bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin (TA-7284); Insulin
Intervention description: The patients will receive Canagliflozin orally for 36 weeks
Intervention MeSH terms: Canagliflozin
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: 20 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      This extension study was designed to evaluate the safety and efficacy of Canagliflozin
      (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The
      extension study was an extension to double-blind study of 16 weeks (TA-7284-11)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients should complete the week 16 assessments in the double-blind study
             (TA-7284-11)

        Exclusion Criteria:

          -  Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Patients with severe diabetic complications (proliferative diabetic retinopathy, stage
             4 nephropathy, or serious diabetic neuropathy)

          -  Patients with serious renal or hepatic disease

          -  Patients who are the excessive alcohol addicts

          -  Patients who are pregnant, lactating and probably pregnant patients and patients who
             can not agree to contraception
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
Condition: Liver Transplant
Intervention: Cyclosporine A; Tacrolimus; Basiliximab; Methylprednisolone; Prednisone
Intervention description: Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery.; Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery; Post-operatively prednisone was tapered from an initial dose of 20mg/day to zero at 3 months or continued at 5-10mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
Intervention MeSH terms: Cyclosporine; Prednisone; Methylprednisolone; Tacrolimus; Cyclosporins; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Keywords: Liver transplant, adults, C2 monitoring

Summary:

      The purpose of this study is to determine whether cyclosporine A (in a micro emulsion
      formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or
      superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In
      addition this study will assess the safety and tolerability of a cyclosporine A regimen based
      on C-2h monitoring in comparison to the standard tacrolimus regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  About to undergo a primary liver transplant (including living donor, non-heart beating
             donor and split liver).

          -  Age between 18 and 75 years.

          -  Expected to be able to receive the first oral dose of CNI within the first 24 hours
             post-transplantation (Tx)

        Exclusion Criteria:

          -  This is a multi-organ transplant or if the patient has previously been transplanted
             with any other organ.

          -  Urine production is <200 ml within 12 hours after reperfusion of the graft

          -  Severe coexisting disease is present or if any unstable medical condition is present
             which could affect the study objectives.

        Other protocol-defined exclusion criteria applied
Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
Condition: Visual Acuity Reduced Transiently; Macular Edema, Cystoid
MeSH terms: Macular Edema; Edema
Intervention: ranibizumab
Intervention description: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Observer-masking (assessment of BCVA, macular thickness, capillary drop-out) is done to guard against detection bias.
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema, Ranibizumab, Visual Acuity, Diabetic Control

Summary:

      The aim of the prospective randomized study is to investigate whether a intensified diabetic
      control program leads to better final visual acuity and less frequent diabetic ocular
      complications in patients with diabetic retinopathy when compared with a normal diabetic
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients with diabetic macular edema relevant to visual acuity

          -  OCT central retinal thickness ≥ 250µm

          -  HbA1c > 6,5% at initial visit

          -  BCVA ≤0.8 and ≥0.05

          -  Age ≥18 years

          -  Written patient informed consent given

        Exclusion Criteria:

          -  Previous treatment with intravitreal drugs in last 6 months

          -  Vitreous hemorrhage as a consequence of proliferative retinopathy

          -  Pregnancy

          -  Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)

          -  Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel
             disease, Addison´s disease, Cushing Syndrome, Uveitis)

          -  Systemic cortisone or anti-VEGF therapy

          -  Acute systemic or ocular infectious diseases
A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites
Condition: Wound Closure Technique
Intervention: Polyglactin 910 sterile synthetic absorbable suture (Ethicon); Chromic Gut Sterile absorbable Suture (Ethicon)
Intervention description: Half of punch biopsy wounds are closed with each absorbablesuture
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      Some Dermatologists prefer absorbable suture to non-absorbable suture in the closure of punch
      biopsy sites. The reason these are often preferred is because patients do not have to pay for
      another visit to get the suture material removed. Also patients are not inconvenienced into
      returning to the office for suture removal1. However, the absorbable suture material
      currently used by most Dermatologists is very expensive.

