bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
Condition: Vitamin D Deficiency
MeSH terms: Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency
Intervention: Vitamin D2; 1,25(OH)2 Vit D3
Intervention description: Treatment with Vit D2.; Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic kidney disease mineral and bone disorder; vitamin D2; parathyroid hormone

Summary:

      It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the
      Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3
      (Rocaltrol) in the patients with CKD stage 3-5.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with age between 18-75 years.

          -  Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney
             disease mineral and bone disorder.

        Exclusion Criteria:

          -  Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in
             urinary system.

          -  New fracture in last 3 months.

          -  Active system immunity diseases.

          -  History of liver failure

          -  History of intestinal malabsorption or chronic diarrhea

          -  Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or
             other medications that could affect vitamin D metabolism

          -  Primary hyperparathyroidism

          -  Treatment with cinacalcet or other calcimimetic within the past 6 months

          -  Anticipated dialysis within 6 months after randomization

          -  Have an unstable medical condition, defined as having been hospitalized within 30 days
             before screening, the expectation of recurrent hospital admissions or life expectancy
             of less than 6 months in the judgment of the investigator

          -  Subject is currently enrolled in, or fewer than 30 days have passed since subject has
             completed another investigational device or drug study(s); or subject is receiving
             another investigational agent(s).

          -  Current treatment with vitamin D 50,000 IU

          -  Using glucocorticoid or immunosuppressive agents.

          -  Acute renal dysfunction.

          -  The expected live time is less than 2 years.

          -  Pregnant or lactating woman.

          -  Suffered from acute myocardial infraction, acute congestive heart failure, or stroke
             in last 6 months.

          -  Patients whose concurrent illnesses, disability, or geographical residence would
             hamper attendance at required study visit.
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
Condition: Heart Disease; Myocardial Infarction; Acute Myocardial Infarction
MeSH terms: Heart Diseases; Myocardial Infarction; Infarction
Intervention: Reteplase 10 Units (U) plus a second dose of reteplase 10 U; Reteplase 10 U; Urgent Percutaneous Coronary Intervention (PCI); Primary Percutaneous Coronary Intervention (PCI)
Intervention description: Thrombolytic-clot busting drug Retavase IV Bolus, 10 U followed by a second 10U dose; Thrombolytic-clot busting drug Retavase IV Bolus in one 10U dose
Intervention MeSH terms: Reteplase; Tissue Plasminogen Activator
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 390.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Disease; Heart Attack; Myocardial Infarction; Thrombolytic Therapy; Emergency Medicine

Summary:

      The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital
      use of a "clot busting" (thrombolytic) drug followed with emergent heart catheterization
      including stenting of the problematic coronary artery, will result in a lower mortality and
      reduced repeat heart attack rates.

      Early identifying and treating heart attacks patients prior to the arriving at the hospital,
      in those patients who qualify for the "clot busting" drugs will lower the size of the heart
      attack damage. This smaller heart attack will lead to fewer problems with less repeat heart
      attacks and death in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ischemic discomfort (squeezing, crushing, or pressure, sub-sternal, unrelated to
             breathing or movement), epigastric discomfort or pre-syncopal symptoms with
             diaphoresis, lasting > 30 minutes.

          2. ST elevation > 0.1 mV in 2 or more contiguous limb leads or > 0.2 mV in 2 or more
             contiguous pre-cordial leads.

          3. Less than 6 hours after onset of sustained chest pain.

          4. Age 18 years or older.

        Exclusion Criteria:

          1. Chest pain described as ripping or tearing, radiating to the back and/or down the leg,
             and/or systolic blood pressure > 15 mmHg difference in each arm.

