bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair
Condition: Pectus Excavatum
MeSH terms: Funnel Chest
Intervention: Hydromorphone; Morphine
Intervention description: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.; This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 62.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling
      pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be
      the mean pain score during postoperative days 0-4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 8- 18 years 2) Patients undergoing minimally invasive pectus excavatum
             repair via Nuss procedure 3) American Society of Anesthesiology Status I-III

        Exclusion Criteria:

          -  1) Refusal of epidural catheter 2) Pregnancy 3) Bleeding History 4) Inability to
             understand how to use the PCA device 5) Medication interfering with blood coagulation
             6) Patients allergic to local anesthetics 7) Patient refusal to participate in study
             8) Developmental delay
Gabapentin for Postop Pain After SSLF
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Intervention: Gabapentin; Placebo oral capsule
Intervention description: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.; Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pelvic Organ Prolapse; postoperative gluteal pain; opioid use

Summary:

      Purpose: To assess the impact of gabapentin versus placebo on overall postoperative pain and
      gluteal pain at 7 days after vaginal sacrospinous ligament suspension for apical pelvic organ
      prolapse.

      Participants: English-speaking women planning to undergo a vaginal SSLF. Concurrent
      procedures can be performed except total vaginal hysterectomy, colpocleisis, anal
      sphincteroplasty, fistula surgery, or urethral diverticulectomy

      Procedures (methods): Patients will be randomized to receive either 2 weeks of gabapentin or
      placebo for 2 weeks post-operatively. Standard of care pain medications will be given to both
      groups. Patients will be followed for 6 weeks post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women age 18+

          -  English-speaking

          -  Planning to undergo a vaginal SSLF

        Exclusion Criteria:

          -  Pregnant or planning to become pregnant during study participation

          -  Prior vaginal mesh surgery for pelvic organ prolapse

          -  Planning a concurrent total vaginal hysterectomy, colpocleisis (total vaginectomy or
             LeFort colpocleisis), mesh excision, anal sphincteroplasty, fistula repair, or
             urethral diverticulectomy

          -  Cognitive impairment (indicated by a score of 0-2 on Mini-Cog)

          -  Currently taking gabapentin or pregabalin (Lyrica) or previous intolerance to
             gabapentin or pregabalin

          -  Daily use of narcotics for ≥ 2 months

          -  Acute or chronic renal failure based on past medical history (PMH) or glomerular
             filtration rate (GFR) < 30ml/min (see meds info below)

          -  Severe uncontrolled depression or bipolar disease based on PMH

          -  Fall risk if history of fall in last year or current use of cane/walker
Fondaparinux in Critically Ill Patients With Renal Failure
Condition: Venous Thromboembolism
MeSH terms: Renal Insufficiency; Thromboembolism; Venous Thromboembolism; Critical Illness
Intervention: Fondaparinux
Intervention description: 2.5 mg every 48 hours
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Fondaparinux; Renal Failure; Critically Ill

Summary:

      The primary objective of this study is to determine whether a dose-adjusted prophylaxis
      fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours
      (hr) in patients with renal failure achieves peak and trough levels similar to patients with
      normal renal function, and protects patients from developing venous thromboembolism (VTE).
      Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing
      interval from q24 to q48 hr, in patients with estimated creatinine clearance of < 30 ml/min,
      will be safe and effective.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years old and ≤ 89 years old

          2. Body weight ≥ 50 kg or ≤ 150 kg

          3. Estimated creatinine clearance of < 30 mL/min

          4. Predicted ICU stay of more than 72 hours.

        Exclusion Criteria:

          1. Pregnant women

          2. Infective Endocarditis

          3. Neuraxial anesthesia or spinal puncture

          4. Active bleeding

          5. Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin

          6. Signs of disseminated intravascular coagulation

          7. Severe liver failure (serum bilirubin > 5 mg/dL)

          8. Surgery planned within 24 hours of ICU admission

          9. Latex allergy
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Condition: Brain Injuries; Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Brain Injuries; Brain Injuries, Traumatic; Endocrine System Diseases; Wounds and Injuries
Intervention: Genotropin; Placebo
Intervention description: Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.; Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: traumatic brain Injury, cognitive function

Summary:

      To establish the effects of genotropin replacement on cognitive function in patients with
      severe growth hormone deficiency after traumatic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a previous traumatic brain injury (more than 1 year and less than 20 years)
             prior to the screening visit.

          -  Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.

