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NCT ID: NCT00724503 Completed - Colorectal Cancer Clinical Trials

FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer

SIRFLOX
Start date: August 2006
Phase: N/A
Study type: Interventional

This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma. Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

NCT ID: NCT00722709 Completed - Colon Surgery Clinical Trials

Intraperitoneal Local Anaesthetic in Colonic Surgery

Start date: September 2008
Phase: Phase 1
Study type: Interventional

Aim: The general aim of this research group is to improve the recovery of patients after abdominal surgery. The specific aim of this study is to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia application on postoperative pain and post-operative fatigue. This will be conducted in the setting of an enhanced recovery after surgery program (ERAS). Methods: Patients will be randomised by computer generated random numbers and opaque envelope method. In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9% saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at 4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of postoperative pain will be performed by visual analogue scale, and fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at various intervals post-operatively. Blood tests for inflammatory markers including glucose, cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be taken. Significance to health: This method of analgesia administration has not been investigated in open major colonic surgery. This trial has wide reaching implications, with the potential to improve pain and thus recovery after abdominal surgery.

NCT ID: NCT00720109 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Start date: July 14, 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This phase II/III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.

NCT ID: NCT00718861 Completed - Clinical trials for Post-menopausal Osteoporosis

3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

Start date: May 2008
Phase: Phase 3
Study type: Interventional

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

NCT ID: NCT00717457 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

Start date: July 2008
Phase: Phase 3
Study type: Interventional

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

NCT ID: NCT00708630 Completed - Vaccination Clinical Trials

The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination

Start date: June 2008
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of providing additional information about possible mild side effects of the yellow fever vaccination on the reporting of physical symptoms. Additionally, the project aims to investigate the relationship between individual characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of physical symptoms, as well as possible interactions between the level of information provided and individual characteristics. We hypothesize that more information about mild symptoms provided to participants will increase the number of reported symptoms after vaccination.

NCT ID: NCT00707889 Completed - Clinical trials for Advanced Colorectal Cancer

Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer

Start date: October 2008
Phase: Phase 2
Study type: Interventional

To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.

NCT ID: NCT00705406 Completed - Clinical trials for Acute, Uncomplicated Human Influenza

A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

NCT ID: NCT00703326 Completed - Breast Cancer Clinical Trials

Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer

Start date: August 6, 2008
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer.

NCT ID: NCT00702910 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Investigate the Effect of Inhaling Single Doses of Different Formulations of GW642444M in Asthmatic Patients

Start date: April 27, 2008
Phase: Phase 1
Study type: Interventional

This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when inhaled in two different formulations as a fine powder by asthmatic patients. In addition, the study is designed to examine the effect of the study drug on the lungs, how the study drug affects parts of the body other than the lungs and to see how the body affects the study drug when it is given in single doses.