bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; TEZ/IVA; IVA
Intervention description: FDC tablet for oral administration.; Fixed-dose combination (FDC) tablet for oral administration.; Mono tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX,
      VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with
      cystic fibrosis (CF) who are homozygous for F508del.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation (F/F)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Omega 3; Optive Advanced; Optive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is
      being developed by Allergan. It is desirable to understand the effect that this new emulsion
      has on tear film evaporation and tear lipid profile via interferometry, in patients with
      evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate
      the retention time of the lipid components of the new emulsion via tear collection and
      analysis in EDE and non-EDE patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to read and comprehend English and give informed consent as demonstrated by
             signing a record of informed consent;

          -  Over 18 years of age;

          -  Not wearing contact lenses in the past 3 months before enrolling

          -  Willing to use eye drops and comply with the study visit schedule as directed by the
             Investigator;

          -  Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye;

          -  At the Screening visit (Day -14), patients must have Ocular Surface Disease Index
             (OSDI) score >18 (0 to 100 scale). At Baseline (Day 1) visits, patients must have OSDI
             score > 12 to continue in the study.

          -  TBUT≤10sec in at least 1 eye at Screening visit and Baseline visit

          -  Corneal sodium fluorescein staining score ≥ 1 and <4 (Oxford scheme) at Screening and
             Baseline visit.

        Exclusion Criteria:

          -  Schirmer test (with anesthesia) ≤ 2 mm in either eye at Screening

          -  Patients who are currently using topical ocular medication or have used topical ocular
             medication within 2 weeks of the Screening visit. Patients who are being treated
             bilaterally with a marketed artificial tear for dry eye can be considered, provided
             they discontinue use at the Screening visit;

          -  Any active anterior segment disease excluding blepharitis;

          -  Any systemic disease that may affect ocular health e.g. Graves disease, and
             auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic
             lupus erythematosus;

          -  History of epilepsy or migraines exacerbated by flashing, strobe-like lights;

          -  Rigid or soft contact lens wearer, including orthokeratology;

          -  History of eye surgery within 6 months prior to enrolment in the study;

          -  Previous corneal refractive surgery
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab; Cabozantinib; Sunitinib; Ipilimumab
Intervention description: Specified dose on specified day; Specified dose on specified days; Specified dose on specified days.; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is
      safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal
      cell carcinoma
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histological confirmation of RCC with a clear-cell component, including participants
             who may also have sarcomatoid features

          -  Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC
             Stage IV) RCC

          -  No prior systemic therapy for RCC with the following exception:

             i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such
             therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence
             occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

        Exclusion Criteria:

          -  Any active CNS metastases

          -  Any active, known or suspected autoimmune disease

          -  Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily
             prednisone equivalent) or other immunosuppressive medications within 14 days of
             randomization

          -  Participants who have received a live/attenuated vaccine within 30 days of first
             treatment

        Other protocol defined inclusion/exclusion criteria could apply
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
Condition: High Risk Stage III Melanoma
MeSH terms: Melanoma
Intervention: ipilimumab; Placebo
Intervention description: IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal; IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
Intervention MeSH terms: Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if ipilimumab is effective in preventing or delaying
      recurrence and prolongs survival after complete resection of high risk stage III melanoma
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Complete and adequate resection of Stage III melanoma with histologically confirmed
             melanoma metastatic to lymph node

          -  Disease-free

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

          -  Randomization within 12 weeks of surgery

        Exclusion Criteria:

          -  Prior therapy for melanoma except surgery

          -  Auto-immune disease
Efficacy of TAP Block in Cesarean Section Patients
Condition: Pain Control
Intervention: TAP block using Bupivacaine 0.5%; TAP block using Bupivacaine 0.25%; TAP block using Normal Saline
Intervention description: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.; Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.; Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1: Bupivacaine 05%, arm 2: Bupivacaine 0.25%, and arm 3: placebo (Normal saline)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The randomization sheet was given to someone who is not involved in the study, also the person who prepare the medicine is not involved in the study.
Enrollment: 60.0
Sex: Female
Healthy volunteers: No

Summary:

      TAP Block done with 2 different concentrations of bupivacaine and placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy pregnant women

        Exclusion Criteria:

          -  Allergy to local anesthetics
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Oteseconazole (VT-1161); Placebo
Intervention description: Oteseconazole (VT-1161) 150mg capsule; matching placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 425.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
      defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of
      oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for
      RVVC than other oral antifungal medicines.

