bioihbjkbjnl/mcl2 huggingface dataset:
Diphenhydramine for Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: metoclopramide; diphenhydramine; placebo
Intervention description: 10 milligrams, administered intravenously over 15 minutes; 50 milligrams, administered intravenously over 15 minutes
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: migraine; headache; metoclopramide; diphenhydramine

Summary:

      Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite
      the fact that data supporting this practice do not exist. The investigators propose a
      randomized double blind study to test the hypothesis that 50mg of intravenous
      diphenhydramine, when added to standard migraine therapy, will result in a greater rate of
      sustained headache relief than standard migraine therapy alone. For this study, standard
      migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is
      defined as achieving a headache level of "mild" or "none" within two hours and maintaining a
      level of "mild" or "none" for 48 hours. Patients who present to the Montefiore emergency room
      (Bronx, NY) with an acute migraine will be approached for participation. They will be
      screened for medication contra-indications and non-migraine etiologies of headache. The study
      will be randomized. Assignment will be concealed. Participants and researchers will be
      blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours
      in the Emergency Department and by telephone 48 hours after medication administration. A
      sample size calculation, based on pilot data, revealed the need for 374 participants. An
      interim analysis will be performed after 200 participants have been enrolled with the goal of
      assessing for lack of conditional power.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute migraine headache

          -  Present to our emergency room in the Bronx, NY for treatment of migraine headache

        Exclusion Criteria:

          -  Temperature > 100.3 F

          -  Pheochromocytoma

          -  Seizure disorder

          -  Parkinson's disease

          -  Use of monoamine oxidase (MAO) inhibitors

          -  Use of anti-rejection transplant medications

          -  Use of potassium supplements

          -  Use of pramlintide
Pilot - Peri-operative Beta Blockade
Condition: Adrenergic Beta-Receptor Blockader; Troponin Levels; Cardiomyopathy, Post-surgical
MeSH terms: Cardiomyopathies
Intervention: metoprolol
Intervention MeSH terms: Metoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 51 Years
Healthy volunteers: No

Summary:

      Perioperative cardiac adverse events [heart injuries caused by general anesthesia and
      surgical procedures] are a significant public health issue, with more than 60,000 deaths per
      annum in patients having surgery for non-heart related issues. There are virtually no
      evidence-based medical strategies for effective prevention of these events. Preoperative drug
      treatment with beta blockade drugs used for high blood pressure, perioperative therapy with
      lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high
      blood pressure, and aspirin have all been investigated as potential mitigating treatments,
      but without positive clinical outcomes and, in some cases, creating more hemodynamic
      instabilities that result in heart injury. In light of this, investigators propose to
      evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately
      after surgery and to assess the value of high-sensitivity cardiac troponin level testing of
      the blood in predicting those patients who would benefit most from perioperative beta blocker
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >50 years

          -  American Society of Anesthesiologists (ASA) risk status III-IV

          -  Revised Cardiac Risk Index ≥2

          -  β-blocker naïve (not having received β-blocker within 30 days prior to surgery)

          -  Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:

          -  History of peripheral vascular disease, or

          -  Diabetes and currently on oral anti-diabetic drug or insulin therapy, or

          -  Chronic renal failure (eGFR <30 m/min)

          -  Major non-cardiac surgery under general anesthesia

        Exclusion Criteria:

          -  History of stroke

          -  Heart rate <55bpm

          -  Heart failure

          -  Second or third degree AV block without pacemaker

          -  Active asthma or COPD

          -  Anemia [Hb<9g/dL]

          -  Allergy to beta-blockade drugs

          -  Hemodynamic instability

          -  Uncontrolled hemorrhage

          -  Unwilling or unable to give consent for participation
Simplified Insulin Protocol Using Lantus in Elderly
Condition: Diabetes
Intervention: Glargine
Intervention description: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: simplification; glargine; elderly

Summary:

      The purpose of this study is to find out if simplifying your diabetes treatment by decreasing
      number of insulin injections, with the help of a long acting insulin called glargine, can
      decrease the episodes of low blood glucose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 70 years or older

          -  Diagnosis of diabetes mellitus Type II

          -  At least 2 (short-acting or mixed) insulin injections per day

          -  At least 1 episode of hypoglycemia (glucose value <70) on screening CGM

        Exclusion Criteria:

          -  Patients with the following illnesses in the past 12 months Myocardial infarction
             Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography
             Cerebrovascular event (stroke, TIA)

          -  Active liver disease (history of cirrhosis or LFT > 3 times normal)

          -  On dialysis or with severe renal dysfunction (creatinine clearance <20 ml/min)

          -  Malignancy that limits life span to less than 18 months

          -  Patients seen in the geriatric clinic who already have simplified regimen as proposed
             in the study
A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Condition: Labor; Forced or Induced, Affecting Fetus or Newborn; Pregnancy
Intervention: Misoprostol
Intervention description: Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: misoprostol; cytotec; cervical ripening; labor, induced; active labor

Summary:

      The purpose of this study is to study if misoprostol administered orally is at least as
      effective as misoprostol administered vaginally for cervical ripening and the induction of
      labor. The main purpose is to show that oral misoprostol administration is non-inferior to
      vaginal misoprostol administration with respect to the time interval from misoprostol
      administration to onset of active phase of labor. The study is a non-inferiority, prospective
      randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus
      vaginal misoprostol given as 25 mcg every 4 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pregnant Female Patients greater than or equal to 18 years of age

          2. Induction of labor for a single live intrauterine pregnancy

          3. Greater than or equal to 37 weeks gestational age

          4. Cephalic presentation

          5. 20 minute reassuring fetal heart rate (reactive nonstress test (NST))

          6. Bishop score based on sterile vaginal exam of less than or equal to 6, for which the
             cervical dilation is less than or equal to 2 cm.

          7. Equal to 3 or less uterine contractions over 10 minutes

        Exclusion Criteria:

          1. Previous uterine scar

          2. Contraindication to vaginal delivery

          3. Patients with preeclampsia

          4. Grand multiparty - greater than or equal to 5 live births or stillbirths

          5. Premature rupture of membranes

          6. Suspected intrauterine growth restriction

          7. Fetal anomalies

          8. Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
Condition: Dystocia
MeSH terms: Dystocia
Intervention: Oxytocin; Sodium Chloride 0.9%
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1003.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Oxytocin is a medication that is often used to strengthen contractions to overcome delayed
      labor progress. The primary aim of this study is to determine whether receiving a higher dose
      of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of
      oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and
      length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal
      Apgar score <5 at 5 minutes, and need for neonatal intensive care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to give informed written consent

          -  Age 18-45 years

          -  Nulliparous

          -  Pregnant with a live singleton gestation that is equal to or greater than 36 weeks

          -  Diagnosed with at least 6 regular uterine contractions in an observation period of no
             more than 60 minutes and at least one of the following: spontaneous rupture of
             membranes, OR cervix greater than or equal to 3 centimeters dilated OR cervix at least
             80% effaced.

          -  The participant's attending obstetric physician or midwife has determined that the
             participant needs administration of oxytocin infusion for labor augmentation. Labor
             augmentation will be defined as stimulation of uterine contractions when spontaneous
             contractions have failed to result in progressive cervical dilation of descent of
             fetus.

        Exclusion Criteria:

          -  Women not meeting the above criteria

          -  History of prior cesarean section or uterine surgery

          -  Fetus in non-cephalic presentation

          -  Participant is undergoing labor induction (i.e. cervical ripening)

          -  Non-English speaking
A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: mirabegron; solifenacin
Intervention description: oral; oral
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: mirabegron; solifenacin

Summary:

      The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on
      therapy in patients with OAB treated with solifenacin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female: postmenopausal OAB outpatient

          -  Male: OAB outpatient who did not wish to have children at all

          -  Patient had been treated with solifenacin at a stable dose once daily for at least 4
             weeks prior to the study

          -  Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3
             score ≥2 points

        Exclusion Criteria:

          -  Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or
             patients with benign prostatic hyperplasia, or lower urinary tract obstruction

          -  Patient had serious heart disease (myocardial infarction, cardiac failure,
             uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver
             disease, kidney disease, immunological disease, lung disease, etc. or patient had
             malignant tumor (except for malignant tumor that has not been treated for at least 5 y
             before the start of the screening period with no risk of recurrence)

          -  Patient had received surgical therapy that may affect the urinary tract function
             within 24 weeks before the start of the screening period
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Calcitriol
Intervention MeSH terms: Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of
      treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat
      pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 2 to 16 years and 11 months of age

