bioihbjkbjnl/mcl2 huggingface dataset:
A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:
Condition: COPD
Intervention: Roflumilast; Placebo; Salbutamol
Intervention description: Roflumilast tablets; Placebo tablets; Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 626.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD; Roflumilast; FEV1; China

Summary:

      The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg
      Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Willingness to sign a written informed consent

          -  Chronic obstructive pulmonary disease (COPD) according to Global Initiative for
             Chronic Obstructive Lung Disease (GOLD) guidelines 2009

          -  Chinese or Malay or Indian ethnicity

          -  History of chronic obstructive pulmonary disease symptoms for at least 12 months prior
             to baseline visit V0

          -  Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio
             (post-bronchodilator) < 70%

          -  Forced expiratory volume in the first second (FEV1) (post-bronchodilator) < 50 % of
             predicted

          -  Former smoker (defined as: smoking cessation at least one year ago) or current smoker
             both with a smoking history of at least 10 pack years

        Main Exclusion Criteria:

          -  Moderate or severe COPD exacerbation and/or COPD exacerbations treated with
             antibiotics not stopped at V0

          -  Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0

          -  History of asthma diagnosis in patients < 40 years of age or relevant lung disease
             other than COPD

          -  Current participation in a pulmonary rehabilitation program or completion of a
             pulmonary rehabilitation program within 3 months preceding the baseline visit V0

          -  Known alpha-1-antitrypsin deficiency
A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: 40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      The purpose of this study is to assess long-term safety and tolerability in adult patients
      who have completed a previous atomoxetine study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed the B4Z-JE-LYEE study (NCT00962104) and signed the
             Informed Consent Document (ICD).

          -  Patients must have been judged by the investigator to be reliable to keep appointments
             for clinic visits and all tests, including venipuncture and examinations, required by
             the protocol.

          -  Patients must possess an educational level and degree of understanding of the language
             of their country that enables them to communicate suitably with the investigator and
             study coordinator.

        Exclusion Criteria:

          -  Patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision criteria for current anxiety disorder and also patients who
             require anti-anxiety drug therapy within previous study except for those taking
             benzodiazepines analogs for anxiety. The dosage of diazepam equivalents should not be
             more than 5 milligrams/day (mg/day).

          -  Patients who, in the opinion of the investigator, are at serious suicidal risk or
             serious risk of harming others, or whose score for Item 11 on the Hamilton Depression
             Rating Scale-17 items is equal or more than 2 at randomization or screening.

          -  Patients with significant medical conditions that are likely to become unstable during
             the trial or would likely be destabilized by treatment with atomoxetine or require
             treatment with excluded medications.

          -  Patients with a history of allergy to atomoxetine, severe allergies to more than 1
             class of medications, or multiple adverse drug reactions.

          -  Patients who have received treatment within the past 30 days with a drug that has not
             received regulatory approval for any indication at the time the informed consent
             document is obtained.
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide; Conventional Asthma Therapy
Intervention description: Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily; According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Asthma; Bronchial

Summary:

      This study will include the patients who are Japanese children with bronchial asthma aged 5
      years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at
      about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of
      100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study
      D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with
      bronchial asthma in need of inhaled glucocorticosteroid treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who complete preceding the Phase III study and provide a signed written
             informed consent by patient's legal representative at Visit 1 or 4 weeks prior to
             Visit 1 of the study. A signed written informed assent should also be obtained from
             the patients themselves as much as possible

          -  When the investigator will obtain the signed written informed consent of Phase III
             study (D5254C00769) from patient's legal representative, the investigator will also
             provide the information of this study

        Exclusion Criteria:

          -  Respiratory infections that, in the opinion of the investigator(s), may affect the
             efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no
             available effective antimicrobial drugs or with deep seated mycosis

          -  Concurrent serious diseases of liver, kidney, heart or other complications which, in
             the opinion of the investigator, may either put the patient at risk because of
             participation in the study, or may influence the results of the study, or the
             patient's ability to participate in the study. Any clinically relevant abnormal
             findings in vital sign or physical examination at Visit 1 in this study, which in the
             opinion of the investigator may put the patient at risk because of his/her
             participation in the study.

          -  Pregnant or possible pregnancy or planning to become pregnant during the study period

          -  Other subjects who are considered inappropriate to participate in this study judged by
             the investigator
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Methotrexate; Placebo; Abatacept; Methotrexate
Intervention description: Intravenous (IV) solution, - weight tiered (500 mg <60 kg); (750 mg 60-100 kg); (1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months; Tablets, Oral, ≥ 15 mg, weekly, 6 months; IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months; Solution, intravenous, 10 mg/kg, every 28 days; Tablets, oral, 15 mg weekly to be adjusted according to patient condition
Intervention MeSH terms: Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis, with inadequate response to methotrexate

Summary:

      The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight
      tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate
      after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and
      an inadequate clinical response to methotrexate
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial
             diagnosis of RA

          -  Patients must have been taking methotrexate for at least 3 months with at least a
             weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)

          -  Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate
             higher doses

        Key Exclusion Criteria:

          -  Evidence (as assessed by the Investigator) of active or latent bacterial or viral
             infections at the time of potential enrollment
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Ursodeoxycholic acid 150mg / day; Ursodeoxycholic acid 600mg / day; Ursodeoxycholic acid 900mg / day
Intervention description: Ursodeoxycholic acid, 150mg/ day, three times a day at meals; Ursodeoxycholic acid, 600mg/ day, three times a day at meals; Ursodeoxycholic acid, 900mg/ day, three times a day at meals
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 596.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C, Ursodeoxycholic acid

Summary:

      This study is a 24-week multicenter, randomized, double-blind control trial with
      ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary
      objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day
      to that of 150mg/day and the safety of UDCA treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must have a clinical diagnosis to apply the conservative medication for
             chronic hepatitis C.

