bioihbjkbjnl/mcl2 huggingface dataset:
Intraoperative Glucose Control in Liver Transplant
Condition: Liver Transplant
Intervention: insulin
Intervention description: bolus or infusion 80 to 110 mg/dl
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: liver; transplant; blood sugar

Summary:

      The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict
      glycemic control to improve survival and infection rates following liver transplantation in a
      randomized, prospective trial.Primary objective: To determine if strict intraoperative blood
      glucose control, when compared to standard intraoperative glycemic control, improves 1-year
      recipient survival and decreases surgical complications, including infections, following
      liver transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years old undergoing liver transplantation

          -  Patients willing and capable of giving written informed consent for study
             participation

        Exclusion Criteria:

          -  Multi-organ transplant recipients

          -  Patients receiving a liver incompatible with A, B or O blood types

          -  HIV infected patients

          -  Recipients of an organ from an HIV+ donor

          -  Patients with severe coexisting disease or presenting with any unstable medical
             condition which could affect the study objectives

          -  Patients with a co-existing alcoholic disease who have not been abstinent for at least
             6 month immediately prior to transplantation and are not expected to be able to remain
             abstinent after transplantation

          -  Patients who are unlikely to comply with the study requirements or unable to give
             informed consent

          -  Use of other investigational drugs at the time of enrollment, or within 30 days or 5
             half-lives of enrollment, whichever is longer or if such therapy is to be instituted
             posttransplantation

          -  Patients transplanted for hepatocellular carcinoma exceeding 3 nodules or with nodule
             diameter larger than 5 cm

          -  History of malignancy of any organ system, treated or untreated, within the past 5
             years whether or not there is evidence of local recurrence or metastases, with the
             exception of localized basal cell carcinoma of the skin

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadatropin (hCG) laboratory test (> 5 milli-International
             units (mIU/ml)
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Prevenar; Prevenar; Prevenar; Prevenar
Intervention description: Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
4 doses starting from 121 to < 212 days of age; Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
3 doses starting from 212 days to < 12 months of age; Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
2 doses starting from 12 months to < 24 months of age; Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
1 dose starting from 24 months to < 72 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 505.0
Sex: All
Minimum age: 121 Days
Maximum age: 72 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevenar; catch-up; pneumococcal; pneumonia

Summary:

      A vaccine called Prevenar is already approved for use in China for vaccination of children
      younger than 6 years old against infections caused by Streptococcus pneumoniae.

      This study is to measure the amount of antibodies (antibodies help people fight off diseases)
      Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar.
      The study will also provide more data on how safe and well tolerated Prevenar is in Chinese
      children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Chinese male or female subjects.

          -  Between 121 days to less than 72 months of age at the time of entry into the study.

        Exclusion Criteria:

          -  Receipt of previous vaccine against Pneumo

          -  Previous anaphylactic reaction to any vaccine or part of a vaccine

          -  Previous proven invasive Pneumo infection

          -  Receipt of investigational drug or device within the proceeding 28 days
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush; EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
Intervention description: Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily; EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution
Intervention MeSH terms: Naltrexone; Morphine
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: opioid; morphine; naltrexone; withdrawal signs; withdrawal symptoms

Summary:

      This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal
      signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are
      stabilized on EMBEDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic moderate to severe non-cancer pain that has been treated with opioid
             analgesics for at least three months (with stabilized pain control and stabilized dose
             for 28 days prior to enrollment).

          -  Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.

          -  Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following
             naloxone administration during the Naloxone Challenge.

        If female and able to become pregnant, must use an approved method of birth control.

          -  Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the
             Investigator to be in generally good health at screening based upon the results of a
             medical history, physical examination, laboratory profile, and 12 lead
             electrocardiogram (ECG).

        Exclusion Criteria:

          -  Female who is pregnant or breastfeeding.

          -  Patient has a known allergy or history of significant adverse reaction to morphine,
             other opioids, naltrexone, acetaminophen, or related compounds.

          -  Patient is receiving systemic chemotherapy, has an active malignancy of any type, or
             has been diagnosed with cancer within the 5 years prior to screening (excluding
             squamous or basal cell carcinoma of the skin).

