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NCT ID: NCT01790945 Not yet recruiting - Clinical trials for Diabetic Macular Edema

Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography

DIVER
Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.

NCT ID: NCT01785485 Not yet recruiting - Clinical trials for Adult Primary Care Patients

IMPACT - Integrative Medicine PrimAry Care Trial

IMPACT
Start date: February 2013
Phase: N/A
Study type: Observational

This study is Phase II of a project by the University of Arizona Center for Integrative Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the clinical and cost effectiveness (outcomes) of an integrative medicine professional practice model for adult primary care delivery (the University of Arizona Integrative Health Center - UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC. In addition, a fidelity evaluation will assess whether the practice model was implemented as planned. The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient data from medical records abstractions, self-report assessments, clinic administrative and service utilization/encounter data, and health insurance claims data; and, 3) Conduct fidelity evaluation of the implementation of the UAIHC model as described in its business plan using patient- and staff-reported fidelity assessments, random chart audits, and abstracted clinic administrative data. Participants. 1) Participants from the clinic patient population for whom clinical and cost outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected (n=14). Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and biomarkers from medical records abstractions; patient reported outcomes and satisfaction questionnaires; clinic service encounter logs; and, cost data from health insurance claims information and clinic financial data. For fidelity evaluation, data will be collected monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually from then on. Patient data for fidelity will be gathered on a single randomized day of the week using a self-administered patient feedback questionnaire. For personnel, fidelity data will be collected at the same intervals using a self-administered provider perceptions questionnaire of inter-professional team and integrative medical care. Data from audits of randomly selected patient charts and administrative records will also be used.

NCT ID: NCT01780896 Not yet recruiting - Clinical trials for Normal Elderly Population

Relationship Between Vestibular Function and Topographic Memory

Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate visual and nonvisual topographic memory impairment and its relationship to vestibular function in humans. Topographic memory refers to the ability to remember current and past locations in topographic (navigational) space and to make and/or adjust to spatial transformations using such memories. Performance on each of these topographic memory tasks will be compared to performance on a set of comparable nontopographic memory tasks. Topographic impairments represent some of the earliest cognitive deficits observed in Alzheimer's Disease, and the brain areas involved in topographic memory are the first to show degenerative changes.

NCT ID: NCT01780129 Not yet recruiting - Shock, Septic Clinical Trials

Polydatin Injectable (HW6) for Shock Treatment

PIST
Start date: February 2013
Phase: Phase 2
Study type: Interventional

HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac function, improves microcirculation, and increases blood pressure and pulse pressure, and improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined multiple target pharmacological effects. Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock patient. This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure stabilization, regardless the types of completed, on-going, or projected Standard of Care or surgery will be recruited to participant in the trial. A total of 120 patients with traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each type of shock, sixty patients each will be in test group and control group. Both adult males and females aged 18-80 years are eligible. The primary clinical endpoint is the time length (TL) between the start of HW6 administration to the onset of the first treatment success, that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour without the use of vasopressors. Several secondary endpoints and biomarkers will be measured. Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment groups and placebo groups. Safety data will also be reported accordingly.

NCT ID: NCT01779128 Not yet recruiting - Ovarian Cancer Clinical Trials

PET-CT vs. Integrated MR-PET Scanning of GYN Cancers

Start date: March 2013
Phase: Phase 0
Study type: Interventional

This research study is an imaging pilot study. Imaging pilot studies explore the potential benefit of one imaging approach compared to another clinically accepted approach. Such studies serve to understand how feasible an approach may be and whether it is worth pursuing in formal and larger clinical trials. Researchers of this study believe that simultaneous Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging will offer additional imaging information to improve cancer detection. MRI and PET are two tests that allow us to take pictures of the body and "look inside" the body without surgery. The MRI scanner uses a powerful magnet to make a picture of the body. The PET scanner makes pictures by using special dyes that "light up" inside the body. PET scans use radiation, similar to the radiation in a standard x-ray. We routinely use both tests to diagnose various types of cancer. As of now, the combination of PET and computed tomography (CT) has been considered a standard of care imaging approach for various cancers. Until recently, MRI and PET tests were done separately. Now there is a new type of test called MR-PET that combines both MRI and PET test results. This scanner uses both MRI and PET tests at the same time. We would like to find out if the MR-PET scanner can produce better and clearer images (pictures) of tumors and information about them inside of the body. This new MR-PET scanner is approved by the US FDA. However, some of the computer programs that tell the machine how to acquire and combine the test results are new and experimental. Experimental means that some of the computer programs are not approved by the FDA. This means that they can only be used in research studies. The MR-PET scanner has been previously used in a few human participants.

NCT ID: NCT01776476 Not yet recruiting - Critical Illness Clinical Trials

A Randomized Controlled Trial of Glutamine Dipeptide in Severe Trauma

GLND Trauma
Start date: February 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out if giving certain amino acids to critically injured patients can improve their condition or recovery, and lower their blood sugar and insulin needs. Amino acids are the 'building blocks' of proteins. The amino acid compound used in this study is called alanyl-glutamine dipeptide, also known as Dipeptiven® or glutamine. Glutamine is investigational, meaning not approved by the Food and Drug Administration (FDA) for intravenous use. However, it is approved by many countries in Europe, Asia and South America. Several studies suggest that giving glutamine has certain benefits in patients who need intensive care. In a study done at Emory University Medical Center using the same dose of glutamine, the number of hospital infections was lower in patients who had had cardiac, blood vessel or intestinal surgery compared to similar patients who received standard feedings without glutamine. No side effects were thought to be due to giving glutamine in that small study. This study is only being done at Vanderbilt University. The investigators plan to enroll 24 patients in the Trauma ICU over the next 12 months.

NCT ID: NCT01776333 Not yet recruiting - Respiratory Failure Clinical Trials

A Randomized Controlled Trial of a Video Decision Aid in the ICU

VIDEO
Start date: January 2013
Phase: N/A
Study type: Interventional

Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.

NCT ID: NCT01760772 Not yet recruiting - Heart Disease Clinical Trials

Effect of GLP-1 on Postprandial Lipid Metabolism

Start date: February 2013
Phase: N/A
Study type: Interventional

Individuals with obesity have an increased risk for heart disease and diabetes. There are current drugs on the market that target the hormone, Glucagon like peptide-1 (GLP-1) to treat diabetes. The investigators want to determine if targeting this hormone will also help people with high cholesterol and triglycerides. In this study, the investigators are looking at the role of GLP-1 in healthy subjects and subjects that have had bariatric surgery.

NCT ID: NCT01734109 Not yet recruiting - Pressure Ulcers Clinical Trials

Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.

Start date: December 2012
Phase: Phase 4
Study type: Interventional

Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.

NCT ID: NCT01731301 Not yet recruiting - Clinical trials for End Stage Renal Disease

A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)

Start date: January 2013
Phase: Phase 4
Study type: Interventional

1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis. 2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir. 3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.