bioihbjkbjnl/mcl2 huggingface dataset:
Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Recurrence
Intervention: HSPPC-96
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:

      The primary objective of the study is to determine whether participants exhibit a measurable
      immune response after multiple administrations of HSPPC-96 (heat shock protein-peptide
      complex 96), as assessed by enzyme linked immunosorbent spot (ELISPOT) assay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmation of histological diagnosis of renal cell carcinoma (RCC) with evidence of
             >= 25% clear cell carcinoma

          -  American joint committee on cancer tumor/node/metastasis tumor stage at intermediate
             risk for recurrence

          -  At least 8 doses of vaccine available from participant's tumor

          -  Life expectancy of at least 3 months

          -  Eastern cooperative oncology group performance status of 0 or 1

          -  Cardiovascular disease status of new york heart association class less than 2

          -  Adequate hematopoietic, renal and hepatic function

          -  Negative serology tests for human immunodeficiency virus (HIV), human T-cell
             lymphotrophic virus (HTLV-1), hepatitis B surface antigen (HBsAg), anti- hepatitis C
             virus antibodies (anti-HCV-Ab)

          -  Females must have negative pregnancy test

        Exclusion Criteria:

          -  Evidence of metastatic or residual RCC

          -  Documented radiological enlarged lymph nodes

          -  Females who are pregnant or breastfeeding

          -  Use of any other investigational product from 4 weeks post-surgery

          -  Splenectomy performed during nephrectomy
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: Fasinumab; Naproxen; Diclofenac; Celecoxib; Placebo
Intervention description: Study drug will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study; Naproxen will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study; Diclofenac will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study; Celecoxib will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study; Matching Placebo will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
Intervention MeSH terms: Celecoxib; Diclofenac; Naproxen; Fasinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this exploratory study is to evaluate the cellular and connective tissue
      composition of joints from patients with Osteoarthritis (OA) who have been treated with
      fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs
      (NSAIDs).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Previously randomized to R475-PN-1523 (NCT02683239), R475-OA-1611 (NCT03161093), or
             R475-OA-1688 (NCT03304379) and received at least 1 dose of study drug

          -  Notified the site that they are planning a knee or hip arthroplasty during the parent
             study between randomization and 24 weeks after the last dose of subcutaneous (SC)
             study drug

          -  Patient's surgeon/pathologist is willing to coordinate with the site regarding
             preparation, storage, and shipping of joint tissue samples collected during
             arthroplasty surgery

        Exclusion Criteria:

          -  None

        Note: Other protocol Inclusion criteria apply
Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis
Condition: Alveolitis, Fibrosing; Fibrosis, Pulmonary; Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Pulmonary Fibrosis; Hypertension; Fibrosis
Intervention: sildenafil
Intervention description: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: alveolitis, fibrosing; exercise, aerobic; fibrosis, pulmonary; hypertension, pulmonary

Summary:

      Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis
      (IPF) patients function better. This study will test whether sildenafil improves the ability
      to exercise in patients with pulmonary fibrosis of unknown cause.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of IPF

          -  40-85 years of age

          -  6-minute walk distance 150-500 m

          -  FVC 40-90% predicted

          -  DLCO 30-90% predicted

        Exclusion Criteria:

          -  Severe pulmonary hypertension

          -  Severe heart failure

          -  FEV1/FVC < 0.7
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization
Intervention: pegaptanib sodium
Intervention description: 1 drop per dosed eye per protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 51 Years
Healthy volunteers: No
Keywords: Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Summary:

      This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients
      with wet-type age-related macular degeneration (AMD), who benefit further treatment and who
      want to continue the treatment after completion of the preceding study (A5751010).
    

