scholarly journals A Randomized Controlled Trial of Assisted Intention Monitoring for the Rehabilitation of Executive Impairments Following Acquired Brain Injury

2016 ◽  
Vol 31 (4) ◽  
pp. 323-333 ◽  
Author(s):  
Fergus Gracey ◽  
Jessica E. Fish ◽  
Eve Greenfield ◽  
Andrew Bateman ◽  
Donna Malley ◽  
...  
Keyword(s):  
Brain Injury ◽  
Controlled Trial ◽  
Phase 1 ◽  
Memory Task ◽  
Acquired Brain Injury ◽  
Text Messages ◽  
Mean Difference ◽  
Medium Effect ◽  
Double Blind ◽  
Baseline Phase

Background. Acquired brain injury (ABI) can impair executive function, impeding planning and attainment of intentions. Research shows promise for some goal-management rehabilitation interventions. However, evidence that alerts assist monitoring and completion of day-to-day intentions is limited. Objective. To examine the efficacy of brief goal-directed rehabilitation paired with periodic SMS text messages designed to enhance executive monitoring of intentions (assisted intention monitoring [AIM]). Methods. A randomized, double-blind, controlled trial was conducted. Following a baseline phase, 74 people with ABI and executive problems were randomized to receive AIM or control (information and games) for 3 weeks (phase 1) before crossing over to either AIM or no intervention (phase 2). The primary outcome was change in composite score of proportion of daily intentions achieved. A total of 59 people (71% male; 46% traumatic brain injury) completed all study phases. Results. Per protocol crossover analysis found a significant benefit of AIM for all intentions [ F(1, 56) = 4.28; P = .04; f = 0.28; 3.7% mean difference; 95% CI = 0.1%-7.4%] and all intentions excluding a proxy prospective memory task [ F(1, 55) = 4.79; P = .033; f = 0.28, medium effect size; 3% mean difference; 95% CI = 0.3%-5.6%] in the absence of significant changes on tests of executive functioning. Intention-to-treat analyses, comparing AIM against control at the end of phase 1 revealed no statistically significant differences in the attainment of intentions. Conclusion. Combining brief executive rehabilitation with alerts may be effective for some in improving achievement of daily intentions, but further evaluation of clinical effectiveness and mechanisms is required.

scholarly journals Publisher Correction to: BRAINSTORMING: A study protocol for a randomised double-blind clinical trial to assess the impact of concurrent brain stimulation (tDCS) and working memory training on cognitive performance in Acquired Brain Injury (ABI)

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Sara Assecondi ◽  
Rong Hu ◽  
Gail Eskes ◽  
Michelle Read ◽  
Chris Griffiths ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Working Memory ◽  
Brain Injury ◽  
Cognitive Performance ◽  
Acquired Brain Injury ◽  
Working Memory Training ◽  
Memory Training ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
The Impact

Following publication of the original article [1], the authors flagged that the article had published with the Acknowledgements erroneously excluded from the declarations at the end of the article.

scholarly journals The role of bovine colostrum on recovery time and length of hospital stay of acute diarrhea in infants and children: a double-blind randomized controlled trial

2016 ◽  
Vol 46 (3) ◽  
pp. 127
Author(s):  
IGN Suwarba ◽  
Sudaryat S ◽  
Hendra S ◽  
IKG Suandi ◽  
Raka Widiana
Keyword(s):  
Hospital Stay ◽  
Acute Diarrhea ◽  
Recovery Time ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Bovine Colostrum ◽  
Mean Difference ◽  
Infants And Children ◽  
Double Blind ◽  
Defecation Frequency

