Kusajili – Centralise les essais cliniques mondiaux

Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

• Pays Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland,
• Organes Aucun
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Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.

• Pays Canada, Denmark, France, Germany, Italy, Poland, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom,
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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

• Pays Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom, United States,
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Diabetes Attitudes Wishes and Needs The study is conducted in Africa, Asia, Europe, Japan, North America and South America. The multinational surveys will explore the experiences and unmet needs of people with diabetes, as well as those of family members of people with diabetes, and of healthcare professionals treating people with diabetes.

• Pays Algeria, Canada, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States,
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FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

• Pays Australia, Belgium, Canada, Denmark, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States,
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Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.

• Pays Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, United Kingdom,
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Combination of Irinotecan and Temozolomide in Children With Brain Tumors This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.

• Pays Australia, Belgium, Denmark, France, Italy, Poland, Spain, United Kingdom,
• Organes Aucun
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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

• Pays Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
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Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

• Pays Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden, United Kingdom, United States,
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EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS) To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms. To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

• Pays Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom,
• Organes Aucun
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