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Background: Throwing injuries of the shoulder and elbow are common among youth baseball players. Hypothesis: A prevention program will reduce the incidence of throwing injuries of the shoulder and elbow by 50% among youth baseball players. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The authors block randomized 16 youth baseball teams consisting of 237 players aged 9 to 11 years into an intervention group (8 teams, 117 players) and a control group (8 teams, 120 players). The intervention program consisted of 5 stretching, 2 dynamic mobility, and 2 balance training exercises performed during warm-up. Both groups were followed up for 12 months, during which the incidence of shoulder and elbow injuries was recorded. In addition, ball speed during pitching as a performance-related factor and variables of physical function (passive range of motion of the elbow, shoulder and hip, dynamic balance, and thoracic kyphosis angle) were assessed during the pre- and postintervention periods. Results: The incidence of shoulder and elbow injuries in the intervention group (1.7 per 1000 athlete-exposures) was significantly lower than that in the control group (3.1 per 1000 athlete-exposures) (hazard ratio, 1.940; 95% CI, 1.175-3.205; P =.010). The factors related to pitching performance, as assessed by ball speed, tended to increase in the intervention group as compared with the control group (P =.010). The program also improved shoulder horizontal adduction deficits on the dominant side, hip internal rotation on the nondominant side, and the thoracic kyphosis angle. Conclusion: A prevention program decreases throwing injuries of the shoulder and elbow and enhances the parameter of pitching performance in youth baseball players. [ABSTRACT FROM AUTHOR]

Objective: To investigate the concomitant effects of two patient-directed interventions for post-stroke depressive symptoms on caregivers' well-being. Design: Secondary analyses of the results of a randomized controlled trial. Subjects: Fifty caregivers of stroke patients receiving outpatient rehabilitation. Interventions: Stroke patients and their caregivers were randomly allocated to either cognitive-behavioural therapy augmented with movement or occupational therapy (n = 23) or computerized cognitive training (n = 27) to alleviate depressive symptoms in patients. Main measures: Emotional burden (Involvement Evaluation Questionnaire), practical burden (Caregiver Strain Index), mental health (General Health Questionnaire) and emotional complaints (Hospital Anxiety and Depression Scale). Results: Caregivers of patients who received cognitive-behavioural therapy reported significantly higher mental health levels (mean difference (MD) = 1.78, 95% confidence interval (CI) = 0.43–3.13, P = 0.01) and less worrying about patients' well-being (MD = 1.9, 95% CI = 0.56–3.24, P < 0.01). In addition, there were positive time effects on the Involvement Evaluation Questionnaire for Brain Injury, particularly the subscales Worrying, Supervision and Tension. Conclusion: The results suggest that augmented cognitive-behavioural therapy aimed at improving patients' emotional, behavioural and social functioning positively affects some aspects of caregivers' well-being. [ABSTRACT FROM AUTHOR]

