bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Olumacostat Glasaretil Gel, 5.0%; Olumacostat Glasaretil Gel, Vehicle
Intervention description: Gel containing Olumacostat Glasaretil; Vehicle (placebo) gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 759.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil
      Gel compared to vehicle in patients with acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent and, for subjects under legal adult age, signed assent

          -  Age ≥ 9 years

          -  Clinical diagnosis of facial acne vulgaris defined as:

               -  At least 20 inflammatory lesions, and

               -  At least 20 non-inflammatory lesions, and

               -  Investigator Global Assessment of 3 or greater

        Exclusion Criteria:

          -  Active cystic acne or acne conglobata, acne fulminans, and secondary acne

          -  Two or more active nodulocystic lesions on the face

          -  Clinically significant abnormal laboratory or ECG result

          -  Subjects who are actively participating in an experimental therapy study or who have
             received experimental therapy within 30 days or 5 half-lives (whichever is longer) of
             the Baseline visit

          -  Treatment with over-the-counter topical medications for the treatment of acne vulgaris
             including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids,
             α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline

          -  Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid
             within 4 weeks prior to Baseline

          -  Treatment with a new hormonal therapy or dose change to existing hormonal therapy
             within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to,
             estrogenic and progestational agents such as birth control pills).

          -  Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks
             prior to Baseline.

          -  Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A
             supplements greater than 10,000 units/day within 6 months prior to Baseline

          -  Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8
             weeks
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Comparator: placebo (unspecified)
Intervention description: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.; Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3006.0
Sex: Female
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV 6/11/16/18 Infection

Summary:

      A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP
      vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine
      type-specific genital disease among Chinese females between the ages of 20 and 45.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women between the ages of 20 and 45

          -  Have used effective contraception for 2 weeks prior to starting in the study

          -  Does not have a temperature within 24 hours before the first injection

        Exclusion Criteria:

          -  Prior history of genital warts

          -  More than 4 lifetime sexual partners

          -  Have undergone hysterectomy

          -  Have active cervical disease or history of cervical disease
Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
Condition: Branch Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Intervention: Macular Laser Photocoagulation; Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week
      study to assess the efficacy and safety of Intravitreal Aflibercept Injection
      (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary
      to BRVO.
    

Eligibility criteria:

        Inclusion Criteria:

        The following inclusion criteria include, but are not limited to:

          1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to
             BRVO diagnosed within 12 months before the screening visit

          2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening
             and at day 1

          3. Provide signed informed consent

        Exclusion Criteria:

        The following exclusion criteria include, but are not limited to:

          1. Current bilateral manifestation of BRVO

          2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous
             filtration surgery in either the study eye or the fellow eye

          3. Insufficient clearing of macular hemorrhage that would prevent the patient from
             receiving laser treatment safely on day 1 (patients that meet this criterion may be
             rescreened once the macular hemorrhage resolves)

          4. Uncontrolled diabetes mellitus (DM)

          5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye

          6. Use of periocular corticosteroids in the study eye within 3 months before day 1

          7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the
             fellow eye within 3 months before day 1

          8. Previous administration of systemic anti-angiogenic medications

          9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid
             photocoagulation in the study eye
Efficacy and Safety Study of XP12B in Women With Menorrhagia
Condition: Menorrhagia; Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Intervention: Tranexamic acid tablets; Placebo tablets
Intervention description: 3900 mg/Day
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Heavy Menstrual Bleeding; Menorrhagia

Summary:

      The purpose of this study is to determine whether XP12B is effective and safe in the
      treatment of women with heavy menstrual bleeding associated with menorrhagia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with menorrhagia

          -  18-49 years of age

          -  Regularly occurring menstrual periods

        Exclusion Criteria:

          -  History or presence of clinically significant disease or abnormalities that may
             confound the study

          -  History of bilateral oophorectomy or hysterectomy

          -  Hormone therapy
Carnitine Supplementation and Skeletal Muscle Function
Condition: Sarcopenia
MeSH terms: Sarcopenia
Intervention: carnitine; placebo
Intervention description: 1500 mg/d l-carnitine-l-tartrate; isonitrogenous
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 65 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: carnitine

Summary:

      Research project objectives The primary aim of the current research project is to use
      carnitine supplementation as the anti-inflammatory intervention for exploring the
      relationship between inflammation and associated with aging reduction of skeletal muscle
      mass.

      Hypothesis The carnitine supplementation modulates the blood cytokines concentration.
      Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with
      aging
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with no history of gastrointestinal disorders, cardiovascular disease or
             hypertension.

        Exclusion Criteria:

          -  Subjects having any illnesses and a history of gastrointestinal disorder,
             cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer,
             alcoholism or other metabolic diseases.
An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 934.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was an extension to study MA21573 [NCT00750880], which was an open label single
      arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or
      combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in
      patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24
      week core study, and had at least a moderate European League Against Rheumatism (EULAR)
      response, were eligible to enter this long-term extension study, and received tocilizumab 8
      mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years,
      and the target sample size was > 500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

        - patients who completed the 24-week MA21573 core study, had at least a moderate response
        based on EULAR definition criteria and no adverse events (AEs), serious adverse events
        (SAEs) or conditions that led to unacceptable risk of continued treatment.

