bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Condition: Post-operative Pain Management
MeSH terms: Pain, Postoperative
Intervention: Exparel; Bupivacaine
Intervention description: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine; 60cc Bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric
      bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine
      injection solution) injections intra-operatively at time of incision site closure. The
      control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of
      incision site closure. The medication for the control group is our current standard of care.
      The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog
      Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will
      be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours
      a member of the research team will administer a 2-part questionnaire containing the VAS and
      the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is
      validated for assessment of the patient's experience of pain and it hindrance to daily
      activity in the post operative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  bariatric surgery patients

          -  laparoscopic roux-en-y gastric bypass

          -  use of EEA stapler anastomosis

        Exclusion Criteria:

          -  age <18 years

          -  previous history of roux-en-y gastric bypass

          -  patients undergoing other bariatric procedures

          -  pre-operative opioid analgesics
Shoulder Contraceptive Implant Study
Condition: Contraception
Intervention: Etonogestrel implant
Intervention description: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
Intervention MeSH terms: Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will be the first to establish pharmacokinetic curves for the etonogestrel
      contraceptive implant with scapular subdermal insertion. By obtaining this pharmacokinetic
      data, the investigators can compare this data to already published pharmacokinetic data with
      conventional implant insertion. This comparison can provide some reassurance that the
      absorption and distribution of etonogestrel from the contraceptive implant with scapular
      insertion is similar to that found with conventional insertion. With similar pharmacokinetic
      properties, the investigators would expect scapular insertion of the implant to maintain
      similar contraceptive efficacy for the populations of women that may benefit from this
      alternative insertion site. Preliminary safety data will also enrich the understanding of any
      potential insertion site side effects with subdermal scapular implant insertion, as the
      investigators currently only have a single case report with side effect outcomes. The
      investigators can then use this pilot data to support future larger investigations on
      subdermal scapular implant insertion given its complete avoidance of the neurovascular
      complications associated with arm insertion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women

        Exclusion Criteria:

          -  Any contraindications to etonogestrel implant use based on the US Medical Eligibility
             Criteria for Contraceptive use (defined as class 3 or 4 recommendation)18

          -  Any known liver conditions that could affect drug metabolism (e.g. cirrhosis,
             hepatitis)

          -  Currently taking any medications or supplements known to be CYP3A4
             inducers/inhibitors19

          -  Body-mass index less than 18.5kg/m2 or greater than 30kg/m2

          -  Currently pregnant or planning to become pregnant in the next 12 months
Coloplast DialogueStudy
Condition: Stoma
Intervention: SenSura
Intervention description: Real life assessment of SenSura
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3017.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stoma; Ostomy

Summary:

      The main purpose of the study is to document real life experience on SenSura with focus on
      skin condition and quality of life.
    

Eligibility criteria:

        Inclusion criteria

          -  Signed informed consent before any study related activities

          -  Subjects with a colostomy, ileostomy or urostomy

          -  Subjects must have had their ostomy for at least 6 months

          -  Subjects must have mental capacity to understand the study and questionnaires

          -  Subjects must be at least 18 years of age.

        Exclusion criteria

          -  Women who are pregnant or breast-feeding

          -  Subjects who have more than one ostomy

          -  Subjects with an ostomy who use plug

          -  Participation in other studies at the same time

          -  Previous participation in this study
Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation
Condition: Liver Transplantation
Intervention: Basiliximab; Tacrolimus; Tacrolimus; Mycophenolic Acid
Intervention description: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4; Day #7 post-transplant or when serum creatinine (SCr) < 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL; Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL; Enteric coated mycophenolic acid 360-720 mg po bid
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Simulect; Myfortic; Orthotopic liver transplantation (OLT); Renal Dysfunction

Summary:

      This is an investigator initiated study at the University of California, Los Angeles (UCLA)
      funded by Novartis looking at using a combination of immunosuppressive drugs in liver
      transplant patients that are at risk of developing kidney problems. Kidney problems following
      liver transplants is the most problematic issue facing liver transplant patients today.

