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Publicly disclosed projects

name therapeutic area description our role  
L-TolX  Liver transplant rejection management.  L-TolX cohort study. Assessment of the safety and benefit of prospective immunosuppressive drug withdrawal in liver transplantation and prediction of operational tolerance. Cohort size: 102 patients. Follow-up: 3 years.  Trial protocol & CRF formalism. Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report. Resource utilization substudy set-up and conduct. Data analysis and modeling. Study master file management. Regulatory submissions.  detail
STARR European registry  Colorectal surgery of intussusception.  Ethicon Endo-Surgery STARR cohort study: Intusuception surgery evaluation. 2838 patients enrolled in Italy, Germany and United Kingdom. Follow-up 1 year  CRF formalism Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report. Study master file management. Regulatory submissions.  detail
Transtar cohort  Colorectal surgery of intussusception.  Transtar Pioneers pilot cohort study: 75 patients. 1 year follow-up  CRF formalism Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report. Study master file management. Regulatory submissions.  detail
ESAT study  Intracranial aneurysm coiling and stenting.  Cordis-Codman ESAT: Intracranial stent evaluation. 120 patients: follow up 1  Trial protocol & CRF formalism. Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report.  detail
SAGB cohort study  Bariatric surgery: adjustable gastric banding.  Ethicon Endo-Surgery SAGB French cohort study: Bariatric surgery patients. 517 patients: follow up 3 year  Trial protocol & CRF formalism. Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report. Study master file management.  detail
Thermachoice cohort study  Intrauterine thermal treatment of functional menhorragia.  Ethicon Thermachoice cohort study of UBT in menorrhagia: 260 patients with 4-6 year follow-up.  Trial protocol & CRF formalism. Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report. Study master file management  detail
ACES trial  Coronary PCI.  Svelte Acrobat Coronary Stent System Effectiveness European Study: RCT, 300 patients. MACE 6 months & resource utilization substudy.  Trial protocol & CRF formalism. Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report. - study master file management  detail
Bariatric model DE UK FR  Bariatric surgery  Systematic literature review. Resource-utilization collection. Specification and programming of dynamic cost-effectiveness model in Germany, UK, France.  Adjustable gastric banding versus gastric bypass versus conventional therapy.  detail
Bariatric model IT AT ES  Bariatric surgery  Resource-utilization collection. Specification and programming of dynamic cost-effectiveness model in Italy, Spain, Austria.  Adjustable gastric banding versus gastric bypass versus conventional therapy.  detail
SLR triclosan  Surgical site infections  Systematic literature review and meta-analysis. Protocol development, conduct, report, manuscript drafting.  Assessment of the risk of surgical site infection with triclosan-coated sutures versus non-coated sutures.  detail
SLR Harmonic Focus  Assessment of outcomes with different surgical hemostatic techniques in thryroidectomy.  Systematic literature review to asses outcomes with Harmonic Focus versus conventional surgery and other advanced energy devices.  Systematic literature review and meta-analysis. Protocol development, conduct, report, manuscript drafting.  detail
EXPRESSO registry  Ablation of cardiac tissue to treat atrial fibrillation.  Biosense-Webster EXPRESSO registry of cardiac conductive tissue ablation in atrial fibrillation: 207 patients. 1-year follow-up  Clinical data electronic capture and data management.  detail
Public health review for European Parliament  Tobacco cessation.  European Parliament. DG Internal policies of the Union. WHO Framework convention on tobacco control. Briefing note.  Systematic literature review and regulatory review of tobacco cessation in Europe further to the implemenation of WHO policies.  detail
Pinnacle Ultamet Cohort Study  Total hip joint replacement.  Depuy International cohort study of Pinnacle Ultamet device in conventional total hip joint replacement: 110 patients. 5-years follow-up  Clinical data electronic capture and data management. Programmed statistical scripts and ran analyses. Wrote study report. Study master file management  detail