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NCT ID: NCT01818752 Completed - Multiple Myeloma Clinical Trials

Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma

CLARION
Start date: July 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

NCT ID: NCT01818609 Completed - Sarcopenia Clinical Trials

Study of Inactivity on Metabolism of Elderly Muscles

Start date: September 2011
Phase: Phase 1
Study type: Interventional

Skeletal muscle mass declines with inactivity (casting is a good example) and increases with activity (such as weightlifting). Whether muscle mass increases or decreases, is determined by whether more new proteins within muscle are made than are broken down. The investigators know that feeding protein increases the synthesis of new proteins but that the response of older muscles to protein feeding is blunted compared with the young. This resistance of the elderly to muscle building stimuli may be the primary reason that muscle mass is lost in aging. The investigators also know that periods of muscle disuse such as casting result in a person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at approximately 1% for every year after. Elderly persons would likely fare well with advancing age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is a 'population view' and does not represent what occurs during short periods of muscle disuse (i.e. during hospitalization or illness), which occur with increasing frequency in elderly persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may be worsened. The investigators will measure how quickly new proteins are made at rest and after protein feeding in elderly men, before and after a 14 day period of reduced activity brought on by having people reduce their daily step count.

NCT ID: NCT01818375 Completed - Postoperative Ileus Clinical Trials

Goal Directed Fluid Therapy and Postoperative Ileus

Start date: February 2013
Phase: N/A
Study type: Interventional

Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing. It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.

NCT ID: NCT01818349 Completed - Stroke Clinical Trials

Impact of Training on Gait and Strength in Stroke Survivors

Start date: March 2002
Phase: N/A
Study type: Interventional

Background: A discrepancy between strength gain and gait changes following various training programs aimed at improving gait function after stroke has been noted. A mismatch between the training program and gait parameters could explain this finding. Objective: To evaluate the impact of an isokinetic-strengthening program, matching the requirements of the affected lower-limb muscle groups involved in the energy generation of gait, to a control intervention, on gait performance and muscle strength. Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce greater changes in gait performance and strength than a control intervention not aiming at training these muscle groups. Design: Single-blinded randomized controlled trial. Participants: A convenient sample of 30 individuals with chronic hemiparesis. Interventions: Participants were randomly assigned into two groups (n=15), each training three times/week for six weeks. The experimental group trained the affected plantarflexors, hip flexors and extensors concentrically, while the control group trained the affected upper-limb muscles. Main outcome measures: Baseline values and post-training values, taken at the end of the training program, of maximal voluntary concentric strength, gait speed and peak positive power.

NCT ID: NCT01818271 Completed - Sequelae of Stroke Clinical Trials

Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility Post Stroke

Start date: April 2013
Phase: N/A
Study type: Interventional

Stroke patients clearly benefit from intensive and coordinated inpatient care. While inpatient rehabilitation care is the preferred form for many patients post-stroke, due to access and financial barriers, many patients do not have this option. Community, outpatient rehabilitation programs will allow the patients with moderately disabling strokes the opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation , while allowing some patients with mild disability to avoid inpatient rehabilitation completely. Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of treating adults who have suffered a single stroke using the following essential treatment components; a) community setting, b) group activity program, c) flexible, task-specific, computer-based exercise regime This program is designed to allow an extension of the in-patient rehabilitation experience to a community-based setting, in a cost-effective manner using paraprofessional staff and rehabilitation specialists, to provide a challenging, functional program to promote recovery and independence from physical impairments affecting balance and walking. The specific objectives are to: 1. assess the benefits and feasibility of the multi-functional group exercise intervention for balance and mobility in a community setting. Secondary objectives 2. identify effective combinations of exercises & activities that translate to increased abilities and participation levels. Hypothesis: Intense training targeting standing balance, and walking will significantly improve stroke clients' functional mobility. Training in a group setting and incorporating interactive and engaging computer gaming further provides the benefits of motivation and peer support while providing treatment in a cost effective manner.