      In order to evaluate ways to reduce costs for patients, we will compare a less expensive
      suture material (chromic gut) with one of the absorbable suture materials currently used in
      clinical practice (PDS).

      Patients who are eligible and choose to participate in the study will undergo a punch biopsy
      and a suture will be used to close the skin. The type of suture received by the patient will
      be randomized, like the flip of a coin. Group A will receive PDS and Group B will receive
      chromic gut suture.

      After one weeks time, the patient will return to clinic and their dermatologist will evaluate
      the biopsy site for redness, wound infection, wound opening, and scar formation. The patients
      will be given a questionnaire evaluating their satisfaction with the cosmetic outcome and any
      pain caused by the suture materials. If the suture came out before the visit, the patient
      will be asked to report on what day the suture fell out. The patients will return two more
      times over the next two weeks to receive the same questionnaire and evaluation by their
      dermatologist.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be age 18 or older

          2. Having a punch biopsy procedure performed for benign reasons

          3. Biopsy site is between the shoulders and ankles

        Exclusion Criteria:

          1. Having a punch biopsy procedure performed for a suspicious cancerous lesion including
             basal and squamous cell carcinoma and melanoma

          2. Biopsy site is on the face, palms, soles or groin area
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
Condition: Lumbar Spine Degeneration
Intervention: 5cc Vivigen and local autograft; Small kit rhBMP-2 with local autograft
Intervention description: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft; The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking description: The surgical team, including the surgeons, will be blinded to the treatment options until decompression/instrumentation have been completed. The patients and all staff, including hospital nursing staff, case management, and physical therapists, will be blinded as to which bone graft treatment the patient received.
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen,
      a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 or older;

          2. Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc
             disease with axial low back pain and neurologic symptoms, failed conservative
             treatment and eligible for a single level lumbar instrumented fusion;

          3. Willing to provide informed consent, participate in study, and comply with study
             protocol.

        Exclusion Criteria:

          1. Pregnant or contemplating pregnancy prior to surgery;

          2. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal
             infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);

          3. Surgery involving more than 2 vertebral levels;

          4. Worker's compensation or personal injury related to lumbar spine (treatment outcomes
             may be affected by patient's personal interests; could also run into potential issues
             with reimbursement).

          5. Lactating women

          6. Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem,
             Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin

          7. Immune compromised patients
Tacrolimus to Sirolimus Conversion for Delayed Graft Function
Condition: Kidney Transplant; Delayed Graft Function
MeSH terms: Delayed Graft Function
Intervention: Tacrolimus; Sirolimus
Intervention description: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol; 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Intervention MeSH terms: Sirolimus; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: kidney transplant; tacrolimus; sirolimus; delayed graft function; Graft survival; Acute rejection; Chronic allograft nephropathy

Summary:

      The objective of this study is to evaluate the safety and efficacy of conversion from
      tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft
      function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic
      allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to
      sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will
      improve graft function and decrease the progression of graft fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age => 18.

          2. Recipient of a deceased donor kidney transplant.

          3. Delayed graft function, defined as need for dialysis during first week after surgery
             or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring
             dialysis

          4. Stable serum creatinine for 2 weeks prior to enrollment.

          5. Able to give informed consent.

          6. Compliant with medical regimen and clinic visits.

        Exclusion Criteria:

          1. Episode of acute rejection within 4 weeks prior to enrollment.

          2. Calculated GFR < 30 ml/min.

          3. Interstitial fibrosis & tubular atrophy in transplant biopsy higher than grade II
             (Banff"05 update).

          4. Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.

          5. Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite
             optimal lipid lowering therapy.

          6. Recipient of pancreas or liver allografts.

          7. Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.

          8. Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.

          9. Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.

         10. Unwilling to comply with study protocol.

         11. Enrollment in another drug trial that precludes use of sirolimus.

         12. Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated
             non-melanoma skin cancer.

