bioihbjkbjnl/mcl2 huggingface dataset:
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Intervention: Placebo; DHEA; DHEA
Intervention description: Placebo vaginal suppository; Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Intervention MeSH terms: Dehydroepiandrosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: Female
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Vulvar/vaginal atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa

Summary:

      The purpose of this Phase III trial is to confirm the efficacy of intravaginal
      dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Postmenopausal women (hysterectomized or non-hysterectomized)

          -  Women between 40 and 75 years of age.

          -  Willing to participate in the study and sign an informed consent.

          -  Women who have self-identified symptom(s)of vaginal atrophy.

          -  For non-hysterectomized women, willing to have endometrial biopsy at screening and end
             of study.

        Main Exclusion Criteria:

          -  Undiagnosed abnormal genital bleeding.

          -  Hypertension equal to or above 140/90 mm Hg.

          -  The administration of any investigational drug within 30 days of screening visit.

          -  Endometrial hyperplasia, cancer or endometrial histology showing proliferative,
             secretory or menstrual type characteristics at histologic evaluation of endometrial
             biopsy performed at screening.
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Tofacitinib
Intervention description: Oral administration twice per day
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if tofacitinib is safe and effective in subjects
      with active ankylosing spondylitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria
             for AS (1984).

          -  Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.

          -  Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or
             intolerant to NSAIDs.

        Exclusion Criteria:

          -  History of known or suspected complete ankylosis of the spine.

          -  History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.

          -  History of any other rheumatic disease.

          -  Any subject with condition affecting oral drug absorption.
Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; Azilect®
Intervention description: Once daily; tablet; orally; 18 weeks; 1 mg daily; tablet; orally; 18 weeks
Intervention MeSH terms: Rasagiline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Azilect; Motor fluctuations; Parkinson´s Disease; Rasagiline

Summary:

      To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the
      change from baseline in mean total daily OFF time during 18 weeks of treatment in
      levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with idiopathic PD

          -  Patients with motor fluctuations averaging at least 1 hour daily in the OFF state
             during the waking hours (not including morning akinesia)

          -  Patients with a Modified Hoehn and Yahr stage <5 in the OFF state

          -  Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at
             least 14 days prior to baseline

          -  Patients receiving at least 3 daily doses of levodopa, not including a bedtime dose,
             and not more than 8 daily doses of levodopa

          -  Patient who have demonstrated the ability to keep accurate 24-hour diaries prior to
             randomisation

        Exclusion Criteria:

          -  Patients with a clinically significant or unstable medical or surgical condition that
             would preclude his/her safe and complete study participation

          -  Patients taking any disallowed medication according to the Azilect® approved label

          -  Patients taking MAO inhibitors within 3 months prior to baseline visit

          -  Patients with a known serious adverse reaction to selegiline

          -  Patients with a clinically significant psychiatric illness, including a major
             depression, which compromises their ability to provide consent or participate fully in
             the study

          -  Patients with a Mini Mental State Examination (MMSE) score <=24

          -  Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
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
Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery
Condition: Cataract
MeSH terms: Cataract; Inflammation
Intervention: Mapracorat; Vehicle
Intervention description: Instill study medication into study eye per dosing instructions for 14 days; Instill study medication into the study eye per dosing instructions for 14 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Inflammation; Pain; Ocular surgery

Summary:

      The objective of this clinical study is to compare the safety and efficacy of Mapracorat
      Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain
      following cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are candidates for routine, uncomplicated cataract surgery

          -  Participants who, in the Investigator's opinion, have potential postoperative pinhole
             Snellen visual acuity (VA) of at least 20/200 in the study eye.

          -  Participants must be willing to wait to undergo cataract surgery on the fellow eye
             until after the study has been completed.

        Exclusion Criteria:

          -  Participants who are expected to require concurrent ocular therapy (either eye) with
             nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines,
             or decongestants.

          -  Participants who are expected to require treatment with any systemic or ocular (either
             eye) corticosteroids or glucocorticoids.

          -  Participants who are expected to require concurrent ocular therapy with
             immunosuppressants (eg, Restasis).

          -  Participants who have known hypersensitivity or contraindication to the study drug(s)
             or their components.