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) is an intervention for children aged 7 to 13 targeting high negative emotion, emotional reactivity, and emotion regulation deficits common across emotional disorders. Our objective was to collect pilot randomized controlled trial (RCT) data on the efficacy of the UP-C, comparing UP-C with an active, anxiety-focused intervention. Participants were 47 children with at least one primary anxiety disorder; approximately one half had elevated depression symptoms. Participants received either UP-C or the anxiety-focused control treatment. No condition-related differences were found with respect to diagnostic remission and anxiety symptoms. However, differences in favor of UP-C were observed with respect to treatment response at follow-up, depression symptoms, sadness dysregulation, and cognitive reappraisal. Results provide preliminary evidence that the UP-C may be at least as efficacious in treating anxiety as well-supported anxiety-specific treatment protocols and may produce greater gains in certain emotion reactivity and regulation variables. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to assess if external focus instructions result in greater improvements in motor skill and automaticity compared to internal focus instructions in stroke patients. Design: Double-blind randomized controlled trial. Setting: Inpatient stroke rehabilitation unit. Subjects: A total of 63 stroke patients (Meanage = 59.6 ± 10.7 years; Meandays since stroke = 28.5 ± 16.6; MedianFunctional Ambulation Categories = 4). Interventions: Patients were randomly assigned to an internal (N = 31) or external (N = 32) focus instruction group. Both groups practiced a balance board stabilization task, three times per week, for three weeks. Balance performance was assessed at baseline, and after one and three weeks of practice. Main measures: Primary outcome was the threshold stiffness (Nm/rad) at which patients could stay balanced. Secondary outcomes were patients' sway (root-mean-square error in degrees) at the baseline threshold stiffness under single- and dual-task conditions, and their performance on the Timed Up and Go Test and Utrecht Scale for Evaluation of Rehabilitation. Results: Both groups achieved similar improvements in threshold stiffness (∆= 27.1 ± 21.1 Nm/rad), and single- (∆= 1.8 ± 2.3° root-mean-square error) and dual-task sway (∆= 1.7 ± 2.1° root-mean-square error) after three weeks of practice. No differences were found in improvements in clinical tests of balance and mobility. Patients with comparatively good balance and sensory function, and low attention capacity showed greatest improvements with external focus instructions. Conclusion: External focus instructions did not result in greater improvement in balance skill in stroke patients compared to internal focus instructions. Results suggest that tailoring instructions to the individual stroke patient may result in optimal improvements in motor skill. [ABSTRACT FROM AUTHOR]

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants' residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture (n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients' digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group (n = 106) and control group (n = 93), 57 (53.8%) and 44 (47.3%) had complications (P = 0.443), 46 (43.4%) and 38 (40.9%) fell (P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital (P = 0.383); the median total days spent in hospital were 11.5 and 11.0 (P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture for pain relief and function improvement in patients with knee osteoarthritis and to determine the feasibility of an eight-week acupuncture intervention. Design: Pilot randomized controlled trial. Setting: Three teaching hospitals in China. Subjects: Patients with knee osteoarthritis (Kellgren grade II or III). Interventions: Patients were randomly assigned to an eight-week (three sessions per week) intervention of either traditional Chinese acupuncture or sham acupuncture. Main measures: The primary outcome was response rate—the proportion of patients achieving score ⩾36% decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function at week 8 compared with baseline. Secondary outcomes included pain, function and quality of life. Results: Of 42 patients randomized, 36 (85.7%) completed the study. There was no significant difference in response rate between the traditional Chinese acupuncture and control groups: 61.9% (13 of 21) versus 42.9% (9 of 21) achieved score ⩾36% decrease in WOMAC pain and function at week 8 (P = 0.217). The sum of WOMAC pain and function scores at week 8 was 11.6 (9.1) in the traditional Chinese acupuncture group compared with 16.3 (10.9) in the control group (P = 0.183). There was no significant difference between groups. Three adverse events were recorded and were classified as mild. Conclusion: It showed that three sessions per week acupuncture intervention of knee osteoarthritis was feasible and safe. No difference was observed between groups due to small sample size. Larger (sample size ⩾ 296) randomized controlled trials of this intervention appear justified. [ABSTRACT FROM AUTHOR]

Little is known about the effects of distraction techniques when undertaking medical procedures with hospitalized pediatric patients in Asian countries. This study examined the effects of distraction interventions on behavioral distress related to venipuncture procedures in Taiwanese children aged 3 to 7 years. Using concealed randomization, eligible children were allocated to receive a picture book (n = 92), or animated cartoon (n = 92) compared with routine oral instructions (n = 92), when being injected with an intravenous cannula. Two trained observers independently scored the responses of each child using the Observational Scale of Behavioral Distress–Revised before, during, and after the procedure. All children experienced distress during needle insertion, but distress was less in the distraction-based intervention groups. Moreover, distraction interventions were more effective for children aged 4 to 5 years. Our culturally tailored intervention engaged child participants, was age-appropriate, and could be adapted for use in other Chinese cultures. [ABSTRACT FROM AUTHOR]

