bioihbjkbjnl/mcl2 huggingface dataset:
Use of Tranexamic Acid in Reduction Mammoplasty
Condition: Hematoma Postoperative; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism; Hematoma
Intervention: Tranexamic acid; Placebo (topical saline)
Intervention description: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.; The untreated breast will receive topical saline.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Each patient undergoing routine bilateral breast reduction randomized to receive the study drug in either the right or left breast
Masking: Double (Participant, Care Provider)
Masking description: The patient and the surgical team will be blinded to which breast has received the study drug
Enrollment: 98.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breast reduction mammoplasty; hematoma; tranexamic acid

Summary:

      Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic
      surgery. However, postoperative hematoma is one of the most common complications following
      BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion,
      wound healing issues, and unfavorable surgical outcomes.

      Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative
      blood loss and need for transfusion. However, despite its consistently reported efficacy, low
      cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery.

      The investigators propose a prospective, double-blinded randomized controlled study of the
      efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction
      mammoplasty. The investigators hope to contribute to the growing body of literature
      supporting tranexamic acid to reduce unwanted surgical bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Being over the age of 18

          -  Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of
             Montefiore Medical Center, Bronx, New York

        Exclusion Criteria:

          -  Oncologic breast reduction

          -  Unilateral breast reduction

          -  History of thromboembolic disease

          -  History of bleeding diatheses

          -  History of stroke

          -  History of seizure disorder

          -  Currently pregnant

          -  Severe comorbidity (defined as American Society of Anesthesiologists (ASA) fitness
             grade IV or above)
Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery
Condition: Arthroscopic Knee Surgery
Intervention: Hyperosmolar Saline; Normal saline
Intervention description: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.; Lactate Ringer's (LR, 273mOsm/L)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An isotonic solution, such as saline (0.9%, 300mOsm/L) or lactated ringer's (273 mOsm/L), is
      commonly used and safely proven for joint irrigation during arthroscopy. Arthroscopic fluid
      is usually pressurized to enable visualization through dilation of the joint or bursa and
      prevent bleeding from the microvasculature. It has been recommended that this pressure be
      maintained at 49mmHg or less below the systolic blood pressure to preserve the clarity of
      view. The combination of large amounts of pressurized irrigation solution and lengthy
      arthroscopic procedures may cause substantial tissue fluid retention. Thus, extravasation of
      irrigation fluid into the periarticular tissues is inevitable and may create technical
      difficulties as well as patient morbidity and complications. Previous investigators have
      reported complications including tracheal obstruction, post-operative airway edema and
      compromise leading to prolonged intubation, excess weight gain, neurologic injuries, skin
      necrosis, and fluid overload associated with excessive fluid extravasation and tissue
      retention. Furthermore, it has been shown that fluid accumulated during the operation is
      slowly released back into the systemic circulation. Although there is not a rapid change in
      circulating volume, there may be implications for elderly patients and those with multiple
      comorbidities during prolonged arthroscopic surgery. Therefore the investigators seek to
      determine if a hyperosmolar solution, similar to what is used in head trauma patients, can
      reduce the degree of fluid extravasation in knee arthroscopy. The investigators also seek to
      determine if a hyperosmolar solution has any effect on post-operative knee pain compared to
      the standard isotonic solution. The third objective is to determine if a hyperosmolar
      solution has any effect on post-operative pain medicine consumption compared to the standard
      isotonic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (18 years of age or greater) undergoing arthroscopic knee surgery who
             are willing and able to consent.

        Exclusion Criteria:

          -  Current pregnancy or breastfeeding

          -  Unable to give consent

          -  Prisoner

          -  Mentally Disabled
Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Condition: Forehead Rhytides; Forehead Wrinkles
Intervention: Botulinum toxin type A; 2.5% lidocaine/2.5% prilocaine; petrolatum ointment
Intervention description: Botulinum toxin type A will be administered to both sides; 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead; petrolatum ointment will be applied to one side of the forehead
Intervention MeSH terms: Lidocaine; Prilocaine; Petrolatum; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rhytides; Forehead Wrinkles

Summary:

      The purpose of this study is to determine whether there is a difference in clinical effect,
      duration of effect, level of discomfort and patient satisfaction in patients receiving
      topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to
      Botulinum Toxin Type A administration for the treatment of forehead rhytides.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 65 years of age

          -  Presence of horizontal forehead rhytides

          -  Good eyebrow excursion (greater than or equal to 5 mm)

