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CLINICAL TRIALS PROFILE FOR ANDROID 25

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01384591	Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly	Completed	Lantheus Medical Imaging	Phase 1/Phase 2	2011-07-01	The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building of muscles. In aging populations, this decreased ability to build muscles may represent a tipping point in the progression towards chronic physical frailty and disability. The goal is to examine whether novel pharmacologic therapies can improve nutritive blood flow to the muscles and muscle building in the elderly. The purpose of this study is 1) to determine if losartan administration will enhance the building of muscles via proteins and suppress muscle breakdown 2) to determine if N-acetylcysteine (NAC) will enhance blood flow to muscles and the building of muscles via proteins. The investigators will study community dwelling, healthy older men and women (60-85 years). Subjects will be randomized to one of three groups: Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo Subjects will admit the night before and get their first dose of NAC/ losartan/ placebo with dinner. Subjects will be fasted after 10 pm. The next morning at 6 am blood samples will be taken and leg blood flow (LBF) will be measured. Subjects will receive their second dose of NAC/ losartan/ placebo. As from 6 am every hour blood will be drawn until 1 pm. At 8am, the second biopsy is taken and LFB and CEU will be measured. At 11am they get their third dose of NAC/ losartan/ placebo together with leucine (oral) and again a muscle biopsy is taken and LBF is measured. Leucine is anabolic to skeletal muscle of elderly and so the investigators will use it to stimulate muscle building.
NCT01384591	Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly	Completed	National Institutes of Health (NIH)	Phase 1/Phase 2	2011-07-01	The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building of muscles. In aging populations, this decreased ability to build muscles may represent a tipping point in the progression towards chronic physical frailty and disability. The goal is to examine whether novel pharmacologic therapies can improve nutritive blood flow to the muscles and muscle building in the elderly. The purpose of this study is 1) to determine if losartan administration will enhance the building of muscles via proteins and suppress muscle breakdown 2) to determine if N-acetylcysteine (NAC) will enhance blood flow to muscles and the building of muscles via proteins. The investigators will study community dwelling, healthy older men and women (60-85 years). Subjects will be randomized to one of three groups: Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo Subjects will admit the night before and get their first dose of NAC/ losartan/ placebo with dinner. Subjects will be fasted after 10 pm. The next morning at 6 am blood samples will be taken and leg blood flow (LBF) will be measured. Subjects will receive their second dose of NAC/ losartan/ placebo. As from 6 am every hour blood will be drawn until 1 pm. At 8am, the second biopsy is taken and LFB and CEU will be measured. At 11am they get their third dose of NAC/ losartan/ placebo together with leucine (oral) and again a muscle biopsy is taken and LBF is measured. Leucine is anabolic to skeletal muscle of elderly and so the investigators will use it to stimulate muscle building.
NCT01384591	Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly	Completed	The University of Texas Medical Branch, Galveston	Phase 1/Phase 2	2011-07-01	The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building of muscles. In aging populations, this decreased ability to build muscles may represent a tipping point in the progression towards chronic physical frailty and disability. The goal is to examine whether novel pharmacologic therapies can improve nutritive blood flow to the muscles and muscle building in the elderly. The purpose of this study is 1) to determine if losartan administration will enhance the building of muscles via proteins and suppress muscle breakdown 2) to determine if N-acetylcysteine (NAC) will enhance blood flow to muscles and the building of muscles via proteins. The investigators will study community dwelling, healthy older men and women (60-85 years). Subjects will be randomized to one of three groups: Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo Subjects will admit the night before and get their first dose of NAC/ losartan/ placebo with dinner. Subjects will be fasted after 10 pm. The next morning at 6 am blood samples will be taken and leg blood flow (LBF) will be measured. Subjects will receive their second dose of NAC/ losartan/ placebo. As from 6 am every hour blood will be drawn until 1 pm. At 8am, the second biopsy is taken and LFB and CEU will be measured. At 11am they get their third dose of NAC/ losartan/ placebo together with leucine (oral) and again a muscle biopsy is taken and LBF is measured. Leucine is anabolic to skeletal muscle of elderly and so the investigators will use it to stimulate muscle building.