          -  Have proven GHD deficiency

        Exclusion Criteria:

          -  Active systemic malignancy or active intracranial tumor. A successfully treated tumor
             or malignancy is not an exclusion criterion if the patient has not had active disease
             for 5 years and is not currently receiving maintenance chemotherapy, (except for basal
             cell skin cancers.

          -  Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other
             oral glucocorticosteroids above replacement doses is not permitted throughout the
             study. Topical and inhaled corticosteroids are permitted.

          -  History of dementia unrelated to TBI

          -  History of benign intracranial hypertension
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Condition: End Stage Heart Disease; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis; Heart Diseases
Intervention: Clinically prescribed direct acting antiviral
Intervention description: HCV treatment for 12 weeks
Intervention MeSH terms: Antiviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Received heart transplant from HCV+ donor
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Disease; Heart Transplant; HCV; Hepatitis C

Summary:

      This is a proof of concept, single center study for the donation of HCV-positive hearts to
      HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of
      commercially available DAA therapy to prevent HCV transmission upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient is Age ≥ 18 years

          -  Serum ALT within normal limits with no history of liver disease

          -  Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high
             likelihood of needing aggressive immunosuppression to treat rejection

        Exclusion Criteria:

          -  Sensitization (i.e. PRA >20%)

          -  Any liver disease in recipient

          -  Albumin < 3g/dl or platelet count < 75 x 103/mL

          -  Need for dual organ transplant
Study of Tomography of Nephrolithiasis Evaluation
Condition: Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi
Intervention: Point-of-care Ultrasound; Radiology Ultrasound; Radiology CT
Intervention description: Perform ultrasonography in the ED (physician).; Diagnostic ultrasound completed in the radiology department at time 0.; Computed tomography of abdomen completed in the radiology department at time 0.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2776.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: kidney stone; urolithiasis; urinary tract infection; ultrasound; computed tomography; safety; cost; accuracy

Summary:

      This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared
      to computed tomography (CT) for the initial emergency room evaluation of patients with
      suspected renal colic. The investigators will compare several measures of effectiveness
      including morbidity related to the patient's underlying disease, or complications related to
      delayed diagnosis, patient status regarding pain/missed days of work, and utilization of
      health care resources based on one of three study arms: ultrasound in the Emergency
      Department, ultrasound in Radiology or CT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men or women = or >18 but <76 years of age presenting with acute renal colic

          -  Emergency department physician highly suspects a primary diagnosis of kidney stones
             (renal colic) or the patient requires imaging to rule out kidney stones.

        Exclusion Criteria:

          -  children < 18 years old

          -  elderly patients > or = 76 years old

          -  pregnancy or planning pregnancy

          -  Morbid obesity (>285 pounds in men, >250 pounds in women)

          -  patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie
             appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).

          -  history of kidney problems (hemodialysis, kidney transplant, presence of only one
             kidney)
Sertraline Pharmacotherapy for Alcoholism Subtypes
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Sertraline; Placebo
Intervention description: Sertraline (to a maximum of 200 mg/day) for 14-week treatment period; Placebo for 14-week treatment period
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol Drinking; Alcohol Dependence; Sertraline Pharmacotherapy; Alcoholism Subtypes; Early- versus Late-Onset Alcoholism

Summary:

      The purpose of this study is to determine whether Sertraline, compared to placebo, is
      effective in the treatment of alcohol dependence as a function of the subtype of alcoholic
      patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or
      an inactive placebo for a 14-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current episode (i.e., in the preceding month) of alcohol dependence defined by
             Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria

          -  18-65 years of age

          -  Abstinent from alcohol for a period of at least 3 days prior to baseline research
             assessment

          -  Able to read English and complete study evaluations

          -  Male, or if female, without active reproductive potential

          -  Participants will have signed informed consent

        Exclusion Criteria:

          -  Currently meets criteria for dependence on a psychoactive substance other than alcohol
             and nicotine

          -  Regular use of psychoactive drugs including anxiolytics and antidepressants

          -  Current use of disulfiram or naltrexone

          -  Current major depression or psychosis (or other severe psychiatric disability e.g.,
             suicidality, current mania)

          -  Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid,
             or cardiac pathology, which in the opinion of the evaluating physician would preclude
             the patient from study adherence or be of potential harm to the subject
Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Condition: Vaccine Efficacy
Intervention: FSME-Immune vaccination
Intervention description: booster vaccination with FSME-Immune
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
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      FSME-Immun® is registered for application into the muscle. This study investigates if
      application under the skin leads to a comparable immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  completed primary TBE immunization + at least one booster immunization

