bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)
Condition: Anesthesia, General
Intervention: sugammadex; neostigmine; vecuronium; rocuronium; glycopyrrolate
Intervention description: Administered as an intravenous (IV) infusion; Administered as an IV infusion; Administered as an IV infusion; Administered as an IV infusion; Administered as an IV infusion
Intervention MeSH terms: Glycopyrrolate; Rocuronium; Vecuronium Bromide; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB)
      induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with
      reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 to 4

          -  18 years or older

          -  Scheduled to undergo an elective surgical procedure under general anesthesia requiring
             the use of rocuronium or vecuronium for endotracheal intubation and maintenance of
             neuromuscular block

          -  Scheduled for surgery in supine position

          -  Given written informed consent

        Exclusion Criteria:

          -  Participants in whom a difficult intubation is expected due to anatomical
             malformations

          -  Known or suspected to have neuromuscular disorders impairing neuromuscular blockade
             and/or significant renal dysfunction

          -  Known or suspected to have a (family) history of malignant hyperthermia

          -  Known or suspected to have an allergy to narcotics, muscle relaxants, or other
             medications used during surgery

          -  Receiving medication known to interfere with neuromuscular blocking agents such as
             anticonvulsants, antibiotics, and magnesium (Mg2+)

          -  Participants in whom the use of neostigmine and/or glycopyrrolate may be
             contraindicated

          -  Female participants who are pregnant or breast-feeding

          -  Females participants of childbearing potential not using an acceptable method of birth
             control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD,
             abstinence]

          -  Participants who had already participated in an Org 25969 trial

          -  Participants who had participated in another clinical trial, not pre-approved by
             Organon, within 30 days of entering into Protocol 19.4.302
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Tofacitinib; Tofacitinib; Methotrexate; Placebo Methotrexate
Intervention description: Tofacitinib 5 mg tablet twice daily; Tofactinib 10 mg tablet twice daily; Methotrexate 7.5-20 mg weekly; Placebo to match active methotrexate orally once a week
Intervention MeSH terms: Methotrexate; Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: The sub-study will be participant, care provider, investigator and outcomes assessor masked.
Enrollment: 686.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tofacitinib; Psoriatic Arthritis; Xeljanz; CP-690550; Jak-inhibitor; oral treatment; psoriasis; OPAL BALANCE; methotrexate; pruritus; itch; DLQI

Summary:

      This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability
      and efficacy of tofacitinib in subjects with active PsA who have previously participated in
      randomized studies of tofacitinib for this indication.

      This study will include a sub-study to evaluate the efficacy, safety and tolerability of
      tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to
      tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be
      available to subjects who have completed at least 24 months of participation in the
      open-label extension study and meet eligibility criteria for the sub-study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in qualifying PsA study involving tofacitinib

        Exclusion Criteria:

          -  Time from End of Study visit of qualifying study is >3 months.

          -  Pregnant female, breastfeeding female or female of childbearing potential unwilling or
             unable to use highly effective birth control for duration of study and one ovulatory
             cycle thereafter.

        Sub-study Inclusion Criteria:

          -  Subjects who have completed at least 24 months of treatment with tofacitinib in the
             extension study

          -  Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

        Sub-study Exclusion Criteria:

        -Subjects who are receiving methotrexate by a route other than oral
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Intervention: Bremelanotide; Placebo
Intervention description: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 723.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSDD; Female Sexual Desire Disorder

Summary:

      A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an
      optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered
      subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without
      decreased arousal) in premenopausal females.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Has met diagnostic criteria for HSDD for at least 6 months

          -  Is willing and able to understand and comply with all study requirements

          -  Has a normal pelvic examination at screening

        Main Exclusion Criteria:

          -  Subjects should be generally healthy premenopausal females with no psychological,
             gynecological or urological conditions which might contribute to the sexual
             dysfunction, compromise study participation, or confound interpretation of the study
             results

          -  Not currently under treatment for the sexual dysfunction and willing to forego other
             treatments through the course of the clinical trial
GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis
Condition: Bile Acid Synthesis Defect; Inborn Error of Bile Acid Metabolism; Inborn Error of Bile Acid Conjugation
Intervention: Glycocholic Acid
Intervention description: 10-15mg/kg body weight/day taken orally. Supplied as either liquid or 50mg capsules.
Intervention MeSH terms: Cholic Acids; Glycocholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 1 Week
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine the way (mechanisms) by which your defect
      in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of
      vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your
      vitamin absorption and your liver disease. An investigational therapy is one that not
      approved by the United States Food and Drug Administration (FDA) and is being provided to you
      under an Investigational New Drug application from the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmation of a diagnosis of an inborn error of bile acid synthesis/conjugation
             based upon urine analysis by FAB-MS.

          2. Any age

          3. Participant must be willing and able to comply with study assessments and procedures.

          4. The participant and/or parent/legal guardian must have signed the written informed
             consent document prior to study start.

        Exclusion Criteria

        1. No confirmed diagnosis of inborn error of bile acid synthesis/conjugation based upon
        urine analysis by FAB-MS.
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS topical; Vehicle topical
Intervention description: topical treatment; topical treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III
      Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with
      Mild to Severe Scalp Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females 18 years of age and older.

        Exclusion Criteria:

          -  Females who are pregnant, lactating or likely to become pregnant during the study.
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Brexpiprazole (OPC-34712); Aripiprazole; Placebo
Intervention description: Once-daily, tablets; Once-daily, tablets; Once-daily, tablets
Intervention MeSH terms: Aripiprazole; Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety & efficacy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 316.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Brexpiprazole; Schizophrenia; Adolescent

Summary:

      To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of
      adolescents with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline
             visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and
             confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to
             screening.

