bioihbjkbjnl/mcl2 huggingface dataset:
Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery
Condition: Delirium
MeSH terms: Delirium; Emergence Delirium
Intervention: IV acetaminophen & IV propofol; IV acetaminophen & IV dexmedetomidine; IV propofol & placebo; IV dexmedetomidine & placebo
Intervention description: use of IV tylenol and IV propofol for pain and sedation (respectively); use of IV tylenol and IV dexmedetomidine for pain and sedation (respectively); use of IV propofol for sedation and morphine, the drug of choice for cardiac pain; use of IV dexmedetomidine for sedation and morphine, the drug of choice for cardiac pain
Intervention MeSH terms: Acetaminophen; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: analgesics; cardiac surgery; sedation

Summary:

      Investigators will assess the incidence and duration of postoperative delirium in patients
      ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery
      (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia.
      Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or
      standard postoperative management using IV propofol with morphine or hydromorphone. The
      Confusion Assessment Method (CAM) will be used to assess delirium in these patients.
      Investigators also seek to compare postoperative (48 hours) analgesic requirements in
      patients with or without IV acetaminophen. Investigators will finally assess postoperative
      cognition in post-surgical patients up to one year post-discharge using a cognitive
      assessment scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 60 years of age

          -  Undergoing CABG with/without valve (aortic and/or mitral) procedure requiring bypass

        Exclusion Criteria:

          -  Pre-operative Left Ventricular Ejection Fraction (LVEF) < 30%

          -  Emergent or urgent procedures, aortic surgery

          -  Pre-existing cognitive impairment (defined based on a short screening assessment),
             Parkinson's disease, Alzheimer's disease, recent seizures (<3 months)

          -  Prophylactic medications for cognitive decline

          -  Serum creatinine > 2 mg/dl

          -  Liver dysfunction (liver enzymes > 4x the baseline, since patients will have a
             baseline liver function tests), history and exam suggestive of jaundice

          -  Known history of alcohol or drug abuse (>10 drinks per week)

          -  Hypersensitivity to any of the study drug and percutaneous procedures

          -  Non-English speaking
Perineural Steroids for Peripheral Nerve Blocks
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: Dexamethasone; Bupivacaine; Epinephrine; Saphenous Peripheral Nerve Block
Intervention description: Used in nerve block mixture; Used in nerve block mixture; Used in nerve block mixture; Peripheral nerve block.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Epinephrine; Bupivacaine; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anesthesia; Anesthesia, Conduction; Anesthesia, Local; Bupivacaine; Dexamethasone; Saphenous; Adductor Canal; Nerve Block; Analgesia; Preanesthetic Medication; Perioperative Period; Peripheral Nerve Block

Summary:

      This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve
      blocks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  elective robotic medial MAKO partial knee arthroplasty

          -  agreed to a regional anesthesia technique

        Exclusion Criteria:

          -  contraindications to regional anesthesia

          -  presence of a progressive neurological deficit

          -  a pre-existing coagulopathy, infection

          -  insulin and non-insulin dependent diabetes mellitus

          -  systemic use of corticosteroids within 30 days of surgery

          -  chronic use of an opioid analgesic (>3 months or a combined total of more than 40 mg
             Oxycodone equivalents a day)

          -  pregnancy

          -  a prior history of an adverse event (for example: psychosis) or an allergy to
             dexamethasone
Examining the Effect of Burosumab on Muscle Function
Condition: X-linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Intervention: Burosumab Injection [Crysvita]
Intervention description: Burosumab/Crysvita SC injection monthly
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Crysvita; Burosumab

Summary:

      Patients with X-linked hypophosphatemia (XLH) often report symptoms of fatigue and weakness
      particularly after exertion, in addition to their skeletal complaints. In previous trials
      using KRN23 (same drug as burosumab/Crysvita®), patients report these symptoms improve. The
      investigators wish to test this hypothesis directly by measuring muscle energy when patients
      begin treatment with Crysvita® for the first time.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-65 years of age

          2. Diagnosis of XLH

          3. eGFR ≥ 50 (estimated glomerular filtration rate)

          4. Normal serum calcium

          5. Phosphate ≤ 2.5 mg/dl

          6. Deemed clinically appropriate for starting therapy with Burosumab/Crysvita® (based on
             the treating physician's evaluation)

          7. Deemed appropriate for MR Spectroscopy

        Exclusion Criteria:

          1. Patients with fixed skeletal abnormalities which would prevent them from successfully
             completing study-related functional assessments

          2. Patients unwilling to stop therapy with supplemental phosphate and calcitriol 2 weeks
             prior to enrollment.

