bioihbjkbjnl/mcl2 huggingface dataset:
Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
Condition: Blepharoptosis
MeSH terms: Blepharoptosis
Intervention: RVL-1201; Vehicle ophthalmic solution
Intervention description: RVL-1201 ophthalmic solution 0.1%; Vehicle placebo ophthalmic solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 164.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to
      placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2
      treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female 9 years of age or older

          2. Females must not be pregnant or planning to get pregnant and must use acceptable form
             of contraception

          3. Must be able to self-administer study medication

          4. Must be able to understand and sign an informed consent form. For minor subjects, the
             subject's parent or legal guardian must provide permission by signing an ICF on behalf
             of the subject and the subject should provide assent.

        Exclusion Criteria:

          1. Congenital ptosis

          2. Horner syndrome

          3. Myasthenia gravis

          4. Mechanical ptosis

          5. Previous ptosis surgery

          6. Resting heart rate outside the normal range

          7. Hypertension with resting diastolic blood pressure

          8. Pregnancy or lactation
Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-118 Lotion; IDP-118 Vehicle Lotion
Intervention description: Lotion; Lotion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the safety and efficacy of a topical lotion.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of
             at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and
             intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or
             4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded
             in this assessment).

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently
             participating in another clinical study with an investigational drug or device.
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Condition: Infant, Newborn; Infant, Small for Gestational Age; Infant, Extremely Low Birth Weight
MeSH terms: Body Weight; Birth Weight
Intervention: Donor Milk; Preterm Formula
Intervention description: Donor milk provided by the Human Milk Banking Association of North America; Preterm Formula determined by center practice.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 483.0
Sex: All
Maximum age: 21 Days
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Neurodevelopmental Impairment; Donor Breast Milk; Preterm Formula

Summary:

      The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26
      months of donor human milk as compared to preterm infant formula as the in-hospital diet for
      infants whose mothers choose not to provide breast milk or are able to provide only a minimal
      amount. Infants will be randomized to receive donor breast milk or formula during their
      hospital stay. Infant's will be followed until they reach 22-26 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age less than 29 weeks.

          -  Admitted to the NICU at less than or equal to 72 hours of life

          -  Survived at least 12 hours

        Exclusion Criteria:

          -  Chromosomal anomalies

          -  Cyanotic congenital heart disease

          -  Diagnosed intrauterine infection

          -  Other congenital disorders known to impair neurodevelopment

          -  NEC or IP prior to seeking consent

          -  Decision documented to limit intensive care therapies

          -  Congenital disorders that may affect feeding

        Feeding Group Eligibility:

          -  Sole Diet Group: Infants will be eligible for the sole diet feeding protocol if the
             mother declines to provide breast milk for the baby.

          -  Supplemental Diet (minimal maternal milk) Group: Infants whose mothers initially
             choose to provide breast milk and begin pumping will be re-screened for eligibility at
             least weekly until the infant is 21 days old. If the mother stops expressing milk at
             any point prior to the infant's 21st day of life, her infant will be eligible for
             randomization. In addition, those whose mothers are providing less than 20% of the
             infant's dietary needs (averaged over past 5 days) when the infant reaches 21 days of
             age will be eligible for randomization at this point. No infant will be randomized
             after reaching 21 days.
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: fosamprenavir (GW433908); ritonavir
Intervention MeSH terms: Ritonavir; Fosamprenavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 753.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: antiretroviral therapy naive subjects; fosamprenavir; HIV-1; protease inhibitor; pro-drug; antiretroviral therapy; LEXIVA; AGENERASE; GW433908; amprenavir

Summary:

      GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble
      and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV
      versus sixteen 150mg capsules daily for APV. This study is designed to provide additional
      information on long term safety and tolerability of FPV containing regimens for those
      subjects who received FPV in previous GlaxoSmithKline studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age
             according to local requirements).

          -  Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or
             PRO30017 or have participated in APV30001 or other studies as deemed appropriate by
             the project team.

        Exclusion Criteria:

          -  Permanent discontinuation of GW433908 in a previous study due to intolerance.

          -  An active CDC Class C Event.

          -  Any condition which, in the opinion of the investigator, would preclude a subject from
             participation.
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: PL2200 Aspirin Capsules; Immediate-Release Aspirin Tablets; Enteric-coated aspirin caplets
Intervention description: 325 mg aspirin; once per day for 3 days; 325 mg aspirin; once per day for 3 days; 325 mg aspirin; once per day for 3 days
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This study will determine if aspirin from PL2200, an investigational product, gets into the
      blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether
      PL2200 is able to prevent blood clots as effectively as these other products, when
      administered to patients with diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 21-79

          -  Body mass index (BMI) of 30-40 kg/m2

          -  Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of >
             6.4% and/or fasting plasma glucose of >125 mg/dL or current anti-diabetic medication)

          -  AA-induced platelet aggregation response of >60% within 3 hours prior to initial dose
             of study drug administration

        Exclusion Criteria:

          -  Contraindications to aspirin

          -  Previous history of vascular disease

          -  Patient requires insulin

          -  Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and
             salicylate-containing nutritional supplements within 2 weeks of randomization
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: AMG 162; Placebo
Intervention description: 60 mg/mL denosumab given day 1, month 6, month 12 and month 18; Placebo given at day 1, month 6, month 12 and month 18
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 332.0
Sex: Female
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis; Postmenopausal

Summary:

      This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss
      in both early and late postmenopausal women with osteopenia, and to further test the safety
      and tolerability of AMG 162 in this population.
    

