bioihbjkbjnl/mcl2 huggingface dataset:
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Sorafenib (Nexavar, BAY43-9006); Carboplatin/Paclitaxel; Placebo
Intervention description: Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19; Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1; Placebo, 2 tablets bid Study Days 2-19
Intervention MeSH terms: Paclitaxel; Carboplatin; Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to compare the anti-tumor activity as measured by
      Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel
      and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects
      with unresectable Stage III or Stage IV melanoma who progressed after receiving only one
      prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a life expectancy of at least 12 weeks

          -  Subjects with histologically or cytologically confirmed unresectable (Stage III) or
             metastatic (Stage IV) melanoma

          -  Subjects must have progressed after receiving at least one cycle of DTIC or TMZ
             containing regimen

          -  Subjects who have an ECOG PS of 0 or 1

          -  Measurable disease defined as at least one lesion that can be accurately and serially
             measured per the modified RECIST criteria

        Exclusion Criteria:

          -  Primary ocular or mucosal melanoma

          -  Previous or concurrent cancer that is distinct in primary site or histology from the
             cancer being evaluated in this study except cervical carcinoma in situ, treated basal
             cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis
             [Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective tissue])
             or any cancer curatively treated < 5 years prior to study entry

          -  History of cardiac disease

          -  Known history of human immunodeficiency virus (HIV) infection
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Condition: Arterial Dysfunction; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Cholecalciferol; Calcitriol
Intervention MeSH terms: Cholecalciferol; Vitamin D; Calcitriol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: chronic kidney disease; vitamin D deficiency

Summary:

      The purpose of this study is to determine whether nutritional (cholecalciferol) or active
      vitamin D (calcitriol) supplementation improves vascular endothelial function in patients
      with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The
      investigators hypothesize that the use of calcitriol supplementation will result in improved
      vascular endothelial function as compared to cholecalciferol supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases
             Formula (Estimated Glomerular Filtration Rate [GFR] 44-15 ml/min/1.73m2)

          -  Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level < 30 ng/mL

          -  Corrected serum calcium < 10.2 mg/dL

          -  Serum phosphate < 4.6 mg/dL

          -  Serum albumin > 3.0 g/dL

          -  Body mass index < 40 kg/m2

          -  Ability to give informed consent

        Exclusion Criteria:

          -  Significant co-morbid conditions that lead the investigator to conclude that life
             expectancy is less than 1 year

          -  Expected to undergo living related kidney transplant in next 6 months

          -  Pregnant, breastfeeding, or unwilling to use adequate birth control

          -  History of severe liver disease

          -  Nephrotic range proteinuria (> 3.5 gm/day)

          -  Use of active vitamin D analogs within 30 days of randomization
An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Condition: Brain Neoplasms
MeSH terms: Glioblastoma; Brain Neoplasms
Intervention: Nivolumab; Temozolomide; Radiotherapy; Nivolumab Placebo
Intervention MeSH terms: Nivolumab; Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 716.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated
      (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus
      radiation therapy. They will be compared to patients receiving nivolumab in addition to
      temozolomide plus radiation therapy.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females, age ≥ 18 years old

          -  Newly diagnosed brain cancer or tumor called glioblastoma or GBM

          -  Karnofsky performance status of ≥ 70 (able to take care of self)

          -  Substantial recovery from surgery resection

          -  Tumor test result shows MGMT methylated or indeterminate tumor subtype

        Exclusion Criteria:

          -  Biopsy-only of GBM with less than 20% of tumor removed

          -  Prior treatment for GBM (other than surgical resection)

          -  Any known tumor outside of the brain

          -  Recurrent or secondary GBM

          -  Active known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)
Condition: Supra-ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
Intervention: Adenosine
Intervention description: A vial of adenosine with 6mg
Intervention MeSH terms: Adenosine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomizes Control trial
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study to compare non inferiority of giving adenosine with the simplified method vs the AHA
      method
    

Eligibility criteria:

        Inclusion Criteria:

          -  Svt

          -  normal blood pressure

          -  normal mentation

          -  Give consent

        Exclusion Criteria:

          -  recent coffee

          -  Allergy to adenosine

          -  Asthma

          -  cardiac operations
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Leflunomide; Methotrexate; Ocrelizumab; Ocrelizumab; Placebo
Intervention description: Oral repeating dose; Oral or parenteral repeating dose; Intravenous repeating dose (200mg); Intravenous repeating dose (500mg); Intravenous repeating dose
Intervention MeSH terms: Methotrexate; Leflunomide; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 836.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RA; SCRIPT; anti-CD20; CD20

Summary:

      This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in
      patients with active rheumatoid arthritis who have an inadequate response to at least one
      anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous
      ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment
      will be administered at weeks 24 and 26. All patients will receive stable doses of either
      concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive
      additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and
      then participants will enter the open label phase until the drug is commercialized. Target
      sample size is 1000.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age

          -  Rheumatoid arthritis for at least 3 months

          -  Inadequate response to previous or current treatment with at least one anti-TNF-alpha
             agent

          -  Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for
             the last 4 weeks

          -  Swollen joint count (SJC) ≥ 4 (66 joint count) and tender joint count (TJC) ≥ 4 (68
             joint count) at screening and baseline.

          -  CRP ≥ 0.6 mg/dL using a high-sensitivity assay.

          -  Positive rheumatoid factor or positive anti-CCP antibody or both.

