bioihbjkbjnl/mcl2 huggingface dataset:
Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Liposomal Bupivacaine; 0.5% Bupivacaine HCL
Intervention description: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL; 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Total Shoulder Arthroplasty (TSA); Interscalene Nerve Block (ISB)

Summary:

      This is a phase IV , randomized, single-blind, single-center study comparing patient related
      outcomes such as postoperative pain and opioid usage for patients who receive ISB 's
      containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine
      HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid
      utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5%
      bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to
      understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene
      block after TSA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing total shoulder arthroplasty;

          -  Patients who consent to be randomized.

        Exclusion Criteria:

          -  Patients younger than 18 and older than 75;

          -  Patients with a history of chronic pain that have used opioids for pain management for
             3 months or longer;

          -  Patients who are allergic to oxycodone;

          -  Patients who are unable to speak English;

          -  Patients with diagnosed or self---reported cognitive dysfunction;

          -  Patients with a history of neurologic disorder that can interfere with pain sensation;

          -  Patients with a history of drug or recorded alcohol abuse;

          -  Patients who are unable to understand or follow instructions;

          -  Patients with severe liver disease, renal insufficiency, congestive heart failure,
             and/or significant heart disease;

          -  Patients with an allergy or contraindication to any of the medications used in the
             study, or patients with a contraindication to any study procedures;

          -  Patients with BMI over 40;

          -  Any patient that the investigators feel cannot comply with all study related
             procedures;

          -  NYU Langone Health students, residents, faculty or staff members
Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
Condition: Pruritus; Nausea/Vomiting
MeSH terms: Pruritus; Vomiting
Intervention: Ondansetron; Placebo Comparator
Intervention description: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.; This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blinded, placebo-controlled trial of ondansetron to prevent pruritus in children who receive intrathecal morphine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study drug (ondansetron/placebo) will be masked for all but the pharmacist
Enrollment: 46.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: intrathecal morphine

Summary:

      This is a prospective randomized, double-blind, placebo-controlled study to compare the
      incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV
      ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group,
      where pruritus and PONV are treated with PRN only medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  3-17 years

          -  weight </= 100kg

          -  scheduled for urologic or orthopedic procedure necessitating intrathecal morphine

          -  ability to use verbal or pictorial pain assessment tools and techniques

          -  informed consent and (if applicable) assent

        Exclusion Criteria:

          -  Inability to use verbal or pictorial pain scoring scales

          -  hypersensitivity to selective 5-HT receptor antagonists

          -  diagnosed congenital long QT syndrome

          -  severe hepatic impairment

          -  pregnancy or nursing mothers
BK Treatment Study
Condition: BK Viremia
MeSH terms: Viremia
Intervention: levofloxacin; placebo
Intervention description: 500 mg tablet, daily, 30 days; no dose, tablet, daily, 30 days
Intervention MeSH terms: Levofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BK viremia; kidney transplantation; BK viremia in kidney transplant recipients

Summary:

      Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients
      with persistent viremia (BK virus found in blood) will impair progress to BK virus induced
      kidney damage by significantly decreasing or eliminating BK virus in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Living and cadaveric kidney transplant recipients over the age of 18 years with BK
             viremia

        Exclusion Criteria:

          -  Female patients of childbearing age who are pregnant or in whom adequate contraception
             cannot be maintained.

          -  Patients with active infections, history of malignancy/Posttransplant
             Lymphoproliferative Disease (PTLD) serologic positivity to HIV.

          -  Patients with evidence of urinary tract obstruction causing allograft dysfunction,
             unless corrected by time of enrollment.

          -  Patients with clinical or morphological evidence of recurrence of primary disease.

          -  Patients with a history of allergic reaction to quinolone antibiotics.

          -  Patients with history of prolong QT interval

          -  Patients with recurrent hypoglycemic episodes

          -  Patients with history of myasthenia gravis

          -  Patients taking Thioridazine
Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients
Condition: COVID, Coronavirus
MeSH terms: Coronavirus Infections
Intervention: Hyperbaric Oxygen Therapy
Intervention description: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a prospective randomized controlled, double blind clinical trial performed on
      laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The
      trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or
      Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the
      standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and
      others.

