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8401. Sensory Cues for Freezing in Parkinson's Disease

Go to Brief Summary: The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess if unexpected (randomized) cues are more effective than anticipated ones. Condition or disease Intervention/treatment Phase Parkinson's Disease Device: Sensory Cueing Device Not Applicable Detailed Description: Freezing of gait (FOG) is defined as a transient halt in motor activity, wherein (...) the patient appears “as if nailed to the floor.” It is a common phenomenon in Parkinson’s disease (PD), both when medications are at their peak (“on state”) and at their lowest effectiveness (“off state”). While “off” FOG often responds to dopaminergic medications, “on” FOG is a difficult to treat, causing significant distress for the patient, and elevating risk of falls and morbidity. A few small studies have suggested that auditory and visual sensory cues, in the form of continuous stimuli

2006 Clinical Trials

8402. A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children

Information provided by: International Hyperbarics Association Study Details Study Description Go to Brief Summary: Autism is a neurodevelopmental disorder currently affecting 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 (...) evidence demonstrates that HBOT increases the production of mitochondria and 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. Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic children. We recently completed a prospective pilot trial using HBOT in 18 children which demonstrated significant clinical

2006 Clinical Trials

8403. Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays

: August 15, 2011 Last Update Posted : May 30, 2017 Sponsor: Mayo Clinic Collaborator: Aventis Pharmaceuticals Information provided by (Responsible Party): Laura Orvidas, Mayo Clinic Study Details Study Description Go to Brief Summary: We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media and/or negative middle ear pressure, as compared to placebo. We further hypothesize that the rate of spontaneous short (...) dealing with allergic rhinitis. Eustachian Tube Dysfunction (ETD) primarily refers to an absent or inadequate ability to open the eustachian tube. The term Serous Otitis Media (SOM) generally referring to an accumulation of fluid within the middle ear space, in absence of signs indicating acute infection. Commonly, this can result in a conductive hearing loss due to restriction of tympanic membrane mobility. Negative Middle Ear Pressure (NMEP) is often a precursor to the development of SOM, and has

2006 Clinical Trials

8404. Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia

of the CLL disease. Condition or disease Intervention/treatment Phase B-Cell Chronic Lymphocytic Leukemia Drug: Alemtuzumab Not Applicable Detailed Description: Fludarabine (F) alone or in combination with cyclophosphamide (FC) is not a curative treatment for patients with CLL, all patients will eventually relapse. Therefore there is a medical need to look for consolidation followed by maintenance therapies which are able to prolong response duration or which can shift anti-tumor therapy induced partial (...) . These findings suggest that Alemtuzumab might be an ideal candidate to eliminate minimal residual disease in a post-remission treatment after anti-tumor therapy and to be used as maintenance therapy. The efficacy of Alemtuzumab as consolidation therapy in CLL can easily be measured. There is evidence from several studies that treatment with Alemtuzumab does not have a negative impact on stem cell mobilization. Therefore, autologous stem cell transplantation still remains as a further treatment option

2006 Clinical Trials

8405. Chiropractic Prone Distraction for Lower Back Pain

by the use of a number of physical manipulations and mobilization techniques, which can be used singly or in combination to treat a variety of medical conditions. Although basic clinical practice guidelines for Chiropractic have been developed, few studies have rigorously compared techniques and their outcomes for specific conditions. Fewer still have sought to correlate treatment modality with both anatomical effect and clinical outcome. Throughout the military, Chiropractic care is available only (...) 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: NCT00269503 Recruitment Status : Terminated First Posted : December 23, 2005 Last Update Posted : May 8, 2008 Sponsor: Samueli Institute for Information Biology Collaborator: National Naval Medical Center Information provided by: Samueli Institute

2005 Clinical Trials

8406. Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nausea and Vomiting Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor Drug: Aprepitant Drug: Cyclophosphamide Drug: Dexamethasone Drug: Granisetron hydrochloride Not Applicable Detailed Description: OBJECTIVES: Primary Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising (...) high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation. Secondary Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients. Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients. Identify side effects of the addition of aprepitant to this regimen in these patients. OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone

2006 Clinical Trials

8407. Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia

for patients with Alzheimer's disease. Cognitive impairment includes concentration and memory difficulties. We will look at how well this medication helps your cognitive impairment, how well you tolerate this medication (including its effects on your motor symptoms of PD) your activities of daily living, your emotions, and any medical conditions you might have. We will interview a person you choose as your "informant". Condition or disease Intervention/treatment Phase Parkinson's Disease Cognitive (...) Impairment Dementia Drug: Memantine Drug: Placebo Oral Tablet Not Applicable Detailed Description: This is a randomized, placebo-controlled, parallel, double-blind 24-week prospective study of memantine at the dosage range 5-20 mg/day in 20 outpatients with idiopathic PD and dementia secondary to PD. Using the dosage escalation regimen approved for Alzheimer disease, subjects will start memantine or comparable placebo at 5 mg daily and advance 5 mg/week to 20 mg /day by week 4, with dosing at 10 mg bid

2006 Clinical Trials

8408. Treatment of Patients With Fecal Incontinence

Therapy for Fecal Incontinence: A Randomized Control Study Behavioral: control group Not Applicable Detailed Description: Fecal incontinence (FI) is a devastating condition that causes psychological stress, shame, embarrassment, and social isolation. It has a major impact on quality of life of patients and their families. It complicates medical illnesses and management, has major economic consequences and can contribute to early nursing home placement. Although FI affects 2.2% to 11% of the general (...) failed medical treatment under the care of their primary care providers and are referred for evaluation and management of current FI. As part of standard care, all referred patients will receive a history and physical examination, including medical, surgical, FI-specific symptoms and physical findings (general, mobility, mental status and anorectal examination). Those who meet inclusion criteria and who agree to participate will be randomly assigned to one of 2 study arms: 1. medical therapy alone, 2

2006 Clinical Trials

8409. Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease

ADLs. This scale assessed a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD Total score (...) , is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study

2006 Clinical Trials

8410. An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy

). The children will receive pre-treatment testing (baseline). After 40 experimental treatments are completed, the children will be retested at 0, 3, and 6 months to evaluate any changes. Condition or disease Intervention/treatment Phase Cerebral Palsy Cerebral Palsy, Spastic Device: Hyperbaric Oxygen Treatment Device: Hyperbaric Air Treatment Not Applicable Detailed Description: The study proposed herein is a randomized, double blind study to evaluate the therapeutic effectiveness of HBO in children (ages 3 (...) -treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Mobility [ Time Frame: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) ] Primary caregiver-reported (through structured interview) child capabilities for 59 items of functional skills grouped under mobility. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-59 and are rescaled to a 0-100% scale. Higher scores

2006 Clinical Trials

8411. Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study

24, 2017 Sponsor: DePuy Orthopaedics Information provided by (Responsible Party): DePuy Orthopaedics Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate long-term clinical and radiographic data between geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee arthroplasty. Condition or disease Intervention/treatment Phase Osteoarthritis, Knee Arthritis, Rheumatoid Device: total knee arthroplasty Not Applicable Detailed (...) of surgery. Prior ipsilateral knee arthroplasty. Metabolic disorders of calcified tissues, such as Paget's disease. Severe diabetes mellitus that is not controlled by diet or oral agents. Require joint replacement due to immunodeficiency syndromes. Skeletal immaturity. Avascular necrosis of the affected knee. Chronic renal disease. Subjects involved in medical-legal or worker's compensation claims. Contacts and Locations Go to Information from the National Library of Medicine To learn more about

2006 Clinical Trials

8412. Partners in Dementia Care

of a care plan that addresses needs of patients and caregivers; 3) on-going monitoring of the status, progress, and barriers encountered; and 4) Reassessment of care needs for patients and caregivers. PDC assisted families by: 1) providing disease-related education and information, 2) offering emotional support and coaching, 3) linking families to medical and non-medical services and resources, and 4) mobilizing and organizing the informal care network. Behavioral: Partners in Dementia Care Partners (...) between VA medical centers and local Alzheimer's Association Chapters. PDC was designed to be a feasible and practical intervention to integrate health, community, and support services. PDC has a standardized protocol for care coordination and support services, including guidelines for care plan assessment, care plan development and implementation, ongoing monitoring, and reassessment. It also offers a structured training curriculum for providers and an operations manual for uniform implementation

2006 Clinical Trials

8413. A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis

/a Stryker. Recruitment status was: Active, not recruiting First Posted : February 13, 2006 Last Update Posted : October 15, 2008 Sponsor: Orthovita d/b/a Stryker Information provided by: Orthovita d/b/a Stryker Study Details Study Description Go to Brief Summary: Doctors are studying an investigational treatment to be used during the vertebroplasty procedure when treating vertebral compression fractures (spine fractures) that may help to reduce pain and restore mobility. If one has experienced back pain (...) polymethylmethacrylate [PMMA] (a Food and Drug Administration [FDA]-approved bone cement) and the other group of patients will have the vertebroplasty procedure using a relatively new (investigational) biomaterial called Cortoss. Condition or disease Intervention/treatment Phase Spinal Fractures Device: Percutaneous Vertebral Augmentation of compression fractures Not Applicable Detailed Description: This is a prospective, multi-center randomized, controlled study designed to evaluate the safety and effectiveness

