bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: BMS-813160; Placebo matching with BMS-813160
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 319.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether BMS-813160 will reduce the amount of
      protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200
             and 3500 mg/g)

          -  Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor
             blocker (ARB) therapy

        Exclusion Criteria:

          -  Clinical diagnosis of type 1 diabetes

          -  Unstable cardiovascular, metabolic, or other chronic disease status

          -  Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2

          -  High risk of infection or immune compromise

          -  Clinically significant ECG conduction abnormalities

          -  Drugs with significant potential to affect BMS-813160 exposure
Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Capecitabine; S-1
Intervention description: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.; 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: Female
Minimum age: 25 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Breast Neoplasms; Drug Therapy

Summary:

      To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary
      chemotherapy in patients with inoperable or recurrent breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-diagnosed breast cancer with metastasis in multiple organs

          -  Performance Status (World Health Organization :WHO) 0-2

          -  Functions below are maintained in major organs:

               -  Leukocyte count: 4,000/mm3 to 12,000/mm3

               -  Neutrophil count: >2,000/mm3 or more

               -  Platelet count: <100,000/mm3 or more

               -  Hemoglobin: >9.5 g/dL

               -  Total bilirubin: >1.5 mg/dL

               -  AST(GOT): within twice a normal upper value in an institution

               -  AST(GPT): within twice a normal upper value in an institution

               -  BUN: < 25 mg/dL

               -  Creatinine: within a normal upper value in the institution

               -  24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)

               -  Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85

          -  Written informed consent will be obtained for patients for entering this study

        Exclusion Criteria:

          -  Patients with synchronous multiple cancers

          -  Complicated with infection

          -  Fever from suspected infection

          -  Metastasis to the central nerve system

          -  A history of ischemic cardiac diseases

          -  Active gastrointestinal ulcer

          -  Severe nerve disorder

          -  Women who are potentially pregnant, pregnant, or breast-feeding

          -  Severe drug allergy

          -  Severe suppression of the bone marrow

          -  Severe renal disorder

          -  Being treated with other pyrimidine fluoride antineoplastic agents (including any
             combination therapy)

          -  Being treated with flucytosine

          -  Complicated with the infection onset which a study doctor assesses to be inappropriate
             for this study
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Condition: Advanced Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: Nivolumab; Ipilimumab; Relatlimab; BMS-986205; BMS-813160
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab; Ipilimumab; Relatlimab; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effectiveness and safety of various nivolumab
      combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced Renal Cell Carcinoma

          -  Must have at least 1 lesion with measurable disease

          -  Life expectancy of at least 3 months

          -  Karnofsky Performance Status (KPS) must be =>70%

        Exclusion Criteria:

          -  Patients/subjects with suspected or known central nervous system metastases unless
             adequately treated

          -  Patients/subjects with autoimmune disease

          -  Patients/subjects who need daily oxygen therapy

        Other protocol defined inclusion/exclusion criteria apply
Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Condition: Carotid Artery Disease
MeSH terms: Carotid Artery Diseases
Intervention: Optison
Intervention description: Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CE-U/S - Contrast-Enhanced U/S; U/S - Ultrasound; Assess effectiveness

Summary:

      The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL,
      0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries
      when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is is greater than or equal to 18 years of age.

          -  The subjects has highly suspected or established carotid artery disease.

          -  The subject has undergone or been referred for either unilateral or bilateral
             intra-arterial X-ray carotid angiography for the determination of subject management
             (within 30 days before or after the U/S procedure).

          -  The subject has non-diagnostic U/S of the carotids as defined by institutional
             standards.

        Exclusion Criteria:

          -  The subject presents any clinically active, serious, life-threatening disease, with a
             life expectancy of less than 1 month or where study participation may compromise the
             management of the subject or other reason that in the judgment of the investigator
             makes the subject unsuitable for participation in the study.

          -  The subject has a history of acute occlusion requiring medical intervention of any
             artery (including aorta) within 6 months of consent.

          -  The subject has a known or suspected hypersensitivity to any of the components of
             Optison, blood, blood products, or albumin.

