bioihbjkbjnl/mcl2 huggingface dataset:
The Use of Intranasal Ketoralac for Pain Management (Sprix)
Condition: Postoperative Pain Management; Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi
Intervention: Intranasal Ketoralac; Placebo
Intervention description: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery; 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sprix; Intranasal ketoralac; Ketoralac; Urolithiasis; Kidney stone; Uretal stone; Ureteroscopic removal of stones; URS; Pain management; Pain

Summary:

      Despite an overall reduction in the perioperative complication rate, post operative pain
      management after ureteroscopic removal of stones (URS) remains a major factor delaying
      discharge of patients. The investigators hypothesize that perioperative usage of intranasal
      ketorolac will provide a reduction in post operative opioid requirements, better post
      operative pain control, higher anesthesia satisfaction and faster recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ureteroscopic stone removal surgeries with stenting

          -  Age ≥ 18 years and < 65 years

          -  Stable patient with stable vital signs

          -  Mentally competent and is able to understand consent form

        Exclusion Criteria:

          -  Unstable patients

          -  Patients with multiple trauma sites

          -  Patients with allergies to ketorolac or any of the components in the nasal spray
             preparation

          -  Patients with active peptic ulcer disease

          -  History of asthma, urticaria, or other allergic-type reactions after taking aspirin or
             other NSAIDs

          -  Renal disease or at risk for renal failure due to volume depletion

          -  Pregnant or nursing mothers

          -  Nasal abnormality or illness that could affect the absorption of intranasal medication
             (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute
             epistaxis, nasal polyp, nasal tumor)

          -  Any other contraindication to the use of Sprix, or in whom use of Sprix would not be
             consistent with the approved package insert
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Thromboembolism; Atrial Flutter
Intervention: dabigatran etexilate mesylate
Intervention description: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.
Intervention MeSH terms: Dabigatran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic
      event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of
      dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency
      ablation, or cryoablation procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female sex, age 18-85 years.

          -  Negative pregnancy test for women of childbearing potential

          -  Planned pulmonary vein isolation by antral radiofrequency or cryoablation for
             paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (NVAF),
             or left atrial flutter following prior left atrial ablation procedures

          -  CHADS2 score of 0-6 or CHADS2-VASc score 0-9

          -  Vascular hemostasis within 4-6 hours of sheath pull

          -  Able to give informed consent

        Exclusion Criteria:

          -  Unable to give informed consent

          -  Currently participating in another clinical treatment trial

          -  History of hereditary hemophilias

          -  Presence of active bleeding

          -  End stage renal disease, CrCl<15 mL/min

          -  Prior treatment failure of dabigatran (stroke or systemic thromboembolism while on
             therapeutic dabigatran)

          -  Known allergic reaction to dabigatran etexilate

          -  Intolerance to dabigatran, if medication naïve, or other contra-indications as per the
             USPI.

          -  Pregnancy

          -  History of non-compliance

          -  Inability to follow-up
IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?
Condition: Transplantation, Kidney
Intervention: Optison; Ultrasound (US); Contrast-enhanced ultrasound (CEUS)
Intervention description: A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.; Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help
      evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus
      help direct the biopsy to the most abnormal part of the renal cortex. This should maximize
      detection and increase the odds of demonstrating the true grade/severity of the
      histopathological abnormality.
    

Eligibility criteria:

        Inclusion

          -  Ability to provide informed consent

          -  Male and female >18 years

          -  Patients undergoing renal transplant ultrasound-guided percutaneous biopsy within 24
             months post transplant including patients undergoing biopsy to evaluate a recent rise
             in serum creatinine so called for cause biopsies and patients undergoing routine
             protocol (surveillance) biopsies without other evident of renal dysfunction

        Exclusion:

          -  Pregnant women or women who are nursing an infant are not able to participate in this
             study

          -  Known patent forearm ovale (PFO)

          -  Significant heart disease
Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Condition: Postoperative Delirium; PD; Postoperative Cognitive Dysfunction; POCD
MeSH terms: Delirium; Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: Precedex (Dexmedetomidine); Placebo
Intervention description: Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.; Matching placebo given prior to surgery and continued for 24 hours postoperatively
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 27.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Postoperative delirium; PD; Postoperative cognitive dysfunction; POCD

Summary:

      This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium
      in non-cardiac surgical patients. The preliminary data regarding the effect of
      dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize
      fifty patients into two different protocols, one using dexmedetomidine until PACU discharge
      (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 65 years and older