      The evaluation procedure includes symptom monitoring, room air saturation, vital signs
      monitoring, pulmonary function and blood tests at baseline, one day and one week after the
      last session. In addition, one hour prior to and post session saturation and vitals will be
      monitored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Within 7 days of patient's need of oxygen supply

          -  Positive SARS-CoV-2 RT-PCR

          -  At least one risk factor for bad prognosis of COVID-19: hypertension, diabetes
             mellitus, ischemic heart disease, smoking, age>50, etc.

          -  Respiratory insufficiency: Room Air SpO2 <94% or PaO2/FiO2<300mmHg

          -  Age>18

          -  Ability to sign an informed consent

        Exclusion Criteria:

          -  Negative SARS-CoV-2 RT-PCR

          -  HBOT contraindication: pneumothorax, pneumomediastinum, claustrophobia, ear/sinus
             disease which aren't allowed in HBOT, known chronic pulmonary disease: severe
             emphysema or known pulmonary bullae.

          -  Pregnancy

          -  Inability to sign an informed consent
Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia
Condition: Myringotomy
MeSH terms: Psychomotor Agitation; Emergence Delirium
Intervention: Dexmedetomidine
Intervention description: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).
All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Emergence Agitation; Myringotomy; Children; General Anesthesia

Summary:

      The investigators are inviting your child to participate in this research study because your
      child is having myringotomy (putting a tiny incision in the eardrum with or without tube
      insertion) under general anesthesia.

      The purpose of this study is to determine whether a single injection of Dexmedetomidine
      (study medication) decreases the frequency of awaking from anesthesia frightened or agitated
      in children having myringotomy surgery as compared to those children who receive placebo
      (sterile saltwater).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I or II (American Society of Anesthesiology classification ASA I means patients
             without systemic disease, ASA II means patients with one controlled systemic medical
             disease eg: Diabetes, Hypertension.)

          -  Between the ages of 1 and 10 years

          -  Undergoing BMT under general anesthesia.

        Exclusion Criteria:

          -  ASA III or higher (Patients with 2 or more medical systemic disease that is not under
             control, eg: uncontrolled Diabetes)

          -  Congenital diseases

          -  Coagulation disorders

          -  Known allergic reaction to dexmedetomidine

          -  Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal,
             neurological or endocrine functions

          -  Severe upper airway infection

          -  Predicted difficult airway

          -  Preexisting psychiatric disorders
Chronotherapy in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Evening Group; Morning Group
Intervention description: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.; Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of two groups: Evening Time or Morning Time. Participants are used as their own control. The evening time group will take their medication in the evening and the morning time group will take the medication in the morning.
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel
      Disease (IBD) medication and disease outcomes when taken in the morning or in the evening.
      The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team
      believes that there may be a benefit to taking the medication at a certain time of day. To
      test this theory the study asks participants who are already taking either azathioprine or
      6-mercaptopurine for IBD to take the medication consistently at either the morning or in the
      evening based on when they currently take their medication. Participation is up to 10 weeks
      +/- 3 days. There will be 2 study visits where the participant will be asked to fill in
      questionnaires related to their IBD symptoms, their sleep habits, sleep quality, and general
      health information followed by a blood draw.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Above the ages of 18

          -  Diagnosis of Crohn's Disease or Ulcerative Colitis

          -  Currently taking azathioprine or 6-mercaptopurine

          -  Willing to sign study consent form

        Exclusion Criteria:

          -  Vulnerable population (pregnant, prisoner, non-English speaking or cognitively
             impaired)

          -  Breastfeeding subject

          -  Have a history of complications related to immunomodulatory therapy

          -  Participating in other research studies involving research interventions

          -  Treated with dual corticosteroid and immunomodulatory therapy
A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Intervention: LUM/IVA; activated smart device; de-activated smart device
Intervention description: LUM 400 mg q12h/IVA 250 mg q12h through Week 48.
Intervention MeSH terms: Ivacaftor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The study will evaluate the impact of smart adherence technology for monitoring on
      lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with
      Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane
      Conductance Regulator (CFTR) mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject (or his or her legally appointed and authorized representative) will sign and
             date an informed consent form (ICF).

