bioihbjkbjnl/mcl2 huggingface dataset:
A Controlled Trial of Erenumab in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Intervention MeSH terms: Erenumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 261.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the efficacy and safety of erenumab for prevention of
      migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent/assent prior to initiation of any study specific
             activities/procedures.

          -  Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age
             upon entry into screening.

          -  History of migraine (with or without aura) for greater than or equal to 12 months
             before screening according to the International Headache Society Classification ICHD-3
             (Headache Classification Committee of the International Headache Society, 2018) based
             on medical records and/or patient self-report

          -  Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months
             before screening based on the following criteria:

               1. CM is defined as greater than or equal to 15 headache days per month of which
                  greater than or equal to 8 headache days on average across the 3 months meet
                  criteria as migraine days

               2. EM is defined as less than 15 headache days per month of which at least 4 or more
                  headache days on average across the 3 months meet criteria as migraine days

        Exclusion Criteria:

          -  Subjects greater than 50 years of age at migraine onset.

          -  History of cluster headache or hemiplegic migraine headache.

          -  Unable to differentiate migraine from other headaches.

          -  Migraine with continuous pain, in which the subject does not experience any pain-free
             periods (of any duration) during the 1 month before the screening period.

          -  Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in
             situ within the last 5 years.

        Other exclusion criteria may apply
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Intervention: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014); PedvaxHIB; Prevnar; M-M-R II; Varivax
Intervention description: Booster dose by intramuscular injection; Booster dose by intramuscular injection; Booster dose by intramuscular injection; Single dose by subcutaneous injection; Single dose by subcutaneous injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 4021.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H. influenzae type B vaccine; Infants; Neisseria meningitidis; Vaccines, conjugate; Meningococcal vaccines; Prophylaxis; Comparative study; Safety; Humans

Summary:

      The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a
      control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00345579).

      No new recruitment will take place during this booster phase of the study. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects enrolled in the primary study (NCT00345579) are eligible for participating in
             the booster study

        Exclusion Criteria:

        Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

          -  History of measles, mumps, rubella or varicella.

          -  Previous vaccination against measles, mumps, rubella or varicella.

          -  Hypersensitivity to any component of the vaccines, including gelatin or neomycin.

          -  Patients receiving immunosuppressive therapy.

          -  Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant
             neoplasms affecting the bone marrow or lymphatic systems.

          -  Individuals with primary and acquired immunodeficiency states.

          -  Individuals with a family history of congenital or hereditary immunodeficiency, until
             the immune competence of the potential vaccine recipient is demonstrated.

          -  Individuals with active tuberculosis.

          -  Acute disease at time of booster vaccination
A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: rivaroxaban; uninterrupted vitamin K antagonist (VKA)
Intervention description: rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal; dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0
Intervention MeSH terms: Vitamin K; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Irregular heart beat; Catheter Ablation; Rivaroxaban

Summary:

      The purpose of this exploratory study is to evaluate the safety of rivaroxaban and
      uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial
      fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major
      bleeding events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation
             (NVAF);

          -  Have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1
             week and <1 year or requiring pharmacological or electrical cardioversion), or long
             standing persistent (>=1 year) NVAF;

          -  Be suitable for anticoagulant therapy and catheter ablation as per the judgment of the
             investigator;

          -  Women must be postmenopausal before entry or practicing a highly effective method of
             birth control when heterosexually active;

          -  Women of childbearing potential must have a negative serum pregnancy test at
             screening;

          -  Be willing and able to adhere to the prohibitions and restrictions specified in the
             study protocol;

          -  Have a life expectancy of at least 6 months

        Exclusion Criteria:

          -  Has a history of a prior stroke, transient ischemic attack (TIA) or non-convulsive
             status epilepticus within 6 months of the screening visit;

          -  Has a history of a major bleeding or thromboembolic event within the 12 months
             immediately preceding the catheter ablation procedure;

          -  Has had major surgery (requiring general anesthesia), within 6 months before screening
             or planned surgery during the time the subject is expected to participate in the
             study;

          -  Has NVAF due to electrolyte imbalance, hyperthyroidism, or other reversible or
             noncardiac cause of NVAF;

          -  Has any condition that, in the opinion of the investigator, would make participation
             not be in the best interest (eg, compromise the well-being) of the participant or that
             could prevent, limit, or confound the protocol-specified assessments
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast; Placebo
Intervention description: 500 mcg, once daily, oral administration in the morning; once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1568.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Roflumilast; COPD; Chronic obstructive pulmonary disease

Summary:

      The aim of the study is to compare the effect of roflumilast on exacerbation rate and
      pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast
      will be administered orally once daily in the morning at one dose level. The study duration
      will be up to 56 weeks. The study will provide further data on safety and tolerability of
      roflumilast.

      For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673
      (toll free).
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  COPD patients having at least one exacerbation within last year

          -  FEV1/FVC ratio (post-bronchodilator) ≤ 70%

          -  FEV1 (post-bronchodilator) ≤ 50% of predicted

        Main Exclusion Criteria:

          -  COPD exacerbation not resolved at first baseline visit

          -  Diagnosis of asthma and/or other relevant lung disease
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
Condition: Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: ombitasvir/paritaprevir/ritonavir; dasabuvir; ribavirin
Intervention description: tablet; paritaprevir co-formulated with ritonavir and ombitasvir; tablet; tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Cirrhosis; Hepatitis C; Child-Pugh B; Hepatitis C Genotype 4; Interferon-Free; Hepatitis C Genotype 1; Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus

Summary:

      The primary objectives of this study are to assess the safety and the SVR12 rate of
      ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with
      decompensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL
             and laboratory result indicating HCV GT1 or GT4 infection at Screening.