NCT02897934	CWI and Discharge After Breast Cancer Surgery	Enrolling by invitation	University College Cork	N/A	2016-08-01	The objectives of this work are threefold: 1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major breast cancer surgery 2. To evaluate objective indices of patient recovery following anaesthesia and surgery in a 23 hour model of care 3. To evaluate patient satisfaction with their care pathway
NCT03172026	Maraviroc to Augment Rehabilitation Outcomes After Stroke	Recruiting	Burke Rehabilitation Hospital	Phase 2/Phase 3	2018-05-01	After stroke, the combination of progressive skills practice in an adequate dose, exercise for fitness, and reduced sedentary time will augment motor and cognitive outcomes. Sensorimotor and cognitive improvements after stroke often reach a general plateau by approximately 12 weeks after onset, however. Drugs that might enhance learning or neural repair, as well as other molecular and synaptic adaptations that occur during skills training and fitness exercise, might extend that recovery curve, although to date only fluoxetine has given any hint of this. Most trials have tested agents that modulate neurotransmitters. Several very recent preclinical experiments and observational studies in patients after stroke suggest that the commercially available medication, Maraviroc, a CCR5 antagonist, may augment skills learning during rehabilitation training, especially during the first three months after onset, by affecting CREB and synaptic plasticity. The investigators will carry out a randomized controlled trial of Maraviroc in patients with disabilities severe enough to have required inpatient stroke rehabilitation and, based on our preclinical data, who can start the drug intervention within 6 weeks of stroke onset. The investigators will compare usual post-stroke care plus placebo versus Maraviroc given for 8 weeks in 60 participants. However, to try to maximize the amount of practice that is most relevant to the primary outcome measurements and determine whether or not Maraviroc can enhance the effects of training, as hypothesized, all participants will be tele-monitored by mobile health devices and will receive weekly telephonic encouragement, based on device data, to walk, reduce sedentary time, and reach and grasp in the home in between usual care therapies. Compliance, serial motor changes over time, and self-management skills in making use of the telerehabilitation devices will be a nested substudy of feasibility of remote monitoring and feedback.
NCT03172026	Maraviroc to Augment Rehabilitation Outcomes After Stroke	Recruiting	University of California, Los Angeles	Phase 2/Phase 3	2018-05-01	After stroke, the combination of progressive skills practice in an adequate dose, exercise for fitness, and reduced sedentary time will augment motor and cognitive outcomes. Sensorimotor and cognitive improvements after stroke often reach a general plateau by approximately 12 weeks after onset, however. Drugs that might enhance learning or neural repair, as well as other molecular and synaptic adaptations that occur during skills training and fitness exercise, might extend that recovery curve, although to date only fluoxetine has given any hint of this. Most trials have tested agents that modulate neurotransmitters. Several very recent preclinical experiments and observational studies in patients after stroke suggest that the commercially available medication, Maraviroc, a CCR5 antagonist, may augment skills learning during rehabilitation training, especially during the first three months after onset, by affecting CREB and synaptic plasticity. The investigators will carry out a randomized controlled trial of Maraviroc in patients with disabilities severe enough to have required inpatient stroke rehabilitation and, based on our preclinical data, who can start the drug intervention within 6 weeks of stroke onset. The investigators will compare usual post-stroke care plus placebo versus Maraviroc given for 8 weeks in 60 participants. However, to try to maximize the amount of practice that is most relevant to the primary outcome measurements and determine whether or not Maraviroc can enhance the effects of training, as hypothesized, all participants will be tele-monitored by mobile health devices and will receive weekly telephonic encouragement, based on device data, to walk, reduce sedentary time, and reach and grasp in the home in between usual care therapies. Compliance, serial motor changes over time, and self-management skills in making use of the telerehabilitation devices will be a nested substudy of feasibility of remote monitoring and feedback.
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