bioihbjkbjnl/mcl2 huggingface dataset:
Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Telmisartan 80 mg and amlodipine 5 mg; Placebo (for telmisartan and amlodipine)
Intervention description: Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 64.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: atrial fibrillation; catheter ablation; left atrium; mechanical function; contractility

Summary:

      The objective of the study was to estimate the efficacy of telmisartan and amlodipine
      combination on the restoration of left atrial mechanical function after atrial fibrillation
      catheter ablation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic (III-IV class by European Heart Rhythm Association scale) paroxysmal
             atrial fibrillation;

          -  Ineffective therapy by at least one of the class I or III antiarrhythmic drugs;

          -  Left atrial diameter 5 cm or less;

          -  Estimated catheter radiofrequency pulmonary vein antrum isolation;

          -  Signed informed consent.

        Exclusion Criteria:

          -  Intolerance/allergy or contraindications to telmisartan, amlodipine, warfarin or
             enoxaparin;

          -  Left atrial thrombosis;

          -  Age greater than 75 years;

          -  Severe (e.g. decompensation of vital functions) or acute (e.g. pneumonia) somatic
             conditions;

          -  Malignant growth in the hematogenic dissemination stage.
BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Condition: Colonoscopy; Bowel Preparation; Endoscopy
Intervention: SUPREP Bowel Prep Kit; FDA approved bowel preparation containing electrolytes
Intervention description: solution for oral administration prior to colonoscopy; solution for oral administration prior to colonoscopy
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved
      control as bowel preparations prior to colonoscopy in adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female outpatients who are undergoing colonoscopy for a routinely accepted
        indication.

        At least 18 years of age

        If female, and of child-bearing potential, is using an acceptable form of birth control

        Negative urine pregnancy test at screening, if applicable

        In the Investigator's judgment, subject is mentally competent to provide informed consent
        to participate in the study

        Exclusion Criteria:

        Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
        obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

        Subjects who had previous significant gastrointestinal surgeries

        Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically
        significant electrolyte abnormalities based on screening laboratory results, such as
        hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or
        those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

        Subjects with a prior history of renal, liver or cardiac insufficiency

        Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

        Subjects undergoing colonoscopy for foreign body removal and/or decompression.

        Subjects who are pregnant or lactating, or intending to become pregnant during the study.

        Subjects of childbearing potential who refuse a pregnancy test.

        Subjects allergic to any preparation components.

        Subjects who, in the opinion of the Investigator, should not be included in the study for
        any reason, including inability to follow study procedures.

        Subjects who have participated in an investigational surgical, drug, or device study within
        the past 30 days.

        Subjects who withdraw consent before completion of Visit 1 procedures.
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Condition: Type 2 Diabetes Mellitus; Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: iobitridol; gadoterate meglumine
Intervention description: Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.; Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study aimed to prospectively investigate the prevalence of myocardial scar on
      Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients
      with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery
      disease on Cardiac Computed Tomography Angiography (CCTA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with onset of type 2 diabetes occurred at age 30 years or older

          -  Patient between the ages of 50 and 75 years at enrolment time

          -  Patient with at least two identified cardiac risk factors who will undergo a CMR and a
             CCTA examinations to evaluate his/her coronary and cardiac status

        Exclusion Criteria:

          -  Patient with angina pectoris or chest discomfort

          -  Patient with stress test or invasive coronary angiography within the prior 3 years

          -  Patient with history of myocardial infarction, overt non compensated heart failure, or
             coronary revascularization

          -  Patient with hemodynamic instability.

