bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: lubiprostone
Intervention description: 24 micrograms twice daily for 1 week
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: constipation; chronic idiopathic constipation; no prior history of surgery to the colon; not on any type of medication that could alter gastrointestinal motility or transit

Summary:

      This prospective study is designed to evaluate how lubiprostone may affect gastric motor and
      sensory function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic idiopathic constipation

        Exclusion Criteria:

          -  medications that slow gastrointestinal (GI) motility

          -  prior surgery to the GI tract
Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
Condition: Obesity; Labor Induction; Cesarean Delivery
Intervention: Vaginal Misoprostol; Foley Balloon + Vaginal Misoprostol
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 236.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts
      to require induction of labor because of increased rates of obstetric complications including
      pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies
      have shown that obese women experience increased labor duration and oxytocin needs when
      compared to normal-weight women. This in turn results in increased rates for unplanned
      cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and
      non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of
      obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix
      (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol
      will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
    

Eligibility criteria:

        Inclusion Criteria

          -  Nulliparous women aged 18 or above

          -  BMI ≥ 30 at the time of labor induction

          -  Singleton gestation

          -  Cephalic presentation (includes successful external cephalic version)

          -  Intact fetal membranes

          -  Unfavorable cervix (Bishop score of ≤ 6)

          -  Gestational age ≥ 32 weeks

        Exclusion Criteria

          -  Patient not candidate for IOL with misoprostol as deemed by the treating physician

          -  Multiple gestation

          -  Major fetal anomalies

          -  Fetal demise
Mechanisms and Treatment of Intradialytic Hypertension
Condition: Intradialytic Hypertension
MeSH terms: Hypertension
Intervention: Carvedilol
Intervention description: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
Intervention MeSH terms: Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypertension; Hemodialysis

Summary:

      1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis
           patients if blood pressure elevations with hemodialysis are associated with decreased
           endothelial cell function (measured by brachial artery flow mediated dilation and
           endothelial progenitor cell number), both of which are novel mechanistic markers in the
           causal pathway for detrimental cardiovascular outcomes; and

        2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood
           pressure elevations with hemodialysis can improve endothelial cell dysfunction as a
           surrogate mechanistic marker for improving cardiovascular outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  on hemodialysis > 30 days

          -  aged 18 to 80 years old

          -  ability to provide informed consent

          -  Primary nephrologist deems patient is at target dry weight

          -  Predialysis SBP >140 or postdialysis SBP>130

        Exclusion Criteria:

          -  Patients with active wounds

          -  Blood pressure unable to be measured by routine mechanisms in the upper extremity

          -  Change in blood pressure medications in the previous 2 weeks

          -  Intolerance of beta or alpha-blockers

          -  pregnancy

          -  Resting heart rate <50

          -  Life expectancy < 6 months

          -  Current therapy with carvedilol or contraindication to carvedilol (ONLY in the
             intervention arm)
The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery
Condition: Oxidative Stress; Cognition Disorders
MeSH terms: Cognition Disorders
Intervention: Dexmedetomidine; Placebo
Intervention description: After skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.; The control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing
      postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use
      cardiopulmonary bypass machine (CPB).

      Materials and Methods: This study was double-blinded, randomized controlled trial. Patients
      scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups,
      dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless
      test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined
      as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for
      IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1),
      arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD
      and the secondary outcomes were inflammatory response, other postoperative complications, ICU
      and hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) physical status I-III.

        Exclusion Criteria:

          -  patients who were allergy to medication in the research regimen

          -  preoperative left ventricular ejection fraction less than 30%

          -  body mass index more than 35 kg/m2

          -  preoperative mean arterial pressure less than 60 mmHg

          -  preoperative heart rate less than 45/min

          -  patients with impaired renal function (serum creatinine more than 1.5 mg/dl in female
             and 2 mg/dl in male)

          -  active liver disease, and who had history of symptomatic cerebrovascular disease

          -  psychiatric problem and other neurological diseases

          -  patients who cannot read
Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Empagliflozin; Placebos
Intervention description: 6 months; placebo equivalent for 6 months
Intervention MeSH terms: Empagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiovascular diseases; Heart Failure; LV remodeling; SGLT-2 Inhibitors; Empagliflozin; Cardiac MRI

Summary:

      Purpose:

      The overall hypothesis of the study is that the benefits attained in the EMPA-OUTCOME were,
      at least in part, mediated by a glucose-independent mechanism. Thus, to demonstrate the
      existence of the postulated non-glucose dependent effects, the researchers will investigate
      the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical
      therapy in heart failure patients with reduced ejection fraction without diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients should meet the following inclusion criteria:

          -  Ambulatory patients age 18-85 years

          -  Diagnosis of Heart failure (NYHA II to III)

          -  LVEF<50% on echocardiography or CMRI in the previous 6 months

          -  Have stable symptoms and therapy for HF within the last 3 months.

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Any history of diabetes by medical history or by any of the established criteria by
             the American Diabetes Association. It also includes patients with history of diabetes
             in remission.

          -  ACS or cardiac surgery within the last 3 months.

          -  Cancer or any other life-threatening condition.

          -  Pancreatitis.

          -  Glomerular Filtration Rate < 45 ml/Kg/min.

          -  Use of continuous parental inotropic agents.

          -  Systolic BP < 90 mm Hg.

          -  Psychiatric disease incompatible with being in study.

          -  Any contraindication to MRI procedures.

          -  Any other medical or physical condition considered to be inappropriate by a study
             physician.
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
Condition: Pelvic Organ Prolapse
MeSH terms: Urinary Retention; Prolapse; Pelvic Organ Prolapse
Intervention: Nitrofurantoin; Placebo
Intervention description: Patients will receive nitrofurantoin 100mg once daily or a placebo. Pills will be identical.; Placebo
Intervention MeSH terms: Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The specific aim of this randomized double-blind placebo-controlled trial is to determine if
      extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic
      urinary tract infection (UTI) compared with placebo for patients undergoing short term
      indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary
      retention following pelvic organ prolapse and/or urinary incontinence surgery.

      Consented patients who undergo urogenital surgery and fail their post-operative voiding trial
      will be randomized to either extended release nitrofurantoin 100mg or an identical appearing
      placebo capsule to be taken daily while performing CISC or while indwelling catheter is in
      place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of
      surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and
      incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women.

      Primary and secondary outcomes will be evaluated with Student t test and chi squared or
      Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to
      nitrofurantoin prophylaxis from 33% to 13%, with 80% power, and a two-sided alpha of 0.05,
      and a 10% dropout rate, we should recruit a total of 154 patients.
    

Eligibility criteria:

        Inclusion Criteria:

        - Women who have undergone surgery for the correction of pelvic organ prolapse and/or
        urinary incontinence and failed a postoperative voiding trial

        Exclusion Criteria:

          -  Known drug allergy to nitrofurantoin

          -  History of renal insufficiency

          -  Renal transplant

          -  Renal nephropathy

          -  Recent history of more than 3 UTIs per year

          -  History of nitrofurantoin-induced pulmonary injury or nitrofurantoin associated
             cholestatic jaundice/hepatic dysfunction

          -  Known immunocompromised condition (organ transplant, chemotherapy, immune suppression
             associated with autoimmune disease).
The Effect of Lipitor on Aortic Stenosis
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Intervention: atorvastatin (Lipitor)
Intervention description: atorvastatin 40 mg by mouth once daily
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: calcific aortic valve stenosis; echocardiography, transthoracic

Summary:

      The purpose of this study is to find out if an approved medicine that is used to lower
      cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve
      in patients with a condition called aortic stenosis. Patients who have aortic stenosis who
      volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a
      physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of
      the heart) at the start of the study and every 6 months, stopping at 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve

          -  Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of
             0.9 to 1.7 cm2 by continuity equation.

          -  Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.