Eligibility criteria:

        Inclusion Criteria:

          -  After completion of the preceding study (A5751010)

        Exclusion Criteria:

          -  Serious heart, kidney and/or liver disease

          -  Diabetic retinopathy
Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Intervention: Furosemide; Placebo
Intervention description: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose; 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Maximum age: 48 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to assess if administration of an early single dose of a
      diuretic (furosemide) to children with moderate to severe bronchiolitis can reduce
      extravascular lung water in an effort to reduce respiratory rate, retractions, intubations,
      and length of stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Acute Bronchiolitis

          -  Admission required per Emergency Department Physician

        Exclusion Criteria:

          -  No legal guardian present

          -  Sulfa allergy

          -  Patient currently on existing diuretic therapy

          -  Tracheostomy

          -  Mild respiratory distress (not requiring admission)

          -  Hypotension / Hemodynamic Instability (defined by age specific criteria at time of
             intervention)

          -  Supplemental Oxygen at home

          -  History of Dialysis / Renal Disease

          -  Those enrolled in another drug interventional study
AGN-229666 for the Treatment of Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AGN-229666; vehicle of AGN-229666
Intervention description: One drop of AGN-229666 into each eye on Day 1 and Day 15.; One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic
      conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients living in Japan with a history of allergic conjunctivitis

          -  Willing to discontinue wearing contact lenses during the study period

        Exclusion Criteria:

          -  Use of nicotine products during the study period

          -  Presence of active eye infection (bacterial, viral, or fungal)

          -  History of an ocular herpetic infection

          -  Eye surgery intervention within 3 months and/or a history of refractive surgery within
             the past 6 months
Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant
Condition: Acute Myeloid Leukemia
Intervention: Fludarabine; Melphalan; Pembrolizumab
Intervention MeSH terms: Pembrolizumab; Fludarabine; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: AML

Summary:

      AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem
      cell transplantation as a possible cure; however, many patients are not candidates for
      allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of
      available donors. Therefore, these patients are unable to receive the therapeutic benefits of
      the "graft-versus-leukemia" effect of donor immune cells. The aim of this study is to
      hopefully break immune tolerance to AML cells to provide better outcomes in patients with
      non-favorable risk AML.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-favorable risk AML

          -  In CR-1 or subsequent CR

          -  Completed at least one cycle of consolidation chemotherapy

          -  Collection of at least 2x106/kg CD34+ cells

          -  KPS of 70% or greater

        Exclusion Criteria:

          -  Received investigational agent within 4 weeks of first dose

          -  Prior chemotherapy, radiation therapy within 2 weeks of first dose

          -  Hypersensitivity to pembrolizumab or any of its excipients

          -  Received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Sildenafil for Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive; Emphysema
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Intervention: sildenafil citrate; Placebo
Intervention description: sildenafil citrate 25 mg by mouth thrice daily (po tid); 25 mg po tid
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Emphysema; Phosphodiesterase inhibitors; Sildenafil; Exercise testing; Quality of life

Summary:

      The purpose of this study is to determine if sildenafil improves the exercise capacity and
      lung function of patients with chronic obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema

          -  FEV1/FVC ratio < 70%

          -  FEV1 < 80%

          -  Stable medication regimen

        Exclusion Criteria:

          -  COPD exacerbation or hospitalization in the past 3 months

          -  Heart disease

          -  Contraindication to sildenafil

          -  Unrelated lung disease

          -  Inability to walk or pedal on a stationary bike

          -  Pregnancy or breast-feeding

          -  Pulmonary hypertension at rest
GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid; Weight Loss
Intervention: Exenatide
Intervention description: Exenatide, subcutaneous injection, 10 mcg, twice per day
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 8 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Obesity; Impaired Glucose Tolerance; Children

Summary:

      The prevalence of severely obese children is on the rise. Behavioral therapies for weight
      loss are successful in some, but others need more aggressive approaches such as drug therapy.
      In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT),
      which places them at significantly elevated risk of developing type 2 diabetes mellitus and
      cardiovascular disease. Although various drug therapies for weight loss and IGT have been
      explored in adults, few have been evaluated in children.

      Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main
      glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose
      disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide
      can induce weight loss by decreasing appetite and slowing gastric motility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 8-19 years old

          -  Subject able to give assent, and parent/guardian capable of giving consent on behalf
             of the child

          -  Body mass index (BMI) ≥ 99th percentile (based on gender and age)

        Exclusion Criteria:

          -  Type 1 or 2 diabetes mellitus

          -  Initiation of a new drug therapy within the past 30 days prior to the screening visit

          -  BMI ≥ 55

          -  History of weight loss surgery

          -  Obesity from a genetic cause (e.g., Prader-Willi)

          -  Central nervous system injury or severe neurological impairment

          -  Known systolic or diastolic dysfunction or heart failure

          -  Females who are currently pregnant or planning to become pregnant

          -  Liver enzymes > 2.5 times upper limit of normal

          -  Severe renal impairment (defined as creatinine clearance <30 mL/min)

          -  Gastrointestinal disease
Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation
Condition: Acute Myelogenous Leukemia; Acute Lymphoid Leukemia; Juvenile Myelomonocytic Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Leukemia, Myelomonocytic, Juvenile; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Intervention: azacitidine; donor lymphocyte infusion
Intervention description: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals; For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Maximum age: 29 Years
Healthy volunteers: No
Keywords: pediatric leukemia myelodysplastic syndrome azacitidine

Summary:

      The goal of this study is to determine whether post-transplant consolidation with azacitidine
      combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the
      prevention of relapse in pediatric and young adult patients with hematologic malignancies who
      have undergone hematopoietic stem cell transplantation (HSCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 0 - 29.9 years undergoing allogeneic peripheral blood stem cell
             transplant

          -  Patients with acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)

          -  Patients with juvenile myelomonocytic leukemia (JMML)

          -  Patients with myelodysplastic syndrome (MDS)

        Exclusion Criteria:

          -  Patients who have had a prior transplant.

          -  Patients with Fanconi anemia or other cancer-predisposition syndromes

          -  Patients with expected survival <12 weeks

          -  Lansky score <60%
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Placebo Inhalation Solution; SPX-101
Intervention description: Normal Saline Inhalation Solution; SPX-101 Inhalation Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-Blind
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult
      subjects with cystic fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of cystic fibrosis

          -  ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%

          -  Stable CF Lung Disease

          -  Males and non-pregnant, non-lactating females

        Exclusion Criteria:

          -  Significant unstable co-morbidities within 28 days of screening

          -  Has received an investigational drug within 28 days of screening
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: dovitinib; sorafenib
Intervention description: 500 mg p.o. o.d. 5 days on/2 days off; 400 mg p.o. b.i.d.
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma; HCC; Liver cancer; Child Pugh A; HCC Stage C

Summary:

      The purpose of this open-label, randomized, phase II study is to compare the safety and
      efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with
      advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the
      Asia-Pacific region.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines

          -  Advance HCC Stage B and C according to BCLC staging classification

          -  Child Pugh A

          -  At least one measurable lesion as assessed by CT or MRI

          -  ECOG PS of 0 or 1

          -  Adequate bone marrow, liver, and renal function

        Exclusion Criteria:

          -  Prior systemic therapy for HCC

          -  Brain metastases

          -  Active bleeding (including variceal bleeding as the result of esophageal varices)
             Patients who have received a liver transplant or are awaiting an immediate transplant

        Other protocol-defined inclusion/exclusion criteria may apply
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis; Anemia, Sickle Cell
Intervention: LDV/SOF
Intervention description: 90/400 mg fixed dose combination (FDC) tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Gilead; Hepatitis C

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for
      12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle
      cell disease (SCD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic genotype 1 or 4 infected patients with sickle cell disease

          -  HCV RNA ≥ 1,000 IU/mL at screening

          -  Cirrhosis determination by transient elastography

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with treatment, assessment or compliance with the protocol

        Note: Other protocol defined inclusion/Exclusion criteria may apply.