bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Cyclosporine A microemulsion; Placebo
Intervention description: Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations; Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Keywords: Cyclosporine, chronic plaque psoriasis, intermittent therapy

Summary:

      The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a
      day), when administered twice a week compared to continuous administration, in patients with
      chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Outpatients 18 years of age and older (max 65 years)

          -  Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI
             before cyclosporine continuous treatment course) entering a maintenance period

          -  Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5
             mg/kg/day) for >8 weeks and <16 weeks

          -  PASI still <75% of PASI before cyclosporine continuous treatment course, at
             randomization to study treatment (8±2 days after disease remission)

        Exclusion criteria:

          -  Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range)

          -  Severe chronic degenerative diseases

          -  Severe uncontrolled hypertension

          -  Body weigh >110 kg

          -  Abnormal liver function

          -  Hyperkalemia or hyperuricemia

          -  Clinically significant impairment of hematopoietic and cardiovascular function

          -  Concomitant therapy with nephrotoxic medications

          -  Patients with malignancy or a history of malignancy

          -  Females of childbearing potential who are planning to become pregnant, who are
             pregnant and/or lactating, who are unwilling to use effective means of contraception

          -  Clinically significant uncontrolled bacterial, viral or fungal infection

          -  Evidence of drug and/or alcohol abuse
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Condition: Stage IV or Recurrent Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
Intervention: Nivolumab; Gemcitabine; Cisplatin; Carboplatin; Paclitaxel; Pemetrexed
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Nivolumab; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 541.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to show that Nivolumab will improve progression free survival in
      subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared
      to chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1

          -  Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic
             anticancer therapy

          -  Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per
             response evaluation criteria in solid tumors version (RECIST) 1.1 criteria

          -  PD-L1+ on immunohistochemistry testing performed by central lab

          -  Men and women, ages ≥ 18 years of age

        Exclusion Criteria:

          -  Known epidermal growth factor receptor (EGFR) mutations which are sensitive to
             available targeted inhibitor therapy

          -  Known anaplastic lymphoma kinase (ALK) translocations

          -  Untreated central nervous system (CNS) metastases

          -  Previous malignancies

          -  Active, known or suspected autoimmune disease
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: RPC1063
Intervention MeSH terms: Ozanimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2494.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS; RMS; Multiple Sclerosis; Relapsing Multiple Sclerosis

Summary:

      The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with
      relapsing multiple sclerosis.
    

Eligibility criteria:

        Eligibility Criteria:

        To be eligible to participate in this trial, patients must meet all of the following
        criteria:

          1. Completed one of the parent trials

          2. Does not have a condition that would require withdrawal from one of the parent trials

          3. Has no conditions requiring treatment with a prohibited concomitant medication

          4. Is not receiving treatment with any of the following drugs or interventions within the
             corresponding timeframe:

             At Baseline (Day 1)

               -  CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin)
                  Two weeks prior to Baseline (Day 1)

               -  Monoamine oxidase inhibitors (eg, selegiline, phenelzine)

          5. Ability to provide written informed consent and to be compliant with the schedule of
             protocol assessments

          6. Female patients of childbearing potential:

        Must agree to practice a highly effective method of contraception throughout the study
        until completion of the 90-day Safety Follow-up Visit. Highly effective methods of
        contraception are those that alone or in combination result in a failure rate of a Pearl
        index of less than 1% per year when used consistently and correctly.

        Acceptable methods of birth control in this study are the following:

          -  Combined hormonal (estrogen and progestogen containing) contraception, which may be
             oral, intravaginal, or transdermal

          -  Progestogen-only hormonal contraception associated with inhibition of ovulation, which
             may be oral, injectable, or implantable

          -  Placement of an intrauterine device (IUD)

          -  Placement of an intrauterine hormone-releasing system (IUS)

          -  Bilateral tubal occlusion

          -  Vasectomised partner

          -  Sexual abstinence.

        Exclusion Criteria:
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
Condition: Pain
Intervention: Fentanyl; Fentanyl; Oxycodone/acetaminophen; oxycodone/acetaminophen
Intervention description: Fentanyl buccal tablet 100 mcg once; Fentanyl buccal tablet 200 mcg once; Oxycodone/acetaminophen 5/325 mg once; Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Fentanyl; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Fentanyl buccal tablet

Summary:

      The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia
      in comparison to standard analgesia, to determine if the FBT allows for faster achievement of
      "significant analgesia"
    

Eligibility criteria:

        Inclusion Criteria:

          -  pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin

          -  only if Emergency Department provider approves

          -  a negative pregnancy test is required for participation for women of childbearing age

        Exclusion Criteria:

          -  If treating provider determines intravenous analgesia is required

          -  allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently
             taking phenothiazines, CNS depressants (including alcohol), or if they have taken an
             monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in
             the past two weeks

          -  if patient has already been administered an opioid analgesic for their current injury

          -  patients on chronic opioids therapy or a history of opioid abuse

          -  breastfeeding mothers

          -  patients who plan to drive home after their emergency department visit

          -  history of phenylketonuria (due to phenylalanine in the formulation of the
             lansoprazole solutab)
A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-809; Placebo; VX-770
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects
      aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF
      transmembrane conductance regulator (CFTR) mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who weigh ≥15 kg without shoes a the Screening Visit

          -  Subjects with confirmed diagnosis of CF at the Screening Visit.

