bioihbjkbjnl/mcl2 huggingface dataset:
Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Condition: Wound Infection
MeSH terms: Wound Infection; Wounds and Injuries
Intervention: Cefazolin PostOperatively; Cefazolin Preoperatively
Intervention description: Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used.; Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.
Intervention MeSH terms: Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vulvectomy; wound infection; wound complication; prophylactic antibiotic; Post-operative wound complications following vulvectomy

Summary:

      This randomized prospective study will specifically investigate the efficacy of a 24 hour
      post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in
      preventing wound infection and wound breakdown following vulvectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All female patients 18 years of age or older undergoing surgery for vulvar carcinoma
             (this includes female patients undergoing any form of vulvectomy - radical, vulvectomy
             without groin node dissection, and partial vulvectomy)

          -  Disease State will not affect inclusion in the study. Women with previous surgery for
             vulvar carcinoma will be included as will those undergoing initial operation.

          -  Number of subjects: 160

        Exclusion Criteria:

          -  Women simultaneously undergoing treatment for other forms of cancer

          -  Women under the age of 18

          -  Pregnant patients
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
Condition: Hypofibrinogenemia; Afibrinogenemia; Bleeding Disorders
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Afibrinogenemia
Intervention: RiaStAP; Saline
Intervention description: To decrease post-operative bleeding volume.; Placebo consisting of normal saline 0.9%
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 1 Day
Maximum age: 1 Year
Healthy volunteers: No
Keywords: CBP, congenital heart defects, cardiopulmonary bypass

Summary:

      The goal of the study is to determine whether the use of Human Fibrinogen Concentrate
      (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and
      infants undergoing cardiopulmonary bypass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus
             Children's Hospital will be eligible for enrollment in the study.

        Exclusion Criteria:

          -  Patients who fall outside of the age range for the study will be excluded. Patients
             known to have had an anaphylactic or severe reaction to the drug or its components
             will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM
             MCF > 15mm, will be excluded.
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
Condition: Allergic Rhinitis; Allergic Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic
Intervention: Fluticasone Propionate Nasal Spray; Saline Nasal Spray
Intervention description: two sprays in each nostril once daily; two sprays in each nostril once daily
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal
      spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following
      ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  provide written informed consent and signed HIPAA form;

          -  be able and willing to follow all instructions and attend the study visits;

          -  if female and of childbearing potential, be not pregnant, nursing or planning a
             pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to
             use adequate method of birth control

          -  have a positive history of seasonal allergic rhinitis to ragweed;

          -  have a positive skin test reaction to ragweed of within the past 24 months;

          -  manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC

        Exclusion Criteria:

          -  known intolerance or allergy to antihistamines or corticosteroids;

          -  have a compromised lung function at Visit 1;

          -  develop a compromised lung function at Visits 2-6

          -  have any presence of active sinus or nasal infection at any visit;

          -  have experienced an acute upper or lower respiratory tract infection or acute
             sinusitis within 30 days of visit 1;

          -  have significant nasal anatomical deformities or any condition that does not allow
             subject to breathe through the nose (includes, but is not limited to: septal
             deviation, septal perforations, nasal polyps, rhinitis medicamentosa)

          -  have had any nasal surgical intervention in the past;

          -  have a known history of glaucoma

          -  have planned surgery (nasal, ocular or systemic) during the trial period or within 30
             days thereafter;

          -  inability or refusal to discontinue contact lens wear during all visits;

          -  use disallowed medications during the study or appropriate pre-study washout period
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
Condition: Patient Adherence
Intervention: Vitamin D Supplement
Intervention description: Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.
Intervention MeSH terms: Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PrEP; Pre exposure Prophylaxis; Truvada; CCTG; 595; Vitamin D; Bone mineral density

Summary:

      CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs.
      standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection
      (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control
      substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In
      CCTG 595, plasma from participants are being collected and stored at entry and every 12
      weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in
      both cases and controls at entry, week 24, and week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must meet CCTG 595 inclusion criteria.

