bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Solanezumab; Placebo
Intervention description: Administered IV; Administered IV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: anti-amyloid; monoclonal antibody

Summary:

      The main purpose of this study is to investigate the safety and efficacy of the study drug
      solanezumab in participants with prodromal Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis by the study investigator of a clinical syndrome of cognitive
             impairment consistent with prodromal AD per International Working Group (IWG)
             diagnostic criteria or mild cognitive impairment (MCI) due to AD per National
             Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.

          -  Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.

          -  Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test
             (FCSRT) (Picture version) at screening.

          -  Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).

          -  Scores >0 on the Functional Activities Questionnaire (FAQ).

          -  Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF)
             result at screening consistent with the presence of amyloid pathology.

        Exclusion Criteria:

          -  Has had MRI or computerized tomography (CT) of brain within previous 2 years showing
             pathology that would be inconsistent with a diagnosis of AD.

          -  Has known allergy to humanized monoclonal antibodies.

          -  Has an ongoing clinically significant laboratory abnormality, as determined by the
             investigator.

          -  Has screening MRI with results showing >4 amyloid related imaging abnormalities H
             (ARIA-H) micro-hemorrhages or presence of ARIA-E.

          -  Has any contraindications for MRI studies, including claustrophobia, the presence of
             metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with
             MRI.

          -  Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor
             or memantine for less than 2 months before randomization. (If a participant has
             recently stopped AChEIs and/or memantine, he or she must have discontinued treatment
             at least 2 months before randomization.)
Hydrocortisone for BPD
Condition: Infant, Newborn; Infant, Small for Gestational Age; Infant, Very Low Birth Weight; Infant, Premature; Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Birth Weight
Intervention: Hydrocortisone; Placebo
Intervention description: Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows:
4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days; Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows:
4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days
Intervention MeSH terms: Hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 800.0
Sex: All
Maximum age: 30 Weeks
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Very Low Birth Weight (VLBW); Prematurity; Mechanical ventilation; Intubation; Neurodevelopmental impairment

Summary:

      The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course
      of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who
      are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or
      placebo. This study will determine if hydrocortisone improves infants'survival without
      moderate or severe BPD and will be associated with improvement in survival without moderate
      or severe neurodevelopmental impairment at 22 - 26 months corrected age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants <30 weeks estimated gestational age

          -  inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age

          -  have received at least 7days of mechanical ventilation;

          -  are receiving mechanical ventilation through an endotracheal tube .

        Exclusion Criteria:

          -  Major congenital anomalies

          -  Decision to limit support

          -  Indomethacin or ibuprofen treatment within 48 hours of study drug

          -  Previous corticosteroid treatment for BPD

          -  Received hydrocortisone for 14 or more cumulative days

          -  Received hydrocortisone within 7 days of study entry
Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Condition: Reducing Psychological Side Effects of Ketamine
Intervention: Lamotrigine 300 MG; Placebo; Ketamine
Intervention description: 300 mg of oral Lamotrigine. One of the key studies in this area was reported at the Society of Neuroscience meeting in 1997 and later published in the Archives of General Psychiatry. This study reported that, in healthy subjects 300 mg oral lamotrigine significantly decreased ketamine-induced perceptual abnormalities as assessed by the Clinician-Administered Dissociative States Scale (P<.001).31 Furthermore lamotrigine increased the immediate mood-elevating effects of ketamine (P<.05).; 300 mg of oral Placebo; 1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery
Intervention MeSH terms: Lamotrigine; Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomization without stratification
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The Pharmacy will know the treatment
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches
      peak level 1-4 hours after oral administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 -65 Years of age

          -  Planned overnight hospital stay

        Exclusion Criteria:

          -  Pregnant and planning to become pregnant

          -  No known History of seizure

          -  No known History of Schizophrenia

          -  No known History of unstable angina

          -  Patients taking Antiepileptic medications

          -  Known history of Lamotrigine intake in past.

          -  Any history of allergic reaction to lamotrigine in the past.
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: CVT-301
Intervention MeSH terms: Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 325.0
Sex: All
Minimum age: 30 Years
Maximum age: 86 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes

Summary:

      This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of
      CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor
      fluctuations (OFF episodes). All patients will receive active treatment, but patients will be
      blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study
      for those patients who participated in that study and remain eligible for this study. In
      addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009
      (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as
      CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;

          -  Hoehn and Yahr Stage 1-3 in an "on" state;

          -  Require levodopa-containing medication regimen at least 3 times during the waking day;

          -  Experience motor fluctuations with a minimum of 2 hours of average daily "off" time
             per waking day (excluding early morning "off" time) and demonstrate levodopa
             responsiveness;

          -  Are on stable PD medication regimen;

          -  Total daily levodopa (LD) dose <1600 mg/day;

          -  Able to perform a spirometry maneuver in the ON and OFF states

          -  Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;

        Exclusion Criteria:

          -  Pregnant or lactating females;

          -  Previous surgery for PD or plan to have stereotactic surgery during the study period.
             Patients who have had deep brain stimulation [DBS] will also be excluded unless the
             procedure was performed more than 6 months prior to study enrollment.