        Exclusion Criteria:

          -  Left ventricular ejection fraction <50%

          -  Valvular area of 0.9 cm2 and a mean gradient >30 mmHg

          -  Rheumatic heart disease

          -  >Moderate (2+) aortic insufficiency

          -  Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other
             HMG-CoA Reductase Inhibitors (statins)

          -  End-stage renal disease (ESRD)

          -  History of thoracic radiation

          -  Unable or unwilling to sign informed consent

          -  Unable to unwilling to return for follow-up

          -  Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or
             hematological disorders, vasculitis, or any other situation or medical condition that,
             in the investigator's opinion, would make survival for the duration of the study
             unlikely, or would otherwise interfere with optimal participation in the study or
             produce a significant risk to the patient

          -  Severe pulmonary hypertension (>55 mmHg)
Remifentanil and Glycemic Response in Cardiac Surgery
Condition: Heart Diseases; Hyperglycemia
MeSH terms: Heart Diseases; Hyperglycemia
Intervention: Remifentanil; Fentanyl
Intervention description: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.; Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
Intervention MeSH terms: Fentanyl; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiopulmonary bypass; Heart surgery

Summary:

      This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery
      to supress the hyperglycemic response in perioperative period. Half of the participants will
      receive continuous intravenous remifentanil during surgery, while the other half will receive
      intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl
      administration is this institution's standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open cardiac surgery through sternotomy approach (coronary artery bypass, valve
             surgery, and any other open heart surgeries)

          -  Surgery with use of cardiopulmonary bypass

          -  Patients over 18 years of age

          -  Both female and male genders

          -  All races

        Exclusion Criteria:

          -  Minimally invasive heart surgery through thoracotomy approach

          -  Patients receiving regional analgesia such as intrathecal morphine

          -  Patients undergoing procedures under deep hypothermic circulatory arrest

          -  Patients with active infections such as acute infective endocarditis

          -  Emergency surgery

          -  Patients undergoing transplantations and ventricular assist device insertion

          -  Patients on any mechanical circulatory support preoperatively

          -  Patient's refusal

          -  Allergy to remifentanil

          -  Positive pregnancy test

          -  Morbid obesity

          -  End stage liver and kidney disease
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Condition: Obesity; Contraception
MeSH terms: Emergencies
Intervention: UPA-ECx1; UPA-ECx2
Intervention description: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC; Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: obesity; body weight; BMI; emergency contraception; levonorgestrel; ulipristal acetate

Summary:

      Obese women are significantly more likely than their normal BMI counterparts to experience
      failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for
      testing a dose escalation strategy in an effort to provide improved efficacy from
      orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency
      contraception containing ulipristal acetate. The overall project will be focused on both
      levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but
      this protocol registration is for the UPA aspect of the study procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy women

          -  Aged 18-35 years old

          -  Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a
             progesterone level of 3 ng/mL or greater

          -  Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI
             <25kg/m2 and a weight of less than 80kg.

        Exclusion Criteria:

          -  Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian
             Syndrome

          -  Impaired liver or renal function

          -  Actively seeking or involved in a weight loss program (must be weight stable)
             pregnancy, breastfeeding, or seeking pregnancy

          -  Recent (within last 8 weeks) use of hormonal contraception

          -  Current use of drugs that interfere with metabolism of sex steroids

          -  Smokers.
Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Rectocele; Prolapse; Pelvic Organ Prolapse
Intervention: Bupivacaine; Placebo
Intervention description: At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).; At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have 30mL total volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sacrocolpopexy; rectocele repair

Summary:

      To determine if the injection of liposomal bupivacaine to laparoscopic port sites and
      rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant
      rectocele repair will result in decreased postoperative pain compared to injection of
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18 years of age or older

          -  Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele
             repair under general anesthesia

          -  Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Allergy to bupivacaine

          -  History of drug/alcohol abuse

          -  Severe cardiovascular, hepatic, renal disease, or neurological impairment

          -  Long-acting opioid use within 3 days or any opioid use within 24 hours before surgery

          -  Contraindication to: acetaminophen, oxycodone, non-steroidal anti- inflammatory drugs
             (NSAID)

          -  Administration of an investigational drug within 30 days before study

          -  Chronic pain syndromes

          -  Daily NSAID/opioid use

          -  Patients not undergoing general anesthesia

          -  Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or
             fistula repair