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Changing functional status within 6 months posttreatment is prognostic of overall survival in patients with head and neck cancer: NRG Oncology Study.
Eldridge, RC, Pugh, SL, Trotti, A, Hu, K, Spencer, S, Yom, SS, Rosenthal, D, Read, N, Desai, A, Gore, E, et al
Head & neck. 2019;(11):3924-3932
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BACKGROUND Is posttreatment functional status prognostic of overall survival in patients with head and neck cancer (HNC). METHODS In an HNC clinical trial, 495 patients had two posttreatment functional assessments measuring diet, public eating, and speech within 6 months. Patients were grouped by impairment (highly, moderately, modestly, or not impaired) and determined if they improved, declined, or did not change from the first assessment to the second. Multivariable Cox models estimated overall mortality. RESULTS Across all three scales, the change in posttreatment patient function strongly predicted overall survival. In diet, patients who declined to highly impaired had three times the mortality of patients who were not impaired at both assessments (hazard ratio [HR] = 3.60; 95% confidence interval, 2.02-6.42). For patients improving from highly impaired, mortality was statistically similar to patients with no impairment (HR = 1.38; 95% CI, 0.82-2.31). CONCLUSIONS Posttreatment functional status is a strong prognostic marker of survival in patients with HNC.
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Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage]).
Hänggi, D, Etminan, N, Aldrich, F, Steiger, HJ, Mayer, SA, Diringer, MN, Hoh, BL, Mocco, J, Faleck, HJ, Macdonald, RL, et al
Stroke. 2017;(1):145-151
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BACKGROUND AND PURPOSE We conducted a randomized, open-label, phase 1/2a, dose-escalation study of intraventricular sustained-release nimodipine (EG-1962) to determine safety, tolerability, pharmacokinetics, and clinical effects in aneurysmal subarachnoid hemorrhage. METHODS Subjects with aneurysmal subarachnoid hemorrhage repaired by clipping or coiling were randomized to EG-1962 or enteral nimodipine. Subjects were World Federation of Neurological Surgeons grade 2 to 4 and had an external ventricular drain. Cohorts of 12 subjects received 100 to 1200 mg EG-1962 (9 per cohort) or enteral nimodipine (3 per cohort). The primary objective was to determine the maximum tolerated dose. RESULTS Fifty-four subjects in North America were randomized to EG-1962, and 18 subjects were randomized to enteral nimodipine. The maximum tolerated dose was 800 mg. One serious adverse event related to EG-1962 (400 mg) and 2 EG-1962 dose-limiting toxicities were without clinical sequelae. There was no EG-1962-related hypotension compared with 17% (3/18) with enteral nimodipine. Favorable outcome at 90 days on the extended Glasgow outcome scale occurred in 27/45 (60%, 95% confidence interval 46%-74%) EG-1962 subjects (5/9 with 100, 6/9 with 200, 7/9 with 400, 4/9 with 600, and 5/9 with 800 mg) and 5/18 (28%, 95% confidence interval 7%-48%, relative risk reduction of unfavorable outcome; 1.45, 95% confidence interval 1.04-2.03; P=0.027) enteral nimodipine subjects. EG-1962 reduced delayed cerebral ischemia (14/45 [31%] EG-1962 versus 11/18 [61%] enteral nimodipine) and rescue therapy (11/45 [24%] versus 10/18 [56%]). CONCLUSIONS EG-1962 was safe and tolerable to 800 mg, and in this, aneurysmal subarachnoid hemorrhage population was associated with reduced delayed cerebral ischemia and rescue therapy. Overall, the rate of favorable clinical outcome was greater in the EG-1962-treated group. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01893190.
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Stressful life events predict delayed functional recovery following treatment for mania in bipolar disorder.
Yan-Meier, L, Eberhart, NK, Hammen, CL, Gitlin, M, Sokolski, K, Altshuler, L
Psychiatry research. 2011;(2-3):267-71
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Identifying predictors of functional recovery in bipolar disorder is critical to treatment efforts to help patients re-establish premorbid levels of role adjustment following an acute manic episode. The current study examined the role of stressful life events as potential obstacles to recovery of functioning in various roles. 65 patients with bipolar I disorder participated in a longitudinal study of functional recovery following clinical recovery from a manic episode. Stressful life events were assessed as predictors of concurrent vs. delayed recovery of role functioning in 4 domains (friends, family, home duties, work/school). Despite clinical recovery, a subset of patients experienced delayed functional recovery in various role domains. Moreover, delayed functional recovery was significantly associated with presence of one or more stressors in the prior 3 months, even after controlling for mood symptoms. Presence of a stressor predicted longer time to functional recovery in life domains, up to 112 days in work/school. Interventions that provide monitoring, support, and problem-solving may be needed to help prevent or mitigate the effects of stress on functional recovery.
