bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659; TEZ/IVA; IVA; Placebo (matched to VX-659/TEZ/IVA); TEZ; VX-561; Placebo (matched to VX-659/TEZ/VX-561)
Intervention description: Tablet for oral administration.; TEZ/IVA fixed-dose combination tablet for oral administration.; Tablet for oral administration.; Placebo matched to VX-659 and TEZ/IVA.; Tablet for oral administration.; Tablet for oral administration.; Placebo matched to VX-659, TEZ and VX-561.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor
      (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the
      safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with
      cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane
      conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del
      mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or
      TEZ/IVA (F/MF genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Body weight ≥35 kg.

          -  Subjects must have an eligibleCFTR genotype.

               -  Part 1 and Part 3: Heterozygous for F508del and an MF mutation (F/MF)

               -  Part 2: Homozygous for F508del (F/F)

          -  FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height

        Key Exclusion Criteria:

          -  History of clinically significant cirrhosis with or without portal hypertension.

          -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Lung infection with organisms associated with a more rapid decline in pulmonary
             status.

          -  History of solid organ or hematological transplantation.

        Other protocol defined Inclusion/Exclusion criteria may apply.
Daratumumab in Treatment of PGNMID and C3 GN
Condition: Membranoproliferative Glomerulonephritis
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranoproliferative
Intervention: Daratumumab
Intervention description: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to see if daratumumab is safe and effective in the treatment of
      proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3
      glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease
      in the kidney due to the production of abnormal proteins. There are no known standard
      effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy.
      These diseases are caused by abnormal production of proteins (monoclonals) by abnormal
      clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma
      a disease which also caused by over production of monoclonal proteins from abnormal clones.
      Everyone in this study will receive daratumumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years of age

          -  Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID or C3 GN

          -  In cases of C3GN serum electrophoresis with immunofixation should confirm presence of
             monoclonal gammopathy

          -  Proteinuria ≥ 1000 mg over 24 hours

          -  eGFR ≥ 20 mL/min/SA

          -  Subjects able and willing to give informed consent

        Exclusion Criteria:

          -  Pregnancy

          -  Hepatitis B or C, HIV

          -  Multiple myeloma

          -  Anemia with Hgb < 8.5 g/dL

          -  Thrombocytopenia with platelet count < 100,000

          -  Leukopenia with WBC < 3.5

          -  Any other disease, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that may affect the
             interpretation of the results or render the patient at high risk from treatment
             complication

          -  Unable to provide consent

          -  Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the
             last 6 weeks

          -  Patients who had received immunosuppressive therapy including cyclophosphamide, MMF,
             cyclosporine, tacrolimus or azathioprine in the last 3 months

          -  Patients who received rituximab previously with CD20 count of zero at the time of
             enrollment
Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)
Condition: CLL; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Eltrombopag
Intervention description: Starting dose 75 mg by mouth (PO) daily for 28 day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CLL; Thrombocytopenia; Small lymphocytic lymphoma; SLL; Eltrombopag; Promacta; thrombopoietin (TPO)-receptor agonist; platelets

Summary:

      The goal of this clinical research study is to learn if eltrombopag can help to increase the
      number of platelets in patients with CLL. The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

          2. Age >/= 18 years

          3. PLT transfusion-dependent, defined as need for transfusion to maintain PLT count
             >/=20K/µL, or the average of two (non-transfused) PLT counts taken within 2 weeks of
             the screening period </=50K/µL, with no individual count >55K/µL

          4. Patients with ITP must have failed at least 1 prior treatment for ITP including one of
             the following: corticosteroids, rituximab, splenectomy, cyclosporine

          5. At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL

          6. ECOG performance status (PS) </=2

          7. Adequate liver function (total bilirubin </=2* upper limit normal (ULN); ALT </=2.5*
             ULN)

          8. Adequate renal function (serum creatinine Cr </=2.2 mg/dL)

          9. For patients with ITP on corticosteroids or cyclosporine, dose of corticosteroids or
             cyclosporine must be stable for 2 weeks prior to enrollment and planned to be tapered
             in patients responding to eltrombopag

         10. Able to provide informed consent

        Exclusion Criteria:

          1. Concurrent chemotherapy for CLL

          2. Diagnosis of Richter's transformation

          3. Uncontrolled autoimmune hemolytic anemia i.e. patients with AIHA that is not
             controlled with treatment such as corticosteroids or cyclosporine. This would include
             patients who require PBRC transfusions or who do not have a stable hemoglobin (HGB)
             due to ongoing hemolysis.

          4. Concurrent treatment for ITP (except for corticosteroids and cyclosporine)

          5. Diagnosis of myelodysplastic syndrome or acute myeloid leukemia

          6. Active infection or significant medical illness as determined by the treating
             physician

          7. Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate
             or Promacta)

          8. Pregnant or breast feeding subjects and subjects not willing to use adequate
             contraceptive precautions
Trial II of Lung Protection With Azithromycin in the Preterm Infant
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Intervention: Azithromycin; Placebo
Intervention description: Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.; vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: premature infant; respiratory distress syndrome; mechanical ventilation

Summary:

      The hypothesis of this study is that administration of azithromycin to ventilated premature
      infants will decrease the incidence and severity of BPD.

      The purpose of this study is to determine if Azithromycin treatment is beneficial for
      prevention of bronchopulmonary dysplasia in preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  birthweight less than 1250 grams admitted to UK NICU

          -  mechanical ventilation within the first 72 hours of life

        Exclusion Criteria:

          -  confirmed sepsis by blood culture

          -  multiple congenital anomalies or known syndromes

          -  intrauterine growth retardation with birthweight less than 10%ile for gestational age

          -  ROM for >7 days
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Intervention: RVT-101 35 mg; RVT-101 70 mg; Placebo
Intervention description: once daily, oral, 35-mg tablets; once daily, oral, 35-mg tablets; once daily, oral, matching tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 484.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Dementia with Lewy bodies; Lewy bodies; intepirdine; RVT-101; dementia

Summary:

      This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients
      with dementia with Lewy bodies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject with probable DLB

          -  Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and
             Baseline

          -  Patient has the ability to comply with procedures for cognitive and other testing in
             the opinion of the investigator

          -  Patient has a reliable caregiver who is willing to report on the subject's status
             throughout the study

          -  Patients currently receiving therapy for DLB are eligible for enrollment

        Exclusion Criteria:

          -  Atypical clinical features or clinical course that would lead the investigator to
             conclude primary symptoms are more likely explained by an alternate dementia
             diagnosis.

          -  Any clinically relevant concomitant disease that, in the opinion of the investigator,
             makes the patient unsuitable for inclusion in the study.
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: GW876008; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome safety

Summary:

      This is a double-blind, placebo-controlled, randomised crossover study to investigate the
      efficacy and safety of GW876008
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has been diagnosed with IBS consistent with the Rome II Criteria as
             adapted in Appendix 3 of the protocol

          -  The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a
             flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years
             of randomization. Otherwise, the appropriate procedure(s) must be performed and normal
             results obtained during the 7-day procedure window (prior to randomization):

        If the subject is < 50 years of age and has not had a colonic examination within 5 years of
        the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed.

        If the subject is = 50 years of age and has not had a colonic examination within 5 years of
        the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be
        performed.

          -  Colonic procedure results must be known prior to randomization into the study and
             dispensing study medication

          -  During the two-week screening phase, the subject must have conducted self assessments
             on = 10 days of 14 day (with 80% compliance on daily IVRS calls) compliance assessment
             using the telephone data entry system

        Exclusion Criteria:

          -  As a result of any of the medical interview, physical examination, evaluation of
             mental state and psychiatric history or screening investigations the physician

          -  Subject reported no stool for 7 consecutive days during the two-week screening phase
             responsible considers the subject unfit for the study

          -  The subject has a concurrent illness or disability that may affect the interpretation
             of clinical data, or otherwise contraindicates participation in this clinical study
             (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine,
             metabolic, gastrointestinal, haematological, or neurological condition).
Mild Encephalopathy in the Newborn Treated With Darbepoetin
Condition: Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy Mild
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain
Intervention: Darbepoetin Alfa; Normal Saline
Intervention description: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age; Single dose of normal saline, IV, given at less than 24 hours of age
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 1 Hour
Maximum age: 24 Hours
Healthy volunteers: No
Keywords: darbepoetin; Brain Diseases

Summary:

      This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial.
      Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on
      the modified Sarnat neurologic examination at less than six hours of age. Participants will
      be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth.
      Neurodevelopmental testing (Bayley (III or IV) and Gross Motor Function Assessment) will be
      performed at 24 months of age. Pharmacokinetics will be assessed on those infants that
      received Darbe.
    

