bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of PIEB vs CEI for Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Programmed Intermittent Epidural Bolus; Continuous Epidural Infusion; Ropivacaine; Fentanyl
Intervention MeSH terms: Fentanyl; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: epidural analgesia

Summary:

      The aim of this prospective, doubled-blinded randomized study is to compare two modes of
      epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus
      continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing,
      for providing labor epidural analgesia. The primary outcome will be the volume of local
      anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus,
      labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of
      successful to unsuccessful attempts, frequency of hypotension, duration of first and second
      stages of labor and level of patient satisfaction. The investigator plans to enroll 120
      nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The
      subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1%
      with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be
      analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be
      analyzed using Chi-square test or Fisher's exact test as appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiology (ASA) class 2 and 3 women

          -  Nulliparous

          -  Age > 18 yrs

          -  gestational age > 36 weeks

          -  singleton pregnancies

          -  vertex pregnancies

          -  spontaneous labor or scheduled induction of labor

          -  cervical dilatation 2-5 cm at time of epidural placement

          -  Pain score > 5

        Exclusion Criteria:

          -  BMI > 50 kg/m2

          -  history of past or current intravenous drug or chronic opioid abuse

          -  chronic analgesic use

          -  allergy or contraindication to any study medications

          -  any maternal or fetal condition requiring planned assisted stage 2 delivery
Conditioned Pharmacotherapeutic Effects in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: carvedilol
Intervention MeSH terms: Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension

Summary:

      The proposed research is designed to determine if the application of classical conditioning
      operations could influence the clinical effects of a regimen of antihypertensive drug
      therapy. It will be determined if, capitalizing on conditioned pharmacotherapeutic effects,
      patients can be effectively treated with smaller cumulative amounts of drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  systolic blood pressure between 140-160 mmHG

          -  between 18-80 years old

        Exclusion Criteria:

          -  abnormal renal function

          -  currently pregnant, or trying to become pregnant

          -  being treated with a beta-blocker

          -  use of illicit drugs
A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Fluticasone propionate; Placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers
      are now an established treatment for COPD. Inhaled steroids can have a number of bad effects
      including suppression of the adrenal glands because of absorption. A previous study in
      patients with COPD.

      C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation.
      Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP
      have also been found in patients with COPD. In some studies, steroid inhalers have reduced
      CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown
      whether this reflects a reduction in lung inflammation or an effect of systemically absorbed
      corticosteroid.

      It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung
      inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current or ex-smokers

          -  Aged over 50years

          -  FEV1/FVC ratio <0.7

          -  FEV1<80% predicted

          -  Improvement in FEV1 following short acting beta-agonist not greater than 15% and
             200ml.

        Exclusion Criteria:

          -  Diagnosis of asthma, bronchiectasis or ABPA

          -  Inability to perform study procedures or give informed consent

          -  Known sensitivity to trial medications
Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: olanzapine; risperidone; risperidone
Intervention description: 10-20 milligrams (mg), oral, daily, 10 weeks.; 2-6 mg, oral, daily, for 10 weeks.; 2-6 mg, oral, daily, 10 weeks
Intervention MeSH terms: Olanzapine; Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 628.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The current study has been designed to address the significance of early onset of response
      prospectively in patients treated with an atypical antipsychotic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must demonstrate acute psychopathologic severity criteria and be at least
             moderately ill.

          -  Patients must have experienced an exacerbation of their illness within the previous 2
             weeks.

          -  Patients in whom a switch to another antipsychotic medication is acutely indicated.

        Exclusion Criteria:

          -  Patients who are deemed nonresponsive to risperidone or olanzapine.

          -  Patients who have been hospitalized for greater than 2 weeks immediately prior to
             Visit 1.

          -  Patients having received olanzapine or risperidone in the past 30 days.

          -  Treatment with clozapine within 1 year prior to Visit 1.

          -  Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of
             Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any
             time during the study), or confirmed on clinical grounds within 72 hours subsequent to
             Visit 1 (or at any time during the study).

          -  A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.
Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging
Condition: Obesity, Visceral
MeSH terms: Obesity, Abdominal
Intervention: [U-13C3] glycerol; Empagliflozin; Placebo (for Empagliflozin)
Intervention description: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).; Active drug; Placebo tablet manufactured to mimic EMPA 10 mg tablet.
Intervention MeSH terms: Empagliflozin; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Visceral; Obesity; Adipose; Diabetes

Summary:

      This study is a clinical study to investigate the gluconeogenesis pathway related to visceral
      adipose tissue (VAT) in obese individuals without type 2 diabetes and the effects of
      empagliflozin (EMPA) on glucose homeostasis in viscerally-obese individuals using functional
      studies of glycerol metabolism in hepatic gluconeogenesis using a well-validated nuclear
      magnetic resonance (NMR) spectroscopy platform.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese, defined as BMI ≥ 30 kg/m2, at both time of abdominal fat imaging and at study
             entry.

          -  Ages 30-65

          -  No prevalent diagnosis of type 2 diabetes mellitus, either at the time of abdominal
             fat imaging or at study entry.

          -  Previous abdominal fat quantification by magnetic resonance imaging in the Dallas
             Heart Study or possible neck-to-knee MRI for VAT measurement may be performed.

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Incarcerated

          -  Chronic kidney or liver disease

          -  History of frequent (>2/year) urinary tract infections

          -  Non-obese either at time of abdominal fat imaging or at present.

          -  Greater than 10% change in body weight (kg) between time of abdominal fat imaging and
             present.

          -  Has donated blood within last 6 weeks

          -  Cannot give informed consent, understand the protocol, or tolerate any aspect of the
             protocol

          -  If undergoing MRI, persons with metal implants contraindicated for 3Tesla MRI exams
             will be excluded. Severe claustrophobia will also be assessed prior to an MRI exam.
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 8 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to investigate the relationship of changes in measures of
      academic performance and problem behaviors, to changes in core
      Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with
      atomoxetine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients between 8 and 11 years of age at study entry

          -  Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical
             Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease
             diagnostic criteria

          -  Patients who have never received medications psychotropic medications specifically to
             treat ADHD, or if they have received medication, that the trial of the psychotropic
             medication(s) was of less than 1 month duration, and occurred more than 6 months prior
             to study entry

          -  Normal intelligence in the judgment of the investigator

          -  Must be able to swallow capsules

        Exclusion Criteria:

          -  Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's
             syndrome, pervasive developmental disorder, or conduct disorder

          -  History of seizure disorder or currently taking anticonvulsants for seizure control

          -  Serious suicidal risk as determined by investigator

          -  Cardiovascular disease; current or past history of hypertension

          -  Previous treatment with atomoxetine
Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block
Condition: Fracture of Ankle
MeSH terms: Ankle Fractures
Intervention: Dexamethasone; Dexamethasone; Saline
Intervention description: IV dexamethsone 8mg in 50mL (diluted in NS); 8mg/2mL; 2mL
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Nerve Block; Anesthesia Recovery Period

Summary:

      Patients scheduled to have foot and ankle surgery will typically receive a single shot
      sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal
      post-operative analgesic plan. The investigators are investigating the use of perineural
      dexamethasone together with local anesthetics can improve the quality of recovery for
      patients receiving sciatic nerve blocks for foot and ankle surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for
             a single injection sciatic nerve block to provide postoperative analgesia.

          -  Surgery confined to the foot and ankle.

          -  Patients aged 18-70 years.

        Exclusion Criteria:

          -  ASA Classification of 4 or higher.

          -  Pre-existing neuropathy

          -  Coagulopathy

          -  Infection at the site

          -  Diabetes

          -  Non-English speaking or reading patients

          -  Systemic use of corticosteroids within 6 months of surgery

          -  Chronic opioid use

          -  Pregnancy

          -  Large (>3cm) skin incision around the medial aspect of the foot

          -  Any other contra-indication to regional anesthesia
A Pharmacodynamic Study With Ticagrelor in Hispanic Patients
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ticagrelor; Clopidogrel
Intervention description: Min - 90mg/Max - 180mg tablets (loading dose); 75mg (once daily)/Max - 600mg tablets (loading dose)
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stable Coronary Artery Disease, CAD

Summary:

      The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic
      patients with stable coronary artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures

          -  Male or female patients aged 18 years or older Documented stable CAD fulfilling and
             taking 75-100mg ASA daily treatment

          -  Females must be post menopausal or surgically sterile Self-identified as Hispanic