Objective: Aim of this trial was to compare efficacy of activated platelet-rich plasma against hyaluronic acid as intra-articular injections to people with osteoarthritis of the knee. Design: Phase-2 randomized controlled trial, with blind patients and outcome assessors. Setting: Outpatient rehabilitation service; years 2011-2013. Subjects: Patients with knee osteoarthritis grades 2-3 at magnetic resonance imaging (MRI) were included after consent and randomized. Target sample size was 25 patients per group. Interventions: Patients received three activated platelet-rich plasma (intervention group) or hyaluronic acid (controls) intra-articular injections at 4-week intervals. Main measures: Main outcome measure was proportion of patients with >1 grade improvement at six months from last injection, as assessed by a radiologist blind to study group. Patients were evaluated over time clinically and with functional scales (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm, Tegner, American Knee Society Score (AKSS), Lequesne, visual analogue scale (VAS) for pain). Results: Overall, 30 patients were randomized to intervention and 28 to control group. For primary outcome, 28 patients (29 knees) in the intervention and 22 (25 knees) in the control group were available. Patients with at least 1 grade improvement at repeat MRI were 14 (48.3%) in the intervention and 2 (8%) in the control group (P < 0.003). Improvement in symptoms and functional scales was consistently higher in the intervention group. No side-effects were observed in either group. Conclusion: Activated platelet-rich plasma reduces articular damage as evident at MRI, as soon as six months after treatment; it reduces pain and improves patient's function and overall quality of life. [ABSTRACT FROM AUTHOR]

Background: The recommended initial treatment for multidirectional instability (MDI) of the shoulder is a rehabilitation program, yet there is very low-quality evidence to support this approach. Purpose/Hypothesis: The purpose was to compare the Watson MDI program and Rockwood Instability program among patients with nontraumatic, nonstructural MDI. The hypothesis was that the Watson MDI program would produce clinically and statistically superior outcomes over the Rockwood Instability program. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-one participants with MDI were randomly allocated to the Watson MDI or Rockwood Instability program. Participants attended 12 weekly physiotherapy sessions for exercise prescription. Outcomes were assessed at baseline and 6, 12, and 24 weeks after randomization. Primary outcomes were the Melbourne Instability Shoulder Score (MISS) and the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Orebro Musculoskeletal Pain Questionnaire, pain, muscle strength, scapular upward rotation, scapular coordinates, global rating of change, satisfaction scales, limiting angle in abduction range, limiting factor in abduction range, and incidence of dislocation. Primary analysis was by intention to treat based on linear mixed models. Results: Between-group differences showed significant effects favoring the Watson program for the WOSI (effect size [ES], 11.1; 95% CI, 1.9-20.2; P = .018) and for the limiting factor in abduction (ES, 0.1; 95% CI, 0.0-1.6; P = .023) at 12 weeks, and for the WOSI (ES, 12.6; 95% CI, 3.4-21.9; P =. 008), MISS (ES, 15.4; 95% CI, 5.9-24.8; P = .002), and pain (ES, -2.0; CI: -2.3 to -0.7, P = .003) at 24 weeks. Conclusion: For people with MDI, 12 sessions of the Watson MDI program were more effective than the Rockwood program at 12- and 24-week follow-up. Registration: ACTRN12613001240730 (Australian New Zealand Clinical Trials Registry). [ABSTRACT FROM AUTHOR]

Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 (P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 (P = .32). There was total resorption in 62% of group 1 and 73% of group 2 (P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period (P < .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry). [ABSTRACT FROM AUTHOR]

Two blinded single-dose studies randomized children 6 months to 11 years old with fever to receive ibuprofen (IBU) pediatric suspension 7.5 mg/kg or acetaminophen (APAP) suspension 10 to 15 mg/kg. The primary efficacy parameter was time-weighted sum of temperature differences (TWSTD) from baseline through 8 hours for each study. Secondary end points included TWSTD from baseline through 6 hours, time to onset and duration of temperature control, and proportion with temperature control. Studies were pooled for post hoc analyses of efficacy and adverse event end points. The primary efficacy parameter significantly favored IBU over APAP in study 1 and the pooled analysis (both P < .001), but was not significant in study 2. Onset of temperature control significantly favored IBU in study 2 (P = .007). Individual and pooled secondary efficacy outcomes supported significant advantages (P < .05) of IBU over APAP. IBU pediatric suspension provided greater temperature reduction versus acetaminophen in febrile children, with a comparable safety profile. [ABSTRACT FROM AUTHOR]