          -  elective major hip replacement or peripheral vascular (major surgery is defined by a
             planned 2 day hospitalization)

          -  ASA physical status I-III

          -  capable and willing to consent

        Exclusion Criteria:

          -  Cardiac surgery

          -  Intracranial Surgery

          -  Emergency Surgery

          -  Patients with severe visual or auditory disorder/handicaps

          -  Illiteracy

          -  Patients with clinically significant Parkinson's Disease

          -  Patients not expected to be able to complete the 3 month postoperative test

          -  Sick sinus syndrome without pacemaker

          -  Hypersensitivity to drug or class

          -  Current 2nd or 3rd degree AV block

          -  History of clinically significant bradycardia

          -  Contraindication to the use of an 2A-agonist

          -  Presence of a major psychiatric condition such as bipolar disorder, major depression,
             schizophrenia, or dementia

          -  ASA physical status IV or V
Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Nitric Oxide; Prostacyclin
Intervention description: inhaled nitric oxide; inhaled prostacyclin
Intervention MeSH terms: Epoprostenol; Nitric Oxide; Tezosentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart failure; hypertension, pulmonary; heart failure, right-sided; heart-assist devices; Heart Transplantation

Summary:

      Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO)
      and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either
      heart transplant or for left ventricular assist device (LVAD) placement. The investigators
      hope to learn if these two medications, when given together after surgery, improve right
      heart function by lowering blood vessel pressures in the lungs. The investigators hope to
      learn if the combined effects of these two medications are better than either medication used
      alone. Participants were selected as a possible participant in this study because right heart
      problems are common during and after surgery for heart transplant and for LVAD placement. In
      addition, iNO is always given during and after these two types of surgeries at Stanford to
      help improve how the right heart functions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult cardiac surgical patients scheduled to undergo either heart transplantation or
             LVAD placement

        Exclusion Criteria:

          -  Patients with prior documented allergic reactions or intolerance to either nitric
             oxide or prostacyclin will be excluded. Patients not undergoing heart transplantation
             or LVAD placement will be excluded.
Best Management of Muscle Relaxation- Objective Monitoring
Condition: Residual Paralysis, Post Anesthesia
MeSH terms: Paralysis; Delayed Emergence from Anesthesia
Intervention: Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex
Intervention description: The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
Intervention MeSH terms: Rocuronium; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that the investigators can reduce residual
      paralysis to a very low incidence, and that the investigators can do this while preserving a
      role for the older and less expensive reversal agent neostigmine. The investigators consider
      this an evidence-based approach because previous reports clearly indicate that neostigmine is
      effective for reversal of the most shallow neuromuscular blocks, a level of block now
      referred to as minimal block. The Investigators also know from previous data that a
      substantial proportion of patients have minimal block. Sugammadex will be used when the block
      to be reversed is deeper than minimal, specifically when the objectively measured TOF-ratio
      is <40%.

      The investigators hypothesize that this protocol will be associated with an incidence of
      residual paralysis of less than 3%. The investigators plan is to study 200 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are 18 years or older

          -  Undergoing surgery expected to last less than 6 hours at HMC or UWMC

          -  Have ASA physical status I-III

          -  Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for
             endotracheal intubation or intraoperative neuromuscular block (NMB)

        Exclusion Criteria:

          -  Allergy to NMBDs, neostigmine, or sugammadex

          -  Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)

          -  Pregnant or lactating women

          -  Non English speaking

          -  Unable to provide informed consent

          -  Severe renal failure with eGFR less than 20 ml/min
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Condition: End Stage Heart Disease; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis; Heart Diseases
Intervention: Clinically prescribed direct acting antiviral
Intervention description: HCV treatment for 12 weeks
Intervention MeSH terms: Antiviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Received heart transplant from HCV+ donor
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Disease; Heart Transplant; HCV; Hepatitis C

Summary:

      This is a proof of concept, single center study for the donation of HCV-positive hearts to
      HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of
      commercially available DAA therapy to prevent HCV transmission upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient is Age ≥ 18 years

          -  Serum ALT within normal limits with no history of liver disease

          -  Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high
             likelihood of needing aggressive immunosuppression to treat rejection

        Exclusion Criteria:

          -  Sensitization (i.e. PRA >20%)

          -  Any liver disease in recipient

          -  Albumin < 3g/dl or platelet count < 75 x 103/mL

          -  Need for dual organ transplant
Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery
Condition: Anesthesia, Pediatrics, Surgery
MeSH terms: Postoperative Nausea and Vomiting
Intervention: regional nerve block; Antiemetic
Intervention description: regional nerve block; Antiemetic
Intervention MeSH terms: Dexamethasone; Ondansetron; Antiemetics; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 37.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: post operative nausea vomiting; Inner ear surgery

Summary:

      The investigators would like to compare the therapeutic and cost effectiveness of established
      therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck
      area an intervention known for analgesia but for which the antiemetic effects hasn't been
      entirely explored.