      This study will generate information in this area of high unmet medical need utilizing
      basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard
      of care medications, after kidney function has normalized.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients eligible for inclusion in this study have to fulfill all of the following
        criteria:

          -  >18 years old

          -  Undergoing first or second OLT

          -  MELD (model for end-stage liver disease) score >25

          -  Serum creatinine > 1.5 or ongoing hemodialysis for less than 4 weeks at the time of
             transplant

          -  Able and agreeable to conform to requirements of the study

          -  Patients or proxy must give written informed consent before any assessment is
             performed.

        Exclusion Criteria:

          -  <18 years old

          -  Serum creatinine <1.5

          -  MELD Score < 25

          -  Ongoing hemodialysis for 4 or more weeks (those patients become eligible for renal
             transplants at that point per UCLA practice).

          -  Receiving OKT3 (Muromonab-CD3), ATG (Antithymocyte Globulin), or IVIG (Intravenous
             Immunoglobulin Therapy) therapy around time of transplant

          -  Participating in another clinical research study involving the evaluation of another
             investigational drug or device

          -  Prior documented allergy to any of the study medications

          -  Active Fungal infection
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic Acid
Intervention description: Intravenous infusion of 5 mg zoledronic acid
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Denosumab; Bone turnover markers; Bone mineral density

Summary:

      Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that
      prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease
      bone resorption and fracture risk, and many patients will reach osteopenic bone mineral
      density (BMD) levels on treatment with denosumab. The treatment effect on bone turnover and
      BMD has, however, been demonstrated to be reversible. This study will show if the bone mass
      can be maintained by administrating zoledronic acid and if timing of the first dose of
      zoledronic acid after last dose of denosumab matters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (postmenopausal for at least two years)

          -  Men above 50 years

          -  Treatment for at least two years with denosumab

          -  Last denosumab injection less than five months ago

        Exclusion Criteria:

          -  Low-energy vertebral fracture at any time

          -  Low-energy hip fracture within the last 12 months

          -  BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)

          -  Alendronate treatment for more than three years prior to denosumab treatment

          -  Ongoing treatment with glucocorticoids

          -  Metabolic bone disease

          -  Hormone replacement therapy

          -  Cancer

          -  Estimated glomerular filtration rate (eGFR) < 35 mL/min

          -  Allergy to zoledronic acid

          -  Hypocalcaemia

          -  Contraindications for zoledronic acid according to the SPC
Treatment Response in Dialysis Anaemia
Condition: Anaemia; Haemodialysis
MeSH terms: Anemia
Intervention: Iron sucrose; Erythopoietin stimulating agent
Intervention description: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl; Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Haemodialysis; Anaemia; Iron; Erythropoeitin stimulating agents

Summary:

      Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two
      current possible treatments for anaemia which are iron and erythropoietin stimulating agents
      (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and
      haemoglobin, but these markers are known to be inaccurate. The current clinical protocol
      therefore tends towards overuse of both agents which can be associated with toxicity, and the
      reliance on these markers prevents retrospective assessment of treatment responsiveness. This
      study is designed to investigate the factors which predict which agent would produce a better
      response. Patients with a fall in haemoglobin will be given treatment with either iron or an
      increased dose of ESA as they are currently, but allocated at random rather than by poorly
      performing biochemical markers. The iron treated and ESA treated groups can then be analysed
      for factors which predict response in o
    

Eligibility criteria:

        Inclusion Criteria:

          -  All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will
             be eligible for inclusion if they have been on dialysis for more than 3 months

        Exclusion Criteria:

          -  Patients with a bone marrow disorder, active infection or active malignancy will be
             excluded as these are non-renal causes of anaemia. Patients unable to give informed
             consent will also not be included within the study.
Bioenergetic Alterations After Exenatide Administration
Condition: Healthy
Intervention: Exenatide
Intervention description: Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exenatide; Byetta; weight loss; energy expenditure; normal volunteers

Summary:

      The purpose of this study is to find out how exenatide causes weight loss. Specifically, the
      study is assessing how exenatide may change how people take in energy (energy intake), as
      well as how it may effect how people use energy (energy expenditure).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years of age

          -  BMI between 30 and 40 kg/m2

          -  Women with a negative pregnancy test at baseline, who are sterile, using
             contraceptives or in a committed relationship with someone who is sterile or using
             contraception

          -  Absence of weight change greater than 3 kg in the previous 6 months

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Current or recent (6 months) enrollment in a commercial or self prescribed weight loss
             or exercise program