          -  Clinical diagnosis of stable mild to moderate plaque psoriasis

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  Hypercalcemia

          -  Past history of kidney stones

          -  Vitamin D deficiency

          -  Other concomitant dermatological disease
Stress Ulcer Prophylaxis in the Intensive Care Unit
Condition: Gastrointestinal Bleeding; Stress Ulcers
MeSH terms: Gastrointestinal Hemorrhage; Ulcer
Intervention: Pantoprazole; Saline (0.9%)
Intervention description: 40 mg x 1 daily intravenously from ICU admission to ICU discharge; 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
Intervention MeSH terms: Pantoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3350.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stress ulcer prophylaxis; Proton pump inhibitor; Pneumonia; Clostridium difficile infection

Summary:

      Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however
      the quantity and quality of evidence is low and potential harm has been reported.

      The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton
      pump inhibitor in adult critically ill patients in the ICU.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Acute admission to the ICU

          -  Age ≥ 18 years

          -  One or more of the following risk factors:

               -  Shock (continuous infusion with vasopressors or inotropes, systolic blood
                  pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg or lactate > 4 mmol/l)

               -  Acute or chronic intermittent or continuous renal replacement therapy

               -  Invasive mechanical ventilation which is expected to last > 24 hours

               -  Coagulopathy (platelets < 50 x 109/l or international normalized ratio (INR) >
                  1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours

               -  Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)

               -  History of coagulopathy (platelets < 50 x 109/l or INR > 1.5 or PT > 20 seconds)
                  within 6 months prior to hospital admission

               -  History of chronic liver disease (portal hypertension, cirrhosis proven by
                  biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding
                  or hepatic encephalopathy in the past medical history)

        EXCLUSION CRITERIA:

          -  Contraindications to PPI

          -  Ongoing treatment with PPI and/or H2RA on a daily basis

          -  GI bleeding of any origin during current hospital admission

          -  Diagnosed with peptic ulcer during current hospital admission

          -  Organ transplant during current hospital admission

          -  Withdrawal from active therapy or brain death

          -  Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG

          -  Consent according to national regulations not obtainable
Weight Loss With Risedronate for Bone Health
Condition: Bariatric Surgery Candidate; Bone Loss; Weight Loss
MeSH terms: Body Weight; Weight Loss
Intervention: Risedronate Sodium 150 MG; Placebo
Intervention description: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.; Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Intervention MeSH terms: Risedronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks
Masking: Double (Participant, Care Provider)
Masking description: Both participant and research associate charged with administering medication or placebo capsules will be blinded.
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bone Health

Summary:

      This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and
      following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT)
      examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical
      weight loss associated loss of bone mass and quality.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects planning a sleeve gastrectomy procedure

          -  40-79 yrs of age

          -  Willingness to provide informed consent

          -  Agreement to all study procedures and assessments

        Exclusion Criteria

          -  Age <40 years

          -  Baseline weight >450 pounds

          -  Chronic anti-reflux treatment

          -  History of medical disorders known to affect bone metabolism

          -  Use of bone-active medications

          -  Known allergy to Risedronate
Prevention of Relapse & Recurrence of Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Recurrence; Depression; Bipolar Disorder
Intervention: Lithium / Fluoxetine; Lithium / Placebo
Intervention description: Individualized Daily Dosage; Individualized Daily Dosage
Intervention MeSH terms: Lithium Carbonate; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Manic Depression; Major Depressive Episode; Mania; Hypomania; Long Term Treatment

Summary:

      The purpose of this study is to determine whether the long-term use of combined
      antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in
      preventing the relapse and recurrence of bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men/women (all races and ethnicity)

          -  Age at least 18 years old

          -  Bipolar Type I Disorder

          -  Current Major Depressive Episode

          -  Able to understand and provide signed informed consent

        Exclusion Criteria:

          -  Current alcohol or drug abuse

          -  Alcohol or drug dependence within 3 months

          -  Allergic to Fluoxetine or Lithium

          -  Unstable medical condition (e.g., uncontrolled thyroid, renal, cardiovascular disease)

          -  Pregnant or nursing women

          -  Women of child-bearing potential unwilling to use a medically acceptable form of
             contraception

          -  Actively suicidal

          -  Requiring hospitalization

          -  Use of medication contraindicated with lithium or fluoxetine

          -  Unable to participate in a year-long trial