bioihbjkbjnl/mcl2 huggingface dataset:
Dexmedetomidine vs Fentanyl for BMT
Condition: Otitis
MeSH terms: Otitis
Intervention: Saline; Fentanyl; Dexmedetomidine; Dexmedetomidine
Intervention description: Normal saline, given intranasally; Fentanyl, nasal transmucosal, 2 micrograms/kilogram; Dexmedetomidine, transmucosal, 1 microgram/kilogram; Dexmedetomidine, 2 microgram/kilogram, transmucosal route
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexmedetomidine, transmucosal, myringotomy,

Summary:

      A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an
      α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet all of the following inclusion criteria to be eligible for
             participation:

               1. The subject is 6 months to 6 years of age

               2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA
                  1 or 2 (see appendix 1)

               3. The subject is scheduled for elective bilateral myringotomy with tube placement

               4. The subject's parent/legally authorized guardian has given written informed
                  consent to participate

                  Exclusion Criteria:

          -  Subjects will be excluded from study participation if any of the following exclusion
             criteria exists:

               1. The subject has a history or a family (parent or sibling) history of malignant
                  hyperthermia

               2. The subject has known significant renal or hepatic disorders determined by
                  medical history, physical examination or laboratory tests

               3. The subject has a known or suspected allergy to opioid analgesics or
                  dexmedetomidine

               4. The subject has history of. cardiovascular issues which would preclude the use of
                  dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where
                  hypotension is to be avoided)

               5. The subject has know central nervous system disease or neurological impairment

               6. The subject is an ASA classification of 3 or greater (See Appendix 1)

               7. The subject has a medical condition requiring an intravenous induction (i.e.
                  severe uncontrolled gastro-esophageal reflux)

               8. The subject refuses inhalation induction

               9. The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy,
                  tonsillectomy)
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
Condition: Non ST Segment Elevation Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Intervention: ticagrelor
Intervention description: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ticagrelor; loading dose; non-ST-segment elevation acute coronary syndromes; percutaneous coronary intervention; the antiplatelet effects; bleeding events; major adverse cardiac events

Summary:

      It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus
      conventional loading dose(180mg) will result in a higher inhibition of platelet
      aggregation(IPA) without increasing the bleeding events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures.

          -  Male or non-pregnant female; aged from 18 to 80 years old.

          -  Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to
             undergoing PCI.

        Exclusion Criteria:

          -  Any contraindication against the use of ticagrelor.

          -  On treatment with a P2Y12 receptor antagonist in past 30 days.

          -  Known allergies to aspirin or ticagrelor.

          -  On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).

          -  Known blood dyscrasia or bleeding diathesis.

          -  ST-segment elevation acute myocardial infarction.

          -  Non-ST segment elevation acute coronary syndrome with high-risk features warranting
             emergency coronary angiography.

          -  Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl;
             history of liver disease; an increased risk of bradycardia, and concomitant therapy
             with drugs interfering with CYP3A4 metabolism.
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Condition: Foot and Ankle Surgeries; Bunion
MeSH terms: Bunion
Intervention: Tranexamic Acid; Normal saline
Intervention description: administered prior to surgical incision; administered prior to surgical incision
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: foot and ankle surgeries; tranexamic acid; wound healing; blood loss

Summary:

      Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often
      underestimated. However there has been growing emphasis on identification of these injuries
      and practice patterns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA (American Society of Anesthesiology) class I-IV

          -  age 8-75.

        Exclusion Criteria:

          -  ASA class V

          -  morbid obesity

          -  patient refusal

          -  patients with known coagulopathy disorder

          -  renal insufficiency

          -  hepatic dysfunction

          -  serious cardiac disease

          -  an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be
             excluded.
Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Intervention: L-Epinephrine and Normal Saline (0.9%); L-Epinephrine and Hypertonic Saline (3%)
Intervention description: 1.5ml of 1:1,000 L-Epinephrine and 4 ml of 0.9% Normal Saline; 1.5ml of 1:1,000 L-Epinephrine and 4 ml of 3% Hypertonic Saline
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 2 Years
Healthy volunteers: No
Keywords: Bronchiolitis; L-Epinephrine; 3% Hypertonic Saline; Clinical Severity Score

Summary:

      To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity
      scores among children aged 6 weeks to 24 months with bronchiolitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6 weeks to 24 Months.

          -  First episode of wheezing

          -  Fever, cough and watery nasal discharge

        Exclusion Criteria :

          -  Any underlying cardiovascular disease.

          -  Prior wheezing.

          -  Clinical Severity Score > 9.

          -  Atopic dermatitis, allergic rhinitis or asthma.

          -  Oxygen saturation (SpO2) <85% on room air.

          -  Obtunded consciousness.

          -  Previous treatment with bronchodilators within 4 hours.

          -  Any steroid therapy within 48 Hours.
Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Condition: Genetic Risk for Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: donepezil HCL; Placebo
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study examines the sensitivity of functional MRI to detect brain changes caused by
      donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for
      Alzheimer's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal general cognitive function

          -  High Risk Group Only: Family history (1st degree relative) of AD

          -  Low Risk Group Only: No family history (1st or 2nd degree relative) of AD

          -  Visual and auditory acuity adequate for neuropsychological testing

        Exclusion Criteria:

          -  Current or past history of

          -  neurological illnesses/conditions

          -  head trauma with significant loss of consciousness

          -  medical illnesses/conditions that may affect brain function

          -  severe psychiatric disorder

          -  substance abuse

          -  unstable or severe cardiovascular disease or asthmatic condition

          -  history of stroke or transient ischemic attack
Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Dexmedetomidine; Propofol
Intervention description: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.; Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 12 Months
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea; MRI; Pediatrics; Dexmedetomidine; Propofol; Anesthesia

Summary:

      The purpose of this research study is to examine the effects of two commonly used anesthetic
      drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in
      children, adolescents, and young adults with a history of obstructive sleep apnea (OSA)
      having an MRI scan.

      The results of this study will help in making the best decisions regarding the anesthesia
      medications that are most appropriate for children, adolescents, and young adults with OSA
      during MRI studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with documented history of OSA by polysomnography who require anesthesia for
             MRI sleep study or MRI brain imaging study.

          2. Subjects must be 12 months to 25 years of age (inclusive)

          3. Either the subject (if subject's age is 18-25) or the subject's legally authorized
             representative has given written informed consent to participate in the study

        Exclusion Criteria:

          1. The subject has life-threatening medical conditions (American Society of
             Anesthesiologists Physical Status 4, 5 or 6). The American Society of
             Anesthesiologists (ASA) classification scale is a measure of physical status or how
             healthy the patient is. For our study, we will focus on children which are defined as
             ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease
             that is mild and well controlled (ASA II) or a child with systemic disease that is
             severe and controlled (ASA III).

          2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.

          3. The subject has a tracheostomy or other mechanical airway device

          4. The subject is not scheduled to receive anesthesia-sedation care for the MRI

          5. The subject has a history or a family (parent or sibling) history of malignant
             hyperthermia.
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Condition: Elderly; Pharmacokinetics; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Trospium Chloride
Intervention description: Extended release, 60 mg, oral daily
Intervention MeSH terms: Trospium chloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 65 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study evaluates the penetration through the blood-brain-barrier of trospium chloride at
      plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium
      levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured.
      Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change
      index to assess if any study subject shows evidence of a clinically and statistically
      significant change in memory.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 65-75 years of age without evidence of memory impairment

          -  Subject has overactive bladder symptoms but otherwise healthy

          -  Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine
             patches, etc., for 6 months prior to the screening visit)

          -  Weight within normal range

          -  Ability to follow study instructions and likely to complete all required visits

        Exclusion Criteria:

          -  Residual urine within bladder greater than 4 ounces

          -  Moderate or severe memory impairment

          -  Bleeding disorder

          -  Blood-thinning agents

          -  Concurrent overactive bladder medication

          -  Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine),
             Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for
             dementia

          -  Chronic kidney failure

          -  Abdominal bypass surgery for obesity
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Paroxetine; Prolonged Exposure Therapy
Intervention description: Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks; Weekly for 10 weeks
Intervention MeSH terms: Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PTSD; anxiety disorders; trauma

Summary:

      This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and
      the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of
      the World Trade Center (WTC) attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Posttraumatic Stress Disorder, chronic, related to World Trade Center Attacks

          -  Age 18-70

          -  CAPS score greater than 45

          -  Willingness to consent

          -  For women, negative pregnancy test and using adequate birth control

        Exclusion Criteria:

          -  Prominent suicidal ideation

          -  Current psychotic disorder

          -  Unstable medical illness

          -  Women who are pregnant or nursing mothers

          -  Alcohol or substance use disorder in the past 3 months

          -  History of seizure disorder

          -  conditions that contraindicate use of paroxetine

          -  inability to tolerate a drug free period prior to beginning the study of 4 weeks for
             MAOIs or fluoxetine and 2 weeks for other psychotropic drugs, except zolpidem for
             insomnia.
Evaluate Effects of Personalized Patient Counselling for Enbrel® Therapy in Adults With Rheumatoid Arthritis
Condition: Persistence to Enbrel
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Personalized Patient Counselling
Intervention description: In the interventional cohort participants enrolled on the study will receive personalized patient counselling using the IMS-model based on the baseline BMQ results through a patient assistance program for patients on Enbrel (Etanercept) therapy.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Enbrel; Rheumatoid Arthritis

Summary:

      This study will evaluate whether the effect of personalized patient counselling tool,
      Information-Motivation-Strategy (IMS) based on the results of the Beliefs about Medicines
      Questionnaire (BMQ) will improve persistence of Enbrel (etanercept) therapy at week 52 in
      subjects with rheumatoid arthritis over the historical control as estimated by the standard
      of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent prior to any study specific procedures

          -  diagnosed with rheumatoid arthritis and eligible for treatment with Enbrel®
             (etanercept)

          -  Subject has been prescribed and has access to commercial Enbrel® (etanercept) (50mg
             once weekly) according to the subject's health insurance

          -  Completion of all required safety assessments before starting treatment with Enbrel®
             (etanercept)

        Other Inclusion Criteria May apply.

        Exclusion Criteria:

          -  previously received treatment with a biologic disease modifying antirheumatic drug
             (DMARD) and/or Tofacitinib.

          -  Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in
             situ) within the last 5 years

          -  refusal to consent to enroll in the Enliven program

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 30 days since ending treatment on another investigational device or drug study(s)

        Other Exclusion Criteria May Apply.
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting (PONV); Nausea
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant; Ondansetron; Promethazine; Dexamethasone
Intervention description: Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction; Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction; Subject will receive 25 mg of Promethazine IV around anesthesia induction; Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Intervention MeSH terms: Promethazine; Diphenhydramine; Dexamethasone; Ondansetron; 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: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neurosurgery

Summary:

      This study is being done to determine the efficacies of two preventative drug combinations
      for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this
      study is to compare the efficacy of using aprepitant instead of ondansetron in combination
      with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By
      completing this comparison study investigators will determine the most efficacious drug
      combination which will allow us to enhance the overall comfort and satisfaction of
      neurosurgical patients in the immediate postoperative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients

          -  18 to 85 years of age

          -  Scheduled for neurosurgery requiring opening of the cranium and dura at Ohio State
             University Medical Center and who consent in writing to participate in this study are
             eligible.

        Exclusion Criteria:

          -  Patients will be excluded from this study if they are

               1. prisoners

               2. pregnant women

               3. mentally ill

               4. under the age of 18 or over the age of 85

               5. American Society of Anesthesiologist (ASA) classification V

               6. alcohol or drug abusers

               7. have a cerebral perfusion pressure (CPP) greater than 150 mmHg or less than 50
                  mmHg.
Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Xeomin®
Intervention description: Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 283.0
Sex: All
Minimum age: 18 Years
Maximum age: 81 Years
Healthy volunteers: No

Summary:

      This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals
      (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the
      response to treatment is comparable in both how it works and any side effects. Xeomin® is
      approved by the United States Food and Drug Administration (FDA) for the treatment of
      cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment
      intervals. An investigational use is one that is not approved by the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia

        Exclusion Criteria:

          -  Current treatment with botulinum toxin of any type for any other indication (including
             aesthetic indications) and for any body region during the study.