bioihbjkbjnl/mcl2 huggingface dataset:
An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis
Condition: Non-filarial Elephantiasis
MeSH terms: Elephantiasis
Intervention: Current skin care regimen plus 2% glycerine added to soaking water; Current skin care regimen
Intervention MeSH terms: Glycerol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: podoconiosis; glycerine; RCT; SBF; TEWL; SC hydration

Summary:

      An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a
      research based skin management regimen compared to the current regimen. The experimental
      group added 2% glycerine to the current skin care regimen and used 1 litre of water in the
      water soak compared to the 6 litres used in the current regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients in Ethiopia with a diagnosis of podoconiosis. That is those living above 1000
             feet sea level with high rainfall, above 1,00mm annually with foot or lower leg oedema
             which had started in the feet, with sensation present in the feet and no hand
             involvement. The diagnosis was determined by the nurses at the outreach clinics.

          -  Patients who were able to understand instructions and give informed consent as
             determined by the nurses at the outreach clinics.

          -  Patients over 18 years of age.

        Exclusion Criteria:

          -  Patients not diagnosed with podoconiosis as determined by nurses at the outreach
             clinics.

          -  Patients who were unable to understand instructions or give informed consent as
             determined by nurses at the outreach clinics.

          -  Patients under 18 years of age.
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
Condition: Major Depressive Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: Administered as capsules.; Administered as capsules.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study is a randomized, double-blind, placebo-controlled study of the safety,
      tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with
      comorbid major depressive disorder (MDD) and insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant had a diagnosis of MDD as diagnosed by structured clinical interview for
             diagnostic and statistical manual of mental disorders, fifth edition, clinical trials
             version (SCID-5-CT), with symptoms that have been present for at least a 4-week
             period.

          2. Participant had a diagnosis of Insomnia that is confirmed at screening based on the
             diagnostic and statistical manual of mental disorders, fifth edition (DSM-5)
             diagnostic criteria using the SCID-5-CT.

          3. Participant had an Insomnia Severity Index (ISI) score greater than or equal to (>=)
             15 (moderate to severe insomnia).

          4. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior
             to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.

        Exclusion Criteria:

          1. Participant had attempted suicide associated within the current episode of MDD.

          2. Participant had onset of the current depressive episode during pregnancy or 4 weeks
             postpartum, or the participant had presented for screening during the 6-month
             postpartum period.

          3. Participant had a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder.

          4. Participant had a medical history of seizures.

          5. Participant had active psychosis per Investigator assessment.
Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
Condition: Neuromuscular Blockade
Intervention: sugammadex; neostigmine
Intervention description: sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion; neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion
Intervention MeSH terms: Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, active-controlled, parallel-group, single-dose, multi-site,
      safety-assessor blinded study comparing sugammadex to neostigmine for reversal of
      neuromuscular blockade in Korean subjects undergoing elective surgical procedures under
      general anesthesia that require rocuronium for neuromuscular blockade. Study medication will
      be administered at reappearance of T2. Time to recovery will be measured from start of study
      medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is
      that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with
      neostigmine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists Class 1 or 2 or 3

          -  >=18 years of age and of either sex

          -  scheduled for elective surgical procedure under general anesthesia requiring the use
             of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade
             in a supine position allowing neuromuscular transmission monitoring and requiring
             reversal of neuromuscular blockade

          -  Korean descent born in Korea, never emigrated out of Korea, and have a Korean home
             address

        Exclusion Criteria:

          -  expected difficult intubation due to anatomic malformations

          -  expected transfer to intensive care unit after surgery

          -  neuromuscular disorders affecting neuromuscular blockade

          -  significant hepatic or renal dysfunction

          -  require use of pneumatic tourniquet during surgery

          -  (family) history of malignant hyperthermia

          -  allergy to cyclodextrins (including sugammadex) or other medication(s) used during
             general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug
             administration; contraindication to use of neostigmine or glycopyrrolate
Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant
Intervention description: Atogepant Tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 685.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Migraine; Aura

Summary:

      The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once
      a day for the prevention of migraine in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and participant privacy information (eg, written
             authorization for use and release of health and research study information) obtained
             from the participant prior to initiation of any study-specific procedures.

          -  Participants must be using a medically acceptable and effective method of birth
             control during the course of the entire study.

          -  Eligible participants who completed the double-blind treatment period (Visit 7) and
             the follow-up period (Visit 8), if applicable, depending on the timing of study
             initiation, of Study 3101-301-002 (NCT03777059) without significant protocol
             deviations (eg, noncompliance to protocol-required procedures).

        Exclusion Criteria:

          -  Female participant is pregnant, planning to become pregnant during the course of the
             study, or currently lactating. Women of childbearing potential must have a negative
             urine pregnancy test at Visit 1.

          -  Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP >
             100 mm Hg at Visit 1.

          -  Participants with clinically significant hematologic, endocrine, cardiovascular,
             pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Olumacostat Glasaretil Gel, 5.0%
Intervention description: Gel containing Olumacostat Glasaretil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 748.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent or assent (for subjects under legal adult age)

          -  Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.

