bioihbjkbjnl/mcl2 huggingface dataset:
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
Condition: Skin Infections, Bacterial
MeSH terms: Cellulitis; Skin Diseases, Infectious; Bacterial Infections
Intervention: Retapamulin Ointment, 1%; Placebo ointment
Intervention description: Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.; Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.
Intervention MeSH terms: Retapamulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 508.0
Sex: All
Minimum age: 2 Months
Healthy volunteers: No
Keywords: infection; retapamulin; secondarily-infected traumatic lesions; placebo

Summary:

      The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin
      ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which
      includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of
      age and older will be treated with topical retapamulin or placebo ointment twice daily for 5
      days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14;
      7-9 days after the end of therapy) in the intent-to-treat clinical population.
    

Eligibility criteria:

        Inclusion criteria:

          -  subject is aged 2 months or older

          -  subject has secondarily-infected traumatic lesion (laceration, sutured wound or
             abrasion)

          -  negative urine pregnancy test

          -  subject has total skin infection rating scale score of at least 8, including
             pus/exudate score of at least 3

          -  subject and/or parent/legal guardian is willing and able to comply with protocol

          -  subject or parent/legal guardian has given written informed consent or assent as
             applicable

        Exclusion criteria:

          -  previous hypersensitivity to pleuromutilin

          -  secondarily-infected animal/human bite or puncture wound

          -  subject has an abscess

          -  chronic ulcerative lesion

          -  underlying skin disease

          -  systemic signs and symptoms of infection

          -  infection not appropriately treated with topical antibiotic

          -  infection requires surgical intervention prior to or during study

          -  subject received systemic antibacterial or steroid, or topical therapeutic agent
             within 24 hours of entry into study

          -  serious underlying disease

          -  subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of
             contraception

          -  other investigational drug within 30 days of study entry

          -  subject previously enrolled in this study
Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Sitagliptin; Placebo to omarigliptin; Placebo to sitagliptin
Intervention description: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly; Sitagliptin 50 mg tablet administered orally once daily; Placebo to omarigliptin 25 mg capsule administered orally once weekly; Placebo to sitagliptin 50 mg tablet administered orally once daily
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 414.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as
      monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up
      to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1)
      Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated
      hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in
      participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in
      participants treated with sitagliptin 50 mg daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  History of any of the following medications: thiazolidinediones and/or insulin within
             12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime
The Study Of Fluconazole For Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Intervention: Fluconazole
Intervention description: Single oral dose of 150mg Fluconazole
Intervention MeSH terms: Fluconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      As for the indication of vulvovaginal candidiasis, a single oral administration of
      fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in
      Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and
      topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose
      of this trial is to confirm the efficacy and safety of single oral administration of
      fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with clinical symptoms and signs of vulvovaginal candidiasis.

          -  Patients tested positive for Candida by fungal culture.

          -  Patients who can agree not to have intercourse up to 28 days after dosing.

        Exclusion Criteria:

          -  Patients with a history of hypersensitivity to fluconazole.

          -  Patients with severe renal dysfunction.

          -  Patients with liver disorder.
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
Condition: Schizoaffective Disorder
MeSH terms: Recurrence; Psychotic Disorders
Intervention: Placebo; paliperidone palmitate
Intervention description: monthly by i.m. injection for 15 months; 78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 667.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizoaffective disorder; paliperidone palmitate; INVEGA SUSTENNA; schizoaffective disorder relapse prevention

Summary:

      This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the
      delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the
      safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of schizoaffective disorder

          -  Experiencing an acute exacerbation of psychotic symptoms

          -  A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1),
             Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4),
             Uncooperativeness (G8), and Poor Impulse Control (G14)

          -  A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21

          -  Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests,
             medical history, and vital signs measurements

        Exclusion Criteria:

          -  A primary active mental illness diagnosis other than schizoaffective disorder

          -  Have attempted suicide within 12 months or are at imminent risk of suicide or violent
             behavior

          -  Subjects with first episode of psychosis

          -  Received electroconvulsive therapy in the past 3 months

          -  History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20%
             Intralipid (placebo)

          -  Received long-acting antipsychotic medication within 2 injection cycles

          -  Received therapy with clozapine within 3 months

          -  A history of neuroleptic malignant syndrome

          -  Previous history of lack of response to antipsychotic medication

          -  Subjects receiving therapy with antidepressants or mood stabilizers that has been
             initiated and/or changed in dose <30 days prior to screening

          -  Receiving therapy with carbamazepine

          -  Receiving therapy with monoamine oxidase inhibitors

          -  Pregnant, breast-feeding, or planning to become pregnant
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543 matching placebo; CTP-543; CTP-543
Intervention description: Administered as tablets.; Administered as tablets.; Administered as tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 706.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alopecia; Hair loss; Hair disease; CTP-543

Summary:

      This study evaluates the safety and effectiveness of an investigational study drug (called
      CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical presentation compatible with alopecia areata with a current episode lasting
             at least 6 months and not exceeding 10 years at the time of Screening. Total disease
             duration greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

          -  Willing to comply with the study visits and requirements of the study protocol.

        Exclusion Criteria:

          -  Treatment with other medications or agents within 1 month of Baseline or during the
             study that may affect hair regrowth or immune response.

