bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI
Condition: Spinal Cord Injuries; Neuropathic Pain
MeSH terms: Spinal Cord Injuries; Neuralgia
Intervention: Gabapentin; No gabapentin
Intervention description: Timing of gabapentin initiation; No gabapentin
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: neuropathic pain; spinal cord injury

Summary:

      Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a
      significant negative effect on quality of life. Efficacy of various treatments, however,
      remains controversial. There is evidence to support that gabapentin and pregabalin have some
      benefit in reducing neuropathic pain. Gabapentin is effective in the management of symptoms
      and concerns related to SCI including motor recovery, spasticity, and mood among others. This
      makes gabapentin an important pharmacologic intervention, which compels providers to define
      treatment guidelines related to its use. One aspect of which should relate to the timing of
      initiation of therapy. The goal of this study is to determine whether timing of initiation of
      treatment with gabapentin will decrease prevalence and intensity of neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of acute spinal cord injury

          2. Admission to acute inpatient rehabilitation

        Exclusion Criteria:

          1. Unable to communicate verbally or by writing, unable to follow basic instructions, or
             unable to answer questions regarding their symptoms
Dexmedetomidine in Pediatric Tonsillectomy
Condition: Pediatric Adenotonsillectomy; Post Operative Analgesia
Intervention: Dexmedetomidine 0.75 mcg/kg; Morphine 50 mcg/kg; Morphine 100 mcg/kg; Dexmedetomidine 1 mcg/kg
Intervention description: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.; Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia; Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia; Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
Intervention MeSH terms: Dexmedetomidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 109.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adenotonsillectomy; Postoperative analgesia; Pediatrics

Summary:

      The hypothesis of this study is that the administration of an intra-operative dose of
      dexmedetomidine will result in adequate analgesia without respiratory depression thereby
      resulting in an early discharge from the post anesthetic care unit following
      adenotonsillectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between ages 3 and 17 years with American Society of Anesthesiology
             classification 1 or 2.

        Exclusion Criteria:

          -  Children less than 3 years

          -  Children with uncorrected cardiac lesions

          -  Children with heart block or liver impairment

          -  Children with American Society of Anesthesiology Class 3 or 4.
Olanzapine for Acute Headaches
Condition: Headache
MeSH terms: Headache
Intervention: Standard of Care as per attending physician; 5mg rapidly dissolving olanzapine
Intervention description: Patients are randomized to standard of care medication (as determined by attending physician); 5mg rapidly dissolving olanzapine
Intervention MeSH terms: Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.
Masking: None (Open Label)
Masking description: Open label, not blinded, randomized 2-arm trial
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is a prospective, randomized, feasibility trial with the primary aim of comparing
      how well oral rapidly dissolving olanzapine controls primary headache pain when compared to
      the current treatment strategies used in emergency departments which often require
      intravenous or intramuscular medications.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patient between 18-65 years of age presenting to the emergency department with
             acute primary headache

          2. Patient approved for inclusion by primary attending physician in the emergency
             department

        Exclusion Criteria:

          1. Age < 18 or > 65

          2. Pregnancy

          3. Known allergy to olanzapine

          4. Known QT prolongation or underlying condition that places patient at risk for QT
             prolongation

          5. Inability to give written consent (intoxication, altered mental status)

          6. Headache of organic origin (trauma, infection, previous recent head or neck surgery)

          7. Patient already prescribed daily olanzapine on an outpatient basis

          8. Patient has been administered olanzapine within the past 24 hours

          9. Language barrier
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
Condition: Ventricular Arrhythmias
MeSH terms: Arrhythmias, Cardiac
Intervention: spironolactone; placebo
Intervention description: aldosterone blocker; identical in appearance to spironolactone study drug
Intervention MeSH terms: Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a prospective, double-blind, randomized trial that assigned patients to receive either spironolactone 25 mg/day or a placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All participants, providers, investigators, and outcome assessors were blinded to treatment assignment. The pharmacy maintained a key to randomization that was not broken until the study was completed and all outcomes had been assessed.
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-Arrhythmia Agents; Ventricular Fibrillation; Ventricular Tachycardia; Defibrillators, Implantable

Summary:

      This study will test whether spironolactone, an approved drug for among other things
      hypertension, will reduce the risk of severe arrhythmias in patients with implanted
      defibrillators. Half the patients in the study will get spironolactone and half will get a
      placebo. Neither the patients or their providers will know if they are getting spironolactone
      or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        -Patients were considered eligible for enrollment only if they had received

          -  an ICD therapy, either a shock or antitachycardia pacing (ATP),

          -  VT/VF in the previous 2 years or

          -  received an ICD for secondary prevention of sustained VT/VF in the previous 6 months.

