A Randomized Clinical Trial of Short-Term Effects of Glasses Correction for Low to Moderate Hyperopia in Children: A Pilot Study

2021 ◽  
pp. 177-194
Keyword(s):  
Clinical Trial ◽  
Reading Comprehension ◽  
Placebo Group ◽  
Outcome Measures ◽  
Visual Function ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Short Term ◽  
Standard Score ◽  
Reading Decoding

Background: To report the short-term effect of glasses correction for low to moderate hyperopia on measures of reading, visual attention and visual function in children using a placebo-controlled, masked, randomized, multi-center clinical trial. Methods: Children ages 6 to <12 years with +1.00 D to < +4.00 D hyperopia and without strabismus or amblyopia were prospectively enrolled. Participants were randomly assigned to Transitions® photochromatic lenses with hyperopic correction or no correction. The primary outcome measures were change in reading (decoding and reading comprehension). Secondary outcome measures were change in attention and changes in visual function. The primary outcome exam was 6 weeks after glasses were dispensed. Results: There were no significant improvements in reading comprehension or decoding after 6 weeks of glasses wear. Participants assigned to the correction group experienced a greater improvement of 9.14 standard score (95% CI: 4.8, 13.5) in CAS Total Attention score while the change was only 3.46 standard score (95% CI: -1.0, 7.9) among those in the placebo group (p = .074). This result appears to have been driven by a significant improvement in Receptive Attention where the change in the correction group was approximately 3.5 times greater than in the placebo group (between-group p = .044). There was a statistically significant between group difference in accommodative response at both the dispensing (immediate change after glasses; p < .001) and 6-week examination (p = .012). Conclusions: Six weeks of glasses correction for low to moderate levels of hyperopia (2.00 D mean) resulted in no change in reading but significant improvements in receptive attention after 6 weeks of treatment in children age 6 to <12 years.

Key lessons learned from short-term treatment trials of cholinesterase inhibitors for amnestic MCI

2008 ◽  
Vol 20 (1) ◽  
pp. 40-46 ◽  
Author(s):  
Stephen Salloway ◽  
Stephen Correia ◽  
Sharon Richardson
Keyword(s):  
Cognitive Impairment ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Rating Scales ◽  
Controlled Trial ◽  
Term Treatment ◽  
Lessons Learned ◽  
Secondary Outcome ◽  
Short Term ◽  
Short Term Treatment

ABSTRACTObjective: This paper reviews the key lessons learned from the first published short-term, placebo-controlled trial of a cholinesterase inhibitor for treatment of mild cognitive impairment (MCI).Methods: The study was a 24-week placebo-controlled trial designed to evaluate the efficacy and safety of donepezil HCl (donepezil) in the treatment of cognitive impairment in subjects with MCI. Primary outcome measures were the NYU Paragraphs Test and the ADCS Clinicians Global-Impression of Change in the intent-to-treat last-observation-carried-forward group.Results: There was no benefit of donepezil treatment on primary outcome measures (NYU Paragraphs and ADCS CGI-C) in the ITT-LOCF group but positive findings were seen on NYU Paragraphs in the fully evaluable group and in certain secondary outcome measures across both groups.Conclusions: The results highlight the need for the use of primary cognitive and functional measures that are reliable and sensitive to change in patients with MCI. Measures of episodic memory, psychomotor speed and complex attention were most sensitive in this study. Functional rating scales are needed that measure change in individual subjects' key areas of functional deficit, which typically involve executive aspects of instrumental ADLs. Tolerability can be increased by use of flexible dosing and efficacy is likely to be enhanced by increasing the length of the trial from six to 12 months and by enriching the sample with subjects more likely to decline during the trial.

scholarly journals Combining Lovastatin and Minocycline for the Treatment of Fragile X Syndrome: Results From the LovaMiX Clinical Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Camille Champigny ◽  
Florence Morin-Parent ◽  
Laurence Bellehumeur-Lefebvre ◽  
Artuela Çaku ◽  
Jean-François Lepage ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fragile X Syndrome ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Fragile X ◽  
Combined Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Global Score

