bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis; Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab; Adalimumab; Placebo
Intervention description: Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.; Adalimumab will be administered according to the labeling recommendations.; Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis

Summary:

      This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of
      subjects with moderate to severe chronic plaque psoriasis (PSO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age

          -  Chronic plaque PSO for at least 6 months prior to the Screening Visit

          -  Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
             >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

          -  Subject is a candidate for systemic PSO therapy and/or phototherapy

          -  Female subject of child bearing potential must be willing to use highly effective
             method of contraception

        Exclusion Criteria:

          -  Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab

          -  Subject has an active infection (except common cold), a serious infection, or a
             history of opportunistic or recurrent chronic infections

          -  Subject has concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
             infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

          -  Subject has any other condition, including medical or psychiatric, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in the study

          -  Subject has had previous exposure to adalimumab

          -  Presence of active suicidal ideation or positive suicide behavior

          -  Presence of moderately severe major depression or severe major depression

          -  Subject has any active malignancy or history of malignancy within 5 years prior to the
             Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
             carcinoma, or in situ cervical cancer
Radial Artery Versus Saphenous Vein Patency (RSVP) Study
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Intervention: Coronary artery bypass graft (CABG) surgery
Intervention description: Patients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Coronary artery bypass; Coronary arteries; Atherosclerosis; Angiography; Blood flow

Summary:

      The purpose of this study is to determine whether the radial artery (artery in the arm) or
      saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass
      surgery, have a greater patency rate (degree of opening)at 5 years after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  on waiting list for clinically-indicated myocardial revascularization surgery

          -  aged 40-70 years

          -  significant stenosis (≥70%) in the circumflex territory as identified on preoperative
             angiograms

          -  negative Allen's test (defined as the return of palmar circulation within 5 seconds of
             releasing ulnar artery compression)

          -  willing to give written informed consent

        Exclusion Criteria:

          -  poor left ventricular (LV) function (LV ejection fraction <25%)

          -  severe diffuse peripheral vascular disease or bilateral varicose venous disease

          -  inability to comply with the angiographic follow-up at 3 months or/and 5 years
Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Intervention: Prednisone; Dexamethasone
Intervention description: Continuous daily therapy; 4-day pulses every 3 weeks
Intervention MeSH terms: Dexamethasone; Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1
      between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and
      six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary
      endpoint is duration of remission defined as platelets ≥50/nl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First episode of ITP

        Exclusion Criteria:

          -  Pregnancy

          -  Glucocorticoid intolerance
A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease
Condition: End Stage Renal Failure on Dialysis
MeSH terms: Kidney Failure, Chronic
Intervention: Hemodialysis; Patiromer Oral Product
Intervention description: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.; Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hemodialysis; Kidney Disease; Kidney Function

Summary:

      The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney
      disease in not known. This pilot trial will randomize patients with incident end-stage kidney
      disease due to chronic kidney disease progression to two different regimens of hemodialysis:
      i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed
      by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. The study will test
      feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on
      residual kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Incident ESKD from CKD progression (including a failing renal transplant)

          -  Are deemed to require dialysis initiation by the treating nephrologist

          -  Have elected HD for renal replacement therapy (RRT)

        Exclusion Criteria:

          -  Have urine output <500ml per day

          -  Have ESKD as a result of severe acute kidney injury (AKI) (stage 3 AKI defined by
             Acute Kidney Injury Network [AKIN]) criteria)

          -  Abrupt decline in kidney function preceding HD therapy initiation (i.e., if eGFR was
             ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy)

          -  Are scheduled to undergo transplantation from a live donor within the next 6 months

          -  Have an active diagnosis of hepatorenal syndrome

          -  Have a significant malignancy that is likely to impact survival

          -  Have a medical condition that would jeopardize the safety of the subject.
An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Ubrogepant; Placebo-matching Ubrogepant; Usual Care
Intervention description: Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.; Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1254.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of intermittent treatment with
      ubrogepant for the acute treatment of migraine over 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

        -Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

        Exclusion Criteria:

          -  Patients with clinically significant electrocardiogram (ECG), vital sign, physical
             exam, or laboratory abnormalities

          -  Requirement for a medication during the study that is on the list of prohibited
             medications.
BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
Condition: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion
MeSH terms: Salivary Gland Diseases
Intervention: Ciprofloxacin; Placebo
Intervention description: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.; Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion; BK Polyomavirus

Summary:

      The purpose of this study is to analyze BK viral infection in salivary gland diseases;
      specifically, to determine a definitive relationship between BK Virus and HIV associated
      salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1
      to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary
      function/protein secretion will be correlated with BK polyomavirus titers. It is expected
      that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will
      benefit from Ciprofloxacin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive with Salivary Gland Disease

          -  Ability to read and understand English

        Exclusion Criteria:

          -  Allergy to the family of fluoroquinolones (including ciprofloxacin)

          -  Currently taking tizanidine

          -  Concurrently taking antiacids containing magnesium hydroxide or aluminum hydroxide