          3. Patients who have undergone an orthopaedic procedure within the previous 6 months
             involving implantation of metal hardware
Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: liposomal bupivacaine; Bupivacaine
Intervention description: Experimental; Active Comparator
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare pain control after arthroscopic rotator cuff repair
      surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene
      block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these
      types of surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients aged greater than 18 years of age that are undergoing arthroscopic
             rotator cuff surgery

        Exclusion Criteria:

          -  Patients with allergy to local anesthetics

          -  Patients with daily use of opioids for more than 3 weeks prior to surgery

          -  Patients who refuse

          -  Patients with coagulopathy

          -  Patients who are non-english speaking

          -  Patients who do not have access to a telephone
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Lucentis
Intervention description: 0.3mg Lucentis
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The protocol will measure a number of cytokines in addition to vascular endothelial growth
      factor in response to 0.3mg Lucentis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetes mellitus

          -  Best corrected visual acuity 20/32 - 20/320

          -  Diabetic macular edema involving the center of the macula

          -  Optical coherence tomography central subfield thickness of at least 250 microns

        Exclusion Criteria:

          -  History of anti-vascular endothelial growth factor treatment in the past 12 months

          -  Any diabetic macular edema treatment in the past 4 months

          -  Heart attack, stroke, transient ischemic attack or acute congestive heart failure
             within 4 months
Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus
Condition: Parkinson's Disease; Deep Brain Stimulation Surgery
MeSH terms: Parkinson Disease
Intervention: Dexmedetomidine
Intervention description: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: SubThalamic Nucleus; Microelectrode recording; Deep Brain Stimulation Electrode implantation

Summary:

      The purpose of this research study is to find out whether dexmedetomidine changes brain cell
      activity in the subthalamic nucleus (STN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo bilateral STN electrode implantation surgery with
             Micro-electrode recording for the treatment of Parkinson's disease.

        Exclusion Criteria:

          -  Hypersensitivity to dexmedetomidine

          -  Bradycardia: Sinus rhythm slower than 50 bpm

          -  Known or suspected obstructive sleep apnea

          -  Suspected difficult intubation

          -  Pregnancy

          -  Under 18 years of age or over 85 years of age

          -  Cognitive disability impairing understanding the experiment or signing the informed
             consent form
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Placebo; Adalimumab
Intervention description: Subcutaneous injections administered as described in arm description; Subcutaneous injections administered as described in arm description
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa; Axilla; Inguinal region; Hurley Stage I, II, or III; Adalimumab; Secondary intention; Abcess and inflammatory nodule (AN) count

Summary:

      The objective of this study was to assess the safety and efficacy of adalimumab prior to
      surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were
      surgical candidates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa
             (HS) for at least 1 year (365 days) prior to the Baseline visit

          -  Participant must have at least 3 distinct anatomical regions involved with
             inflammatory (also termed 'active') HS lesions; plus

               -  either one axilla or one inguinal region (limited to the inguino-crural fold and
                  adjacent areas) that requires excisional surgery, and

               -  with at least one of the other affected HS regions (e.g., contralateral inguinal
                  region, buttocks, inframammary region) rated as Hurley Stage II or III

          -  Participant must have a total abscess and inflammatory nodule (AN) count of greater
             than or equal to 3 at the Baseline visit within the HS non-surgical sites

          -  The HS surgical site must contain at least one active HS lesion

          -  The HS surgical site must require excisional surgery and is large enough to require
             healing by secondary intention as assessed by the designated surgeon

        Exclusion Criteria:

          -  Participant has a draining fistula count of greater than 20 at the Baseline visit

          -  Participant requires surgery at any anatomical site other than an unilateral axilla or
             inguinal region site

          -  Participant requires surgical management prior to Week 13

          -  Participant requires, based on the designated surgeon's assessment, excisional surgery
             with primary closure as the method of closure being most beneficial for the
             participant
Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)
Condition: Aortic Stenosis; Inflammation; Thrombosis
MeSH terms: Thrombosis; Aortic Valve Stenosis; Inflammation; Constriction, Pathologic
Intervention: Clopidogrel; Ticagrelor
Intervention description: Standard ADP receptor blockade; High potency ADP receptor blockade
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The central hypothesis of this study is that TAVR leads to platelet deposition and
      inflammatory cell activation that can be attenuated by the potent anti-platelet and/or
      pleiotropic effects of ticagrelor.

      This single center, prospective randomized trial addresses the following specific aims:

        1. To determine whether high-potency ADP receptor blockade reduces measures of platelet
           activation in patients after TAVR.

