bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)
Condition: Hypotension
MeSH terms: Hypotension
Intervention: Phenylephrine bolus; phenylephrine infusion
Intervention description: 10 ml of 100mcg/ml phenylephrine and placebo infusion; 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 178.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spinal induced hypotension; nausea and vomiting; cesarean delivery

Summary:

      Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35).
      This subgroup of patients represents a large portion of the obstetric patient population
      locally and nationally. It is unclear whether previous research should be extrapolated to the
      obese patient population. This study is being done to compare the incidence of hypotension,
      intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive
      a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the
      treatment of established hypotension. This study will help us determine whether using a
      phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal
      induced hypotension during cesarean deliveries in obese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking

          -  ASA Physical Status I-II

          -  Non-laboring women

          -  Single gestations ≥ 36 weeks

          -  Obese women (Body Mass Index 35 - 55 kg/m2)

          -  Non-emergent CD under spinal anesthesia

        Exclusion Criteria:

          -  Height < 5'0"

          -  Antiemetic drug use in the 24 hours prior to CD

          -  Allergy to phenylephrine, or any other standardized medication

          -  Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia)

          -  Chronic hypertension receiving antihypertensive treatment

          -  Severe Cardiac disease in pregnancy with marked functional limitations

          -  Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

          -  Subject enrollment in another study involving a study medication within 30 days of CD

          -  Any other physical or psychiatric condition which may impair their ability to
             cooperate with study data collection
Changes in Bone Turnover With Increased Incretin Hormone Exposure
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: sitagliptin; Placebo
Intervention description: sitagliptin 100mg daily; 1 pill daily
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 2 diabetes; sitagliptin; Januvia

Summary:

      The purpose of this study is to determine if the use of sitagliptin increases bone formation
      and reduces bone turnover in postmenopausal women with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (as defined by age >55 years old or amenorrhea for >1years)

          -  Type 2 DM currently not on diabetes-specific medication(s) or treated with monotherapy
             of metformin or a sulfonylurea. Patients treated with insulin monotherapy will also be
             eligible if the total daily dose of insulin is <10units.

          -  Hemoglobin A1c (HbA1c) of 6.5-9.0%

        Exclusion Criteria:

          -  Use of an incretin mimetic (i.e. exenatide), a DPP-4 inhibitor (i.e. sitagliptin,
             saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to
             the study will not be eligible

          -  Known osteoporosis or patients treated with an osteoporosis-specific medication
             (bisphosphonate, teriparatide) or estrogen (including Selective Estrogen Receptor
             Modulators (SERMs)) or those who anticipate imminent treatment with one of these
             medications will be excluded from the study

          -  Chronic kidney disease (calculated GFR <30 ml/min) or a disease known to affect bone
             turnover (i.e. Paget Disease, Osteogenesis Imperfecta, HIV) will be excluded from the
             study.

          -  History of pancreatitis
Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Condition: Suicide, Attempted
MeSH terms: Suicide; Suicide, Attempted
Intervention: Intravenous ketamine; Cognitive training; Sham Training
Intervention description: Single subanesthetic infusion of ketamine (0.5mg/kg); 8 sessions of computer-based cognitive training; 8 sessions of computer-based sham training
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This project seeks to identify the acute and longer-term impact of a single dose of
      intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in
      the medical inpatient setting. The investigators will then test whether ketamine's rapid
      effects can be extended by introducing helpful information delivered by a computer-based
      training protocol. This work could ultimately lead to the ability to treat suicidality more
      efficiently and with broader dissemination by rapidly priming the brain for helpful forms of
      learning.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants will:

          1. be between the ages of 18 and 65 years

          2. be a medical inpatient referred for psychiatric consultation/liaison due to
             suicidality

          3. possess a level of judgment and understanding sufficient to agree to all procedures
             required by the protocol and must sign an informed consent document

          4. be deemed an appropriate and reasonable medical candidate for intravenous ketamine by
             a physician authorized to prescribe medication to the patient during inpatient
             hospitalization

        Exclusion Criteria:

          1. Presence of current psychotic or autism spectrum disorder or current delirium

          2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks

          3. Current pregnancy or breastfeeding

          4. Reading level <5th grade as per WRAT-3 reading subtest

          5. Past intolerance or hypersensitivity to ketamine

          6. Patients taking any of the following medications: St John's Wort, theophylline,
             tramadol, metrizamide

          7. Patients who have received ECT in the past 6 months prior to intake

          8. Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate
             withdrawal) or who present with substance-induced psychosis

          9. Patients who, based on expressed preference and/or home geographic location, are
             deemed by the Psychiatric Consultation/Liaison service to be likely to receive
             inpatient psychiatric hospitalization at an alternate location outside of Western
             Psychiatric Institute & Clinic
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Intervention: Propofol; Methohexital
Intervention description: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved; Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
Intervention MeSH terms: Propofol; Methohexital
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardioversion; Propofol; Deep sedation; Intravenous anesthetics

Summary:

      A randomized, open-blinded, prospective study to evaluate the timeliness and safety of direct
      current cardioversion (DCCV) when using methohexital when compared to the more often used
      propofol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who present to Wake Forest Baptist Medical Center for a direct current
             cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as
             atrial flutter.

        Exclusion Criteria:

          -  Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV

          -  Hemodynamically compromised patients (as defined by hypotension <90/50 mmHg, altered
             mental status, shock, ischemic chest discomfort, or heart failure)
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
Condition: Diabetic Ketoacidosis
MeSH terms: Ketosis; Acidosis; Diabetic Ketoacidosis
Intervention: insulin glargine+ glulisine; NPH + Regular insulin
Intervention description: Daily insulin glargine + glulisine before meals; Split-mixed NPH + Regular insulin twice daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetic ketoacidosis; insulin therapy; DKA

Summary:

      The study is a multicenter, randomized controlled trial to compare the safety and efficacy of
      insulin analogs and human insulins both during acute intravenous treatment and during the
      transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted to Grady Memorial Hospital who meet diagnosis criteria of DKA
             and who are willing to participate in the study protocol will be considered candidates
             for inclusion into the study.

          -  Diagnostic Criteria for DKA: Blood glucose > 250 mg/dL, arterial or venous phenol
             hydroxylase (pH) < 7.3, serum bicarbonate < 18 milliequivalent/L, and moderate to
             severe ketonemia (acetoacetate ≥ 1:4 or βeta-hydroxybutyrate > 3 mmol).

        Exclusion Criteria:

          -  Hemodynamic instability (MAP < 50 or patients requiring pressor)

          -  Significant identifiable medical or surgical illness, including but not limited to:
             acute myocardial infarction, congestive heart failure; respiratory failure requiring
             mechanical ventilation; acute or chronic renal insufficiency (serum creatinine > 3.0
             mg/dl); end stage liver failure, and cirrhosis.

          -  Patients with dementia or persistent altered mental status that would prevent
             collection of consent form and reliable information.

          -  Pregnancy
Pancreatic Enzyme Supplementation for Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Intervention: pancrelipase
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pancreatic enzyme supplementation

Summary:

      The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic
      enzyme supplementation will improve symptoms in individuals with celiac disease who suffer
      persistent symptoms despite a gluten free diet. This protocol specifically aims to:

        1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of
           gastrointestinal symptoms in patients with celiac disease on a gluten free diet.

        2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme
           supplementation in patients with celiac disease on a gluten free diet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven celiac disease.

          -  Age 18-80.

          -  Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in
             period.

          -  Subject must be following a gluten free diet.

          -  tTG < 40 units at screening.

        Exclusion Criteria:

          -  Taking prescription or over the counter enzyme supplements for 1 month prior to
             enrollment.

          -  Pregnant, breastfeeding or planning pregnancy. Woman using acceptable methods of
             contraception will be included. Acceptable methods of contraception include oral
             hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide,
             condoms, intra-uterine device, abstinence, and male partner vasectomy.

          -  Patients with a pork allergy or who are unwilling to consume pork products.

          -  English proficiency unsuitable for completion of surveys.

          -  Known severe pancreatic disease.

          -  Known history of prior cancer (except squamous or basal cell skin cancer).

          -  Patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2
             tablespoons) of whole milk per day.

          -  Clinically significant abnormality in safety lab values (i.e. CBC and BMP) at
             screening that may impact subject safety or the scientific integrity of the study.

          -  Other known active GI condition including but not limited to inflammatory bowel
             disease, small intestine bacterial overgrowth, and obvious FODMAP intolerance.