          -  Patient with a contraindication or intolerance to Beta-Blocker administration
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Condition: Peritoneal Dialysis Complication; Hyperphosphatemia; Hypoalbuminemia
MeSH terms: Hypoalbuminemia; Hyperphosphatemia
Intervention: Sucroferric Oxyhydroxide Chewable Tablet
Intervention description: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Intervention MeSH terms: Ferric Compounds
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Prospective pilot study to determine if changing the phosphate binder to sucroferric
      oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in
      peritoneal dialysis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7

          -  Use of Automated Peritoneal Dialysis

          -  Serum phosphate > 5.5 mg/dL or <5.5 mg/dL on a binder other than velphoro

          -  Serum albumin ≤ 3.7 g/dL

          -  Able to provide consent

          -  Ability to complete self-reported questionnaire

        Exclusion Criteria:

          -  Inadequate dialysis

          -  Current use of sucroferric oxyhydroxide

          -  Significant comorbid conditions that lead the investigator to conclude that life
             expectancy is less than 6 months

          -  Active malignancy

          -  Recent episode of peritonitis

          -  Pregnancy or planning to become pregnant

          -  Anticipated kidney transplantation within 6 months

          -  Factors judged to limit adherence to interventions

          -  Known adverse side effect to sucroferric oxydroxide
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
Condition: Lung Diseases, Obstructive; Sarcoidosis; Wegener's Granulomatosis; Rhinoscleroma; Recurrent Respiratory Papillomatosis
MeSH terms: Respiratory Tract Infections; Papillomavirus Infections; Rhinoscleroma; Papilloma; Lung Diseases; Granulomatosis with Polyangiitis; Lung Diseases, Obstructive; Sarcoidosis
Intervention: CryoSpray Ablation
Intervention description: Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days
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
Keywords: Benign Airway Disease; Airway Injury; Sarcoidosis; Wegener's Granulomatosis; Rhinoscleroma; Recurrent Respiratory Papillomatosis(RRP)

Summary:

      The purpose of this study is to evaluate the safety, effectiveness, and side effects of the
      CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat
      benign airway disease in the lung using liquid nitrogen sprayed through a catheter via
      flexible fiber optic bronchoscopy (FFB)
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  Deemed a candidate for cryotherapy based on physician physical or medical history
             review

          -  Deemed operable based on institutional criteria.

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Planning to sire a child while enrolled in the study

          -  Known history of unresolved drug or alcohol dependency that would limit ability to
             comprehend or follow instructions related to informed consent, post-treatment
             instructions, or follow-up guidelines.

          -  Refusal or inability to give consent.

          -  Concurrent chemotherapy.

          -  Prior radiation therapy which involved the any area between the vocal chords and the
             diaphragm

          -  Medical contraindication or potential problem that would preclude study participation

          -  Concurrent participation in other experimental studies Uncontrolled coagulopathy or
             bleeding diathesis

        Serious medical illness, including:

          -  Uncontrolled congestive heart failure

          -  Uncontrolled angina

          -  Myocardial infarction

          -  Cerebrovascular accident within 6 months prior to study entry
Pain Management in Response to Exparel vs. Standard Bupivicaine
Condition: Pain
Intervention: Liposomal Bupivicaine; 0.25% standard bupivicaine
Intervention description: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.; standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exparel; Thoracoscopy; Bupivicaine; Liposomal

Summary:

      This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on
      decreasing the amount of consumed pain medications.

      Patients will be randomly selected to received either Exparel or standard bupivicaine
      injection during surgery. Patients will be followed up to assess pain levels using a visual
      pain scale, and to assess how much pain medication was consumed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients over 18 years of age

          -  Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

        Exclusion Criteria:

          -  Previous ipsilateral thoracic surgery

          -  Need for operative pleurectomy or pleurodesis

          -  Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs
             (NSAIDs), sedatives, or hypnotics

          -  Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or
             acetaminophen

          -  Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)

          -  Renal dysfunction (eGFR < 60ml/min/1.73m2)

          -  History of peptic ulcerative disease

          -  Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen
             supplementation

          -  Inability to consent

          -  Pregnancy

          -  Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy

          -  Patient is discharged from the hospital with a chest tube in place

          -  Patient fails to comply with post-operative instructions
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]
Intervention description: Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in
      patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A
      (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180
      micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free
      follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 18-65 years of age

          -  HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve

          -  Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)

        Exclusion Criteria:

          -  Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)

