bioihbjkbjnl/mcl2 huggingface dataset:
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
Condition: Plaque Type Psoriasis
MeSH terms: Psoriasis
Intervention: GP2017 Adalimumab; Humira ® Adalimumab
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 465.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque type psoriasis; equivalent efficacy; safety and immunogenicity; GP2017; Humira®

Summary:

      The aim of the study is to demonstrate equivalent efficacy and similarity in the safety
      profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women at least 18 years of age at time of screening

          -  Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization

          -  Moderate to severe psoriasis as defined at baseline by:

               -  PASI score of 12 or greater

               -  Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 -
                  4) and,

               -  Body Surface Area affected by plaque-type psoriasis of 10% or greater

          -  Chronic plaque-type psoriasis patients who have previously received phototherapy or
             systemic psoriasis therapy at least once or who are candidates for such therapies in
             the opinion of the investigator.

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type

          -  Drug-induced psoriasis

          -  Ongoing use of prohibited psoriasis treatments

          -  Previous exposure to adalimumab

          -  Active ongoing inflammatory diseases other than psoriasis that might confound the
             evaluation of the benefit of treatment with adalimumab

        Other In-/Exclusion criteria may apply
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome; Syndrome
Intervention: Rufinamide; Any other approved Antiepileptic Drug
Intervention description: Rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs); Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)
Intervention MeSH terms: Rufinamide; Anticonvulsants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 1 Year
Maximum age: 3 Years
Healthy volunteers: No
Keywords: Central Nervous System

Summary:

      This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK)
      of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric
      participants already taking other anti-epileptic drugs.
    

Eligibility criteria:

        Key Inclusion:

          1. Clinical diagnosis of LGS, which might include the presence of a slow background
             electroencephalogram (EEG) rhythm, slow spikes-waves pattern (less than 3 Hz), the
             presence of polyspikes; care should be taken not to include benign myoclonic epilepsy
             of infancy, atypical benign partial epilepsy (pseudo-Lennox syndrome), or continuous
             spike-waves of slow sleep (CSWS).

          2. On a fixed and documented dose of one to three concomitant regionally approved
             antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to randomization with an
             inadequate response to treatment.

          3. Consistent seizure documentation (i.e., no uncertainty of the presence of seizures)
             during the pre-randomization phase.

        Key Exclusion:

          1. Familial short QT syndrome

          2. Prior treatment with rufinamide within 30 days of baseline visit or discontinuation of
             rufinamide treatment due to safety issues related to rufinamide
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Condition: Irritable Bowel Syndrome With Constipation; Chronic Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide
Intervention description: Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the long-term safety of linaclotide administered to
      patients with chronic constipation (CC) or irritable bowel syndrome with constipation
      (IBS-C).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have

               -  entered study MCP-103-303 or MCP-103-302 and at minimum completed the
                  pre-treatment period or

               -  completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201,
                  MCP-103-202

          -  Sexually active patients of childbearing potential agree to use birth control

          -  Females of childbearing potential must have a negative urine pregnancy test prior to
             dosing

          -  Lactating females must agree not to breastfeed

          -  Patient must meet protocol criteria for CC or IBS-C

        Exclusion Criteria:

          -  Patient must not use protocol-defined prohibited medicine

          -  Patient is planning to receive an investigational drug at any time during the study

          -  Patient has an unresolved adverse events or a clinically significant finding on a
             physical examination, 12-lead electrocardiogram, or clinical laboratory test
Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib
Intervention description: Idelalisib tablet(s) administered orally twice daily
Intervention MeSH terms: Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; CAL-101; CAL 101; GS-1101; GS 1101; PI3K; Leukemia; GS-US-312-0116; idelalisib

Summary:

      The primary objective of this extension study (GS-US-312-0117) that is a companion study to
      Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset,
      magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and
      carried forward to study GS-US-312-117.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant

          -  Tolerating primary study therapy

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vedolizumab
Intervention description: Vedolizumab intravenous infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this multicenter, open-label study is to collect data on the occurrence of
      important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study
             C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the
             investigator, was well tolerated OR b. Moderate to severe Crohn's disease or
             ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)

          2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or
             ulcerative colitis as defined by the protocol

        Exclusion Criteria:

        1. Development of any new, unstable, or uncontrolled disease
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Condition: Food Preferences
MeSH terms: Noncommunicable Diseases
Intervention: Exposure to beverage health information; Exposure to beverage calorie information
Intervention description: Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information; Calories for sugar-sweetened and non-sugar-sweetened beverages
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three private schools will be enrolled in the study (two larger, one smaller) that have students between the ages of 12 and 18. There will be no posters displayed at any of the schools during the baseline period. The two larger schools will be randomized to either an SSB warning/non-SSB promoting poster or a calorie/control poster that will be implemented in the school cafeterias during a four-week intervention period. To increase the sample size for the intervention condition, the intervention will also be implemented at a smaller school. For the primary analysis, data only from schools that were randomized to condition will be used. Data was collected from both a sample of participants & from the cash registers directly.
Masking: None (Open Label)
Masking description: Participants will be told the researchers are interested in cafeteria purchase preferences, but participants will not know which condition has been assigned to individual participants.
Enrollment: 628.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Food Labeling; Adolescents

Summary:

      Sugar-sweetened beverages are a significant contributor to adult and childhood obesity in
      Guatemala. Policies to place health warning labels on sugar-sweetened beverages are being
      pursued, but there is little empirical data on how such labels influence people. The primary
      aim of this study is to test the association between sugar-sweetened beverage (SSB) warning
      posters compared to control posters and change in SSBs purchased compared to baseline by
      adolescents shopping at school cafeterias in Guatemala City, Guatemala. The hypothesis is
      that posters with information warning people of the health harms associated with
      overconsuming SSBs and promoting low sugar beverages will be associated with greater
      reductions in SSB purchases compared to a control poster.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 12 and 18 years old

          -  Made a food or beverage purchase

          -  Has permission from parent or caregiver to participate

          -  Has not yet completed the purchase assessment

        Exclusion Criteria:

          -  Under 12 or over 18 years old

          -  Did not make a food or beverage purchase

          -  Parent or caregiver refused to give child permission to participate

          -  Already participated in the purchase assessment
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
Condition: Multiple Sclerosis; Relapsing Multiple Sclerosis; Advancing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Siponimod
Intervention description: Siponimod 2mg tablets taken once daily
Intervention MeSH terms: Siponimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label single arm study
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Relapsing multiple sclerosis; Advancing multiple sclerosis; conversion; siponimod; adult; BAF312; disease modifying therapies; cognitive assessment; open-label

Summary:

      To assess safety and tolerability of patients converting from approved Relapsing Multiple
      Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Signed informed consent.

          2. Male or female aged 18 to 65 years (inclusive).

          3. Patients with advancing RMS as defined by the principal investigator.

          4. Prior history of relapsing MS (RMS), with or without progressive features, according
             to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).

          5. EDSS score of >/= 2.0 to 6.5 (inclusive).

          6. Having been continuously treated with RMS Disease Modifying Therapies.

        Key Exclusion criteria:

          1. Pregnant or nursing (lactating) women.

          2. Patients with any medically unstable condition as determined by the investigator.

          3. Certain cardiac risk factors defined in the protocol

          4. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

        Other protocol-defined inclusion/exclusion criteria may apply.
Greater Occipital Nerve Block With Bupivacaine for Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Greater occipital nerve block; Bupivacaine
Intervention description: Bilateral greater occipital nerve block; 0.5 cc of 0.5% bupivacaine injected intradermally
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using
      bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only
      enrolled if they fail first line therapy with metoclopramide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ED patient with acute migraine or probable migraine

          -  Fail first line therapy with metoclopramide

        Exclusion Criteria:

          -  Can't obtain consent

          -  Concern for secondary headache

          -  Skull defect

          -  Propensity for bleeding

          -  Overlying infection

          -  Pregnancy

          -  Allergy, intolerance study medication
Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: TP-03; TP-03 Vehicle
Intervention description: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day; Vehicle of TP-03 ophthalmic solution, administered twice a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active arm: TP-03, 0.25% Control arm: Vehicle of TP-03
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
Enrollment: 412.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Demodex

Summary:

      The purpose of this study is to compare the safety and efficacy of TP-03, an eyedrop, to its
      vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite
      frequently found in human hair follicles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be willing to sign the informed consent and deemed capable of complying with the
             requirements of the study protocol

          -  Meet all of the following criteria in at least one eye: Have more than 10 lashes with
             collarettes present on the upper lid; have at least mild erythema of the upper eyelid
             margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or
             more mites per lash

        Exclusion Criteria:

          -  Have used lid hygiene products within 14 days of Screening or unwilling to forego the
             use of lid hygiene products during the study

          -  Have used a prostaglandin analogue to promote eyelash growth within 30 days of
             Screening or any plans to initiate treatment during the study

          -  Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be
             unwilling to forego their use during the study

          -  Be pregnant or lactating at the time of Screening
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Condition: Pain
Intervention: Placebo; Acurox 5/30 mg; Acurox 7.5/30
Intervention description: 2 tablets every 6 hours for 48 hours; 2 tablets every 6 hours for 48 hours; 2 tablets every 6 hours for 48 hours
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain

Summary:

      The purpose of this study is to determine whether oxycodone HCl and niacin are effective in
      the treatment of pain following bunionectomy surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female at least 18 years of age

          -  For women of child-bearing potential: woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Patient is scheduled to have a bunionectomy

          -  Patient must be willing to stay at the study site for at least 48 hours from the
             initial dose of study medication post-surgery

        Exclusion Criteria:

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen

          -  Patient is hypersensitive to any of the medications to be used in the study

          -  Patient has taken another investigational drug within 30 days prior to Screening
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol; Placebo
Intervention description: Albuterol 90mcg; Placebo
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 95.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Pediatric asthma

Summary:

      This study is designed to evaluate the repeat-dose safety and effectiveness of a
      bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11
      years with asthma. The dosing period lasts three weeks and starts following a three-week
      run-in period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent asthma of a minimum of six months duration that has been stable for at
             least four weeks prior to screening

          -  Male and female children aged 4-11 years, inclusive, with predicted forced expiratory
             volume in 1 second (FEV1) 60-90%

          -  Ability to perform spirometry

          -  Demonstrate 12% airways reversibility

        Exclusion Criteria:

          -  Require continuous treatment with beta-blockers, monoamine oxidase inhibitors,
             tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids

          -  Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic
             diseases