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8601. The Development and Testing of an Electronic Tool to Measure Physical Activity in Domestic Settings

Sponsor: Boston Medical Center Collaborators: Massachusetts Institute of Technology Stanford University Information provided by: Boston Medical Center Study Details Study Description Go to Brief Summary: The purpose of this study is to develop a tool that can more accurately assess the intensity and kind of physical activity that a person performs. The experimental tool, which will use a mobile computing device as a way of automatically identifying when a certain activity is being performed (...) promotion research is limited by self- report data that is confounded by participants' ability to accurately remember and record their physical activity. A potentially new method of accurately assessing moderate-intensity physical activity is called context sensitive- ecological momentary assessment (CS-EMA). Mobile computing devices (personal computing devices, PDAs) that automatically identify when a specific type of physical activity (e.g., moderate-intensity physical activity) is being performed has

2005 Clinical Trials

8602. Functional Electrical Stimulation for Footdrop in Hemiparesis

of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke. Condition or disease Intervention/treatment Phase Stroke Hemiplegia Device: Odstock Dropped-Foot Stimulator (ODFS) Other: Conventional Standard of Care Procedure: Traditional Physical Therapy Treatment Not Applicable Detailed Description: Hemiplegia is a major consequence of stroke and contributes (...) for Footdrop in Hemiparesis 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: NCT00148343 Recruitment Status : Completed First Posted : September 7, 2005 Results First Posted : June 1, 2018 Last Update Posted : June 1, 2018 Sponsor: MetroHealth Medical Center Collaborators: Eunice Kennedy Shriver National

2005 Clinical Trials

8603. 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

8604. 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

8605. 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

8606. 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

8607. 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

8608. 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

8609. 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

8610. 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

8611. 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

8612. 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

8613. Paraplegic Cycling: Improving Health After Spinal Cord Injury

, and to reductions in the likelihood of the development of pressure sores and fractures. We hope that this type of exercise will lead to general improvements in the fitness of people who might use the system in future. Condition or disease Intervention/treatment Phase Spinal Cord Injury Device: Surface Functional Electrical Stimulation Not Applicable Detailed Description: Background: Spinal cord injury (SCI) prevents normal leg exercise which leads to secondary complications, including cardiopulmonary (...) Spinal Injuries Unit, Southern General Hospital. We will also document the mobile recumbent tricycle system as a design specification, in preparation for commercialisation. The project will be based around three centres, in London, Glasgow and Nottwil, and brings together an interdisciplinary team of engineers, exercise scientists, therapists and clinicians. Aims: Engineering Development. To develop the equipment and methods for recreational cycling to the stage of a pre-commercial design

2005 Clinical Trials

8614. 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

8615. 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

8616. Multiple Sclerosis Rehabilitation Study

no rehabilitation. Condition or disease Intervention/treatment Phase Multiple Sclerosis Behavioral: Physiotherapy Behavioral: Occupational therapy Behavioral: Speech pathology Not Applicable Detailed Description: Routine rehabilitation inervention in patients with MS. This comprises of medical and nursing input, physiotherapy, occupational therapy, speech pathology, neuropsychology, compared with a "control" group on the waiting list for rehabilitation intervention. Duration of intervention is 6 weeks. Study (...) (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups.- Age 19-64 years.- Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2). Exclusion Criteria: Patients residing in nursing home and other residential care.- Those with severe cognitive problems

2005 Clinical Trials

8617. Safety, Tolerance and Acceptability Trial of the Invisible Condom® in Healthy Women

-week period of gel application. In part B of the protocol, the extended safety of the gel alone, gel plus SLS and placebo will be studied when applied intravaginally twice daily for 8 weeks in sexually active healthy subjects. In this part B (actually represents Phase II of the trial), 80 healthy sexually active subjects for the gel alone group and 80 subjects for the gel + SLS group and 40 subjects for the placebo group, will be studied. The part B involves the participation of a total of 200 (...) subjects. Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application. The gel will be applied between menses. The gel should be applied less than 1 hour before sexual intercourse, if planned, but no more than twice a day. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 452 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention Official

2005 Clinical Trials

8618. Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

Society of Cataract and Refractive Surgeons(ESCRS) Santen Gmbh Information provided by: City, University of London Study Details Study Description Go to Brief Summary: Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye (...) at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out

2005 Clinical Trials

8619. A Brief Community Linkage Intervention for Dually Diagnosed Individuals

and a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder. Patients seeking outpatient treatment for the above disorders from the VA. Physically mobile Agree to take public transportation if they do not have other private sources. Exclusion Criteria: Patients who only have either a mental health problem, or a substance abuse problem, but not both. Patients who do not have a residence where they can stay upon discharge from the hospital. Patients who are not sufficiently medically (...) Intervention Case Management along with 3) Peer Support with the goal of assisting individuals with the transition from inpatient to outpatient care. Condition or disease Intervention/treatment Phase Schizophrenia Psychotic Disorders Substance-Related Disorders Bipolar Disorder Behavioral: Time limited case management Behavioral: Health Education Not Applicable Detailed Description: This study involved a randomized attention controlled trial of 102 individuals recruited on the inpatient psychiatry service

2005 Clinical Trials

8620. 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

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