Background: Limited success of previous clinical trials for Fragile X syndrome (FXS) has led researchers to consider combining different drugs to correct the pleiotropic consequences caused by the absence of the Fragile X mental retardation protein (FMRP). Here, we report the results of the LovaMiX clinical trial, the first trial for FXS combining two disease-modifying drugs, lovastatin, and minocycline, which have both shown positive effects when used independently.Aim: The main goals of the study were to assess the safety and efficacy of a treatment combining lovastatin and minocycline for patients with FXS.Design: Pilot Phase II open-label clinical trial. Patients with a molecular diagnostic of FXS were first randomized to receive, in two-step titration either lovastatin or minocycline for 8 weeks, followed by dual treatment with lovastatin 40 mg and minocycline 100 mg for 2 weeks. Clinical assessments were performed at the beginning, after 8 weeks of monotherapy, and at week 20 (12 weeks of combined therapy).Outcome Measures: The primary outcome measure was the Aberrant Behavior Checklist-Community (ABC-C) global score. Secondary outcome measures included subscales of the FXS specific ABC-C (ABC-CFX), the Anxiety, Depression, and Mood Scale (ADAMS), the Social Responsiveness Scale (SRS), the Behavior Rating Inventory of Executive Functions (BRIEF), and the Vineland Adaptive Behavior Scale second edition (VABS-II).Results: Twenty-one individuals out of 22 completed the trial. There were no serious adverse events related to the use of either drugs alone or in combination, suggesting good tolerability and safety profile of the combined therapy. Significant improvement was noted on the primary outcome measure with a 40% decrease on ABC-C global score with the combined therapy. Several outcome measures also showed significance.Conclusion: The combination of lovastatin and minocycline is safe in patients for FXS individuals and appears to improve several elements of the behavior. These results set the stage for a larger, placebo-controlled double-blind clinical trial to confirm the beneficial effects of the combined therapy.

scholarly journals Efficacy of a strategy-based intervention on text-level reading comprehension in persons with aphasia: a study protocol for a repeated measures study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048126
Author(s):  
Sarah-Maria Thumbeck ◽  
Philipp Schmid ◽  
Sophie Chesneau ◽  
Frank Domahs
Keyword(s):  
Reading Comprehension ◽  
Outcome Measures ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Primary Objective ◽  
Secondary Outcome ◽  
Waiting Period ◽  
Reading Activities

IntroductionAt least 68% of persons with aphasia (PWA) experience reading difficulties. Even though strategy-based interventions are a promising treatment approach for text level reading comprehension deficits in PWA, empirical evidence for their efficacy remains rare. The primary objective of this study is the analysis of the efficacy of a strategy-based intervention on text-level reading comprehension and on reading activities in PWA.Methods and analysisIn a repeated measures trial, 24 PWA will first participate in a waiting period and then in a strategy-based intervention (14 face-to-face-sessions, 60 min each). We will apply two combinations of strategies to treat either the microstructure or the macrostructure, respectively. Participants will be randomly allocated to two parallel groups that will receive these combinations in interchanged sequences. Assessments will be implemented before and after each period as well as 3 and 6 months after the intervention. The primary outcome measure is text-level reading comprehension measured with a German version of the Test de Compréhension de Textes (TCT-D) and represented by the score TCT-D Total . A non-blinded and a blinded rater will evaluate the primary outcome measure. Secondary outcome measures will address specific reading functions, reading activities and cognitive functions. The sample size was determined with an a priori power analysis. For statistical analysis, we will use contrast analyses within repeated measures analysis of variance models. We expect significant improvements in primary and secondary outcome measures during the intervention as compared with changes during the waiting period.Ethics and disseminationThis study was approved by the ethics committee of Deutscher Bundesverband für akademische Sprachtherapie und Logopädie (20–10074-KA-MunmErw+Ko). Results and relevant data will be disseminated in peer-reviewed journals, at conferences and on the Open Science Framework.Trial registration numberDRKS00021411 (see Supplementary Table 1).

scholarly journals A feasibility randomised controlled trial of short-term fasting prior to CAPOX chemotherapy for stage 2/3 colorectal cancer: SWiFT protocol

