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8421. A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 were presented. Secondary Outcome Measures : Mean change from Baseline in percentage awake time spent "off (...) twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values

2006 Clinical Trials

8422. Effect of Self-Management on Improving Sleep Apnea Outcomes

): VA Office of Research and Development Study Details Study Description Go to Brief Summary: Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood (...) on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization. Condition or disease Intervention

2006 Clinical Trials

8423. Comparison of Airway Clearance Efficacy of Two High Frequency Chest Wall Oscillation (HFCWO) Devices in Cystic Fibrosis

this and there is currently no agreement as to which form of therapy is most effective. High frequency chest wall oscillation (HFCWO is used for this purpose by CF patients throughout the United States and abroad. To perform this therapy, the patient wears a vest which fits over the entire torso and is connected to an air compressor. The compressor generates oscillating air pulses that are transmitted to the lungs, thereby mobilizing secretions. The oscillations produced by the most commonly used device have a sinusoidal (...) chest wall oscillator Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 15 participants Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Primary Purpose: Treatment Official Title: Comparison of Airway Clearance Efficacy of Sine Wave and Triangular Wave High Frequency Chest Wall Oscillation (HFCWO) Devices in Patients With Cystic Fibrosis Study Start Date : February 2006 Actual Primary

2006 Clinical Trials

8424. Once Weekly Radiation for Lung Cancer With Chemotherapy

Not Applicable Detailed Description: 40 patients with locally advanced and metastatic NSCLC will be enrolled (stages III and IV) and treated once per week for a total of 12 cycles (12 weeks) according to the schedule outlined below. Chemotherapy: The suggested phase II dose for weekly Taxotere with concomitant standard chest radiotherapy was determined to be 20mg/m2. In our unpublished phase I clinical trial, we found 35 mg/m2 to be well tolerated and therefore this dose is chosen for this phase II study (...) neuropathy (> grade 1) are not eligible for this study. No other serious concurrent medical illness or active infection which would jeopardize the ability of the patient to receive with reasonable safety the chemotherapy and surgery program outlined in this protocol is allowed. Signed informed consent: each patient must be aware of the neoplastic nature of his/her disease and willingly consent to participate in the study after being informed of the procedure to be followed, the experimental nature

2005 Clinical Trials

8425. Efficacy of the WalkAide and AFOs for CVA

Go to Brief Summary: To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop. The comparison will involve physical measurements (e.g. walking speed, physiological cost index, Modified Rivermead Mobility Index, etc.) and questionnaires on the quality of life and acceptance of the technology by stroke survivors. Condition or disease Intervention/treatment Phase Stroke Device: WalkAide Device: AFO Not Applicable Detailed Description: Stroke is the third leading (...) drop", since the foot drops or drags along the ground during the swing phase. Swing phase abnormalities can result in decreased velocity, limited endurance and an increased risk for falls. These factors can limit mobility and independence in the community. Therefore, intervention is warranted. The conventional approach to address the poor swing limb function, specifically, insufficient ankle dorsiflexion, is the prescription of an ankle-foot orthosis (AFO). An AFO commonly limits ankle

2005 Clinical Trials

8426. 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

8427. Temporary Prosthesis in Traumatic Below-knee Amputation

by the National Library of Medicine related topics: Arms and Interventions Go to Intervention Details: Device: Temporary tuber-ischii bearing prosthesis Tuber ischii-bearing holster is connected by hinged metal bars to foot device to enable immediate postoperative mobilization of transtibial amputees. No other medical interventions or pharmaceutical treatment. Outcome Measures Go to Primary Outcome Measures : Pain: Patient-rated [ Time Frame: 1, 3, and 6 months postinjury ] Pain: clinical exam rated [ Time (...) Collaborators: Medical University of Joenkoeping, Sweden NCHADS - Ministry of Health of Cambodia Information provided by (Responsible Party): University Hospital of North Norway Study Details Study Description Go to Brief Summary: Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The actual study aims at reducing post-injury chronic pain and improving function by immediate temporary

