bioihbjkbjnl/mcl2 huggingface dataset:
Intermittent Use of Aerosolized Ribavirin for Treatment of RSV
Condition: Hematological Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: Ribavirin; Ribavirin
Intervention description: Arm 1 = 6 Grams Over 18 hours Every 24 Hours; Arm 2 = 2 Grams Over 3 Hours Every 8 Hours.
Intervention MeSH terms: Ribavirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Hematological Malignancies; Respiratory Infection; Respiratory Syncytial Virus; RSV; Ribavirin; Virazole

Summary:

      Primary Objectives:

        1. To determine whether aerosolized ribavirin is effective when given at an intermittent
           dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection
           (URI) and whether it can prevent progression to pneumonia.

        2. To determine the effect of this regimen on persistence of viral shedding.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with these underlying malignancies will be eligible for this study:
             Autologous BMT patients, Allogeneic BMT patients, and patients with hematological
             malignancy.

          2. Patients must be at least 5 years of age.

          3. Only patients with infection limited to the URT will be eligible for entry on study

          4. Patients will be eligible for entry on study if a nasopharyngeal wash or throat swab
             specimen is positive by rapid RSV antigen testing or by a positive culture for RSV.

        Exclusion Criteria:

          1. Patients with evidence of RSV LRTI as documented by a positive rapid RSV antigen
             testing or by a positive culture for RSV from a nasopharyngeal wash or throat swab AND
             new infiltrates on chest radiograph and/or abnormal blood gas determination

          2. Patients with hypersensitivity to ribavirin or its components

          3. Pregnant women. Participants must practice birth control during the study if they are
             sexually active. If the participant is pregnant, she may not be enrolled on this
             study. Mothers should refrain from breast-feeding during the study to avoid injury to
             their children.

          4. Patients with positive RSV by rapid testing or culture in bronchoalveolar lavage
             regardless of the chest radiographic results.
Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints
Condition: Minor Procedural Pain
MeSH terms: Pain, Procedural
Intervention: Lazanda
Intervention description: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: intranasal fentanyl; conscious sedation

Summary:

      The purpose of this study is to evaluate the effectiveness, feasibility and safety of
      intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to
      produce anxiolysis and improve patient comfort during and after radiofrequency ablations of
      the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to
      be feasible and safe for use during procedures, future larger scale studies can be done.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients ASA(American Society of Anesthesiologist physical
             classification system) I-III

          -  18 years of age and older Referred for lumbar facet RFA (radio-frequency ablation) by
             Womack IPMC (Interdisciplinary Pain Management Center)

        Exclusion Criteria:

          -  Known allergy to Fentanyl or naloxone

          -  Diagnoses of allergic rhinitis with active rhinorrhea

          -  Pregnant or Breastfeeding

          -  Asthma or COPD (chronic obstructive pulmonary disease) that requires frequent rescue
             medications.

          -  Hepatic insufficiency with abnormal liver enzymes

          -  Noted decreased mental function

          -  Heart rate under 50 or BP below 90 systolic and/or 60 diastolic

          -  Myasthenia gravis diagnoses

          -  Acute narrow angle glaucoma

          -  Allergy to meperidine

          -  On medications with a known dangerous drug interactions to Fentanyl
Remifentanil and Glycemic Response in Cardiac Surgery
Condition: Heart Diseases; Hyperglycemia
MeSH terms: Heart Diseases; Hyperglycemia
Intervention: Remifentanil; Fentanyl
Intervention description: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.; Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
Intervention MeSH terms: Fentanyl; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiopulmonary bypass; Heart surgery

Summary:

      This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery
      to supress the hyperglycemic response in perioperative period. Half of the participants will
      receive continuous intravenous remifentanil during surgery, while the other half will receive
      intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl
      administration is this institution's standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open cardiac surgery through sternotomy approach (coronary artery bypass, valve
             surgery, and any other open heart surgeries)

          -  Surgery with use of cardiopulmonary bypass

          -  Patients over 18 years of age

          -  Both female and male genders

          -  All races

        Exclusion Criteria:

          -  Minimally invasive heart surgery through thoracotomy approach

          -  Patients receiving regional analgesia such as intrathecal morphine

          -  Patients undergoing procedures under deep hypothermic circulatory arrest

          -  Patients with active infections such as acute infective endocarditis

          -  Emergency surgery

          -  Patients undergoing transplantations and ventricular assist device insertion

          -  Patients on any mechanical circulatory support preoperatively

          -  Patient's refusal

          -  Allergy to remifentanil

          -  Positive pregnancy test

          -  Morbid obesity

          -  End stage liver and kidney disease
Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
Condition: Nasolabial Folds
Intervention: Radiesse® Injectable Dermal Filler Mixed with Lidocaine; Radiesse® Injectable Dermal Filler without Lidocaine
Intervention description: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl); Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Moderate to severe wrinkles and folds such as nasolabial folds

Summary:

      To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler
      mixed with lidocaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years of age.