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ellie Shingler ◽  
Claire Perks ◽  
Georgia Herbert ◽  
Andy Ness ◽  
Charlotte Atkinson
Keyword(s):  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
Dietary Advice ◽  
Short Term ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted. Methods The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia. Discussion It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. Trial registration This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717

scholarly journals Retrospective Assessment of the Efficacy of Modified Progressive Tinnitus Management Skills Education in a Military Medical Treatment Facility

2019 ◽  
Vol 184 (9-10) ◽  
pp. e468-e473 ◽  
Author(s):  
LaGuinn P Sherlock ◽  
Candice E Ortiz ◽  
Georgina P Blasco ◽  
Daniel I Brooks
Keyword(s):  
Medical Treatment ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Published Data ◽  
Treatment Facility ◽  
Coping Ability ◽  
Medical Treatment Facility ◽  
Treatment Facilities ◽  
Skills Education

Abstract Introduction The number-one service-connected disability is tinnitus. Tinnitus currently has no cure, but the functional impact of tinnitus has been shown to be mitigated by Progressive Tinnitus Management (PTM), a multi-level management approach. The duration of PTM Level 3 skills education (PTM-SE) and the inclusion of mental health providers have been identified as barriers to implementation of PTM-SE in Department of Defense (DOD) medical treatment facilities. The goal of this study was to determine if a version of PTM-SE modified for use in DOD medical treatment facilities resulted in positive changes in tinnitus-related outcomes. Materials and Methods A retrospective study was conducted by examining the medical records of patients who attended modified PTM-SE appointments. The study was approved by the Walter Reed National Military Medical Center Institutional Review Board. The study sample included 130 patients who completed modified PTM-SE between January 2015 and June 2016. Primary outcome measures were tinnitus awareness and tinnitus annoyance; secondary outcome measures were effect on life and self-perceived coping ability. Outcome measures were analyzed with nonparametric statistics and logistic regression. Results Modified PTM-SE resulted in clinically significant improvements in the primary outcome measures (awareness, p &lt; 0.0001; annoyance, p &lt; 0.0001). The proportion of patients who indicated an improvement in coping with tinnitus was similar to other published data with similar modifications to PTM-SE. Conclusions The evidence supports the assumption that PTM is a flexible program of tinnitus management that even when modified to be suitable for use in a DOD medical treatment facility provides meaningful reductions in tinnitus awareness and annoyance and improves tinnitus coping ability among military beneficiaries. These findings should encourage audiologists to modify PTM to work within their military medical treatment facility.

ST03: A randomized trial of perioperative epirubicin, cisplatin plus capecitabine (ECX) with or without bevacizumab (B) in patients (pts) with operable gastric, oesophagogastric junction (OGJ) or lower oesophageal adenocarcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4143-TPS4143 ◽  
Author(s):  
Elizabeth C Smyth ◽  
Ruth E Langley ◽  
Sally P Stenning ◽  
Laura Stevenson ◽  
William H. Allum ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Disease Free Survival ◽  
Stage I ◽  
Stage Ii ◽  
Oesophageal Adenocarcinoma ◽  
Secondary Outcome ◽  
Free Survival ◽  
Oesophagogastric Junction

TPS4143 Background: Perioperative ECX chemotherapy is a standard of care for localised gastric/OGJ/lower oesophageal adenocarcinoma (Cunningham NEJM 2006). B is a monoclonal antibody targeting VEGF-A, and in combination with chemotherapy results in improved response rates (RR) and progression free survival in advanced gastric cancer (Ohtsu JCO 2011). The aim of ST03 is to assess the safety and feasibility (stage I, first 200 pts) and efficacy (stage II) of the addition of B to perioperative ECX chemotherapy. Methods: ST03 is a multicentre, open-label, phase II/III randomised trial ongoing at 92 UK centres; sites in Germany will open in 2012. Eligibility criteria are histologically proven, untreated, resectable, lower oesophageal, OGJ or gastric adenocarcinoma; age ≥18 years; WHO PS 0-1; and adequate cardiac ejection fraction (EF). Exclusion criteria are TIA/CVA or MI ≤1 year; uncontrolled hypertension; ≥Grade II NYHA heart failure; recent gastrointestinal inflammatory conditions or major surgery/trauma/open biopsy <28d of study entry. Pts receive 3 pre- and 3 postoperative ECX (epirubicin 50 mg/m2 iv D1, cisplatin 60 mg/m2 iv D1 and capecitabine 1250mg/m2/D1-21) +/- B 7.5mg/kg D1 q3wk during chemotherapy, then 6 Bev q3wk (investigational arm). Surgery is pre-specified and laparoscopic procedures allowed only after quality assurance review. All specimens undergo central pathology review; blood and tissue collection for translational correlates is ongoing. The primary outcome measures for Stage I (safety results including cardiac EF) have been reported (Okines ASCO 2011). The stage II primary outcome measure is overall survival. Secondary outcome measures are RR, resection rate, disease free survival, toxicity, and QoL. An MRI substudy is open, a PET substudy is planned. 558 of ~950 pts required have been recruited, accrual expected to complete in 2013. An embedded pilot study within ST03 randomising HER2 positive patients to ECX ± lapatanib will open in 2012. Trial sponsored and co-ordinated by the MRC Clinical Trials Unit and funded by Cancer Research UK (CRUK06/025, NCT00450203).

