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NCT ID: NCT01999400 Active, not recruiting - Clinical trials for Local Drug Concentration in Gastrointestinal Tract

Correlation of Mesalamine Pharmacokinetics With Local Availability

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

This study is designed to provide data to the FDA correlating pharmacokinetics with local availability of medications within the gastrointestinal tract. This study will support the establishment of scientifically based standards for evaluating drugs which act locally within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve the physiologically based models for drug absorption from the intestine. Information from this study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of mesalamine products.

NCT ID: NCT02058680 Active, not recruiting - Prostate Cancer Clinical Trials

Phase 1A/1B Study of PSA/IL-2/GM-CSF Vaccine for Recurrent Prostate Cancer in Hormone Naive and Hormone Independent Patients

PSA
Start date: April 2012
Phase: Phase 1
Study type: Interventional

This study is investigating the safety and efficacy of a vaccine directed against prostate tumor cells. The researchers are interested in evaluating the safety and tolerability of the vaccine, and the effects of the vaccine on survivability, time to measurable disease, prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine. Eligible patients include those with recurrent prostate cancer as shown by elevated levels of PSA, although there is no evidence of tumors that are measurable by imaging studies. In addition, to be eligible patients must have prostate cancer that either has not been treated by hormonal therapy or is not responsive to hormonal therapy.

NCT ID: NCT02310308 Active, not recruiting - Dental Caries Clinical Trials

Effect of a Sugar-Free Chewing Gum Containing Magnolia Bark Extract on Caries Lesions in Healthy Adult Volunteers

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

The effect of chewing gums containing MBE and xylitol on different variables related to caries and gingivitis in a sample of adult volunteers with a high risk for caries will be evaluated. The main result of that double-blind randomized controlled interventional trial will be that chewing gum containing MBE was more effective in reducing plaque acidogenicity, salivary mutans streptococci concentration and gingival bleeding compared to a xylitol and sugar-free chewing gum.

NCT ID: NCT02353481 Active, not recruiting - Heart Failure Clinical Trials

1 Year Post Discharge Prognostic Model From the National Heart Failure Audit (NHFA)

Start date: April 2012
Phase: N/A
Study type: Observational

The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales.

NCT ID: NCT02366117 Active, not recruiting - Schizophrenia Clinical Trials

Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems

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

The study design is that of a cluster randomised controlled trial The aims of the study were: 1) to assess the quality of care of the residential units for people with long-term mental disorders; 2) to design a training intervention for the staff of the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and 8 months after it ended. The main outcome variable was level of activity of the users. Secondary outcome variables were the QuIRC dimensions. The selection of the sample was by residential units for people with long-term mental disorders. The inclusion criteria were all the middle and high-support residential units in Portugal. Units that had only one type of service users (e.g., mental retardation, dementia) were excluded. The quality of care of the units was assessed with the QuIRC filled on line by the managers of the units and validated with Service Users Interview Schedule, a face-to-face interview with the users (users that could not give informed consent or collaborate in the interview were excluded).

NCT ID: NCT02815930 Active, not recruiting - Clinical trials for Senior High Cost Users (HCU)

Characterizing the Senior High Cost User (HCU) in Ontario

Start date: April 2012
Phase:
Study type: Observational

High cost users (HCUs) are a small group of patients who use a disproportionate amount of health care resources. This study is a retrospective population-based matched cohort analysis of newly incident senior High Cost Users (HCUs) defined as Ontarians aged 66 years or older in the top 5% of healthcare expenditure users in fiscal year 2013 (FY2013). The study objectives are to characterize and contrast Ontario senior HCUs to non-HCUs based on their demographics, co-morbidities, medication use, health service utilization, healthcare expenditures, medication costs and clinical outcomes, and to determine the relative contribution of medications to senior HCUs expenditures

NCT ID: NCT03038373 Active, not recruiting - Morbid Obesity Clinical Trials

Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery

Start date: April 2012
Phase:
Study type: Observational

The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes in the morbid obese patients after laparoscopic sleeve gastrectomy.

NCT ID: NCT01654796 Active, not recruiting - Clinical trials for Treatment Resistant Depression

Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

RAPID
Start date: April 2013
Phase: N/A
Study type: Interventional

This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

NCT ID: NCT01728818 Active, not recruiting - Clinical trials for Focus of Study Instead

Afatinib as Cancer Therapy for Exocrine Pancreatic Tumours

ACCEPT
Start date: April 2013
Phase: Phase 2
Study type: Interventional

Single-agent gemcitabine is currently still regarded as one international standard of care for patients with advanced pancreatic cancer (Burris 1997 [4]). The oral EGFR tyrosine kinase inhibitor erlotinib received EMEA-approval for the treatment of patients with metastatic pancreatic cancer in January 2007. In the pivotal phase III trial, the combination of gemcitabine plus erlotinib was associated with a statistically significant prolongation of OS (compared to single-agent gemcitabine), however, the absolute survival benefit was - for the overall study population - clinically moderate (median OS: 6.24 vs 5.91 months, 1-year OS rate: 23% vs 17%; HR = 0.82, p=0.038) (Moore 2007 [19]). The recently presented FOLFIRINOX regimen shows enhanced activity in metastatic pancreatic cancer patients. This regimen is, however, limited to patients with good performance status (ECOG 0-1), no major comorbidity, age <75 years, and bilirubin <1.5 ULN (Conroy 2011 [6]). The majority of pancreatic cancer patients will therefore not be treated with this regimen. Accordingly, novel treatment concepts are urgently needed in pancreatic cancer and pre-clinical data indicate an important role of the EGFR1/erbB2 receptor signalling in the pathogenesis of pancreatic adenocarcinoma (Yeh 2007 [24]). A recent publication (Larbouret 2010 [16]) indicates that the combination of cetuximab and trastuzumab induced superior antitumour activity in human pancreatic carcinoma xenografts compared to gemcitabine alone (see also Larbouret 2007 [15]). Furthermore, synergistic antitumour activity was observed when monoclonal antibodies directed against the EGFR1 and erbB2 were combined (Ben-Kasus 2009 [3]). Based on these data, there is a good rationale to further investigate the combined inhibition of the erbB family in pancreatic cancer patients. Afatinib (BIBW 2992) is a novel irreversible EGFR1- and HER2 and HER4 inhibitor that is applied orally. The purpose of the present trial is to investigate the erbB family inhibition by afatinib in patients with metastatic pancreatic cancer. In the planned trial, afatinib will be applied at the dose (40 mg/day) that was chosen for the randomised phase III trial (LUX 5 study) that investigates afatinib plus weekly paclitaxel (80mg/m2). Presently there is also a phase I study ongoing that investigates the combination of afatinib with gemcitabine (ClinicalTrials.gov Identifier: NCT01251653 U10-2249-02 ). Possibly the data will be available once the study is ready to start. Otherwise a modification of the regimen will be planned once the respective data will be available. In this trial, we integrate a translational project which may allow the identification of patients that primarily benefit from this novel treatment approach. The availability of tumour tissue- and blood samples from each patient is therefore an important inclusion criterion. A 2:1 randomisation is chosen favouring the experimental arm since a large body of data is available on gemcitabine alone and since sufficient efficacy and toxicity data shall be gained in the experimental arm. In addition, the patients' motivation to take part in the trial will be greatly enhanced by a greater chance to receive the experimental agent.

NCT ID: NCT01730937 Active, not recruiting - Clinical trials for Advanced Adult Primary Liver Cancer

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

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

This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.