          -  The subject has right to left, bi-directional or transient right to left cardiac
             shunts.
Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: gemcitabine; paclitaxel; carboplatin; cisplatin
Intervention description: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles; 150 mg/m2, IV, every 14 days x 8 cycles; Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles; 50 mg/m2, IV, every 14 days x 8 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the
      treatments of MBC; however, the optimal dosing schedules for these combinations have not yet
      been determined. The primary objective of this study is to compare the response rates of the
      gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when
      administered on a biweekly schedule in metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with histological or cytological proven diagnosis of breast cancer

          -  Stage IV disease

          -  Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale

          -  Patients had to have previously received anthracycline based regimens as a adjuvant
             therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic
             disease

          -  Adequate organ function

        Exclusion Criteria:

          -  Prior chemotherapy for metastatic disease

          -  Previous radiation therapy is allowed but must not have included whole pelvis
             radiation

          -  Known or suspected brain metastasis. Serious concomitant disorders that would
             compromise the safety of the patient or compromise the patient's ability to complete
             the study, at the discretion of the investigator

          -  Concurrent administration of any other tumor therapy, including cytotoxic
             chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))

          -  Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History
             of significant neurological or mental disorder, including seizures or dementia
Optimizing Anesthesia for Post Partum Tubal Ligations
Condition: Pregnancy Related
Intervention: Chloroprocaine; Bupivacaine
Intervention description: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural; 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
Intervention MeSH terms: Bupivacaine; Chloroprocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to
      low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients
      undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded
      study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible
      for enrollment in this study. Outcomes measured will include: ability to achieve an adequate
      level required for surgery (T6), rate of epidural activation, and duration of the block. The
      investigators hope to determine the usefulness of each drug using the EVE technique in the
      setting of PPBTL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center
             will be eligible for the study

        Exclusion Criteria:

          -  age less than 18 years old

          -  allergy to either local anesthetic class (amide or ester)

          -  contraindication to spinal anesthesia
Study of Occipital Nerve Stimulation for Drug Refractory Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Precision
Intervention description: Implantable Neurostimulator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Headache; Migraine; Refractory; Chronic; Pain

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of an implantable
      device to treat migraine. There are a significant number of patients who have drug refractory
      migraine and alternative therapies are needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be diagnosed with multiple migraines per month of moderate to severe intensity;

          -  Be refractory to medication;

          -  Be an appropriate candidate for the surgical procedures required fo this study;

          -  Be willing and able to comply with all study related procedures;

          -  Be capable of reading and understanding patient information materials and giving
             written informed consent.

        Exclusion Criteria:

          -  Have onset of headache after age 50;

          -  Are current substance abusers (including alcohol and illicit drugs);

          -  Have a significant psychiatric disorder;

          -  Have previously been treated with occipital nerve stimulation (either temporary trial
             or permanent implant);

          -  Have had nerve stimulation for pain relief.

          -  Have had an injection of botulinum toxin in the head or neck within 6 months prior to
             enrollment;

          -  Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or
             trigeminal distribution or have an occipital blockade or radiofrequency procedure
             currently in effect.

          -  Have a condition currently requiring or likely to require the use of MRI or diathermy;

          -  Have an active implantable device;

          -  Are pregnant or lactating or planning to become pregnant in the next 14 months;

          -  Have participated in any drug or device trial in the last 4 weeks or plant to
             participate in any other study during the next 14 months.
Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients
Condition: Atrial Fibrillation; Coronary Artery Disease
MeSH terms: Atrial Fibrillation; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Regadenoson MRI; Gadobenate dimeglumine
Intervention description: AF patients will be provided with a regadenoson stress MRI to see if coronary artery disease can be detected with more sensitivity /specificity.; Resting perfusion with Multihance Gd-BOPTA contrast agent will be performed first, then a regadenoson injection will be given and MR imaging performed with a Gd-BOPTA contrast agent bolus 60-100 seconds later.
Intervention MeSH terms: Regadenoson
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: MRI; Atrial Fibrillation

Summary:

      Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a need
      for research to elucidate the prevalence of ischemic cardiomyopathy in patients diagnosed
      with AF. The objective of this study is to demonstrate the utility of MRI in assessment of
      coronary artery disease. The specific objective is to demonstrate sensitivity/specificity
      comparable to that reported in meta-analyses of non-AF patients and adenosine (90% /80%) in
      an AF population using the time-efficient vasodilator regadenoson that requires only a single
      intravenous (IV).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease
        who will undergo catheterization X-ray angiography

        Exclusion Criteria:

          1. Critically ill patients, patients on ventilators patients with hypotension,
             asthmatics, and other patients whose medical care or safety may be compromised from
             undergoing an MRI examination will be excluded.