          -  Able to understand and sign an informed consent form that has been approved by the
             Committee for the Protection of Human Subjects

        Exclusion Criteria:

          -  Previous injection of botulinum toxin in the intended treatment area for the study
             within the last 4 months

          -  Known allergy to botulinum toxin

          -  Known history of sensitivity to local anesthetics of the amide type

          -  Existing disorder of neuromuscular transmission

          -  Usage of medication with effect on neuromuscular function

          -  Women of childbearing potential (who are not postmenopausal for at least 1 year or
             surgically sterile), who are pregnant or nursing or intend to become pregnant during
             the time of the study

          -  Significant brow asymmetry (> 5mm)

          -  Unable to follow-up for the duration of the study (16 weeks)
Antifungal Locks to Treat Fungal-related Central Line Infections
Condition: Central Line Fungal Infections
MeSH terms: Infections; Mycoses
Intervention: amphotericin B liposomal (Ambisome)
Intervention description: After enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy. Systemic therapy will be amphotericin B liposomal (Ambisome) administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing sufficient amphotericin B liposomal (Ambisome [2 mg/ml]) lock solution into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days (largest CVC = 2.3 mL).
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 30 Days
Maximum age: 21 Years
Healthy volunteers: No
Keywords: central line fungal infections; antifungal lock therapy; Ambisome lock therapy

Summary:

      The purpose of this study is to evaluate the usefulness of antifungal lock therapy with
      liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients
      with catheter-related blood stream infections with fungal organisms, whose catheter has not
      been removed because of the continuing critical need for central line access. The primary
      group of potential patients will be those with intestinal insufficiency, including post-op
      small bowel transplant recipients.

      The recommendation of the Infectious Disease Society of America (IDSA) is to remove all
      catheters with fungal infections and treat systemically for 14 days after the last positive
      culture. However, in certain intestinal failure patients, removal of an infected line might
      significantly reduce or eliminate intravenous (IV) access and create a life threatening
      situation. Thus, the investigators' aim is to determine the usefulness of antifungal lock
      therapy in intestinal failure patients whose catheter has not been removed. The
      investigators' hope is to salvage central line catheters rather than to remove them.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with intestinal insufficiency and central venous access.

          -  Culture positive fungal-related CRBSI.

          -  Females of childbearing potential will be eligible for the study.

          -  Ambisome carries a category B Pregnancy Risk Factor. Since this is a minimal pregnancy
             risk category, no special precautions will be taken to determine that the patient is
             not pregnant.

          -  HIV serostatus will not be determined for the purpose of participating in this study.

        Exclusion Criteria:

          -  Patients less than 30 days of age

          -  Patients greater than 21 years of age
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
Condition: Congestive Heart Failure; Cardiac Resynchronization Therapy
MeSH terms: Heart Failure
Intervention: Kronos LV-T, Lumax HF-T
Intervention description: Implanted CRT-device sends out device diagnostics (e.g. heart rate, device and lead integrity, patient activity) via CardioMessenger on daily basis. In addition, daily weight and blood pressure readings are taken; remote data are analyzed by investigational sites via the internet on a weekly basis.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Congestive Heart Failure; Cardiac Resynchronization Therapy; Home Monitoring; Telemonitoring; Remote Monitoring

Summary:

      This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK
      Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the
      follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy
      Implantable Cardioverter Defibrillator (CRT-D). The feasibility study is designed to plan and
      define endpoints for a larger randomized study. The study will assess the HM-parameter trends
      correlation with daily weight and blood pressure changes. The patient compliance rate of the
      two different telemonitoring systems (HM & ETM) will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written informed consent

          -  Implanted within the past 45 days or being considered for implant with a BIOTRONIK
             CRT-D

          -  Age 18 years

          -  Able to follow and comply with the study related procedures

          -  Phone jack with landline connection at home to connect both the BIOTRONIK HM and the
             ETM system

          -  Sufficient cognitive and reading skills to operate weight & BP system Ambulatory

          -  Weight ≤ 400 lbs

        Exclusion Criteria:

          -  Participation in another cardiovascular clinical study

          -  Life expectancy <6 months
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: bimatoprost ophthalmic solution 0.01%; travoprost ophthalmic solution 0.004%; latanoprost ophthalmic solution 0.005%
Intervention description: One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks.; One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks.; One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.
Intervention MeSH terms: Bimatoprost; Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluated the ocular surface tolerability of the prostaglandin analogues
      bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004%
      (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously
      treated with Xalatan® who have open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring
             treatment with an anti-glaucoma/ocular hypertensive medication