        Exclusion Criteria:

        -Important exclusion criteria were

          -  an indication for spironolactone based on the RALES trial (EF of <35% and -New York
             Heart Association (NYHA) class III or IV),

          -  unstable angina,

          -  primary hepatic failure,

          -  known intolerance to spironolactone,

          -  a serum creatinine concentration of >2.5 mg/dL,

          -  a serum potassium concentration of >5.0 mmol/L, and

          -  a life expectancy of <2 years.
Using Clonidine to Improve Leg Weakness in People With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Clonidine Patch; Matching Placebo Patch
Intervention description: A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.; A matching placebo patch to be worn for a period of 3 months.
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Leg Weakness; Skeletal Myopathy; Sympathetic Nerve Activity

Summary:

      People with heart failure often have weakness in their leg muscles. This study will determine
      whether the leg weakness is due to very high adrenaline levels and whether the medication
      clonidine can improve leg weakness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart failure

        Exclusion Criteria:

          -  Currently on Coumadin therapy

          -  Experienced a heart attack in the 3 months before study entry

          -  Medically unable to receive clonidine

          -  Advanced kidney or liver disease
Exercise Pulmonary Transit Time
Condition: Heart Failure, Diastolic
MeSH terms: Heart Failure, Diastolic
Intervention: contrast echocardiography
Intervention description: giving echocardiographic contrast and taking echocardiographic images before and after exercise
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: small pilot study to test technical feasibility
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study seeks to measure pulmonary transit time via contrast-echocardiography before and
      after exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years old

          2. Able to give informed consent

        Exclusion Criteria:

          1. Known allergic reaction to Definity or Optison ultrasound contrast

          2. Pregnancy/Nursing - as assessed/disclosed by the participant
Pharmacokinetics of Preoperative Vancomycin
Condition: Surgical Site Infection; Vancomycin
MeSH terms: Surgical Wound Infection
Intervention: Administration of Vancomycin
Intervention description: Intravenous Vancomycin Administration
Intervention MeSH terms: Vancomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 31 Days
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Neurosurgery patients between the ages of 31 days up to 18 years

          2. Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal
             fluid (CSF) shunt placement or revision.

          3. Orthopedic surgical patients between the ages of 31 days up to 18 years

          4. Receiving a single dose of vancomycin administered prior to surgery for definitive
             spinal fusion.

        Exclusion Criteria:

          1. Patients already receiving vancomycin for treatment of an active infection,

          2. Patients who have a Creatinine ≥1.2,

          3. Patients who's creatinine clearance less than 50,

          4. Known chronic renal failure and are on dialysis,

          5. Patients with a known allergy to vancomycin, not including Red Man Syndrome.
Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Condition: Bleeding; Surgical Blood Loss
MeSH terms: Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
Intervention: Tranexamic Acid
Intervention description: Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The pharmacy will prepare 1 syringe of 50 ml of topical TA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Cardiac surgery

Summary:

      The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of
      application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in
      patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will
      assess the feasibility to perform a large randomized international trial exploring this
      objective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female >= 18 years old

          -  Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and
             median sternotomy

          -  Provide written informed consent

        Exclusion Criteria:

          -  Poor (English) language comprehension

          -  Minimally invasive valve surgery

          -  Off-pump procedures

          -  Emergency operations

          -  Known history of increased bleeding disorder

          -  Thromboembolic disease

          -  Allergy to tranexamic acid

          -  Severe renal impairment (eGFR <30 mL/min/1.73m2 )
Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant
Condition: Renal Transplant Rejection; Immunosuppression
Intervention: Everolimus
Intervention description: Replacement of tacrolimus by everolimus, 30 days after transplat. It was done after kidney biopsy (excluding acute rejection), blood and urine analysis.
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic allograft nephropathy; cytokines; kidney transplant; calcineurin inhibitors withdrawn

Summary:

      Currently, acute kidney injury is diagnosed by increased serum creatinine. However,
      creatinine is not a reliable marker for acute changes in renal function.