        2. To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic
           inflammatory response observed after TAVR.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Valvular heart disease and a clinical indication for TAVR

          2. Age of 18 years or older

          3. Capable of informed consent

          4. Planned transfemoral TAVR

        Exclusion Criteria:

          1. Prior history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage

          2. Established bleeding diathesis or thrombocytopenia (<150k/dl)

          3. End-stage renal disease

          4. Severe hepatic impairment or liver cirrhosis

          5. Pregnancy

          6. Current infection

          7. History of autoimmune disease

          8. Established allergy to contrast agents, thienopyridines, aspirin, or ticagrelor

          9. History of solid organ transplantation

         10. Atrial Fibrillation, DVT, PE or other indication for long term anti-coagulation

         11. Plan for direct aortic access or trans-apical TAVR

         12. Enrollment in another clinical trial

         13. Recent (< 12 months) or active excessive bleeding
Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation
Condition: Liver Transplantation
Intervention: Basiliximab; Tacrolimus; Tacrolimus; Mycophenolic Acid
Intervention description: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4; Day #7 post-transplant or when serum creatinine (SCr) < 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL; Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL; Enteric coated mycophenolic acid 360-720 mg po bid
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Simulect; Myfortic; Orthotopic liver transplantation (OLT); Renal Dysfunction

Summary:

      This is an investigator initiated study at the University of California, Los Angeles (UCLA)
      funded by Novartis looking at using a combination of immunosuppressive drugs in liver
      transplant patients that are at risk of developing kidney problems. Kidney problems following
      liver transplants is the most problematic issue facing liver transplant patients today.

      This study will generate information in this area of high unmet medical need utilizing
      basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard
      of care medications, after kidney function has normalized.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients eligible for inclusion in this study have to fulfill all of the following
        criteria:

          -  >18 years old

          -  Undergoing first or second OLT

          -  MELD (model for end-stage liver disease) score >25

          -  Serum creatinine > 1.5 or ongoing hemodialysis for less than 4 weeks at the time of
             transplant

          -  Able and agreeable to conform to requirements of the study

          -  Patients or proxy must give written informed consent before any assessment is
             performed.

        Exclusion Criteria:

          -  <18 years old

          -  Serum creatinine <1.5

          -  MELD Score < 25

          -  Ongoing hemodialysis for 4 or more weeks (those patients become eligible for renal
             transplants at that point per UCLA practice).

          -  Receiving OKT3 (Muromonab-CD3), ATG (Antithymocyte Globulin), or IVIG (Intravenous
             Immunoglobulin Therapy) therapy around time of transplant

          -  Participating in another clinical research study involving the evaluation of another
             investigational drug or device

          -  Prior documented allergy to any of the study medications

          -  Active Fungal infection
Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
Condition: Pain, Acute
MeSH terms: Acute Pain
Intervention: Bupivacaine; Fentanyl
Intervention MeSH terms: Fentanyl; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior
      studies in labor epidurals have demonstrated that a programmed intermittent bolus application
      of local anesthesia can improve pain control by reducing the amount of local anesthetic
      required as well as improve patient satisfaction when compared to continuous epidural
      infusions. The effects of programmed intermittent bolus of epidural local anesthetics
      compared to continuous epidural infusions in a surgical setting have yet to be elucidated.
      Our goal is to evaluate the use of programmed intermittent bolus compared to continuous
      epidural infusion in a surgical patient population. We plan to enroll patients already
      undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology,
      urological where epidural anesthesia can be employed. The primary endpoints of the study will
      be the total local anesthetic consumption and total opioid consumption as surrogate markers
      for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional
      measurements, patient satisfaction, and incidence of hypotension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesia physical classification I - III, scheduled for surgery
             with anticipated an epidural anesthesia (including but not limited to colorectal,
             surgical oncology, urology, gynecology) as part of their perioperative treatment

        Exclusion Criteria:

          -  Age younger than 18 years of age, non-English speaking, contraindication for neuraxial
             anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to
             local anesthetic), preexisting neurologic deficits, inability to consent due to
             cognitive dysfunction, patients with pain numeric rating score > 5 each day for
             greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14
             consecutive days prior to surgery, patient refusal.
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Condition: Helicobacter Pylori Infection
MeSH terms: Infections
Intervention: Amoxicillin; Omeprazole; Clarithromycin
Intervention description: 1 g; 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.; 500 mg twice daily
Intervention MeSH terms: Amoxicillin; Clarithromycin; Omeprazole
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
Healthy volunteers: No
Keywords: high-dose dual therapy; standard triple therapy; helicobacter pylori eradication; clarithromycin resistance

Summary:

      A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high
      dose dual therapy vs standard triple therapy in a diverse, urban New York City population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Treatment-naïve

          -  Clinical diagnosis of helicobacter pylori infection based on urea breath test,
             endoscopy or stool antigen test

          -  Subject willing to participate and able to provide informed consent.

        Exclusion Criteria:

          -  Prior helicobacter pylori treatment failure

          -  Antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis

          -  Pregnancy or breastfeeding

          -  Penicillin allergy

          -  History of active or non-gastric malignancy

          -  Severe illness requiring hospitalization during treatment period

          -  Starting additional antibiotic while on treatment