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NCT ID: NCT01568021 Completed - Macular Edema Clinical Trials

Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

Start date: October 2011
Phase: N/A
Study type: Observational

This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.

NCT ID: NCT01567085 Completed - Clinical trials for Stage V Chronic Kidney Disease

Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Start date: August 29, 2012
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

NCT ID: NCT01566929 Completed - Obesity Clinical Trials

Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)

Start date: October 2010
Phase: N/A
Study type: Interventional

The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.

NCT ID: NCT01566747 Completed - Clinical trials for Renal Cell Carcinoma

Second-line Pazopanib Renal Cell Carcinoma (RCC) Study. CTRIAL-IE (ICORG) 10-01, V5

Start date: March 2011
Phase: Phase 2
Study type: Interventional

This is a phase II open label, single arm study evaluating treatment with pazopanib post sunitinib treatment in 43 patients with metastatic renal cell carcinoma. Patients will receive 800mg pazopanib per day given continuously until disease progression. Patients must have received treatment with sunitinib and relapsed. Patient must have received prior treatment with sunitinib for at least 12 weeks. Prior treatment with either temsirolimus or everolimus in addition to sunitinib is allowed. The trial design uses a Simons two stage design with an interim analysis planned after the first 15 evaluable patients. If 8 or more of the first 15 evaluable patients remains disease free at 4 months, then a further 28 patients will be enrolled for a total of 43 metastatic renal cell cancer patients. It is estimated that there could be up to 10% of patients dropping out and so to achieve the required number of 43 evaluable patients the study will recruit up to 48 patients to ensure that 43 complete if stage 2 is required. Patients will receive treatment until disease progression, unacceptable toxicity or withdrawal of patient consent. Response assessments will be carried out every 8 weeks until disease progression. Safety assessments will be carried out every 4 weeks (plus a visit for liver function tests after 2 weeks) for the first six months and then every eight weeks until disease progression. A further safety assessment will be carried out 4 weeks after treatment discontinuation.

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01566695 Completed - Clinical trials for Myelodysplastic Syndrome

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

Start date: April 26, 2013
Phase: Phase 3
Study type: Interventional

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

NCT ID: NCT01565967 Completed - Trauma Clinical Trials

Registry AutoLog Lipid Removal and Blood Component Characterization

Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives: 1. to determine the lipid removal capabilities of the Medtronic AutoLog System. 2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

NCT ID: NCT01565824 Completed - Pregnancy Clinical Trials

Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)

MODIAB-web
Start date: November 2011
Phase: N/A
Study type: Interventional

The aim is to investigate whether the implementation of a web-based support to women with type 1 diabetes during pregnancy and early motherhood can improve well-being and self management of diabetes. Type 1 diabetes is associated with increased medical risks and increased psychosocial pressure in relation to childbearing. There is need for extended support from both health care professionals and peers. Web-based interventions can improve personal capacity and self-management in people with long- term illnesses but are not evaluated in childbearing women with type 1 diabetes. A web site prototype for full-size browsers and mobile devices has been developed through a participatory design by multidisciplinary researchers, health care professionals, experienced mothers with type 1 diabetes and web designers. In a randomised control study the developed web site offering information, communication with health care professionals, person-centred self-care diaries and online social community of included women, is provided to the intervention group in early pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden. A control group will receive standard care (usual care). Total n = 160. Primary outcomes are Well-Being Questionnaire and Diabetes Empowerment Scale. The intervention offers proactive solutions for strengthening patients' decision making of diabetes in daily life during pregnancy and early motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of diabetes.

NCT ID: NCT01565707 Completed - Clinical trials for Urinary Bladder, Overactive

A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

LION
Start date: June 7, 2012
Phase: Phase 3
Study type: Interventional

Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.

NCT ID: NCT01565213 Completed - Anxiety Disorders Clinical Trials

Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care

Start date: January 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of CBT and MMI on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre.