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8461. High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Waldenström Macroglobulinemia Drug: etoposide Drug: cyclophosphamide Drug: carmustine Drug: melphalan Drug: busulfan Drug: carboplatin Drug: thiotepa Radiation: total-body irradiation Procedure: autologous hematopoietic stem cell transplantation Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Not Applicable Detailed Description: PRIMARY OBJECTIVES: I. Estimate (...) with the following laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number < 100,000 per microliter and with Infectious Disease clearance Acute Leukemia, HL, NHL, MM and Solid Tumor patients must have received 2 cycles of chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells; small round blue cell tumor patients must have received either standard therapy or surgical intervention; the disease status and response to therapy must be known

2007 Clinical Trials

8462. Individualized Chiropractic and Integrative Care for Low Back Pain

, integrative care in 200 patients with sub-acute or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure in this study is patient-rated back pain. Chiropractic care will include therapies within the professional scope of practice. Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise, and patient education. Secondary (...) aims are to assess between group differences in frequency of symptoms, disability, fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and long-term. This innovative study is an exciting collaboration between

2007 Clinical Trials

8463. Education/Exercise and Chiropractic for Chronic Back Pain

" session involved a 5 minute exam, 5 minutes of hot pack application to the low back, and 5 minutes of light massage to the low back. During these visits, participants did not receive SMT, mobilization or other active chiropractic treatment. The recruitment goal is to generate the potential to randomize 6-10 participants/month. Recruitment feasibility will be assessed by tracking the number of patients who make initial inquiries, undergo screening and in-clinic evaluation, and are randomized. Further (...) /treatment Phase Low Back Pain Behavioral: Education & Exercise Procedure: Chiropractic treatment (plus Education & Exercise) Not Applicable Detailed Description: Chronic low back pain (LBP) is associated with poor health, lower quality of life, high costs, and is highly prevalent in veterans. Both chiropractic care and exercise have modestly reduced pain and/or improved function in randomized controlled trials (RCTs) of patients with chronic LBP. However, effects may not apply similarly to all

2007 Clinical Trials

8464. Treatment of Hand Dysfunction After Stroke

by the primary physician and covered by the subject's health care policy. Standard care will include: soft tissue mobilization; assisted motion exercise; active motion exercise; resistive exercise; task practice; use of assistive devices; and modality applications conventionally prescribed. FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week. The subjects will be present for a fourth hour each day, which will be used for breaks and rest periods that will be interspersed (...) in a sub-acute stroke population. It is a randomized, controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The control group will receive standard care for upper limb rehabilitation consisting of passive and active exercise, stretching, bracing, and use of adaptive devices. The experimental group will receive the experimental intervention in addition to their standard care. CONTROL GROUP INTERVENTION. The control group will receive the standard medical care prescribed

2007 Clinical Trials

8465. Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care

and racial minority HF patients. Condition or disease Intervention/treatment Phase Heart Failure, Congestive Behavioral: Interactive Voice Response System Behavioral: Nurse-Led Group Clinic Visits Not Applicable Detailed Description: HF is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. It is important for individuals with heart failure to closely monitor their symptoms, seek out medical attention when appropriate, and effectively self-manage (...) strategies. Study staff will monitor participants' use of the IVR system, including the dates, duration, and recipients of all phone calls. At Months 6 and 12, all participants will complete questionnaires and undergo a medical record review to assess hospitalization and death rates, quality of life, self-management behaviors, social support, satisfaction with HF care, and depression symptoms. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual

2007 Clinical Trials

8466. Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery

-based) Outcome Measures Go to Primary Outcome Measures : Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal)) [ Time Frame: 30 days ] Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable (...) Update Posted : February 25, 2019 Sponsor: University of Lausanne Hospitals Information provided by (Responsible Party): Nicolas DEMARTINES, University of Lausanne Hospitals Study Details Study Description Go to Brief Summary: The purpose of this study is to determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery. Condition or disease Intervention/treatment Phase Laparoscopic Colectomy Procedure

2007 Clinical Trials

8467. The HERCULES Trial

, 2012 Sponsor: Abbott Medical Devices Information provided by (Responsible Party): Abbott Medical Devices Study Details Study Description Go to Brief Summary: The purpose of this study is to determine whether the Herculink Elite Renal Stent System is safe and effective in the treatment of renal artery stenosis in patients with less than optimal angioplasty results and uncontrolled hypertension. CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by Federal (U.S (...) .) Law to Investigational Use Only. Condition or disease Intervention/treatment Phase Renal Artery Obstruction Hypertension, Renal Device: Herculink Elite Renal Stent System Not Applicable Detailed Description: To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension. CAUTION

2007 Clinical Trials

8468. A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health. Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score [ Time Frame: Baseline (...) , Month 12, 24 ] EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition

2007 Clinical Trials

8469. Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations

Intervention/treatment Phase Accidental Falls Behavioral: Marketing program to motivate exercise class participation Not Applicable Detailed Description: Injuries from falls are a leading cause of emergency visits, hospitalizations, and deaths in older US adults, resulting in total lifetime costs of more than $19 billion in 2000. Fall injuries reduce independence and mobility, and increase disability and institutionalization. There is good evidence that community-based group exercise classes focusing (...) -dwelling members of enrolled churches who are aged 60 and older, English- or Spanish-speaking, ambulatory with or without assistive devices, and cognitively able to consent and be tested. Exclusion Criteria: Older adults with any medical condition that precludes participation in an exercise program, as determined by the participant or their physician, or who are not physically able to pass the Modified-Clinical Test of Sensory Interaction in Balance (M-CTSIB) at baseline Contacts and Locations Go

2007 Clinical Trials

8470. Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

Pigmentosa Device: Retina implant is surgically placed into subretinal position Not Applicable Detailed Description: Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light (...) in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility. Other Names: Retina Implant, subretinal implant, vision prosthesis, medical device for restoration of vision Outcome Measures Go to Primary Outcome Measures : Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY) [ Time Frame: within implantation period ] Patient treatment shows acceptable results

2007 Clinical Trials

8471. The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty

studies before adding more. The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty 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: NCT00492674 Recruitment Status : Unknown Verified April 2007 by Assaf-Harofeh Medical Center. Recruitment status was: Not yet recruiting (...) First Posted : June 27, 2007 Last Update Posted : June 27, 2007 Sponsor: Assaf-Harofeh Medical Center Information provided by: Assaf-Harofeh Medical Center Study Details Study Description Go to Brief Summary: Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Previous studies have shown that there is correlation between both pre-operative functional status

2007 Clinical Trials

8472. Chiropractic and Self-care for Back-Related Leg Pain

, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior. Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed. Condition or disease Intervention/treatment Phase Sub-acute (...) and Chronic Back-related Leg Pain Other: Home exercise Other: Chiropractic Spinal Manipulative Therapy + Home exercise Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 192 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment Official Title: Chiropractic and Self-care for Back-Related Leg Pain Study Start Date : June 2007 Actual Primary

2007 Clinical Trials

8473. Postoperative Function Following Partial and Total Knee Replacement

, and standing still with the knees straight and also bent to 45 degrees. Condition or disease Intervention/treatment Phase Osteoarthritis Post-traumatic Arthritis Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses Device: Total Knee Replacement Not Applicable Detailed Description: Patients will be asked for a brief medical history so that we may determine if he/she can participate in the study. If the patient is going to have partial knee replacement, he/she will be randomly assigned (...) Collaborator: Zimmer Biomet Information provided by: New Lexington Clinic Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if patients with a fixed-bearing or mobile-bearing partial knee replacement perform functional activities differently than patients that have had total knee replacement or healthy volunteers that have not had knee surgery. The activities we are interested in include getting up out of a chair, stepping up and over a small wooden box

2007 Clinical Trials

8474. Clinical Trial of Peripheral Prism Glasses for Hemianopia

will be assessed relative to sham peripheral prism glasses. Condition or disease Intervention/treatment Phase Homonymous Hemianopia Device: High power (57 prism diopter) peripheral prism glasses Device: Low power sham peripheral prism glasses Not Applicable Detailed Description: Patients with hemianopic field loss are unaware of objects in their blind (non-seeing) hemi-field and often experience difficulties with mobility and navigation, such as walking into obstacles on the side of the field loss. In 2000 (...) ) Information provided by (Responsible Party): Alexandra Bowers, Schepens Eye Research Institute Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the functional utility for general mobility (walking) of new high power permanent peripheral prism glasses, which provide visual field expansion device for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes). The efficacy of real peripheral prism glasses

2007 Clinical Trials

8475. Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery

and informed consent Exclusion Criteria: Subjects who undergo conversion to the open approach before mobilization of the colon or pedicle ligation will be excluded from the analysis Subjects who are pregnant Subjects who have undergone a previous colectomy Subjects with a medical condition that may interfere with the evaluation of safety or effectiveness of the study device Subjects who have another condition that in the opinion of the investigator precludes further participation in the study Contacts (...) . Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery 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: NCT00487409 Recruitment Status : Completed First Posted : June 18, 2007 Last Update Posted : December 15, 2014 Sponsor: University Hospitals Cleveland Medical Center Collaborator

2007 Clinical Trials

8476. 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

8477. Sublingual Versus Vaginal Misoprostol for Labor Induction at Term

the uterus and cervix. Therefore, in theory, the sublingual route may have lower hyperstimulation rates and would have the advantage of a less invasive administration and lack of restriction of mobility. Although many studies have been published on the use of sublingual misoprostol for medical abortion in the first and second trimesters, 7-11, only two studies (by the same group) have compared sublingual to oral misoprostol, in different doses.12,13 The 50-µg dose was chosen because it is the dose most (...) Misoprostol for Labor Induction at Term 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: NCT00140114 Recruitment Status : Completed First Posted : September 1, 2005 Last Update Posted : July 13, 2012 Sponsor: American University of Beirut Medical Center Information provided by: American University of Beirut

2005 Clinical Trials

8478. 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

8479. 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

8480. 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

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