2005 Clinical Trials

8428. Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis

. Restrictions will be at the discretion of the physician. After 2 failures to progress to phase 3, the patient will be considered a failure of treatment. In the event of relapse after successful completion of therapy, the protocol will be repeated. GROUP 2 (iontopatch) One volt patch with dexamethasone phosphate will be used.Patient will be treated with one patch every 2 days for a total of 3 patches. Application will be per the Birchpoint Medical Group Iontopatch 80 protocol. The patches will correlate (...) Ford Health System Collaborator: Birch Point Medical Information provided by: Henry Ford Health System Study Details Study Description Go to Brief Summary: The purpose of this project is to compare different treatment options for lateral epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the forearm originating from the lateral epicondyle. Controversy exists regarding the method of delivering pain relief so that conditioning and strengthening can be initiated

2005 Clinical Trials

8429. Improving Care for Patients With Bipolar Disorder

Description Go to Brief Summary: The purpose of this research study is to learn whether or not a coordinated medical and psychiatric care program can improve outcomes of care for patients with bipolar disorder. We hypothesize that coordinated care via a Care Manager will improve physical and mental health-related quality of life, improve functioning, and reduce symptoms. Condition or disease Intervention/treatment Phase Bipolar Disorder Behavioral: Disease Management Not Applicable Detailed Description (...) or drugs) at the time of enrollment already enrolled in a mental health program with a mobile outreach component in which clinical caregivers deliver services to the patient in the community (e.g., Assertive Community Treatment or Intensive Case Management) have a terminal medical illness with <3 years expected longevity, or unable to provide informed consent for this study. (Ineligibility to be confirmed based on registry review and Survey Coordinator's assessment) Contacts and Locations Go

2005 Clinical Trials

8430. Walking Aids in the Management of Knee Osteoarthritis

Office of Research and Development Study Details Study Description Go to Brief Summary: The purpose of this study is to assess whether the single point cane will relieve pain and disability in overweight or obese people with knee OA through altered joint biomechanics and what factors influence acceptance of cane use. Condition or disease Intervention/treatment Phase Obesity Osteoarthritis Device: Single point cane Not Applicable Detailed Description: Knee OA is an important cause of disability (...) and falls in overweight or obese individuals and limits their attempts at exercise and subsequent weight loss. Walking aids such as canes have been recommended in the management of knee OA in order to decrease pain by reducing loading across the knee and to increase physical activity. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with limited mobility. No randomized controlled trials have studied the efficacy of walking

2005 Clinical Trials

8431. Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?

guidelines regarding management of hip fracture were published in the Medical Journal of Australia in 1999 and updated in 2003. Seventeen aspects of treatment were systematically reviewed, including mobilisation after surgery. Early assisted ambulation within 48 hours post surgery was recommended (Chilov 2003 p 490). However, the recommendation was based on observational (level 3) evidence only. Early mobilization post surgery is resource intensive. Early mobilization is challenging and uncomfortable (...) the groups. Data collection On admission: gender, age, preoperative mobility, social supports, mental ability and medical comorbidity,pre-existing medical comorbidity (cardiac, respiratory, neurological, diabetes) and mental ability. Additional data from each patients medical record including: type of surgical fixation (nail/screw and plate, hemi-arthroplasty), wait time to surgery, time surgery completed, and time to first sit out of bed and time to first walk. Outcome measures The primary outcome

2005 Clinical Trials

8432. Combination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas

Government. Read our for details. ClinicalTrials.gov Identifier: NCT00253487 Recruitment Status : Completed First Posted : November 15, 2005 Last Update Posted : January 6, 2014 Sponsor: Children's Hospital Medical Center, Cincinnati Collaborator: National Cancer Institute (NCI) Information provided by: National Cancer Institute (NCI) Study Details Study Description Go to Brief Summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, busulfan, and O6-benzylguanine, work in different ways (...) for newly diagnosed gliomas. Condition or disease Intervention/treatment Phase Brain and Central Nervous System Tumors Drug: O6-benzylguanine Drug: busulfan Drug: temozolomide Procedure: adjuvant therapy Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Not Applicable Detailed Description: OBJECTIVES: Primary Determine the safety and feasibility of a conditioning regimen comprising

2005 Clinical Trials

8433. 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

8434. Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)

