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8481. An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions

/treatment Phase Pressure Ulcer Device: Skin Protection Wheelchair Seat Cushion Device: Segmented Foam Wheelchair Seat Cushion Not Applicable Detailed Description: Pressure ulcers (aka pressure sores, bed sores and decubitus ulcers) are a significant healthcare problem for the growing number of United States elderly long-term care (LTC) residents. Pressure ulcers (PU) diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare (...) . Consequently, elderly Medicare beneficiaries are being denied access to medically necessary and clinically appropriate interventions and instead are most frequently provided with convoluted or segmented-foam cushions that are not designed for pressure ulcer prevention. The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home

2005 Clinical Trials

8482. Improving Chronic Disease Care With PatientSite

of this randomized, controlled trial is to test whether educational interventions - directed toward empowering patients and delivered via the Beth Israel Deaconess Medical Center (BIDMC's) secure patient Internet portal PatientSite - can improve the outcomes and satisfaction with care of adult primary care patients with 3 common conditions: chronic pain, depression, and progressive difficulty walking. Condition or disease Intervention/treatment Phase Depression Pain Mobility Difficulty Behavioral: E-mail (...) aged 18 and older, of participating physicians within 5 internal medicine practices in Boston Registered users of patient-provider internet portal called PatientSite Screened positive for depression, chronic pain, or lower extremity mobility difficulty Exclusion Criteria: Current treatment for screened condition by medical or surgical specialist or other appropriate licensed health professional such as a physical therapist or mental health counselor Contacts and Locations Go to Information from

2005 Clinical Trials

8483. Senior Falls Prevention Study

by: Washington State, Department of Health Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the effectiveness of a best practice model for senior falls prevention when implemented in a community setting. Condition or disease Intervention/treatment Phase Falls Among Older Adults Behavioral: Exercise, education and medical management Not Applicable Detailed Description: This study will measure differences in the incidence of falls and fall risk factors among (...) ; and recommendations for medical care management of identified fall risk factors. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 453 participants Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Primary Purpose: Prevention Official Title: Targeted Injury Prevention Program: Preventing Falls Among Older Adults Study Start Date : September 2003 Study Completion Date : May 2005 Resource links provided by the National

2005 Clinical Trials

8484. Evidence Based Amputee Rehabilitation (EBAR) Program

of Research and Development ( US Department of Veterans Affairs ) Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if an evidence based exercise intervention improves the functional mobility of diabetic amputees (single lower leg amputation) who have already completed standard rehabilitation and prosthetic training. Condition or disease Intervention/treatment Phase Amputation Stumps Diabetes Mellitus Other: EBAR Program Not Applicable Detailed Description (...) : May 2008 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: EBAR Program Evidence Based Amputee Rehabilitation Program (rehabilitation program based on performance of the Amputee Mobility Predictor Other: EBAR Program Evidence Based Amputee Rehabilitation Program No Intervention: Wait List Control Wait List Control Group Outcome Measures Go to Primary Outcome Measures : Amputee Mobility Predictor [ Time

2005 Clinical Trials

8485. Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring

or disease Intervention/treatment Phase Atrial Fibrillation Device: Mobile Cardiac Outpatient Telemetry Not Applicable Detailed Description: This is an open, randomized controlled trial to compare a standard rate-control strategy with one using the Cardionet device to guide therapy for the management of atrial fibrillation. Patients presenting to an outpatient clinic or to the Emergency Department with atrial fibrillation with a ventricular rate greater than 100 bpm at rest will be enrolled. Treatment (...) adding more. Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00115843 Recruitment Status : Withdrawn First Posted : June 27, 2005 Last Update Posted : April 5, 2017 Sponsor: Beth Israel Deaconess Medical Center

2005 Clinical Trials

8486. Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

in Euroqol-5D (EQ-5D) Index Score [ Time Frame: Baseline to Week 48 ] The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three (...) adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once. Secondary Outcome Measures : Number of Participants With a Platelet Response [ Time Frame: Duration of treatment (up to 277 weeks) ] Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications. Number of Participants With a Reduction or Discontinuation of Concurrent ITP

2005 Clinical Trials

8487. Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough?