Objective: To identify the extent to which exercise intervention studies in multiple sclerosis rehabilitation are addressing comorbidities and if researchers consider comorbidities as possible moderators or mediators of exercise outcomes. Methods: Five databases were searched from inception to January 8, 2016, for exercise-related terms in combination with multiple sclerosis. Studies were screened and limited to randomized control trials, full text, and English language. We assessed whether comorbidities were excluded or included, how they were reported and described, and if they were examined as possible moderators or mediators of exercise outcomes. Results: We reviewed 99 articles that included various exercise interventions, where the most common were general multi-faceted exercise training (n=34), cardiovascular training (n=18), progressive- resistance training (n=12), and balance and gait training (n=12). In total, 77 of 99 studies reported one or more comorbidities as an exclusion criterion. The most commonly excluded comorbidities were cardiovascular diseases, cognitive impairments or psychiatric disorders, and unspecified conditions or contraindications. Only nine studies reported details on excluded participants with comorbidities. Across studies that reported comorbidities of included participants (n=8), none examined comorbidities as possible moderators or mediators of exercise outcomes. Conclusion: Although a variety of exercise interventions have positive outcomes, there is limited evidence that these interventions are generalizable to people with multiple sclerosis who have comorbid conditions. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy of a web-based multimodal training programme, ‘Move it to improve it’ (MitiiTM), to usual care on gross motor capacity and performance for children with an acquired brain injury. Design: Randomized waitlist controlled trial. Setting: Home environment. Participants: A total of 60 independently ambulant children (30 in each group), minimum 12 months post-acquired brain injury were recruited and randomly allocated to receive either 20 weeks of MitiiTM training (30 minutes/day, six days/week, total 60 hours) immediately, or waitlisted (usual care control group) for 20 weeks. A total of 58 children completed baseline assessments (32 males; age 11 years 11 months ± 2 years 6 months; Gross Motor Function Classification System equivalent I = 29, II = 29). Intervention: The MitiiTM program comprised of gross motor, upper limb and visual perception/cognitive activities. Main measures: The primary outcome was 30-second, repetition maximum functional strength tests for the lower limb (sit-to-stand, step-ups, half-kneel to stand). Secondary outcomes were the 6-minute walk test, High-level Mobility Assessment Tool, Timed Up and Go Test and habitual physical activity as captured by four-day accelerometry. Results: Groups were equivalent at baseline on demographic and clinical measures. The MitiiTM group demonstrated significantly greater improvements on combined score of functional strength tests (mean difference 10.19 repetitions; 95% confidence interval, 3.26–17.11; p = 0.006) compared with the control group. There were no other between-group differences on secondary outcomes. Conclusion: Although the MitiiTM programme demonstrated statistically significant improvements in the functional strength tests of the lower limb, results did not exceed the minimum detectable change and cannot be considered clinically relevant for children with an acquired brain injury. Clinical Trial Registration: Australian New Zealand Clinical Trials Registration Number, ANZCTR12613000403730. [ABSTRACT FROM AUTHOR]

Background: The Canadian Network for Mood and Anxiety Treatments (CANMAT) conducted a revision of the 2009 guidelines by updating the evidence and recommendations. The scope of the 2016 guidelines remains the management of major depressive disorder (MDD) in adults, with a target audience of psychiatrists and other mental health professionals.Methods: Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. "Pharmacological Treatments" is the third of six sections of the 2016 guidelines. With little new information on older medications, treatment recommendations focus on second-generation antidepressants.Results: Evidence-informed responses are given for 21 questions under 4 broad categories: 1) principles of pharmacological management, including individualized assessment of patient and medication factors for antidepressant selection, regular and frequent monitoring, and assessing clinical and functional outcomes with measurement-based care; 2) comparative aspects of antidepressant medications based on efficacy, tolerability, and safety, including summaries of newly approved drugs since 2009; 3) practical approaches to pharmacological management, including drug-drug interactions and maintenance recommendations; and 4) managing inadequate response and treatment resistance, with a focus on switching antidepressants, applying adjunctive treatments, and new and emerging agents.Conclusions: Evidence-based pharmacological treatments are available for first-line treatment of MDD and for management of inadequate response. However, given the limitations of the evidence base, pharmacological management of MDD still depends on tailoring treatments to the patient. [ABSTRACT FROM AUTHOR]

