bioihbjkbjnl/mcl2 huggingface dataset:
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Condition: Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Acute Coronary Syndrome; Atherosclerosis
Intervention: Alirocumab; Placebo; LMT
Intervention description: Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.; Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.; Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18924.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV)
      events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial
      infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring
      hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to
      52 weeks prior to randomization and were treated with evidence-based medical and dietary
      management of dyslipidemia.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD
           event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic
           stroke, CHD deaths, CV deaths, all cause mortality).

        -  To evaluate the safety and tolerability of alirocumab.

        -  To evaluate the effect of alirocumab on lipid parameters.
    

Eligibility criteria:

        Inclusion criteria :

        Recently (< 52 weeks) hospitalized for ACS.

        Exclusion criteria:

          -  Age < 40 years.

          -  ACS event occurring more than 52 weeks prior to randomization visit.

          -  LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL
             (<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59
             mmol/L) with evidence-based medical and dietary management of dyslipidemia.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
Condition: Oocyte Donation
Intervention: FSH (Follicle Stimulating Hormone)
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy
      volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation
      program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte
             donation with the following characteristics:

          -  Able and willing to sign the Subject Consent Form and adhere to the study visit
             schedule;

          -  >=18 and <35 years old;

          -  Regular menstrual cycle (26 - 35 days);

          -  BMI between 18 and 30 kg/m2;

          -  First gonadotrophin treatment (i.e. naïve Subjects with regard to exposure to human
             derived or recombinant gonadotrophins);

          -  basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l);

          -  Normal TSH levels;

          -  Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out
             period of two months).

        Exclusion Criteria:

          -  Age <18 and >=35 years;

          -  PCOS;

          -  Endometriosis;

          -  Subjects with evidences of autoimmune or rheumatic diseases;

          -  Hypersensitivity to the active substance or to any of the excipients (lactose);

          -  Abnormal bleeding of undetermined origin;

          -  Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal
             diseases);

          -  Uncontrolled adrenal dysfunction;

          -  Neoplasia;

          -  Severe impairment of renal and/or hepatic function;

          -  Use of concomitant medications that might interfere with study evaluations (e.g.
             immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin,
             growth hormone…).
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: E10030; bevacizumab or aflibercept; E10030 sham injection
Intervention description: Patients are randomized to receive either bevacizumab or aflibercept; Pressure on the eye with a syringe with no needle
Intervention MeSH terms: Bevacizumab; Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 645.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; choroidal neovascularization; Fovista®; E10030; Avastin®; Eylea®

Summary:

      The objectives of this study are to evaluate the safety and efficacy of intravitreal
      administration of Fovista® administered in combination with either Avastin® or Eylea®
      compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal
      neovascularization secondary to age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Active subfoveal choroidal neovascularization (CNV) secondary to AMD

          -  Presence of sub-retinal hyper-reflective material (SD-OCT)

        Exclusion Criteria:

          -  Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral
             supplements of vitamins and minerals

          -  Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless
             of indication (including intravitreal corticosteroids)

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy are excluded

          -  Diabetes mellitus
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
Condition: Postmenopausal Women With Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: GP2411; EU-Prolia (EU-authorized Prolia®)
Intervention description: 60 mg /mL subcutaneous injection every 6 months; 60 mg /mL subcutaneous injection every 6 months
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 527.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prolia; GP2411; denosumab; postmenopausal osteoporosis

Summary:

      This study was conducted to assess if there were any clinically meaningful differences in
      pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between
      GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women, diagnosed with osteoporosis

          -  Aged ≥ 55 and ≤ 80 years at screening

          -  Body weight ≥ 50 kg and ≤ 90 kg at screening

          -  Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar
             spine as measured by DXA

          -  At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by
             DXA

        Exclusion Criteria:

          -  Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)

          -  History and/or presence of one severe or more than two moderate vertebral fractures or
             hip fracture

          -  History and/or presence of bone metastases, bone disease or metabolic disease

          -  Ongoing use of any osteoporosis treatment or use of prohibited treatment

          -  Other bone active drugs

          -  History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or
             hypercalcemia
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Circadin; placebo circadin
Intervention description: Prolonged release melatonin 2 mg; placebo circadin tablets
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 930.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Primary insomnia as defined by DSM IV criteria

Summary:

      This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment
      period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged
      18-80 with melatonin deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female and aged 18-80 years.

          -  Are willing to take a 6-SMT level evaluation test.

          -  Suffering from primary insomnia according to DSM-IV. criteria (307.42 primary
             insomnia, Appendix 24.3) .

          -  Sleep latency of at least 20 minutes.

          -  Have not been using benzodiazepines (BZD) and non-BZD hypnotics for the past 2 weeks
             or more.

          -  Have not been using psychotropic treatments for the past 3 months or more.

          -  Are stabilized on non-psychotropic treatments for more than 1 month.

