bioihbjkbjnl/mcl2 huggingface dataset:
Chewed Versus Integral Pill of Ticagrelor
Condition: Percutaneous Coronary Intervention
Intervention: Ticagrelor; Ticagrelor
Intervention description: Chewed; Integral
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Ticagrelor; Stent

Summary:

      Hypothesis The primary question the investigators propose to answer is whether all patients
      undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed
      ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as
      compared to integral pill form 1 hour after drug administration.
    

Eligibility criteria:

        Inclusion Criteria:

        • All patients presenting to the cardiac catheterization lab for percutaneous coronary
        intervention.

        Exclusion Criteria:

          -  Age <18 years or Age >89 years

          -  Known coagulopathy, bleeding diathesis, or active bleeding

          -  History of recent gastrointestinal or genitourinary bleed within 2 months

          -  Known chronic therapy with clopidogrel, prasugrel, or ticagrelor

          -  Major surgery within last 6 weeks

          -  History of intracranial bleed or intracranial neoplasm

          -  Suspected aortic dissection

          -  Severe hemodynamic instability, cardiogenic shock

          -  Life expectancy <1 year

          -  Known severe liver or renal disease

          -  Known HIV treatment

          -  Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any
             use during the procedure

          -  Any use of Cangrelor during or after the procedure

          -  Hemoglobin <10 g/dL, platelet (PLT) <100x10^9/L

          -  Pregnancy

          -  Known allergy to study medication
Trial of High Dose Vitamin D in Patient's With Crohn's Disease
Condition: Crohn's Disease; Vitamin D Deficiency
MeSH terms: Crohn Disease; Vitamin D Deficiency
Intervention: Cholecalciferol 10,000 IU; Cholecalciferol 400 IU
Intervention description: Cholecalciferol 10,000 IU po daily; Cholecalciferol 400 IU po daily
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's disease; Vitamin D deficiency

Summary:

      Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is
      a major source of vitamin D. There is some research to suggest that patient's with higher
      vitamin D levels are less likely to undergo surgeries and have better control of their
      disease. We intend to study the effects of high dose vitamin D supplementation in patients
      with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses
      will have less hospitalizations, surgeries, steroid use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CD

          -  Age >= 18 and <75

          -  Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml)

        Exclusion Criteria:

          -  Corticosteroid use in the last 4 weeks

          -  CD-related surgery in the last 6 months

          -  CD-related hospitalization in the last 4 weeks

          -  Pregnancy, intended pregnancy during the study period or nursing

          -  Serum calcium >10.2 mg/dL

          -  History of primary sclerosing cholangitis

          -  History of undergoing an ileal pouch-anal anastomosis

          -  Current active perianal disease

          -  History of nephrolithiasis in the past 2 years

          -  Anticipated change in therapy in the next 30 days (steroids, biologic initiation)

          -  modified Harvey-Bradshaw Index of 10 or more

          -  History of decreased renal function (glomerular filtration rate <30ml/min based on
             MDRD) or polycystic kidney disease

          -  History of sarcoidosis

          -  History of hyperparathyroidism

          -  Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma

          -  Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or
             primidone

          -  Osteoporosis
Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; alpha-glucosidase inhibitors; DPP-4 inhibitors; meglitinides; SGLT-2 inhibitors; sulphonylurea; thiazolidinediones
Intervention description: Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Intervention MeSH terms: Liraglutide; 2,4-thiazolidinedione; Meglitinide; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1991.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate efficacy in
      controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment
      vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects
      with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female at least 18 years of age at the time of signing
        informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above
        90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal
        to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit -
        HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior
        to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or
        intends to become pregnant or is of childbearing potential and not using adequate
        contraceptive methods (adequate contraceptive measures as required by local regulation or
        practice) - Treatment with any medication for the indication of diabetes other than
        metformin in a period of 60 days before the screening visit. An exception is short-term
        treatment (below or equal to 7 days in total) with insulin in connection with intercurrent
        illness - Receipt of any investigational medicinal product within 30 days before the
        screening visit - Any disorder, which in the investigator's opinion might jeopardise
        subject's safety or compliance with the protocol
Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks
Condition: Total Knee Arthroplasty; Knee Pain
Intervention: 0.1% and 0.4% perineural ropivicaine
Intervention description: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TKA; Bilateral; Cleveland Clinic; UCSD; Catheter; Nerve block; Postoperative pain; Femoral Catheter; Bilateral Total Knee Arthroplasty; Bilateral Femoral Catheter

Summary:

      This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing
      bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one
      of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The
      contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%.
      The basal rate and patient-controlled bolus volume will depend upon the treatment group, but
      the total dose of local anesthetic is the same for each. For the duration of the study, all
      patients will receive the current usual and customary analgesics for bilateral TKA patients.
      All patients will receive a ropivacaine perineural infusions initiated in the operating room
      and continued until at least the afternoon of postoperative day (POD) 2, as well as oral
      acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of
      administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with
      0 equal to no pain and 10 being the worst imaginable pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary, bilateral TKA

          -  Age 18 years or older

          -  Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

        Exclusion Criteria:

          -  Chronic, high-dose opioid use

          -  History of opioid abuse

          -  Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles

          -  Pregnancy

          -  Incarceration
Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Condition: Pain; Obesity; Hypoxia
MeSH terms: Hypoxia
Intervention: Ketamine; placebo
Intervention description: Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).; Group P (placebo) will receive the same amount of saline.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Quality of Recovery 40 Questionaire; Pain; Hypoxia; Gastric Surgery; Obesity; Ketamine

Summary:

      Laparoscopic surgery for gastric reduction is frequently associated with high levels of
      postoperative pain. Postoperative pain is very often treated with opioids. However large
      doses of opioids can result in respiratory depression with hypoxemia especially in high risk
      patients with obstructive sleep apnea. since a large group of patients undergoing surgery for
      gastric reduction surgery also have obstructive sleep apnea, it is expected that these
      patients are also at high risk for postoperative respiratory depression and hypoxemia.

