bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Intervention: Infasurf surfactant (ONY, Inc.); Sham (No Treatment)
Intervention description: Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.; Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Intervention MeSH terms: Pulmonary Surfactants; Calfactant
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 7 Days
Maximum age: 14 Days
Healthy volunteers: No
Keywords: nitric oxide; surfactant; BPD; prematurity; neonates; iNO; pulmonary outcome; neurodevelopmental outcome; Infasurf; lung function; Surfactant Dysfunction; Bronchopulmonary Dysplasia

Summary:

      The purpose of this study is to determine if late doses of Infasurf surfactant given when
      patients are receiving inhaled nitric oxide will interact to improve surfactant function and
      increase survival without BPD in treated infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  <=28 0/7 weeks gestational age

          -  Day of life 7-14

          -  Intubated and mechanically ventilated

          -  Plan to treat with inhaled nitric oxide

        Exclusion Criteria:

          -  Serious congenital malformations or chromosomal abnormalities

          -  Life expectancy <7 days from enrollment

          -  Clinically unstable

          -  Less tha 48 hours since last dose surfactant

          -  Ability to obtain 36 week primary outcome information is unlikely
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Daclatasvir; Peg-Interferon Alfa-2a; Ribavirin
Intervention description: Tablet, Oral, 60 mg, once daily, 24 weeks; Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response; Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 448.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the rates of sustained virologic response in each
      cohort (Black-African Americans, Latinos) in this study to historical rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants chronically infected with Hepatitis C virus (HCV) genotype 1

          -  HCV RNA viral load of ≥10,000 IU/mL at screening

          -  No previous exposure to interferon formulation, ribavirin or HCV direct antiviral
             agent

          -  Self-described as Black-African American, Latino or White-Caucasian

          -  Results of a liver biopsy obtained ≤36 months prior to first treatment compensated
             cirrhotics with HCV liver biopsy from any time prior to first treatment.

        Compensated cirrhotics were capped at approximately 25%

        Exclusion Criteria:

          -  Evidence of decompensated liver disease

          -  Documented or suspected Hepatocellular carcinoma (HCC)

          -  Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Condition: Chronic Sinusitis
MeSH terms: Sinusitis; Chronic Disease
Intervention: Sinus Stent with drug coating; Non Coated Sinus Stent
Intervention description: Sinus stent coated with 370 ug of the corticosteroid mometasone furoate; Sinus stent (visually identical) without drug coating
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of the Propel mometasone
      furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients
      with Chronic Sinusitis (CS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has bilateral chronic sinusitis confirmed by CT scan and defined as
             inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive
             weeks' duration.

          -  Patient is indicated for and has consented to FESS.

          -  FESS successfully completed without significant complication that in the opinion of
             the physician would confound study results and the patient's anatomy remains amenable
             to Sinus Stent placement.

        CT Imaging Inclusion Criteria:

          -  CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.

          -  Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral
             ethmoid sinus disease confirmed by CT.

        Exclusion Criteria:

          -  insulin dependent diabetics

          -  oral steroid dependent condition

          -  glaucoma, ocular hypertension, posterior subcapsular cataracts

          -  middle turbinate resection
Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Radiation Therapy; Conventional radiation
Intervention description: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks; Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; Stages II or III non-small cell lung cancer

Summary:

      The study is designed to determine whether an accelerated course of hypofractionated
      radiation therapy with daily image guidance and motion assessment/control will allow more
      effective treatment of poor performance status patients with stage II-III NSCLC, who would
      benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per
      fraction).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must be willing and capable to provide informed consent to participate in
             the protocol.

          -  Patients must have appropriate staging studies identifying them as AJCC stage II or
             III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix
             III), or recurrent non small cell lung cancer. Histologic confirmation of cancer will
             be required by biopsy or cytology within 6 months of study entry.

          -  Patients must have the potential for benefit from local therapy (at the discretion of
             the investigator).