          -  Current use of Theophylline

          -  Previous tendon disorder such as Rheumatoid arthritis

          -  History of seizures

          -  Current use of phenytoin

          -  Current use of glyburide

          -  Current use of methotrexate

          -  Severe renal impairment (known creatinine clearance < 30 or on dialysis)
An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: 8 mg/kg administered intravenously (IV) every 4 weeks for 104 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm, multicenter long-term extension study of WA19926 evaluated the
      safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to
      severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients
      received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/= 18 years of age

          -  Participants who complete their last WA19926 core study visit (Week 104) and who may
             benefit from study drug treatment according to the Investigator's assessment

          -  No current or recent adverse event or laboratory finding preventing the use of the
             study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit

          -  Women of childbearing potential must agree to use adequate contraception as defined by
             protocol during the treatment period

        Exclusion Criteria:

          -  Pregnant females

          -  Participants who have withdrawn prematurely from the WA19926 core study for any reason

          -  Treatment with any investigational agent or cell-depleting therapies since the last
             administration of study drug in WA19926

          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
             or a T-cell costimulation modulator since the last administration of study drug in
             WA19926

          -  Immunization with a live/attenuated vaccine since the last administration of study
             drug in WA19926

          -  Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other
             than rheumatoid arthritis

          -  Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than
             rheumatoid arthritis

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies, including tocilizumab and its excipients

          -  Evidence of severe uncontrolled concomitant disease or disorder

          -  Known active or history of recurrent infections

          -  Active tuberculosis requiring treatment in the previous 3 years

          -  History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent pneumococcal conjugate vaccine
Intervention description: A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 6 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety, tolerability and immunogenicity of a single dose of
      13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are
      considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal
      vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese males and females aged 6 to <65 years at enrollment.

          -  Subjects with an increased risk of pneumococcal disease determined by documented
             medical history, physical examination, and clinical judgment of the investigator.

        Exclusion Criteria:

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt during study participation.

          -  End-stage disease including but not limited to metastatic malignancy, severe chronic
             obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal
             disease with or without dialysis.

          -  Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months
             before investigational product administration or history of HSCT, or potential for
             solid organ transplant or HSCT during study participation.

          -  Receipt of cytotoxic chemotherapy or blood products within 3 months before
             investigational product administration or anti-B-cell antibodies within 6 months
             before investigational product administration through completion of study
             participation.

          -  Any contraindication to vaccination or vaccine components, including previous
             anaphylactic reaction to any vaccine or vaccine-related components.

          -  Documented S pneumoniae infection within the past 5 years before investigational
             product administration.
A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Olumacostat Glasaretil Gel, 5.0%
Intervention description: Gel containing Olumacostat Glasaretil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 748.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel,
      5.0% in patients with acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent or assent (for subjects under legal adult age)

          -  Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.

          -  Willing to comply with the protocol. Subjects under legal adult age will be assessed
             by the investigator as to their ability to comply with the protocol

          -  Willing to refrain from using any treatments on the face for acne vulgaris, other than
             the investigational product, including topical or systemic antibiotics.

        Exclusion Criteria:

          -  Abnormal clinically significant findings on physical exam, vital signs or ECG at Week
             12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further
             treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the
             Investigator

          -  Any other condition which, in the judgment of the investigator, would put the subject
             at unacceptable risk for participation in the study
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Tablet, Flexible dosing up to 200 mg/day, twice daily.
The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 767.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures; Adjunctive treatment

Summary:

      This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and
      single arm study of brivaracetam (BRV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject completed the Treatment Period of N01358 or the evaluation period of N01258

          -  Male/female subject from 16 years or older. Subject under 18 years may only be
             included where legally permitted and ethically accepted

          -  Subject for whom the Investigator believes a reasonable benefit from the long term
             administration of BRV may be expected

          -  Female subject without childbearing potential (premenarcheal, postmenopausal for at
             least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are
             eligible

        Exclusion Criteria:

          -  Subject has developed hypersensitivity to any components of the investigational
             medicinal product (IMP) or comparative drugs as stated in this protocol during the
             course of the core studies

          -  Severe medical, neurological, or psychiatric disorders, or laboratory values which may
             have an impact on the safety of the subject

          -  Poor compliance with the visit schedule or medication intake in the previous BRV study

          -  Planned participation in any other clinical study of another investigational drug or
             device during this study

          -  Pregnant or lactating woman

          -  Any medical condition which, in the Investigator's opinion, warrants exclusion

          -  Subject has a lifetime history of suicide attempt or has suicidal ideation in the past
             6 months
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant; Placebo
Intervention description: Atogepant tablet; Placebo-matching atogepant tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 910.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Migraine; Aura

Summary:

      To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the
      prevention of migraine in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a
             diagnosis.

          -  Age of the participant at the time of migraine onset <50 years.

        Exclusion Criteria:

          -  Has a history of migraine accompanied by diplopia or decreased level of consciousness
             or retinal migraine.

          -  Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal
             autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy.

          -  History of an inadequate response to >4 medications (2 of which have different
             mechanisms of action) prescribed for the prevention of migraine.

          -  Participants with clinically significant hematologic, endocrine, cardiovascular,
             pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.