      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the
      treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for
      the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd
      part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg
      or a placebo (according to a random assignment), and then a 36-week follow-up period.

      In addition, at participating sites, an amendment to the study allows US patients who
      complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a
      48-week observational extension period designed to evaluate the continued effectiveness of
      oteseconazole (VT-1161).

      This study is identical to VMT-VT-1161-CL-011.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  3 or more episodes of acute VVC in the past 12 months

          -  Positive KOH or Gram stain test

          -  Total vulvovaginal signs and symptoms score of ≥3 at screening visit

          -  Total vulvovaginal signs and symptoms score of <3 at baseline visit

          -  Must be able to swallow pills

        Key Exclusion Criteria:

          -  Presence or a history of another vaginal or vulvar condition(s)

          -  Evidence of major organ system disease

          -  History of cervical cancer

          -  Poorly controlled diabetes mellitus

          -  Pregnant

          -  Recent use of topical or systemic antifungal or antibacterial drugs

          -  Recent use of immunosuppressive or systemic corticosteroid therapies
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Intervention: JZP-110; Placebo oral tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm
      parallel group study of safety and efficacy of JZP-110 in the treatment of excessive
      sleepiness in adult subjects with OSA.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Male or female between 18 and 75 years of age, inclusive

          2. Diagnosis of OSA according to ICSD-3 criteria

          3. Body mass index from 18 to <45 kg/m2

          4. Consent to use a medically acceptable method of contraception

          5. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          4. History or presence of any acutely unstable medical condition, behavioral or
             psychiatric disorder (including active suicidal ideation), or surgical history that
             could affect the safety of the subject or interfere with study efficacy, safety, PK
             assessments, or the ability of the subject to complete the trial per the judgment of
             the Investigator.

          5. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          6. Presence or history of significant cardiovascular disease

          7. Use of any over-the-counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          8. Received an investigational drug in the past 30 days or five half-lives

          9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05,
             R228060, or YKP10A)

         10. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: CVT-301 Low Dose; CVT-301 High Dose; Placebo
Intervention MeSH terms: Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 351.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes

Summary:

      This randomized, multicenter, placebo-controlled, double-blind study will evaluate the
      efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing
      motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the
      clinic.

      Patients who successfully complete this study will be eligible to enroll into a 12 month
      treatment extension (CVT-301-004E) study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 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 LD dose <1600 mg/day;

          -  Able to perform a spirometry maneuver in the ON and OFF states;

          -  Normal cognition confirmed by MMSE score ≥25

        Exclusion Criteria:

          -  Pregnant or lactating females;

          -  Previous surgery for PD or plan to have stereotactic surgery during the study period;

          -  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 contraindication to performing routine spirometry.
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: dalcetrapib; Placebo
Intervention description: Cholesterol Ester Transfer Protein inhibitor; matching placebo tablets
Intervention MeSH terms: Dalcetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6147.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study
      in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects
      will provide informed consent before any study-specific procedures are performed. Subject
      enrollment may begin in the hospital and will continue following release from the hospital.
      Screening procedures may be performed at the time of the index ACS event or anytime
      thereafter, with the condition that randomization must occur within the mandated window (4-12
      weeks after the index event). Subjects will be assessed based on their medical history. Those
      who are likely to qualify will undergo Genotype Assay testing to evaluate genetic
      determination for the presence of AA genotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with the appropriate genetic background and recently hospitalized for ACS
             (between 4 and 12 weeks following the index event), will be enrolled in this trial.

          -  AA genotype at variant gene as determined by Genotype Assay testing, conducted at a
             designated investigational testing site (ITS)

          -  Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for
             at least 1 week prior to randomization

          -  Prior to randomization, subject must have evidence of guidelines-based management of
             LDL-C, at a minimum to include medical and dietary treatment to a target level of
             LDL-C <100 mg/dl (<2.6 mmol/L).

        Exclusion Criteria:

          -  Females who are pregnant (negative pregnancy test required for all women of
             child-bearing potential at Visit 2, Day 0) or breast-feeding

          -  Women of childbearing potential (women who are not surgically sterile or
             postmenopausal defined as amenorrhea for >12 months) who are not using at least one
             method of contraception*

          -  New York Heart Association (NYHA) Class III or IV heart failure

          -  Last known hemoglobin <10 g/dL

          -  Index ACS event presumed due to uncontrolled hypertension

        (*) Varies by region