          -  History of, or ongoing, alcohol or drug abuse.

          -  Patient has made a donation of blood or has had a significant blood loss within 30
             days prior to screening.
Prebiotic Treatment in People With Schizophrenia - Pilot Study
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Prebiotin; Placebo
Intervention description: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI); placebo-OEI
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine changes in serum butyrate levels with the prebiotic:
      Prebiotin (12g/day), an oligofructose-enriched inulin (OEI); the effect of OEI on the
      composition of the gastrointestinal microbiota in people with schizophrenia; and the
      relationship of the composition of the gut microbiota to various clinical, cognitive, and
      neuroimaging variables.
    

Eligibility criteria:

        Inclusion Criteria:

          1. DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;

          2. Age 18-60 years

          3. Clinically stable as determined by opinion of treating clinician

          4. Currently treated with an antipsychotic, with no dose changes in last 14 days

          5. Ability to participate in the informed consent process, as determined by a score of 10
             or greater on the Evaluation to Sign Consent.

          6. BMI ≤ 35

        Exclusion Criteria:

          1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable
             Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the
             presentation or treatment of schizophrenia or significantly increase the risk
             associated with the proposed treatment protocol

          2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain
             injury, Loss of consciousness (LOC) for more than 30 minutes

          3. Intellectual disability

          4. Antibiotic or immune therapy within the last three months

          5. Prebiotic or probiotic treatment within the last three months

          6. Inability to understand English

          7. Inability to cooperate with study procedures

          8. Pregnant or lactating women secondary to pregnancy

          9. Meet DSM-5 criteria for alcohol or substance use disorders (except Tobacco Use
             Disorder) within last 3 months
Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin
Condition: Healthy
Intervention: Pitavastatin (NK-104); Diltiazem (Cardizem LA) 240 mg QD
Intervention description: pitavastatin (NK-104) 4 mg once daily (QD); Diltiazem (Cardizem LA) 240 mg QD
Intervention MeSH terms: Diltiazem; Pitavastatin
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug
      interaction study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or female volunteer aged 18 to 45 years, inclusive.

          -  Subject has a body mass index of 18 to 30 kg/m2, inclusive.

          -  Subject has normal hematology, serum chemistry, and urinalysis test results.

          -  Subject is able and willing to abstain from alcohol, grapefruit-containing foods or
             beverages, caffeine, or caffeine-containing products, St John's wort, and herbal
             supplements for 4 days before Day 1 and until after completion of this study.

          -  Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of
             study drug and until after study completion.

        Exclusion Criteria:

          -  Subject has had any surgery of the gastrointestinal tract likely to affect drug
             absorption, distribution, metabolism, or excretion.

          -  Subject has had a previous allergy or intolerance to treatment with pitavastatin,
             diltiazem, or any drugs in these classes.

          -  Subject has a history of drug or alcohol abuse.

          -  Subject has had a clinically significant illness within 4 weeks before the first dose
             of study drug.
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Condition: Bipolar Depression
MeSH terms: Bipolar Disorder
Intervention: Lurasidone
Intervention description: Participant will have an open label trial of lurasidone for eight weeks.
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The goal of this project is to understand what causes bipolar disorder and how medications
      treat bipolar depression. Particularly, the project focuses on the importance of dopamine
      signaling in the process. Participants will have two different brain scans (MRI and PET
      scan). They will also have treatment for your depression with an FDA approved medication,
      lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to
      improve the treatment of bipolar disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bipolar I disorder, bipolar II disorder or other specified bipolar disorder

          -  Currently in a major depressive episode and moderately depressed

          -  Age 18-50 years old

          -  Patients on psychiatric medications will not be benefitting from those medications

          -  Females of childbearing potential must be willing to use an acceptable form of birth
             control throughout the study

        Exclusion Criteria:

          -  Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance
             use disorder, recent anorexia or bulimia nervosa

          -  Previous failed trial of lurasidone, or had intolerable side effects of lurasidone

          -  Significant active physical illness

          -  Actively suicidal

          -  ECT within the past 6 months

          -  Recent pregnancy, abortion or miscarriage or plans to conceive during the study;
             currently lactating

