bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
Condition: Breast Reconstruction; Anesthesia; Transverse Abdominis Plane Block
Intervention: Liposomal bupivacaine; Regular bupivacaine
Intervention description: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.; 20mL of 0.25% bupivacaine injected on each side.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking description: Participants and plastic surgeons will be blinded to the study treatment arm
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will compare the efficiency of transversus abominus plane (TAP) block using
      liposomal bupivacaine versus plain bupivacaine that is administered in the operating room
      under ultrasound guidance prior to the in patients undergoing abdominally-based free flap
      breast reconstruction at Vanderbilt University Medical Center.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age between 18-85 years

          2. males or females

          3. plastic surgery for abdominally-based free flap breast reconstruction.

        Exclusion Criteria:

          1. those not candidates for TAP blocks due to allergies to the medications (e.g.,
             bupivacaine)

          2. those with anatomic contra-indications to performing a TAP block

          3. those unwilling to participate in follow-up assessments

          4. vulnerable populations

          5. chronic pain or associated diagnosis
Oral Dexamethasone for Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Dexamethasone; placebo
Intervention description: Single dose oral dexamethasone 8mg at time of ED discharge; Single dose oral placebo at ED discharge
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Rebound headache

Summary:

      The aim of this project is to determine if a single dose of oral dexamethasone at the time of
      discharge from the emergency department (ED) [after successful treatment] prevents rebound
      headache.

      Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who
      suffer rebound headache after treatment for migraine in the ED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in
             the ED who are willing and able to be contacted between 48-72 hours after discharge
             for follow-up

        Exclusion Criteria:

          -  Failure to consent

          -  Pregnancy

          -  Allergy to study medication

          -  Findings inconsistent with migraine

          -  Patients requiring hospital admission for further investigation and treatment

          -  Patients with active peptic ulcer disease

          -  Patients with Type 1 diabetes

          -  Patients taking corticosteroids for another condition within 7 days

          -  Active systemic fungal infection

          -  Patients previously enrolled in the study
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
Condition: Thrombosis
MeSH terms: Thrombosis
Intervention: Desirudin
Intervention description: Desirudin SC 15mg q12h
Intervention MeSH terms: Desirudin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 516.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anticoagulation; Prophylaxis; Desirudin; Direct thrombin inhibitor; Heparin-induced thrombocytopenia

Summary:

      The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin
      for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent before initiation of any study related procedures.

          2. Be at least 18 years of age.

          3. Patients requiring anticoagulation for the prophylaxis of thrombosis.

          4. In the opinion of the Investigator, an alternative to heparin-based anticoagulant
             therapies is desirable.

        Exclusion Criteria:

          1. Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy
             test).

          2. Intracranial neoplasm, arteriovenous malformation or aneurysm.

          3. Severe renal insufficiency (chronic or acute) with a GFR of < or equal to 30 mL/min as
             determined by measured or estimated creatinine clearance using Cockroft-Gault method
             or by estimated GFR using the MDRD formula.

          4. Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any
             component of the product

          5. Participation in other clinical research studies involving the evaluation of other
             investigational or FDA-approved drugs or devices within 30 days of enrollment
             (participation in observational studies of FDA-approved products is acceptable).

          6. Refusal to undergo blood transfusion should it become necessary

          7. Active bleeding or irreversible coagulation abnormality.

          8. Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.

          9. Patients requiring anticoagulation for left-ventricular assist device, intra-aortic
             balloon pump, veno-venous ultra filtration or ECMO.

         10. Any other disease or condition which, in the judgment of the Investigator, would place
             a patient at undue risk by being enrolled in the trial, or cause inability to comply
             with the trial.
A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy
Condition: Hysterectomy
Intervention: Robotic hysterectomy; Standard Hysterectomy
Intervention description: Robotic hysterectomy.; Standard hysterectomy.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: robotic; laparoscopic surgical procedures

Summary:

      Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo
      Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500
      procedures performed. Similar to the laparoscopic approach, small incisions are utilized with
      the robotic approach. Robotic instruments differ from laparoscopic instruments in that the
      tips of the instruments can rotate more like the human wrist. The instruments are attached to
      the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's
      console which is located 12 feet from the patient while the surgical assistant is at your
      bedside assisting in the procedure.