          2. Patients with claustrophobia will also be excluded since MRI is conducted in a closed
             environment.

          3. Patients with contraindications to MRI (pacemaker, metal implants).

          4. Pregnant subjects (or women who may become pregnant), minors, and prisoners will be
             excluded from this study.

          5. Subjects are over 60 or have any suspicion of abnormal kidney function (a blood test
             to determine Glomerular filtration rate (GFR) will be performed prior to imaging.
             Subjects with GFR<30 will be excluded from the study. This is standard practice for
             clinical scans in Radiology due to the extremely small but not negligible relationship
             between gadolinium contrast agent and nephrogenic systemic fibrosis in patients with
             severely impaired renal function.
Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-alcoholic Fatty Liver Disease (NAFLD); Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: AZ compound; Placebo
Intervention description: AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).; Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 21-75

          -  Body Mass Index (BMI) >19 kg/m^2

          -  Subjects with biopsy/MRE proven NASH [MRE liver fat ≥ 5%, with elevated liver enzymes
             ALT <5x upper limit normal (ULN)].

          -  Subjects with NAFLD and MRE shows F0 or greater fibrosis

          -  Subjects with history suggestive of NAFLD/NASH

          -  Total bilirubin must be < 1.5 x ULN and INR must be < 1.3 at baseline screening.

          -  TSH and CPK will be within normal limits (WNL) at screening.

          -  Subjects with type 2 diabetes who are on stable doses of medications (except
             pioglitazone) to control hyperglycemia and have baseline HbA1c of 10% or lower.

          -  Hemoglobin must be greater than or equal to 12.0 in males and 11.0 in females.

        Exclusion Criteria:

          -  Medications that may affect glucose metabolism such as corticosteroids, opiates,
             barbiturates, and anticoagulants.

          -  Subjects with anemia, and symptoms suggestive of undiagnosed illness, overt hepatic
             disease, stroke, Alzheimer's disease, autoimmune hepatitis, alcoholism or increased
             alcohol consumption over the American Diabetes Association (ADA) guidelines.

          -  Any disorder that may potentially impact the outcome measures.

          -  Pregnant women and children.

          -  Subjects planning weight loss or in any weight loss program.

          -  Subjects taking TZD's, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum
             marianum and Valeriana officinalis.
Phase II Trial Evaluating Elimination of Radiation Therapy
Condition: Cancer of the Larynx
MeSH terms: Laryngeal Neoplasms
Intervention: Intensity modulated radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if reducing or eliminating radiation treatment to
      one or both sides of the neck where there is no evidence of cancer can help spare the side
      effects of radiation treatment for head and neck cancer. In this study, the investigators
      plan to reduce the amount of radiation treatment received to healthy tissue
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or
             hypopharynx .

          -  Treated with surgical resection with one (or both) side(s) of the neck pathologically
             N0.

          -  Indication for radiation therapy at the primary site or neck consisting of any of the
             below characteristics:

               -  Close margin (<= 0.5 cm)

               -  Positive margin

               -  Perineural invasion

               -  Lymphovascular space invasion

               -  Metastatic disease in more than one lymph node

               -  Metastatic disease in more than one lymph node group

               -  Extracapsular extension in any lymph node

               -  Constellation of factors considered to be at risk based on the multi-disciplinary
                  tumor board discussion.

          -  Age >= 18.

          -  Patients must sign study specific, Institutional Review Board (IRB)-approved consent
             form.

        Exclusion Criteria:

          -  Previous head and neck cancer other than non melanoma skin cancer.

          -  Previous head and neck surgery.

          -  Female patients who are pregnant or nursing.