bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin phosphate; Comparator: Placebo; Acarbose; Glimepiride
Intervention description: Sitagliptin, 100 mg tablet once daily, orally for 24 weeks; Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks; Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks; Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy.
Intervention MeSH terms: Sitagliptin Phosphate; Glimepiride; Acarbose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 380.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; T2DM

Summary:

      This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C)
      more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a
      steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg
      once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM
      with inadequate glycemic control on acarbose monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has T2DM and is on acarbose alone at a stable dose of at least 50 mg t.i.d.(three
             times a day) for at least 10 weeks or on acarbose at a stable dose of at least 50 mg
             t.i.d. (three times a day) for at least 10 weeks in combination with another
             antihyperglycemic agent (AHA)

          -  is at least 18 years of age (for participants in India: between 18 and 65 years of
             age)

          -  male or female who is unlikely to conceive (not of reproductive potential, or agrees
             to remain abstinent or use [or have partner use] acceptable birth control if of
             reproductive potential)

        Exclusion Criteria:

          -  has a history of type 1 diabetes mellitus

          -  use of thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors,
             glucagon-like peptide-1 (GLP-1) receptor agonists, or insulin

          -  has the following cardiovascular disorders: acute coronary syndrome; new or worsening
             symptoms of coronary heart disease; coronary artery intervention; stroke or transient
             ischemic neurological disorder

          -  has liver or kidney disease

          -  has cancer or any clinically significant disease or disorder as judged by the
             Investigator
Mylan Insulin Aspart Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: MYL-1601D Product; FlexPen NovoLog®
Intervention description: (100 U/mL); (100 U/mL)
Intervention MeSH terms: Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy
      profile between MYL-1601D and NovoLog® in patients with T1DM.
    

Eligibility criteria:

        Inclusion criteria

          1. Written and signed informed consent.

          2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to
             screening.

          3. Subject is able and willing to comply with the requirements of the study protocol.

        Exclusion Criteria

          1. History or presence of a medical condition or disease that in the Investigator's
             opinion would place the subject at an unacceptable risk from study participation.

          2. History of hypersensitivity to any of the active or inactive ingredients of the
             insulin/insulin analogue preparations used in the study, OR history of significant
             allergic drug reactions.

          3. Any clinically significant abnormality in electrocardiogram or safety laboratory
             tests.

          4. Any elective surgery requiring hospitalization planned during the study period.

          5. History of a significant medical condition, such as unstable angina, myocardial
             infarction, stroke or transient ischemic attack in the 6 months before screening.

          6. Subjects with major depressive illness in the last 3 years.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial
Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder; Tic Disorder
MeSH terms: Tic Disorders; Tics; Tourette Syndrome
Intervention: Aripiprazole
Intervention description: Open Label: Once-Daily formulation of aripiprazole flex dose regimine
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Tourette Syndrome; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Tics; Movement Disorders; Mental Disorders; Aripiprazole

Summary:

      The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing
      Total Tic Severity in children and adolescents with Tourette's Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed participation in Trial 31-12-293

          -  Written ICF obtained from a legally acceptable representative & informed assent at
             Baseline as applicable by trial center's IRB/IEC

          -  The subject, designated guardian(s) or caregiver(s) are able to comprehend and
             satisfactorily comply with the protocol requirements, as evaluated by the investigator

        Exclusion Criteria:

          -  Experienced AEs during the double-blind trial (31-12-293) that would, in the
             investigator's judgment, preclude further exposure to aripiprazole.

          -  The subject had protocol violations during the double-blind trial considered major in
             the judgment of the investigator which would deem the subject a poor candidate for the
             trial

          -  A positive drug screen

          -  Sexually active patients not using 2 approved methods of contraception

          -  Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving
             trial drug)

          -  Risk of committing suicide

          -  Body weight lower than 16 kg

          -  Abnormal laboratory test results, vital signs and ECG results
Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-01 (varenicline) nasal spray; Placebo (vehicle) nasal spray
Intervention description: OC-01 (varenicline) nasal spray; Placebo (vehicle) nasal spray
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 758.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray
      as compared to placebo on signs and symptoms of dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - Have used and/or desired to use an artificial tear substitute for dry eye symptoms within
        6 months prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in
             either eye within three months or refractive surgery (e.g. laser-assisted in-situ
             keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or
             corneal implant) within twelve months of Visit 1.