NCT ID: NCT01817595 Completed - Clinical trials for Type 2 Diabetes Mellitus

Evaluation of Iphone Technology in Diabetes Treatment

Start date: April 2013
Phase: N/A
Study type: Interventional

Background With the emergence of the internet, health care professionals are changing the way they approach diabetes management. Internet Blood Glucose Monitoring Systems (IBGMS) are aimed at keeping blood glucose levels normal or in the range of acceptable levels to prevent the complications associated with diabetes. The Principal Investigators have completed a randomized clinical trial supporting the efficacy of IBGMS (1,2). Patient satisfaction of reporting platform is essential to encourage patient reporting and participation in IBGMS. In this study, we wish to compare two different types of meters which will be used to internet blood glucose monitoring: the BG Star Meter (Conventional Meter), and the iBG Star Group (iPhone Technology). Purpose and Rationale Patients who are more satisfied with their meter and internet reporting platform are more likely to participate in an internet monitoring system. Patients often lack the motivation to report to their endocrinologist. With increased reporting to their healthcare professional, patients are more likely to benefit from such a system. This study aims to compare two types of meters and their respective internet reporting platforms to encourage patient participation. Objectives Our main goal is to compare the two types of meters. Primary Outcomes Include: 1. Patient Satisfaction as measured by the "Diabetes Treatment Satisfaction Questionnaire" (DTSQ) 2. Frequency of reporting to endocrinologist 3. Number of Self-Monitoring Blood Glucose (SMBG) tests 4. Time taken to teach each patient the platforms Research Design/Methods Sample Size: 50 patients will be randomized into two groups: BG Star Group (Conventional Meter) 25 patients will use the (conventional) BG star meter in which patients will upload their readings onto a computer and send in their readings via email. IBG Star Group (iPhone Technology) 25 patients will be randomized to the iBGstar system will upload their readings to their iPhone and send in their readings using the iPhone. Patients will be recruited from a Physician's private office. Both the (Conventional meter) BG star and iBG star (iPhone Technology) group will be asked to perform SMBG 3 or more times per day and to upload their metered glucose values online every 2 weeks to be reviewed by the doctor. Inclusion criteria: - Type 1s - Type 2s, can be on insulin, oral antihyperglycemic agents, or in combination. - Willingness to test blood glucose levels a minimum of 3 times daily - Willingness to be randomized - Trained in self-blood glucose monitoring - Internet Access Exclusion criteria: Patients who do not meet the above criteria or are not willing to participate will not be included in the study.

NCT ID: NCT01817075 Completed - Malignant Neoplasm Clinical Trials

Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant

Start date: November 4, 2013
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant organisms in younger patients with cancer or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.

NCT ID: NCT01817049 Completed - Sport Injury Clinical Trials

The Effect of a Behavioural Intervention on Injury Prevention Program Adherence in Female Youth Soccer

Start date: March 2013
Phase: N/A
Study type: Interventional

Soccer accounts for more than 10% of all sport injuries in youth requiring medical attention. The injury rates in youth soccer where there is no established injury prevention program are estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000 participation hours. Risk reductions ranging from 32-43% have been found for youth players participating in neuromuscular training programs, such as the FIFA 11+, that include agility, balance training, and strengthening components. Although studies have shown that the FIFA 11+ is effective at reducing injuries, there is poor uptake of the program in the youth soccer community. It is therefore important to develop ways of delivering the program to soccer coaches and players in order to maximize its protective benefit. The Health Action Process Approach (HAPA) is a behavior change theory that has been used to successfully predict the uptake of health behaviours in a number of populations, such as cancer screening and exercise, but has not been tested in sport injury prevention settings. The primary objective of this study is to examine the effect of a HAPA-based coach education intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the course of one outdoor and one indoor season. The secondary objective is to examine the dose-response relationship between program adherence and injury, comparing program adherence and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches receive a HAPA-based intervention will have greater adherence to the program than teams whose coaches do not receive the intervention, and that that injury incidence will decrease as adherence to the program increases. It is expected that program adherence will be lower and injury rates will be higher in indoor soccer compared to outdoor soccer.

NCT ID: NCT01816828 Completed - HIV Clinical Trials

Intervention Research to Reduce HIV Sexual Transmission Among HIV Positive Men Who Have Sex With Men

Start date: March 2013
Phase: N/A
Study type: Interventional

Gay Poz Sex (GPS) is a peer-facilitated holistic sexual health program for gay and bisexual HIV-positive men. Groups of five to eight men attend eight weekly sessions which cover basic sexual health information, review the current legal context surrounding HIV non-disclosure and use motivational interviewing (MI) to support participants in setting and achieving personal goals. In this randomized control trial phase of the research, the investigators are assessing the efficacy of the group counseling intervention, GPS. Participants are randomized to receive GPS immediately or to a wait list/standard of care condition. Participants are followed for a 6 month period and are asked to complete baseline quantitative assessments, as well as two qualitative interviews.

NCT ID: NCT01816295 Completed - Hypogonadism Clinical Trials

A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.