         13. For women, pregnancy.

         14. Allergy to iodine
Phenylephrine Versus Ephedrine in Pre-eclampsia
Condition: Pre-eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Intervention: Phenylephrine; Ephedrine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Ephedrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cesarean delivery; Spinal Anesthesia

Summary:

      Phenylephrine administration is associated with reductions in CO and SctO2 compared with
      ephedrine when used for blood pressure management in women with pre-eclampsia undergoing
      cesarean delivery under spinal anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking

          -  Age ≥18 yrs

          -  Pre-eclampsia (mild, or severe)

          -  Non-laboring women

          -  CD under spinal anesthesia

        Exclusion Criteria:

          -  Height < 5'0"

          -  Allergy to phenylephrine or ephedrine, or any other standardized medication

          -  Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III
             and IV)

          -  Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

          -  History of recent amphetamine or cocaine use.

          -  Subject enrollment in another study involving a study medication within 30 days of CD

          -  Any other physical or psychiatric condition which may impair their ability to
             cooperate with study data collection
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Condition: Scabies; Households
MeSH terms: Scabies
Intervention: Benzyl Benzoate 25% Topical Application Lotion
Intervention description: Applied to skin for the treatment of scabies
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Healthy volunteers: No

Summary:

      It is unclear whether individual treatment of scabies is similarly effective compared to
      household treatment. This study therefore compares these two treatment strategies with
      topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon.

      Subjects presenting with uncomplicated scabies are randomized into either the Individual
      Treatment group, where only the affected subjects receive treatment, or the Household
      Treatment group, where all family members are treated in parallel to the affected subjects
      regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the
      secondary endpoint is the proportion of affected household members per household after 28
      days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with active, uncomplicated scabies

          -  no known hypersensitivity or allergy against benzyl benzoate

        Exclusion Criteria:

          -  hypersensitivity or allergy against benzyl benzoate

          -  severe superinfection of scabies lesions
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
Condition: Previously Treated PH + CML
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Bosutinib
Intervention description: 100 mg and 500 mg tablets, once daily dosage up to 4 years duration
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bosutinib; Chronic Myeloid Leukemia; CML; Leukemia; Myelogenous; Chronic; BC-ABL Positive

Summary:

      The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to
      the European Medicines Agency in providing additional safety and efficacy data in
      approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with
      high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase
      patients in the fourth or later line treatment setting (i.e., after treatment with at least 3
      other Tyrosine Kinase Inhibitors).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed
             BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative
             Chronic Myeloid Leukemia (from initial diagnosis).

          -  Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib
             and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).

          -  Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to
             receive treatment with imatinib, dasatinib and/or nilotinib for any reason.

        Exclusion Criteria:

          -  Participation in any other clinical studies involving investigational drug(s) within
             14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to
             the first dose of bosutinib.

          -  Prior treatment with bosutinib.

          -  Prior treatment with ponatinib.

          -  Known T315I or V299L mutation.
Effect of Omega-3 Fatty Acid on Vitamin D Activation
Condition: Hemodialysis Patients; Vitamin D Insufficiency; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Omega-3 fatty acid ethylester 90; Olive oil; cholecalciferol
Intervention description: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks; Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks; if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
Intervention MeSH terms: Cholecalciferol; Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 17.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Omega-3 fatty acid; vitamin D; ergocalciferol; hemodialysis

Summary:

      Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1,
      25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high
      dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D
      concentrations were significantly increased after 3 months of omega-3 FA supplementation
      compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients.
      In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D
      supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to
      25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or
      deficient 25-hydroxyvitamin D levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who were treated with hemodialysis for at least 6 months with
             25-hydroxyvitamin D < 30 ng/mL

        Exclusion Criteria:

          -  Patients with a history of active infection within 3 months,

          -  Patients with fish oil or omega-3 fatty acid supplementation within 3 months,

          -  Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,

          -  Patients with a history of hospital admission within 3 months,

          -  Patients with a history of bleeding within 3 months,

          -  Patients with thrombocytopenia,

          -  Patients with current use of warfarin,

          -  Patients with an albumin level < 3.0 g/dL,

          -  Patients with malignancy and/or liver cirrhosis