          -  PANSS score >= 80, inclusive, at screening and baseline

        Exclusion Criteria:

          -  Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary
             focus of treatment within 3 months of screening.

          -  Subjects with a clinical presentation or history that is consistent with delirium,
             dementia, amnesia or other cognitive disorders

          -  Subjects who have been hospitalized > 21 days for a current exacerbation of
             schizophrenia at the time of baseline.

          -  Any neurological disorder other than Tourette's Syndrome

          -  Subjects at significant risk of committing violent acts, serious self-harm or suicide
             based on history

          -  Subjects with epilepsy, a history of seizures, severe head trauma or stroke

          -  Subjects who test positive for drugs of abuse at screening
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
Condition: Chronic HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF
Intervention description: 90/400 mg FDC tablet administered orally once daily without regard to food
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 384.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in
      treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C
      virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other
             approved or experimental HCV-specific direct-acting antiviral agent; OR HCV
             treatment-experienced with medical records that include sufficient detail of prior
             IFN-based treatment to allow for categorization of prior response as either
             intolerant, non-responder, or experienced viral breakthrough or relapse.

          -  Genotype 1 HCV at screening

          -  HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

        Key Exclusion Criteria:

          -  Pregnant or nursing female

          -  Chronic liver disease of a non-HCV etiology

          -  Current or prior history of any clinically-significant illness (other than HCV)

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 790.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of nivolumab adjuvant
      immunotherapy compared to placebo in adults and pediatric participants after complete
      resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for
      recurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had a negative sentinel lymph node biopsy

          -  Participant has not been previously treated for melanoma

          -  ECOG 0 or 1

          -  Participants must have been diagnosed with histologically confirmed, Resected, Stage
             IIB/C cutaneous melanoma

        Exclusion Criteria:

          -  History of ocular or mucosal melanoma.

          -  Pregnant or nursing women

          -  Participants with active known or suspected autoimmune disease

          -  Known history of allergy or hypersensitivity to study drug components

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4
             antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint
             pathways

        Other protocol defined inclusion/exclusion criteria apply.
Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Etanercept; Methotrexate; Placebo to Etanercept; Placebo to Methotrexate
Intervention description: Etanercept was administered by subcutaneous injection once a week; Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.; Placebo to etanercept was administered by subcutaneous injection once a week.; Placebo to methotrexate capsules taken orally once a week.
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 851.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Arthritis, Psoriasis; Etanercept; Enbrel; Methotrexate; Minimal Disease Activity

Summary:

      The purpose of this study is to learn more about the role of etanercept alone or in
      combination with methotrexate on disease activity in adults with psoriatic arthritis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification
             Criteria for Psoriatic Arthritis (CASPAR) criteria.

          -  Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.

          -  Subject has an active psoriatic skin lesion

          -  Subject is naïve to etanercept and any other biologic for the treatment for PsA or
             psoriasis.

          -  Subject has no prior use of methotrexate for PsA.

          -  Subject has no history of tuberculosis

          -  Subject has a negative test for tuberculosis, hepatitis B and C.

        Exclusion Criteria:

          -  Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or
             immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.

          -  Subject has any active infection (including chronic or localized infections) for which
             anti-infectives were indicated within 4 weeks prior to the first dose of
             investigational product.

          -  Subject has a serious infection, defined as requiring hospitalization or intravenous
             anti-infectives within 8 weeks prior to the first dose of investigational product.
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALK3831; Olanzapine; Placebo
Intervention description: Daily dosing; Daily dosing; Daily dosing
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Acute Exacerbation of Schizophrenia

Summary:

      This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation
      of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2

          -  Meets criteria for the diagnosis of schizophrenia

          -  Resides in a stable living situation when not hospitalized

          -  Is willing and able to provide government-issued identification

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Has had a psychiatric hospitalization for more than 30 days during the 90 days before
             screening

          -  Subject initiated first antipsychotic treatment within the past 12 months, or <1 year
             has elapsed since the initial onset of active-phase of schizophrenia symptoms

          -  Subject poses a current suicide risk

          -  Subject has a history of treatment resistance

          -  Subject has a history of poor or inadequate response to treatment with olanzapine

          -  Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month
             period prior to screening

          -  Subject has a diagnosis of moderate or severe alcohol or drug use disorder

          -  Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine,
             phencyclidine, or cocaine at screening

          -  Additional criteria may apply
Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome
Condition: Ischemic Stroke; Excitotoxicity; Memantine
MeSH terms: Ischemic Stroke; Ischemia
Intervention: Placebo; Memantine
Intervention description: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.; Beside the usual treatment for ischemic stroke this group will be treated by memantine.
Intervention MeSH terms: Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The researchers aim to investigate the effect of memantine on stroke outcome in a randomized
      double-blind placebo-controlled clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presentation at first 24hrs of disease onset

          -  Confirmation of ischemic stroke in MCA territory by imaging.

          -  Accepted consent form

        Exclusion Criteria:

          -  Allergy history to memantine

          -  Stage 4 -5 renal failure base on Acute Kidney Injury Network criteria

          -  Moderate to severe hepatic failure (Child-Pugh criteria, grade B and C)

          -  History of epilepsy

          -  History of dementia

          -  History of memantine use in recent 6 months

          -  Pregnancy or breastfeeding

          -  Severe drug adverse effects