        Exclusion Criteria:

          -  All subjects must meet CCTG 595 exclusion criteria.

          -  Current or prior use of bisphosphonate therapy.

          -  Current use of Vitamin D supplements greater than 400 IU/day.

          -  Current use of androgenic hormones or growth hormones.

          -  History of nephrolithiasis (kidney stones).

          -  History of fragility fracture.

          -  No use of tenofovir prior to entry into CCTG 595
Predictors of Response to Iron and Erythropoietin Stimulating Agents
Condition: Renal Failure Chronic; Anemia
MeSH terms: Kidney Failure, Chronic
Intervention: Iron Sucrose Solution for Injection; Epoetin Beta
Intervention description: 200mg iron sucrose given on 5 successive haemodialysis sessions; Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis

Summary:

      The purpose of the study is to identify predictors of treatment response. This involves
      collected baseline clinical parameters and bloods for biochemical parameters prior to
      administering the study treatment. A positive outcome following treatment was defined as an
      uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the
      participants response to treatment against the clinical and biochemical information collected
      prior to treatment being received.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All prevalent haemodialysis patients, established for greater than 3 months

        Exclusion Criteria:

        Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active
        infection Active malignancy Frail with either frequent hospital admissions or unable to
        follow trial protocol due to differing target haemoglobin
Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
Condition: Hepatitis C, Chronic; Lung Transplant
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: Epclusa
Intervention description: Patients will be treated with this drug for 12 weeks post lung transplant.
Intervention MeSH terms: Sofosbuvir-velpatasvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate whether treatment with Epclusa
      (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C
      infection is feasible, safe and effective at curing HCV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV RNA >= 10^3 IU/ml at screening

          -  Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6
             months prior to screening

          -  HCV Genotype 1, 2, 3, 4, 5 or 6

          -  Otherwise eligible for lung transplant at study site

        Exclusion Criteria:

          -  Age <18

          -  Treatment with any of the following agents:

               -  Amiodarone. Subjects previously treated with amiodarone must have stopped the
                  amiodarone at least 60 days prior to day 1 SOF/VEL

               -  Carbamazepine, phenytoin, phenobarbital, oxcarbazepine

               -  Rifabutin, rifampin or rifapentine

               -  HIV regimens containing tenofovir or tipranavir/ritonavir

               -  St John's wort

               -  PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole,
                  dexlansoprazole, rabeprazole

               -  Modafinil

          -  Have any serious or active medical or psychiatric illness which, in the opinion of the
             investigator, would interfere with subject treatment, assessment or compliance

          -  Hepatitis B surface antigen positive

          -  History of hepatic encephalopathy or variceal hemorrhage

          -  Abnormal hematological and biochemical parameters, including:

               -  Hemoglobin <8g/dL

               -  Platelets <= 50,000/mm^3

               -  ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline
                  phosphatase >=10 times ULN

               -  Total bilirubin >3mg/dL

               -  Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min

          -  Pregnant women or women planning to become pregnant

          -  Women or are breastfeeding

          -  Active or recent history (<=1 year) of drug or alcohol abuse
Ranolazine in Ischemic Cardiomyopathy
Condition: Cardiomyopathy; Chest Pain; Dyspnea
MeSH terms: Dyspnea; Cardiomyopathies; Chest Pain
Intervention: Ranexa; Placebo
Intervention description: 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.; 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and
      shortness of breath despite conventional medical therapy and/or revascularization. The
      purpose of this study is to determine the efficacy of taking Ranexa versus placebo in
      patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional
      medical therapy and/or percutaneous revascularization.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical
             treatment is defined as the continued symptoms of chest pain or dyspnea despite
             treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless
             contraindicated, all cardiomyopathy patients should be treated with a beta blocker and
             an ACEI/ARB.

