bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
Condition: Diabetes Mellitus, Type 2; Exocrine Pancreatic Insufficiency
MeSH terms: Exocrine Pancreatic Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Epanova® (omega-3 carboxylic acids); Omacor® (omega-3-acid ethyl esters)
Intervention description: 4 g (administered orally as 4 x 1 g capsules); 4 g (administered orally as 4 x 1 g capsules)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 490.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: omega-3 carboxylic acid

Summary:

      This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase
      II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients
      with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of
      EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott Healthcare
      Products Ltd) following a single oral dose in patients with different degrees of PEI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged ≥18 years and ≤70 years, with suitable veins for cannulation or
             repeated venipuncture.

          -  Clinically diagnosed Type 2 diabetics (American Diabetes Association guidelines;), on
             oral antibiotic drug use ≥3 months and HbA1c value ≥6.5% and ≤9.0% at Visit 1.

          -  Have a body mass index ≥18 kg/m2 and ≤40 kg/m2 and weigh at least 50 kg.

        Exclusion Criteria:

          -  Intolerance to Omega-3 fatty acids, ethyl esters or fish.

          -  On insulin therapy or treated with injectable Glucagon-like peptide-1 (GLP-1).

          -  Treated with bile acid sequestrants.

          -  Serum levels of TGs >10 mmol/L at any time during the study.
A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; tocilizumab [RoActemra/Actemra]
Intervention description: 8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration; 8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using
      2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have
      shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or
      anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv
      every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion
      time for the first administration, followed by a 31 minute infusion time for subsequent
      administrations (unless drug-related infusion reactions occur).The anticipated time on study
      treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  active moderate or severe rheumatoid arthritis;

          -  active disease for >6 months;

          -  inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than rheumatoid arthritis;

          -  prior history of, or current inflammatory joint disease other than rheumatoid
             arthritis;

          -  major surgery (including joint surgery) within 8 weeks prior to screening, or planned
             major surgery within 6 months following enrollment.
Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: calcitriol; dexamethasone; clinical observation
Intervention description: Given orally; Given orally; No intervention before surgery
Intervention MeSH terms: Calcitriol; Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage II prostate cancer; stage III prostate cancer

Summary:

      RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.

      PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with
      dexamethasone before radical prostatectomy works in treating patients with localized stage II
      or stage III adenocarcinoma (cancer) of the prostate.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Organ-confined disease

               -  cT1, cT2, or cT3 tumors

                    -  Patients with cT1 tumors are eligible if ≥ 1 core biopsies have ≥ 50% of the
                       tumor OR if 50% of the cores examined contain the tumor

               -  No small cell carcinoma of the prostate

          -  Scheduled for radical prostatectomy

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  WBC ≥ 3,500/mm^3

        Hepatic

          -  ALT and AST ≤ 4 times normal

          -  Bilirubin ≤ 2 mg/dL

        Renal

          -  Creatinine ≤ 2 times upper limit of normal

          -  Calcium ≤ 10.5 mg/dL

          -  No detectable renal stones by CT scan or ultrasound

        Other

          -  No history of diabetes mellitus requiring pharmacotherapy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  More than 5 years since prior antiestrogens, antiandrogens, luteinizing
             hormone-releasing hormone agonists, estrogen, or progestational agents

        Radiotherapy

          -  Not specified

        Surgery

          -  See Disease Characteristics

          -  No prior nephrectomy

          -  No prior prostatic surgery

          -  No prior cryotherapy or transurethral resection of the prostate
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Vancomycin; Placebo
Intervention description: Oral vancomycin 250mg capsules; Placebo Pills distributed by Research Pharmacy labeled "placebo."
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized double-blinded placebo-controlled crossover study
Masking: Double (Participant, Care Provider)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if multiple doses of vancomycin over the course of
      3 months will perturb the intestinal flora (microbiome) and result in reduced serum
      concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the
      study will permit investigators to assess the variability of serum uremic retention solute
      concentrations with and without antibiotic over a three-month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV
             graft.