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with dry eye
             disease are allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject.
Study of 0416 Ointment in the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 0416; Vehicle of 0416 test product; tacrolimus ointment 0.1%
Intervention description: Topical 0416 test product applied twice daily for 2 weeks; Vehicle of 0416 test product applied twice daily for 2 weeks; Reference Product for 0416 test product. Apply twice daily for 2 weeks.
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 793.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis

Summary:

      The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic
      Dermatitis.

      Treatment medication will be administered as follows: Apply a thin layer of ointment to
      affected skin areas twice daily and rub in gently and completely. Study medication will be
      applied twice a day, approximately 12 hours apart, for approximately 2 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Atopic Dermatitis

          -  Good health with the exception of Atopic Dermatitis

          -  Percent Body Surface Area minimum requirements

        Exclusion Criteria:

          -  Subjects who are pregnant, nursing, or planning a pregnancy within the study
             participation period.

          -  Subjects who have any systemic or dermatological disorders with the exception of
             Atopic Dermatitis
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Levetiracetam
Intervention description: Pharmaceutical form: Oral tablets and oral solution
Route of administration: Oral use
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Pediatric; Partial onset epilepsy; Levetiracetam; Keppra

Summary:

      Open-label study to allow pediatric patients who have participated in prior Levetiracetam
      (Keppra®) studies to continue their treatment with adequate monitoring and standardized
      follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the
      completion of the development program for pediatrics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed Study N151, or any other applicable pediatric trials of Levetiracetam
             (Keppra®)

          -  Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential
             benefit such that the patient/parent(s)/legal guardian and the Investigator agree to
             continue treatment.

        Exclusion Criteria:

          -  Not be on a ketogenic diet (during the course of this study).

          -  Not have seizures too close together to accurately count (i.e., the patient's seizures
             must be countable).
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
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Intervention: JZP-110; Placebo oral tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter,
      4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of
      excessive sleepiness in adult subjects with narcolepsy.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Males and females between 18 and 75 years of age, inclusive

          2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria

          3. Body mass index from 18 to <45 kg/m2

          4. Consent to use a medically acceptable method of contraception

          5. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Moderate or severe sleep apnea on the baseline PSG.

          3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          5. History or presence of any acutely unstable medical condition, behavioral or
             psychiatric disorder (including active suicidal ideation), or surgical history that
             could affect the safety of the subject or interfere with study efficacy, safety, PK
             assessments, or the ability of the subject to complete the trial per the judgment of
             the Investigator

          6. History of bariatric surgery within the past year or a history of any gastic bypass
             procedure

          7. Presence or history of significant cardiovascular disease

          8. Use of any over-the-counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          9. Use of any medications that could affect the evaluation of cataplexy

         10. Received an investigational drug in the past 30 days or five half-lives (whichever is
             longer)

         11. Previous exposure to or participation in a previous clinical trial of JZP-110
             (ADX-N05, R228060, YKP10A)

         12. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Upadacitinib; Dupilumab; Placebo to dupilumab; Placebo to upadacitinib
Intervention description: Extended release tablet; Dupilumab is administered as a subcutaneous (SC) injection; Placebo administered as a subcutaneous injection; Tablet
Intervention MeSH terms: Upadacitinib; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 692.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Upadacitinib; ABT-494; Dupilumab; Atopic Dermatitis

Summary:

      This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with
      moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema
             Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10%
             body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and
             Baseline weekly average of daily Worst Pruritus NRS ≥ 4.

          -  Participant is a candidate for systemic therapy or have recently required systemic
             therapy for AD.

        Exclusion Criteria:

          -  Participant has prior exposure to Janus Kinase (JAK) inhibitor.

          -  Participant has prior exposure to dupilumab.

          -  Participant is unable or unwilling to discontinue current AD treatments prior to the
             study.

          -  Participant has requirement of prohibited medications during the study.

          -  Participant has other active skin diseases or skin infections requiring systemic
             treatment or would interfere with appropriate assessment of AD lesions.

          -  Female participant who is pregnant, breastfeeding, or considering pregnancy during the
             study.
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of tezacaftor in combination
      with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older,
      homozygous or heterozygous for the F508del mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the Week 24 Visit in Study 113 Part B or the Week 8 Visit in Study 115.

          -  Eligible CFTR Mutation.

        Exclusion Criteria:

          -  Pregnant and nursing females.

          -  History of poor compliance with study drug and/or procedures in a previous study as
             deemed by the investigator.

          -  Ongoing participation in another study with investigational drug.

        Other protocol defined Inclusion/Exclusion criteria may apply.