bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 438.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; ixekizumab; skin condition; skin disease; itching; psoriasis vulgaris; immune-mediated systemic disease; skin lesions; scaly patches; papules

Summary:

      The purpose of this study is to determine the efficacy and safety of the study drug
      ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris
             for at least 6 months prior to baseline.

          -  Have ≥10% BSA involvement at screening and baseline.

          -  Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.

          -  Are candidates for phototherapy and/or systemic therapy.

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic
             and/or guttate psoriasis) at screening or baseline.

          -  Drug-induced psoriasis.

          -  Ongoing use of prohibited treatments.

          -  Have previously completed or withdrawn from this study, or have previously exposed to
             ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such
             as secukinumab) or the IL-17 receptor.

          -  Have concurrent or recent use of any biologic agent within washout periods or <5
             half-lives prior to baseline, whichever is longer.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test.
Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Condition: Procedural Sedation and Analgesia
MeSH terms: Emergencies
Intervention: Ketamine; Ketamine Co-administered with Propofol
Intervention description: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person); 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 183.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Ketamine; Propofol; Procedural Sedation and Analgesia

Summary:

      The purpose of this study is to compare the effectiveness of the co-administration of
      intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural
      sedation in the pediatric emergency department. The investigators hypothesize that patients
      receiving co-administration of ketamine and propofol will have a lower rate of adverse
      events, compared to patients receiving ketamine for procedural sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages > 3 years and < 21 years

          -  American Society of Anesthesiologists (ASA) class I or II

          -  Fracture or dislocation requiring reduction under procedural sedation with ketamine as
             deemed by the attending emergency medicine physician

          -  Parent/Legal Guardian or Patient (if 18 years of age or older) has already given
             verbal consent for procedural sedation as part of standard care for their condition

        Exclusion Criteria:

          -  Hypertension (Blood Pressure > 95th percentile for age)

          -  Glaucoma or acute globe injury

          -  Increased intracranial pressure or central nervous system mass lesion

          -  Porphyria

          -  Previous allergic reaction to ketamine

          -  Previous allergic reaction to Propofol or its components including soybean oil,
             glycerol, egg lecithin, and disodium edentate

          -  Disorders of lipid metabolism including primary hyperlipoproteinemia, diabetic
             hyperlipemia, or pancreatitis

          -  Mitochondrial myopathies or disorders of electron transport

          -  Pregnancy

          -  Parent, guardian or patient unwilling/unable to provide informed consent/assent
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
Condition: Contraception
Intervention: Radiopaque Implanon; Implanon (etonogestrel implant)
Intervention description: Radiopaque rod for 3 years; Implanon (etonogestrel implant) for 3 years
Intervention MeSH terms: Etonogestrel; Desogestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and
      Radiopaque IMPLANON.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 but not older than 40 years of age at the time of screening

          -  Good physical and mental health

          -  Regular cycles with a usual length between 24 and 35 days

          -  Body mass index ≥ 18 and ≤ 29

          -  Willing to give informed consent in writing

        Exclusion Criteria:

          -  Contraindications:

               -  known or suspected pregnancy

               -  active venous thromboembolic disorder (e.g. deep vein thrombosis,pulmonary
                  embolism)

               -  presence or history of severe hepatic disease as long as liver function values
                  have not returned to normal

               -  malignancy or pre-malignancy, if sex -steroid-influenced

               -  undiagnosed vaginal bleeding

               -  hypersensitivity to any of the components of Implanon/Radiopaque Implanon

          -  Hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood pressure >
             90 mmHg.

          -  A history during pregnancy or during previous use of sex steroids of: jaundice and/or
             severe pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus
             erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis;
             otosclerosis-related hearing loss

          -  Present use or use during 2 months prior to the start of Implanon/Radiopaque Implanon
             of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine,
             rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin
             or the herbal remedy St John's wort.