          -  Willing to comply with the protocol. Subjects under legal adult age will be assessed
             by the investigator as to their ability to comply with the protocol

          -  Willing to refrain from using any treatments on the face for acne vulgaris, other than
             the investigational product, including topical or systemic antibiotics.

        Exclusion Criteria:

          -  Abnormal clinically significant findings on physical exam, vital signs or ECG at Week
             12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further
             treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the
             Investigator

          -  Any other condition which, in the judgment of the investigator, would put the subject
             at unacceptable risk for participation in the study
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Condition: Anemia
MeSH terms: Anemia
Intervention: iron sucrose injection USP; stable erythropoietin therapy
Intervention MeSH terms: Epoetin Alfa; Ferric Oxide, Saccharated
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Cancer; Chemotherapy

Summary:

      To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly,
      fixed doses of erythropoietin in patients who had or had not responded to erythropoietin
      therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological Diagnosis of Cancer

          -  Hgb </= 10

          -  Ongoing or Planned Chemotherapy

          -  Body Weight >50kg

          -  Free of Active Infection

          -  Karnofsky Status 60% to 100%

        Exclusion Criteria:

          -  Active infection

          -  Use of Multivitamins with iron within one week of entry

          -  Myelophthisic bone marrow involvement by tumor except hematologic malignancy

          -  Concurrent medical condition that would prevent compliance or jeopardize the health of
             the patient

          -  Use of any IV iron products within two months of study entry

          -  Blood Transfusions

          -  Hypoplastic bone marrow failure state

          -  Acute Leukemia

          -  Myeloproliferative syndrome

          -  Uncontrolled hypertension
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: teduglutide 0.05 mg/kg/d; teduglutide 0.10 mg/kg/d
Intervention description: 0.05 mg/kg/d subcutaneous injection; 0.10 mg/kg/d subcutaneous injection
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Short Bowel Syndrome; Parenteral Nutrition; SBS; Teduglutide

Summary:

      The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily
      administration of teduglutide.
    

Eligibility criteria:

        Inclusion Criteria:

        At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their
        participation in this study.

        Subjects who meet all of the following criteria can be enrolled in this study:

          -  Signed and dated informed consent form (ICF) to participate before any study-related
             procedures are performed

          -  Completion of protocol CL0600-004 (NCT00081458)

        Exclusion Criteria:

          -  History of cancer or clinically significant lymphoproliferative disease with fewer
             than 5 years documented disease-free state

          -  History of alcohol or drug abuse (within previous year)

          -  Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit

          -  Pregnant or lactating women

          -  Any condition or circumstance, which in the investigator's opinion would put the
             subject at any undue risk, prevent completion of the study, or interfere with analysis
             of the study results
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; CHS-0214
Intervention description: Head-to-head comparison
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 647.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CHS-0214; Enbrel; RA; Biosimilar; Etanercept

Summary:

      This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid
      arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic
      therapies.

      Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center
      global study. The primary end point is 20% improvement in American College of Rheumatology
      criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.

      Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response
      receive CHS-0214. Continued response and safety will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults

          -  RA (Rheumatoid Arthritis) diagnosis for 6 months

          -  On stable dose of MTX of 8mg to 25mg per week

          -  Active disease: greater than 6 tender joints, greater than 6 swollen joints,
             C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score
             (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2

        Exclusion Criteria:

          -  Use of prednisone greater than 10mg/day

          -  Use of greater than one non-steroidal anti-inflammatory drug (NSAID)

          -  Use of biologic therapies for any cause

          -  Chemistry and hematology values outside protocol specified range

          -  Positive QuantiFERON-tuberculosis (TB) Gold Test

          -  Evidence of active lung disease on chest x-ray

          -  Major systemic infections

          -  Presence of significant comorbid conditions

          -  Known allergy to latex

          -  Women who are pregnant or nursing
An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide/formoterol (SYMBICORT) pMDI; Budesonide HFA pMDI
Intervention description: SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily; Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 558.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Moderate asthma; Severe asthma

Summary:

      The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a
      medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, Hispanic (self-reported), > 12 years of age

          -  Moderate to severe asthma requiring treatment with an inhaled corticosteroid

          -  Diagnosis of asthma for at least 6 months

        Exclusion Criteria:

          -  Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral,
             ocular)

          -  Any significant disease or disorder that may jeopardize a subject's safety
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: DF289; DF277; DF289 plus DF277
Intervention description: Ear drops; Ear drops; Ear drops
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 331.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No
Keywords: with tubes

Summary:

      The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and
      effective in treating middle ear infections in children with ear tubes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 months to 12 years

          -  ear tube in the ear which will be treated

          -  otorrhea for 3 weeks or less

          -  moderate or severe otorrhea

        Exclusion Criteria:

          -  other ear diseases
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Intervention description: Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 9 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent
      Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India.
      Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11,
      16, and 18.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Females Age 9 To 15 Years

          -  Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study

          -  No Fevers 24 Hours Prior To The First Injection

        Exclusion Criteria:

          -  Participant Had Received A Prior Vaccination With A HPV Vaccine

          -  Participant Has Allergies To Vaccine Component Including Aluminum And Yeast

          -  Participant Has (Human Immunodeficiency Virus) HIV Infection

          -  Participant Is Immunocompromised

          -  Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior
             To The First Injection

          -  Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months
             To The First Injection