scholarly journals Douching With Water Works Device for Perceived Vaginal Odor With or Without Complaints of Discharge in Women With No Infectious Cause of Vaginitis: A Pilot Study

2006 ◽  
Vol 2006 ◽  
pp. 1-4 ◽  
Author(s):  
Ashwin J. Chatwani ◽  
Sarmina Hassan ◽  
Salma Rahimi ◽  
Stacey Jeronis ◽  
Vani Dandolu
Keyword(s):  
Pilot Study ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Open Label ◽  
Significant Change

Objective. To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem.Methods. Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device.Results. At week 4, there was improvement in vaginal odor (P=.0006) and there was no significant change in lactobacilli score.Conclusion. Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.

scholarly journals Electrophysiological and fundoscopic detection of intracranial hypertension in craniosynostosis

Eye ◽  
2022 ◽  
Author(s):  
Sohaib R. Rufai ◽  
Oliver R. Marmoy ◽  
Dorothy A. Thompson ◽  
Lara S. van de Lande ◽  
R. William Breakey ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Intracranial Hypertension ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Study Data ◽  
Secondary Outcome ◽  
Single Centre ◽  
Diagnostic Indices ◽  
Accuracy Study ◽  
Clinically Significant

Abstract Aims To assess the diagnostic accuracy of fundoscopy and visual evoked potentials (VEPs) in detecting intracranial hypertension (IH) in patients with craniosynostosis undergoing spring-assisted posterior vault expansion (sPVE). Methods Children with craniosynostosis undergoing sPVE and 48-hour intracranial pressure (ICP) monitoring were included in this single-centre, retrospective, diagnostic accuracy study. Data for ICP, fundoscopy and VEPs were analysed. Primary outcome measures were papilloedema on fundoscopy, VEP assessments and IH, defined as mean ICP > 20 mmHg. Diagnostic indices were calculated for fundoscopy and VEPs against IH. Secondary outcome measures included final visual outcomes. Results Fundoscopic examinations were available for 35 children and isolated VEPs for 30 children, 22 of whom had at least three serial VEPs. Sensitivity was 32.1% for fundoscopy (95% confidence intervals [CI]: 15.9–52.4) and 58.3% for isolated VEPs (95% CI 36.6–77.9). Specificity for IH was 100% for fundoscopy (95% CI: 59.0–100) and 83.3% for isolated VEPs (95% CI: 35.9–99.6). Where longitudinal deterioration was suspected from some prVEPs but not corroborated by all, sensitivity increased to 70.6% (95% CI: 44.0–89.7), while specificity decreased to 60% (95% CI: 14.7–94.7). Where longitudinal deterioration was clinically significant, sensitivity decreased to 47.1% (23.0–72.2) and specificity increased to 100% (47.8–100). Median final BCVA was 0.24 logMAR (n = 36). UK driving standard BCVA was achieved by 26 patients (72.2%), defined as ≥0.30 logMAR in the better eye. Conclusion Papilloedema present on fundoscopy reliably indicated IH, but its absence did not exclude IH. VEP testing boosted sensitivity at the expense of specificity, depending on method of analysis.

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

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