bioihbjkbjnl/mcl2 huggingface dataset:
Preoperative IV Versus Oral Acetaminophen
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: IV Acetaminophen; PO Acetaminophen; PO Placebo; IV Solution Placebo
Intervention description: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively; Acetaminophen PO 1000mg once pre-operatively; PO placebo capsule compounded to match PO Acetaminophen capsule; This will serve as the placebo for the IV Acetaminophen intervention
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will use a randomized, double-blind, placebo controlled design with two arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current study proposes to examine whether there is a significant difference in patient
      outcomes related to the administration route of preoperative Acetaminophen. Specifically, the
      study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical
      patients who receive oral Acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years old or older

          -  Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical
             procedure performed under general anesthesia

        Exclusion Criteria:

          -  Allergy to Acetaminophen

          -  Lactose intolerance or lactose allergy (placebo capsules contain lactose)

          -  Hepatic disease

          -  Having taken a product containing acetaminophen within 6 hours of scheduled surgery
             time

          -  Pregnant

          -  Weight less than 50kg

          -  Opioid addiction - admits to current opioid addiction and/or substance abuse disorder,
             and/or currently in treatment for opioid addiction or substance abuse

          -  Emergent or on-call procedures

          -  Inpatient surgery
MAST Trial: Multi-modal Analgesic Strategies in Trauma
Condition: Nonspecific Pain Post Traumatic Injury
MeSH terms: Wounds and Injuries
Intervention: Acetaminophen IV/PO; Acetaminophen PO; Ketorolac; Celebrex; Naproxen; Tramadol; Pregabalin; Gabapentin; Lidocaine; Opioids; Regional anesthesia
Intervention description: Acetaminophen 1g IV/PO every 6 hours; Acetaminophen 1g PO every 6 hours; Ketorolac 30mg IV once; Celebrex 200mg PO every 12 hours; Naproxen 500mg PO every 12 hours; Tramadol 100mg PO every 6 hours; Pregabalin 100mg PO every 8 hours; Gabapentin 300mg PO every 8 hours; Lidocaine patch every 12 hours; Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl); Regional anesthesia
Intervention MeSH terms: Acetaminophen; Ketorolac; Naproxen; Celecoxib; Lidocaine; Pregabalin; Gabapentin; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1561.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This is a comparative effectiveness study of current pain management strategies in acutely
      injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies
      will be compared [original multimodal pain regimen (MMPR) compared to multi-modal analgesic
      strategies for trauma (MAST) MMPR].
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted to the trauma service who are 16 years and older.

        Exclusion Criteria:

          -  pregnant

          -  prisoner

          -  patients placed in observation (i.e. not admitted to the hospital)
Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
Condition: Non-ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Infarction
Intervention: Tirofiban
Intervention MeSH terms: Tirofiban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 140.0
Sex: All
Minimum age: 19 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Tirofiban; Resistance to antiplatelet agents

Summary:

      Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for
      Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with NSTE-ACS who need PCI

          -  loaded with aspirin and clopidogrel at least 6 h before the procedure

        Exclusion Criteria:

          -  thrombocytopenia (platelet count <100,000/μL)

          -  history of hemorrhagic stroke

          -  history of ischemic stroke in the recent 2 year

          -  history of major surgery 6 months prior
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Condition: Onychomycosis; Tinea Unguium
MeSH terms: Onychomycosis
Intervention: Tavaborole 5% Topical Solution
Intervention description: topical solution for application to toenails
Intervention MeSH terms: Tavaborole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This was a single group study.
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 72 Months
Maximum age: 203 Months
Healthy volunteers: No
Keywords: Fungal infection of the nail

Summary:

      This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5%
      topical solution in treating distal subungual onychomycosis (a fungal infection) of the
      toenail in children and adolescents (ages 6 to 16 years).

      Following confirmation of eligibility, including laboratory evidence of a fungal organism in
      the toenail, tavaborole topical solution was applied once daily to all affected toenails for
      a 48-week treatment period.

      Clinical assessment of the extent of infection and safety assessments were performed
      periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after
      stopping the treatment).

      A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small
      area of surrounding skin during the first 28 days. These subjects had blood samples analyzed
      to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical
      solution in children and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males or females, ages >/= 6 years and </= 16 years and 11 months

          -  clinical diagnosis of distal subungual onychomycosis affecting at least 20% of one of
             the great toenails (target nail); and with positive KOH and positive culture for T.
             rubrum or T. mentagrophytes from either great toenail

        Exclusion Criteria:

          -  the target toenail has proximal subungual onychomycosis, onychomycosis involving the
             nail lunula, superficial white onychomycosis, dermatophytoma, exclusively lateral
             disease, or yellow or brown spikes, or has co-infection with certain fungi or molds

          -  anatomic abnormalities of the toes or toenail

          -  current or past history of chronic moccasin-type tinea pedis

          -  current or past history of psoriasis or lichen planus

          -  history of significant chronic fungal disease (other than onychomycosis)

          -  diabetes

          -  immunodeficiency
Corticosteroids for Acute Migraine in the Emergency Department
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: metoclopramide; Dexamethasone; methylprednisolone acetate
Intervention description: metoclopramide 10mg intravenous infusion over 15 minutes; dexamethasone 10mg intramuscular injection; methylprednislone acetate 160mg intramuscular injection
Intervention MeSH terms: Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Metoclopramide; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an emergency department based randomized trial in which we compare two different
      treatment for migraine headache. The goal is to decrease the number of headache days during
      the week after ED discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Migraine without aura criteria (International Classification of Headache Disorders 3B
             )

          -  Headache rated as moderate or severe in intensity

        Exclusion Criteria:

          -  Concern for secondary cause of headache

          -  Contra-indications to investigational medications
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hyperglycemia
Intervention: Pramlintide; Exenatide; Insulin
Intervention description: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months; Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months; Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
Intervention MeSH terms: Exenatide; Pramlintide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: type 1 diabetes; Symlin; Byetta; CGMS iPro

Summary:

      The main purpose of the study is to determine the effects of 16 weeks of adjunctive
      pramlintide or exenatide use on glycemic control in Type 1 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 12 to 21 years.

          2. HbA1C less than 9%

          3. Subjects must be on intensive insulin management

          4. Tanner stage greater than or equal to 3

          5. Having Type 1 Diabetes for at least one year

          6. Type 1Diabetes defined by ADA criteria and having at least one of the following
             antibodies a. Anti-GAD (glutamic acid decarboxylase) b. Anti-islet cell 512 (ICA512)
             c. Anti-insulin

          7. Willing to give consent.

        Exclusion Criteria:

          1. Type 2 diabetes.

          2. Having any other chronic condition except hypothyroidism stable on medications.

          3. On chronic medications that may affect glucose excursions.

          4. Anemia as defined as Hb less than 9 gm/dl.

          5. Abnormal amylase, lipase or creatinine (twice normal).

          6. Abnormal Liver function tests(three times above normal)

          7. Unsupportive family environment as determined by clinicians and/or social workers.

          8. Pregnant or lactating mothers
Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)
Condition: Labor Pain; Complications; Cesarean Section; Pregnancy
MeSH terms: Labor Pain
Intervention: Epidural anesthesia; Combined spinal and epidural anesthesia
Intervention description: ￼An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.
Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.; A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
Intervention MeSH terms: Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 46.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: trial of labor after cesarean; vaginal birth after cesarean; epidural vs combined spinal epidural

Summary:

      To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on
      the success of Trial of Labor After Cesarean (TOLAC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients meeting ACOG guidelines for TOLAC

          -  at least one previous elective cesarean delivery

          -  <40 weeks gestational age (GA)

          -  vertex singleton pregnancy with use of continuous fetal monitoring

        Exclusion Criteria:

          -  Patient refusal of regional anesthetic or with contraindication for regional
             anesthesia

          -  BMI >40

          -  associated comorbidities such as gestational diabetes, preeclampsia, abnormal
             placentation
Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
Condition: DENT IMPLANTS; LASER
Intervention: Conventional mechanical therapy; Saline; Methylene Blue; Light emitting laser; Non-light emitting laser
Intervention description: Both experimental and sham arms will receive the Conventional mechanical therapy; Sham group will receive saline as a sham for methylene blue; Experimental arm will receive methylene blue; Experimental arm will receive Light emitting laser; Sham group will receive Non-light emitting laser
Intervention MeSH terms: Methylene Blue
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dental implants; Laser; Antimicrobial photodynamic therapy; Low level laser therapy; Peri-implant mucositis; Peri-implantitis

Summary:

      The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and
      probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites
      exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic
      therapy (aPDT) and assess the microbiologic profile of plaque samples before and after
      treatment with or without aPDT samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least one implant with peri-implant inflammation that requires non-surgical
             treatment.

          -  Peri-implant diseases included are peri-implant mucositis and peri-implantitis

        Criteria for diagnosis of peri-implant mucositis or peri-implantitis:

          1. Red, swollen gingival tissues surrounding the implant

          2. Presence of bleeding and/or suppuration on gentle probing around the implant

          3. Increased probing depth compared to probing depth after restoration of the implant
             (greater than 2mm increase in probing depth)

          4. May or may not have progressive bone loss in relation to radiographic bone levels
             assessed either 1 year following restoration of the implant OR ≥3mm of radiographic
             bone loss from the implant platform -systemically healthy or with controlled common
             systemic conditions, such as hypertension, that will not affect wound healing.

        Exclusion Criteria:

          -  current heavy smokers (>10 cigarettes/day)

          -  have diabetes or other systemic diseases that may comprise healing

          -  take antibiotics within 3 months before the procedure
Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy
Condition: Disorder of Knee; Anesthesia
Intervention: Hyperbaric Levobupivacaine 0.75%
Intervention description: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
Intervention MeSH terms: Levobupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Knee Arthroscopy; Levobupivacaine; Spinal Anesthesia; Motor Block

Summary:

      The purpose of this study is to evaluate motor block probability throughout time and clinical
      profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a
      unilateral spinal block technique.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)

        Exclusion Criteria:

          -  Cardiac or pulmonary disease

          -  Antiplatelet or anticoagulant drugs use during 7 days before surgery

          -  History of coagulative disorders

          -  Bilateral procedures
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
Condition: Hyperphosphatemia; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Hyperphosphatemia
Intervention: Tenapanor; Sevelamer Carbonate
Intervention description: NHE3 Inhibitor; Phosphate binder
Intervention MeSH terms: Sevelamer
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Healthy volunteers: No

Summary:

      The study is designed to evaluate the ability of tenapanor alone or in combination with
      sevelamer to achieve serum phosphorus concentration (sP) within the population reference
      range (sP >2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis
      with hyperphosphatemia (>4.5 mg/dL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must complete TEN-02-301 (PHREEDOM)

        Exclusion Criteria:

          1. Schedlued for kidney transplant

          2. Life expectancy <12 months
Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Condition: Hip Arthroscopy
Intervention: Acetaminophen; Percocet
Intervention description: acetaminophen 600 mg to be taken every 8 hours (TID); Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.
Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to
      analgesia for patient's pain after hip arthroscopy and to also assess if this new approach
      will result in a reduction in post-operative narcotic use.

      This study is a single-center, randomized prospective study comparing post-operative pain
      scores and narcotic consumption between individuals receiving acetaminophen along with a
      reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals
      receiving Percocet only. Both pain management options are considered to be standard of care.
      Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic
      ossification prophylaxis.

      The primary objective of the study are to compare patients' narcotic consumption and reported
      pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate
      pain relief compared to a narcotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA class I-II

          -  Patients indicated and scheduled for arthroscopic hip surgery

        Exclusion Criteria:

          -  Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity,
             history of GI or bleeding disorder)

          -  Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia,
             etc.)

          -  Younger than 18 years of age or older than 65

          -  Any patient considered a vulnerable subject

          -  Patients on pain medication prior to surgery