Background: Achilles tendinopathy (AT) is a common and difficult to treat musculoskeletal disorder. Purpose: To examine whether 1 injection of platelet-rich plasma (PRP) would improve outcomes more effectively than placebo (saline) after 3 months in patients with AT. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 24 patients with chronic AT (median disease duration, 33 months) were randomized (1:1) to receive either a blinded injection of PRP (n = 12) or saline (n = 12). The primary endpoint was improvement in Victorian Institute of Sports Assessment–Achilles (VISA-A) score at 3 months. Secondary outcomes were pain at rest, pain while walking, pain when tendon was squeezed, ultrasonographic changes in tendon thickness, and color Doppler activity. Patients were informed that they could drop out after 3 months if they were dissatisfied with the treatment. Results: After 3 months, all 24 patients were reassessed (no dropouts). No difference between the PRP and the saline group could be observed with regard to the primary outcome (VISA-A score: mean difference [MD], –1.3; 95% CI, −17.8 to 15.2; P = .868). Secondary outcomes were pain at rest (MD, 1.6; 95% CI, −0.5 to 3.7; P = .137), pain while walking (MD, 0.8; 95% CI, −1.8 to 3.3; P = .544), pain when tendon was squeezed (MD, 0.3; 95% CI, −0.2 to 0.9; P = .208), color Doppler activity (MD, 0.3; 95% CI, −0.2 to 0.8; P = .260), and tendon thickness (MD, 0.8 mm; 95% CI, 0.1 to 1.6 mm; P = .030). After the 3-month follow-up, a large dropout was observed: 75% of patients in the PRP group and 33% in the saline group. Conclusion: PRP injection did not result in an improved VISA-A score over a 3-month period in patients with chronic AT compared with placebo. The only secondary outcome demonstrating a statistically significant difference between the groups was change in tendon thickness; this difference indicates that a PRP injection could increase tendon thickness compared with saline injection. The conclusions are limited to the 3 months after treatment owing to the large dropout rate. [ABSTRACT FROM AUTHOR]

Background: The aim of this prospective randomized study was to compare the outcomes of the anatomic double-bundle (DB) and anatomic single-bundle (SB) techniques 5 years after anterior cruciate ligament (ACL) reconstruction. Since more effective restoration of rotational laxity is considered the main advantage of the DB technique, the pivot-shift test was the primary outcome variable of the study. Hypothesis: Double-bundle ACL reconstruction will result in a better outcome in terms of the pivot-shift test. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 105 patients (33 women, 72 men; median age, 27 years; range, 18-52 years) were randomized and underwent ACL reconstruction (DB group, n = 53; SB group, n = 52). All reconstructions were performed anatomically by identifying the ACL footprints, using the anteromedial portal for the femoral tunnel drilling, and utilizing interference screw for tibial and femoral fixation. A single blinded observer examined the patients preoperatively and at follow-up (median, 64 months; range, 55-75 months). Multiple subjective and objective clinical evaluation tests and radiographic assessments of osteoarthritis (OA) were performed using the Ahlbäck, Kellgren-Lawrence, and Fairbank grading systems at 6 weeks postoperatively and at the final follow-up evaluation. Results: Preoperatively, no differences were found between the study groups, apart from the preinjury Tegner activity level, which was lower in the DB group (SB: mean, 7.8 [range, 3-9]; DB: mean, 7.3 [range, 0-9]; P = .02). Eighty-seven patients (83%) were available for examination at the 5-year follow-up. Statistical differences could not be found between the groups in terms of the pivot-shift test, KT-1000 arthrometer laxity measurements, manual Lachman test, single-legged-hop test, square-hop test, range of motion, Lysholm knee scoring scale, Tegner activity scale, or Knee injury and Osteoarthritis Outcome Score. Correspondingly, no differences were found between the groups regarding the presence of OA at follow-up. However, a significant increase of OA was found within the DB group at the 5-year follow-up. Both groups improved at follow-up compared with the preoperative assessment in terms of the laxity tests, hop tests, and scoring scales. Conclusion: At the 5-year follow-up of an unselected group of patients, anatomic DB reconstruction was not superior to anatomic SB reconstruction in terms of the pivot-shift test. [ABSTRACT FROM AUTHOR]

