bioihbjkbjnl/mcl2 huggingface dataset:
Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant; Placebo
Intervention description: 40 mg administered orally with a sip of water prior to anesthesia induction.; Placebo
Intervention MeSH terms: Aprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Elective hysterectomy

Summary:

      The purpose of the study is to determine whether 40 mg aprepitant administered before surgery
      is effective for preventing vomiting in the first 24 hours after surgery in women undergoing
      elective hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for elective hysterectomy at Mayo Clinic in Arizona

          -  ASA I, II, or III

        Exclusion Criteria:

          -  Pregnancy

          -  Concomitant bowel surgery other than appendectomy

          -  Hypersensitivity to study drug or rescue medication

          -  Preoperative score for nausea greater than 4 out of 10 points

          -  Severe hepatic insufficiency (Child-Pugh score > 9)

          -  Any condition which impairs the patient's ability to complete study assessments

          -  Intraoperative hemodynamic instability

          -  ICU admission

          -  Prolonged postoperative intubation

          -  Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4
             activity

          -  Other antiemetic within 12 hours prior to surgery

          -  Participation in a clinical trial using an investigational product
Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
Condition: Sezary Syndrome; Pruritus
MeSH terms: Sezary Syndrome; Pruritus; Syndrome
Intervention: Aprepitant; Placebo
Intervention description: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.; Placebo will be given orally for a total of 7 days.
Intervention MeSH terms: Aprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sezary Syndrome; Pruritus; Aprepitant; Neurokinin-1

Summary:

      The purpose of this randomized, double-blinded, placebo-controlled study is to test the
      hypothesis that administration of aprepitant will decrease the severity of pruritus in
      patients with Sèzary Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known Sezary Syndrome

          -  Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale > 4.

          -  Age 18 through 80 years of age.

          -  Stable medication regimens for both Sezary Syndrome and pruritus for 3 months prior to
             study participation.

        Exclusion Criteria:

          -  Known hepatic impairment (defined as liver function tests >3 times the upper limit of
             normal).

          -  Pregnancy (all women of child-bearing potential will undergo urine beta-hcg testing).

          -  Concurrent use of pimozide, terfenadine, astemizole, or cisapride.
Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Intervention: Cocaine; Adrenaline
Intervention description: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).; Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).
Intervention MeSH terms: Epinephrine; Racepinephrine; Cocaine; Pharmaceutical Solutions; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endoscopic sinus surgery; Bleeding; Topical Vasocontriction; Cocaine; Adrenaline

Summary:

      The purpose of our study is to assess the effect of topical vasoconstriction (cocaine 4%
      versus adrenaline 1/1000) on the surgical field during endoscopic sinus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients older than 18 years undergoing bilateral ESS for chronic sinusitis.

        Exclusion Criteria:

          -  Patients with heart disease

          -  History of bleeding diathesis

          -  Patients with untreated or poorly controlled high blood pressure

          -  Aspirin, anticoagulant or natural herbal medication usage in the last 4 weeks

          -  Hypersensitivity to adrenaline or cocaine

          -  Significant asymmetry between the right and left side disease extent as determine by
             findings on their pre-operative CT scan and nasal endoscopy.
Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Intervention: Mesh Fixation
Intervention description: Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 16 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hernia, laparoscopic, recurrence, pain, inguinal

Summary:

      The purpose of the study is

        1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal
           hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia

        2. To test whether non-fixation of mesh leads to less pain compared to the repair when the
           mesh is fixed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All reducible inguinal hernias will be included in the study

        Exclusion Criteria:

          -  Irreducible hernia after anesthesia

          -  Obstructed and strangulated hernias

          -  Pediatric hernias

          -  Associated other hernias like ventral hernias

          -  Unfit for spinal anesthesia
The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Donepezil
Intervention description: 2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Alzheimer's disease

Summary:

      This study attempts to differentiate the clinical responses of Choline Acetyltransferase and
      Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
    

Eligibility criteria:

        Inclusion criteria:

          1. Age: 60 - 90 years old.

          2. CDR: 0.5 - 2.0.

          3. Patients who do not have severe depressive symptoms that affect cognition on
             depression scale of CERAD-K(C), GDS-K: 19 and below.

          4. Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.

          5. NINCDS-ADRDA criteria: Probable AD.

        Exclusion criteria:

          1. Patients who have delusions and other conscious dysfunction.

          2. Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor,
             normal pressure hydrocephalus, etc., on history and neurologic examination.

          3. Patients who have history of infectious and inflammatory brain disease owing to virus,
             fungus and syphilis.

          4. Patients with severe cerebrovascular pathology.

          5. Patients who have present history of major psychological diseases such as depression
             and mania according to DSM-IV criteria.

          6. Patients who have history of alcoholism or drug addiction.

          7. Patients who have severe depressive symptoms that affect cognition on depression scale
             of CERAD-K.
Metformin Versus Insulin in Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Intervention: metformin; insulin
Intervention description: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily; subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: Female
Healthy volunteers: No
Keywords: gestational diabetes; metformin; insulin

Summary:

      Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used
      worldwide in the treatment of type 2 diabetes and also in a few studies on patients with
      gestational diabetes. The investigators aim is to compare insulin and metformin in the
      treatment of gestational diabetes. The investigators hypothesis is that there is no
      difference between insulin and metformin treated mothers in the main outcome criteria (birth
      weight, neonatal complications).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mothers with gestational diabetes who had at least twice plasma glucose at fasting >
             5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks

        Exclusion Criteria:

          1. Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or
             Glycosylated hemoglobin A1c (HbA1c) > 7.0%

          2. Renal, hepatic or cardiac failure

          3. Pregestational use of metformin

          4. Pregnancy with multiple fetuses
Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia
Condition: Asthma
MeSH terms: Asthma
Intervention: Symbicort (Budesonide/Formoterol)
Intervention description: Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 862.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Symbicort SMART

Summary:

      The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy
      (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a
      real life situation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent

          -  Asthma diagnosis at least 6 months before visit 1 of study

          -  Patients who have reversible airway obstruction continuous asthma treatment except
             Symbicort at least within 4 weeks before visit 1 of study

        Exclusion Criteria:

          -  Known or suspected allergy to active ingredients of study medication or excipients

          -  Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study

          -  Smoking, current or previous with a smoking history of ≥ 10 pack years
Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study
Condition: Subarachnoid Hemorrhage; Intracranial Hemorrhage; Ischemic Strokes; Subdural Hematoma
MeSH terms: Ischemic Stroke; Subarachnoid Hemorrhage; Intracranial Hemorrhages; Hematoma, Subdural; Hemorrhage; Hematoma
Intervention: Glycerna; Jevity - Control Diet
Intervention description: Diabetes specific formula; Control Diet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: glycemic control; glycemic variability; mean blood glucose level

Summary:

      Primary Objective:

      To determine the effects of a diabetes specific enteral formula compared to a standard
      formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose
      and glycemic variability in a homogenous group of critically ill patients in a neurological
      ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor.
      The primary end points will be the difference between the mean blood glucose levels and the
      glucose variability between the control and intervention groups for the time period that the
      patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.

      Secondary Objectives:

      To determine the effects of the diabetes specific versus standard tube feeds on the change in
      muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients
      ICU stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged between 18 and 89 years old

          -  Patients with critical illness including ischemic or hemorrhagic stroke,
             epidural/subdural bleeds and subarachnoid hemorrhage

          -  Patients who are expected to stay in the ICU for at least 5 days

          -  Hyperglycemia is not an inclusion criteria

        Exclusion Criteria:

          -  Patients who have received or will be treated with systemic corticosteroids.

