scholarly journals Effect of Memantine on Prolonging Safe Driving in Early AD: a Pilot Study

2021 ◽  
Vol 24 (4) ◽  
pp. 292-296
Author(s):  
Peter J. Holland ◽  
Ruth M. Tappen ◽  
David O. Newman ◽  
Katherine C. Freeman-Costin ◽  
Lori J. Fisher
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Pilot Study ◽  
Randomized Trial ◽  
Driving Ability ◽  
Double Blind ◽  
Screening Criteria ◽  
Safe Driving ◽  
Potential Effectiveness ◽  
Test Outcomes

 Background  To determine the feasibility of conducting an RCT on the potential effectiveness of memantine hydrochloride in prolonging safe driving in mild AD.  Methods  A placebo-controlled, double blind randomized trial was conducted. Forty-three individuals ≥60 with mild AD met screening criteria and were randomized. Driving ability was measured by a standardized on-road driving test. Outcomes were driving capacity at 6 and 12 months and completion of the 12-month intervention.  Results  Of 43 participants randomized, 59% of the memantine group and 52% of the placebo group completed the on-road test at 12 months (p = .66). All 13 memantine group participants maintained their driving status at 12 months, whereas only 8 of the 11 placebo group participants did (p = .040, OR = 4.45).  Conclusions  Results provide the framework for designing a rigorous multisite clinical trial of memantine effect on maintaining driving capacity in mild AD. 

Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

2007 ◽  
Vol 28 (9) ◽  
pp. 1036-1043 ◽  
Author(s):  
C. Wendt ◽  
S. Schinke ◽  
M. Württemberger ◽  
K. Oberdorfer ◽  
O. Bock-Hensley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treatment Group ◽  
Solution Treatment ◽  
University Hospital ◽  
Whole Body ◽  
Double Blind ◽  
Antiseptic Solution ◽  
Double Blind Clinical Trial ◽  
Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

scholarly journals Subcutaneous granulocyte colony-stimulating factor administration for subacute traumatic spinal cord injuries, report of neurological and functional outcomes: a double-blind randomized controlled clinical trial

2019 ◽  
Vol 30 (1) ◽  
pp. 19-30 ◽  
Author(s):  
Nazi Derakhshanrad ◽  
Hooshang Saberi ◽  
Mir Saeed Yekaninejad ◽  
Mohammad Taghi Joghataei
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Placebo Group ◽  
Spinal Cord Injuries ◽  
Functional Improvement ◽  
Granulocyte Colony Stimulating Factor ◽  
Double Blind ◽  
Cord Injury ◽  
The Mean ◽  
Stimulating Factor

OBJECTIVEGranulocyte-colony stimulating factor (G-CSF) is a major cytokine that has already been clinically verified for chronic traumatic spinal cord injuries (TSCIs). In this study, the authors set out to determine the safety and efficacy of G-CSF administration for neurological and functional improvement in subacute, incomplete TSCI.METHODSThis phase II/III, prospective, double-blind, placebo-controlled, parallel randomized clinical trial was performed in 60 eligible patients (30 treatment, 30 placebo). Patients with incomplete subacute TSCIs with American Spinal Injury Association Impairment Scale (AIS) grades B, C, and D were enrolled. Patients were assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, Spinal Cord Independence Measure (SCIM-III) and International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), just before intervention and at 1, 3, and 6 months, after 7 daily subcutaneous administrations of 300 μg/day of G-CSF in the treatment group and placebo in the control group.RESULTSAmong 60 participants, 28 patients (93.3%) in the G-CSF group and 26 patients (86.6%) in the placebo group completed the study protocol. After 6 months of follow-up, the AIS grade remained unchanged in the placebo group, while in the G-CSF group 5 patients (45.5%) improved from AIS grade B to C, 5 (45.5%) improved from AIS grade C to grade D, and 1 patient (16.7%) improved from AIS grade D to E. The mean ± SEM change in ISNCSCI motor score in the G-CSF group was 14.9 ± 2.6 points, which was significantly greater than in the placebo group (1.4 ± 0.34 points, p < 0.001). The mean ± SEM light-touch and pinprick sensory scores improved by 8.8 ± 1.9 and 10.7 ± 2.6 points in the G-CSF group, while those in the placebo group improved by 2.5 ± 0.60 and 1.2 ± 0.40 points, (p = 0.005 and 0.002, respectively). Evaluation of functional improvement according to the IANR-SCIFRS instrument revealed significantly more functional improvement in the G-CSF group (10.3 ± 1.3 points than in the placebo group (3.0 ± 0.81 points; p < 0.001). A significant difference was also observed between the 2 groups as measured by the SCIM-III instrument (29.6 ± 4.1 vs 10.3 ± 2.2, p < 0.001).CONCLUSIONSIncomplete subacute TSCI is associated with significant motor, sensory, and functional improvement after administration of G-CSF.Clinical trial registration no.: IRCT201407177441N3 (www.irct.ir)

