bioihbjkbjnl/mcl2 huggingface dataset:
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Intervention: Ablation of the incompetent small saphenous vein
Intervention description: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic venous insufficiency; varicose vein; small saphenous vein

Summary:

      The aim of this study is to perform a randomized, prospective trial comparing the two current
      methods of treatment for chronic venous insufficiency related to the Small Saphenous Vein
      (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one
      is superior to the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic chronic venous insufficiency.

          -  Patients in whom endovenous thermal ablation is clinically indicated.

          -  Have previously undergone at least 6 weeks of conservative treatment with compression
             stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).

          -  Have symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow
             in the saphenous vein >0.5 seconds after calf compression or while standing.

        Exclusion Criteria:

          -  Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive
             of spider vein injections or other cosmetic surface procedures).

          -  Have a history of Deep Venous Thrombosis (DVT).

          -  Have a history of hypercoaguability disorder.

          -  Are pregnant or breastfeeding.

          -  Are nonambulatory.
Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
Condition: Asthma; Croup
MeSH terms: Asthma; Croup
Intervention: Dexamethasone IV for PO; Dexamethasone crushed tablets
Intervention description: Common pediatric emergency department practice; Alternative route of administration for patients unable to swallow tablet whole
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed
      in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given
      orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce
      or pudding will be more palatable and acceptable for pediatric patients receiving
      dexamethasone for an acute asthma exacerbation or croup.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt
             Children's Hospital Emergency Department

          -  Age 1 to 7 years

          -  Dexamethasone treatment indicated

          -  No other acute or chronic process accounting for signs and symptoms (e.g., foreign
             body aspiration, pneumonia, cystic fibrosis)

          -  Have not received systemic corticosteroid for current episode prior to enrollment

        Exclusion Criteria:

          -  Allergy to dexamethasone or apple sauce and pudding

          -  Unable to take medication orally
An Open-Label Preference Evaluation of BLI800
Condition: Colonoscopy
Intervention: BLI800
Intervention description: BLI800 Bowel Preparation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate patient experience ratings of BLI800 in adult
      patients undergoing colonoscopy.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication

          -  18 to 85 years of age (inclusive)

          -  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

        Primary Exclusion Criteria:

          -  Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon

          -  Subjects with ongoing severe, acute inflammatory bowel disease

          -  Subjects who had previous significant gastrointestinal surgeries

          -  Subjects with known severe renal, hepatic or cardiac insufficiency

          -  Subjects undergoing insulin therapy for any indication

          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration

          -  Subjects undergoing colonoscopy for foreign body removal and/or decompression
Clinical and Economic Implications of Genetic Testing for Warfarin Management
Condition: Blood Coagulation Disorders
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: Warfarin
Intervention description: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Intervention MeSH terms: Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coumadine; genotype; genes; Warfarin

Summary:

      The purpose of this study is to explore how knowing genes that individuals inherit from their
      parents can make warfarin dosing more safe and effective. This study is being done to
      determine whether providing doctors with data on the genes their patients inherited and
      warfarin dosing recommendations based on those genes affects the costs and outcomes of care
      and after hospitalization for patients from different ethnic/racial backgrounds, and how
      physicians use this information in decision making.
    

Eligibility criteria:

        Inclusion Criteria:

          -  warfarin-naive patients

          -  ages 18 and older

          -  are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that
             necessitate anticoagulation

        Exclusion Criteria:

          -  patients who are not warfarin-naive

          -  17 years of age or younger
SCHEDULE Follow Up Visit 5-7 yr
Condition: Heart Transplantation
Intervention: Everolimus; Cyclosporine; Mycophenolate mofetil; Corticosteroids
Intervention description: All patients, independent of their initial randomization in the core study, were followed up as in one single group
Commercially available everolimus (Certican®), oral route, was used.; Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3); Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11; Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Healthy volunteers: No
Keywords: allograft rejection; xenograft rejection; host vs graft disease; transplant

Summary:

      The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7
      years) of early initiation of everolimus and early elimination of CsA compared to standard
      immunosuppressive regimen including CsA on primary and secondary endpoints investigated in
      the SCHEDULE (NCT01266148) main study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in the SCHEDULE 12-month main study, and who completed the 3
             year follow-up visit

          -  Patients who are coming for a regular annual clinic visit 5 to 7 years after
             randomization in the main study

          -  Obtaining of a separate signed patient informed consent will be required for
             participation in this follow-up examination.