          -  The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod
             performance status 0-1 and weight loss >10% are considered eligible. In addition,
             patients determined to be medically unfit or refusing combined modality therapy are
             eligible.

          -  Age ≥ 18.

          -  Patients must have measurable or evaluable disease.

          -  Women of childbearing potential and male participants must agree to use an effective
             method of contraception.

          -  Patients must sign study specific informed consent prior to study entry.

          -  Patients must not have plans for concurrent chemoradiation therapy.

          -  Patients must complete all required pretreatment evaluations

        Exclusion Criteria:

          -  Total (aggregate) gross tumor volume > 500 cm3 (500 cc's or 0.5 Liters)

          -  Prior radiotherapy to the region of the study cancer that would result in direct
             overlap of radiation therapy fields.

          -  Chemotherapy given within one week of study registration.

          -  Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
             or fetus.
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Fluconazole Tablet; IBREXAFUNGERP; Placebo oral tablet
Intervention description: 150 mg every 72 hours for 3 doses; 300 mg BID (one day) every 4 weeks for a total of 6 dosing days; BID (one day) every 4 weeks for a total of 6 dosing days
Intervention MeSH terms: Fluconazole; Ibrexafungerp
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label (acute phase treatment) followed by Randomized, Double Blinded phase
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 440.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Recurrent yeast infection; Recurrent yeast vaginitis; Chronic yeast vaginitis; Ibrexafungerp; SCY-078; RVVC

Summary:

      This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to
      placebo in female subjects 12 years and older with recurrent VVC (RVVC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast
             and normal vaginal pH.

          -  History of 3 or more episodes of VVC in the past 12 months.

          -  Culture confirmation and resolution of the signs and symptoms of the initial VVC
             episode (with treatment).

          -  Able to take oral tablets and capsules.

        Key exclusion Criteria:

          -  Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or
             evaluation of response to therapy.

          -  Recent use of systemic and/or topical vaginal antifungal products.

          -  Pregnant.

          -  History of major system organ disease.
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Condition: Low Bone Mineral Density
MeSH terms: Bone Diseases, Metabolic
Intervention: AMG 162
Intervention description: AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: Female
Healthy volunteers: No
Keywords: bone loss; osteoporosis

Summary:

      An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab
      Administration in Postmenopausal Women with Low Bone Mineral Density
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be ambulatory

          -  Subject must have atteneded the 20010223 end-of-study visit and have completed all
             tests and procedures during the end-of-study visit

          -  signed informed consent must be obtained before any study-specific procedures

        Exclusion Criteria:

          -  Experienced severe and/or serious adverse event which were thought to be related to
             denosumab administration during the 20010223 study.

          -  Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria
             for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow
             up or did not have diagnosis or treatment.

          -  Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other
             bone diseases, renal disease.

          -  Using therapies while participating in the 20010223 study such as oral
             bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Condition: Epilepsy; Generalized Tonic-clonic Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam
Intervention description: formulation: tablet or dry syrup
strength: 250 mg tablet, 500 mg tablet, dry syrup 50%
dosage: Sb ≥16 years and ≥4 and <16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and <16 years (<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day
frequency: twice daily
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: Levetiracetam; Epilepsy; Generalized tonic-clonic seizures

Summary:

      The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are
      judged to benefit from continued treatment with Levetiracetam by the investigators and who
      are willing to continuously receive this drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject in Japan has completed either of the studies N01159 or N01363 or has
             discontinued the N01159 study due to lack of efficacy.

          -  The subject who is judged to benefit from continued treatment with Levetiracetam by
             the investigators

        Exclusion Criteria:

          -  Subjects with multiple protocol deviations during N01159 or N01363, such as missing
             laboratory data, and low or noncompliance with the study medication, and who the
             investigator considers not to have the potential to have deviations stopped are
             ineligible
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: reslizumab
Intervention MeSH terms: Reslizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Eosinophilic Esophagitis; Cinquil

Summary:

      This study is an open-label study where all subjects will receive active drug, reslizumab.
      Subjects are able to enter this trial only through completion of study Res-05-0002
      (NCT00538434).