        Exclusion Criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease, other than RA

          -  Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline
Pre-exposure Prophylaxis for SARS-Coronavirus-2
Condition: COVID-19; Corona Virus Infection; ARDS; Acute Respiratory Distress Syndrome
MeSH terms: Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Intervention: Hydroxychloroquine; Placebo
Intervention description: Hydroxychloroquine; 200mg tablet; oral; Placebo; tablet; oral
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1483.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for
      the prevention of COVID-19 disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - A healthcare worker at high risk for COVID-19 exposure (defined below):

          -  Persons primarily working in emergency departments (physicians, nurses, ancillary
             staff, triage personnel)

          -  Persons primarily working in intensive care units (physicians, nurses, ancillary
             staff, respiratory therapists)

          -  Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse
             anesthetists (CRNAs)

          -  First responders (i.e. EMTs, paramedics)

        Exclusion Criteria:

          -  Active COVID-19 disease

          -  Prior COVID-19 disease

          -  Current fever, cough, shortness of breath

          -  Allergy to chloroquine or hydroxychloroquine

          -  Prior retinal eye disease

          -  Known Chronic Kidney disease, Stage 4 or 5 or dialysis

          -  Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency

          -  Weight <40 kg

          -  Prolonged QT syndrome

          -  Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide,
             amiodarone, digoxin, procainamide, or propafenone

          -  Current use of medications with known significant drug-drug interactions: artemether,
             lumefantrine, mefloquine, tamoxifen, or methotrexate.
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix; Leuprolide 7.5 mg
Intervention description: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.; Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.; Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 620.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      The study was a three-arm, active-control, multi-centre, parallel group study.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Patients, aged 18 years or over, with histologically proven prostate cancer of all
             stages in whom endocrine treatment is indicated.

          -  Baseline testosterone >1.5 ng/mL.

          -  Life expectancy of at least 12 months.
A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
Condition: Obesity
Intervention: bariatric surgery; control
Intervention description: Roux en Y bariatric surgery; No surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastric Bypass; Sertraline; Pharmacokinetics

Summary:

      The purpose of this study is to determine the difference, if any, in the area under the
      sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post
      Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and
      gender.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between the ages of 18 and 60 years.

          -  Subjects must be of good general health by history and physical exam.

          -  Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI
             requirement.

          -  Five subjects matched for body mass index, age and sex to the post bariatric surgery
             group.

          -  No contraindications to receiving a single dose of 100 mg of sertraline.

          -  Women of child bearing potential must be practicing an accepted method of birth
             control (barrier method or oral contraception) and have a negative pregnancy test at
             baseline.

        Exclusion Criteria:

          -  Allergy to sertraline or any of its constituents.

          -  Candidates currently receiving sertraline or any other antidepressant.

          -  Candidates currently receiving a medication that interacts with sertraline (Zoloft)

          -  Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes.

          -  Candidates experiencing clinically significant, unstable neurological, hepatic, renal
             or cardiovascular disease.

          -  Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for
             schizophrenia, schizoaffective disorder, bipolar disorder.

          -  Candidates who have participated in an investigational drug study in past 30 days.

          -  Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or
             who have a history of drug/alcohol abuse or dependency.

          -  Candidates who are pregnant or nursing at time of study.
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Exantide with Dapagliflozin; Exentide; Dapagliflozin
Intervention description: 2 mg weekly suspension injection and 10 mg Dapagliflozin; 2 mg; 10 mg once daily Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 695.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Exenatide; Dapagliflozin; Diabetes medication; Treatment efficacy; Placebo; Metabolism; Cardiovascular metabolic

Summary:

      Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,
      Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous
      administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)
      compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes
      who have inadequate glycemic control on metformin.
    

Eligibility criteria:

        Inclusion criteria

          -  Has a diagnosis of T2DM.

          -  Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.

          -  Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to
             Screening.

        Exclusion criteria

          -  FPG ≥280 mg/dL (15.6 mmol/L).

          -  Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)

          -  Clinically significant abnormal free T4 values or patients needing initiation or
             adjustment of thyroid treatment according to the investigator.

          -  Abnormal thyroid stimulating hormone (TSH) value at Screening will be further
             evaluated by free T4.Patients with clinically significant abnormal free T4 values will
             be excluded.

          -  Known active proliferative retinopathy.

          -  History of, or currently have, acute or chronic pancreatitis, or have triglyceride
             concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1

          -  History or presence of inflammatory bowel disease or other severe GI diseases,
             particularly those which may impact gastric emptying, such as gastroparesis or pyloric
             stenosis.

          -  History of gastric bypass surgery or gastric banding surgery, or either procedure is
             planned during the time period of the study. Current use of gastric balloons is also
             excluded.
A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
Condition: Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: Bevacizumab [Avastin]; Interferon alfa 2a [Roferon]; Placebo
Intervention description: 10 mg/kg IV every 2 weeks; 9 MIU SC 3 times/week; IV every 2 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 649.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in
      combination with Roferon as first-line treatment in participants with metastatic renal cell
      cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is
      1-2 years, and the target sample size is greater than (>)500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  metastatic renal cell cancer (clear cell type);

          -  nephrectomy;

          -  absence of proteinuria.

        Exclusion Criteria:

          -  prior systemic treatment for metastatic renal cell cancer;

          -  major surgical procedure, open biopsy or significant traumatic injury within 28 days
             prior to study treatment start;

          -  presence of brain metastases or spinal cord compression;

          -  ongoing need for full dose anticoagulants;

          -  uncontrolled hypertension;

          -  clinically significant cardiovascular disease.
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: AMG 162; Placebo
Intervention description: 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30; 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1468.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Bone Loss with Prostate Cancer; Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC).

Summary:

      This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing
      Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
    

Eligibility criteria:

        Other criteria also apply