          -  History of all major gastrointestinal surgery other than appendectomy or
             cholecystectomy.

          -  Comorbid condition that in the opinion of the investigator would interfere with the
             subject's participation in the study or would confound the results of the study.
FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Intermitent Dosing
Intervention description: Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is designed to compare the control and the experimental arm groups for 24 weeks of treatment. After 24 weeks, subjects on the control arm then cross over to the experimental intervention.
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV/AIDS; efavirenz; tenofovir; emtricitabine; FOTO; treatment interruption; Atripla; Truvada; Treatment Experienced

Summary:

      For people with HIV who are currently taking specific medications (including Sustiva
      (efavirenz)) and have no detectable viral load, this study tracks how patients do if they
      take their medications for five days of the week compared with seven days of the week.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  CD4 count > or = 200

          -  Viral load < 50

          -  Treatment with a regimen containing efavirenz and tenofovir and lamivudine or
             emtricitabine for at least 90 days prior to screening

        Exclusion Criteria:

          -  Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening

          -  Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or
             cytidine analogues

          -  Hepatitis B infection
Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy
Condition: Hysterectomy
Intervention: Bupivacaine; Liposomal bupivacaine; Saline
Intervention description: 0.25% bupivacaine for TAP block; Exparel for TAP block; Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to one of three study groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TAP block; Liposomal bupivicaine

Summary:

      The goal of this study is to evaluate the effectiveness of different formulations of
      bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain
      management after open abdominal hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective open abdominal hysterectomy with midline incision, age > 18 years, American
             Society of Anesthesiologist classification score (ASA classification) 1-3.

        Exclusion Criteria:

          -  Patient with a chronic pain condition, major unexpected surgical complication,
             unexpected prolonged intubation, patient refusal, local anesthetic allergy, any
             contraindication to regional anesthesia, greater than 2 attempts by resident and
             greater than 1 attempt by staff anesthesiologist for TAP block.
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
Condition: Graves Disease; Hyperthyroidism
MeSH terms: Graves Disease; Hyperthyroidism
Intervention: Potassium Iodide
Intervention description: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Graves Disease

Summary:

      The purpose of this study is to determine whether a brief course of SSKI (saturated solution
      of potassium iodide) administered preoperatively provides any benefit in the surgical
      management of patients undergoing thyroidectomy as definitive management of their Graves
      Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with a clinical diagnosis of Graves Disease

          -  Patients who have selected surgical resection as treatment of their Graves Disease

          -  Prior use of anti thyroid medication so that patient is clinically and biochemically
             euthyroid

        Exclusion Criteria:

          -  Patients deemed unfit for surgery by operating surgeon or anesthesist

          -  Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of
             normal
Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: SIMVASTATIN 40 mg; SIMVASTATIN/EZETIMIBE 10/10 mg
Intervention description: SIMVASTATIN 40 mg/day for 3 months; SIMVASTATIN/EZETIMIBE 10/10 mg/day for 3 months
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Healthy volunteers: No
Keywords: hypercholesterolemia; statins; simvastatin; ezetimibe; LDL particles

Summary:

      Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein
      cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential
      effects of these two treatment options on small dense LDL-C (sdLDL-C) concentration have not
      been assessed.

      The aim of the present study is to compare the effects of simvastatin 40 mg versus
      simvastatin/ezetimibe 10/10 mg on sdLDL-C concentration. The primary efficacy endpoint will
      be changes in LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) at 3
      months after treatment initiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  LDL-C levels above those recommended by the National Cholesterol Education

          -  Program Adult Treatment Panel III (NCEP-ATP III) based on each patient risk factors
             following a 3-month period of lifestyle changes.

        Exclusion Criteria:

          -  Triglycerides >500 mg/dL, renal disease (serum creatinine levels >1.6 mg/dL),
             hypothyroidism [thyroid stimulating hormone (TSH) >5 IU/mL] and liver disease (ALT
             and/or AST levels >3-fold upper limit of normal in 2 consecutive measurements).

          -  Patients with hypertension will be included in the study if they are on stable
             medication for at least 3 months and their blood pressure is adequately controlled (no
             change in their treatment will be made during the study period).

          -  Patients currently taking lipid lowering drugs or having stopped them less than 4
             weeks before study entry will be excluded