        Exclusion Criteria:

          -  Antibiotics received within the last 3 months;

          -  recent diarrhea

          -  known allergy to vancomycin

          -  history of C. difficile infection

          -  elevation of white blood cell count or fever within one week of enrollment.
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone 20 mg; Lurasidone 40mg; Lurasidone 80 mg; Haloperidol 10mg; Placebo
Intervention description: Lurasidone 20mg/day tablets; Lurasidone 40mg/day tablets; Lurasidone 80mg/day - 2 40mg tablets; Haloperidol 10mg/day tablets; Matching Placebo to Lurasdione and Haloperidol
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Lurasidone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Schizophrenia; Latuda; Lurasidone

Summary:

      The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a
      placebo and to haloperidol in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion criteria:

          -  The patient has a primary diagnosis of schizophrenia

          -  The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks
             of screening

          -  The patient has had a duration of illness of at least one year.

          -  The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in
             two or more items of the positive symptom subcluster on the PANSS

          -  The patient is able to remain off antipsychotic medication for a 4 day washout period

        Exclusion criteria:

          -  The patient has had psychiatric hospitalizations other than current hospitalizations
             within 1 month prior to screening.

          -  The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200
             ng/mL at baseline

          -  Pregnancy
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: CTX-4430; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the
      safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Forced expiratory volume at one second (FEV1) ≥50 percent predicted at Screening

          -  At least 1 pulmonary exacerbation in the 12 months before Screening

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Medical condition that is unstable, could be adversely impacted by participation in
             the study, or could impact assessment of the study results

          -  History of organ transplantation

          -  History of alcoholism or drug abuse within 2 years before Screening

          -  Regular use of a high-dose NSAID within 60 days before Screening
Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
Condition: Kidney Transplantation
Intervention: Mycophenolic Acid; Standard of Care: CNI and MPA
Intervention description: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months; Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: mycophenolate; living donor

Summary:

      This randomized trial will enroll adult recipients of HLA-identical living kidney transplants
      who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or
      cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to
      either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The
      hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal
      allograft function in the absence of long-term calcineurin inhibitors in this fully matched
      renal transplant cohort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 18-75 years of age.

          -  Subjects who are recipients of HLA-identical living donor renal allografts from a
             sibling and are at least 1 year post transplant, their donors and mothers.

          -  Subjects must be capable of understanding the purpose and risks of the study and must
             sign a statement of informed consent.

        Exclusion Criteria:

          -  GFR <40ml/min;

          -  diagnosis of SLE,

          -  Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount
             less than this deemed significant on an individual subject basis by the principal
             investigator),,

          -  multi-organ transplant;

          -  known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;

          -  history of documented post transplant non-compliance with medications, transplant
             clinic or laboratory follow-up;

          -  therapy with an investigational immunosuppressive drug within 6 weeks of study entry;

          -  history of a psychological illness or condition such as to interfere with the
             patient's ability to understand the requirements of the study;

          -  patients on less than 500 mg PO BID of CellCept or 360 mg PO BID of Myfortic at the
             time of potential randomization,

          -  history of humoral rejection post transplant,

          -  maintenance or for cause treatment with steroids (prednisone) within 3 months of
             enrollment.
Medtronic Reveal XT Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Reveal XT implantation
Intervention description: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients

Summary:

      While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years,
      virtually all of the historical series reported only the recurrence of symptomatic AF and
      have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of
      traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the
      Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative
      arrhythmia burden following surgical treatment for AF in patients undergoing either lone or
      concomitant heart surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing planned, elective AF surgery, either as a stand-alone procedure or
             as a concomitant cardiac operation.

          2. Patients will have either a Cox-Maze procedure (full-biatrial lesion set) or surgical
             pulmonary vein isolation (PVI).