          -  History of psychotic symptoms requiring treatment, or suicide ideation or attempt
             within last year;

          -  Known contraindication to the use of levodopa;

          -  Any significant condition, severe concurrent disease, abnormality or finding that
             would make patients unsuitable or may compromise patient safety;

          -  Any any contraindication to performing routine spirometry.
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Inflammation; Pain; Cataract
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol Etabonate Gel (BID); Loteprednol Etabonate Gel (TID); Vehicle (BID); Vehicle (TID)
Intervention description: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days; One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.; One drop of vehicle instilled into the study eye two times per day (BID) for 14 days; One drop of vehicle instilled into the study eye three times per day (TID) for 14 days
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate
      ophthalmic gel
    

Eligibility criteria:

        Inclusion Criteria:

        Visit 1 (Screening Visit)

          -  Be willing and able to comply with all treatment and follow-up/study procedures.

          -  Be a candidate for routine, uncomplicated cataract surgery

        Visit 3 (Postoperative Day 1)

          -  Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with
             posterior chamber IOL implantation, not combined with any other surgery) in the study
             eye.

          -  Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

        Exclusion Criteria:

          -  Have a severe/serious ocular condition or history/presence of chronic generalized
             systemic disease that the Investigator feels might increase the risk to the subject or
             confound the result(s) of the study.

          -  Have known hypersensitivity or contraindication to the study drug(s) or their
             components.
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.
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
Condition: Metastatic Castration-resistant Prostate Cancer; Metastatic Breast Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Prednisone
Intervention description: Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily; Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
Intervention MeSH terms: Prednisone; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Healthy volunteers: No
Keywords: Metastatic castration-resistant prostate cancer; Metastatic breast cancer; Abiraterone acetate; Low-dose corticosteroid treatment; Long-term access

Summary:

      The purpose of this study is to collect follow-up safety data from participants in completed
      abiraterone acetate studies for a maximum duration of 9 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently participating in an abiraterone acetate clinical study considered complete
             and had received at least 3 months of treatment with abiraterone acetate tablets.

        Exclusion Criteria:

          -  Medical conditions that require hospitalization.

          -  Any condition or situation which, in the opinion of the investigator, may put the
             patient at significant risk, may confound the study results, or may interfere
             significantly with the patient's participation in the study.
Study of Eteplirsen in DMD Patients
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: eteplirsen
Intervention description: Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks, followed by a safety extension (not to exceed 48 weeks).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: Male
Minimum age: 7 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51

Summary:

      The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658)
      in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51.
      Additional objectives include evaluation of safety, biomarkers and the long-term effects of
      eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male 7-16 years old

          -  Diagnosed with DMD, genotypically confirmed

          -  Stable dose of corticosteroids for at least 24 weeks

          -  Have intact right and left alternative upper muscle groups

          -  Mean 6MWT greater than 300m (primary analysis on 300 to 450 meters)

          -  Stable pulmonary and cardiac function: predicted FVC equal to or greater than 50% and
             LVEF of greater than 50%

        Exclusion Criteria:

          -  Previous treatment with drisapersen or any other RNA antisense agent or any gene
             therapy within the last 6 months

          -  Participation in any other DMD interventional clinical study within 12 weeks

          -  Major surgery within 3 months

          -  Presence of other clinically significant illness

          -  Major change in the physical therapy regime within 3 months

        Other inclusion/exclusion criteria apply.
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: AMDC-USR; Placebo
Intervention description: AMDC-USR Treatment; Placebo treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Incontinence, Stress; Tissue Therapy (Cell Therapy); Transplantation, Autologous

Summary:

      This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived
      Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary
      incontinence (SUI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patient has primary symptoms of SUI, as confirmed by patient medical history
             and clinical symptoms, including a focused incontinence evaluation.

        Exclusion Criteria:

          -  Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of
             etiology from a patient medical history, including a focused incontinence history.

          -  Patient has symptoms of mixed urinary incontinence where urge incontinence is the
             predominant factor.

          -  Patient has had stress urinary incontinence symptoms less than 6 months prior to
             signing the informed consent.

          -  Patient has not previously attempted conservative treatment for at least 1 month prior
             to signing the informed consent. (Examples of conservative treatment include behavior
             modifications, bladder exercises, biofeedback, etc.)

          -  Patient has more than 2 episode of awakening to void during normal sleeping hours.

          -  Patient cannot be maintained on a stable dose and/or frequency of medication
             (including diuretics) known to affect lower urinary tract function, including but not
             limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers,
             for at least 2 weeks prior to randomization or is likely to change during the course
             of the study.

          -  Patient is pregnant, lactating, or plans to become pregnant during the course of the
             study.

          -  Patient refuses to provide written informed consent.

          -  Patient is not at least 18 years of age.

          -  Patient is not available for the follow-up evaluations as required by the protocol.
Multi-Center Study of New Medications to Treat Vaginal Infections
Condition: Vaginal Infection
MeSH terms: Infections
Intervention: Terconazole; Metronidazole; Terconazole/metronidazole
Intervention MeSH terms: Metronidazole; Terconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 475.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole
      gel in the treatment of vaginal infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:

          -  Capable of providing written informed consent or assent

          -  Currently not menstruating and not anticipating menses during treatment

          -  If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically
             sterile, or practicing an acceptable form of birth control

          -  Negative pregnancy test

          -  Other criteria as identified in the protocol

        Exclusion Criteria:

          -  Other infectious causes of vulvovaginitis

          -  Subject has recently used, or is expected to require the concomitant use of prohibited
             medications/products

          -  Nursing mother

          -  Use of any investigational drug within 30 days of enrollment

          -  History of hypersensitivity to any ingredient/component of the formulations

          -  Other criteria as identified in the protocol