          -  Is a candidate for nasolabial fold treatment using Radiesse.

          -  Understands and accepts the obligation not to receive any other facial procedures in
             the lower half of the face for 1 month.

          -  Understands and accepts the obligation to present for all scheduled follow-up visits
             and is logistically able to meet all study requirements.

          -  Has approximately symmetrical nasolabial folds.

        Exclusion Criteria:

          -  Has received any type of treatment or procedures including surgery in the nasolabial
             folds.

          -  Has received neurotoxins in the lower half of the face in the past 6 months.

          -  Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in
             the lower half of the face within past 1 ½ years.

          -  Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other
             permanent filler in the lower half of the face.

          -  Has nasolabial folds that are too severe to be corrected in one treatment session.

          -  Has a history of chronic or recurrent infection or inflammation that would preclude
             participation in the study.

          -  Has a known bleeding disorder or is receiving medication that will likely increase the
             risk of bleeding.

          -  Is female and of child bearing potential and is pregnant or not using acceptable
             method of birth control.

          -  Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.

          -  Has a history of anaphylaxis or multiple severe allergies.

          -  Has received any investigational product within 30 days prior to study enrollment or
             is planning to participate in another investigation during the course of this study.
Effect of Ketoconazole on Breathlessness
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Intervention: ketoconazole; inert powder
Intervention description: 600 mg capsule oral once; oral once
Intervention MeSH terms: Ketoconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: breathlessness; resistive load breathing; beta-endorphins

Summary:

      Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter
      the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases
      blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce
      ratings of breathlessness induced by resistive breathing loads.
    

Eligibility criteria:

        Inclusion Criteria:

          -  50 years of age or older;

          -  diagnosis of COPD;

          -  current or former smoker of at least 10 pack-years;

          -  post-bronchodilator FEV1 greater than or equal to 30% predicted and less than or equal
             to 80% predicted; post-bronchodilator ratio < 70%

        Exclusion Criteria:

          -  any concomitant disease that might interfere with study procedures;

          -  use of a drug that may cause a possible drug interaction with ketoconazole
Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
Condition: Blood Loss
MeSH terms: Hemorrhage
Intervention: Intravenous Placebo; Intravenous Tranexamic Acid
Intervention description: IV 0.9% sterile saline; 1g TXA IVPB (intravenous piggyback)
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: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Total hip arthroplasty; Total knee arthroplasty

Summary:

      This research study aims to study the use of tranexamic acid (TXA) in total joint replacement
      (arthroplasty) of the hip (THR) and knee (TKR).
    

Eligibility criteria:

        Inclusion Criteria

          -  All patients 18 years and older who are already scheduled for primary total joint
             arthroplasty of the hip or knee

        Exclusion Criteria for IV TXA administration

          -  Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)

          -  If patient is on anticoagulant, patient must have documented approval from a
             cardiologist that patient can be removed from anticoagulant for total joint
             arthroplasty procedure

          -  Renal impairment defined as serum Cr > 1.5 or Cr Clearance < 50 mL/min

          -  Severe ischemic heart disease

          -  Color blindness or problems with color vision

        Criteria for Use of Topical TXA

          -  Topical TXA can be used in any patient meeting one of the exclusion criteria for IV
             TXA administration (Section 5.3b) as there is minimal systemic absorption with topical
             TXA

        Absolute Exclusion Criteria

          -  History of deep vein thrombosis (DVT) or pulmonary embolism (PE)

          -  Known congenital thrombophilia

          -  History of thromboembolic or vascular disease

          -  Disseminated intravascular coagulation (DIC)

          -  History of seizures
Efficacy Study of Vaginal Mesh for Anterior Prolapse
Condition: Vaginal Prolapse; Uterine Prolapse; Cystocele; Pelvic Organ Prolapse
MeSH terms: Cystocele; Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Intervention: synthetic polypropylene mesh
Intervention description: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 65.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: prolapse; uterus; mesh; bladder

Summary:

      The primary aim of this double-blind, randomized clinical trial (RCT) is to test the
      hypothesis that the addition of a standardized technique of interpositional synthetic
      polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery
      for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.
    

Eligibility criteria:

        Inclusion Criteria:

          1. women age > 21

          2. diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery

          3. available for 12 months of follow-up

          4. able to complete study questionnaires and assessments.

          5. available for 12 months follow-up

        Exclusion Criteria:

          1. Uterus in place.

          2. No anterior vaginal prolapse.

          3. Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection,
             history of pelvic irradiation, history of lower urinary tract malignancy, chronic
             steroid use or a compromised immune system.

