40 years of age or older

          -  having a 10 pack year smoking history

          -  able to perform serial pulmonary function tests

          -  able to use both a DPI and Respimat device

        Exclusion Criteria:

        Significant other disease

          -  clinically relevant abnormal hematology, chemistry, or urinalysis

          -  history of asthma

          -  diagnosis of thyrotoxicosis

          -  paroxysmal tachycardia related to beta agonists

          -  history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure
             within 1 year

          -  active tuberculosis, cystic fibrosis, clinically evident bronchiectasis

          -  significant alcohol or drug use

          -  pulmonary resection

          -  taking oral beta adrenergics

          -  taking unstable oral steroids

          -  daytime oxygen

          -  enrolled in rehabilitation program

          -  enrolled in another study or taking investigational products

          -  pregnant or nursing women, women of child bearing potential not willing to use two
             methods of birth control

          -  those who are not willing to comply with pulmonary medication washouts
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Placebo; Brivaracetam
Intervention description: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 480.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures

Summary:

      This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo
      in subjects suffering from Epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were aged from 16 to 70 years, inclusive. Subjects under 18 years of age were
             only included where legally permitted and ethically accepted

          -  Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy
             according to the International League Against Epilepsy (ILAE) classification

          -  For subjects suffering from localization-related Epilepsy: subjects had at least 2
             Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during
             the 3 months preceding Visit 1 according to the ILAE classification

          -  For subjects suffering from localization-related Epilepsy: subjects had at least 4
             Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week
             Baseline Period according to the ILAE classification

          -  For subjects suffering from generalized Epilepsy: subjects had at least 2 Type
             II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE
             classification

          -  For subjects suffering from generalized Epilepsy: subjects had at least 4 Type
             II-seizure days during the 4 week Baseline Period according to the ILAE classification

          -  Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic
             Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant
             AED

        Exclusion Criteria:

          -  For subjects who suffered from localization-related Epilepsy: history or presence of
             Seizures occurring only in clusters (too frequently or indistinctly separated to be
             reliably counted) before Visit 2 or occurring only as Type IA non-motor

          -  Subjects with a history or presence of Status Epilepticus during the year preceding
             Visit 1 or during Baseline
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Condition: Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51; IC51; IC51
Intervention description: 0.25 ml, 2 i.m. vaccinations at Day 0 and 28; 0.5 ml, 2 i.m. vaccinations at Day 0 and 28; 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 2 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pediatric; Japanese Encephalitis Vaccine; non-endemic countries; to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51

Summary:

      The primary objective is to assess the safety profile of IC51 in a pediatric population from
      regions where JEV is not endemic
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female healthy children and adolescents aged >=2 months to <18 years at the
             time of first vaccination

          -  Written informed consent by the subject's legal representative(s), according to local
             requirements, and written informed assent of the subject, if applicable

          -  Female subjects: either no childbearing potential or negative pregnancy test. For
             females after menarche willingness to practice a reliable method of contraception.

          -  The subject is planning to travel to an area where JE is endemic after completion of
             the vaccination schedule. Exposure to JE should be avoided until 1 week after the
             second IC51 dose and subjects should return from travel to JE endemic areas before the
             Month 7 visit. The planned travel to JE endemic areas should not interfere with the
             study visits and can take place between Visit 2 + 7 days to Month 7.

        Exclusion Criteria:

          -  Clinical manifestation or history of any Flavivirus disease

          -  Vaccination against JE (except within this protocol), Yellow fever, West Nile virus
             and Dengue at any time prior or during the study

          -  History of immunodeficiency or immunosuppressive therapy

          -  Known HIV, HBV or HCV infection

          -  History of hypersensitivity reactions to other vaccines

          -  Acute febrile infection at each visit during which the subject receives a vaccination

          -  Active or passive immunization within 1 week before and 1 week after each IC51
             vaccination.
Effect on Weight Loss of Exenatide Versus Placebo
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Weight Loss
Intervention: exenatide; placebo
Intervention description: subcutaneous injection, 5mcg or 10mcg, twice a day; subcutaneous injection, volume equivalent to exenatide dose, twice a day
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; overweight; obesity; weight loss; exenatide; Amylin; Lilly

Summary:

      This trial is designed to compare the effects of twice-daily exenatide and twice-daily
      placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2
      diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus
      a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their
      current oral antidiabetes agent regimen and participate in a lifestyle modification program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for at least 6 months

          -  Have been treated with a stable dose of the following for at least 6 weeks prior to
             screening: *immediate or extended release metformin, or *a sulfonylurea, or *a
             fixed-dose sulfonylurea/metformin combination therapy

          -  Have an HbA1c of 6.6% to 10.0%, inclusive

          -  Have a Body Mass Index (BMI) of 25 kg/m^2 to 39.9 kg/m^2, inclusive

        Exclusion Criteria:

          -  Are treated with any of the following excluded medications: *exogenous insulin,
             thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks
             of screening; *Symlin injection at any time; * Byetta injection within 3 months of
             screening or discontinuation of therapy at any time due to adverse reaction; *drugs
             that directly affect gastrointestinal motility; *use of a weight loss drug (including
             those available over the counter) within 3 months of screening; *chronic (lasting
             longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and
             inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of
             screening

          -  Have conditions contraindicating metformin and/or sulfonylurea use

          -  Have had a change in lipid-lowering agents within 6 weeks of screening

          -  Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV
             inhibitors (DPP-IV inhibitors) or have previously participated in this study

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry