bioihbjkbjnl/mcl2 huggingface dataset:
Labetalol and Esmolol: Vital Signs and Post Operative Pain Management
Condition: Laparoscopic Surgery
Intervention: Fentanyl; Labetalol; Esmolol
Intervention description: Fentanyl 50 micrograms/ml boluses will be given:
at the induction time
at the time before surgical incision, and
as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Labetalol 5 mg/ml boluses will be given:
at the induction time
at the time before surgical incision, and
as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Esmolol 10 mg/ml boluses will be given:
at the induction time
at the time before surgical incision, and
as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Intervention MeSH terms: Labetalol; Fentanyl; Esmolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Labetalol; Esmolol; Fentanyl; Anesthetic adjuvant; Ambulatory surgery; Outpatient surgery; Pain management; Hemodynamic stability; Perioperative outcomes

Summary:

      This study proposes to investigate the effects of labetalol or esmolol on managing the vital
      signs (like blood pressure and heart rate) during surgery, on pain management, and on the
      later recovery after surgery.

      It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo outpatient surgery procedures

          -  Willingness and ability to sign an informed consent document

          -  No allergies to anesthetic or analgesic medications

          -  18 - 80 years of age

          -  American Society of Anesthesiologists (ASA) physical status classification I - III
             adults of either sex

          -  Women of childbearing potential must be currently practicing an acceptable form of
             birth control, and have a negative urine pregnancy test

        Exclusion Criteria:

          -  Patients with known allergy, hypersensitivity or contraindications to anesthetic or
             analgesic medications

          -  Patients with clinically-significant medical conditions, such as brain, heart, kidney,
             endocrine, or liver diseases, peptic ulcer disease or bleeding disorders

          -  Pregnant or lactating women

          -  Subjects with a history of alcohol or drug abuse within the past 3 months

          -  Any other conditions or use of any medication which may interfere with the conduct of
             the study
Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Nitroglycerin
Intervention description: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal
      administration of Nitroglycerin. Aim of this prospective research study is to investigate
      equivalence on image quality after sublingual or transdermal Nitroglycerin administration
      (H0).

      Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled cCTA with contrast.

          2. Able to comprehend and sign the consent form.

        Exclusion Criteria:

          1. Known hypersensitivity to glyceryl trinitrate, and related organic nitrates.

          2. Acute circulatory failure associated with marked hypotension (shock).

          3. Conditions associated with elevated intracranial pressure, cerebral haemorrhage and
             head trauma.

          4. Closed-angle glaucoma.

          5. Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®), tadalafil
             (Cialis), or vardenafil (Levitra) within the last 24 hours

          6. Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)

          7. Critical aortic stenosis

          8. Systolic blood pressure < 90 mmHg

          9. Pregnant or lactating female; premenopausal women with a positive urine pregnancy
             test.

         10. Age under 18

         11. Unwilling or unable to inform consent.
A Smoking Cessation Intervention for Yale Dining Employees
Condition: Smoking Cessation
Intervention: Contingency management; Nicotine replacement therapy; Varenicline; Additional behavioral support
Intervention description: Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.; Participants have the option of using nicotine patch in combination with nicotine gum or lozenge; Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative; Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a smoking cessation program for employees at the
      Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3
      control sites) will be offered a contingency management/pharmacotherapy smoking cessation
      intervention at the work site.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current smoker

          -  Interested in receiving treatment for quitting smoking.

          -  Employed for more than 20 hours per week by one of the 7 residential college dining
             halls selected for inclusion in this study.

          -  English speaker.

        Exclusion Criteria:

          -  None specified, other than failure to meet all inclusion criteria listed above.
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Condition: Bleeding Peptic Ulcer
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Intervention: argon plasma coagulation; hemoclipping
Intervention description: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan); clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention device: argon plasma coagulation ( (PSD-60/Endoplasma, Olympus Corp., Tokyo,Japan) ; hemoclipping (Olympus HX 110/610) Intervention drug: distilled water design setting: argon plasma coagulation plus distilled water injection vs hemoclipping plus distilled water
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: argon plasma coagulation; hemoclipping; distilled water injection

Summary:

      Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper
      gastrointestinal bleeding. However, the additional hemostatic efficacy of argon plasma
      coagulation (APC) has not been widely investigated. We designed a randomized trial comparing
      APC plus injection therapy vs hemoclipping plus injection therapy for peptic ulcer bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

        ． high-risk peptic ulcer bleeding. High-risk bleeding ulcers were defined as participants
        with stigmata of a bleeding visible vessels (eg, spurting, oozing), a non-bleeding visible
        vessels (NBVV) or adherent clot.4 A NBVV at endoscopy was defined as a raised red, red-blue
        or pale hemispheric vessel protruding from the ulcer bed, without active bleeding. An
        adherent clot was defined as an overlying blood clot that was resistant to vigorous
        irrigation.

        Exclusion Criteria:

          -  the presence of another possible bleeding site (eg, gastroesophageal varix, gastric
             cancer, reflux esophagitis)

          -  coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial
             infarction, surgical abdomen)

          -  treatment with an anticoagulant (eg, warfarin)

          -  pregnancy

          -  the presence of operated stomach

          -  refusal to participate in the study
Lymphedema Study for Arm or Leg Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Intervention: Ketoprofen; Placebo
Intervention description: Placebo to match ketoprofen.
Intervention MeSH terms: Ketoprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Lymphedema; edema; swelling

Summary:

      This study compares the effectiveness of a study drug versus placebo in the treatment of
      lymphedema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a history of lymphedema of one or more limbs (unilateral or bilateral), with a
             duration of > 6 months.

        Exclusion Criteria:

          -  Patients with active cancer, infection or bleeding tendency will be excluded.

          -  We will also exclude patients with medical contraindications to NSAIDs, including
             history of allergies, know gastrointestinal intolerance, or other serious systemic
             illness (e.g., renal failure, hepatic dysfunction, congestive heart failure,
             neurological or psychological impairment) that would impair the patients' ability to
             participate.

          -  Minors (<18 years of age) *>90 years of age
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
Condition: Uveitis, Posterior; Uveitis, Intermediate; Panuveitis
MeSH terms: Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis
Intervention: Acthar Gel
Intervention description: Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.

      Also, safety information when using it for this purpose will be collected.
    

Eligibility criteria:

        Inclusion criteria:

          -  Is male or nonpregnant, nonlactating female

          -  Has been diagnosed with current severe NIPPU

          -  Has active disease at the Baseline Visit as defined by the presence of at least 1 of
             the following parameters in at least one eye despite at least 2 weeks of maintenance
             therapy with oral prednisone (or oral corticosteroid equivalent):

               1. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular
                  lesion

               2. Has ≥ 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN)
                  criteria]

               3. Has ≥ 1.5+ vitreous haze

          -  Is willing to taper current doses of corticosteroid and immunomodulatory therapy to
             the minimum effective dose during the study.

          -  If under treatment with any immunosuppressants, immunomodulators, or biologic agents
             for a comorbid condition, has been on a stable dose for 2 weeks before screening

        Exclusion criteria:

          -  Has proliferative or severe nonproliferative diabetic retinopathy, clinically
             significant macular edema due to diabetic retinopathy, neovascular/wet age-related
             macular degeneration, abnormality of vitreoretinal interface with the potential for
             macular structural damage independent of the inflammatory process or severe vitreous
             haze that precludes visualization of the fundus at the Baseline Visit

          -  Has Type 1 or Type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic
             ulcer, active infection, or any contraindication for treatment with Acthar Gel
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Condition: Tetralogy of Fallot; Transposition of the Great Vessels With an Arterial Switch; Single Ventricle With a Fontan Palliation
MeSH terms: Heart Diseases; Heart Defects, Congenital; Univentricular Heart; Tetralogy of Fallot; Transposition of Great Vessels
Intervention: Eplerenone
Intervention MeSH terms: Eplerenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Hypothesis:

      By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the
      great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident
      heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias
      decreased through decreases in myocardial fibrosis.

      Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6
      minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months
      without therapy, after 6 months on therapy, then finally after 12 months of eplerenone
      therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12
      months on therapy. Patients will be randomly assigned to drug free period up front versus at
      the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated
      up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at
      enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for
      monitoring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of tetralogy of Fallot, transposition of the great vessels with
             a systemic right ventricle, or Fontan type palliation

          -  Patient followed regularly at Washington University-affiliated institution

          -  If female, willing to use 2 forms of contraception including one barrier method during
             protocol

        Exclusion Criteria:

          -  GFR <30 ml/min

          -  Potassium >5.0 mmol/L

          -  Unable or unwilling to comply with study protocol

          -  Use of potassium sparing diuretics

          -  Use of an aldosterone blocker currently or previously

          -  Known intolerance of eplerenone or aldosterone blockade

          -  Pregnant, breastfeeding, or actively trying to get pregnant
Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia
Condition: Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Intervention: Sugammadex Injection [Bridion]; Neostigmine+Glycopyrronium
Intervention description: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.; Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe.
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 2 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: emergence delirium; tonsillectomy

Summary:

      The aim of this study is to investigate the effect of sugammadex vs. a conventional
      acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during
      sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features
      of sugammadex compared to neostigmine will be examined by measuring the time from start of
      administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and
      0.9.

      Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty
      during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of
      neuromuscular blockade with sugammadex in pediatric patients maintained with
      sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular
      blockade and decreased possibility of residual blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologist (ASA) physical status I or II, preschool children
             scheduled for an elective tonsillectomy with or without adenoidectomy will be included
             in the study.

        Exclusion Criteria:

          -  Patients will be excluded in cases of emergency surgery, developmental, psychological,
             cognitive or communication disorders, known or suspected neuromuscular disorders that
             may impair neuromuscular blockade, significant renal or hepatic dysfunction,
             coagulation disorders, family history of malignant hyperthermia, allergy to any of the
             drugs included in the study protocol, or usage of medication known to interact with
             rocuronium or sugammadex.
Study to Assess the Efficacy and Safety of Raxone in LHON Patients
Condition: Leber's Hereditary Optic Neuropathy (LHON)
MeSH terms: Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Intervention: Idebenone
Intervention MeSH terms: Idebenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy
      and safety of Raxone® in the long-term treatment of LHON patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Impaired visual acuity in affected eyes due to LHON

          2. No explanation for visual loss besides LHON

          3. Age more or equal 12 years

          4. Onset of symptoms ≤5 years of Baseline

          5. Confirmation of either G11778A, G3460A or T14484C LHON mtDNA (for the Intent-to Treat
             (ITT) population, not required for enrolment)

          6. Written informed consent obtained from the patient

          7. Ability and willingness to comply with study procedures and visits

          8. Women of Childbearing Potential (WCBP) who have a negative urine or serum pregnancy
             test at Baseline visit and who are willing to use a highly effective contraceptive
             measure and maintain it until treatment discontinuation.

        Exclusion Criteria:

          1. Patient has provided natural history data to the Case Record Survey (SNT-CRS-002)

          2. Any previous use of idebenone

          3. Any other cause of visual impairment (e.g. glaucoma, diabetic retinopathy, AIDS
             related visual impairment, cataract, macular degeneration, etc.) or any active ocular
             disorder (uveitis, infections, inflammatory retinal disease, thyroid eye disease,
             etc.)

          4. Known history of clinically significant elevations (greater than 3 times the upper
             limit of normal) of aspartate aminotransferase (AST), alanine transaminase (ALT) or
             creatinine

          5. Patient has a condition or is in a situation which, in an investigator's opinion may
             put the patient at significant risk, may confound study results or may interfere
             significantly with the patient's participation in the study

          6. Participation in another clinical trial of any investigational drug within 3 months
             prior to Baseline

          7. Hypersensitivity to the active substance or to any of the following excipients (as
             listed in section 6.1 of Raxone SmPC): Lactose monohydrate, Microcrystalline
             cellulose, Croscarmellose sodium, Povidone K25, Magnesium stearate, Colloidal silica,
             Macrogol 3350, Poly(vinyl alcohol), Talc, Titanium dioxide, Sunset yellow FCF (E110).

          8. Women who are pregnant or have a positive pregnancy test at Baseline visit

          9. Women who are breastfeeding
Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects
Condition: Endothelial Dysfunction
Intervention: Ezetimibe
Intervention MeSH terms: Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to show that Ezetimibe will improve endothelial function
      following high cholesterol meals in healthy subjects by decreasing absorption of cholesterol
      and thus affecting concentration and composition of remnant-like particles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy adults over 18 yrs of age

        Exclusion Criteria:

          -  presence of known metabolic syndrome

          -  as history of coronary artery disease

          -  hypertension

          -  diabetes

          -  cardiomyopathy

          -  tobacco use