          2. Suspected cocaine or amphetamine use within previous 3 days.

          3. Known or suspected pregnancy.

          4. Cardiac arrest requiring intubation.

          5. Cardiac arrest requiring greater than 20 minutes CPR.

          6. Coronary intervention (PTCA/stent/CABG) within previous 4 weeks.
Maintenance Treatment of Bipolar Depression
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lamotrigine; Divalproex (DIV) ER; Placebo
Intervention description: If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects.; If the participant is naive to DIV and if LAM was initiated before the start of treatment with DIV, DIV can be started at any point of time in the study provided the participant has been on LAM for at least 2 weeks. DIV will be started at 500 mg and titrated by increments of 500 mg every 3 to 4 days until a therapeutic blood level is attained up to 2500 mg.; During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fashion.
Intervention MeSH terms: Lamotrigine; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lamotrigine; Divalproex; Antidepressant

Summary:

      This study will compare two different antidepressant treatment regimens to determine which is
      more effective in reducing symptoms of bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar disorder I or II

          -  Experiencing symptoms of depression at study entry OR have experienced symptoms of
             depression within 6 months prior to study entry

          -  Willing to use acceptable methods of contraception

          -  Parent or guardian willing to provide informed consent, if applicable

        Exclusion Criteria:

          -  History of liver disease

          -  History of substance abuse

          -  Previous treatment with lamotrigine or divalproex

          -  Lamotrigine or divalproex intolerance
Seprafilm® Adhesion Barrier and Cesarean Delivery
Condition: Adhesions; Cesarean Section; Delivery, Obstetric
MeSH terms: Tissue Adhesions
Intervention: modified sodium hyaluronic acid and carboxymethylcellulose; Placebo
Intervention description: Adhesion barrier applied at the time of initial cesarean delivery; Routine abdominal closure without placement of adhesion barrier
Intervention MeSH terms: Carboxymethylcellulose Sodium; Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 753.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adhesion; Seprafilm; Cesarean section

Summary:

      A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of
      Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary
      outcome will be measurement of the extent and severity of adhesions at the time of subsequent
      cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex.,
      incision-delivery; total operative time).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women who are planning or have the potential to undergo cesarean delivery

          -  Age over 18

          -  Able to consent to study

        Exclusion Criteria:

          -  Planned tubal ligation

          -  Known allergy to hyaluronic acid

          -  Medical or other serious condition which will interfere with compliance and/or ability
             to complete study protocol
Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery
Condition: Hypoglycemia; Evidence of Previous Gastric Surgery
MeSH terms: Hypoglycemia
Intervention: Pramlintide
Intervention description: See description above (arm description).
Intervention MeSH terms: Pramlintide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants in this study were asked to complete 4 study visits.
Arm/Phase 1: Baseline: Study V1 was a screening visit. Participants kept a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At V2, a baseline mixed meal tolerance test (MMTT) was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom logs were reviewed.
Arm / Phase 2: Pramlintide treatment Pramlintide was prescribed at the end of visit 2 (following MMTT), with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants kept a record of all hypoglycemic symptoms and blood glucose measurements at those times.
Study visit 3 occurred at week 4 of treatment and focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants underwent a repeat MMTT.
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypoglycemia; Gastric bypass surgery

Summary:

      The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce
      the frequency and severity of hypoglycemia in individuals who have had gastric bypass
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  severe hypoglycemic episodes post-gastric bypass surgery

          -  normal fasting glucose

          -  age 21 to 65

          -  hypoglycemia must not have responded to dietary intervention (low glycemic index,
             controlled carbohydrate portions) and a trial of acarbose therapy at the maximally
             tolerated dose

        Exclusion Criteria:

          -  Hypoglycemia in the fasting state (greater than 12 hours fast)

          -  History of preoperative diabetes mellitus

          -  Use of medications that affect gastrointestinal motility (e.g., cisapride,
             metoclopramide)

          -  Impaired renal function (creatinine clearance < 20 ml/min or on dialysis

          -  Hepatic disease (defined as liver enzymes > 2 times upper normal limit for alanine
             transaminase (ALT) and aspartate aminotransferase (AST))

          -  Blood donation for 2 months prior to the study.