          -  Administration of investigational drugs within 2 months prior to the start of
             Implanon/Radiopaque Implanon
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Placebo; Nalmefene
Intervention description: as-needed use, tablets, orally, 52 weeks; 18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Intervention MeSH terms: Nalmefene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharmacologic Actions; Alcohol-Related Disorders; Alcoholism; Mental Disorders; Central Nervous System Agents

Summary:

      The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in
      patients with alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

        In- and outpatients who:

          -  had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical
             Manual of Mental Disorders - text revision (DSM-IV-TR) criteria

          -  had had ≥6 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

        Exclusion Criteria:

        The patient:

          -  had a severe psychiatric disorder or an antisocial personality disorder

          -  had risk of suicide evaluated by the suicidality module of the Mini-International
             Neuropsychiatric Interview (MINI)

          -  had a history of delirium tremens or alcohol withdrawal seizures

          -  reported current or recent (within 3 months preceding screening) treatment with
             disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid
             antagonists

          -  was pregnant or breast-feeding

        Other protocol-defined inclusion and exclusion criteria may apply.
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: OnabotulinumtoxinA
Intervention description: OnabotulinumtoxinA injected into the detrusor wall on Day 1.
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: 114.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the
      treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric
      participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and
      effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary incontinence due to neurogenic detrusor overactivity

          -  Regularly using clean intermittent catheterization to empty the bladder

        Exclusion Criteria:

          -  Surgery of the spinal cord within 6 months

          -  Diagnosis of cerebral palsy

          -  Current or planned use of a baclofen pump

          -  Current or planned use of an electrostimulation/neuromodulation device for urinary
             incontinence

          -  Use of an indwelling catheter for urinary incontinence instead of using clean
             intermittent catheterization to empty the bladder

          -  Previous or current use of botulinum toxin therapy of any serotype for any urological
             condition, or treatment with botulinum toxin of any serotype within 3 months for any
             other condition or use

          -  Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Ropinirole XL (formerly CR)
Intervention description: Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.
Intervention MeSH terms: Ropinirole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: ropinirole IR; efficacy; safety; open-label; long term safety; REQUIP; ropinirole XL; ropinirole CR; Parkinson's disease

Summary:

      The purpose of this study is to obtain information on the long-term safety, tolerability, and
      therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for
      patients who participated in either Study 167 or Study 164 to continue receiving ropinirole
      XL if they chose to do so.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or non-pregnant/non-breast feeding females

          -  At least 30 years of age

          -  Diagnosis of idiopathic Parkinson''s disease (Hoehn & Yahr criteria)

          -  Completed either Study 167 or Study 164

        Exclusion Criteria:

          -  Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological,
             neurological, cardiovascular disease or active malignancy

          -  Dizziness or fainting due to orthostatic hypotension on standing

          -  Significant sleep disorder

          -  Drug abuse or alcoholism
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Placebo; Brivaracetam 2.5 mg; Brivaracetam 10 mg; Brivaracetam 25 mg
Intervention description: Active Substance: Placebo
Pharmaceutical Form: Film-coated tablet
Concentration: 2.5 mg, 10 mg and 25 mg
Route of Administration: Oral use; Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 2.5 mg
Route of Administration: Oral use; Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 10 mg
Route of Administration: Oral use; Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 25 mg
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: 400.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures, Adolescents & Adults

Summary:

      This study will evaluate the efficacy and safety of Brivaracetam to support the submission
      file in the indication of adjunctive treatment in adolescents and adults with partial onset
      seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only
             included where legally permitted and ethically accepted

          -  Subjects with well-characterized focal epilepsy or epileptic syndrome according to the
             International League Against Epilepsy (ILAE) classification

          -  Subjects had a history of partial onset seizures (POS) whether or not secondarily
             generalized (Type I seizures according to the ILAE classification)

          -  Subjects had at least 2 POS whether or not secondarily generalized per month during
             the 3 months preceding Visit 1 (V1)