      The rational is based on the knowledge of the anatomical innervation of the inner ear and the
      role of the parasympathetic nervous system in the emetic act. A lot of focus has been given
      on its counterpart the sympathetic nervous system and its role in painful conditions. The
      investigators believe that the nerve blockade of the parasympathetic innervation can have
      some beneficial effect in the post-surgical patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient Age 1-18 yo

          -  Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery

          -  Past history of PONV susceptibility

        Exclusion Criteria:

          -  Patient/ Parents refusal

          -  Infection at the site of local anesthetic injection

          -  Known coagulopathy

          -  Existing VP shunt

          -  Severe mental disability

          -  Any known allergic to dexamethasone (Decadron) and/or ondansetron ( Zofran)
Aspirin and Enoxaparin for VTE in Trauma
Condition: Venous Thromboembolism; Thromboprophylaxis; Trauma
MeSH terms: Thromboembolism; Venous Thromboembolism; Wounds and Injuries
Intervention: Aspirin; Enoxaparin
Intervention description: Daily dose is 81 mg oral tablet; Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.
Intervention MeSH terms: Aspirin; Enoxaparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aspirin; Enoxaparin; Thromboprophylaxis; Trauma; Venous thromboembolism

Summary:

      The purpose of this study is to determine if the addition of antiplatelet therapy (i.e.
      aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of
      venous thromboembolism (VTE) in high-risk critically injured patients. The investigators
      further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and
      enoxaparin for decreasing the incidence of VTE after trauma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Blunt or penetrating trauma

          -  Requires VTE thromboprophylaxis

          -  High-risk for VTE

        Exclusion Criteria:

          -  Presence of VTE upon admission

          -  Pregnant or nursing

          -  Inability to give informed consent by patient or healthcare proxy

          -  Contraindication to enoxaparin

          -  Contraindication to aspirin

          -  Epidural or subdural hematoma

          -  Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or
             recent (within the last 12 hours) epidural or spinal anesthesia/procedures
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Condition: Pain; Pain, Acute; Anesthesia
MeSH terms: Acute Pain
Intervention: Sublingual Sufentanil; IV Fentanyl
Intervention description: 30 mcg of sublingual sufentanil; 50 mcg of IV fentanyl
Intervention MeSH terms: Fentanyl; Sufentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a single dose of sublingual sufentanil is as or
      more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing outpatient ambulatory surgery

          -  recipient of general anesthesia

          -  pain score of 4 or greater in the PACU

        Exclusion Criteria:

          -  non-english speaking patients

          -  cancer surgeries

          -  patients who have allergy or intolerance to the study drugs or derivatives

          -  patients on chronic opioids (defined as daily opioids for 3 months or longer)
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Condition: Hospitalization; Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Chlorhexidine gluconate (CHG); Iodophor (10% povidone-iodine)
Intervention description: 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.; Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13952.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nursing Homes; Health Facilities; Infections; Readmissions; Multi-Drug resistance; Antibiotic Use

Summary:

      This is a cluster-randomized trial of nursing homes to assess whether decolonization with
      routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce
      hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant
      organism (MDRO) prevalence. The comparator arm will be routine bathing care.
    

Eligibility criteria:

        Inclusion Criteria

        Nursing homes will be eligible to participate if they meet the following criteria:

          -  Licensed nursing home in Orange County or Southern Los Angeles County serving adults

          -  Minimal use of chlorhexidine bathing*

          -  Minimal use of nasal decolonization* *Minimal use defined as <15% of residents
             receiving at least one chlorhexidine bath or nasal decolonization treatment during
             their nursing home stay.

        Exclusion Criteria

        Nursing homes will not be eligible to participate if they meet the following criteria:

          -  Facilities routinely using decolonization

          -  Dedicated psychiatric nursing homes

          -  Facilities with a resident population with >=20% combative patients

          -  Pediatric facilities

        Note: in any participating nursing home, residents with active end-of-life comfort care
        only measures are excluded