bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Daridorexant 10 mg; Daridorexant 25 mg; Daridorexant 50 mg; Placebo
Intervention description: Daridorexant 10 mg film-coated tablets; Daridorexant 25 mg film-coated tablets; Daridorexant 50 mg film-coated tablets; Matching placebo film-coated tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 804.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to assess the long term safety and tolerability of daridorexant in adult and elderly
      subjects suffering from difficulties to sleep
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure (Visit 1).

          -  Having completed the DB study treatment and the run-out period of ID-078A301
             (NCT03545191) or ID-078A302 (NCT03575104).

          -  For woman of childbearing potential, the following is required:

               -  Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)

               -  Agreement to use the contraception scheme as required by the protocol from Visit
                  1 up to at least 30 days after EODBT.

        Exclusion Criteria:

          -  Unstable medical condition, significant medical disorder or acute illness, C-SSRS©,
             ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in
             the opinion of the investigator could affect the subject's safety or interfere with
             the study assessments (Visit 1).

          -  For female subjects: lactating or planning to become pregnant during the duration of
             the study (Visit 1).

          -  Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates,
             amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by
             breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or
             Visit 1 if within 7 days after EOT).
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 433.0
Sex: All
Minimum age: 37 Months
Maximum age: 63 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Children; Persistence; Booster dose

Summary:

      The primary objective was to evaluate the persistence of bactericidal antibodies in children
      40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received
      Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have
      never received any meningococcal vaccine (naïve subjects) to serve as a control group. In
      addition, the response of a booster dose at 60 months was evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children eligible to be enrolled in the study are those whose parents provide written
             informed consent, and are in generally good health based on the clinical judgment of
             the investigators.

          -  Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of
             enrollment and participated in the original V59P14 study (NCT00474526).

          -  Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children
             ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment,
             respectively.

        Exclusion Criteria:

          -  Serious, acute, or chronic illnesses are reasons for exclusion.

          -  Subjects who have received any vaccine (excluding influenza vaccines) 28 days
             preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for
             the 14 days prior to the enrollment visit.

          -  Subjects who have received any meningococcal vaccine since birth (Groups 3 & 4 -naive)
             or last study dose in V59P14 (NCT00474526) trial (Groups 1 & 2 - follow on).
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Placebo
Intervention description: IVA 150 mg tablet.; Placebo matched to IVA tablet.
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of
      age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF based on protocol-specified clinical features and at least
             one of the following: increased sweat chloride level, identification of 2 CF causing
             mutations, or demonstration of abnormal nasal epithelial ion transport.

          -  A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele.

          -  FEV1 ≥40% of predicted and ≤105% of predicted at screening.

        Exclusion Criteria:

          -  A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H
             mutation.

          -  History of any illness or any clinical condition that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject.

          -  Ongoing or prior participation in an investigational drug study within 30 days before
             the Screening Visit.

          -  Protocol-specified abnormal laboratory values at the Screening Visit

          -  For subjects <18 years of age at the Screening Visit, evidence of cataract/lens
             opacity determined to be clinically significant by the ophthalmologist or optometrist
             during the ophthalmologic examination (OE) at the Screening Visit.

          -  Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A,
             including consumption of certain herbal medications and certain fruit and fruit
             juices, within 14 days before Day 1.

          -  Pregnant, breastfeeding, or planning to become pregnant during the study.

          -  Sexually active subjects of reproductive potential must be willing to use appropriate
             contraception.
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
Condition: Analgesia
Intervention: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Intervention description: Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1083.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Self-selection and actual use/compliance trial.