          -  Use of weight loss medication

          -  A history of metabolic disease i.e. renal, endocrine, hepatic or gastrointestinal
             disease that would impact the outcome of the study

          -  Presence of medical conditions that are known to affect energy expenditure (i.e.
             hyperthyroidism, rheumatoid arthritis, AIDS among others)

          -  History of hypoglycemia

          -  A history of psychiatric or eating disorder

          -  Abnormal EKG

          -  Previous history of pancreatitis

          -  Previous history of gastroparesis or GI motility disorder

          -  Use of medications that can affect GI motility

          -  History of organ transplantation

          -  Other comorbid conditions which may preclude the subject's ability to complete the
             study

          -  Use of a carbonic anhydrase inhibitor such as acetazolamide
The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
Condition: Cardiac Diagnostic Procedure; Cardiac Interventional Procedure; Femoral Access Site Closure
Intervention: Mynx Vascular Closure System; Manual Compression
Intervention description: MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.; manual pressure applied to your groin for approximately 5-10 minutes
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure
      following both diagnostic and interventional procedures as assessed by clinical and imaging
      criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients > 18 years of age scheduled for a percutaneous diagnostic or interventional
             procedure that have either a 5, 6, or 7F sheath placed in the common femoral vein.

        Exclusion Criteria:

          1. Patient has a history of a bleeding disorder

          2. Previous history of venous thrombosis or thromboembolism

          3. Patient is pregnant or lactating

          4. Patient has a known severe allergy to contrast medium

          5. Patient has a known allergy to PEG

        7. Patient is known to require an extended hospitalization or re-hospitalization (e.g.
        patient is undergoing coronary artery bypass graft (CABG) surgery) or patient is scheduled
        to have a CABG surgery <30 days following the procedure) 9. Multiple (>1) attempts at
        venous access were attempted in the target vein 10. Patient has intra-procedural bleeding
        around the access site prior to sheath removal 11. Critically ill patients requiring
        intravenous vasopressors for blood pressure stabilization 12. Ipsilateral femoral artery
        puncture or sheath insertion 13. Glycoprotein IIb/IIIIa use 14. Any bleeding or vascular
        access-site complication evident pre-venous closure
Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
Condition: Glaucoma, Angle-Closure
MeSH terms: Glaucoma; Glaucoma, Angle-Closure
Intervention: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution; latanoprost
Intervention description: COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.; Latanoprost administered in the affected eye(s) as prescribed by physician.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Ophthalmic Solutions; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of patients switched from latanoprost
      monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol
      0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has been administering latanoprost eye drops in affected eye(s) for at least
             12 weeks prior to study

          -  Patient must have at least partially responded to latanoprost and requiring further
             IOP lowering eye drops

          -  Diagnosis of chronic angle-closure glaucoma

          -  Patients using COMBIGAN® in the past must not have been discontinued due to adverse
             events or lack of efficacy.

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to COMBIGAN®

          -  Corneal abnormalities that would preclude accurate IOP readings

          -  Any other active ocular disease other than glaucoma or ocular hypertension

          -  Ocular surgery within the past 3 months.
Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Condition: Growth Hormone Deficiency; Septo-Optic Dysplasia; Hypopituitarism
MeSH terms: Dwarfism, Pituitary; Hypopituitarism; Optic Nerve Hypoplasia; Septo-Optic Dysplasia; Endocrine System Diseases
Intervention: Nutropin AQ
Intervention description: Daily injection. Dosage dependent on weight.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Optic Nerve Hypoplasia

Summary:

      Hypotheses:

        1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular,
           among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is
           commonly thought.

        2. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes.

      Aims:

        1. Determine the prevalence and types of endocrinopathies in children diagnosed with ONH.

        2. Correlate endocrine outcome with radiographic, ocular, and developmental findings in
           children with ONH.

        3. Examine the effect of GH treatment on growth and obesity in children with ONH,
           GH-deficiency, and either subnormal or normal growth compared to children with ONH that
           are not GH-deficient.

        4. Compare growth outcomes between children with isolated GH-deficiency and those with
           multiple hormone deficiencies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  New subjects diagnosed with ONH less than or equal to 2 years of age and subjects
             actively enrolled (in currently approved prospective ONH study) will be eligible for
             enrollment.