bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene/Benzoyl Peroxide; Adapalene; Benzoyl Peroxide; Topical Gel Vehicle
Intervention description: Topical Gel, One application daily in the evening for 12 weeks; Topical Gel,One application daily in the evening for 12 weeks; Topical Gel, one application daily in the evening for 12 weeks; Topical Gel Vehicle,one application daily in the evening for 12 weeks
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1670.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne vulgaris; Adapalene; Benzoyl Peroxide

Summary:

      This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of
      treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening
      (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment
      evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a
      subject should remain the same during the study.

      The primary objective is to demonstrate the superiority in efficacy and assess safety of
      Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene
      Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide
      Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of acne vulgaris with facial involvement.

          -  A minimum of 20 but not more than 50 Inflammatory lesions

          -  A minimum of 30 but not more than 100 Noninflammatory lesions

          -  A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

        Exclusion Criteria:

          -  More than one acne nodule or any acne cyst.

          -  Acne conglobata, acne fulminans, secondary acne, or severe acne.

          -  Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.

          -  Underlying diseases that require the use of interfering topical or systemic therapy.

          -  Use of prohibited medications prior to the study unless appropriate washout period is
             documented

          -  Use of hormonal contraceptives solely for control of acne
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ozanimod; Ozanimod placebo; Interferon beta-1a; Interferon beta-1a placebo
Intervention description: Oral capsule, daily for 24 months; Oral capsule, daily for 24 months; Intramuscular injection, 30 µg, weekly for 24 months; Intramuscular injection, weekly for 24 months
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ozanimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1320.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented
      within this record.

      The primary objective of Part B is to assess whether the clinical efficacy of ozanimod
      (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of
      clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria

          -  Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

        Exclusion Criteria:

          -  Primary progressive multiple sclerosis
Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Peripheral Neuropathy

Summary:

      The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating
      the pain and other symptoms associated with diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who have completed double-blind treatment in study 322 (NCT01050218) for
             DPN. Subjects must have completed all scheduled evaluations, with no major protocol
             violations and no events that, in the opinion of the investigator, would preclude the
             subject's entry into the long-term open-label study.

          -  Women of childbearing potential must have a negative serum pregnancy test on day 91 of
             the short-term study. A woman of childbearing potential is one who is biologically
             capable of becoming pregnant. "Biologically capable" includes women who are using
             contraceptives or whose sexual partners are either sterile or using contraceptives.
             Sexually active women participating in the study who are biologically capable of
             becoming pregnant must use a medically acceptable form of contraception during the
             study and for at least 15 days after the last dose of test article. Medically
             acceptable forms of contraception include oral contraceptives, transdermal,
             injectable, or implantable methods, intrauterine devices, or properly used
             double-barrier contraception, eg, condom plus diaphragm.

        Exclusion Criteria:

          -  Presence of any new and/or clinically important medical condition that might
             compromise subject safety (including, but not limited to, significant changes in
             glycemic control).

          -  Pregnancy, lactation, or plans to become pregnant during the study.

          -  Use of prohibited treatments.

          -  Meets any of the exclusion criteria listed for study 322 (NCT01050218).
Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: INVOS Somanetics Cerebral Oximeter; INVOS Somanetics Cerebral Oximeter
Intervention description: Sequence of Interventions To Increase Cerebral Oxygen Saturation
Check head and cannula position
Increase mean arterial pressure
Increase pump flow
Increase systemic oxygenation
Increase PaCO2 > 45
Increase anesthetic depth by increasing volatile anesthetic or by administering propofol boluses
Consider PRBC transfusion for Hct < 21%; INVOS Cerebral Oximetry blinded monitoring with no deviation in surgical procedures or standard of care in anesthesia.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Aortic Surgeries; Deep Hypothermic Circulatory Arrest

Summary:

      The investigators hypothesize that early intervention to optimize regional cerebral
      oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory
      arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient
      and permanent neurological dysfunction and improve neurocognitive impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female patients 18-80 years of age scheduled for aortic surgery
             requiring DHCA and intention to use antegrade selective cerebral perfusion with or
             without RCP

        Exclusion Criteria:

          -  Adult male and female patients 18-80 years of age undergoing aortic surgery NOT
             scheduled for DHCA

          -  Patients with ejection fraction < 15%

          -  Pregnancy

          -  Prisoners

          -  Patients mentally impaired (Screening Criteria i.e. MMSE score ≤ 23) History of stroke
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Atorvastatin; Ezetimibe; Alirocumab; Placebo
Intervention description: Atorvastatin over-encapsulated tablets.; Ezetimibe over-encapsulated tablet.; Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.; Placebo for alirocumab, ezitimibe and atorvastatin.
Intervention MeSH terms: Atorvastatin; Ezetimibe; Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, double-dummy, active-controlled, parallel-group,
      multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe
      in participants with primary hypercholesterolemia and moderate, high, or very high CV risk,
      who are intolerant to statins. An atorvastatin arm is added to determine that the population
      selected in the study is a truly statin intolerant population by assessing skeletal
      muscle-related adverse events.
    