Summary:

      A self-selection and actual use trial to evaluate the extent to which consumers will
      appropriately select and use the 600 mg immediate release/extended release caplets and comply
      with dosing instructions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 12 years of age

          -  use of at least 5 doses per month of over-the-counter pain relievers over the past 3
             months

          -  provide written informed consent (subjects 12-<18 years of age provide a written
             assent and parent/guardian will provide written informed consent)

          -  capable of and willing to swallow the study medication

        Exclusion Criteria:

          -  participated in other research studies in the last 6 months

          -  they or someone else in their household work for a pharmaceutical company, is a
             relative of study site personnel involved with the study, or an immediate family
             member is already enrolled in the study

          -  have a history of known allergies to ibuprofen, aspirin, or other NSAIDs

          -  have a history of heart surgery in the last 60 days or planned heart surgery in the
             next 60 days

          -  female subjects are pregnant or breast feeding
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid; Placebo
Intervention description: intravenous infusion; intravenous infusion
Intervention MeSH terms: Zoledronic 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: 34.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Osteoporosis, children and adolescents, zoledronic acid, chronic inflammation, Duchenne muscular dystrophy, glucocorticoids, chronic inflammatory conditions

Summary:

      This study was designed to evaluate the efficacy and safety of zoledronic acid compared to
      placebo in osteoporotic children treated with glucocorticoids
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A diagnosis of chronic rheumatologic conditions or inflammatory bowel disease or
             Duchenne muscular dystrophy requiring systemic glucocorticoids (i.v. or oral) within
             12 months prior to screening

          -  Lumbar Spine BMDZ-score of -0.5 or worse

          -  Evidence of at least at least 1 vertebral compression fracture of Genant Grade 1 or
             higher (or radiographic signs of vertebral fracture) within 1 month from Screening
             visit OR One or more, low-trauma, lower extremity long-bone fracture which occurred
             sometime within the 2 years PRECEDING enrollment in the study OR Two or more,
             low-trauma, upper extremity long-bone fractures which occurred sometime within the 2
             years PRECEDING enrollment in the study

          -  Consent/assent to study participation

        Key Exclusion Criteria:

          -  History of primary bone disease (OI, Idiopathic Juvenile Osteoporosis,
             Rickets/Osteomalacia)

          -  Any medical condition that might have interfered with the evaluation of lumbar spine
             BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable
             vertebrae by Dual Energy X-ray Absorptiometry (DXA) evaluation in the region of
             interest lumbar 1 (L1) to lumbar 4 (L4),

          -  Hypocalcemia and hypophosphatemia

          -  Serum 25-hydroxy vitamin D concentrations of <20 ng/mL or <50 nmol/L

          -  estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2

          -  serum creatinine increase between Visit 1 and Visit 2 >0.5 mg/dL (44.2 μmol/L)

          -  Uncontrolled symptoms of cardiac failure or arrhythmia

          -  Any prior use of bisphosphonates, or high dose sodium fluoride
A Study of Nilotinib Versus Imatinib in GIST Patients
Condition: Gastrointestinal Stromal Tumor (GIST)
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: Nilotinib (AMN107); imatinib (STI571)
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 644.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Unresectable GIST; metastatic GIST; nilotinib; AMN107; imatinib; STI571

Summary:

      This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients
      with unresectable or metastatic gastrointestinal stromal tumors (GIST).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and
             either:

               -  have not received any prior anti-neoplastic therapy other than adjuvant imatinib.
                  Note: newly diagnosed patients may have received up to 14 days of treatment with
                  imatinib for disease management while awaiting entry to the study or

               -  recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent
                  treatment with any other therapies.

          2. At least one measurable site of disease on CT/MRI scan

          3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)

          4. Normal organ, electrolyte and marrow function

        Exclusion Criteria:

          1. Any prior anti-neoplastic therapy with the exception of patients who have received
             adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose
             disease requires therapy while awaiting entry to the study.

          2. Disease progression during adjuvant therapy with imatinib

          3. History of active malignancy (other than GIST) within 10 years prior to study entry
             with the exception of previous or concomitant basal cell skin cancer, previous
             cervical carcinoma in situ.

