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NCT ID: NCT00451932 Completed - Clinical trials for Liver Transplantation

A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients

Start date: October 2002
Phase: Phase 2
Study type: Interventional

A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

NCT ID: NCT00451906 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

Start date: October 2006
Phase: Phase 4
Study type: Interventional

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

NCT ID: NCT00451789 Completed - Clinical trials for Traumatic Brain Injury

Risk Factors of Minor Head Injury

Start date: December 2004
Phase: N/A
Study type: Observational

Introduction and Aims: The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.

NCT ID: NCT00450684 Completed - Clinical trials for Congenital Heart Defects

Cardiac Resynchronization Therapy in Congenital Heart Defects

CARE-CHD
Start date: May 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design). The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max). 55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).

NCT ID: NCT00449033 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

NEXUS
Start date: February 2007
Phase: Phase 3
Study type: Interventional

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00448591 Completed - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

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

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

NCT ID: NCT00447772 Completed - Cervical Dystonia Clinical Trials

Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

Start date: October 2004
Phase: Phase 3
Study type: Interventional

The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.

NCT ID: NCT00447057 Completed - Clinical trials for Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Start date: March 2007
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

NCT ID: NCT00445081 Completed - Atopic Dermatitis Clinical Trials

Prednisolone vs. Ciclosporine in Severe Atopic Eczema

PROVE
Start date: March 2007
Phase: Phase 4
Study type: Interventional

To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.

NCT ID: NCT00444041 Completed - Clinical trials for Metastatic Colorectal Cancer

Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer

ASSO-LM1
Start date: January 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Major attempt is being given to the potential of curing patients with metastatic colorectal cancer due to the recognition of dramatic change in survival figures achieved in palliative chemotherapy combination treatment protocols. Achieving resectablity rates in previously unresectable patients has been defined as study endpoint among other well known primary and secondary objectives. Curing metastatic colorectal cancer is most likely in resectable patients and therefore the logical next step after completion of chemotherapy combination studies (e.g. EORTC 40983) is the addition of targeted agents. Bevacizumab has the most valid data of improving outcome figures and was therefore chosen as additional agent. Safety of the combination with Xelox was demonstrated in the investigators pilot trial (Gruenberger JCO 2006, ASCO 2006, WCGC 2006, ESMO 2006), consequently response rate and resection rate will be the primary endpoints in this trial. STUDY OBJECTIVES Primary Objective The primary objective of this study is the Resectability (R0) rate after neoadjuvant Bevacizumab in potentially resectable mCRC. Secondary Objectives The secondary objectives of this study include - Feasibility with regards to GI bleeding and wound healing complications after surgery of liver metastases - General safety - Overall Response Rate (ORR) - Recurrence Free Survival (RFS) - Overall Survival (OS) STUDY DURATION Recruitment is planned for 12 months. Patients will be treated for 6 cycles XELOX and 5 cycles Bevacizumab. Surgery will be performed 2 weeks after the last Capecitabine administration, allowing a time window of 5 weeks between the last Bevacizumab administration and surgery. Therapy with 6 cycles of XELOX and Bevacizumab will be restarted 4-5 weeks after surgery. With a Follow up period of 2 years after the last enrolled patient, in order to assess RFS and OS, the trial will last for approx. 3 years. NUMBER OF CENTRES Four centres with a high level of experience in the surgery of liver metastases are planned to participate in this study. SELECTION CRITERIA Total Number of Patients and Target Population The planned total sample size for this study is 43 patients. Patients with potentially resectable metastatic colorectal cancer previously untreated for metastatic disease will be enrolled in this trial.