      This study is being done to compare the procedure times and results after laparoscopic
      hysterectomies to laparoscopic hysterectomies performed with robotic assistance.
    

Eligibility criteria:

        Inclusion Criteria:

        - All subjects eligible for a laparoscopic hysterectomy with or without bilateral
        salpingo-oophorectomy, and with or without appendectomy will be recruited.

        Exclusion Criteria:

        - Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure
        on an emergent basis.
Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients
Condition: Infectious Peritonitis
MeSH terms: Peritonitis
Intervention: Dalbavancin via Intravenous Administration; Dalbavancin via Intraperitoneal Administration
Intervention description: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.; Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
Intervention MeSH terms: Dalbavancin; Teicoplanin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the pharmacokinetic properties of dalbavancin when administered as
      an intravenous infusion and instilled into the peritoneal space in patients who are
      undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed by
      intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the
      patients will then receive dalbavancin instilled into their peritoneal space followed by the
      same intensive plasma and peritoneal dialyses fluid sampling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 to ≤89 years of age

          -  Actively receiving chronic peritoneal dialysis

          -  Ability and willingness to provide written informed consent

        Exclusion Criteria:

          -  Patients currently receiving antimicrobial therapy or have received antibiotic therapy
             within 14 days prior to study

          -  Patients with known hypersensitivity reactions to dalbavancin or other glycopeptides

          -  Prisoners

          -  Pregnant or breastfeeding women

          -  Decisionally challenged patients
A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: duloxetine hydrochloride; placebo
Intervention description: 60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).; oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once
      daily in comparison to placebo on symptom improvement in patients meeting criteria for
      fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo,
      however, all patients will receive duloxetine at some point in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients

          -  aged 18 and older who meet criteria for fibromyalgia as defined by the American
             College of Rheumatology

          -  have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI)
             (modified short form) at visits 1 and 2

          -  all females must test negative for pregnancy at the time of enrollment

          -  have a degree of understanding such that the patient can provide informed consent,
             complete protocol required assessments and communicate intelligibly with the
             investigator and study coordinator.

        Exclusion Criteria:

          -  have pain symptoms related to traumatic injury, structural rheumatic disease, or
             regional rheumatic disease that will interfere with interpretation of outcome measures

          -  have regional pain syndrome, multiple surgeries or failed back syndrome

          -  have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory
             arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus
             erythematosus)
A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Topiramate
Intervention description: The patients will receive topiramate tablet twice daily orally up to 16 weeks.
Intervention MeSH terms: Topiramate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsy; Seizures; Topiramate; Anti-epileptic drug; Nervous disorder

Summary:

      The purpose of this dose optimization study is to assess tolerability and efficacy of
      topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive
      or have failed one anti-epileptic drug (AED) treatment in monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has been diagnosed with epilepsy within the past 5 years with Primary Generalized
             Tonic-Clonic (PGTC) seizures as well as partial onset seizures with or without
             secondary generalization

          -  Therapy naive, or being treated with their first anti-epileptic drug (AED) in
             monotherapy that fails in efficacy, tolerability, or both, and not in need of a
             combination AED therapy

          -  Informed Assent in children at least 7 years and older

        Exclusion Criteria:

          -  Have pseudoseizures or the treatable cause of the seizures (eg, metabolic disorder,
             toxic exposure, active infection or neoplasia)

          -  Has any clinically relevant progressive or serious illness (eg, liver or renal
             insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine,
             neurological, psychiatric, or metabolic disturbance)

          -  Pregnant or breast-feeding

          -  Has a history or suspicion of alcohol or drug abuse

          -  Must have on current treatment with furosemide, hydrochlorothiazide, monoamine oxidase
             inhibitors
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Condition: Physiological Effect of Drugs; Morphine; Analgesics; Analgesics, Opioid; Central Nervous System Depressants; Narcotics
Intervention: 2% lidocaine with 1:200,000 epinephrine and epidural morphine; 3% 2-chloroprocaine and epidural morphine
Intervention description: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.; Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
Intervention MeSH terms: Lidocaine; Epinephrine; Morphine; Chloroprocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: cesarean delivery; c-section; chloroprocaine; lidocaine; morphine; post-operative pain; post-cesarean analgesia

Summary:

      The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural
      morphine administration will be not inferior to the effect of epidural 2% lidocaine with
      1:200,000 epinephrine on total opioid use for 24h
    

Eligibility criteria:

        Inclusion Criteria:

          -  pregnant patients

          -  live singleton pregnancy

        Exclusion Criteria:

          -  BMI >40

          -  obstructive sleep apnea

          -  drug abuse

          -  chronic pain

          -  chronic opioid use

          -  nonfunctioning epidural
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
Condition: Kidney Transplantation
Intervention: DT; Daclizumab; KLH
Intervention description: Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show >=1.5 fold increase in lymphocyte proliferative response but have a humoral response.; The fifth dose (1 milligram per kilogram [mg/kg]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses).; KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.
Intervention MeSH terms: Daclizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 2 Years
Maximum age: 19 Years
Healthy volunteers: No

Summary:

      This study will assess whether daclizumab impairs the ability of children receiving a kidney
      transplant to elicit a primary immune response. The anticipated time on study treatment is 1
      day, and the target sample size is 82 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary renal transplant recipients between 2 and 19 years of age

          -  Receiving or have received daclizumab in the previous 4-18 months

          -  Receiving or have received daclizumab less than (<) 24 hours pretransplant and
             additional courses every other week

          -  Single organ recipients (kidney only)

          -  Previous vaccination with tetanus toxoid (TT) prior to transplant

          -  Receiving a maintenance immunosuppression regimen of a calcineurin inhibitor,
             mycophenolate mofetil, and prednisone (or equivalent corticosteroid)

        Exclusion Criteria:

          -  Received intravenous gamma globulin or a TT vaccination since transplant

          -  Experienced rejection within 3 months of receiving study vaccinations and/or treated
             with lymphocyte preparation or methylprednisolone to reverse suspected acute rejection
             within 3 months of receiving study vaccinations

          -  Received any vaccine within 30 days of receiving study vaccinations

          -  Received plasmapheresis treatment or growth hormone treatment since transplant
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
Condition: Wet Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intervention description: Aflibercept 2mg is intravitreally injected.
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Eylea,; Aflibercept; Treat and Extend regimen; Age-related macular degeneration

Summary:

      To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different
      approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet)
      Age-related Macular Degeneration (wAMD) .

      To assess the safety of IVT administration of aflibercept with two different approaches of
      Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese men and women ≥ 50 years of age

          -  Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD,
             including juxta-foveal lesions that affect the fovea as evidenced by fluorescein
             angiography (FA) in the study eye

          -  Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA)
             of 73 to 25 letters (approximately 20/40 to 20/320 at Snellen equivalent) in the study
             eye

        Exclusion Criteria:

          -  Prior treatment of the study eye with intraocular anti-VEGF(Vascular Endothelial
             Growth Factor) agents, verteporfin photodynamic therapy (PDT), other laser,
             intraocular corticosteroids, surgical interventions (except cataract surgery more than
             30 days prior to screening) or systemic use of anti-VEGF products within 3 months
             prior to study entry

          -  Active or suspected infection in or surrounding of the study eye

          -  Active severe intraocular inflammation in the study eye

          -  Intraocular pressure (IOP) ≥ 25 mmHg in the study eye

          -  Ocular condition in the study eye which may impact vision and confound study outcomes