bioihbjkbjnl/mcl2 huggingface dataset:
Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
Condition: Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sitravatinib; Nivolumab
Intervention description: Sitravatinib oral capsule administered daily for 6-8 weeks in segments 1 and 2.; Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks in segment 2.
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ccRCC; MGCD516; Antineoplastic Agents; Immunologic factors; nivolumab; Tyrosine Kinase Inhibitor; VEGFR; TAM RTKs; PD-1; PD-L1

Summary:

      The study will evaluate the clinical activity of sitravatinib in combination with nivolumab
      in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant
      setting prior to nephrectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Imaging results consistent with locally-advanced RCC

          2. Candidate for partial or complete nephrectomy as part of treatment plan.

          3. Measurable disease per RECIST version 1.1.

          4. ECOG performance status 0 or 1.

          5. Adequate bone marrow and organ function.

        Exclusion Criteria:

          1. Prior systemic anti-tumor treatment for RCC.

          2. Patients who are receiving any other investigational agents.

          3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted
             regardless of whether neoadjuvant therapy is to be administered, as assessed by the
             treating surgeon.

          4. Inability to undergo baseline tumor biopsy.

          5. Active or prior documented autoimmune or immunocompromising conditions.

          6. Uncontrolled hypertension.
Creatine Safety & Tolerability in Huntington's Disease
Condition: Huntington's Disease (HD)
MeSH terms: Huntington Disease
Intervention: Creatine monohydrate
Intervention description: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Symptomatic; Huntington's Disease; HD

Summary:

      The purpose of this study is to extend findings from the creatine dose-finding study
      (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and
      clinical impact of high dose creatine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals who have completed the CREST-UP1 study.

          -  Individuals who are able to take oral medication.

          -  Individuals capable of providing informed consent and complying with trial procedures.

        Exclusion Criteria:

          -  History of known sensitivity or intolerability to creatine.

          -  Clinical evidence of unstable medical illness in the investigator's judgment.

        Additional eligibility criteria apply.
Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)
Condition: GERD
Intervention: PEGJ tube
Intervention description: The self-propelled PEGJ feeding tube
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: PEGJ; PEG-J; percutaneous endoscopic gastrostomy; feeding tube; gastroparesis; acute pancreatitis; stroke; respiratory failure; GERD; balloon; self-propelled

Summary:

      This research is being done to study the safety of an investigational percutaneous endoscopic
      gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube
      prevents it from slipping back into the stomach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-90 years

          -  need for post-pyloric feeding (patients unable to eat due to stroke, intubated
             patients with respiratory failure, patients with acute pancreatitis, etc)

          -  ability to give informed consent for the study

        Exclusion Criteria:

          -  patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less
             than 50,000)

          -  inability to get informed consent for the study from patients or their families

          -  pregnancy (all women of child-bearing age will undergo urine pregnancy testing)
Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Condition: Oral Chronic Graft-versus-host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Tacrolimus; Dexamethasone
Intervention description: Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks; Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
Intervention MeSH terms: Dexamethasone; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: tacrolimus; dexamethasone; oral rinse

Summary:

      The purpose of this research study is to determine the effectiveness of topical steroid
      therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment
      of oral chronic Graft-Versus-Host Disease (cGVHD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with oral chronic graft-versus-host disease

          -  Patients 4 years of age or older

          -  Stable cGVHD medication regimen for the four weeks prior to study enrollment

        Exclusion Criteria:

          -  Patients already on topical steroid or tacrolimus therapies
The Effect of Thiamine vs. Placebo on VO2 in Critical Illness
Condition: Critically Ill; Respiratory Failure
MeSH terms: Respiratory Insufficiency; Critical Illness
Intervention: Thiamine
Intervention description: 200 mg IV thiamine
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VO2, critically ill, oxygen consumption

Summary:

      The objective of this study is to determine the effect of thiamine therapy on oxygen
      consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before
      and after thiamine or placebo administration in patients admitted to the ICU and requiring
      mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on
      the metabolic profile of the patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients (age > 18 yrs) admitted to an ICU

          2. Mechanically ventilated for an acute illness, with stable respiratory status (no
             changes in ventilator settings in the 3 hours prior to enrollment)

          3. Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by
             Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.