          -  Best corrected visual acuity score of 20/100 or better in both eyes

          -  Females on birth control pills must be on same type of pill and dose for at least 3
             month

        Exclusion Criteria:

          -  Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months

          -  History of or active ocular infection/inflammation (eg, uveitis)

          -  Punctal plug use

          -  Required use of ocular medications during the study other than study medication
             (intermittent use of certain types artificial tears acceptable)

          -  Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months

          -  History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)

          -  Planned contact lens wear during study
Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics
Condition: Laparoscopic Renal Surgery; Laparoscopy; Muscle Relaxation
Intervention: Rocuronium; Rocuronium
Intervention description: Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.; Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Respiratory mechanics; Respiratory function test; Hemodynamics

Summary:

      The primary objective of the current study is to compare intraoperative respiratory mechanics
      in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and
      under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative
      hemodynamics and postoperative pulmonary function between the two groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I or II patients scheduled to undergo laparoscopic renal surgery

        Exclusion Criteria:

          -  BMI ≥35 kg/m2

          -  Known neuromuscular disease

          -  History of chronic obstructive pulmonary disease

          -  Asthma

          -  Pneumothorax

          -  Bronchopleural fistula

          -  Previous lung surgery

          -  Previous retroperitoneal surgery

          -  Hemodynamic instability

          -  History of cardiopulmonary disease

          -  Renal insufficiency
A Study of Different Use Regimens Using Two Acne Treatments
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: benzoyl peroxide wash; Tretinoin gel
Intervention description: 5% benzoyl peroxide wash; 0.04% tretinoin gel
Intervention MeSH terms: Tretinoin; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 247.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: acne; irritation; objective sensory methods

Summary:

      A study to determine if using 2 acne products in the morning is as safe and efficacious as
      using one product in the morning and one product in the evening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-pregnant or non-nursing females, 12 years or older, with facial acne
             vulgaris;

          -  Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);

          -  Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed
             comedones);

          -  Must have at least a rating of grade 3 on the Investigator Global severity scale at
             baseline

        Exclusion Criteria:

          -  Known sensitivity to any of the ingredients in the study medication;

          -  Any nodulocystic acne lesions;

          -  Use of acne devices or systemic therapy with antibiotics within two months prior to
             start and throughout the duration of the study;

          -  Use of systemic therapy with retinoids within four months prior to study start and
             throughout the duration of the study;

          -  Topical use of retinoids within two weeks prior to study start and throughout the
             duration of the study;

          -  Topical use of antibiotics, steroids and/or other non-retinoid topical acne products
             within two weeks prior to study start and throughout the duration of the study;

          -  If subject is taking birth control pills, she must be stabilized for at least three
             months prior to study start;

          -  History of evidence of other skin conditions or diseases that may require concurrent
             therapy or may interfere with the evaluation of the study medication;

          -  Any significant medical conditions that could confound the interpretation of the
             study;

          -  Excessive facial hair that may interfere with evaluations;

          -  No use of tanning booths, sun lamps, etc.
Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin
Condition: Venous Thromboembolic Disease; Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis; Thromboembolism
Intervention: 5000 Units unfractionated Heparin Q 8 hr; 30mg enoxaparin Q12 hr
Intervention description: Venous thromboembolic prophylaxis medication; Venous thromboembolic prophylaxis
Intervention MeSH terms: Heparin; Enoxaparin; Calcium heparin; Enoxaparin sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 495.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: venous thromboembolic disease; deep vein thrombosis; pulmonary embolism; trauma; antithrombotic prophylaxis

Summary:

      The rate of venous thromboembolic events in trauma patients at high risk for deep vein
      thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours
      will be equivalent or less than a similar group of patients given a standard every 12 hour
      dose of low molecular weight heparin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to Scripps Mercy Trauma Service

          -  ≥18 Years old

          -  Stratified to either Significant or Highest risk of VTE by ACCP guidelines

        Exclusion Criteria:

          -  Estimated Injury Severity Score (ISS) ≤9

          -  Likely to be discharged before hospital day 7

          -  Systemic coagulopathy defined with an International Normalized Ratio (INR) of ≥1.2

          -  Body Mass Index (BMI) >40

          -  Likely to Survive for <7 Days

          -  Pregnancy

          -  Evidence of renal insufficiency (Cr ≥1.3)

          -  Delayed transfer to this facility (>24 hrs)

          -  Prisoners