          2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e.,
             computed tomography [CT] scan or magnetic resonance imaging [MRI]).

          3. Child-Pugh Score of 7 - 9, inclusive, at time of Screening.

        Exclusion Criteria:

          1. Women who are pregnant or breastfeeding.

          2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies
             (HIV Ab).

          3. Prior or current use of any other investigational or commercially available anti-HCV
             agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including
             but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).

          4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as
             CT scan or MRI within 3 months prior to Screening or on an ultrasound performed at
             Screening (a positive ultrasound result will be confirmed with CT scan or MRI).

          5. Any current or past evidence of Child-Pugh C classification.
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
Condition: Dyspepsia; Helicobacter Pylori Infection
MeSH terms: Infections; Dyspepsia
Intervention: RHB-105; Placebo
Intervention description: The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:
Rifabutin 150 mg
Amoxicillin 3000 mg
Omeprazole 120 mg
Subjects will take study drug every 8 hours with food for 14 consecutive days.; Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Helicobacter pylori; H. pylori; Dyspepsia

Summary:

      The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is
      rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a
      new triple therapy to treat H. pylori infection in dyspeptic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be ≥18 years of age and ≤ 65 years

          2. Have symptoms consistent with dyspepsia of at least two weeks duration (defined as
             recurrent pain or discomfort centered in the upper abdomen, often with a relation to
             meals)

          3. Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test

          4. Be informed of the nature of the study and provide written informed consent before any
             study specific procedures are performed (or have a legally authorized representative
             sign consent)

        Exclusion Criteria:

          1. Have alarm symptoms/signs (including unexplained anemia [iron deficiency), melena /
             hematemesis, anorexia, dysphagia, jaundice, weight loss)

          2. Have taken antibiotics in the 4 weeks prior to screening

          3. Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to
             screening

          4. Have a history of any previous esophageal or gastric surgery, except for simple
             closure of perforated ulcer

          5. Have a history of gastric outlet obstruction

          6. Have a history of hypersecretory state such as Zollinger-Ellison Syndrome

          7. Have a history of gastric cancer

          8. Have the presence of active gastric and duodenal ulcers or presence of 3 or more
             active ulcers
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
Condition: Kidney Transplantation; Graft Rejection
Intervention: Everolimus; Mycophenolic Acid (MPA); Cyclosporine A (CsA); Basiliximab; Corticosteroids
Intervention description: oral, bis in diem/twice a day (bid); 2 oral capsules of mycophenolic acid 360mg administered bid; CsA dose adjustments were based on CsA trough levels (C0).; All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.; Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Basiliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 833.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Renal transplantation, kidney, and organ transplant; Renal transplant rejection

Summary:

      The purpose of this study was to compare the safety and efficacy of three immunosuppressive
      treatment regimens following a kidney transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients of any race between 18 to 70 years old (inclusive)

          -  Patients who gave written informed consent to participate in the study

        Exclusion Criteria:

          -  Recipients of multi-organ transplantation

          -  Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA)
             identical living donor kidney transplantation.

          -  Graft cold ischemia time greater than 40 hours.

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study in Adults With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2963016; Lantus; OAMs
Intervention description: Administered subcutaneously; Administered subcutaneously; Administered orally
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 759.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Type 2 Diabetes

Summary:

      The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus
      Lantus in controlling blood sugar levels in combination with two or more oral diabetes
      medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health
             Organization (WHO) classification

          -  Have been taking at least 2 types of oral diabetes medications for at least 12 weeks
             prior to entering the study

          -  Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or
             equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c
             must be less than or equal to 11.0 percent

          -  Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)

        Exclusion Criteria:

          -  Have significant liver, cardiac or gastrointestinal disease

          -  Have active cancer or have had cancer within the past 5 years (with the exception of
             basal cell carcinoma or carcinoma in situ)

          -  Have an excessive resistance to insulin or hypersensitivity to Lantus

          -  Have had more than one episode of severe low blood sugar (defined as needing someone
             else to help because you had very low blood sugar) within the 6 months before entering
             the study

          -  Have taken any other insulin other than Lantus within the past 30 days

          -  Taking any other diabetes medicines that are not allowed in the study or not approved
             to be taken with insulin
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone
Intervention description: Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles.; Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 587.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose
      dexamethasone.

      Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone
      in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and
      then every 4 weeks after the third cycle until disease progression is documented, study drug
      is discontinued for any reason or lenalidomide becomes commercially available for this
      indication. Assessments of safety and quality of life are performed during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of
             anti-myeloma treatment or that has relapsed with progressive disease after treatment.

          -  Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first
             dose of study drug with the exception of radiation therapy initiated prior to
             baseline.

          -  Females of childbearing potential must agree to use two reliable forms of
             contraception simultaneously or to practice complete abstinence.

        Exclusion Criteria:

          -  Pregnant or lactating females
Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: generalized pustular psoriasis; skin condition; skin disease,

Summary:

      The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese
      subjects with generalized pustular psoriasis (GPP). This study was expected to support the
      filing of secukinumab in the indication of pustular psoriasis in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At baseline, presence of GPP classified on the basis of the criteria for diagnosis of
             GPP by Japanese Dermatological Association (JDA)

          -  At baseline, erythema area with pustule ≥ 10%

        Exclusion Criteria:

          -  Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.

          -  At baseline, : total score of JDA severity index for GPP ≥ 14

          -  Drug-induced psoriasis

          -  Ongoing use of prohibited psoriasis treatments.