        Exclusion Criteria:

          -  Patients with a retransplanted heart since the original SCHEDULE study
Subject Satisfaction With AbobutulinumtoxinA Treatment
Condition: Glabellar Frown Lines
Intervention: AbobotulinumtoxinA
Intervention description: AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to Severe Glabellar Lines at Maximum Frown

          -  Understands study requirements and signs an informed consent

        Exclusion Criteria:

          -  Known allergy to any component of study product

          -  Pregnant or breast feeding or intending to get pregnant during the study

          -  Botulinum toxin treatment in the face within 9 months
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Dyslipidemia Associated With Type II Diabetes Mellitus; Percutaneous Coronary Intervention
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
Intervention: Evolocumab; Placebo
Intervention description: Patients will receive evolocumab 420 mg administered subcutaneously; Patients will receive placebo administered subcutaneously
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Healthy volunteers: No

Summary:

      Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The
      study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and
      Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible
      patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2)
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus

          -  Dyslipidemia

          -  Undergoing elective PCI

        Exclusion Criteria:

          -  Patients with recent Acute Coronary Syndrome (≤1 month)

          -  Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel

          -  Patients undergoing urgent/emergent PCI for stent thrombosis

          -  Severe acute or chronic medical or psychiatric condition

          -  Pregnancy

          -  Participation in another experimental clinical trial, without formal approval

          -  Unwillingness or inability to comply with the requirements of this protocol
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Depobupivacaine; OnQ pump; 0.25% Bupivacaine
Intervention description: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.; group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.; group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: local anesthetic continuous infusion pump; local injection of Exparel

Summary:

      Effective post surgical pain control in patients undergoing unilateral deep inferior
      epigastric perforator (DIEP) free flap reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non pregnant women

          -  age 18 years or older

          -  scheduled to have unilateral DIEP flap breast reconstruction.

          -  Must have ASA physical status classification of 1,2, or 3

        Exclusion Criteria:

          -  concurrent or recent medical condition that could interfere with study participation

          -  history of any of the following:

          -  hepatitis

          -  alcohol/substance abuse

          -  uncontrolled psychiatric disorders

          -  known allergy/ contraindication to any of the following:

          -  amide-type local anesthetics

          -  opioids

          -  propofol

          -  Body weight of less than 50 kg

          -  have participated in another study involving an investigational medication with in the
             past 30 days

          -  taking analgesics, antidepressants, or glucocorticoids within the 3 days before
             surgery
BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Intervention: Cefepime, Meropenem, or Piperacillin/Tazobactam; Cefepime, Meropenem, or Piperacillin/Tazobactam
Intervention description: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam); A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam)
Intervention MeSH terms: Meropenem; Tazobactam; Piperacillin; Cefepime; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The study plans to randomize a total of 240 patients infected with Gram-negative bacterial
      pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous
      or intermittent infusion and collect baseline and regular follow-up respiratory cultures to
      assess the development of new resistance. The investigators will measure beta-lactam
      concentration to assess the impact of drug exposure on the bacterial resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to the ICU with severe pneumonia (IDSA/ATS 2016/2019): presence of signs,
             symptoms and confirmatory chest imaging consistent with pneumonia (e.g. fever, cough
             and pulmonary infiltrate by chest radiograph)

          -  Age ≥18 years

          -  Positive respiratory culture (with or without an initial positive rapid identification
             test and/or Gram stain) for Gram-negative bacteria including, but not limited to, P.
             aeruginosa, K. pneumoniae, E. coli, S. marcescens, H. influenzae, Enterobacter spp.,
             M. catarrhalis, A. baumannii, Achromobacter spp., P. mirabilis, and/or B. cepacia

          -  Received within the last 72 hours or will receive meropenem, cefepime, or
             piperacillin/tazobactam therapy

        Exclusion Criteria:

          -  Pregnancy

          -  Prisoners

          -  Allergy to the beta-lactams to be administered in this study

          -  On renal replacement therapy at the time of randomization

          -  Baseline culture resistant to the beta-lactams in the study

          -  COVID patients enrolled in other trials
Assessing a Risk Model for G6PD Deficiency
Condition: Malaria, Vivax; G6PD Deficiency
MeSH terms: Malaria, Vivax; Glucosephosphate Dehydrogenase Deficiency
Intervention: primaquine; chloroquine + primaquine
Intervention description: Participants receive primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.; Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.
Intervention MeSH terms: Chloroquine; Primaquine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into one of two arms. 1a will receive primaquine for 14 days, and Arm 1b will receive chloroquine for 3 days and concomitant primaquine for 14 days.
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A clinical study designed to develop and inform an individual risk of hemolysis model based
      on individual red blood cell G6PD levels. Volunteers who are eligible to treatment with
      primaquine as per national guidelines and with confirmed normal G6PD levels as per the
      fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14
      days or 3 day chloroquine with concomitant primaquine for 14 days. The volunteers will be
      followed intensively during treatment and for 14 days after treatment for haematologic
      measures, G6PD quantification, and drug level assays.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous G6PD test at Shoklo Malaria Research Unit (SMRU) clinic with one of following
             results: 1) G6PD homozygous wildtype females (G6PD genotype normal) 2) G6PD
             heterozygous females with a normal FST (G6PD genotype abnormal with G6PD activity ≥40%
             and ≤80% of normal ) 3) G6PD hemizygous wildtype males (G6PD genotype normal)

          -  Willing to participate and sign informed consent form

          -  Willing to allow donated samples to be used in future research

          -  Aged ≥18 years

          -  Ability (in the investigators' opinion) and willing to comply with all study
             requirements

        Exclusion Criteria:

        All participants:

          -  Malaria or other illness

          -  Recent history (within 20 days) of anti-malarial treatment

          -  History of allergy or adverse reaction to chloroquine or primaquine

          -  Blood transfusion in the past 3 months

          -  G6PD activity less than 40% normal activity or 3.00 IU/gHb by the quantitative G6PD
             spectrophotometric assay

          -  Haemoglobin ≤10 g/dL

          -  Presence of any condition which in the judgment of the investigator would place the
             subject at undue risk or interfere with the results of the study

        Female participants only:

          -  Pregnancy at the time of screening

          -  Breastfeeding
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Condition: Pelvic Organ Prolapse
MeSH terms: Pain, Postoperative; Prolapse; Pelvic Organ Prolapse
Intervention: IV Acetaminophen; IV normal saline
Intervention description: IV normal saline
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IV acetaminophen; Postoperative pain; Pelvic organ prolapse surgery; Pelvic organ prolapse repair

Summary:

      The purpose of this study is to determine whether preoperative IV Acetaminophen reduces
      postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic
      organ prolapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 18 years of age

          -  scheduled to undergo surgery for POP via a vaginal or minimally invasive
             (laparoscopic/robotic) route at the University of Pittsburgh Medical Center

          -  women anticipated to have a hospital stay ≥24 hours

        Exclusion Criteria:

          -  allergy/intolerance to acetaminophen

          -  hepatic dysfunction

          -  significant alcohol use - defined as patient reported consumption of more than 7
             standard drinks per week and/or 3 drinks per day