Science Center at San Antonio Collaborators: South Texas Veterans Health Care System Brooke Army Medical Center Wilford Hall Medical Center TRICARE Southwest Department of Health and Human Services Centers for Disease Control and Prevention Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio Study Details Study Description Go to Brief Summary: This is a health services demonstration project that evaluates three methods of health care delivery (...) quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care. Condition or disease Intervention/treatment Phase Asthma Behavioral: Disease Management Behavioral: Disease Management + Educational Home Visits Not Applicable Detailed Description: This trial addresses the real-world concerns of asthma

2005 Clinical Trials

8488. Exercise Training for Patients With Poor Leg Circulation

Mellitus, Type 2 Intermittent Claudication Behavioral: Physical exercise Behavioral: Physical walking Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 50 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Official Title: Perfusion and Metabolism During Exercise in Peripheral Arterial Disease Study Start Date : June 2005 Actual Primary Completion Date : December (...) : All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Group I (n=25 PAD patients). This sample will represent the population of veterans with PAD with mild mobility impairment secondary to intermittent claudication in the gastrocsoleus muscles. Inclusion Criteria for PAD Subjects: diagnosis of PAD (acute or chronic occlusive arterial disease), with or without diabetes mellitus positive Edinburgh Claudication Questionnaire Fontaine stage IIa only (mild claudication, walking distance

2005 Clinical Trials

8489. Epidemiology and Cost of Falls in Veterans With a Spinal Cord Injury

Office of Research and Development ( US Department of Veterans Affairs ) Study Details Study Description Go to Brief Summary: Brief Summary Detailed Description Background: A multitude of risk factors for falling has been reported for the elderly, however many of these risk factors are not applicable to persons with a spinal cord injury, who use a wheelchair for mobility. The objectives of this study are to: (1) describe the incidence and prevalence of tips, falls, and fall-related injuries in SCI (...) factors and develop a model for predicting tips and falls; (5) determine healthcare utilization and direct and indirect costs; and (6) describe perceived short- and long-term consequences of falls in SCI. Methods: This is a prospective cohort study. Data was collected through patient surveys, medical records, and VA databases. Baseline information includes risk factors (e.g., user characteristics, wheelchair features, wheelchair activities, etc.) and physical environmental data. Monthly follow-up

2005 Clinical Trials

8490. Improving Functioning in Peripheral Arterial Disease

McDermott, Northwestern University Study Details Study Description Go to Brief Summary: The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease. Condition or disease Intervention/treatment Phase Cardiovascular Diseases Peripheral Vascular Diseases Behavioral: Exercise Behavioral: Diet Not Applicable Detailed Description: BACKGROUND: Previous work demonstrates (...) walk distance and the summary performance score. The summary performance score is a composite measure of lower extremity functioning (usual walking speed, standing balance, and time required for five repeated chair rises) measured on a 0-12 scale that predicts future risk of nursing home placement, mobility loss, and mortality. The study will also identify mechanisms by which the exercise interventions improve functioning in PAD. Mechanisms to be studied include changes in blood viscosity, calf

2005 Clinical Trials

8491. Dutch EASYcare Study

is an intermediate care program in which the GP refers elderly patients with a problem in cognition, mood, behavior, mobility, and nutrition. A geriatric specialist nurse applies a guideline based intervention in a maximum of six visits during a maximum of three months. The nurse starts the intervention with the application of the EASYcare instrument for geriatric screening. The EASYcare instrument assesses (instrumental) activities of daily life, cognition, mood, and includes a goal setting item. During (...) the effects of nursing home visits in independently living elderly people on their functional performance and health-related quality of life. The general practitioner (GP) can refer elderly people to this intervention model after identification of a problem in cognition, mood, behavior, mobility, or nutrition. A specialist geriatric nurse visits the patients at home up to six times and coaches the patient in cooperation with the GP and geriatrician. Condition or disease Intervention/treatment Phase

2005 Clinical Trials

8492. Evaluation of the Effects of Response Elaboration Training for Aphasia

of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs (...) Behavioral: Response Elaboration Training Not Applicable Detailed Description: Detailed Description: Extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied. Example: Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport

2005 Clinical Trials

8493. RNS® System Feasibility Study

Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or caregiver Subject has seizures that are severe enough to cause injuries or significantly impair functional ability in domains including employment, psychosocial, education and mobility Subject failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment Subject (...) patients with medically refractory (hard to treat) epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of effectiveness of the RNS® System to support the commencement of a pivotal clinical investigation. Condition or disease Intervention/treatment Phase Epilepsy Procedure: RNS® System implantation Device: RNS® System responsive stimulation Phase 2 Detailed Description: NeuroPace, Inc. is sponsoring an investigational device feasibility study of the RNS® System

2004 Clinical Trials

8494. Exercise Training and Walking Ability After Chronic Stroke

, aerobic fitness and improved gait. This longitudinal study will be conducted as a double blinded factorial randomized controlled trial of exercise training for chronic stroke patients. Condition or disease Intervention/treatment Phase Stroke Procedure: [A] Aerobic isokinetic cycling exercise Procedure: [B] Progressive Resistance Training Procedure: [A] + [B] Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 48 participants (...) will undertake a 6 min walking test for maximum distance Secondary Outcome Measures : Cardiorespiratory Fitness Lower limb muscular strength and endurance Mobility variables Scales and questionnaires Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research