          -  adults of both sexes between 18 and 60 years of age

          -  willingness to sign written informed consent form

        Exclusion Criteria:

          -  age < 18 and > 60 years

          -  prior TBE infection

          -  pregnancy and breast feeding

          -  acute infection on day of inclusion (day 0), (body temperature > 37,9°C)

          -  concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive
             therapy 4 weeks prior to or during study

          -  administration of other vaccines 4 weeks before/after day 0

          -  planned surgery within 2 weeks before/after TBE booster vaccination

          -  specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination

          -  any contraindication to administration of FSME-Immun® vaccine according to
             manufacturer's instructions

          -  history of malignant disease within the last 5 years

          -  autoimmune diseases

          -  drug addictions

          -  plasma donors

          -  receipt of blood transfusions or immuno globulins within 3 month before study entry
Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris
Condition: Tinea Pedis; Tinea Cruris
MeSH terms: Tinea; Tinea Pedis; Tinea cruris
Intervention: Luliconazole Cream 1%
Intervention description: Luliconazole cream will be applied topically per schedule specified in the arms.
Intervention MeSH terms: Luliconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as
      measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole
      cream 1% is applied to participants of 12 years to less than (<) 18 years of age with
      moderate to severe inter-digital tinea pedis or tinea cruris.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants (or legal guardian) with the ability and willingness to sign a written
             informed consent.

          -  Participants of either gender at least 12 years to <18 years old (12 to 17 years,
             inclusive).

          -  Participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by
             the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount.

          -  Participants with the ability and willingness to follow all study procedures, attend
             all scheduled visits, have all blood draws, and successfully complete the study.

          -  Participants must be in good general health and free of any disease that in the
             Investigator's opinion might interfere with the study evaluations.

          -  Participants must be able to communicate, be able to understand the study procedures,
             and be willing to comply with the study requirements.

        Key Exclusion Criteria:

          -  Participants with both tinea pedis and tinea cruris.

          -  Participants with active atopic or contact dermatitis in the treatment area.

          -  Female participants who are pregnant and/or nursing or planning a pregnancy during the
             course of the trial. Participants who test positive for pregnancy after start of test
             treatment will be discontinued from test treatment but will be followed for safety
             purposes.

          -  Participants who are immunocompromised (due to disease, for example; human
             immunodeficiency virus [HIV] or medications).

          -  Participants who have a recent history of or current drug or alcohol abuse.
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: alemtuzumab GZ402673
Intervention description: Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Intervention MeSH terms: Alemtuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1062.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate long-term safety of alemtuzumab.

      Secondary Objectives:

        -  To evaluate long term efficacy of alemtuzumab.

        -  To evaluate the safety profile of participants who received other Disease Modifying
           Treatment (DMT) following alemtuzumab treatment.

        -  To evaluate participant-reported Quality of Life (QoL) outcomes and health resource
           utilization of participant who received alemtuzumab.

        -  To evaluate as needed re-treatment with alemtuzumab and other DMTs.
    

Eligibility criteria:

        Inclusion criteria:

        Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed
        written informed consent form.

        Exclusion criteria:

        Participant participating in another investigational interventional study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Prevention of Atrial Fibrillation Following Esophagectomy
Condition: Atrial Fibrillation; Esophagectomy
MeSH terms: Atrial Fibrillation
Intervention: Amiodarone; Control
Intervention description: Intravenous amiodarone continuous infusion x 4 days; No amiodarone
Intervention MeSH terms: Amiodarone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Amiodarone; Atrial fibrillation; Surgical procedures, thoracic

Summary:

      The investigators hypothesize that the medication amiodarone decreases the incidence of
      atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:

      Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy
      surgery; Determine the influence of the prevention of AF following esophagectomy surgery on
      post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical
      hospital stay; and Determine the safety of amiodarone for the prevention of AF following
      esophagectomy surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females over the age of 40

          -  Scheduled to undergo esophagectomy

        Exclusion Criteria:

          -  History of atrial fibrillation

          -  Prior severe side effects from amiodarone

          -  Elevated liver enzymes >3 times the upper limit of normal (UNL)

          -  Corrected QT interval > 450 ms

          -  Receiving class Ia or class III antiarrhythmics