bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Dimebon; Placebo; Dimebon; Placebo
Intervention description: 10 mg TID for week 1 followed by 20 mg TID through Week 26; 10 mg TID for week 1 followed by 20 mg TID through Week 26; 10 mg TID for week 1 followed by 20 mg TID through Week 12; 20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 742.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Dimebon; Safety; Tolerability

Summary:

      This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in
      2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon
      20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with
      Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the
      study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label
      extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Alzheimer's Disease.

          -  MMSE 12-26 inclusive.

          -  If on existing anti-dementia therapy, have been on a stable dose of anti-dementia
             therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to
             dosing in study.

          -  If not taking existing anti-dementia therapy, have not received therapy with
             cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this
             study.

        Exclusion Criteria:

          -  Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma,
             hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a
             single lesion in a critical region [e.g., thalamus, hippocampus]).

          -  Have any major medical illness or unstable medical condition within six months of
             screening that may interfere with the patient's ability to comply with study
             procedures and abide by study restrictions.

          -  Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to
             dosing or intend to start anti-dementia therapy during the double blind portion of the
             study.

          -  Reside in a nursing home or assisted care facility with need for 24-hour care and
             supervision.
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Recurrence
Intervention: Metronidazole oral tablets 500mg; 1% SPL7013 Gel; Placebo gel
Intervention description: One tablet taken orally twice daily for seven consecutive days; 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.; 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 586.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on
      alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in
      women with a history of recurrent BV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current active episode of BV (diagnosis defined as: At least 3 of the 4 Amsel
             criteria; Nugent score of at least 4; presence of BV-related symptoms)

          -  History of recurrent BV (at least 3 episodes in previous year including current
             episode)

          -  Using an effective method of contraception

        Exclusion Criteria:

          -  Test positive for a sexually transmitted infection

          -  Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV)
             lesions requiring treatment

          -  Abnormal pelvic exam, including presence of other vaginal or urinary tract infections

          -  Pregnancy
A Study In Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: GSK523338
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 diabetes Type II

Summary:

      This study evaluates the effect of medicines for type 2 diabetes and lipids control. This
      study will require about 6 office visits for lab tests and examinations. All study related
      medicines and medical examinations will be provided at no cost to the subjects.
    

Eligibility criteria:

        Inclusion criteria:

          -  A clinical diagnosis type 2 diabetes mellitus.

          -  Women must not be pregnant or breastfeeding during the study and 30 days after the
             study.

          -  Must sign an informed consent form at the study clinic.

        Exclusion criteria:

          -  Severe chronic diseases that would prevent from participating and completing the study
             by investigator's judgement.

          -  Use of an investigational drug within 30 days or 5 half lives before first dose of
             study medication.

          -  Insulin use for > 1 week in past 3 months.
On Open-Label Study in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease
MeSH terms: Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases
Intervention: LY2127399; Placebo
Intervention description: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.; Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1518.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus; SLE; Systemic Lupus Erythematosus; Immune System Disease

Summary:

      The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399
      in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)

          -  Given written informed consent

          -  Test negative for pregnancy at the time of enrollment

          -  Agree to use a reliable method of birth control

        Exclusion Criteria:

          -  Unwilling to comply with study procedures

          -  Any condition that renders the participants unable to understand the nature and scope
             and possible consequences of the study

          -  Any condition that in the opinion of the investigator poses an unacceptable risk to
             the participants if study drug would be administered
To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel; BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%; Placebo
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1100.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,
      designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5%
      topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel,
      Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne
      vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical
             diagnosis of acne vulgaris.

          2. Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25
             non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions
             (nodules and cysts) and have an IGA score of 2, 3 or 4.

        Exclusion Criteria:

          1. Subject has more than 2 facial nodular lesions; any nodules present will be documented
             but not included in the inflammatory lesion count for analysis.

          2. Subject has active cystic acne.

          3. Subject has acne conglobata.

          4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that
             would interfere with the diagnosis or assessment of acne.
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: Rilpivirine
Intervention description: 25 mg once daily
Intervention MeSH terms: Rilpivirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1 Infection; HIV-1; HIV; TMC278-TiDP6-C222; TMC278-C222; TMC278; Rilpivirine

Summary:

      The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients
      who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are HIV-1 infected and were previously randomized to receive TMC278 in a
             TMC278 clinical trial and completed the protocol-defined treatment period.

          -  Patients continue to benefit from treatment with TMC278 in the opinion of the
             investigator.

          -  Patient can comply with the current protocol requirements.

          -  The patient's general medical condition, in the investigator's opinion, does not
             interfere with participation in the trial.

        Exclusion Criteria:

          -  Use of disallowed concomitant therapy.

          -  Females of childbearing potential who are pregnant, or without the use of effective
             birth control methods, or not willing to continue practicing these birth control
             methods during the trial and for at least 1 month after the end of the trial (or last
             intake of TMC278).