          -  Willing and able to comply with scheduled visits, treatment plan, study restrictions,
             laboratory tests, contraceptive guidelines, and other study procedures.

          -  Confirmed diagnosis of CF and homozygous for the F508del-CFTR mutation

          -  Forced Expiratory Volume in one second/forced vital capacity (FEV1) ≥40% of predicted
             normal for age, sex, and height

        Exclusion Criteria:

          -  Presence of moderate or severe hepatic impairment (Child-Pugh Class B or C)

          -  Subjects currently receiving invasive mechanical ventilation

          -  Known history of alcohol or drug abuse in the past year

          -  Clinically significant abnormal laboratory values during screening

          -  Pregnant or nursing females

          -  Female subjects and female partners of male subjects who plan to become pregnant
             during Treatment Period or within 90 days following the last dose of study drug

          -  History of solid organ or hematological transplantation

          -  Ongoing or prior participation in an investigational drug study within 30 days of
             screening

          -  Current use of commercial LUM/IVA combination therapy
Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery
Condition: Neuromuscular Blockade; Surgery; Anesthesia; Spinal Diseases
MeSH terms: Spinal Diseases
Intervention: sufficient dose of rocuronium; sugammadex 10 min after position change
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Neuromuscular blockade; Surgical rating scale; Rocuronium; Sugammadex; Spinal surgery; General anesthesia

Summary:

      The investigators aim to investigate operating conditions, postoperative recovery and overall
      satisfaction of surgeons between deep neuromuscular blockade (NMB) group and restricted NMB
      group during spinal surgery under general anesthesia. The investigators hypothesize that this
      study can present good surgical conditions, postoperative recovery outcomes and overall
      satisfaction of surgeons in deep NMB group, thereby proving the advantages of deep NMB as
      well as flaws of restricted NMB in spine surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) physical status I-II adult patients
             scheduled for elective spinal (cervical or lumbar) surgery under general anesthesia

        Exclusion Criteria:

          -  Pregnancy

          -  Present medication known to interfere with neuromuscular blockade

          -  Diseases affecting neuromuscular transmission

          -  History of hypersensitivity on rocuronium or sugammadex

          -  Emergent spinal surgery

          -  Spinal surgeries which have lesions more than 3 spinal levels

          -  Spinal surgeries which have duration less than 1 hour

          -  Spinal surgeries which are not performed under prone position

          -  Spinal surgeries which are not performed under total intravenous anesthesia (TIVA).

          -  Patients who will have hemodynamic instability (mean blood pressure increase or fall
             of > 30% from baseline lasting for more than 5 min) during surgery

          -  Patients who will have blood loss > 1 L during surgery

          -  MEP monitored spinal surgeries
Lipids of the Human Tear Film and Their Effect on Tear Stability
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: doxycycline; azithromycin
Intervention description: Oral doxycycline 100mg bid; topical 1% azithromycin daily to eye
Intervention MeSH terms: Azithromycin; Doxycycline; Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meibomian gland dysfunction; Lid margin disease; doxycycline; azithromycin; essential fatty acid

Summary:

      This prospective, randomized, comparative clinical trial evaluates the effect of either oral
      doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of
      the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meibomian gland dysfunction

        Exclusion Criteria:

          -  Lid margin scarring; herpetic blepharitis
Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Intervention description: the effects of the drug on the colon preparation for colonoscopy
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Miralax with gatorade and dulcolax; Movi pre; Patient satisfaction and efficacy

Summary:

      This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade
      versus Movi Prep for outpatient colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  outpatient colonoscopy for screening for other Gi related problems

        Exclusion Criteria:

          -  Severe Congestive Heart Failure (CHF),

          -  Chronic Kidney Disease (CKD),

          -  less than age 18 or more than 80 years