bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Condition: Partial Seizures With or Without Secondary Generalization; Epilepsy
MeSH terms: Neoplasm Metastasis; Epilepsy; Seizures
Intervention: Placebo; Brivaracetam
Intervention description: Pharmaceutical form: Film-coated tablets
Route of administration: Oral use; Pharmaceutical form: Film-coated tablets
Concentration: 25 mg tablets and 50 mg tablets
Route of administration: Oral use
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: 449.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial seizures with or without secondary generalization; Brivaracetam; Briviact

Summary:

      The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to
      placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial
      seizures with or without secondary generalization despite current treatment with 1 or 2
      concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in
      subjects >= 16 years to 80 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive

          -  Female subjects with childbearing potential are eligible if they use a medically
             accepted contraceptive method

          -  Subjects having at least 8 partial seizures (according to the 1981 ILAE
             classification) during the 8-Week Baseline Period with at least 2 partial seizures
             during each 4-week interval of the Baseline Period

          -  Subjects having at least 2 partial seizures whether or not secondary generalization
             per month during the 3 months preceding Visit 1

          -  Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug
             [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a
             concomitant AED

        Exclusion Criteria:

          -  Subject has history or presence of status epilepticus during the year preceding Visit
             1 or during Baseline

          -  Subject is currently treated with levetiracetam

          -  Subject has taken levetiracetam within 90 days prior to Visit 1
Patisiran in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) Disease Progression Post-Liver Transplant
Condition: Amyloidosis, Familial; Transthyretin Amyloidosis
MeSH terms: Amyloidosis, Familial; Amyloidosis; Disease Progression
Intervention: Patisiran
Intervention description: Patisiran was administered via IV infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of
      patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR
      amyloidosis) with disease progression after liver transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received liver transplant for treatment of hATTR amyloidosis ≥12 months before study
             start

          -  Has increase in polyneuropathy disability (PND) score after liver transplant

          -  Has received stable immunosuppressive regimen with ≤10 mg/day of prednisone for at
             least 3 months before study start

          -  Has Karnofsky Performance Status (KPS) of ≥70%

          -  Has vitamin A level greater than or equal to lower limit of normal

        Exclusion Criteria:

          -  Has previously received inotersen or patisiran

          -  Has clinically significant liver function test abnormalities

          -  Has known portal hypertension with ascites

          -  Has estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m^2

          -  Has known leptomeningeal amyloidosis

          -  Has infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)

          -  Has New York Heart Association heart failure classification of >2

          -  Is wheelchair bound or bedridden

          -  Has received organ transplants other than liver transplant

          -  Will be using another tetramer stabilizer during the study
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
Condition: Infantile Refsum's Disease; Zellweger Syndrome; Adrenoleukodystrophy; Peroxisomal Disorders; Cholestasis
MeSH terms: Cholestasis; Zellweger Syndrome; Adrenoleukodystrophy; Refsum Disease; Refsum Disease, Infantile; Peroxisomal Disorders
Intervention: Cholic Acids
Intervention description: 10-15 mg/kg body weight/day taken orally.
Intervention MeSH terms: Cholic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Healthy volunteers: No

Summary:

      OBJECTIVES:

      I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate
      treatment to patients with identified inborn errors of bile acid synthesis and metabolism

      II. To assess the safety and tolerability of cholic acid
    

Eligibility criteria:

        PROTOCOL ENTRY CRITERIA:

        --Disease Characteristics--

        Clinical or biochemical evidence of liver disease, unexplained fat-soluble vitamin
        malabsorption, or peroxisomal dysfunction that compromises bile acid biosynthesis

        Inclusion criteria for enrollment were:

          -  Infants < age 3 months

          -  Children presenting for evaluation of cholestasis defined as a conjugated bilirubin >
             2mg/dl or increased serum bile acids

          -  Older subjects of any age with cholestatic liver disease if urine screens suggested
             that they had inborn errors of bile acid metabolism

          -  Confirmation of a diagnosis of an inborn error of bile acid synthesis based upon urine
             analysis by FAB-MS to determine whether specific abnormalities in bile acid synthesis
             are indicated

          -  The patient and/or parent/legal guardian must have signed the written informed consent
             document before study start.