          4. Current intermittent self catheterization.

          5. Pregnancy or desire for future fertility.

          6. Presence of an adnexal or ovarian mass.

          7. Shortened vagina.

          8. Other laparoscopic or abdominal/pelvic surgery in the past 3 months.*

          9. Known neurologic or medical condition affecting bladder function, e.g. multiple
             sclerosis, spinal cord injury.

         10. Need for surgery requiring an abdominal incision.

         11. <12 months post-partum. (Enrollment can be deferred until time requirement has been
             met).
Trilogy AB Acetabular Hip System Post Approval Study
Condition: Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Traumatic Arthritis
MeSH terms: Arthritis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis
Intervention: Trilogy AB Acetabular Hip Implant System
Intervention description: Total hip replacement with ceramic on ceramic treatment surfaces.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Arthritis; Total Hip; Ceramic; Hip Replacement; Total Hip Arthroplasty (THA); Joint Disease

Summary:

      This is a post-approval study with prospective enrollment in the United States and a
      retrospective enrollment outside the United States to obtain functional, quality of life and
      radiographic data, which will facilitate assessment of the clinical performance of the Zimmer
      Trilogy AB Acetabular Hip System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-obese patients

          -  The patient is a good candidate for a primary hip arthroplasty using the Zimmer
             Trilogy AB Acetabular Hip System.

          -  Patient is willing and able to give informed consent to participate in the follow-up
             program.

          -  Patient is suitable for surgery and able to participate in the follow-up program.

        Exclusion Criteria:

          -  Skeletally immature

          -  Rheumatoid arthritis

          -  Osteoradionecrosis

          -  Infection

          -  Nerve or muscle disease that may have a negative affect on gait or weight bearing

          -  Loss of abductor musculature in the affected limb

          -  Poor bone stock

          -  Poor skin coverage around the hip joint

          -  Rapid disease progression as obvious by joint destruction or bone absorption seen on
             x-ray

          -  Previous total or cemented hemi-arthroplasty of the affected hip

          -  Previous pinning or plating of the affected hip

          -  Patients with heavy labor jobs or extreme activity levels

          -  Patients who participate in sports activities or require deep flexion

          -  Patients who are obese

          -  Patients who have other disabilities

          -  Patients who are unwilling or unable to give consent, or to comply with the protocol
             and follow-up program.
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Eplerenone; Placebo
Intervention description: Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.; Matching placebo tablets
Intervention MeSH terms: Eplerenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1012.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eplerenone; myocardial infarction; mortality; morbidity

Summary:

      Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction,
      in patients without heart failure, reduces cardiovascular mortality / morbidity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have experienced a myocardial infarction (STEMI) within the previous 24
             hours confirmed by symptoms and ECG.

        Exclusion Criteria:

          -  Subjects with a known low ejection fraction of less than 40% or any previous history
             of heart failure.

          -  Subjects treated with eplerenone or other aldosterone antagonists within the past 1
             month.

          -  The subject has uncontrolled hypotension (SBP<90mmHg).

          -  Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD
             formula) or serum creatinine ≥220µmol/L.
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
Condition: Vitreomacular Traction; Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: Ocriplasmin 0.125 mg in a 0.1 mL volume
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VMT; sVMA; vitrectomy; ocriplasmin

Summary:

      The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin
      (JETREA™®) over a 6-month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of VMT/sVMA, with evidence of focal VMT visible on Spectral Domain - Optical
             Coherence Tomography (SD-OCT).

          -  Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed
             consent form.

          -  Willing and able to attend all study visits.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential if pregnant, test positive on a urine pregnancy test,
             intend to become pregnant during the study period, breastfeeding, or not in agreement
             to use adequate birth control methods to prevent pregnancy throughout the study.

          -  Hypersensitivity to ocriplasmin or any of the JETREA™® excipients.

          -  Active or suspected intraocular or periocular infection in either eye.

          -  Participation in any interventional clinical trial within 30 days prior to baseline.

          -  Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.

          -  Broad VMT/VMA > 1500 microns at baseline in the study eye.

          -  History of vitrectomy in the study eye.

          -  History of laser photocoagulation to the macula in the study eye.

          -  Any relevant concomitant ocular condition in the study eye that, in the opinion of the
             Investigator, could be expected to worsen or require surgical intervention during the
             study period.

          -  Macular hole of > 400 microns diameter in the study eye.

          -  High myopia in the study eye.

          -  Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study
             eye that, in the Investigator's opinion, suggests lens/zonular instability.

          -  Aphakia in the study eye.

          -  History of retinal detachment in the study eye.

          -  Recent ocular surgery or ocular injection in the study eye within the past 90 days
             (including laser therapy).

          -  Proliferative diabetic retinopathy or ischemic retinopathies in the study eye.

          -  Retinal vein occlusions in the study eye.

          -  Exudative age-related macular degeneration (AMD) in the study eye.

          -  Vitreous hemorrhage in the study eye.

          -  Other protocol-specified exclusion criteria may apply.