bioihbjkbjnl/mcl2 huggingface dataset:
Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy
Condition: Diagnostic Colonoscopy Screening
Intervention: Remifentanil; Midazolam; Meperidine; placebo (for remifentanil); placebo (for midazolam); placebo (for meperidine)
Intervention description: continuous infusion 0.4 mcg/kg/min; bolus injection; bolus injection for 30 sec 1.0 mg/kg; normal saline mimic diluted remifentanil; normal saline mimic to midazolam injection; normal saline mimic meperidine injection
Intervention MeSH terms: Midazolam; Meperidine; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: colonoscopy; remifentanil; midazolam; meperidine

Summary:

      The aim of the present study is to compare patient's recovery times after elective
      colonoscopy employing remifentanil only vs conventional combination of midazolam and
      meperidine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 19-65 years

          -  American Society of Anesthesiologists physical status (ASA PS) 1-2

          -  Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a
             University Hospital

          -  Patients who signed on written informed consent.

        Exclusion Criteria:

          -  The exclusion criteria are refusal or inability to provide written informed consent

          -  Age < 18 years

          -  Pregnancy

          -  Previous large bowel surgery

          -  Psychiatric disorders

          -  History of addiction to opiates and / or sedatives, and previous adverse reaction to
             any drug used in the study.
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren
Intervention description: Aliskiren 300 mg once daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 589.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Food effect, hypertension, aliskiren

Summary:

      The purpose of this study is to evaluate the effect of food on aliskiren's efficacy,
      pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light
      meal versus fasted conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with essential hypertension, untreated or currently taking antihypertensive
             therapy (monotherapy or combination therapy).

          -  Patients with an office BP ≥ 140/90 mmHg and < 180/110mmHg at the randomization visit
             and the preceding visit

          -  Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and their
             msDBP between the randomization visit and the preceding visit

        Exclusion Criteria:

          -  Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP
             ≥180 mmHg or msDBP ≥110 mmHg)

          -  History or evidence of a secondary form of hypertension, such as renal parenchymal
             hypertension, renovascular hypertension, coarctation of the aorta, primary
             hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or
             bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD).

          -  Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 8%

          -  Evidence of renal impairment as determined by one of the following: serum creatinine
             >1.5 x ULN or eGFR < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history
             of nephrotic syndrome

        Other protocol-defined inclusion/exclusion criteria may apply.

        -
Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Emergencies
Intervention: insulin aspart; insulin detemir
Intervention description: insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.
If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.; insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.
If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will examine two questions: 1. Whether insulin treatment of high blood sugar in
      patients with diabetes while they are in the emergency room will improve how quickly they
      recover from illness if they need to be hospitalized. 2. Whether immediately beginning long
      lasting insulin detemir in patients with diabetes when they are admitted to hospital from the
      emergency room will improve how quickly they recover from the illness which necessitated
      hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-80 years

          2. History of type 2 diabetes mellitus for at least 3 months

          3. Prior therapy with dietary management, oral agents, or insulin

          4. Non child-bearing potential or a negative urine pregnancy test

          5. Initial blood glucose in ER > 200 mg/dl

        Exclusion Criteria:

          1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after
             initial evaluation.

          2. Patients with critical illness suspected to require intensive care unit admission or
             direct surgical intervention.

          3. History of current drug or alcohol abuse.

          4. History of current mental illness

          5. Inability to give informed consent

          6. Female patients who are pregnant or are breast feeding

          7. Patients who have clinically significant liver disease with AST/ALT (aspartate
             transaminase/alanine transaminase) > 3 times the upper range of normal

          8. Patients currently treated with dialysis
Improving Bowel Cleansing With a Smart Phone Application
Condition: Cathartics; Mobile Applications
Intervention: Smart Phone Application; Written instructions with visual aids
Intervention description: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure; written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group).
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Bowel preparation; colonoscopy; Smartphone application

Summary:

      Getting ready for a colonoscopy is difficult and involves a lot of steps. The information
      given to patients is very important to adherence to treatment. The investigators have created
      a novel smart phone application (SPA) aimed to increased bowel preparation quality and
      patient satisfaction, using different educational tools.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective colonoscopy

          -  Owners of a smartphone

        Exclusion Criteria:

          -  No owners of a smartphone
MAST Trial: Multi-modal Analgesic Strategies in Trauma
Condition: Nonspecific Pain Post Traumatic Injury
MeSH terms: Wounds and Injuries
Intervention: Acetaminophen IV/PO; Acetaminophen PO; Ketorolac; Celebrex; Naproxen; Tramadol; Pregabalin; Gabapentin; Lidocaine; Opioids; Regional anesthesia
Intervention description: Acetaminophen 1g IV/PO every 6 hours; Acetaminophen 1g PO every 6 hours; Ketorolac 30mg IV once; Celebrex 200mg PO every 12 hours; Naproxen 500mg PO every 12 hours; Tramadol 100mg PO every 6 hours; Pregabalin 100mg PO every 8 hours; Gabapentin 300mg PO every 8 hours; Lidocaine patch every 12 hours; Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl); Regional anesthesia
Intervention MeSH terms: Acetaminophen; Ketorolac; Naproxen; Celecoxib; Lidocaine; Pregabalin; Gabapentin; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1561.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This is a comparative effectiveness study of current pain management strategies in acutely
      injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies
      will be compared [original multimodal pain regimen (MMPR) compared to multi-modal analgesic
      strategies for trauma (MAST) MMPR].
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted to the trauma service who are 16 years and older.

        Exclusion Criteria:

          -  pregnant

          -  prisoner

          -  patients placed in observation (i.e. not admitted to the hospital)
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
Condition: Nasolabial Folds
Intervention: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine; A gel of hyaluronic acid (concentration of 20 mg/mL)
Intervention description: Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL; Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
Intervention MeSH terms: Lidocaine; Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aesthetic correction of nasolabial folds

Summary:

      Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with
      Restylane in the correction of nasolabial folds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Desires correction of moderate to severe nasolabial folds (NLFs)

          -  Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)

          -  Females of childbearing potential must have a negative urine pregnancy test result at
             baseline and practice a reliable method of contraception throughout the study

        Exclusion Criteria:

          -  Cosmetic facial procedures [e.g., facelift, resurfacing (laser, photomodulation,
             intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative
             or non-ablative procedures), tissue augmentation with dermal fillers or fat
             injections, BOTOX Cosmetic injections, or mesotherapy] in the lower 2/3 of the face,
             including the neck, within 1 month prior to study entry or be planning to undergo any
             of these procedures at any time during the study

          -  Initiating use of any new over-the-counter or prescription, oral or topical,
             anti-wrinkle products in the NLF area within 1 month prior to enrollment or during the
             study

          -  Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the
             last 12 months prior to enrollment is within 5mL of the recommended annual maximum
             volume for HA dermal fillers

          -  Previous injection of semi-permanent fillers or placement of facial implants anywhere
             in the head and neck or implantation of any of these products during the study

          -  Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal
             protein

          -  Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in
             the NLF region

          -  Current treatment with anti-coagulation therapy or use of non-steroidal
             anti-inflammatory drugs or other substances known to increase coagulation time within
             10 days of undergoing study injections
Post-Operative Drainage Following Lymph Node Dissection
Condition: Malignant Melanoma; Carcinoma, Squamous Cell
MeSH terms: Melanoma; Carcinoma, Squamous Cell
Intervention: Fibrin Sealant (Tisseel) used in the Experimental Arm.
Intervention description: For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK.
For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects).
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Groin dissection; Axilla (or axillary) dissection; Lymph node dissection; Lymphadenectomy; Seroma; Wound drainage; Fibrin sealant; Malignant melanoma; Squamous cell carcinoma

Summary:

      The purpose of this study is to determine whether the use of fibrin sealant reduces
      post-operative drainage following groin and axillary lymph node dissection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over 18 years of age

          -  Requiring groin or axillary lymph node dissection for malignant disease.

        Exclusion Criteria:

          -  Patients under age 18 years.

          -  Patients unable to speak English.

          -  Patients with learning difficulties.

          -  Patients with mental illness.

          -  Prisoners.