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or other scalp condition that
             may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the
             body at Screening and/or Baseline.

          -  Treatment with systemic immunosuppressive medications within 3 months of Screening or
             during the study, or biologics within 6 months of Screening or during the study.

          -  Females who are nursing, pregnant, or planning to become pregnant while in the study,
             and for 30 days after last dose of study drug.

          -  Clinically significant medical condition, psychiatric disease, or social condition, as
             determined by the Investigator, that may unfavorably alter the risk-benefit of study
             participation, adversely affect study compliance, or confound interpretation of study
             results.
Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
Condition: Attention Deficit-Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: MYDAYIS; Placebo
Intervention description: MYDAYIS treatment will be given at a minimum dose of 12.5mg/day and will increase in increments of 12.5mg, up to 37.5mg, based upon clinical response and tolerability.; During the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized
      by problems with sustaining attention, organization, planning, procrastination, daydreaming,
      restlessness, impulsivity and hyperactivity.This is an outpatient study for subjects between
      the ages of 18-60, who have an Attention deficit hyperactivity disorder (ADHD) diagnosis
      meeting all inclusion criteria and not meeting any of the exclusion criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 18-60 of all races and ethnicity.

          -  Meets DSM V-TR criteria for a primary diagnosis of ADHD (including predominantly
             inattentive presentation, or combined presentation) as diagnosed via the Adult ADHD
             Clinician Diagnostic Scale version 1.2 (ACDS v1.2)

        Exclusion Criteria:

          -  Meets DSM V-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD as
             diagnosed via the ACDS v1.2.

          -  Any other current psychiatric disorder, determined via the M.I.N.I, which requires
             pharmacotherapy treatment.

          -  Current suicidal ideation or history of suicide attempts, based on the Columbia-
             Suicide Severity Rating Scale(C-SSRS)

          -  Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I

          -  Pregnant, breastfeeding or women planning to become pregnant.

          -  Positive urine drug toxicology are excluded.

          -  Any other reason that, in the opinion of the investigator, prevents the subject from
             participating in the study or compromise the subject safety.
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Intervention: cyclosporine; vehicle of OTX-101
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 745.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: KCS; dry eye; cyclosporine

Summary:

      This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of
      OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis
      sicca to be conducted at approximately 50 sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of dry eye syndrome (KCS) for a period of at least 6 months

          -  Clinical diagnosis of bilateral KCS

          -  Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible
             score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the
             Screening and Baseline Visits.

          -  Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits

          -  Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

        Exclusion Criteria:

          -  Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the
             Screening Visit.

          -  Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion
             0.05% (Restasis).

          -  Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.

          -  Clinical diagnosis or any history of seasonal and/or perennial allergic
             conjunctivitis.

          -  Use of systemic or topical medications within 7 days prior to the Screening Visit or
             during the study period that are known to cause dry eye.

          -  Use of any topical ophthalmic medications, prescription (including anti-glaucoma
             medications) or over the counter (including artificial tears), other than the assigned
             study medication during the study period.

          -  Current active eye disease other than dry wyw syndrome (i.e., any disease for which
             topical or systemic ophthalmic medication is necessary).

          -  History of herpes keratitis.

          -  Corneal transplant

          -  Corneal refractive surgery within 6 months prior to the Screening Visit or
             postoperative refractive surgery symptoms of dryness that have not resolved.

          -  Cataract surgery within 3 months prior to the Screening Visit.
Patient Computer Dialog in Primary Care
Condition: Patient Computer Dialog
Intervention: Computer-based medical history
Intervention description: The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: computers; diagnosis; medical records; physician patient relations; medical history taking; medical informatics applications

Summary:

      With this clinical study, we hoped to find out if interactive, computer-based medical
      interviews, when carefully tested and honed and made available to patients in their homes on
      the Internet, will improve both the efficiency and quality of medical care and be well
      received and found helpful by patients and their physicians. We developed the computer-based
      medical interview consisting of over 6000 questions and a corresponding program that provides
      a concisely written, summary of the patient's responses to the questions in the interview. We
      then conducted read aloud and test/retest reliability evaluations of the interview and
      summary programs and determined the programs to be reliable. Results were published in the
      November 27, 2010 issue of the Journal of the American medical Informatics Association. We
      also developed, edited, and revised a program that provides a concisely written, summary of
      the patient's responses to the questions in the interview.

      We obtained a grant from the Rx Foundation to conduct clinical trial of our medical history.
      At the time of the office visit, the summary of the computer-based history of those patients
      who had completed the interview was available on the doctor's computer screen for the doctor
      and patient to use together on a voluntary basis. The results of this trial were published in
      the January 2012 issue of the Journal of the American Informatics Association.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Request for an initial appointment with a primary care physician at Beth Israel
             Deaconess Medical Center who has agreed to participate in the study

          -  English as first language

          -  Internet access at home

        Exclusion Criteria

          -  Under 18 years of age
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg tablet administered orally once daily; Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Intervention MeSH terms: Ribavirin; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the antiviral efficacy, safety, and
      tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC)
      and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV)
      infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genotype 1 or 2 HCV infection

          -  Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical
             history or liver biopsy

          -  Previously treated with a DAA-containing regimen of at least 4 week duration

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.