bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: OPC-14597 (Aripiprazole)
Intervention description: administered orally once daily, 3 to 15 mg daily, 52 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To examine the safety and efficacy of long term administration of aripiprazole as an
      adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor
      (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major
      depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who are either inpatients or outpatients

          2. Patients who have the ability to understand and to provide informed consent to the
             examination, observation, and evaluation processes specified in this protocol, and
             have signed the informed consent form based on a full understanding of the trial

          3. Patients diagnosed as having either "296.2x Major Depressive Disorder, Single Episode"
             or "296.3x Major Depressive Disorder, Recurrent" according to DSM-IV-TR, and for whom
             the current episode of major depressive disorder has been ongoing for more than 8
             weeks.

        Exclusion Criteria:

          1. Female patients of child bearing potential who wish to become pregnant during the
             treatment period, or within 4 weeks after study completion/discontinuation

          2. Female patients who are pregnant, possibly pregnant, or breast feeding

          3. Patients judged to be unable to tolerate any type of antidepressant treatment
             (including drugs not being used in the current episode of major depressive disorder),
             based on treatment history to date

          4. Patients who have previously received electro-convulsive therapy

          5. Patients who have participated in clinical studies on medical devices or other drugs
             within the past month

          6. Patients at risk of having serious adverse events or developing symptoms that could
             interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia
             syndrome overlapping with symptoms of depression), based on previous medical history

          7. Patients with a history or a complication of diabetes

          8. Patients with thyroid disease (excluding patients who are stabilized on drug therapy
             for at least 3 months)

          9. Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant
             syndrome

         10. Patients with a history of seizure disorder (epilepsy etc.)
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
Condition: Lipid Metabolism, Inborn Errors; Hypercholesterolemia, Autosomal Dominant; Hyperlipidemias; Metabolic Diseases; Hyperlipoproteinemia Type II; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolic Disorder; Congenital Abnormalities; Hypercholesterolemia; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders
MeSH terms: Congenital Abnormalities; Hyperlipoproteinemia Type II; Genetic Diseases, Inborn; Homozygous Familial Hypercholesterolemia; Infant, Newborn, Diseases; Metabolism, Inborn Errors; Lipid Metabolism, Inborn Errors; Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Metabolic Diseases; Lipid Metabolism Disorders
Intervention: mipomersen; Placebo
Intervention description: 200 mg mipomersen administered once a week for 26 weeks as a 1 mL subcutaneous injection. Subjects weighing less than 50 kg received a lower dose of 160 mg (0.8mL) mipomersen.; 1 mL subcutaneous injection once a week for 26 weeks. Subjects weighing less than 50 kg received 0.8 mL subcutaneous injection.
Intervention MeSH terms: Mipomersen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Apolipoprotein B; Homozygous Familial Hypercholesterolemia; LDL-receptor gene

Summary:

      The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012)
      in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.

      This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up
      period. Following treatment and Week 28 evaluations, participants could elect to enroll in an
      open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or
      elected not to enroll in the open-label extension study or who discontinued during the
      28-week treatment period were followed in this study for 24 weeks from administration of the
      last dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Homozygous Familial Hypercholesterolemia (HoFH)

          -  Stable lipid-lowering therapy for 12 weeks

          -  Stable weight for 6 weeks

          -  Stable low fat diet for 8 weeks

        Exclusion Criteria:

          -  Significant health problems in the recent past including heart attack, stroke, blood
             disorders, cancer, or digestive problems
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: OTO-104
Intervention description: Single intratympanic injection of 12 mg OTO-104
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study of a single intratympanic injection of OTO-104 given
      every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study
      104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of
      OTO-104) in order to be eligible for this open-label extension study.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3
             (104-201508) clinical study.

          -  Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS
             criteria

        Exclusion Criteria includes, but is not limited to:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has experienced an adverse reaction to intratympanic injection of steroids.
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: TWINRIX™ ADULT; Engerix TM
Intervention description: 2 doses IM injection in primary study; If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis A; Hepatitis B; TWINRIX™ ADULT

Summary:

      The aim of this study is to evaluate the long-term persistence of hepatitis A and B
      antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary
      vaccination schedule of combined hepatitis A/hepatitis B vaccine.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      6 through to 10.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects participating in this study should have participated in the primary study
             with combined hepatitis A/ hepatitis B vaccine.