          2. Anginal chest pain or dyspnea

          3. Documentation of non treatable or optimally treated coronary artery disease

          4. Ejection Fraction of less than or equal to 40%

        Exclusion Criteria:

          1. Less than 18 years of age

          2. Pregnant or breast feeding

          3. Patients with non ischemic cardiomyopathy
Effect of Samples on Acne Treatment With Epiduo® Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene + benzoyl peroxide samples; Adapalene + benzoyl peroxide from standard tube
Intervention description: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.; Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: adherence; adapalene; benzoyl peroxide; sample; topical treatment

Summary:

      The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel
      in patients with mild to moderate acne who receive a medication sample and instructions on
      proper application with their stock size medication tube versus patients who receive only the
      stock size medication tube.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject with mild to moderate acne, aged 12 and older, who agrees to
             participate and provides written consent.

          -  Have an Acne Global Assessment (AGA) of mild to moderate acne (an AGA score of 2 or 3)

        Exclusion Criteria:

          -  Presence of a concurrent medical condition or skin condition, which is determined by
             the investigator to potentially interfere with study outcomes or patient assessments.

          -  Subjects with known allergy or sensitivity to Epiduo® Gel (or Benzoyl Peroxide Gel) or
             components therein, including adapalene or benzoyl peroxide

          -  Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or
             willing to practice effective contraception during the study. Reliable methods of
             birth control are: abstinence (not having sex), oral contraceptives, intrauterine
             device (IUD), Depo-Provera, tubal ligation, or vasectomy of the partner (with
             confirmed negative sperm counts) in a monogamous relationship (same partner). An
             acceptable, although less reliable, method involves the careful use of condoms and
             spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant
             women and women planning to become pregnant while on study are to be excluded.
Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
Condition: Delirium on Emergence
MeSH terms: Delirium; Emergence Delirium
Intervention: Propofol; Propofol; Sevoflurane; Isoflurane
Intervention description: Propofol infusion with nasal oxygen; Propofol infusion with an LMA; Sevoflurane with an LMA; Isoflurane with an LMA
Intervention MeSH terms: Propofol; Sevoflurane; Isoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: children; sevoflurane; isoflurane; propofol; anesthesia; MRI; delirium

Summary:

      Children who receive general anesthesia may become agitated (emergence delirium) in the
      recovery period. This occurs more often after inhalational anesthetics, particularly
      sevoflurane and desflurane than after propofol. However, agitation after anesthesia in
      children may be difficult to distinguish from pain; accordingly studies are ideally designed
      during MRI to obviate the contribution of pain during emergence. Airway complications have
      been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs.
      Whether the airway complications were due to the LMA or the isoflurane was unclear.
      Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane
      compared with IV propofol and 2. airway complications after LMA or nasal prongs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2-12yrs,

          -  ASA Class I-II,

          -  Fasting,

          -  Unmedicated,

          -  Elective MRI scan

        Exclusion Criteria:

          -  Cognitive impairment,

          -  On psychotropic medications,

          -  Taking multiple (>2) antiepileptic medications,

          -  Requiring endotracheal intubation for GA
The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
Condition: Caries
MeSH terms: Dental Caries
Intervention: Silver Diamine Fluoride (SDF)
Intervention description: No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet
Intervention MeSH terms: Fluorides
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Caries; Cavity; Silver Diamine Fluoride (SDF); HOMINGS

Summary:

      The study will compare bacteria levels in cavities before and after silver diamine fluoride
      (SDF) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy adult participants 18 years of age and older.

          -  At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the
             gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft
             active carious lesions exposing dentin).

        Exclusion Criteria:

          -  Adult participants who suffer from serious life-threatening medical diseases that
             interfere with basic daily self care activities.

          -  Patients taking antibiotics within the last two weeks.

          -  Patients using chlorhexidine or fluoride mouth washes within the last two weeks.

          -  Pregnant or breastfeeding women.

          -  Teeth with arrested (hard) cervical or root caries lesions.

          -  Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are
             mobile.