scholarly journals Randomized Controlled Trial of Strain-Specific Probiotic Formulation (Renadyl) in Dialysis Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Ranganathan Natarajan ◽  
Bohdan Pechenyak ◽  
Usha Vyas ◽  
Pari Ranganathan ◽  
Alan Weinberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Venous Blood ◽  
Small Sample ◽  
Uremic Toxin ◽  
Double Blind

Background. Primary goal of this randomized, double-blind, placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins. Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress.Methods. Two 2-month treatment periods separated by 2-month washout and crossover, with physical examinations, venous blood testing, and quality of life questionnaires completed at each visit. Data were analyzed with SAS V9.2.Results. 22 subjects (79%) completed the study. Observed trends were as follows (none reaching statistical significance): decline in WBC count(-0.51×109/L,P=0.057)and reductions in levels of C-reactive protein(-8.61 mg/L,P=0.071)and total indoxyl glucuronide(-0.11 mg%,P=0.058). No statistically significant changes were observed in other uremic toxin levels or measures of QOL.Conclusions. Renadyl appeared to be safe to administer to ESRD patients on hemodialysis. Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease. Efficacy could not be confirmed definitively, primarily due to small sample size and low statistical power—further studies are warranted.

Three-year results of phase I retinal gene therapy trial for CNGA3-mutated achromatopsia: results of a non randomised controlled trial

2021 ◽  
pp. bjophthalmol-2021-319067
Author(s):  
Felix Friedrich Reichel ◽  
Stylianos Michalakis ◽  
Barbara Wilhelm ◽  
Ditta Zobor ◽  
Regine Muehlfriedel ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Primary Endpoint ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Small Sample ◽  
Functional Improvement ◽  
Limiting Factor ◽  
Serious Adverse Events

AimsTo determine long-term safety and efficacy outcomes of a subretinal gene therapy for CNGA3-associated achromatopsia. We present data from an open-label, nonrandomised controlled trial (NCT02610582).MethodsDetails of the study design have been previously described. Briefly, nine patients were treated in three escalating dose groups with subretinal AAV8.CNGA3 gene therapy between November 2015 and October 2016. After the first year, patients were seen on a yearly basis. Safety assessment constituted the primary endpoint. On a secondary level, multiple functional tests were carried out to determine efficacy of the therapy.ResultsNo adverse or serious adverse events deemed related to the study drug occurred after year 1. Safety of the therapy, as the primary endpoint of this trial, can, therefore, be confirmed. The functional benefits that were noted in the treated eye at year 1 were persistent throughout the following visits at years 2 and 3. While functional improvement in the treated eye reached statistical significance for some secondary endpoints, for most endpoints, this was not the case when the treated eye was compared with the untreated fellow eye.ConclusionThe results demonstrate a very good safety profile of the therapy even at the highest dose administered. The small sample size limits the statistical power of efficacy analyses. However, trial results inform on the most promising design and endpoints for future clinical trials. Such trials have to determine whether treatment of younger patients results in greater functional gains by avoiding amblyopia as a potential limiting factor.

scholarly journals Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study)

2014 ◽  
Vol 72 (6) ◽  
pp. 411-417 ◽  
Author(s):  
Paulo Caramelli ◽  
Jerson Laks ◽  
André Luis Fernandes Palmini ◽  
Ricardo Nitrini ◽  
Márcia Lorena Fagundes Chaves ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sex Education ◽  
Small Sample Size ◽  
Drug Dose ◽  
Small Sample ◽  
Mixed Dementia ◽  
Double Blind ◽  
Cognitive Benefits ◽  
Cognitive Speed