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Alcohol consumption and functional outcome after stroke in men.
Rist, PM, Berger, K, Buring, JE, Kase, CS, Gaziano, JM, Kurth, T
Stroke. 2010;(1):141-6
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BACKGROUND AND PURPOSE Light-to-moderate alcohol consumption has been associated with reduced risk of total and ischemic stroke. However, data on the relationship between alcohol consumption and functional outcomes from stroke are sparse. METHODS Prospective cohort study among 21 860 men enrolled in the Physicians' Health Study who provided information on alcohol consumption at baseline and had no prior history of stroke or transient ischemic attack (TIA). Alcohol consumption was divided into 5 categories: <1 drink/wk, 1 drink/wk, 2 to 4 drinks/wk, 5 to 6 drinks/wk, and ≥1 drink/d. Possible functional outcomes included TIA, modified Rankin Scale (mRS)=0 to 1, mRS=2 to 3, and mRS=4 to 6. We used multinomial logistic regression to evaluate the relationship between levels of alcohol consumption and functional outcomes from stroke. RESULTS During a mean of 21.6 years of follow-up, 766 TIAs and 1393 strokes (1157 ischemic, 222 hemorrhagic, and 14 unknown type) occurred. Men who consumed 1 drink/wk had lowest associated odds for any outcome. Compared with men who did not experience a TIA or stroke and who consumed <1 drink/wk, men who consumed 1 drink/wk had odds ratio (95% CI) for total stroke of 0.85 (0.60 to 1.21) for mRS=0 to 1, 0.84 (0.64 to 1.10) for mRS=2 to 3, and 0.60 (0.37 to 0.97) for mRS=4 to 6. The odds ratio for TIA was 0.95 (0.73 to 1.23). The pattern of association did not substantially differ for ischemic and hemorrhagic stroke. Higher alcohol consumption showed no association with functional outcome after stroke. CONCLUSIONS Our data do not show strong associations between alcohol consumption and functional outcome after stroke. Modest beneficial associations exist with low alcohol consumption.
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Oral creatine supplementation facilitates the rehabilitation of disuse atrophy and alters the expression of muscle myogenic factors in humans.
Hespel, P, Op't Eijnde, B, Van Leemputte, M, Ursø, B, Greenhaff, PL, Labarque, V, Dymarkowski, S, Van Hecke, P, Richter, EA
The Journal of physiology. 2001;(Pt 2):625-33
Abstract
1. We investigated the effect of oral creatine supplementation during leg immobilization and rehabilitation on muscle volume and function, and on myogenic transcription factor expression in human subjects. 2. A double-blind trial was performed in young healthy volunteers (n = 22). A cast was used to immobilize the right leg for 2 weeks. Thereafter the subjects participated in a knee-extension rehabilitation programme (3 sessions x week(-1), 10 weeks). Half of the subjects received creatine monohydrate (CR; from 20 g down to 5 g daily), whilst the others ingested placebo (P; maltodextrin). 3. Before and after immobilization, and after 3 and 10 weeks of rehabilitation training, the cross-sectional area (CSA) of the quadriceps muscle was assessed by NMR imaging. In addition, an isokinetic dynamometer was used to measure maximal knee-extension power (Wmax), and needle biopsy samples taken from the vastus lateralis muscle were examined to asses expression of the myogenic transcription factors MyoD, myogenin, Myf5, and MRF4, and muscle fibre diameters. 4. Immobilization decreased quadriceps muscle CSA (approximately 10 %) and Wmax (approximately 25 %) by the same magnitude in both groups. During rehabilitation, CSA and Wmax recovered at a faster rate in CR than in P (P < 0.05 for both parameters). Immobilization changed myogenic factor protein expression in neither P nor CR. However, after rehabilitation myogenin protein expression was increased in P but not in CR (P < 0.05), whilst MRF4 protein expression was increased in CR but not in P (P < 0.05). In addition, the change in MRF4 expression was correlated with the change in mean muscle fibre diameter (r = 0.73, P < 0.05). 5. It is concluded that oral creatine supplementation stimulates muscle hypertrophy during rehabilitative strength training. This effect may be mediated by a creatine-induced change in MRF4 and myogenin expression.