bioihbjkbjnl/mcl2 huggingface dataset:
Assessing Dextenza Insert After SMILE Procedure
Condition: Post Procedural Infection
Intervention: Dexamethasone ophthalmic insert 0.4 mg; Topical Prednisolone Acetate Ophthalmic Drops
Intervention description: intracanalicular dexamethasone insert; Topical Prednisolone acetate ophthalmic drops per standard of care:
Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This three-month prospective, open-label, single-center, randomized investigator initiated
      clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower
      canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral
      SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA
      insertion
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older

          -  Scheduled for bilateral SMILE surgery

          -  Willing and able to comply with clinic visits and study related procedures

          -  Willing and able to sign the informed consent form

        Exclusion Criteria:

          -  Patients under the age of 18.

          -  Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)

          -  Active infectious systemic disease

          -  Active infectious ocular or extraocular disease

          -  Obstructed nasolacrimal duct in the study eye(s)

          -  Hypersensitivity to dexamethasone

          -  Patients being treated with immunomodulating agents in the study eye(s)

          -  Patients being treated with immunosuppressants and/or oral steroids Patients with
             severe disease that warrants critical attention, deemed unsafe for the study by the
             investigator
Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Condition: Anemia
Intervention: Ferumoxytol injection
Intervention description: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
Intervention MeSH terms: Ferrosoferric Oxide
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: 19 Years
Maximum age: 110 Years
Healthy volunteers: No

Summary:

      Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is
      FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron
      repletion in fewer doses (2) when compared with other available injectable iron formulations
      (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and
      expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is
      common in patients after placement of a ventricular assist device (VAD) for treatment of
      end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with
      ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency
      after placement of a VAD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Status post placement of durable ventricular assist device with stable clinical status
             for >30days

          -  Hemoglobin >6 g/dL AND <13 g/dL (men) or <12 g/dL (women) within last 90 days

          -  Serum ferritin <100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation
             <20% within last 90 days

          -  Able and willing to provide written informed consent

        Exclusion Criteria:

          -  Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation

          -  History of anaphylaxis

          -  Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months

          -  Renal failure on hemodialysis

          -  Respiratory failure on mechanical ventilation

          -  Disabling Stroke

          -  Ventricular assist device thrombosis

          -  Evidence of active gastrointestinal bleeding or other active blood loss

          -  Hospitalization <30 days

          -  Pregnant or breastfeeding women
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Intravenous Acetaminophen; Placebo (0.9% Normal Saline infusion)
Intervention description: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.; Infusion of 100 ml of 0.9% NS
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Pain, Postoperative; Ofirmev; Acetaminophen; Analgesics, Non-Narcotic; Arthroscopy

Summary:

      The purpose of this randomized, placebo controlled, single blind study is to determine if
      postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are
      reduced with the administration of IV acetaminophen when compared to a control group.
      Particular focus will be on the postoperative opioid consumption. In addition, we will
      ascertain if the total time the participant is in the PACU differs in those who receive the
      IV acetaminophen versus those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is scheduled for knee arthroscopy with or without chondroplasty.

          -  Scheduled arthroscopy procedure will not include ligament repairs or ligament
             reconstructions and/or bone cutting or fixation procedures.

          -  Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the
             initiation of surgery.

          -  Is willing and able to sign an informed consent.

        Exclusion Criteria:

          -  Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or
             fixation procedures

          -  Has self-reported and/or documented previous hypersensitivity to acetaminophen.

          -  Has self-reported and/or documented history of hepatic disease or impairment.

          -  Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.

          -  Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic
             beverages per day.