          4. Upper central venous line in place

        Exclusion Criteria:

          1. Unstable ventilator settings during measurement of VO2

          2. Temperature >100.5

          3. FIO2>60%

          4. Endotracheal cuff leak, chest tube, or other evident source of air leak

          5. Positive end expiratory pressure > 12cmH2O

          6. Intravenous thiamine supplementation within 2 weeks of enrollment, or oral
             supplementation more than that found in a multivitamin.

          7. Protected populations (pregnant woman, prisoners, cognitively impaired)
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL; SOF/VEL
Intervention description: SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment); SOF/VEL FDC 200/50 mg oral granules
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.

      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm
      the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric
      participants with chronic hepatitis C virus (HCV) infection.

      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of
      SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and
             pediatric individuals aged 3 to < 18 as determined at Day 1.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Nebulized Heparin for COVID19-associated Acute Respiratory Failure
Condition: Covid19
MeSH terms: COVID-19; Respiratory Insufficiency
Intervention: Heparin; Placebo
Intervention description: Nebulized heparin 25,000 units every 6 hours; Sodium chloride 0.9% every 6 hours
Intervention MeSH terms: Heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the utilization of nebulized heparin to
      circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic
      anticoagulation.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS
        (paO2/FiO2 ratio =300) within 48 hours

        Exclusion Criteria:

          -  Allergy to heparin

          -  Any history of heparin-induced thrombocytopenia

          -  High risk of bleeding (platelet count < 50,000/µL or international normalized ratio >
             1.5)

          -  Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)

          -  Active bleeding

          -  Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank
             bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring
             repeated suctioning, and temporally associated with acute deterioration in respiratory
             status)

          -  Neurosurgical procedures during this hospital admission or such procedures are planned

          -  Epidural catheter in place

          -  Any history of intracranial, spinal or epidural hemorrhage

          -  Tracheostomy in place

          -  Cervical spinal cord injury associated with reduced long-term ability to breathe
             independently

          -  Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to
             breathe independently

          -  Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy

          -  Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure

          -  Death is deemed imminent or inevitable or there is an underlying disease with a life
             expectancy of fewer than 90 days

          -  Pregnant or might be pregnant.

          -  Objection from the treating clinician

          -  Consent refused by the patient or substitute decision maker.

          -  History of thrombosis (VTE or cardiovascular event)
Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Standard of care ADT + (HMB + arginine + glutamine); Standard of care ADT
Intervention description: 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.
Take one packet twice daily for 3 months; Patient will receive standard of care androgen deprivation therapy (ADT) alone
Intervention MeSH terms: Androgens
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Men; Androgen Deprivation Therapy; Elderly; Geriatric; Nutritional supplementation

Summary:

      This is a study of HMB plus amino acids in older men with prostate cancer starting androgen
      deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional
      supplementation will decrease the loss of muscle mass and strength that occurs when men start
      ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed adenocarcinoma of the prostate

          2. Age 60 years or older

          3. Patients with asymptomatic or minimally symptomatic prostate cancer for which they are
             about to start androgen deprivation therapy (ADT) per provider recommendation

               -  Asymptomatic or minimally symptomatic (as judged by treating physician)
                  metastases allowed

               -  Men receiving ADT for localized prostate cancer are allowed

          4. Patient able to give informed consent.

        Exclusion Criteria:

          1. Patient already on ADT

          2. Patients who are visiting clinic for a second opinion only

          3. Patients with a diagnosis of dementia

          4. Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
Condition: Covid19; SARS-CoV-2 Infection
MeSH terms: Infections; COVID-19; Critical Illness
Intervention: GC4419; Placebo
Intervention description: 180 Minute IV Infusion; 180 Minute IV Infusion
Intervention MeSH terms: Avasopasem manganese
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID19; SARS-CoV-2 Infection

Summary:

      A Trial of GC4419 in Patients with Critical Illness due to COVID-19
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects at least 18 years of age.

          2. Ability to understand and the willingness to sign a written informed consent.

          3. Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test
             documented prior to randomization

          4. Requirement for intensive inpatient hospital care

          5. Acute hypoxemic respiratory failure typifying ARDS

          6. Adequate liver function

          7. Use of effective contraception

        Exclusion Criteria:

          1. Expected survival for less than 48 hours after randomization

          2. Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to
             cirrhosis

          3. Stage IV chronic kidney disease or end-stage kidney disease on maintenance
             hemodialysis

          4. Requirement for extra-corporeal membrane oxygenation (ECMO)

          5. Acute Myocardial Infarction (AMI)

          6. Active bleeding requiring transfusion

          7. Concurrent participation in another clinical trial of experimental treatment for
             SARSCoV-2

          8. Female patients who are pregnant or breastfeeding

          9. Requirement for concurrent treatment with nitrates
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: ND-L02-s0201 (Low Dose); ND-L02-s0201 (High Dose); Other: Placebo
Intervention description: Intravenous administration every 2 weeks; Intravenous administration every 2 weeks; Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the
      safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for
      Injection in subjects with IPF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Forced vital capacity (FVC) ≥ 45% of predicted.

          -  Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥
             30% of predicted value

          -  Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.

        Exclusion Criteria:

          -  Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.

          -  Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months
             before screening.

          -  Anticipated to receive a lung transplant during the subject's participation in the
             study.

          -  Active smoker or smoking cessation within 12 weeks before screening.

          -  Malignancy within the last 5 years, with the exception of curable cancer that has
             received adequate treatment.

          -  Evidence of any unstable or untreated, clinically significant disease or condition
             that, in the opinion of the Investigator, might confound the interpretation of the
             study or place the subject at increased risk.

          -  Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted
             therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is
             longer) before screening

          -  Participation in an investigational study with the last dose of investigational
             product occurring within 8 weeks or 5 half-lives (whichever is longer) before
             screening.

          -  Pregnant or breastfeeding.

          -  Medical history of infection with HIV, hepatitis B, or hepatitis C.

          -  History of alcohol abuse and/or dependence within the last 2 years.

          -  History within the last 2 years of significant mental illness, or physical dependence
             on any opioid or illicit drugs.

        Other protocol defined inclusion/exclusion criteria could apply.
Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Carboplatin; Proton Radiotherapy; Paclitaxel
Intervention description: 2 area under curve (AUC) by vein Weekly; 2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks).; 50 mg/m^2 by vein Weekly
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; Proton Radiotherapy; Proton Beam; Paclitaxel; Taxol; Carboplatin; Paraplatin; NSCLC

Summary:

      The goal of this clinical research study is to learn if proton radiotherapy given with
      standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally
      advanced NSCLC. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically documented NSCLC.

          2. Inoperable stage IIIA (T1--3N2MO, T3N1MO) and IIIB (T1-3N3MO, T4NO-3MO) disease
             excluding malignant pleural effusion.

          3. Performance score Karnofsky Performance Status (KPS) 70-100, Weight loss: less or
             equal to 10% in 6 months prior to diagnosis.

          4. Patient consented for the protocol

          5. Induction chemotherapy is allowed.

        Exclusion Criteria:

          1. Prior chest radiotherapy.

          2. Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ
             of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial
             transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated
             more than 3 years ago for cure.

          3. Pregnancy. Patients (men and women) of child bearing potential should use an effective
             (for them) method of birth control throughout their participation in this study.

          4. Off study criteria: a) If a patient is found to have distant metastasis during
             treatment and/or immediate after the treatment (<60 days) indicating inaccurate cancer
             stage, he or she will be taken off study. b) If a patient does not follow up at MD
             Anderson and does not forward his or her medical records such as CT, PET/CT, pulmonary
             function test (PFT) or pathology report as required by protocol, he or she will be
             taken off study. c) If a patient does not have any required post-treatment evaluation
             such as images, he or she will be taken off study.