          -  Subjects who are homozygous for the F508del CFTR mutation

          -  Subjects with ppFEV1 of ≥70 percentage points adjusted for age, sex, and height

          -  Subjects with a screening LCI2.5 result greater than or equal to 7.5

        Exclusion Criteria:

          -  History of any comorbidity reviewed at the Screening Visit that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject.

          -  Any clinically significant laboratory abnormalities at the Screening Visit that would
             interfere with the study assessments or pose an undue risk for the subject

          -  Clinically significant abnormalities in hemoglobin, liver function, or renal function
             at the Screening Visit.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy for pulmonary disease within 28 days before Day 1

          -  History of solid organ or hematological transplantation at the Screening Visit
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
Condition: Liver Transplantation
Intervention: everolimus; basiliximab; CNI
Intervention description: Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.; All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.; Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
Intervention MeSH terms: Everolimus; Basiliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Liver transplantation, everolimus, CNI

Summary:

      The study is designed to show that everolimus initiation together with reduction and
      thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal
      function in de novo liver transplant recipients as compared to continuation of CNI-based
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 18 - 70 years old

          -  Liver transplant recipient (living or deceased donor)

          -  Patients in whom an allograft biopsy will not be contraindicated

        Exclusion Criteria:

          -  Recipients of multiple solid organ transplants or patients that have already received
             a transplant in the past

          -  HCV positive patients who need an active anti-viral treatment (HCV- positive patients
             without active antiviral treatment are allowed)

          -  HIV positive patients

          -  Patients who are breast feeding

          -  Patients with a current severe systemic infection

          -  Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)

          -  Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the
             judgment of the investigator, will not significantly improve after transplantation
             (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4
             weeks post transplantation)

          -  Patients that have received Simulect prior to this study.

          -  Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
Condition: Anesthesia, General
Intervention: Sugammadex; Rocurium
Intervention description: intravenous (IV) single bolus dose of 0.6 mg.kg-1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of
      sugammadex in participants 65 and over with participants under 65. There is no hypothesis
      defined for the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 to 3

          -  18 years of age or older

          -  Scheduled for elective surgical procedure under general anesthesia requiring
             neuromuscular block with the use of rocuronium

          -  Scheduled for surgery in supine position

          -  Given written informed consent

        Exclusion Criteria:

          -  Participants in whom a difficult intubation is expected due to anatomical
             malformations

          -  Participants known or suspected to have neuromuscular disorders impairing
             neuromuscular blockade and/or significant renal dysfunction

          -  Participants known or suspected to have a (family) history of malignant hyperthermia

          -  Participants known or suspected to have an allergy to narcotics, muscle relaxants or
             other medications used during surgery

          -  Participants receiving medication known to interfere with neuromuscular blocking
             agents such as anticonvulsants, antibiotics and magnesium

          -  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),
             intrauterine device (IUD), abstinence]

          -  Participants who had already participated in a Org 25969 trial including Protocol
             19.4.305

          -  Participants who had participated in another clinical trial, not pre-approved by
             Organon, within 30 days of entering into Protocol 19.4.305
BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
Condition: Post-Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Ibandronate
Intervention description: 150 mg orally once monthly for 6 months
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 677.0
Sex: Female
Healthy volunteers: No

Summary:

      This single arm study will assess participant preference for monthly Bonviva, versus daily or
      weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis.
      Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or
      risedronate) will answer a questionnaire to identify participants who may benefit from a
      monthly Bonviva regimen. Eligible participants will then discontinue their present
      bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning
      and end of Bonviva treatment, all participants will complete an Osteoporosis Patient
      Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the
      target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  post-menopausal women;

          -  >=3 months daily or weekly alendronate or risedronate for treatment or prevention of
             post-menopausal osteoporosis.

        Exclusion Criteria:

          -  inability to stand or sit in an upright position for at least 60 minutes;

          -  hypersensitivity to bisphosphonates;

          -  treatment with other drugs affecting bone metabolism;

          -  abnormalities of the oesophagus, which delay oesophageal emptying.
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Cariprazine; Placebo; Antidepressant Therapy (ADT)
Intervention description: Cariprazine capsules 1.5 to 4.5 mg/day; Dose-matched placebo capsule once per day; ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1022.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD; Major Depressive Disorder

Summary:

      The objective of this study is to evaluate the efficacy, safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided consent prior to any specific procedure

          -  Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text
             revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)

          -  Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at
             Visits 1 and 2

        Exclusion Criteria:

          -  Patients who do not meet DSM-IV-TR criteria for MDD
Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Gel-200
Intervention description: Single Intra-articular Injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a single or repeat intra-articular injection of
      Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to
      determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in study SI-6606/01.

        Exclusion Criteria:

          -  Female subjects who are pregnant or lactating.
A Study to Investigate the Antihypertensive Efficacy of MK0954
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium; Comparator: losartan; Comparator: Placebo
Intervention description: 50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.; 50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.; Placebo to Losartan
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 366.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms,
      after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks.
      This study evaluated if losartan is more effective than placebo in lowering sitting diastolic
      blood pressure and is well tolerated in patients with mild to moderate hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)

          -  Patient has no medical problems or treatments that might effect their blood pressure

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Patient has secondary hypertension or malignant hypertension

          -  Sitting systolic blood pressure > 210 mm Hg

          -  History of stroke

          -  History of myocardial infarction with in past year

          -  Current or prior history of heart failure

          -  Known hypersensitivity to losartan

          -  Prior exposure to losartan

          -  Patients known to be HIV positive

          -  Patient is abusing or has abused alcohol or other drugs within the past 4 years