2005 Clinical Trials

8495. Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

Posted : May 7, 2004 Last Update Posted : January 11, 2008 Sponsor: NeurogesX Information provided by: NeurogesX Study Details Study Description Go to Brief Summary: This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN (...) , or postherpetic neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average. Must not have significant pain due to other causes (for example, arthritis). Must have intact skin at the treatment area. Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks). Must not use topical pain medications on painful areas. Must be able to comply with study requirements such as completing daily pain diary

2004 Clinical Trials

8496. Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation

in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation. Condition or disease Intervention/treatment Phase Kidney Cancer Leukemia Lymphoma Neuroblastoma Oral Complications Sarcoma Drug: Traumeel S Other: Placebo Not Applicable Detailed Description: OBJECTIVES: Compare the efficacy of Traumeel® S vs placebo in reducing the severity and duration of chemotherapy-induced (with or without total body (...) for transplantation must be myeloablative Source of stem cells from any of the following: Bone marrow Placental cord Cytokine-mobilized peripheral blood Availability of 1 of the following donor types: HLA-matched sibling or parent Related donor mismatched for a single HLA locus (class I or II) Unrelated marrow or peripheral blood stem cell donor Unrelated umbilical cord blood HLA-matched or mismatched (class I) donor PATIENT CHARACTERISTICS: Age 3 to 25 Performance status Not specified Life expectancy

2004 Clinical Trials

8497. Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)

Off Not Applicable Detailed Description: Our study investigates the influence of automatic remote patient monitoring on quality of life (QOL), anxiety and depression in patients with implantable cardioverter-defibrillators (ICDs), and frequency of (un-)scheduled patient-physician contacts. The study also evaluates monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy. The patients will receive BIOTRONIK Lexos-T or Lumos-T ICD models, with the integrated Home (...) antiarrhythmic therapy, may help the patients to deal with their situations in the best possible way. The researchers investigate the influence of automatic remote patient monitoring on QOL, anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy. Condition or disease Intervention/treatment Phase Arrhythmia Quality of Life Device: HM on Device: HM

2006 Clinical Trials

8498. Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study

Hyperbarics Association Study Details Study Description Go to Brief Summary: Autism is a neurodevelopmental disorder that currently affects as many as 1 out of 166 children in the United States. Autism is considered by many to be a permanent condition with little hope for improvement. Treatment for autism is centered on special schooling and behavioral therapy; medical science currently has little to offer. Recent research has discovered that some autistic individuals have decreased blood flow (...) levels in ischemic tissue. In addition, animal studies have shown that HBOT has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent evidence demonstrates that HBOT mobilizes stem cells from human bone marrow which may aid recovery in neurodegenerative diseases. Based upon these findings, it is hypothesized that HBOT will improve symptoms in autistic individuals. The purpose of this study is to determine if HBOT improves clinical outcomes in children with autism

2006 Clinical Trials

8499. Self-Management of Osteoarthritis

) Study Details Study Description Go to Brief Summary: The purpose of this study is to examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee. Condition or disease Intervention/treatment Phase Osteoarthritis Behavioral: Health Education Behavioral: Osteoarthritis Self-Management Not Applicable Detailed Description: Background / Rationale: Osteoarthritis (OA) is the one of the most common (...) 2009 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Health Education Intervention Health Education Intervention Behavioral: Health Education 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics. No Intervention: Usual Medical Care Usual Medical Care Experimental

2006 Clinical Trials

8500. Acupuncture for Acute and Chronic Pain in Air Force Personnel

acupuncture treatment for acute and chronic pain. Perform an analysis of costs, including any system cost savings, associated with providing acupuncture services to pain patients. Serve as a model to expand the project to Scott AFB and Travis AFB as per the request of the Air Mobility Command Surgeon General. (AMC/SG). Condition or disease Intervention/treatment Phase Acute Pain Procedure: Acupuncture Not Applicable Detailed Description: Adult patients referred to the MGMC Acupuncture Clinic (...) provided by: Samueli Institute for Information Biology Study Details Study Description Go to Brief Summary: The purpose of this project is to conduct a scientifically rigorous investigation of the clinical outcomes, quality of life, and cost associated with the delivery of acupuncture in the treatment of acute and chronic pain in patients at Malcolm Grow Medical Center, Andrews Air Force Base. The specific aims of this study are to: Gather outcomes and patient satisfaction data on patients receiving

2006 Clinical Trials

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