Eligibility criteria:

        Inclusion:

          1. Patients with primary hypercholesterolemia [Heterozygous Familial Hypercholesterolemia
             (heFH) or non-FH] with moderate, high or very high CV risk and a history of statin
             intolerance

          2. Provide signed informed consent

        Exclusion:

          1. Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk at the screening
             visit

          2. Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the
             screening visit

          3. A 10-year fatal cardiovascular disease risk score <1% at the screening visit

        (The inclusion/ exclusion criteria provided above is not intended to contain all
        considerations relevant to a patient's potential participation in this clinical trial).
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol; Placebo; Methotrexate
Intervention description: Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50.; 2 syringes Placebo at Baseline, Week 2 and Week 4, followed by 1 syringe Placebo every 2 Weeks.; The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate ≥ 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 880.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol - Cimzia; Methotrexate; Rheumatoid Arthritis

Summary:

      This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in
      combination with Methotrexate (MTX) for inducing and sustaining clinical response in the
      treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active
      Rheumatoid Arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA)
             less than 1 year as defined by the 2010 ACR/EULAR classification criteria from
             Screening Visit

          -  Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide
             Antibody (anti-CCP)

          -  Active RA disease

          -  DMARD-naïve

          -  Subject is naïve to RA related biologics

        Exclusion Criteria:

          -  A diagnosis of any other inflammatory Arthritis

          -  History of infected joint prosthesis, or other significant infection and other serious
             medical condition

          -  Known Tuberculosis (TB) disease or high risk of acquiring TB infection
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
Condition: Moderate to Severe Convexity of Submental Fat; Safety; Efficacy
Intervention: ATX-101; Placebo
Intervention description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 65 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this study are to explore the safety and efficacy of subcutaneous
      injections of Deoxycholic Acid relative to placebo, in the submental area of participants who
      are 65 to 75 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 65 to 75 years of age

          -  Stable Body Weight

          -  Dissatisfaction with the submental area expressed by participants

          -  Acceptable volume of submental fat graded by clinician

          -  BMI of ≤40.0 kg/m^2

          -  Signed informed consent (ICF)

          -  SMF rating of 2 or 3 by clinician and patient

        Exclusion Criteria:

          -  No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic
             agents)

          -  Absence of clinically significant health problems

          -  Anatomical features for which reduction in SMF may result in aesthetically
             unacceptable outcome, judged by clinician

          -  History of trauma associated with the chin or neck areas that in the judgment of the
             investigator may affect evaluation of safety or efficacy

          -  Body mass index of ≥40.0 kg/m^2
Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent
Condition: Magnetic Resonance Imaging
Intervention: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)
Intervention description: Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Maximum age: 2 Months
Healthy volunteers: No

Summary:

      This is an open-label, multi-center study involving babies 0-2 months of age who have liver
      problems (pathology) and need to have their liver and possibly, the bile ducts imaged using
      magnetic resonance imaging and injection of a contrast agent (dye). This agent is called
      Eovist. It has been marketed since 2004 and used in many countries all over the world.

      The baby will have blood tests before and after the imaging is done to make sure that there
      are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours
      after the injection will be obtained in order to measure how much of the dye is in the blood.
      The baby will have an intravenous line which can be used for the blood samples and will not
      need to be stick for the blood samples. Several radiologists will evaluate the images. The
      family doctor will be contacted to find out what was the diagnosis and treatment after the
      results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s)
      will be contacted to make sure the that baby did not have any problems, especially with the
      skin, joints and eyes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 0-2 months (must be gestational age 37 to 41 weeks)

          -  Scheduled to undergo routine contrast-enhanced liver MRI

          -  Able to comly with the study procedures

        Exclusion Criteria:

          -  Scheduled for any intervention (except lumbar puncture and bone marrow aspiration)
             during the study period

          -  If receiving chemotherapy, may have a change in treatment during the study period

          -  Contraindication for MRI

          -  Renal insufficiency (estimated glomerular filtration rate < 80% of age-adjusted normal
             mean value using the Schwartz formula)

          -  Acute renal failure

          -  Clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper
             limit of the normal range, in particular, liver enzymes and renal function. (Note: if
             elevations in liver enzyme levels are consistent with the underlying hepatobiliary
             disease, then the subject may be enrolled.)
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
Condition: Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
MeSH terms: COVID-19; Pneumonia; Syndrome; Cytokine Release Syndrome
Intervention: Canakinumab; Placebo
Intervention description: Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.; 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 454.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; cytokine release syndrome; SARS-CoV-2; canakinumab; COVID; coronavirus; CAN-COVID; pneumonia; CRS

Summary:

      This was a multicenter, randomized, double-blind, placebo-controlled study to assess the
      efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC
      in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
    

Eligibility criteria:

        Key inclusion Criteria:

          -  Adults ≥ 18 years old (for US only: patients ≥ 12 years old, although no children ever
             enrolled. This was an adult trial.)

          -  Body weight ≥40 kg

          -  Informed consent must be obtained prior to participation in this study. For US
             patients 12 - < 18 years old; parent/guardian consent must be obtained and assent if
             applicable.

          -  Clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic
             methodology

          -  Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan with
             pulmonary infiltrates

          -  SpO2 ≤ 93% on room air or arterial oxygen partial pressure (PaO2)/ fraction of
             inspired oxygen (FiO2) < 300mmHg

          -  C-reactive protein ≥20 mg/L or ferritin level ≥600 µg/L

        Key exclusion Criteria:

          -  History of hypersensitivity to canakinumab or to biologic drugs

          -  Intubated and on mechanical ventilation (invasive) at time of randomization

          -  Treatment with immunomodulators or immunosuppressant drugs, including but not limited
             to tocilizumab, TNF inhibitors and anti-IL-17 agents within 5 half-lives or 30 days
             (whichever is longer) prior to randomization with the exception of anakinra which is
             excluded within 5 half-lives only. Note: Immunomodulators (topical or inhaled) for
             asthma and atopic dermatitis and corticosteroids (any route of administration) are
             permitted.

          -  Suspected or known untreated active bacterial, fungal, viral, or parasitic infection
             with the exception of COVID-19