Background WHO standard treatment for acute diarrhea remainsunsatisfying to the parents of acute diarrhea patients, particularlythe need of medical treatment. Bovine colostrum contains immuneand growth factors that is thought able to neutralize some agentscausing acute diarrhea in infants and children.Objective To evaluate the efficacy of bovine colostrum as adju-vant therapy on recovery time and length of hospital stay for acutediarrhea in infants and children.Methods A double-blind randomized controlled trial was conductedon infants and children with acute diarrhea admitted to SanglahHospital. Treatment group received standard therapy with bovinecolostrums and control group received standard therapy plus pla-cebo. The primary outcomes were achievement of recovery timeand length of hospital stay. Recovery time was determined by thenumber of days needed to achieve defecation frequency <3 times/day and needed to achieve normal stool consistency.Results Seventy infants and children were enrolled. The treatmentgroup significantly achieved recovery time earlier than the control groupin regard to the time of achieving defecation frequency to <3 times/day [2.31 (0.76) vs 3.34 (1.45); mean difference of -1.03; P= 0.001; CI95% -1.58;-0.48] and normal stool consistency [2.40 (0.77) vs 3.43(1.48); mean difference of -1.03; P = 0.001; CI 95% -1.59;-0.46]. Lengthof hospital stay was shorter in the treatment group than the controlgroup [2.89 (0.78) vs 3.94 (1.53); mean difference of -1.05; P= 0.001;CI 95% (-1.3;-0.7)]. No significant difference was found in mean ofbody weight recovery in two groups [0.47 (0.16) vs 0.49 (0.20); meandifference of -0.03; P=0.556; CI 95%: -0.11;0.06]. Age, nutritionalstatus, breastfeeding, and diarrhea before admission did not influ-ence the study outcome.Conclusion Bovine colostrums as an adjuvant in standard therapyfor acute diarrhea in infants and children is effective in regard toachieve earlier recovery time and shorter length of hospital stay

scholarly journals Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial

2021 ◽  
Author(s):  
Kathryn E. Stephenson ◽  
Boris Julg ◽  
C. Sabrina Tan ◽  
Rebecca Zash ◽  
Stephen R. Walsh ◽  
...  
Keyword(s):  
Viral Load ◽  
T Cell ◽  
Adverse Events ◽  
Antiviral Activity ◽  
Controlled Trial ◽  
Phase 1 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Cell Counts ◽  
Hiv 1

AbstractHuman immunodeficiency virus (HIV)-1-specific broadly neutralizing monoclonal antibodies are currently under development to treat and prevent HIV-1 infection. We performed a single-center, randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30 mg kg–1 in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30 mg kg–1 in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4+ T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48 participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade 3 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous/injection site tenderness, pain and headache. Absolute and relative CD4+ T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77 log in viremic participants, with a viral load nadir at a median of 8.5 days. Two individuals with low baseline viral loads experienced ART-free viral suppression for ≥168 days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.

scholarly journals Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Nut Koonrungsesomboon ◽  
Saowaros Nopnithipat ◽  
Supanimit Teekachunhatean ◽  
Natthakarn Chiranthanut ◽  
Chaichan Sangdee ◽  
...  
Keyword(s):  
Knee Pain ◽  
Controlled Trial ◽  
Common Adverse Event ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Osteoarthritis Of The Knee ◽  
Efficacy And Safety ◽  
Short Term Treatment ◽  
Double Blind ◽  
Herbal Formulation

Background. Osteoarthritis of the knee is the most common form of arthritis. Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region. This study aimed to evaluate the efficacy and safety of Thai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee. Methods. This randomized, double-blind, active-controlled, noninferiority trial randomly assigned patients with osteoarthritis of the knee to receive either THF-6 or diclofenac for four weeks. The primary outcome measure was the change from baseline in knee pain as measured by a 100 mm visual analog scale (VAS). Secondary outcome measures included knee stiffness, a stair climb test, the Knee Injury and Osteoarthritis Outcome Score, and safety parameters. Outcomes were assessed on a biweekly basis. Modified intention-to-treat (MITT) and perprotocol (PP) analyses were applied. Results. A total of 200 patients were enrolled of whom 175 (87.5%) were included in the MITT analysis and 153 (76.5%) in the PP analysis. The mean change in VAS pain did not differ between the two groups, and the upper limit of the two-sided 95% confidence interval (CI) for comparison between the two groups was within the prespecified margin of 10 mm for noninferiority (MITT analysis: mean difference = 0.86, 95% CI = -4.39 to 6.10, p = 0.748 ; PP analysis: mean difference = 1.98, 95% CI = -3.61 to 7.56, p = 0.486 ). Significant improvement was observed in all the efficacy parameters in both groups. Dyspepsia was the most common adverse event: 23 patients in the THF-6 group and 28 in the diclofenac group p = 0.417 . Conclusions. THF-6 offers an alternative to oral diclofenac for the short-term treatment of osteoarthritis of the knee. It was shown to be noninferior to oral diclofenac in relieving knee pain. This trial is registered with ChiCTR-IPR-15007213.

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