          -  Non-vasectomized heterosexually active male patients without the use of effective
             birth control methods or not willing to continue practicing these birth control
             methods during the trial and for at least 1 month after the end of the trial (or after
             last intake of TMC278).
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Perampanel
Intervention description: Perampanel 2 mg tablets. Doses of perampanel can be adjusted based on clinical judgment. A minimum perampanel dose of 2 mg per day is required to continue in the study. The maximum daily dose of perampanel permitted will be 12 mg per day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; Perampanel

Summary:

      To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in
      participants with epilepsy. This study will be continued until perampanel is commercially
      available.
    

Eligibility criteria:

        Inclusion Criteria

          1. Participants participating in the designated perampanel study as below, and who in the
             opinion of the investigator continue to benefit from treatment with perampanel
             Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of
             total exposure to perampanel).

          2. Provide written informed consent/assent signed by participant or legal guardian prior
             to entering the study or undergoing any study procedures. If the written informed
             consent is provided by the legal guardian because the participant is unable to do so,
             a written or verbal assent from the participant must also be obtained.

          3. Female participants of childbearing potential must agree for the duration of the study
             and for a period of at least 1 month following the last dose of perampanel to be
             abstinent or to commit to the consistent and correct use of a medically acceptable
             method of birth control (eg, a double-barrier method [condom plus spermicide, condom
             plus diaphragm with spermicide]).

        Exclusion Criteria

          1. Participants residing in countries where perampanel is commercially available with
             respect to the indication or formulation of the designated perampanel study.

          2. Female participants who are nursing, pregnant, or planning to become pregnant.
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
Condition: Vaccines, Pneumococcal
Intervention: 13 valent pneumococcal conjugate vaccine; 7vPnc pneumococcal conjugate vaccine
Intervention description: 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.; 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 666.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the
      13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC)
      and to compare the immune response to concomitant vaccines administered with 13vPnC and
      7vPnC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month-old infants.

          -  Available for the entire study period.

        Exclusion criteria:

          -  Previous vaccination with any vaccine before the start of the study.

          -  Known contraindication to vaccination.
Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Intervention: Placebo + ADT; Brexpiprazole +ADT
Intervention description: Placebo + ADT Placebo + FDA Approved Antidepressant (ADT); Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 837.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment; Anxious Distress

Summary:

      The purpose of this study is to assess the tolerability, safety, and efficacy of
      brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD
      with and without anxious distress
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female subjects between 18-65 years of age, with diagnosis of major
             depressive disorder with or without anxious distress

          -  Current depressive episode must be at least 8 weeks in duration

        Exclusion Criteria:

          -  Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome

          -  Subjects who report an inadequate response to more than 3 antidepressant treatments in
             the current episode

          -  Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other
             cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic
             disorder, Bipolar I or II disorder
A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: abciximab placebo; reteplase placebo, abciximab, abciximab; Abciximab; reteplase; abciximab placebo; abciximab; abciximab; reteplase placebo; abciximab placebo; abciximab; abciximab placebo; reteplase placebo, abciximab, abciximab; abciximab; reteplase placebo; abciximab placebo; abciximab; Abciximab; reteplase; abciximab placebo; abciximab
Intervention description: placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h; 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h; 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h; placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h; 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h; 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
Intervention MeSH terms: Reteplase; Tissue Plasminogen Activator; Abciximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2461.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Myocardial infarction; percutaneous coronary intervention; abciximab; reteplase; safety and efficacy

Summary:

      The purpose of this study is to determine whether abciximab given in combination with
      reteplase, before patients have a coronary intervention (a standard treatment where a
      catheter is inserted into the heart artery to get blood flowing past the clot), is safe and
      effective in the treatment of heart attacks compared to only abciximab given during coronary
      intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have prolonged, continuous (lasting at least 20 minutes) signs and
             symptoms of A heart attack not eliminated with nitrates and onset within 6 hours of
             randomization,and confirmation by Electrocardiogram

        Exclusion Criteria:

          -  Low risk clinical presentation

          -  patients who will not be undergoing a catherization within 4 hours of the qualifying
             Electrocardiogram
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine transdermal patch; Buprenorphine transdermal patch; Buprenorphine transdermal patch
Intervention description: Buprenorphine transdermal patch 5 mcg/h applied transdermally for 7-day wear.; Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear.; Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 196.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Opioid; Transdermal

Summary:

      The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS.
      Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a
      maximum of BTDS 20 to achieve stable pain control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed all visits of the double-blind phase on study drug and subjects
             who discontinued study drug due to lack of therapeutic effect in the double-blind
             phase but completed all visits of the double-blind phase off study drug are eligible
             to enroll in the extension phase.

        Exclusion Criteria:

          -  Subjects who prematurely discontinue study drug in the double-blind phase due to
             adverse event, subject's choice, administrative reason or lost to follow-up are NOT
             eligible to enter the extension phase

          -  Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate
             using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued
             from the extension phase.

          -  Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an
             every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase
             should be discontinued from the study.

        Refer to core study for additional inclusion/exclusion information.