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NCT ID: NCT01607372 Completed - Asthma and Rhinitis Clinical Trials

A Study to Investigate the Safety and Pharmacodynamics of Repeat Intranasal Administration of the TLR7 Agonist GSK2245035 in Subjects With Respiratory Allergies

Start date: April 2012
Phase: Phase 2
Study type: Interventional

GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates preferentially the induction of type I interferons. Intranasal (i.n.) administration of GSK2245035 in humans causes immune changes in the upper airways milieu that may alter bystander immune responsiveness to aeroallergens and contribute to reduction of allergic reactivity in subjects with respiratory allergies. The purpose of this study is to examine the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with respiratory allergies. The safety and pharmacodynamic response of four weekly administrations of escalating doses of i.n. GSK2245035 will be investigated and the maximum tolerated dose will be established. The study will be conducted in patients with symptomatic allergic rhinitis and mild asthma. The overall duration of the study will be up to a maximum of approximately 122 days considering 90 days screening period, 22 days treatment period and 10 days follow-up period.

NCT ID: NCT01606995 Completed - Atrial Fibrillation Clinical Trials

Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

XANTUS
Start date: June 12, 2012
Phase:
Study type: Observational

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

NCT ID: NCT01606878 Completed - Clinical trials for Recurrent Neuroblastoma

Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Start date: April 29, 2013
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and the best dose of crizotinib when given together with combination chemotherapy in treating younger patients with solid tumors or anaplastic large cell lymphoma that has returned or does not respond to treatment. Crizotinib may stop the growth of tumor or cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, topotecan hydrochloride, dexrazoxane hydrochloride, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving crizotinib together with combination chemotherapy may be a better treatment for patients with solid tumors or anaplastic large cell lymphoma.

NCT ID: NCT01606761 Completed - Clinical trials for Arthritis, Rheumatoid

A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)

Start date: August 6, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

NCT ID: NCT01606007 Completed - Type 2 Diabetes Clinical Trials

Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

NCT ID: NCT01605227 Completed - Prostate Cancer Clinical Trials

Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100

COMET-1
Start date: July 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

NCT ID: NCT01605097 Completed - Prostate Cancer Clinical Trials

High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule

Dosepainting
Start date: May 2012
Phase: N/A
Study type: Interventional

This study will investigate the feasibility of using technology of ultrasound guided HDR brachytherapy to focally increase dose to regions within the prostate that are heavily infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL) can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS) prior to the brachytherapy procedure to design a dose distribution that will encompass the malignant volume with higher than the prescription dose. By its nature, brachytherapy has subvolumes that receive (for example)125% of the prescription dose or 150% of the prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to coincide with the DIL. The limit of dose escalation has been reached at whole prostate external beam doses of 81-86 Gy and still failure rates for intermediate and high risk disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided HDR brachytherapy is perfectly suited to achieving this.

NCT ID: NCT01604993 Completed - Healthy Clinical Trials

Acute Effect of Nitrate From Natural Dietary Sources on Arterial Stiffness and Blood Pressures in Healthy Individuals

DNAB
Start date: October 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates on aortic augmentation index, brachial and aortic blood pressures, and subendocardial viability ration (SEVR).

NCT ID: NCT01604980 Completed - Healthy Females Clinical Trials

Determination of Protein Requirements in Elderly Female Subjects >75 Yrs Old

Start date: March 2012
Phase: N/A
Study type: Interventional

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements. The current DRI requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA). Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population. The goal of this study therefore is to measure the protein requirement of female elderly subjects >75 years using the IAAO technique.

NCT ID: NCT01604954 Completed - Obesity Clinical Trials

Does Food Labeling Influence Long-term Food Intake and Eating-related Variables in Women?

MENU
Start date: August 2011
Phase: N/A
Study type: Interventional

Weight management is a critical issue in developed countries where the prevalence of obesity is always increasing. While the mismatch of energy intake and energy expenditure is recognized as a leading cause of obesity, knowledge related to the determinants of healthy eating patterns are still an important issue to further address. Various nutrition-education campaigns have been implemented as a way to increase knowledge about healthy foods and facilitate the adoption of better eating behaviors. There is currently social and politic pressure on health authorities to increase availability of nutrition information as a way to tackle the obesity epidemic. Does nutrition information on food labels really contribute to improving dietary intake among the population and to helping them to better manage their body weight? Some evidence suggests that describing foods as healthy might have unintended enhancement effects on the acute amount of food and calories consumed. A better understanding of how and why nutrient and calorie labels influence acute and chronic intake is thus needed. This study investigate how providing nutritional information on food labels influences intake and eating-related variables over a 10-day period among women characterized by varying levels of adiposity. As it has never been investigated before, the present research will provide important knowledge on the long-term impacts of different food labeling strategies on the regulation of food intake. It will also help to determine whether weight status could influence the effects of perceptions about foods on intake, so that the investigators can identify individuals who mostly tend to overeat in specific situations. Consumer advocacy organizations are urging government to adopt policies regarding food labeling. Such research is thus of great relevance for the promotion of healthy body weight at the population level, as it will clearly contribute to assess how food labels should be used by health governing bodies in the context of the obesity epidemic.