          -  Metal in the body that is not MRI compatible

          -  Current, past or anticipated exposure to radiation

          -  Currently taking an anticoagulant medication
PREvention of VENous ThromboEmbolism Following Radical Prostatectomy
Condition: Prostate Cancer; Venous Thromboembolism; Lymphocele After Surgical Procedure; Deep Venous Thrombosis; Pulmonary Embolism
MeSH terms: Lymphocele; Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Subcutaneous Heparin
Intervention description: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.
Intervention MeSH terms: Heparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, single-institution, multi-surgeon, stratified randomized controlled trial. Randomization will be stratified into four groups by procedure approach (open or robotic) and whether patients elect to undergo a screening 30-day lower extremity Duplex (ultrasound or no ultrasound). Patients will then be randomized, within each of the strata, to the two arms (subcutaneous heparin versus no subcutaneous heparin).
Masking: Single (Outcomes Assessor)
Enrollment: 501.0
Sex: Male
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis
      (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of
      IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy
      (RP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 18-100 years of age with histologically confirmed prostate cancer of any stage
             undergoing RP

          -  Patients who would have otherwise been eligible to receive routine post-RP care

        Exclusion Criteria:

          -  Active treatment for VTE

          -  Patients judged by patients' urologist, primary care doctor, or in the preoperative
             evaluation center (PEC) to be unsafe to forgo pharmacologic prophylaxis or systemic
             anticoagulation postoperatively (whether or not patients are on systematic
             anticoagulation for indications other than VTE)

          -  Known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy)

          -  Epidural analgesia

          -  Spinal anesthesia

          -  Participation in a different trial that increases a patient's risk of VTE
The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
Condition: Post-operative Pain; Colon Cancer; Diverticulitis
MeSH terms: Diverticulitis; Pain, Postoperative
Intervention: Bupivacaine; Bupivacaine liposome suspension
Intervention description: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR; 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exparel; liposomal bupivicaine; post operative pain control; local anesthetic after surgery; colorectal surgery; marcaine; long acting local anesthetic; pain medication use after surgery

Summary:

      The purpose of the study is to evaluate the effect of Exparel on pain control and patient
      outcome after colon resection. The investigators will evaluate the clinical course of the
      patients who receive exparel as compared to the patients who do not receive exparel. Exparel
      is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three
      days. A long acting local anesthetic should provide better pain control than conventional
      bupivacaine which has a 3.5 hour half-life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective colon resection for both benign and malignant disease

          -  Laparoscopic, robotic and open techniques

        Exclusion Criteria:

          -  emergent colon cases

          -  cases preformed by surgeons other than Dr. Raman or Dr. Kraemer

          -  pregnant patients

          -  patients currently breast feeding

          -  patients under the age of 18

          -  other patients unable to give informed consent

          -  bupivacaine use within 96 hours

          -  allergy to amide anesthetics

          -  prisoners

          -  caution will be used in patients with renal or hepatic failure.
Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; Etanercept; Placebo
Intervention description: 50 mg etanercept once weekly + methotrexate; 25mg etanercept once weekly + methotrexate; Placebo comparator once weekly + methotrexate
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study involves Rheumatoid Arthritis patients in regular clinical setting who are already
      on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is
      intended to identify parameters that can serve as guidance in clinical settings. This study
      will consider the clinical and radiographic course in subjects when etanercept treatment is
      tapered or discontinued, and analyze the subjects' experience of disease worsening and the
      predictive values of clinical parameters, serum biomarkers and imaging on the clinical and
      radiographic course in different treatment groups. The effect of re-treatment with etanercept
      at treatment failure will also be studied.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subject has a current DAS28 equal to or less than 3.2.

          -  Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or
             50 mg once weekly, for a minimum of 14 months at baseline

          -  Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5
             mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

        Exclusion Criteria:

          -  Subject has earlier had an attempt of discontinuing etanercept for reasons of
             remission or low disease activity state.

          -  Subject has received any disease-modifying anti-rheumatic drug, other than
             methotrexate, within one month before baseline.

          -  Subject has had a dose of prednisone (or equivalent) >7.5 mg/day or has received
             intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one
             month of baseline.