          -  Evidence of decompensated liver disease

          -  A medical condition associated with chronic liver disease other than viral hepatitis
A Comparison of Tumescence in Breast Reduction Surgery
Condition: Pain, Postoperative; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Intervention: Tumescent solution with dilute lidocaine and epinephrine; Tumescent Solution with dilute epinephrine
Intervention description: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000); Tumescent Solution containing dilute epinephrine (1:1,000,000) only
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Pharmaceutical Solutions; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain, postoperative; Postoperative Nausea and Vomiting; Patient Readmission; Time to Discharge

Summary:

      The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent
      solution containing both dilute lidocaine and epinephrine will lead to better control of
      postoperative pain, nausea, vomiting, shorter time through postoperative phases of care,
      quicker discharge from the hospital and lower numbers of hospital readmissions than the use
      of tumescent solution containing only dilute epinephrine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients presenting for breast reduction surgery at the University of Wisconsin
             Hospital and Clinics and the University of Wisconsin Transformations Surgery Center
             and who do not meet any of the exclusion criteria.

        Exclusion Criteria:

          -  Women under the age of 18 years

          -  Breast feeding or pregnant women

          -  Incarcerated women.

          -  Women unable to give consent because of impaired decision making ability.

          -  Women who have reported allergies to the substances that will be used in the study.
Use of Cidofovir for Recurrent Respiratory Papillomatosis
Condition: Recurrent Respiratory Papillomatosis
MeSH terms: Respiratory Tract Infections; Papillomavirus Infections; Papilloma; Recurrence
Intervention: Cidofovir; Placebo
Intervention description: With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults. The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected. Because the volumes of cidofovir injected into the airway will be reasonably small (typically less than 2 mL), the total systemic dose of cidofovir administered per visit will be far below the FDA-approved systemic limit of 5 mg/kg for HIV-related CMV retinitis.; On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
Intervention MeSH terms: Cidofovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No

Summary:

      Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx
      in the pediatric population. The impact of the disease on patients and families can be
      tremendous due to the need for frequent treatment. It would be highly beneficial to develop
      effective medical therapies as adjunctive measures to surgical ablation with the goal of
      reducing the frequency of reoccurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4 surgeries for RRP in last 12 months

        Exclusion Criteria:

          -  Renal insufficiency

          -  Nephrotoxic drugs in the last 7 days

          -  Sulfa allergies

          -  Currently treated with systemic or topical HPV chemotherapeutic agents

          -  Females of childbearing potential with a positive pregnancy test

          -  Women who are breast feeding
A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Esomeprazole 40 mg; Physical Exam; Quality of Life Questionnaires; pregnancy test, if applicable
Intervention description: Once a day; every visit; every visit; as needed
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heartburn; reflux; proton; pump; inhibitor

Summary:

      The purpose of this study is to assess how patients with gastro-oesophageal reflux disease
      (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still
      experiencing symptoms will benefit from a change in treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persisting symptoms of GORD despite previous treatment with a full dose proton pump
             inhibitor

          -  informed consent

          -  over 18 years of age

        Exclusion Criteria:

          -  Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to
             enrolment in the study

          -  More than 1 other course of PPI treatment in the previous 12 month

          -  previous use of esomeprazole

          -  presence of alarm symptoms
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Condition: Total Knee Arthroplasty
MeSH terms: Acute Pain
Intervention: Placebo; Duloxetine 60mg
Intervention description: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.; Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine
      reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the
      investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores
      2 weeks after TKA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with osteoarthritis scheduled for primary tricompartmental total knee
             arthroplasty with a participating surgeon

          -  Age 25 to 75 years

          -  Planned use of regional anesthesia

          -  Ability to follow study protocol

          -  English speaking (primary outcome obtained via telephone call and secondary outcomes
             include questionnaires validated in English only)

          -  Patients planning on being discharged home or to a rehabilitation center that has
             agreed to participate

        Exclusion Criteria:

          -  Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants,
             triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan,
             almotriptan, frovatriptan), lithium, buspirone, St. John's Wort

          -  Hepatic insufficiency

          -  Renal insufficiency

          -  Patients younger than 25 years old and older than 75

          -  Patients intending to receive general anesthesia

          -  Allergy or intolerance to one of the study medications

          -  Patients with an ASA of IV

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months)

          -  Patients with major prior ipsilateral open knee surgery