bioihbjkbjnl/mcl2 huggingface dataset:
Nitrite Infusion in Islet Cell Transplantation
Condition: Diabetes
Intervention: Control; Pre-Isolation Infusion; Post-Isolation Infusion
Intervention description: A saline infusion will be administered during the pre-isolation and post-isolation phases.; A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.; A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Insulin Resistance; Nitrite; Pancreatic islet cells; Autotransplantation; Ischemia reperfusion injury; Mitigation; Cure; Nitric oxide; Sodium nitrite; Islet cell; Survival; Pancreas; Liver

Summary:

      This study seeks to investigate the effects of administering nitrite to pancreatic islet
      cells that have been removed from a patient for autotransplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients greater than or equal to 18 years of age

          -  Scheduled to undergo Islet Cell auto-transplantation by Dr. Jared White or Dr. Bart
             Rose

          -  Subjects who can provide informed written consent and are willing to do so

        Exclusion Criteria:

        -Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)
A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: HL036 ophthalmic solution; Placebo vehicle solution
Intervention description: HL036 ophthalmic solution; Placebo vehicle solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036
      Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a patient-reported history of dry eye for at least 6 months prior to enrollment

          -  Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
             of Visit 1

          -  Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

        Exclusion Criteria:

          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1

          -  Have used Restasis® or Xiidra® within 60 days of Visit 1

          -  Be currently taking any topical ophthalmic prescription (including medications for
             glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and
             cannot discontinue these medications for the duration of the trial (excluding
             medications allowed for the conduct of the study)

          -  Have an uncontrolled systemic disease

          -  Be a woman who is pregnant, nursing or planning a pregnancy
Study to Collect and Assess Long-term Safety of Everolimus in Patients Who Are on Everolimus Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator.
Condition: Neoplasms
Intervention: Everolimus
Intervention description: Everolimus was provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration.
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RAD001, everolimus, roll-over

Summary:

      The purpose of this study was to collect and assess long-term safety of everolimus in
      patients who were currently receiving everolimus treatment in a Novartis-sponsored, Oncology
      CD&MA study that had reached its study objectives, were not progressing on the current study
      treatment as defined by the parent protocol, and were unable to access everolimus treatment
      outside of a clinical study. Parent studies eligible to participate in the roll-over study
      were decided by Novartis. Investigator initiated trials (IITs) were not included. The primary
      objective of the parent study must have been reached and the parent study must have been in
      the process of being completed and reported.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is currently enrolled in a Novartis-sponsored, CD&MA study receiving
             everolimus or everolimus plus Sandostatin LAR Depot and has fulfilled all their
             requirements in the parent study

          -  Patient is currently benefiting from treatment with everolimus, as determined by the
             guidelines of the parent protocol.

        Exclusion Criteria:

          -  Patient has been permanently discontinued from everolimus study treatment in the
             parent study.
Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: Vitamin D3
Intervention description: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cathelicidin; Vitamin D

Summary:

      This proposal will evaluate a potential mechanism of increased risk of lung function
      impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this
      pathway. This study will improve the understanding of factors which can lead to chronic lung
      disease. If effective, this application would also provide the justification to study vitamin
      D as a therapy to improve lung health.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18-65 who are current or former smokers

          -  Serum calcium<10.5mg/dL

          -  25-Hydroxy Vitamin D (OHD)<20 ng/mL

          -  Creatinine Clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation

          -  Women of reproductive potential with negative serum or urine pregnancy test and
             subjects must refrain from participating in a conception process and subject/partner
             must use at least 2 reliable forms of contraceptives for the duration of the study

          -  For participants with COPD, Forced Expiratory Volume in 1 second (FEV1) greater than
             50% predicted.

          -  For smokers, current cigarette use (defined as regularly smoking 5 cigarettes per day)

        Exclusion Criteria:

          -  Current use of vitamin D supplements

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or
             their formulations

          -  Pregnancy or currently breast-feeding

          -  History of nephrolithiasis

          -  HIV positive serostatus

          -  Continuous oxygen use >2 liters/min via nasal cannula

          -  Any condition that, in the opinion of the site investigator, would compromise the
             subject's ability to participate in the study.
Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Ipilimumab; Platinum Doublet Chemotherapy
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of part 1 of this study is to determine the objective response rate (ORR) in
      stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line
      therapy.

      The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab
      and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and Women ≥ 18 years of age

          -  Diagnosed with stage IV Non-Small Cell Lung Cancer

          -  Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous
             concurrent chemoradiation with no further curative options.

        Exclusion Criteria:

          -  Subjects with untreated CNS metastases are excluded.

          -  Subjects with carcinomatous meningitis

          -  Subjects with an active, known or suspected autoimmune disease.

          -  Subjects with a condition requiring systemic treatment with either corticosteroids ( >
             10 mg daily prednisone equivalent) or other immunosuppressive medications within 14
             days of first treatment.

          -  Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.