      The biology of the renal graft is influenced by chemokines from reperfusion (just after the
      kidney transplant) and throughout its course, when acute and chronic inflammatory changes
      occurs. Moreover, the evaluation of changes in urinary cytokines reflects kidney interstitial
      patterns, and can predict renal function, acute rejection episodes and their response to
      treatment.

      Today there are several studies comparing the relative immunosuppression of renal function,
      but few noticed its relationship with cytokines and chemokines. Thus, we proposed studying
      the inflammatory consequences of early calcineurin inhibitors (ICN) withdrawing in transplant
      patients by urine analysis. Kidney biopsy was done before ICN withdrawn and replaced by
      everolimus (3 months after transplant), and 1 year after transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over 18 years old and under 65 years old

          -  Recipients of first kidney transplant

          -  Donor younger than 65 years old

          -  PRA (panel reactive antigen) ≤ 30% in class I or class II

          -  No acute rejection episodes

          -  Proteinuria <1000 mg / day

        Exclusion Criteria:

          -  multiple organ transplant recipient

          -  Chronic liver failure

          -  Asymptomatic bacteriuria or urinary infection at randomization time

          -  Creatinine ≥ 2 mg / dL at randomization time (90 days after transplant)

          -  Presence of uncontrolled hypercholesterolemia (≥ 350 mg / dL, ≥ 9.1 mmol / L) or
             hypertriglyceridemia (≥ 500 mg / dL, ≥ 5.6 mmol / L) at randomization time (90 days
             after transplant)
Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
Condition: Drug Effect; Rib Fractures; Rib Trauma; Surgical Procedure, Unspecified; Pain; Catheter (Other); Nerve Pain; Local Infiltration; Anesthesia, Local; Intercostal Rib; Opioid Dependence; Chest Injury Trauma; Pneumonia
MeSH terms: Neuralgia; Opioid-Related Disorders; Fractures, Bone; Wounds and Injuries; Rib Fractures; Thoracic Injuries
Intervention: Liposomal bupivacaine injection; Bupivacaine indwelling catheter
Intervention description: A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS; Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-inferiority, randomized, clinical trial
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Rib fractures represent a common injury pattern this is highly associated with patient
      morbidity and mortality, as pain control remains a challenge. Even after surgical
      stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes
      such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic
      epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but
      are subject to a wide array of limitations. A more directed therapy with liposomal
      bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have
      undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current
      clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via
      video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable
      analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and
      postoperative narcotic use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing SSRF at Denver Health Medical Center

        Exclusion Criteria:

          -  Allergy or hypersensitivity to bupivacaine

          -  Pregnancy

          -  Incarceration

          -  Age < 18 years

          -  Indwelling continuous thoracic epidural analgesia
Evaluating Treatment Resistant Dermatitis TaroIIR
Condition: Atopic Dermatitis; Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Intervention: Phone calls; Desoximetasone 0.25% spray
Intervention description: Phone calls twice daily; Desoximetasone 0.25% spray applied twice daily
Intervention MeSH terms: Desoximetasone
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: 18 Years
Healthy volunteers: No

Summary:

      Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a
      significant amount of patients in most dermatological practices. Topical corticosteroid
      agents are often prescribed for treatment of both these conditions, especially when they are
      localized rather than wide spread. The development of resistance to treatment is termed
      tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary
      cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to
      determine, under conditions designed to assure good adherence, whether topical 0.25%
      desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory
      skin disease defined by failure of previous topical steroid treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female ≥18 years of age at baseline visit.

        Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one
        or more clinical features

        Written informed consent (and assent when applicable) obtained from subject or subject's
        legal representative and ability for subject to comply with the requirements of the study

        Exclusion Criteria:

        Pregnant, breastfeeding, or unwilling to practice birth control during participation in the
        study.

        Presence of a condition or abnormality that in the opinion of the Investigator would
        compromise the safety of the patient or the quality of the data.

        No access to a phone throughout the day

        Subject is diagnosed with a disease that is known to effect adherence and would otherwise
        bias our results (Such as Alzheimer's or dementia)

        Patient had a history of allergy or sensitivity to corticosteroids or history of any drug
        hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise
        the safety of the patient or the results of the study.