          -  The patient must be willing and able to comply with all study assessments and
             procedures.
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Cariprazine
Intervention description: Placebo was supplied in capsules.; Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase
Enrollment: 765.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizophrenic disorder

Summary:

      The objective of this study is to evaluate the efficacy and safety of cariprazine relative to
      placebo in the prevention of relapse of symptoms in participants with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have provided informed consent prior to any study specific
             procedures.

          -  Participants currently meeting the Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.

          -  Participants with normal physical examination, laboratory, vital signs, and/or
             electrocardiogram (ECG).

          -  Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).

          -  Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1
             (Screening) and Visit 2 (beginning of Run-in Phase).

          -  Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to
             female participants of childbearing potential only).

          -  Body mass index between 18 and 40 kg/m^2, inclusive.

        Exclusion Criteria:

          -  Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder,
             schizophreniform disorder, bipolar I and II and known or suspected borderline or
             antisocial personality disorder. or other DSM-IV-TR axis II disorders.

          -  Participants in their first episode of psychosis.

          -  Treatment-resistant schizophrenia over the last 2 years.

          -  Positive result from the blood alcohol test or from the urine drug screen for any
             prohibited medication.

          -  At imminent risk of injuring self or others or causing significant damage to property.

          -  Suicide risk.
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Condition: Kidney Transplantation
Intervention: Belatacept; Tacrolimus; Cyclosporine
Intervention MeSH terms: Cyclosporine; Abatacept; Tacrolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 446.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose is to assess the benefits and risks of changing from Cyclosporine or
      Tacrolimus to Belatacept between 6-60 months after kidney transplant.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women, ages 18-75 inclusive

          -  Adult recipients of a renal allograft from a living donor or a deceased donor between
             6-60 months prior to enrollment

          -  Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A
             (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated
             Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids

          -  Stable renal function for 12 weeks prior to enrollment without new onset proteinuria

          -  Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification
             of Diet in Renal Disease study (MDRD) 4-formula]

        Exclusion Criteria:

          -  Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown

          -  History of acute rejection (AR) within 3 months prior to enrollment

          -  History of antibody mediated rejection

          -  Positive T-cell lymphocytotoxic cross match

          -  Proteinuria >1 g/day or >0.5 g/day if diabetic
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
Condition: Sjogren-Larsson Syndrome
MeSH terms: Sjogren's Syndrome; Sjogren-Larsson Syndrome; Syndrome
Intervention: ADX-102 1% Topical Dermal Cream (reproxalap); Vehicle of ADX-102 Topical Dermal Cream
Intervention description: ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.; Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No
Keywords: ADX-102, Sjögren-Larsson Syndrome

Summary:

      A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the
      Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson
      Syndrome (SLS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is aged 3 years or older

          -  Subject has a genetically-confirmed diagnosis of SLS.

          -  Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis
             Severity (VIIS) score.

          -  Females of child-bearing potential: Negative pregnancy test at Screening and Baseline
             Visits.

        Exclusion Criteria:

          -  Subject has evidence of a serious active infection.

          -  Systemic or topical retinoids or other topical medications, not including emollients,
             within the past 30 days Baseline Visit 1.

          -  Subject has received an investigational systemic or topically administered drug within
             the past 30 days prior to Baseline Visit 1.

          -  Subject is currently receiving immunosuppressive therapy, including intermittent or
             low-dose systemic corticosteroids.

          -  Subject has a known allergic reaction to any ingredients of study drug formulation.