        Exclusion Criteria:

          -  Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or
             prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel,
             ASA dose other than 75 to 100 mg daily) during study period

          -  Patients who had ACS or stent placed within 12 months of screening Patients with a
             history of moderate or severe hepatic impairment

          -  Current smokers, including the use of tobacco containing products in the past 1 month
             of randomization

          -  Patients requiring dialysis
Lower Third Molar Removal With 2% and 4% Articaine
Condition: Impacted Third Molar Tooth; Adverse Reaction to Other Local Anesthetics
MeSH terms: Tooth, Impacted
Intervention: Surgery with 2%Articaine first, then Surgery with 4% Articaine; Surgery with 4%Articaine first, then Surgery with 2% Articaine
Intervention description: First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne); First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)
Intervention MeSH terms: Carticaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Articaine; Lower third molar; Oral Surgery

Summary:

      The present clinical trial randomized compared the clinical efficacy of the local anesthetics
      articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the
      removal of lower third molars. Onset, duration of postoperative analgesia, duration of
      anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters,
      postoperative mouth opening and wound healing at the 7th postoperative day were evaluated.
      For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower
      third molars, in two separate appointments (one to two months apart), under local anesthesia
      with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized
      and crossed manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Need of lower third molar surgeries in similar positions

        Exclusion Criteria:

          -  Presence of systemic diseases;

          -  Presence of local inflammation and/or infection;

          -  Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or
             ulceration;

          -  Cardiovascular and kidney diseases;

          -  Asthma and allergy to aspirin, piroxicam or any other non-steroidal antiinflammatory
             drug;

          -  Regular use of any non-steroidal antiinflammatory drug, pregnancy or breast feeding.
Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
Condition: ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)); c-PCI
Intervention description: The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration; conventional PCI without Guard wire
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 126.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ST-elevation myocardial infarction; percutaneous coronary intervention; cardiac magnetic resonance imaging; microvascular occlusion; myocardial salvage

Summary:

      The investigators examined the mechanism underlying the lack of benefit from distal
      protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial
      Infarction (STEMI) in a prospective, randomized trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  30 and less than 80 years presenting with STEMI

          -  more than 30 minutes but less than 12 hours after symptom onset

          -  with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably
             new left bundle-branch block

          -  for whom primary PCI was intended

        Exclusion Criteria:

          -  included thrombolytic therapy before PCI;

          -  spontaneous restoration of coronary flow (> TIMI grade II or III);

          -  cardiogenic shock (Killip class IV);

          -  major surgery or active bleeding within 6 weeks;

          -  aspirin, thienopyridine, or heparin allergy;

          -  neutropenia (<1000 neutrophils/mm3), thrombocytopenia (<100000 platelets/mm3), hepatic
             dysfunction, or renal insufficiency (serum creatinine level >2.5 mg/dL [221 μmol/L]);

          -  noncardiac condition with expected survival less than 1 year;

          -  current participation in other investigations.
Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients
Condition: Pain
MeSH terms: Emergencies
Intervention: Vapocoolant; Sterile water
Intervention description: Topical stream of 4 to 10 seconds duration to skin; Topical intervention of sterile water stream 4 to 10 seconds to skin.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vapocoolant

Summary:

      To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in
      decreasing the pain of intravenous cannulation.

      To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water)
      stream.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients needing intravenous cannulation

          -  Adults age 18 years equal or greater than.

          -  Stable patient

          -  Mentally competent patient able to understand the consent form

        Exclusion Criteria:

          -  Patients with any allergies to the spray components ( e.g.1,1,3,3, pentafluoropropane
             or 1,1,1,2 tetrafluoroethane )

          -  Critically ill or unstable patient (e.g. sepsis or shock)

          -  Infants and children of age , <18 years.

          -  Pregnant

          -  Intravenous cannulation site located in area of compromised blood supply. (ex:
             patients with Peripheral Vascular Disease , Raynaud's disease, gangrene, Buerger's
             disease)

          -  Intravenous cannulation site located in area of insensitive skin; such as , patients
             with a peripheral neuropathy including diabetic neuropathy.

          -  Patient intolerant of cold or with hypersensitivity to the cold.

          -  Patient unable or unwilling to give consent.