          -  Participants participating in any drug or device clinical investigation within 30 days
             prior to entry into this study and/or during the period of study participation.
Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Cognitive Processing Therapy Group Videoteleconference; Cognitive Processing Therapy Group In-Person
Intervention description: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.; Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cognitive processing therapy; combat; veterans; PTSD; Telemental Health; Videoteleconference; outcome; Rural; Remote; CPT; VTC

Summary:

      The immediate objective of this project was to evaluate the clinical effectiveness of a
      telemental health modality (video-teleconferencing) for providing an evidence-based group
      intervention (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National
      Guardsmen, and veterans suffering with PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of current combat related PTSD determined by the Clinician Administered PSTD
             Scale (CAPS-IV)

          -  participants taking psychoactive medications have to have a stable regimen for at
             least 45 days prior to study entry

        Exclusion Criteria:

          -  active psychotic symptoms/disorder as determined by the SCID for DSM-IV

          -  active homicidal or suicidal ideation as determined by the structured clinical
             interview

          -  any significant cognitive impairment or history of Organic Mental Disorder as
             determined by the structured clinical interview

          -  active (current) substance dependence as determined by the SCID (lifetime substance
             dependence/abuse not excluded)

          -  unwillingness to refrain from substance abuse during treatment

          -  female veterans
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide; Aclidinium bromide
Intervention description: Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment; Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 291.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Summary:

      The purpose of this extension study is to evaluate the long-term safety, tolerability, and
      efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe
      chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a
      52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week
      lead-in study. All patients will be randomized from the lead-in study at one of two doses of
      aclidinium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of a lead-in study (NCT00891462)

        Exclusion Criteria:

          -  Use or anticipated use of any medication prohibited in this study

          -  Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic
             (ECG) results or the presence of abnormities in physical examination findings

          -  The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow
             angle glaucoma)

          -  QTcB of >500 msec on both the pre-dose and post-dose ECG

          -  Women who are pregnant, intend to become pregnant, or are breast-feeding

          -  A life expectancy of less than 1 year

          -  Noncompliance with IP dosing and/or attending clinic visits during the lead-in study

          -  Significant interruption of double-blind therapy during the transition from the
             lead-in study into the extension study.
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ofatumumab subcutaneous injection; Teriflunomide-matching placebo capsules; Teriflunomide capsule; Matching placebo of ofatumumab subcutaneous injections
Intervention description: Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter; Placebo capsule, matching in appearance to teriflunomide, taken orally once daily; Teriflunomide 14 mg oral capsule taken once daily; Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Intervention MeSH terms: Teriflunomide; Ofatumumab; 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: 930.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; Ofatumumab; adult; OMB157; multiple sclerosis; T1 lesions; T2 lesions; relapse; GD-enhancing MRI; McDonald criteria; RRMS; SPMS

Summary:

      To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4
      weeks versus teriflunomide administered orally once daily in patients with relapsing multiple
      sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 55 years of age

          -  Diagnosis of multiple sclerosis (MS)

          -  Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)

          -  At least 1 relapse during the previous 1 year or 2 relapses during the previous 2
             years or a positive gadolinium-enhancing MRI scan in previous year

          -  Expanded disability status scale (EDSS) score of 0 to 5.5

        Exclusion Criteria:

          -  Primary progressive MS

          -  Disease duration of more than 10 years in patients with an EDSS score of 2 or less

          -  Patients with an active chronic disease of the immune system other than MS

          -  Patients at risk of developing or having reactivation of hepatitis

          -  Patients with active systemic infections or with neurological findings consistent with
             PML
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC; 13vPnC; PPSV23; Saline
Intervention description: 20vPnC; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Placebo
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a
      20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and
             older.

          2. Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease, defined as disease not requiring significant change in therapy in the
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before
             receipt of investigational product.

          3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing
             potential.

        Exclusion Criteria:

          1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          2. History of microbiologically proven invasive disease caused by S pneumoniae.

          3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,
             in the investigator's opinion, excludes the subject from participating in the study.

          4. Pregnant female subjects or breastfeeding female subjects.
Methotrexate-Inadequate Response Study
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Subcutaneous (SC) Abatacept; Intravenous (IV) Abatacept
Intervention description: Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.; Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
500mg (for body weight up to 60 kg)
750 mg (body weight between 61 and 100 kg)
1g (body weight above 100 kg)infusions
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2492.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept
      yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in
      participants with rheumatoid arthritis and an inadequate response to current methotrexate
      therapy.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects who are considered methotrexate inadequate responders

          -  10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint
             count)

        Exclusion Criteria:

          -  Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies

          -  Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
             erythematous)

          -  Subjects with active vasculitis of a major organ system (except for subcutaneous
             rheumatoid nodules)

          -  Subjects with severe chronic or recurrent bacterial infections

          -  Subjects who have received treatment with rituximab

        An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using
        the same treatment as the Main study in order to assess the immunogenicity and safety in
        the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and
        participants were permitted to roll into the LT Open Label Period.