/unexpected events were to occur. If the outcomes appear better than could be expected, this will provide a bridge to extend this current approach for other innovative therapies. Condition or disease Intervention/treatment Phase Hematologic Diseases Hematologic Malignancies Drug: Granulocyte Colony Stimulating Factor Not Applicable Detailed Description: This study is a single-arm, non-randomized trial. Patients meeting the criteria for this study will be entered sequentially until completion or closure (...) have a life expectancy of at least 12 weeks and a performance status of at least 2 Zubrod or 70% Karnofsky status prior to transplantation. Patients who are acceptable candidates for marrow transplantation based on their pre-BMT evaluation. Patients who have available histocompatible siblings who have been medically approved as marrow donors. Patients who sign informed consent for the protocol approved by the Institutional Review Board of Emory University/Children's Healthcare of Atlanta. Donors

2005 Clinical Trials

8435. Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-assisted Transhiatal Esophagectomy: A Prospective Trial.

the use of video-assisted thoracoscopy or laparoscopy to facilitate esophagectomy [2-6]. Most of these reports have utilized a standard laparotomy in combination with thoracoscopy to perform esophageal mobilization or laparoscopy with a mini-laparotomy to perform esophagectomy. DePaula was the first to report a large series of 48 patients undergoing laparoscopic transhiatal esophagectomy for benign (n=24) and malignant disease (n=24) [7]. In 2 patients, conversion to open surgery was required and 2 (...) Adenocarcinoma Procedure: Laparoscopic Esophagectomy Not Applicable Detailed Description: RATIONALE: Open esophagectomy can be associated with significant morbidity. We hypothesize that laparoscopic esophagectomy is associated with reduced morbidity and a faster recovery. HYPOTHESES: Combined thoracoscopic and laparoscopic esophagectomy can be performed safely. Combined thoracoscopic and laparoscopic esophagectomy is associated with reduced postoperative pain, decrease ICU and hospital stay, and reduced

2005 Clinical Trials

8436. 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

8437. Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial

of Medicine related topics: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Incidence of pressure ulcers [ Time Frame: during 5 weeks ] Time to develop pressure ulcers Secondary Outcome Measures : Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate (...) Information provided by: University Ghent Study Details Study Description Go to Brief Summary: Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies. Condition or disease Intervention/treatment Phase Pressure Ulcer Lesions (Grade 2 or More) Procedure: Different turning frequencies Not Applicable Detailed Description: Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending

2005 Clinical Trials

8438. BIONs, for Improved Tissue Health and Pressure Sore Prevention

Health and Pressure Sore Prevention 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: NCT00262457 Recruitment Status : Withdrawn (It was found that the devices were not suitable for the application.) First Posted : December 6, 2005 Last Update Posted : September 17, 2013 Sponsor: US Department of Veterans (...) electrical stimulation system Not Applicable Detailed Description: The overall goal of this project was to implement the use of a gluteal stimulation system incorporating BION microstimulators for pressure ulcer prevention in patients at high risk of tissue breakdown as a standard clinical practice.The specific goal of this study is to establish the feasibility of a system incorporating BION microstimulators for long term use. This will be achieved by a two phase study. The initial phase of the study

2005 Clinical Trials

8439. Environmental Exposure to Lead and Progressive Renal Insufficiency in Type II Diabetic Nephropathy

the ensuing 12 months, the renal function will be regularly followed up every 3 months and EDTA mobilization tests will be assessed every 6 months. If body lead burden of the study group patients increase more than 60μg, the chelation therapy will be performed again until their body burden are less than 60 μg. The primary end point is an increase in the serum creatinine level to 2 times the base-line value during the observation period. A secondary end point is the change in renal function during (...) the follow up period. Condition or disease Intervention/treatment Phase Diabetic Nephropathies Diabetes Mellitus, Type II Drug: EDTA chelating agents Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment Official Title: Environmental Lead Exposure and Progressive Renal Insufficiency in Patients With Type II Diabetes and Diabetic Nephropathy

2005 Clinical Trials

8440. Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients

with the protocol requirements. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Patient is 65 years old or younger at the time of signing the informed consent Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable double method of birth control (i.e (...) for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy. Patient was diagnosed with symptomatic multiple myeloma based on standard criteria (9), and has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion

2007 Clinical Trials

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