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NCT ID: NCT01064063 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

Vanguard
Start date: February 15, 2011
Phase: N/A
Study type: Interventional

This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.

NCT ID: NCT01049594 Active, not recruiting - Cerebral Palsy Clinical Trials

ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants

ePrime
Start date: April 2010
Phase: N/A
Study type: Observational

Preterm infants face an uncertain future because premature birth often leads to problems with brain development and can cause cerebral palsy. A trial needs to be done to see if Magnetic Resonance Imaging (MRI) helps families and professionals by predicting long term problems more accurately, allowing better targeting of care to children with problems and reassuring the parents of normal babies. This programme will provide the evidence-base for the National Health System (NHS) policy on the use of magnetic resonance imaging of the brain for preterm infants.

NCT ID: NCT01038479 Active, not recruiting - Dental Caries Clinical Trials

Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)

MaXED
Start date: December 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the Childsmile programme (www.child−smile.org) with the additional maternal use of xylitol is more effective at reducing dental decay in children than a Childsmile program alone. The children will be compared in the two groups at age two, to determine how the interventions affected the early colonization of mutans streptococci, an important risk factor of tooth decay. At three and at five years the investigators will also examine the amount of tooth decay in these children. Using MIDAS (Scotland's national health service dental data) records, the investigators will follow the oral health of the children until the age of 5 years. Main hypothesis: The maternal consumption of xylitol reduces early childhood caries

NCT ID: NCT01037049 Active, not recruiting - Neoplasms Clinical Trials

Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

Start date: October 16, 2009
Phase: Phase 2
Study type: Interventional

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks. Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.

NCT ID: NCT01024829 Active, not recruiting - NSCLC Clinical Trials

Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using FDG-PET-CT Scan in Stage IB, II and III NSCLC

PET Boost
Start date: May 2010
Phase: N/A
Study type: Interventional

Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. All patients will receive 24 radiations. Dose increasement will be enabled by a so called integrated boost. Furthermore: - PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.

NCT ID: NCT00987857 Active, not recruiting - Esophageal Cancer Clinical Trials

Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus

Start date: March 2009
Phase: N/A
Study type: Interventional

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus. PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.

NCT ID: NCT00985205 Active, not recruiting - Burns Clinical Trials

The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury

RE-ENERGIZE
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the following hypotheses: 1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries. 2. Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries. 3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care. The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 1200 patients in 80 sites: 1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital 2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?

NCT ID: NCT00981058 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin

SQUIRE
Start date: January 7, 2010
Phase: Phase 3
Study type: Interventional

The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

NCT ID: NCT00979238 Active, not recruiting - Hemophilia B Clinical Trials

Dose-Escalation Study Of A Self Complementary Adeno-Associated Viral Vector For Gene Transfer in Hemophilia B

Start date: February 22, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety of giving a normal factor IX gene to treat individuals who have an abnormal or no factor IX gene. Recruitment will be limited to adults (≥ 18 years) with a confirmed diagnosis of hemophilia B (HB), resulting from a missense mutation in the coagulation factor IX (FIX) gene or a nonsense mutation that has not been associated with an inhibitor. Only subjects who have no evidence of active hepatitis or anti-hFIX antibodies, and who have been treated/exposed to Factor IX concentrates for at least ten years and have had an average of 3 bleeding episodes per year requiring FIX administration will be enrolled. Patients will be recruited within the United States for treatment at St. Jude Children's Research Hospital, and patients will be recruited in England and other countries for treatment in London by our British collaborators.

NCT ID: NCT00976989 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Patients With HER2-Positive Breast Cancer

Start date: December 2009
Phase: Phase 2
Study type: Interventional

This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in patients with locally advanced, inflammatory or early stage HER2-positive breast cancer. Before surgery, patients will be randomized to receive either A) 6 cycles of pertuzumab plus Herceptin, with FEC (5-fluorouracil/epirubicin/cyclophosphamide) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus Herceptin with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus Herceptin with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv, then 6mg/kg iv 3-weekly, docetaxel at 75mg/m2 iv, increased to 100mg/m2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery patients will receive Herceptin 6mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.