Eligibility criteria:

        Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational
        age > 34 weeks by best obstetric estimate, are <24 hours old and have evidence of mild
        encephalopathy as defined by Shankaran et al based on a modified Sarnat examination
        performed at <6 hours of age.

          1. History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart
             rate abnormality, or meconium staining)

          2. Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for
             TH.

          3. Infant has an IV for clinical treatment

        Exclusion Criteria:

          1. Moderate/Severe encephalopathy on modified Sarnat examination at < 6 hours of age

          2. Major congenital and/or chromosomal abnormalities

          3. Prenatal diagnosis of brain abnormality or hydrocephalus

          4. Severe growth restriction (< 3%)

          5. Central venous hematocrit >65%, platelet count >600,000/dL, and/or neutropenia
             (ANC<500 μL)

          6. ECMO

          7. Infant judged critically ill and unlikely to benefit from neonatal intensive care by
             the attending neonatologist
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: INC280; Gefitinib
Intervention description: During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.; Gefitinib 250 mg taken once daily
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: EGFR; c-MET; Lung cancer; Gefitinib; Erlotinib; Non-small cell lung cancer (NSCLC); lung adenocarcinoma; large-cell lung carcinoma

Summary:

      This study assessed the safety and efficacy of escalating doses INC280 when added to
      gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET
      pathway and who had failed after benefiting on a prior treatment with either gefitinib or
      erlotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented EGFR mutation

          -  Documented c-MET dysregulation

          -  Prior clinical benefit on EGFR inhibitors and then subsequent progression

             -≥ 18 year old

          -  Life expectancy of ≥ 3 months

          -  ECOG performance status ≤ 2

        Exclusion Criteria:

          -  Unable to swallow tables once or twice daily

          -  Previous treatment with c-MET inhibitor

          -  Any unresolved toxicity from previous anticancer therapy greater than grade 1

          -  History of cystic fibrosis

          -  History of acute or chronic pancreatitis

          -  Unable to undergo MRI or CT scans

          -  Known history of HIV

          -  Undergone a bone marrow or solid organ transplant

          -  Clinically significant wound or lung tumor lesions with increased likelihood of
             bleeding

          -  Pregnant or nursing
Miami Membrane for Potency (MMEP) Trial
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Amniotic Membrane Placement; EPIC 26; PSA Measurement; Sexual History Inventory for Men
Intervention description: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.; Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.; Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.; SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.
Enrollment: 24.0
Sex: Male
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Amniotic Membrane Placement; Robotic Assisted Radical Prostatectomy; RARP; Human Amniotic Membrane Allograft

Summary:

      The use of dehydrated human amnionic membrane allograft improves erectile function recovery
      (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic
      assisted radical prostatectomy (RARP) compared to a control group with no allograft.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve
             sparing RARP at the University of Miami

        Exclusion Criteria:

          -  Men with poor urinary control at baseline requiring the use of pads for leakage

          -  Previous treatment for prostate cancer

          -  Previous history of pelvic radiation

          -  Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous
             injections, MUSE, penile prosthesis.
Study of T-PRED(TM) Compared to Pred Forte(R)
Condition: Cataract
MeSH terms: Cataract
Intervention: T-PRED; Pred Forte
Intervention description: T-PRED sterile ophthalmic solution; Pred Forte sterile ophthalmic solution
Intervention MeSH terms: Prednisone; Prednisolone acetate; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of T-PRED(TM) compared to Pred Forte(R)
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

        Exclusion Criteria:

          -  No active or adverse disease