Background: Evidence from preclinical and human studies indicates the presence of reduced dopamine-1 receptor (D1R) signaling in the cortex, where D1Rs predominate, in patients with schizophrenia (SCZ), which may contribute to their cognitive deficits. Furthermore, studies in nonhuman primates (NHP) have suggested that intermittent administration of low doses of D1R agonists produce long-lasting reversals in cognitive deficits. The purpose of this trial was to test whether a similar design, involving subacute intermittent administration of low doses of a full, selective agonist at D1Rs, DAR-0100A, would improve cognitive deficits in SCZ.Methods: We randomized 49 clinically stable individuals with SCZ to three weeks of intermittent treatment with 0.5 mg or 15 mg of DAR-0100A, or placebo (normal saline). Functional magnetic resonance imaging (fMRI) BOLD was used to evaluate the effects of drug administration on brain activity during a working memory (WM) task. Effects on cognition were also assessed using the MATRICS and the N-back task as primary endpoints. The CogState battery was used as a secondary endpoint.Results: There were no observed treatment effects on either the BOLD fMRI signal during WM tasks or the WM domains of the MATRICS. Moderate improvement was detected on the CogState battery and on the attention domain of the MATRICS.Conclusion: These results suggest that low doses of D1 agonists that do not result in measureable occupancy of the D1R do not reliably improve cognition in SCZ, unlike the observations in NHP. As this drug is limited by its pharmacokinetic profile, better D1R agonists that can achieve adequate levels of D1R occupancy are needed to test the efficacy of this mechanism for cognitive enhancement in SCZ. [ABSTRACT FROM AUTHOR]

Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a β-tricalcium phosphate (β-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-β-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with β-TCP-following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/β-TCP groups with significant improvements over control and 0.1% rh-FGF-2/β-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/β-TCP (ClinicalTrials.gov NCT01728844). [ABSTRACT FROM AUTHOR]

Background. Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown. Methods. In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 109 colony forming units per day), or high-dose (8 × 109 colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism. Results. The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI −14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose. Conclusions. The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required. [ABSTRACT FROM AUTHOR]

Statins have been shown to decrease depressive symptoms in certain groups of patients, an effect that is mostly attributed to their anti-inflammatory and neurotransmitter modulatory potentials. We aimed to investigate the antidepressant effects of simvastatin as an adjuvant therapy in patients with moderate to severe depression. In this double-blind placebo-controlled clinical trial, 48 patients were randomly allocated to receive simvastatin or placebo as an adjunct to fluoxetine for six weeks. Patients were evaluated with the Hamilton Depression Rating Scale (HDRS) at baseline and weeks 2, 4 and 6. Probable clinical and laboratory adverse events were also monitored and compared between the two groups. Simvastatin-treated patients experienced significantly more reductions in HDRS scores compared to the placebo group by the end of the trial (p=0.02). Early improvement and response rates were significantly greater in the simvastatin group than the placebo group (p=0.02 and p=0.01, respectively) but remission rate was not significantly different between the two groups (p=0.36). No serious adverse event was reported during this trial. In conclusion, simvastatin seems to be a safe and effective adjuvant therapy for patients suffering from major depressive disorder. However, more confirmatory studies are warranted. [ABSTRACT FROM AUTHOR]

The article focuses on a randomized, single-blind study which investigates the effectiveness of Wii Sports Resort™ training and if they possess benefits. Topics include consideration of hemiplegic children with cerebral palsy for study, health benefits of regular participation in physical activity, people with cerebral palsy and virtual reality as a training tool that encourages ability to prescribe the dose of exercise.