          2. Serum alanine aminotransferase levels measured at 4-week before the initiation of
             treatment must be over 61 IU/mL.

          3. Subject's age must be 20 years or older.

        Exclusion Criteria:

          1. Subject who received a treatment of antiviral agents (interferon) within 20 weeks
             before the start of 8-week observation period

          2. Subject who received a treatment of corticosteroids, immunosuppressive drugs,
             glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic
             function during 8-week observation period.

          3. Subject with decompensated cirrhosis

          4. Subject infecting with other hepatic virus

          5. Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic
             disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer

          6. Subject who require hospitalization for complications of the heart, kidney or pancreas

          7. Pregnancy

          8. Alcoholics

          9. Alcohol intake more than 27 ml/day

         10. Subject who involved in other clinical trial within 4 weeks before the start of
             observation period

         11. Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products
Tecfidera Slow-Titration Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: dimethyl fumarate
Intervention description: Participants will be dosed twice daily for 12 weeks.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess whether a 6-week titration (compared with a
      1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF
      [Tecfidera])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple
      sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration
      (compared with a 1-week titration) is effective in reducing the average severity and duration
      of GI symptoms over 12 weeks of DMF treatment in this study population.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of MS consistent with locally labeled indication for DMF

          -  No prior treatment with DMF

          -  Female subjects of childbearing potential who are not surgically sterile and male
             subjects must practice effective contraception during their participation in the study

          -  Have had a recent complete blood count (CBC), including lymphocyte count, that does
             not preclude participation in the study, in the judgement of the investigator

        Key Exclusion Criteria:

          -  Have a recent history or ongoing GI illness (e.g., peptic ulcer, irritable bowel
             syndrome) or any other current condition with GI signs and symptoms (e.g., nausea,
             vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study
             endpoints

          -  Have other major comorbid conditions that preclude participation in the study, as
             determined by the investigator

          -  Participant is pregnant, breastfeeding, or planning a pregnancy during the study
             period

          -  Are receiving concomitant disease-modifying therapies for MS including, but not
             limited to, natalizumab, interferon beta, glatiramer acetate, fingolimod, alemtuzumab,
             teriflunomide, or laquinimod at screening

          -  History of severe allergic or anaphylactic reactions or known drug hypersensitivity

          -  NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg; Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
Intervention description: Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks; Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: GW642444; COPD; Fluticasone Furoate

Summary:

      The primary purpose of the study is to evaluate the safety and tolerability of fluticasone
      furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese
      patients with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Out patient at least 40 years of age

          -  Both genders; females childbearing potencial must be willing to use birth control
             method

          -  A diagnosis of COPD at Screening

          -  Subjects with a current or prior history of at least 10 pack-years of cigarett smoking
             at Screening

          -  Post-bronchodilator FEV1/FVC ratio of less than 70%

          -  Post-bronchodilator FEV1 of less than 80%

        Exclusion Criteria:

          -  Current diagnosis of sthma

          -  Respiratory disorders other than COPD

          -  Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to
             Screening

          -  Concurrent other disease that would confound study participation or affect subject
             safety

          -  Allergies to study drugs, study drugs' excipients, medications related to study drugs

          -  Taking another investigational medication or medication prohibited for use during this
             study
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: pregabalin
Intervention description: Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety of the long-term use of pregabalin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed the 13-week treatment of postherpetic neuralgia in Study
             A0081120.

          -  Patients must be able to understand and cooperate with study procedures and have
             signed a written informed consent prior to entering the study.

        Exclusion Criteria:

          -  Patients who experienced serious adverse events in the preceding study (A0081120) that
             were determined by the investigator or the study sponsor to be causally related to the
             study medication.

          -  Patients exhibiting treatment non-compliance in the preceding study (A0081120)
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 154.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatrics

Summary:

      The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and
      pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants
      with type 2 diabetes. The study duration is approximately 60 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or
             basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks
             prior to study screening.

          -  Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine
             for diabetes, HbA1c must be between >6.5 % to ≤9%.

          -  Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50
             kilograms (110 pounds).

        Exclusion Criteria:

          -  Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic
             ketoacidosis or hyperglycemic hyperosmolar syndrome.

          -  A history of, or at risk for pancreatitis.

          -  Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid
             C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20
             picograms per milliliter (pg/ml) at screening.

          -  A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100
             mmHg.

          -  Active or treated cancer.

          -  A blood disorder where an accurate HbA1c may not be obtainable.

          -  A female of childbearing age, sexually active and not on birth control.

          -  Pregnant or plan to be pregnant during the study, or breastfeeding.

          -  Taking any diabetic medication other than metformin or basal insulin and have not
             stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime
             insulin).

          -  Have taken oral steroids within the last 60 days or more than 20 days use within the
             past year or 1000 micrograms fluticasone propionate per day.

          -  Using prescription weight loss medications in the last 30 days, or plan to use.

          -  Taking psychiatric medications for depression or illness or attention deficit
             hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.