          -  Patients who will be receiving high doses of propofol (>40 cc/hr)

          -  Patients with type 1 Diabetes

          -  Patients with sepsis or acute trauma

          -  Patients with an expected stay in the ICU of less than 4 days

          -  Patients who are unable to receive enteral nutrition or who have medical conditions
             precluding nutrition by the enteral route including allergies to formula components

          -  Pregnant and lactating patients

          -  Patients with prior history of gastroparesis

          -  Patients with acute kidney failure (creatinine > 2.5mg/dl)

          -  Patients with acute liver failure (bilirubin > 2.0 mg/dl)
Treatment of Insomnia and Glucose Metabolism
Condition: Sleep; Insomnia; Insulin Resistance
MeSH terms: Sleep Initiation and Maintenance Disorders; Insulin Resistance
Intervention: Eszopiclone; Placebo
Intervention description: Eszopiclone 3 mg by mouth daily at bedtime for 9 days; Placebo by mouth daily at bedtime for 9 days
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sleep; eszopiclone; insulin secretion; insulin action; glucose tolerance

Summary:

      Available data suggest that obtaining adequate sleep is associated with a better ability of
      the body to use carbohydrates as a source of energy and a lower risk of developing diabetes.
      The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug
      Administration for the treatment of people who complain of trouble falling or staying asleep.
      This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the
      sleep of people with insomnia may also improve the use of sugar in their body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age between 35 and 64

          -  must have long-standing trouble falling or staying asleep

          -  BMI between 22 and 34 kg/m2

        Exclusion Criteria:

          -  sleep apnea or other sleep disorder other than insomnia

          -  diagnosis of diabetes requiring treatment with pills or insulin

          -  smoking

          -  night or shift work

          -  presence of a medical condition that can disrupt sleep

          -  women only: irregular menstrual periods or pregnancy

          -  use of medications/compounds that can disrupt sleep
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Condition: HIV Infections; Fatigue
MeSH terms: Fatigue
Intervention: Armodafinil; Placebo
Intervention description: Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.; Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Armodafinil; Depression

Summary:

      This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is
      effective in reducing fatigue in adults with HIV/AIDS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18-75

          2. HIV+

          3. Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus
             impairment on 1+ categories of Role Function Scale)

          4. Fatigue duration for 3+ months

          5. English-speaking

          6. Able to give informed consent

          7. Fecund women uses barrier method of contraception

        Exclusion Criteria:

          1. Primary care doctor does not approve of study participation

          2. Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic
             infection in past month)

          3. Untreated hypogonadism, except for men for whom testosterone replacement is medically
             contraindicated (serum testosterone below the reference range)

          4. Untreated hypothyroidism (Thyroid Stimulating Hormone over 5 IUI/mL)

          5. Untreated and uncontrolled hypertension

          6. Clinically significant anemia (hematocrit <30%)

          7. Started testosterone or nandrolone in past 6 weeks

          8. Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the
             change; otherwise, started or changed regimen in past 2 months

          9. Untreated or under-treated major depressive disorder

         10. Started antidepressant medication within past 6 weeks

         11. Substance abuse/dependence (past 4 months)

         12. Regular and frequent cannabis use (> twice/week regularly)

         13. Currently clinically significant suicidal ideation or Hamilton Depression Scale
             (HAM-D) score >24

         14. History or current psychosis or bipolar disorder

         15. Pregnant or breastfeeding

         16. Significant untreated insomnia (score >3 on HAM-D insomnia items)

         17. Currently taking psychostimulant medication or past nonresponse to modafinil

         18. Has no alternative viable antiretroviral regimen after the current one

         19. Left ventricular hypertrophy; mitral valve prolapse
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
Condition: Uterine Atony; Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Uterine Inertia; Hemorrhage
Intervention: Oxytocin
Intervention description: See arms
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1798.0
Sex: Female
Healthy volunteers: No
Keywords: Uterine atony; Postpartum hemorrhage; clinical trial; Prophylactic oxytocin

Summary:

      This is a double-blind 3-arm randomized clinical trial to determine whether higher dose
      oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony
      and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the
      uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of
      maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and
      effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not
      known.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 24 weeks, viable pregnancy, singleton or twins

        Exclusion Criteria:

          -  No consent

          -  Contraindication to oxytocin

          -  Antepartum fetal demise

          -  Intrapartum use of concentrated oxytocin

          -  Planned cesarean

          -  DIC or coagulopathy