Kusajili – Centralise les essais cliniques mondiaux

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

• Pays Argentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Portugal, Romania, Serbia, Singapore, South Africa, Spain, Taiwan, Province of China, United Kingdom, United States,
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Study of Prognosis of Follicular Lymphoma Through a Prospective Collection of Data (F2-study) The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI). The F2-study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are to validate the FLIPI and to verify whether a prognostic collection of data would allow the development of a more accurate prognostic index.

• Pays Argentina, Czech Republic, France, Italy, Spain, Switzerland, United Kingdom, United States,
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Study of CP-675,206 in Refractory Melanoma CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

• Pays Argentina, Australia, Canada, France, Germany, Italy, Spain, United Kingdom, United States,
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Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

• Pays Argentina, Australia, Belgium, Canada, Colombia, Egypt, Finland, France, Germany, Guatemala, Hungary, Iceland, India, Italy, Korea, Republic of, Philippines, Poland, Romania, Singapore, Spain, Sweden, United Kingdom, United States,
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Efficacy and Safety of Adalimumab in Patients With Active Uveitis A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.

• Pays Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Switzerland, United Kingdom, United States,
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Predictive Markers in GHD and TS Children Treated With SAIZEN® The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children. The study will recruit approximately 360 children in several countries worldwide. The study lasts for about the first one month of daily growth hormone treatment. There will be three clinic visits during the month of the study. There is an initial visit, then a visit before growth hormone treatment starts and finally a visit at the fourth week of treatment. The study requires two additional blood tests to a regular Saizen treatment follow-up. One sample is taken before growth hormone injections start and one additional blood sample is taken at the fourth week of treatment.

• Pays Argentina, Australia, Austria, Canada, France, Germany, Italy, Norway, Russian Federation, Singapore, Spain, Sweden, United Kingdom,
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Observational Study on the Incidence of NSF in Renal Impaired Patients Following DOTAREM Administration The main purpose of this study is to prospectively estimate the incidence of NSF in patients with moderate to severe renal impairment after administration of DOTAREM®

• Pays Argentina, Belgium, Colombia, France, Germany, Italy, Korea, Republic of, Spain, Turkey, United Kingdom, United States,
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CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

• Pays Argentina, Australia, Austria, Belgium, Canada, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States,
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