2006 Clinical Trials

8414. VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL

or disease Intervention/treatment Phase Lymphoma Biological: filgrastim Biological: rituximab Not Applicable Detailed Description: OBJECTIVES: Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without rituximab influences CD34+ cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkin's lymphoma. Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization (...) in these patients. OUTLINE: This is a randomized study. Stem cell mobilization: Patients are randomized to 1 of 2 mobilization arms. Arm I: Patients receive rituximab IV over 4 hours on days 1, 8, and 15. Patients also receive etoposide IV over 4 hours on day 15 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 17 and continuing until approximately day 25. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed

2006 Clinical Trials

8415. Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

. The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence, and that poor adherence may be associated with low socioeconomic standing, increased mobility, and distance from clinic. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 400 participants Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Official Title: HAART Adherence (...) Diseases (NIAID) Information provided by (Responsible Party): University of Washington Study Details Study Description Go to Brief Summary: This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence. Condition or disease Intervention/treatment Phase HIV Infections Behavioral: Adherence counseling Device: Alarm device Not Applicable Detailed Description: The study will be a prospective

2006 Clinical Trials

8416. Blood Cell Collection for Future Use in Individuals With Fanconi Anemia

with FA. All participants will undergo a bone marrow biopsy within 3 months of study entry. Based on the results of this biopsy, participants will undergo either a bone marrow harvest procedure or a cytokine mobilized peripheral blood stem cell (PBSC) collection procedure. Prior to both procedures, medical history will be reviewed, blood will be drawn, liver and kidney function will be evaluated, and a physical examination will be performed. Participants who undergo the bone marrow harvest procedure (...) Hospital Medical Center, Cincinnati Information provided by: National Heart, Lung, and Blood Institute (NHLBI) Study Details Study Description Go to Brief Summary: Fanconi anemia (FA) is a disease that affects an individual's bone marrow. It is caused by a defective gene in the CD34+ cells, which are responsible for producing various types of blood cells. Individuals with FA may experience fatigue, bleeding, and increased infections. The purpose of this study is to collect and purify blood cells from

2005 Clinical Trials

8417. Effect of Exercise on Gait and Balance in Peripheral Neuropathy

compromise patient safety. Mobility limitations due to altered lower extremity skin integrity/ulcer, where pain would limit gait and weight-bearing would be contraindicated such as stasis and foot ulcers or claudication. Medically unstable upon exam, i.e. poorly controlled blood pressure and blood sugar, coronary artery disease, where group participation would compromise medical status. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you (...) Diseases Peripheral Nervous System Diseases Behavioral: Tai Chi Behavioral: Functional Balance Behavioral: Education Control group Not Applicable Detailed Description: Since the 1970's, researchers and epidemiologists have documented that patient falls are a high-risk, high volume, high cost adverse events contributing to morbidity, mortality, decreased quality of life, and premature nursing home placement. Despite thousands of research studies published on patient falls, few studies have focused

2005 Clinical Trials

8418. Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

flap Not Applicable Detailed Description: Osteoporosis leading to increased risk of fracture, especially in the ipsilateral limb, is well documented in lower limb amputees. The purpose of this research is to examine the clinical utility of two amputation surgical procedures in: a) minimizing short and longer-term deleterious effects of amputation on bone integrity relative to the antecedents of osteoporotic change: reduced weight bearing capacity, inflammation, impaired muscle viability (...) will compare rehabilitation and functional outcome in patients undergoing standard amputation versus osteomyoplastic reconstruction by assessing prosthetic mobility, functional capacity, activity levels, and quality of life. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 95 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Bone Physiology

2005 Clinical Trials

8419. Exercise and Activity Guidance in Older Adults With Diabetes

Intervention/treatment Phase Type 2 Diabetes Behavioral: Functional circuit training with lifestyle behavior Not Applicable Detailed Description: Information and health screening: Interested persons are screened for eligibility and undergo a directed medical history and examination, echocardiogram (if not done within one year), limited ABI test, and maximal treadmill test with oxygen kinetics. Measure fitness level at the beginning of the exercise training, at 10 and 20 weeks: DEXA scan, body fat analysis (...) of Michigan Study Details Study Description Go to Brief Summary: The purpose of the project is to better understand how exercise and education will help mobility and health in older adults with diabetes. The investigators are trying to learn what type of exercises and classes are needed to help older adults stay active. This knowledge will eventually prove useful in helping patients and doctors understand what is needed to keep older adults with Type 2 diabetes as healthy as possible. Condition or disease

2006 Clinical Trials

8420. Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease

with Alzheimer's Disease (AD). This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The scale includes 23 items relating to instrumental activities of daily living and 17 items relating to basic self-care. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. Total score was obtained by adding the rating (...) , is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with the currently approved AD medication, Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects their response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed

2006 Clinical Trials

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