        Other protocol defined inclusion/exclusion criteria apply
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
Condition: HCV Infection
MeSH terms: Infections; Hepatitis C; Renal Insufficiency
Intervention: SOF; RBV; LDV/SOF
Intervention description: Tablet(s) administered orally once daily; 200 mg tablet administered orally once daily; 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir
      (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and
      to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in
      participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic
      renal insufficiency (impaired kidney function).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection

          -  Cohort 3: chronic genotype 1 or 4 HCV infection

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Screening labs within defined thresholds

          -  Cirrhosis determination at screening

        Key Exclusion Criteria:

          -  Females who are pregnant or nursing or males who have a pregnant partner

          -  Prior null response to pegylated interferon (Peg-IFN)+RBV therapy (Cohorts 1 and 2) or
             for individuals with cirrhosis, prior treatment failure with IFN-based therapy not
             resulting from treatment intolerance (Cohort 3)

          -  Current of prior history of hepatic decompensation

          -  Infection with hepatitis B virus (HBV) or HIV

          -  History of clinically significant illness (including psychiatric or cardiac) or any
             other medical disorder that may interfere with individual's treatment and/or adherence
             to the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Glucose Intolerance
Intervention: Azeliragon; Placebo
Intervention description: Azeliragon 5 mg capsule administered orally, once daily; Matching placebo capsule administered orally, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Receptor for Advanced Glycation Endproducts (RAGE); ADAS-cog; CDR-sb

Summary:

      This is a study to evaluate the efficacy and safety of azeliragon in patients with mild
      Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon
      or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21
      months (in Part 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression
             of disease

          -  Mini Mental State Examination (MMSE) score of 21-26, inclusive

          -  Clinical Dementia Rating global score of 0.5 or 1

          -  Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more

          -  Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD

          -  Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least
             2 months prior to screening

          -  Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive

          -  Caregiver willing to participate and be able to attend clinic visits with patient

          -  Ability to ingest oral medications

        Exclusion Criteria:

          -  Significant neurological or psychiatric disease other than Alzheimer's disease

          -  Previous clinical trial participation within 90 days of screening

          -  Previous exposure to putative disease modifying therapy for Alzheimer's disease within
             1 year of screening

          -  History of cancer within the last 5 years except adequately treated cervical carcinoma
             in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate
             cancer not requiring current treatment

          -  Women of childbearing potential

          -  Uncontrolled blood pressure and/or blood pressure above 140/90

          -  Participants receiving medications that may negatively impact cognitive function

          -  History of diabetic ketoacidosis within the past year

          -  History of chronic pancreatitis

          -  Stage 4 kidney disease

          -  Use of insulin therapy
MC-5A for Chemotherapy Induced Peripheral Neuropathy
Condition: Neuropathy, Paraneoplastic
MeSH terms: Paraneoplastic Polyneuropathy; Peripheral Nervous System Diseases
Intervention: MC-5A; Sham device
Intervention description: 45 minutes daily x 10 treatments (given over the course of 2 weeks); Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuropathy,paraneoplastic; paraneoplastic peripheral neuropathy; pain; hyperalgesia

Summary:

      Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer
      therapy with few treatment options. CIPN is a complex side effect that varies between
      individuals and can be difficult to describe, difficult to treat and can significantly effect
      quality of life for patients.

      The purpose of this study is to determine if patients with painful CIPN will have a decrease
      in pain scores after treatment with the MC-5A device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  painful peripheral neuropathy resulting from chemotherapy

          -  pain must be present for minimum of 6 months

          -  must be able to read/understand English

          -  stable analgesics regimens allowed (no change for past 7 days)

        Exclusion Criteria:

          -  painful peripheral neuropathy that is not the result of chemotherapy

          -  pregnant women

          -  patients unable to wean off anti-epileptics

          -  patients currently receiving chemotherapy known to cause peripheral neuropathy

          -  patients with pacemakers or implanted defibrillators

          -  patients with vena cava or aneurysm clips

          -  patients with a history of epilepsy
Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access
Condition: AV Fistula
MeSH terms: Arteriovenous Fistula; Fistula
Intervention: Vorapaxar sulfate; Placebo
Intervention description: The study drug (12-week supply of study drug) will be dispensed to enrolled patients on the first day following surgery.; The placebo will match the study drug, vorapaxar sulfate, in appearance. A 12-week supply will be dispensed to enrolled patients on the first day following surgery.
Intervention MeSH terms: Vorapaxar
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Objectives of this study are:

        1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional
           maturation when administered during the maturation process compared with placebo.

        2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary
           procedures to aid in fistula maturation compared with placebo.

        3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for
           hemodialysis compared with placebo.

      This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be
      conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will
      be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health
      Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The
      investigators expect to enroll 128 patients. Patients will be assigned to treatment groups
      with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation.
      Patients will be stratified based on fistula location (lower arm versus upper arm).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18

          2. Receiving or planning to receive maintenance hemodialysis

          3. Ability to sign informed consent

          4. 3 mm venous diameter within recipient vein

        Exclusion Criteria:

          1. History of stroke, transient ischemic attack or intracranial hemorrhage

          2. History of or high level of suspicion for, severe arterial insufficiency of the hand

          3. Indication or ongoing therapy with other antiplatelet agents, other than aspirin 81 mg
             daily

          4. Indication or ongoing therapy with anticoagulants, including warfarin, low molecular
             weight heparin, factor Xa inhibitors or direct thrombin and other inhibitors.
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Capecitabine; Cisplatin; Pertuzumab; Pertuzumab; Trastuzumab
Intervention description: 1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle; 80 mg/m2 on Day 1 of each cycle; loading dose of 840 mg, then 420 mg once every three weeks; 840 mg once every three weeks; loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
Intervention MeSH terms: Capecitabine; Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, multicenter, open-label study will evaluate two different doses of
      pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line
      treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or
      gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment
      arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of
      840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab
      840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both
      treatment arms will receive trastuzumab, cisplatin, and capecitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, greater than or equal to (>=) 18 of age

          -  Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally
             advanced or metastatic disease, not amenable to curative therapy

          -  Measurable disease, according to the Response Evaluation Criteria in Solid Tumors
             (RECIST), v1.1

          -  HER2-positive tumor

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Life expectancy of at least 3 months

        Exclusion Criteria:

          -  Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or
             neoadjuvant therapy at least 6 months before enrollment in the study)

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome

          -  Active (significant or uncontrolled) gastrointestinal bleeding

          -  Abnormal laboratory values