      The goal of the study is to show longer term safety and efficacy in pediatric subjects who
      have eosinophilic esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)

          -  Did not withdraw from Study Res-05-0002 due to drug related adverse event

          -  Completed End of Treatment Visit for Study Res-05-0002

        Exclusion Criteria:

          -  Pregnant or nursing females

          -  Concurrent Immunodeficiency

          -  Current use of immunosuppressive drugs

          -  Did not tolerate study drug in Study Res-05-0002
Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
Condition: HCV; Hepatitis C Infection; Genotype 4
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Intervention: 2 DAA; RBV
Intervention description: ABT-450/r/ABT-267 tablets; Ribavirin tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Genotype 4; non-responder; treatment experienced; HCV; naive; relapser; hepatitis infection; compensated cirrhosis; hepatitis c; Cirrhosis; Egypt; null responder; partial responder

Summary:

      This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive
      and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid
             [RNA] level greater than 1,000 IU/mL at Screening)

          -  Subjects must meet one of the following:

               -  Treatment-naive: Subject has never received antiviral treatment for HCV infection
                  OR

               -  Treatment Experienced (Prior null responders, Partial responders or Relapsers to
                  pegylated-interferon [pegIFN]/RBV);

          -  Females must be post-menopausal, of non-child bearing potential or practicing specific
             forms of birth control

          -  In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or
             Fibroscan

          -  In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
             with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of
             hepatocellular carcinoma

        Exclusion Criteria:

          -  Females who are pregnant or breastfeeding

          -  Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus
             antibody

          -  HCV genotype performed during screening indicating unable to genotype or co-infection
             with any other HCV genotype

          -  abnormal laboratory tests

          -  self-reports current drinking more than 2 drinks per day

          -  current enrollment in another investigational study

          -  previous treatment with a direct acting antiviral agent (DAA) containing regimen

          -  In substudy 1, evidence of liver cirrhosis

          -  In substudy 2, evidence of current or past Child-Pugh B or C classification and
             confirmed presence of hepatocellular carcinoma
Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)
Condition: Saphenous Vein Graft Disease
MeSH terms: Aggression
Intervention: Atorvastatin 80 mg daily; Atorvastatin 10 mg daily
Intervention description: Atorvastatin 80 mg daily for 1 year; Atorvastatin 10 mg daily for 1 year
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Statin,; CABG,; saphenous vein graft,; graft occlusion,; lipids

Summary:

      During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to
      bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein
      bypasses themselves develop blockages over time, a process termed saphenous vein graft
      disease. By lowering cholesterol levels in the blood, statin medications are used after
      surgery to prevent the development of atherosclerotic blockages in the vein bypasses.
      Recently, higher doses of statin medications have been introduced, with some studies showing
      that they are more effective than traditional doses when used in heart attack patients.
      Furthermore, laboratory tests have shown that higher doses of statin medications can slow the
      development of atherosclerosis. Despite these benefits, very little is known regarding the
      use of high-dose statin therapy after bypass surgery in humans.

      The goal of this study will be to see if high-dose statin therapy will prevent the
      development of vein graft occlusion during the first year after bypass surgery. Patients will
      be randomized to receive either high-dose statin therapy or conventional moderate-dose statin
      therapy starting within 4 days of surgery and continuing for the duration of one year after
      the operation. The statin medication will be given in capsule form. During the course of this
      study, neither the patient nor the health care team will know which treatment each patient is
      receiving. One year after bypass surgery, a computed tomography (CT) coronary angiogram will
      be performed to evaluate the patency of the vein bypasses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing first-time CABG with at least 1 saphenous vein graft

        Exclusion Criteria:

          -  Redo-CABG

          -  Statin allergy

          -  Severe renal dysfunction

          -  Severe liver disease