          -  Written informed consent will be obtained from each subject and/ or parent or guardian
             of the subject before the blood sampling visit of each year.
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 458.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor
      (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic
      fibrosis (CF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently participating in study VX17-659-105 (NCT03447262)

        Exclusion Criteria:

          -  History of drug intolerance in study VX17-659-105 that would pose an additional risk
             to the participant in the opinion of the investigator

          -  Current participation in an investigational drug trial (other than study VX17-659-105)

        Other protocol defined Inclusion/Exclusion criteria may apply.
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin; Canagliflozin; Placebo
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: MT-2412; MP-513; TA-7284; Teneligliptin; Canagliflozin

Summary:

      The purpose of this study is to evaluate the efficacy and safety of co-administration of
      Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese
      patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and
      have inadequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women who are 20 - 75 years old

          -  HbA1c of ≥7.0% and <10.5%

          -  FPG of ≤ 270 mg/dL

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 8 weeks before run-in period

        Exclusion Criteria:

          -  Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder,
             or secondary diabetes

          -  Patients with serious diabetic complications

          -  Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Patients with Class III/IV heart failure symptoms according to New York Heart
             Association (NYHA) functional classification

          -  Patients with severe hepatic disorder or severe renal disorder.
Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Condition: Familial Cold Autoinflammatory Syndrome (FCAS); Familial Cold Urticaria; Muckle-Wells Syndrome (MWS); Genetic Diseases, Inborn
MeSH terms: Genetic Diseases, Inborn; Cryopyrin-Associated Periodic Syndromes; Urticaria; Syndrome
Intervention: rilonacept 160 mg; Placebo; rilonacept 160 mg
Intervention description: Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. On Day 1, subjects received two injections of rilonacept (for a total of 320 mg).; Subcutaneous injection of Placebo occurred during first 6 weeks of the study or during randomized withdrawal (weeks 15-24). On Day 1, subjects received two placebo injections.; Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. No loading dose was given for subjects who entered directly into the open-label.
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: 104.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No
Keywords: Familial Cold Autoinflammatory Syndrome (FCAS); Muckle-Wells Syndrome (MWS); CIAS1; NLRP-3; PYPAF1; Cryopyrin; CAPS; Interleukin-1

Summary:

      Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations
      in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1).
      These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that
      stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the
      interleukin-1 cytokine and prevent it from binding to its receptors in the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Double-blind phases: adults age 18 and above; Open-label extension: Adults and
             children aged 7 years and older.

          -  Was diagnosed with Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells
             Syndrome (MWS) based upon clinical signs and symptoms

          -  Had documented mutation in NLRP-3 (Cold Induced Autoinflammatory Syndrome-1 or CIAS1)
             in subject or relative, and willingness to have a confirmatory genetic
             (Deoxyribonucleic acid or DNA) test (cheek swab).

          -  Was able to understand and comply with study procedures and was able to provide
             informed consent

          -  If female, was not currently pregnant and was willing to use contraception during the
             study

        Exclusion Criteria:

          -  Had evidence of untreated tuberculosis or other conditions/therapies that made the
             subject inappropriate for this study.
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: somapacitan; Norditropin
Intervention description: Once weekly subcutaneous injections (s.c., under the skin); Daily subcutaneous injections (s.c., under the skin)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once
      weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in
      previously human growth hormone treated Japanese adults with growth hormone deficiency.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years
        of age at the time of signing informed consent - GHD diagnosed for at least 6 months
        (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive
        months (defined as 180 days) at screening - If applicable, hormone replacement therapies
        for any other hormone deficiencies, adequate and stable for at least 90 days prior to
        randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease
        or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ
        carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete
        local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant
        tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years
        is documented in the subject's medical records - For subjects with surgical removal or
        debulking of pituitary adenoma or other benign intracranial tumour within the last 5
        years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within
        the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of
        growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT
        scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined
        as below or equal to 270 days) prior to randomisation
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: folate; methotrexate; methylprednisolone; placebo; rituximab
Intervention description: Intravenous repeating dose; Oral or parenteral repeating dose; Intravenous repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Methylprednisolone; Rituximab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 755.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rituxan; MTX; RA; IMAGE; WA17047

Summary:

      This is a phase III, randomized, controlled, double-blind, parallel group, international
      study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to
      Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be
      enrolled and will be allocated equally between 3 treatment arms.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult patients 18-80 years of age

          -  RA for ≥ 2 months;

          -  Receiving outpatient treatment

          -  Patients naive to, and considered to be candidates for, methotrexate treatment

        Exclusion criteria:

          -  Rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA

          -  Inflammatory joint disease other than RA, or other systemic autoimmune disorder

          -  Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16

          -  Surgery within 12 weeks of study

          -  Previous treatment with any approved or investigational biologic agent for RA, an
             anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy

          -  Concurrent treatment with any biologic agent or DMARD other than methotrexate
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Condition: Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Andecaliximab; Placebo; Leucovorin; 5-fluorouracil; Oxaliplatin
Intervention description: 800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle; Administered intravenously on Days 1 and 15 of each treatment cycle; Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle; Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle; Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal junction (GEJ); Stomach cancer

Summary:

      The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745)
      versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and
      oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal
             junction that is inoperable, locally advanced or metastatic and not amenable to
             curative therapy

          -  Adequate hematologic, liver, coagulation and kidney function

          -  Eastern Cooperative Oncology Group (ECOG) ≤ 1

          -  Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

        Key Exclusion Criteria:

          -  Previous chemotherapy for locally advanced or metastatic gastric cancer.

          -  Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer

          -  HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

          -  Pregnant or breast feeding women

          -  Individuals with known or suspected central nervous system metastases or individuals
             requiring chronic daily treatment with oral corticosteroids

          -  Grade ≥ 2 peripheral neuropathy

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.