          4. Impaired cardiac function

        Other protocol-defined inclusion/exclusion criteria may apply
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
Condition: Sjogrens Disease
MeSH terms: Sjogren's Syndrome
Intervention: Abatacept; Placebo
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in
      patients with Sjögren's Syndrome.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5

          -  Positive anti-SS-A/Ro antibody at screening

          -  meet the 2016 American College of Rheumatology (ACR) / European League Against
             Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)

        Exclusion Criteria:

          -  Secondary Sjögrens syndrome

          -  Active life-threatening or organ-threatening complications of Sjögren's-syndrome

          -  Other medical condition associated with sicca syndrome

        Other protocol defined inclusion/exclusion criteria could apply
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Condition: Glaucoma; Open Angle or Ocular Hypertension
MeSH terms: Ocular Hypertension
Intervention: brinzolamide 1% ophthalmic suspension; Azopt 1%
Intervention description: brinzolamide 1% ophthalmic suspension; Azopt 1%, RLD
Intervention MeSH terms: Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this prospective study is to demonstrate the therapeutic equivalence of
      topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic
      suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females 18 years of age or older,

          -  diagnosed with primary open-angle glaucoma or ocular hypertension.

        Exclusion Criteria:

          -  Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal
             tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle
             glaucoma,

          -  ocular hypertension.
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
Condition: Heart Defects, Congenital; Heart Failure, Congestive
MeSH terms: Heart Failure; Univentricular Heart; Heart Defects, Congenital; Congenital Abnormalities
Intervention: Enalapril; Placebo
Intervention description: Enalapril to target dose of .4mg/kg/day divided to twice per day (BID); Participants will receive placebo
Intervention MeSH terms: Enalapril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Maximum age: 45 Days
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of administering an angiotensin converting
      enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study
      will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the
      effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental
      and functional status, ventricular geometry, function, and atrioventricular (AV) valve
      regurgitation. In addition, the study will determine the relationship between genetic
      polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I
      therapy and compare the incidence of adverse events in subjects treated with ACE-I with those
      in subjects treated with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Less than or equal to 45 days of age

          -  Age greater than 1 week if born at 35 weeks gestation

          -  Single ventricle physiology

          -  Stable systemic and pulmonary blood flow

          -  Planned Glenn shunt surgery (or variant known as hemi-Fontan)

        Exclusion Criteria:

          -  Birth weight less than or equal to 2.5 kg if gestational age is greater than or equal
             to 38 weeks

          -  Birth weight less than the 10th percentile for gestational age if gestational age is
             35 to 37 weeks

          -  Less than 35 weeks gestation

          -  Anatomic diagnosis of pulmonary atresia with intact ventricular septum

          -  Less than 3 days after palliative cardiac surgical procedure, if performed

          -  Aortic oxygen saturation less than 65%

          -  Current mechanical ventilatory support

          -  Current intravenous inotropic support

          -  Creatinine greater than 1.0 mg/dL

          -  Absolute neutrophil count less than 1,000 cells/mL

          -  Chromosomal or recognizable phenotypic syndrome of noncardiac congenital abnormalities
             associated with growth failure (e.g., Trisomy 21, Noonan's syndrome, Turner's
             syndrome)

          -  Prior ACE inhibitor use for greater than 7 consecutive days
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 9072, Low Dose; ALKS 9072, High Dose
Intervention description: Intramuscular injection, given monthly; Intramuscular injection, given monthly
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: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to
      continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects
      with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the treatment period of Study ALK9072-003EXT

          -  Continues to require chronic treatment with an antipsychotic medication

          -  Continues to reside in a stable living situation

          -  Continues to have an identified reliable informant

        Exclusion Criteria:

          -  Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding
             during participation in Study ALK9072-003EXT that was clinically relevant and related
             to study drug

          -  Missed more than 1 scheduled study visit during participation in the preceding Study
             ALK9072-003EXT

          -  Has a significant or unstable medical condition that would preclude safe completion of
             the current study

          -  Subject is pregnant or breastfeeding

          -  Subject expects to be incarcerated, or has pending legal action which may impact
             compliance with study participation or procedures