The effects of galantamine (GAL) on quality of life (QoL) and cognitive speed, as well its effects combined with nimodipine (NIM) in Alzheimer disease (AD) with cerebrovascular disease (mixed dementia), have not been explored. Method : Double-blind, placebo-controlled, multicenter Brazilian trial, studying the effects of GAL/NIM vs. GAL/placebo (PLA) in mild to moderate mixed dementia. Patients were randomized to receive GAL/NIM or GAL/PLA for 24 weeks. Primary efficacy measures were changes on a computerized neuropsychological battery (CNTB) and QoL Scale in Alzheimer's Disease (QoL-AD) from baseline to week 24. Results : Twenty-one patients received at least one drug dose (9 GAL/NIM and 12 GAL/PLA). Groups were matched for age, sex, education, cognitive and QoL scores at baseline. No significant differences were observed between groups on primary or secondary measures. QoL and cognitive performance showed significant improvement (p<0.05) from baseline when all GAL-treated patients were analyzed. Adverse events were predominantly mild to moderate. Conclusion : GAL treatment improved QoL in mixed dementia, in addition to its previously known cognitive benefits. The combination GAL/NIM was not advantageous. However, the small sample size precludes any definitive conclusions. Trial registered at ClinicalTrials.gov: NCT00814658

scholarly journals Experimental pilot study after surgery on a food supplement for athletes to protect articular knee cartilage. A functional and biochemical study

2021 ◽  
Vol 38 (3) ◽  
pp. 168-172
Author(s):  
J Alfaro-Adrián ◽  
M Araña Ciordia ◽  
M Barajas Vélez
Keyword(s):  
Quality Of Life ◽  
Biochemical Study ◽  
Small Sample Size ◽  
Arthroscopic Surgery ◽  
Food Supplement ◽  
Small Sample ◽  
Ligamentous Injury ◽  
Sports Activity ◽  
Double Blind

This double-blind experimental study evaluates the efficacy of chondroprotective supplementation (Carticure Plus®, 5000 mg Collagen – Bioactive Peptides, 1500 mg Glucosamine Hydrochloride, 1200 mg Chondroitin Sulfate, 1.1 mg Copper, 80 mg Vitamin C, 2 mg Manganese) in patients with meniscal and ligament pathology who have required arthroscopic surgery. 12 patients with ligamentous injury and 12 patients with meniscopathy were selected, who underwent the measurement of different inflammatory markers using ELISA, collagen 2A and hyaluronic acid, in addition to evaluating pain as well as functionality and quality of life through VAS (Visual Analogue Scale), WOMAC (Western Ontario McMaster Universities Osteoarthritis Index) and KOOS (Knee Injury and Osteoarthritis Outcome Score). Statistically significant differences of clinical improvement were observed in favor of Carticure Plus®, with an improvement in the functional capacity of the WOMAC scale, 76% Carticure Plus® vs 53% placebo, for all patients and with a clear improvement in the first month in meniscal injury, in improvement of the activities of daily life (KOOS), Carticure Plus® 31% vs placebo -1%, sports activity, (Carticure Plus® 41% vs placebo 13,2%) and sports and recreational activities (KOOS) (Carticure Plus® 128% vs Placebo 10,4%). On the other hand, in ligamentous injury an improvement in quality of life (KOOS) Carticure Plus® 75% vs Placebo -8,8% and pain (KOOS) Carticure Plus® 49,6% vs Placebo 0,3% was observed in the first month compared to the baseline. In the patient group, pain (KOOS) Carticure Plus® 31,4% vs Placebo 1,3% and activities of daily living (KOOS) Carticure Plus® 43,9% vs Placebo 27,1% in the third month from baseline, are associated with an improvement due to Carticure Plus® when compared to the placebo group. Despite the small sample size, it is remarkable the fact that statistically significant differences have been found, the efficacy of Carticure Plus® could be assumed.

Safety and Tolerability of Ganoderma lucidum in Healthy Subjects: A Double-Blind Randomized Placebo-Controlled Trial

2007 ◽  
Vol 35 (03) ◽  
pp. 407-414 ◽  
Author(s):  
Sheila M. Wicks ◽  
Robin Tong ◽  
Chong-Zhi Wang ◽  
Michael O'Connor ◽  
Theodore Karrison ◽  
...  
Keyword(s):  
Ganoderma Lucidum ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Blood Chemistry ◽  
Small Sample ◽  
Controlled Study ◽  
Double Blind ◽  
Human Volunteers ◽  
Complete Blood Counts