          -  Severe hypoglycemic unawareness, as defined by inability to recognize adrenergic or
             neuroglycopenic symptoms of hypoglycemia despite detailed education
Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes
Condition: Healthy
Intervention: Placebo; Propofol; Thiopental
Intervention description: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.; A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.; A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
Intervention MeSH terms: Thiopental; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: N/A healthy volunteers

Summary:

      This study involves 60 healthy volunteers aged between 18 and 50 recruited from the general
      community. It involves doing a set of simple memory tests while inside a fMRI machine. The
      subject is given a very low dose of an anesthetic drug intravenously while in the scanner.
      The subject then sees a sequence of pictures on a screen, and presses a button if they
      remember seeing the picture before. While this is happening, the scanner will be capturing
      images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal
      and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will
      be altered by intravenous anesthetics such that suppression of hippocampal and amygdala
      activities will be dissociable. This dissociation pattern will be different between the drugs
      propofol and thiopental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age b/w 18 and 50

          -  right-handed

          -  minimum of high school education

          -  fluent in English

          -  normal vocabulary

        Exclusion Criteria:

          -  any significant medical/psychiatric comorbidity

          -  deficit in vision or hearing that would impede the study

          -  allergies to any of the study drugs, to soybeans, or eggs.

          -  history of head trauma

          -  family history of major psychiatric illness

          -  body mass index > 30 kg/m2

          -  claustrophobia

          -  prior exposure to IAPS pictures

          -  pregnancy

          -  permanent metal objects anywhere in the body

          -  a personal/family history of any porphyria
The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery
Condition: Oxidative Stress; Cognition Disorders
MeSH terms: Cognition Disorders
Intervention: Dexmedetomidine; Placebo
Intervention description: After skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.; The control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing
      postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use
      cardiopulmonary bypass machine (CPB).

      Materials and Methods: This study was double-blinded, randomized controlled trial. Patients
      scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups,
      dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless
      test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined
      as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for
      IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1),
      arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD
      and the secondary outcomes were inflammatory response, other postoperative complications, ICU
      and hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) physical status I-III.

        Exclusion Criteria:

          -  patients who were allergy to medication in the research regimen

          -  preoperative left ventricular ejection fraction less than 30%

          -  body mass index more than 35 kg/m2

          -  preoperative mean arterial pressure less than 60 mmHg

          -  preoperative heart rate less than 45/min

          -  patients with impaired renal function (serum creatinine more than 1.5 mg/dl in female
             and 2 mg/dl in male)

          -  active liver disease, and who had history of symptomatic cerebrovascular disease

          -  psychiatric problem and other neurological diseases

          -  patients who cannot read
PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Condition: Pneumonia; Pneumonia, Ventilator-Associated; Urinary Tract Infections
MeSH terms: Infections; Pneumonia; Urinary Tract Infections; Pneumonia, Ventilator-Associated
Intervention: doripenem
Intervention description: 500mg vial by injection every 8 hours for 5 to 14 days
Intervention MeSH terms: Doripenem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carbapenem; Doripenem; Doribax; Nosocomial pneumonia, Intra-abdominal infections; Urinary tract infection

Summary:

      The purpose of this study is to understand the utilization patterns of doripenem in Asia
      Pacific, including the profile of the patients treated with carbapenems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients hospitalized either in the ICU or ward, with a diagnosis of pneumonia,
             complicated abdominal infections, or complicated urinary tract infection using the
             protocol-defined Guidelines for Diagnosis

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Allergies to Doripenem or its derivatives

          -  Infected by a bacteria that is resistant to Doripenem

          -  Taking probenecid

          -  Severe allergies to other antibiotics like penicillins, cephalosporins, or carbapenems

          -  Severe kidney disease, in an unstable disease state and assessed as unlikely to
             survive until the study follow up period

          -  Signs of severe sepsis with treatment failure with other carbapenems, who received
             other carbapenem within 2 weeks before first dose of study drug, and who has any
             condition that, in the opinion of the investigator, would compromise the well-being of
             the patient or the study or prevent the patient from meeting or performing study
             requirements
SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
Condition: Non Small Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib
Intervention description: Gefitinib tablet 250mg once daily orally
Intervention MeSH terms: Gefitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Carcinoma; Non Small Cell Lung; EGFR mutation; Gefitinib

Summary:

      The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a
      second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid
      Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type
      of tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma

          -  Previously failed the first-line chemotherapy

          -  Patient who can provide sample for EGFR mutation test

        Exclusion Criteria:

          -  Central Nervous System metastasis or spinal cord compression that has not yet been
             definitively treated with surgery and/or radiation

          -  Any evidence of clinically active interstitial lung disease