          3. Patients 18 years or older.

          4. All eligible patients will be considered, regardless of gender or race.

          5. Patients able and willing to provide informed consent and willing to comply with the
             required interval follow-up.

        Exclusion Criteria:

          1. Patients with a preoperative permanent pacemaker.

          2. Patients with a projected lifespan of less than six months.

          3. Patients requiring emergent cardiac surgery.

          4. Patients unwilling or unable to give written informed consent.

          5. Patients undergoing a right atrial or left atrial lesion set procedure.
Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Brentuximab Vedotin; Adriamycin, vinblastine, and dacarbazine
Intervention description: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg; Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Brentuximab Vedotin; Dacarbazine; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-bulky; limited stage

Summary:

      Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a
      protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the
      antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy
      portion, which attempts to destroy the cell.

      The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you
      will receive in this research study are approved for use in people with Hodgkin Lymphoma. A
      drug called bleomycin is usually included with AVD, but since it appears to be a less
      effective drug with significant potential risks, it is being replaced in this study with the
      drug brentuximab.

      In this research study, the investigators are looking to see whether brentuximab in
      combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma

          -  Non-bulky disease defined as less than 10 cm in maximal diameter

          -  Measurable disease greater than or equal to 1.5 cm

          -  ECOG performance status of 0 or 2

          -  Willing to use 2 effective forms of birth control

        Exclusion Criteria:

          -  No prior chemotherapy or radiotherapy for Hodgkin lymphoma

          -  Not receiving any other investigational agents

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab

          -  No pre-existing grade 3 or greater neuropathy

          -  No uncontrolled intercurrent illness

          -  Not pregnant or breastfeeding

          -  No history of a different malignancy unless disease free for at least one year
Impact of Probiotics for Reducing Infections in Veterans: The IMPROVE Study
Condition: Anti-biotic Resistance
MeSH terms: Infections
Intervention: Lactobacillus rhamnosus HN001; sugar pill (placebo)
Intervention description: Subjects will be given a pill formulation of a probiotic L. rhamnosus HN001 to be taken once a day, at a dose of 1 x 10^10 organisms; Placebo identical to the active product will be given
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: infection; probiotics

Summary:

      The investigators have two hypotheses: (1) The probiotic L. rhamnosus HN001, when compared to
      placebo, will reduce S. aureus nasal colonization when taken for four weeks. (2) The
      probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus
      gastrointestinal colonization when taken for four weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Colonized at nasal or gastrointestinal source by S. aureus including MRSA

          -  Age 18 years or older

          -  Able to take oral medications

          -  Able to provide informed consent

        Exclusion Criteria:

        Uncontrolled psychiatric illness

          -  On a decolonization protocol for MRSA (e.g mupirocin, tea tree oil)

          -  Current involvement in another investigational trial

          -  Pregnancy

          -  Persistent diarrhea (> 3 loose stools per day for at least 2 days)

          -  Active infection with S.aureus or MRSA
Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Condition: Spinal Cord Injuries; Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Spinal Cord Injuries
Intervention: Mirtazapine; Placebo
Intervention description: 15 mg dose before bed-time; One placebo pill before bed-time
Intervention MeSH terms: Mirtazapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the effect of using Mirtazapine to target a specific
      pathway in the body, that relies on a natural chemical the body produces called 'serotonin',
      in patients with spinal cord injury (SCI) and non-injured persons during sleep. During this
      part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo
      in a random fashion, each for a one week period (drug period) of time followed by one week
      without drugs (washout period). The drugs will not be taken all at the same time, but each
      will be taken separately for one weeks followed by a night study to look at the effect the
      Mirtazapine/placebo pill has on the way the body responds during sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with SCI (>6months after spinal cord injury) at the T6 level/above

          -  Non-injured adults

        Exclusion Criteria:

          -  Pregnant and lactating females

          -  Heart failure, vascular disease, or stroke

          -  Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic
             kidney disease

          -  BMI >38 kg/m2

          -  Mechanical ventilation dependence