          -  Subject has any clinically significant laboratory test abnormalities or a history of
             any other condition that, in the opinion of the Investigator, could compromise the
             subject's ability to comply with the protocol or that could compromise the subject's
             safety or the interpretation of the study results.
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Glycopyrronium Topical Wipes
Intervention description: Glycopyrronium Topical Wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 564.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up
      to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04
      or DRM04-HH05 studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80%
             treatment compliance

          -  Male or females

        Exclusion Criteria:

          -  Subject has a clinically significant abnormality on physical exam, vital signs or ECG
             at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further
             treatment with glycopyrronium contraindicated

          -  Male with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy

          -  Any other condition which, in the judgement of the Investigator, would put the subject
             at unacceptable risk for participation in the study
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Condition: Narcolepsy; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Narcolepsy; Sleepiness
Intervention: JZP-110
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 645.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110
      in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or
      ADX-N05 202.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Subject meets one of the following:

               1. Completed Study 14-002 or 14-003 (Group A)

               2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)

          2. Body mass index from 18 to <45 kg/m2

          3. Consent to use a medically acceptable method of contraception

          4. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             narcolepsy or OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          4. Presence of any acutely unstable medical condition, behavioral or psychiatric disorder
             (including active suicidal ideation), or surgical history that could affect the safety
             of the subject or interfere with study efficacy or safety assessments, or the ability
             of the subject to complete the trial per the judgment of the Investigator

          5. History of bariatric surgery within the past year or a history of roux-en-y procedure

          6. Presence or history of significant cardiovascular disease

          7. Use of any over the counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          8. Received an investigational drug other than JZP-110 in the past 30 days or five
             half-lives (whichever is longer)

          9. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ZD9393 (Zoladex) 10.8 mg; ZD9393 (Zoladex) 3.6 mg
Intervention description: 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).; 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
Intervention MeSH terms: Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: Female
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: ZOLADEX; Pre-menopausal; Oestrogen Receptor; Advanced Breast Cancer; Progression Free Survival

Summary:

      The purpose of this study is to examine the efficacy and safety as well as the
      characteristics of the female hormone and study medications after administration in
      pre-menopausal women with estrogen receptor positive advanced breast cancer who were
      randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot
      group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1
             year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of
             randomisation.

          -  Hormone sensitivity (ER positive) of primary or secondary tumour tissue.

          -  Histological/cytological confirmation of breast cancer and are candidates to receive
             hormonal therapy as therapy for advanced breast cancer.

        Exclusion Criteria:

          -  Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy
             for breast cancer within 24 weeks before randomisation and/or who have received prior
             treatment with hormonal therapies for advanced breast cancer

          -  Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks
             before randomisation

          -  Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after
             completion of adjuvant hormonal therapy and/or
Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
Condition: Leukaemia, Lymphocytic, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: OFC Infusion; FC infusion
Intervention description: Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles; Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed; Oncology; Safety; Chronic Lymphocytic Leukemia; Ofatumumab; Efficacy

Summary:

      The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to
      fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  confirmed and active CLL requiring treatment

          -  at least one previous treatment for CLL and having achieved a complete or partial
             remission/response but after a period of 6 or more months, shows evidence of disease
             progression

          -  fully active at a minimum or fully capable of selfcare and up and about more than 50%
             of waking hours

          -  age 18yrs or older

          -  signed written informed consent

        Key Exclusion Criteria:

          -  diagnosis of refractory CLL (failure to achieve a complete or partial
             remission/response or disease progression within 6 months of last anti-CLL treatment

          -  abnormal/inadequate blood values, liver and kidney function

          -  certain heart problems, serious significant diseases, AIHA, other current cancers or
             within the last 5 years

          -  active or chronic infections

          -  use of drugs to suppress allergic or inflammatory responses (glucocorticoids)

          -  CLL transformation

          -  CLL central nervous system involvement

          -  current participation in other clinical study

          -  inability to comply with the protocol activities

          -  lactating or pregnant women or female patients of child-bearing potential (or male
             patients with such partners) not willing to use adequate contraception