          -  Other vulnerable groups.
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
Condition: Renal Transplantation
Intervention: Everolimus (RAD001)
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal transplantation; everolimus; immunosuppressants; wound-healing

Summary:

      The purpose of this study is to evaluate if the delayed administration of everolimus could
      reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing
      disorder) while maintaining efficacy, when compared to the immediate administration of
      everolimus in de novo renal transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of cadaveric kidney transplants

          -  Patients at risk of DGF defined as one or more of the following:

               -  Donor age > 55 years

               -  Cold ischemic time (CIT) ≥ 24 hours but < 40 hours

               -  Second or subsequent renal transplantation

        Exclusion Criteria:

          -  Patients who have received an investigational drug within 4 weeks of baseline period

          -  Patients who are recipients of multiple organ transplants, including more than one
             kidney, or previous transplant with any organ other than kidney

          -  Patients with body mass index (BMI) > 32 kg/m2

        Other protocol-defined exclusion criteria may apply.
Extension Study Evaluating Etanercept in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Enbrel (etanercept)
Intervention description: Etanercept 50 mg SC injection once weekly
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the health care resource utilization and
      work status of patients with ankylosing spondylitis undergoing treatment with etanercept by
      comparing study evaluations with the baseline evaluations in the ASCEND
      (0881A3-402)(NCT00247962) study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients who completed 16 weeks of treatment and have completed the baseline health
             care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW
             from participating countries.

        Exclusion criteria:

          -  Withdrawal from the ASCEND study for safety or any other reason.
Prospective, Double Blind, Placebo Control, Bariatric IV Ace
Condition: Obesity
Intervention: intravenous acetaminophen; Placebo
Intervention description: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia; Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bariatric; Post-operative nausea and vomiting; laparoscopic Sleeve gastrectomy; intravenous acetaminophen

Summary:

      The purpose of this study is to determine if the administration of acetaminophen given
      intravenously (through an IV) beginning during surgery and then for 3 additional doses during
      the first 24 hours post-operatively will reduce the length of time subjects undergoing
      elective sleeve gastrectomy spend in the hospital following this operation. Additional
      questions that may be answered include whether administration of the study medication leads
      to improvement in pain control, a reduction in post-operative nausea and vomiting, and an
      overall improvement in quality of recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old

          -  BMI > 30

          -  Undergoing Elective Sleeve Gastrectomy

          -  Able to consent

        Exclusion Criteria:

          -  Allergy/ Hypersensitive to acetaminophen or formulation incipients

          -  Allergy/Hypersensitive to aprepitant, ondasteron (serotonin type 3 receptor
             antagonists), dexamethasone

          -  Allergy to Propofol or formulation incipients (egg albumin, soy lecithin)

          -  Diagnosis or positive family history of malignant hyperthermia

          -  Abnormal LFTs (AST and ALT) >2x local upper limits of normal

          -  Renal impairment (creatinine clearance (CrCl) ≤ 30mL/min adjusted for obesity))

          -  Pregnancy

          -  Alcohol consumption > 3 drinks/day

          -  Requires awake intubation

          -  Unable to provide consent
Mupirocin-Iodophor ICU Decolonization Swap Out Trial
Condition: Staphylococcus Aureus
Intervention: Arm 1. Routine Care (Mupirocin/CHG); Arm 2. Iodophor/CHG Decolonization
Intervention description: The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.; The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
Intervention MeSH terms: Mupirocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-inferiority cluster randomized controlled trial
Masking: None (Open Label)
Enrollment: 353323.0
Sex: All
Healthy volunteers: No
Keywords: MRSA; healthcare-associated infections; mupirocin; iodophor; resistance

Summary:

      The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the
      non-inferiority of two decolonization regimens:

      Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the
      context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with
      iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that
      enrolled "subjects" represents 137 individual HCA Hospitals (representing ~235 ICUs) that
      have been randomized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria includes all U.S. HCA hospitals with an adult ICU;

          -  Note: Unit of randomization is the hospital, but the participants are hospital adult
             ICUs

          -  All patients within adult ICUs are included, including rare patients <18 years and
             >=12 years.

        Exclusion Criteria:

          -  Exclusion criteria includes ICUs with an average length of stay of less than 2 days;

          -  HCA hospitals that are not able to transfer or merge data into the centralized data
             warehouse for the baseline and intervention periods of the study are also excluded.