          -  Has a medical history of substance dependence (i.e. prescription analgesics or illegal
             drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment
             of the physician PI/Sub-I.
Penicillin Allergy Testing in STD Clinics
Condition: Penicillin Allergy
MeSH terms: Hypersensitivity; Drug Hypersensitivity
Intervention: Penicillin Major Determinant (PrePen) Skin Testing; Direct Oral challenge
Intervention description: Skin testing followed by oral challenge with amoxicillin 250 mg single dose; Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Intervention MeSH terms: Penicillins; Penicillin G
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Demonstration project to implement penicillin allergy testing in STD outpatients using a
      questionnaire and pen allergy testing
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior history of PCN allergy

        Exclusion Criteria:

          -  No immunodeficiency or contraindication to skin testing
Effect of Ketamine on Analgesia Post-Cardiac Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Normal Saline Flush, 0.9% Injectable Solution_#1; Ketamine Hydrochloride
Intervention description: Normal saline infusion mimicking infusion rate of ketamine for a given weight; Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ketamine; Cardiac surgery; Pain

Summary:

      Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative
      infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in
      coronary artery bypass surgery patients receiving a median sternotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or older coming for coronary artery bypass surgery with a
             left ventricular ejection fraction over 50% and able to consent prior to surgery

        Exclusion Criteria:

          -  Minimally invasive cardiac surgery

          -  Preoperative opioid use

          -  Preoperative hepatic or renal dysfunction
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Condition: Type 2 Diabetes; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: 0.5 units/kg daily insulin; 0.25 units/kg daily insulin
Intervention description: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.; Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants are randomized to one of the two dosing groups using a 1:1 allocation
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glargine; glulisine; type 2 diabetes; renal insufficiency

Summary:

      It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in
      renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily
      plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction
      algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR
      by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based
      calculation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes Mellitus of mor than 1year

          -  GFR less than 30 ml/min/1.73m2 or dialysis

          -  Age greater than 18years

          -  Entry blood glucose (fasting or random) greater than 180mg%

        Exclusion Criteria:

          -  Type 1 Diabetes Mellitus

          -  New onset hyperglycemia

          -  Pregnant

          -  Solid organ transplant within 1 year

          -  Steroids prednisone greater than 7.5mg/day or equivalent

          -  Hospital LOS predicted less than 2 days

          -  Severe liver disease

          -  Known hypopituitarism or adrenal insufficiency

          -  Patients in the ICU

          -  Patients with hypoglycemic unawareness

          -  Outpatient insulin dose less than 0.6 units/kg
ECT Pulse Amplitude and Medial Temporal Lobe Engagement
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: MECTA Spectrum 5000Q Amplitude
Intervention description: Current
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized to right unilateral ECT with 600, 700, or 800 mA pulse amplitude.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Double-blind (participant and outcomes assessor)
Enrollment: 62.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: electroconvulsive therapy; MRI; major depressive disorder

Summary:

      Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with
      depressive episodes. During a typical four-week ECT series, most depressive episodes will
      respond to treatment and people will improve their level of functioning (return to work or
      family). Independent of the antidepressant effect of ECT, many patients experience transient
      memory impairment. This investigation will examine the impact of one ECT parameter (pulse
      amplitude or current) on brain changes (structure of connections within the brain) and
      clinical outcomes. The goal of this investigation is to determine the optimal parameter for
      an individual patient that will maintain the clinical response (reduce depression severity)
      and minimize side effects (eliminate memory issues related to treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of major depressive disorder (with or without psychotic features)

          2. the clinical indications for ECT including treatment resistance or a need for a rapid
             and definitive response

          3. Hamilton Depression Rating Scale 24-item (HDRS-24) > 21

          4. age range between 50 and 80 years of age

          5. right-handedness

        Exclusion Criteria:

          1. Defined neurological or neurodegenerative disorder (e.g., history of head injury with
             loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease)

          2. other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar
             disorder)

          3. current drug or alcohol use disorder, except for nicotine; and 4) contraindications to
             MRI.
Treatment of Tracheostomy Granulomas
Condition: Granuloma; Tracheostomy
MeSH terms: Granuloma
Intervention: Betadine; Silver Nitrate; Hydrocortisone Butyrate Cream, 1.0%
Intervention description: Apply locally as needed.; Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.; Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
Intervention MeSH terms: Povidone-Iodine; Silver Nitrate; Hydrocortisone; Hydrocortisone-17-butyrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 31 Days
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study plans to learn more about the different ways used to treat tracheostomy
      granulomas. Investigators want to see which standard of care method (steroid application,
      silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children's Hospital Colorado inpatient or outpatient

          -  31 days to 17 years (inclusive)

          -  Needs treatment for a tracheostomy granuloma

        Exclusion Criteria:

          -  Tracheostomy granuloma has been treated in the last two weeks
Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
Condition: Brain Neoplasm
MeSH terms: Brain Neoplasms
Intervention: Injection Tramadol; placebo
Intervention description: 0.9% Normal saline in 10 ml syringe
Intervention MeSH terms: Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: supratentorial craniotomy; extubation response; emergence; tramadol

Summary:

      Several modalities have been studied to prevent coughing during emergence, including
      extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no
      reliable method is recommended as standard of care. The advantages of administering tramadol
      includes a long duration of action, rapid recovery, limited depression of respiratory
      function and no effect on platelet makes it a safe medication to use for neurosurgical
      patients after craniotomy. The primary objective of the study is to observe the effect of
      single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic
      response (measurement of B.P and H.R) during extubation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with craniotomy for supratentorial tumors under general anesthesia

          -  American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients

          -  Elective surgery

          -  Patients with Glasgow Coma Scale (GCS) 15/15

        Exclusion Criteria:

          -  Patients with a history of allergy or hypersensitivity to tramadol.

          -  History of epilepsy or convulsions due to any reason.

          -  Chronic usage of analgesic drugs.

          -  Patients using monoamine oxidase inhibitors.

          -  Patients with clinical signs of raised ICP.

          -  Obesity (women with a body mass index >35 kg/m2 or men with a body mass index >42
             kg/m2)

          -  Language barrier.

          -  Patients taking B-blockers or Ca channel blockers.

          -  Patients above 65 years of age ( Physiology difference)
PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial
Condition: Portopulmonary Hypertension
MeSH terms: Hypertension
Intervention: Macitentan; Placebo
Intervention description: Macitentan film-coated tablet 10 mg once daily.; Matching placebo tablet once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      24-week study to evaluate the efficacy and safety of macitentan for the treatment of
      portopulmonary hypertension.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Male or female of at least 18 years of age

          -  Confirmed diagnosis of portopulmonary hypertension

        Main Exclusion Criteria:

          -  Severe hepatic impairment

          -  Severe obstructive or restrictive lung disease

          -  Pulmonary veno-occlusive disease

          -  Systolic blood pressure (SBP) < 90 mmHg at Screening

          -  ALT/AST >= 3 x ULN

          -  Bilirubin >= 3 mg/dL at Screening

          -  Any known factor or disease that might interfere with treatment compliance, study
             conduct, or interpretation of results
Assessing Maternal Post-partum Pain With Suppositories
Condition: Pain
Intervention: Belladonna and opioid suppository; Glycerin Suppository
Intervention description: Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery; A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
Intervention MeSH terms: Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive either a belladonna and opioid suppository or a glycerin suppository (placebo) every eight hours after delivery during the first 24 hours after delivery using a 1:1 allocation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Belladonna; Opium; Suppository

Summary:

      This trial will evaluate whether the routine use of belladonna/opium (B&O) suppositories
      improve patients' self-reported pain control in the first 24-hours after delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anticipated Vaginal or Cesarean delivery at Gottlieb Medical Center or Loyola
             University Medical Center

          -  > 34 weeks gestation at time of delivery

          -  > 18 years old

          -  No known allergy to belladonna, opium, or vegetable oil suppositories

          -  Able to consent and complete study documents

        Exclusion Criteria:

          -  Chronic pain condition or on narcotic medication prior to admission

          -  Contraindications to B&O suppositories, including patients with glaucoma, severe
             hepatic, or renal disease; bronchial asthma; narcotic idiosyncrasies; respiratory
             depression; convulsive disorders; acute alcoholism; delirium tremens; history of
             hypersensitivity to any component of product.
The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain
Condition: Nephrolithiasis
MeSH terms: Nephrolithiasis; Kidney Calculi
Intervention: Belladonna and Opium; Placebo suppository
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ureteral stent pain; nephrolithiasis; kidney stone

Summary:

      The purpose of this study is to determine if preemptive B&O suppository placement will
      decrease post-operative pain in patients undergoing ureteral stent placement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who will receive ureteroscopy with concurrent placement of a ureteral stent.

        Exclusion Criteria:

          -  age < 18,

          -  neurologic deficits of any kind

          -  non-English speaking patients.