Ganoderma lucidum is a herbal medicine commonly used in oriental countries as a remedy for treating various medical conditions. In this controlled study, we evaluated the safety and tolerance of oral administration of Ganoderma lucidum in 16 human volunteers who received 2 grams of the extract or placebo twice daily for 10 consecutive days. During the study, information from subjective questionnaires were obtained, electrocardiograms, complete blood counts, blood chemistry analysis and urinalysis were performed. In addition, blood tests reflecting immunity were done. Our data showed that compared to placebo group, no adverse effects were observed after the extract intake. Although there were no obvious changes in CD4, CD8, and CD19 levels after the extract, CD56 cell count increased during the study and returned to baseline 10 days after the herbal intake. However, due to relatively high variability and small sample size, this CD56 increase did not achieve statistical significance, and remains to be re-evaluated in the future. It appears that an additional long-term safety and tolerance trial with herbal dose-escalating design is warranted.

scholarly journals Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

scholarly journals Amelioration of mild and moderate depression through Pranic Healing as adjuvant therapy: randomised double-blind controlled trial

2017 ◽  
Vol 26 (1) ◽  
pp. 82-87 ◽  
Author(s):  
R Rajagopal ◽  
Srikanth N Jois ◽  
Sumanth Mallikarjuna Majgi ◽  
MN Anil Kumar ◽  
HB Shashidhar
Keyword(s):  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Mental Disorder ◽  
Controlled Trial ◽  
Antidepressant Drug ◽  
Double Blind ◽  
Average Decrease ◽  
Moderate Depression ◽  
Post Assessment

Objectives: Depression is a mental disorder, affecting the quality of life. Our study explores the efficacy of Pranic Healing (PH), as an adjuvant therapy in treating depression Methods: In this randomised double-blind controlled trial, 52 participants with a mean age of 34.4 years, with mild to moderate depression were assessed using the Hamilton Depression Rating (HAM-D) scale during the 5-week study. Both Medication + PH (MedPH) and Medication + Mock PH (MedMockPH) groups comprising 26 members received Pranic and mock healing lasting 20 minutes per session respectively once a week for 4 weeks, along with the antidepressant drug. Results: The average decrease in HAM-D score in MedPH was median 11 (Interquartile Range (IQR) 7–12) and was significantly higher compared with the MedMockPH group median 6.5 (IQR 3–9). At pre-assessment, both groups had 8 cases of mild and 18 cases of moderate depression. At post-assessment, HAM-D showed that the improvement in depression category was seen in 69.2% of participants in the MedMockPH group and 100% in MedPH group. Conclusions: These results give first the evidence that PH can aid as an adjuvant therapy for depressed people.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

An initial validation of a new quality of life measure for adults with intellectual disability: The Mini-MANS-LD

2018 ◽  
Vol 24 (2) ◽  
pp. 177-193
Author(s):  
Roman Raczka ◽  
Kate Theodore ◽  
Janice Williams
Keyword(s):  
Quality Of Life ◽  
Intellectual Disability ◽  
Small Sample Size ◽  
Initial Study ◽  
Small Sample ◽  
Self Report ◽  
Life Measure ◽  
Acceptable Internal Consistency ◽  
Report Measure

There is an appropriate increasing focus on the need to ensure the voices of people with intellectual disability are captured as part of assessing individuals’ quality of life; however, there remains a lack of a consensus on ways to achieve this. This article describes the development of a self-report measure of quality of life for people with intellectual disability, the ‘Mini-MANS-LD’, based on the concepts of Maslow’s hierarchy of needs. Following use with 33 individuals with intellectual disability, the Mini-MANS-LD was found to have acceptable psychometric properties, including moderate congruent validity and acceptable internal consistency. Administrators’ feedback suggested good acceptability and feasibility, and the measure was relatively quick to administer, easy to use and acceptable to service users. Despite a small sample size, this initial study suggests that the Mini-MANS-LD may present a conceptually relevant, feasible and acceptable self-report measure of quality of life for people with intellectual disability.

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