Eligibility criteria:

        Eligibility Criteria

        - Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between
        1.0 and -2.5)
Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis
Condition: Pregnancy; Infertility
MeSH terms: Infertility; Varicocele
Intervention: Timed intercourse; Microsurgical varicocelectomy; Intrauterine insemination
Intervention description: Timed intercourse; Microsurgical varicocelectomy; Intrauterine insemination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Infertility; Pregnancy; Men; Palpable varicocele; Abnormal semen analysis; Intrauterine insemination; Microsurgical varicocelectomy

Summary:

      The primary research hypothesis is that microsurgical varicocelectomy will result in an
      increase in live birth in infertile couples where the male partner has a palpable varicocele
      and an abnormal semen analysis in comparison to male partners who do not have microsurgical
      varicocelectomy.

      The secondary hypotheses include:

        1. To assess whether up to 4 cycles of intrauterine insemination confers any additional
           increase in live birth rates compared to timed intercourse;

        2. To examine spousal pregnancy rate as the secondary outcome; and

        3. To study the effect of varicocelectomy in men with infertility, an abnormal semen
           analysis, and a palpable varicocele on

             -  Testicular semen analysis parameters;

             -  Serological measures of FSH, LH, total and free testosterone and

             -  Measures of quality of life and sexual function in both partners.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 months of infertility (primary or secondary - randomization will be stratified to
             allow equal numbers of primary and secondary infertility couples in the treatment vs.
             observation group), male partner > 18 years of age and < 50 years of age

          -  Female partner > 18 years of age and <= 40 years of age - randomization will be
             stratified for two groups - female partner <35 and female partner >=35

          -  Evidence of a hysterosalpingogram or Saline Infusion Sonogram with one patent tube and
             regular ovulatory cycles as defined by the recruiting site >25 days and <35 days in
             duration in the female partner

          -  Evidence of a bilateral grade I or unilateral grade II-III varicocele on physical exam
             in the male partner

          -  Abnormal semen analysis as defined by WHO II criteria with a sperm count of >5 X106
             /ml or the presence of abnormal strict morphology as defined by Kruger criteria.

        Exclusion Criteria:

          -  The presence of retrograde ejaculation or uncorrectable ejaculatory dysfunction

          -  Decreased ovarian reserve in the female partner as evidence by a day #3 FSH > 12
             mIU/ml
NET-PD LS-1 Creatine in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: creatine; placebo
Intervention description: Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
The study is comparing creatine 5 grams twice daily with placebo.; an inactive substance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1741.0
Sex: All
Healthy volunteers: No
Keywords: Parkinson's disease; creatine; NET-PD; neuroprotection; PD

Summary:

      The purpose of this trial is to determine if the nutritional supplement creatine slows the
      progression of Parkinson's disease over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give informed consent and willing to commit to long-term follow-up

          -  PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or
             rigidity) within 5 years of diagnosis

          -  Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at
             least 90 days, but not more than 2 years.

        Exclusion Criteria:

          -  Use of creatine 14 days prior to baseline or during the study

          -  History of known hypersensitivity or intolerability to creatine

          -  Any unstable or clinically significant condition that would impair the subject's
             ability to comply with long term study follow-up

          -  Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.),
             or any significant features suggestive of a diagnosis of atypical parkinsonism.
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Condition: Gout
MeSH terms: Gout
Intervention: Rilonacept; Placebo
Intervention description: Rilonacept 160 mg subcutaneous injection once a week; Placebo subcutaneous injection once a week
Intervention MeSH terms: Rilonacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1315.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Metabolism, Inborn Errors; Allopurinol; Metabolic Disease; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine Pyrimidine Metabolism, Inborn Errors; Gout; Intercritical Gout

Summary:

      The purpose of this clinical research study is to determine the safety and effectiveness of
      an experimental drug called rilonacept in subjects with gout who are on urate-lowering
      therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is
      being studied for use in preventing gout flares in subjects on urate-lowering therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 to 80 years of age;

          -  Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for
             the classification of acute gout arthritis of primary gout;

          -  Subjects with history of gout, initiating or currently on urate lowering; therapy who
             are at risk of gout flare.

        Exclusion Criteria:

          -  Acute gout flare within 2 weeks prior to the screening visit and during the screening
             visit;

          -  Persistent chronic or active infections;

          -  History of an allergic reaction to allopurinol;

          -  History or presence of cancer within 5 years of the Screening Visit;;;
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as Galcanezumab in Japanese participants with migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Episodic Migraine participants: Participants who completed the treatment period of
             Galcanezumab study CGAN.

          -  Have a diagnosis of chronic migraine as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines
             (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, and migraine onset prior to age 50.

        Exclusion Criteria:

          -  For Chronic Migraine participants:

               -  Are currently enrolled in or have participated within the last 30 days or within
                  5 half-lives (whichever is longer) in a clinical trial involving an
                  investigational product.

               -  Current use or prior exposure to Galcanezumab or other antibodies of calcitonin
                  gene-related peptide (CGRP) or its receptor.

               -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other
                  therapeutic proteins, or to Galcanezumab and the excipients in the
                  investigational product.

               -  History of persistent daily headache, cluster headache or migraine subtypes
                  including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine,
                  and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3
                  beta.

               -  Failure to respond to 3 or more adequately dosed migraine preventive treatments
                  from different classes (that is, maximum tolerated dose for at least 2 months).