      Intraoperative ketamine has been used as an effective multimodal agent to reduce
      postoperative pain. However, ketamine alone has not been examined to improve postoperative
      pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is
      unknown if the use of intraoperative ketamine can lead to better overall quality of recovery
      in the same patient population. In addition, ketamine has been shown to improve ventilation
      but it remains to be determined if the intraoperative use of ketamine will result in less
      postoperative hypoxemic events.

      The main objective of the current investigation is to examine the effect of intraoperative
      ketamine on postoperative quality of recovery after gastric reduction surgery. The
      investigators hypothesize that subjects receiving ketamine will have a greater global quality
      of recovery score than the ones receiving saline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-64

          -  surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)

          -  ASA physical status classification I, II, III

          -  Body Mass Index >35kg/m2

          -  Fluent in English

        Exclusion Criteria:

          -  History of allergy to protocol medications

          -  History of chronic opioid use

          -  Pregnant patients

          -  Drop out: Conversion to an open surgical route, patient or surgeon request.
Treatment Study of Vitamin D Deficiency in Adolescents
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Vitamin D3
Intervention description: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 13 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adolescents; minority

Summary:

      To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU
      weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of
      vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly
      Hispanic and black adolescents with vitamin D deficiency [25(OH)D level <20 ng/ml] by
      assessing change in 25(OH)D levels before and after 8 weeks of treatment.

      To compare the effects of vitamin D repletion [25(OH)D level >20 ng/mL] on selected
      musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black
      adolescents with vitamin D deficiency [25(OH)D level < 20 ng/mL].

      Hypothesis 1: Increase in vitamin D level will be associated with improvement in
      musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist
      circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 13-20

        Exclusion Criteria:

          -  currently receiving treatment for hypovitaminosis D

          -  hepatic or renal disease

          -  metabolic rickets

          -  inability to complete the questionnaire
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Xalatan; Travatan Z
Intervention description: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime; one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
Intervention MeSH terms: Travoprost; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Masking description: Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.
Enrollment: 58.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: glaucoma; impression cytology; ocular surface changes; prostaglandins

Summary:

      To determine whether one glaucoma eye drop is less likely to cause changes to the surface of
      the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan
      Z.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21 or older

          -  Able to understand protocol and agree to 3 visits

          -  Any type of glaucoma

          -  Selective laser trabeculoplasty, Argon laser trabeculoplasty, peripheral iridotomy
             accepted

          -  Naïve: No prior glaucoma treatment (medical or surgical)

          -  If patient non-compliant, must be off meds 3 months

          -  Xalatan: At least one month use

        Exclusion Criteria:

          -  Both Groups: Any history of ocular surface disease

          -  Dry eye syndrome or prior Restasis use

          -  Prior ocular surgery other than cataract extractions

          -  Uveitis or other inflammatory disease of the eye or adnexa

          -  Systemic medications that might influence ocular inflammation

          -  Any active inflammation or infection

          -  Pregnancy or intention to become pregnant

          -  Naïve: Prior use of topical glaucoma medication unless off for 3 months.

          -  Use of preserved artificial tear preparations in last 30 days and more than one year
             history of chronic use

          -  Xalatan: Prior use of Travatan or Travatan Z
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention description: three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B, Vaccine; Randomized Controlled Trial; HIV; Immunogenicity

Summary:

      Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and
      their immune function and immune response to hepatitis B vaccination were also suboptimal,
      indicating that the current practice of hepatitis B vaccination can't protect HIV-infected
      adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination
      remains a challenge.

      This is a randomized, open-label trial, conducted among HIV-infected adults with drug
      rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of
      three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6
      among HIV-infected adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected

          -  Aged between 18 and 70 years

          -  Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface
             antibody (anti-HBs) at enrollment

          -  Willing to adhere to the study protocol

        Exclusion Criteria:

          -  Being pregnant

          -  Acute cytolysis in the last three months before enrollment

          -  Any vaccination before or during the month preceding enrollment

          -  Any Intolerance or allergy to any component of the vaccine

          -  Ongoing opportunistic infection

          -  Hematological disorder

          -  Cancer

          -  Unexplained fever the week before enrollment

          -  Immunosuppressive or immunomodulating treatment in the last six months

          -  Liver disease
The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Bupivacaine; Morphine; Methylprednisolone; Cefazolin; Normal saline; Midazolam; Propofol; Dexamethasone; 8 MHz. Chiba needle, 22 G / 4 inches
Intervention MeSH terms: Cefazolin; Dexamethasone; Methylprednisolone; Midazolam; Morphine; Bupivacaine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Nerve Block; Rehabilitation; Knee Replacement, Total

Summary:

      Total knee replacement is associated with severe post-operative pain. The purpose of this
      study is to compare two methods of treatment for pain control following Total Knee
      Replacement with an accelerated physical therapy protocol to aid the achievement of rehab
      milestones.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with osteoarthritis scheduled for primary tricompartmental total knee
             arthroplasty with a participating surgeon

          -  Age 18 to 80 years

          -  Planned use of regional anesthesia

          -  Ability to follow study protocol

          -  English speaking (secondary outcomes include questionnaires validated in English only)

        Exclusion Criteria:

        Hepatic or renal insufficiency Patients younger than 18 years old and older than 80
        Patients intending to receive general anesthesia Patients planning to go to rehab post
        operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one
        of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use
        (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3
        months) Diabetes Patients on workers compensation or disability