        Exclusion Criteria:

        -as for MA21573.
Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Celecoxib; Diclofenac SR
Intervention description: capsule, 200 mg QD, 6-12 weeks; tablet, 75 mg QD,6-12 weeks
Intervention MeSH terms: Celecoxib; Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a local, multicenter, randomized, active comparator, double-blind, parallel group
      study with extension will be conducted to evaluate the efficacy and safety of celecoxib
      versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis

          -  With axial involvement

          -  Without peripheral joint involvement (synovitis) at the time of study entry,
             (excluding involvement of the hips, knees and shoulders)

          -  Need for daily treatment with NSAIDs during the previous 30 days before study entry

        Exclusion Criteria:

          -  Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)

          -  Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)

          -  Known vertebral compression

          -  Need for a corset during the study
Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
Condition: Stage II Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage I Prostate Cancer; PSA Level Five to Ten; PSA Level Less Than Five; PSA Level Ten to Fifty
MeSH terms: Prostatic Neoplasms
Intervention: Internet-Based Intervention; Internet-Based Intervention; Best Practice; Quality-of-Life Assessment; Questionnaire Administration; Survey Administration; Laboratory Biomarker Analysis
Intervention description: Receive "Knowing your Options" decision aid; Receive "Prostate Choice" decision aid; Undergo usual care; Ancillary studies; Ancillary studies; Ancillary studies; Correlative studies
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well decision aids work in improving knowledge in
      patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge
      of their condition and options for treatment, and may also help when talking with their
      doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have prostate biopsy within 4 months prior to registration showing newly
             diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason
             score 6-10

          -  Prostate-specific antigen (PSA) < 50 ng/mL

          -  Patients who have had a history of non-cutaneous malignancy in the previous 5 years
             are not eligible; exception: patients with history of non-melanoma skin cancer are
             eligible

          -  Scheduled prostate cancer consultation to be the first consultation after diagnosis
             (i.e. not a second-opinion or a consultation following previous discussions of
             treatment options)

          -  Patients may not be concurrently enrolled to another clinical trial for the treatment
             of cancer; co-enrollment to biospecimen studies is allowed

          -  Patients with impaired decision-making capacity (such as with a diagnosis of dementia
             or memory loss) are not eligible for this study

          -  Patients must be able to read and comprehend English; non-English-speaking patients
             may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is
             present for consent, for the decision aid administration, and gathering of baseline
             and follow-up measures
Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Intervention: Collection of clinical samples
Intervention description: The following samples were obtained from each subject:
Vesicle fluid (VF) and vesicle swabs (VS) from four vesicles (for a total of eight samples)
Papule swabs (PS) from four papules
Crusts from two lesions
One throat swab (TS) Up to 15 samples were to be obtained for each subject, when possible. VFs, VSs, PSs, and crusts were either stored dry or in liquid medium. TS samples were stored in liquid medium.
After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 1 Day
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study is conducted in order to collect clinical samples from patients who are diagnosed
      of having chickenpox infection. The results of this study will provide basic scientific
      information about chickenpox disease.
    

Eligibility criteria:

        Pediatric patients who are diagnosed of having varicella and are presenting varicella
        dermal lesions.
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: HEPLISAV and/or Placebo; Engerix-B
Intervention description: Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24; Intramuscular (IM) injections on Week 0, Week 4, and Week 24
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2428.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HBV vaccine; Hepatitis B vaccine; Hepatitis B; Hepatitis; HBV; Immunostimulatory sequence (ISS)

Summary:

      The purpose of this study is to find out if a new investigational hepatitis B virus vaccine,
      HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years
      old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at
      least as good as that of Engerix-B®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give written informed consent

          -  Is serum negative for HBV antibodies

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Any previous HBV infection

          -  Previous vaccination with any HBV vaccine (1 or more doses)

          -  Any autoimmune disease

          -  Received any blood products or antibodies within 3 months prior to study entry

          -  Ever received an injection with DNA plasmids or oligonucleotides

          -  Received any vaccines within 4 weeks prior to study entry

          -  Received any other investigational medicinal agent within 4 weeks prior to study entry
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Condition: Hypoxia
MeSH terms: Hypoxia
Intervention: Caffeine citrate 6 mg/kg/day
Intervention description: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.
Intervention MeSH terms: Caffeine; Caffeine citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 33 Weeks
Maximum age: 37 Weeks
Healthy volunteers: No
Keywords: Prematurity; Apnea of prematurity; Intermittent hypoxia

Summary:

      The purpose of this pilot study is to document the extent to which intermittent hypoxia
      persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect
      of caffeine treatment on the number of intermittent hypoxia episodes and the total number of
      seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks
             PMA at randomization

          2. Prior treatment with caffeine based on routine clinical indications, and clinical
             caffeine now discontinued ≥5 days before randomization

          3. Previously tolerated clinical treatment with caffeine

          4. Breathing room air (no current supplemental O2 treatment; may have previously required
             respiratory support)

          5. Parental consent to enroll in pilot study

        Exclusion Criteria:

          1. Congenital syndrome or other medical diagnosis associated with known risk for
             neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or
             greater, cyanotic congenital heart disease, confirmed central nervous system
             infection, or fetal alcohol syndrome

          2. Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy

          3. Clinical decision to restart caffeine prior to completing 5 days of continuous
             physiologic monitoring after clinical caffeine stopped

          4. Anticipated inability to meet protocol requirements