          -  Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week
             Baseline Period

          -  Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic
             drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a
             concomitant AED

        Exclusion Criteria:

          -  History or presence of seizures occurring only in clusters (too frequently or
             indistinctly separated to be reliably counted) before Visit 3

          -  History or presence of status epilepticus during the year preceding Visit 1 or during
             Baseline
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Condition: Kidney Transplantation
Intervention: mycophenolate mofetil; mycophenolate mofetil; anti-IL-2R; methylprednisolone; cyclosporine
Intervention description: 3 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52, adapted to MPA by AUC on Weeks 2, 6, 12, 26, and 52 to obtain AUC0-12 of 50 milligrams (mg) multiplied by (*) height (h)/ liter(L).; 2 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52.; Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.; 500 mg intravenous (i.v.) was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 to Day 7.; 100-1500 nanograms (ng) per milliliter (mL) from Day 0 to Week 4, 800-1200 ng/mL from Week 4 to Week 12 and 500-800 ng/mL from Week 12 to Week 52
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Methylprednisolone; Methylprednisolone Hemisuccinate; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will compare the incidence of acute clinical or subclinical rejection between
      immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug
      monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in
      kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and
      early discontinuation of steroids. Patients will be randomized to one of the two treatment
      arms. The anticipated time on study treatment is 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, aged 18-75 years of age;

          -  in receipt of first donor kidney;

          -  eligible to receive immunosuppressive treatment comprising IRL2, CellCept,
             cyclosporine and steroids;

          -  eligible to receive oral treatment from the first day post-transplantation.

        Exclusion Criteria:

          -  patients receiving a second or subsequent kidney transplant, or multi-organ
             transplant;

          -  history of malignancy in the last 5 years (except successfully treated squamous cell
             or basal cell cancer and cervical cancer in situ);

          -  patients with active hepatitis B and/or hepatitis C, or HIV infection.
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: Placebo; Comparator: Varivax; Comparator: M-M-R II
Intervention description: a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90; a single 0.5 mL subcutaneous placebo injection at Day 0; a single 0.5 mL subcutaneous injection of Varivax at Day 0; a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 480.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant
      administration of Varivax and M-M-R II vaccines in healthy children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health

          -  Negative clinical history of varicella, shingles, measles, mumps, and rubella

        Exclusion Criteria:

          -  Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or
             in combination

          -  Any immune impairment or deficiency

          -  Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to
             vaccination

          -  Vaccination with an inactive vaccine with in the past 14 days

          -  Vaccination with a live vaccine within the past 30 days

          -  Immune globulin or any blood product administered in the past 3 months
Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Intervention: Coronary artery bypass - on-pump; Coronary artery bypass - off-pump
Intervention description: CABG procedure performed on heart lung machine; CABG procedure performed without the use of the heart lung machine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2203.0
Sex: All
Healthy volunteers: No

Summary:

      Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover,
      5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in Fiscal
      Year (FY) 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial
      revascularization is now being performed using two surgical techniques. One technique is
      performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest ("on-pump") and
      the other without CPB on a beating heart ("off-pump"). The overall purpose of this proposed
      randomized, controlled, clinical trial is to rigorously evaluate the impact of using an
      on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only)
      procedures (performed with a traditional median sternotomy incision) upon patient clinical
      outcomes and resource utilization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective or Urgent CABG

          -  CABG only procedure to be performed

        Exclusion Criteria:

          -  Patient's surgeon is not a participant that meets study off-pup criteria

          -  Valve or Valve/CABG procedure

          -  Emergent, hemodynamically unstable, or in cardiogenic shock preoperatively

          -  Moderate, moderate, to severe, or severe valvular disease

          -  Enrolled in another therapeutic or interventional study

          -  Majority of diffusely diseased distal vessels

          -  Clinical Care Team has reservations

          -  History of on-compliance

          -  Patient preference for treatment arm

          -  Inability to provide informed consent