          -  Are willing to sign a written informed consent to participate in the study.

        Exclusion Criteria:

          -  Use of benzodiazepines or other hypnotics (including psychotropic treatments) during
             the study and preceding two weeks.

          -  Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.

          -  Pharmacological immunosuppression.

          -  Participation in a clinical trial with any investigational agent within two months
             prior to study enrollment.

          -  According to DSM IV, subjects belonging to the following groups are excluded: 780.59
             (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47
             (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical
             condition).

          -  Severe neurological, psychiatric disorders (especially psychosis, anxiety and
             depression) and alcoholism.

          -  Other serious diseases that could interfere with patient assessment.

          -  Pregnant or breast feeding women.
A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: DMARDs; Tocilizumab
Intervention description: Participants may continue on a stable dose of their current DMARD therapy as prescribed. The choice of DMARD is at the discretion of the treating physician and is not specified by the protocol.; Tocilizumab will be given as 8 mg/kg via IV infusion every 4 weeks for a total of 12 infusions. The maximum allowed dose is 800 mg.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in
      combination with DMARDs in participants with moderate to severe active rheumatoid arthritis
      who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8
      milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to
      their current DMARD therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe active RA of ≥6 months duration

          -  DAS28 >3.2

          -  Inadequate response to a stable dose of non-biologic DMARD for ≥2 months

          -  Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the
             28 days prior to first study treatment

        Exclusion Criteria:

          -  Rheumatic autoimmune disease other than RA

          -  History of or current inflammatory joint disease other than RA

          -  Previous treatment with alkylating agents or total lymphoid irradiation

          -  Intra-articular or parenteral corticosteroids within 6 weeks prior to Baseline

          -  Previous treatment with any cell-depleting therapies

          -  American College of Rheumatology (ACR) Functional Class IV
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; High Blood Sugar
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Dapagliflozin; Dapagliflozin; Placebo
Intervention description: Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose; Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose; Matching placebo for Dapagliflozin 5mg/10mg oral dose
Intervention MeSH terms: Dapagliflozin
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
Healthy volunteers: No
Keywords: Phase3; Clinical trial; Type2 Diabetes Mellitus

Summary:

      This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and
      safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who
      have inadequate glycemic control with diet and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Men or women age ≥20 years old (Either gender needs to be 40% or higher of total
             number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before
             randomization

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  FPG >240 mg/dL before randomization

          -  Subjects who have history of unstable or rapidly progressing renal disease

          -  Subjects who have severe hepatic insufficiency and/or significant abnormal liver
             function

          -  Significant cardiovascular history
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Aggression
Intervention: Inotuzumab ozogamicin; Rituximab; rituximab + gemcitabine; rituximab +bendamustine
Intervention description: 1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles; 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles; rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles
Intervention MeSH terms: Rituximab; Inotuzumab Ozogamicin; Gemcitabine; Bendamustine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: inotuzumab ozogamicin; aggressive Non-Hodgkin lymphoma; diffuse large b-cell lymphoma; relapsed/refractory lymphoma

Summary:

      The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab
      in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for
      intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of
      this combination compared with an active comparator arm (investigator's choice of
      rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall
      survival.
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Exclusion Criteria:

        -
A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Botulinum Toxin Type A 300U; Botulinum Toxin Type A 200U
Intervention description: Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.; Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long-term safety and effectiveness of botulinum
      toxin type A on patients with overactive bladder as a result of spinal cord injury or
      multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376
      and NCT00461292).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has participated in study 191622-515 or 191622-516 and the following criteria
             fulfilled:

               -  Patient completed at least 52 weeks in the preceding study.

               -  No longer than 6 months has elapsed since completion of the preceding study

               -  Patient has not received any prohibited medications during any intervening period
                  between the preceding study and this long-term study.

        Exclusion Criteria:

          -  History or evidence of pelvic or urologic abnormality.

          -  Previous or current diagnosis of bladder or prostate cancer.
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
Condition: Huntingtons Disease
MeSH terms: Huntington Disease
Intervention: RO7234292; Placebo
Intervention description: Intrathecal injection; Intrathecal injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 899.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HD, RG6042, intrathecal, ASO, antisense oligonucleotide

Summary:

      This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042)
      compared with placebo in participants with manifest Huntington's disease (HD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Manifest HD diagnosis, defined as a DCL score of 4

          -  Independence Scale (IS) score >= 70

          -  Genetically confirmed disease by direct DNA testing with a CAP score >400

          -  Clinical assessment to ensure individual has intact functional independence at
             baseline to maintain self-care and core activities of daily living (ADLs).

        Exclusion Criteria:

          -  Any serious medical condition or clinically significant laboratory, or vital sign
             abnormality or claustrophobia at screening that, in the investigator's judgment,
             precludes the patient's safe participation in and completion of the study

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             5 months after the final dose of study drug