scholarly journals The efficacy of trimethoprim-sulfamethoxazole treatment in children with acute bloody diarrhea

2007 ◽  
Vol 47 (1) ◽  
pp. 17
Author(s):  
Selvi Nafianti ◽  
Oke R. Ramayani ◽  
Dedy G. Daulay ◽  
Supriatmo Supriatmo ◽  
Berlian Hasibuan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Developing Countries ◽  
Placebo Group ◽  
Campylobacter Jejuni ◽  
Bloody Diarrhea ◽  
Fecal Analysis ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Stool Analysis

Background The etiologies of bloody diarrhea are shigella,amoeba, enterocolitis, trichuriasis, and other causes i.e, EIEC,Campylobacter jejuni or rotavirus. In developing countries,trimetroprim-sulfamethoxazole (TMP-SMP) is effective in 80%of children with bloody diarrhea.Objective To determine the efficacy of trimethoprim-sulfa-methoxazole (TMP-SMX) treatment in children with acute bloodydiarrhea.Methods A randomized double blind clinical trial was conductedin Adam Malik Hospital and Dr. Pirngadi Hospital Medan duringSeptember 2003-March 2004. Children aged 2-24 months oldwith diagnosis of acute bloody diarrhea were randomized into twogroups to either receive TMP-SMX or placebo for 5 days.Microscopic fecal analysis was performed on the first, second,fifth and twelfth day, and the results were compared.Results A total of 68 children consisted of 48 (71%) boys and 20(29%) girls were enrolled. Each group had 34 participants.Analysis of the first day showed leukocyte and erythrocyte in thestool specimens, which were all absent on the twelfth day in bothgroups. There was no difference in stool analysis between TMP-SMX and placebo group in day two (P=0.758), day five (P=0.341)and day twelve. Diarrhea duration in TMP-SMX and placebogroup was 7.18 days and 6.65 days, respectively. This differentwas statistically not significant (P=0.385).Conclusion There is no difference in the efficacy of trimethoprim-sulfamethoxazole treatment compared to placebo in children withacute bloody diarrhea.

scholarly journals A Pilot Randomized Trial of Oral Magnesium Supplementation on Supraventricular Arrhythmias

2017 ◽  
Author(s):  
Pamela L. Lutsey ◽  
Lin Y. Chen ◽  
Anne Eaton ◽  
Melanie Jaeb ◽  
Kyle D. Rudser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Pilot Study ◽  
Randomized Trial ◽  
Magnesium Concentration ◽  
Magnesium Supplementation ◽  
Supplement Group ◽  
Gastrointestinal Problems ◽  
Magnesium Supplement ◽  
Oral Magnesium

AbstractBackgroundMagnesium is believed to have a physiologic role in cardiac contractility, and evidence from epidemiologic and clinical studies has suggested that low serum concentrations of magnesium may be associated with increased risk of atrial fibrillation (AF).ObjectiveAs part of the planning effort for a large randomized trial to prevent AF with magnesium supplementation, we conducted a 12-week pilot study to assess adherence to oral magnesium supplementation and matching placebo, estimate the effect on circulating magnesium concentrations, and evaluate the feasibility of using an ambulatory monitoring device (ZioPatch) for assessing premature atrial contractions (PACs), a predictor of AF.DesignDouble-blind randomized pilot clinical trial comparing supplementation with 400 mg magnesium oxide daily (versus placebo) over 12 weeks of follow-up. The ZioPatch was applied for 14 days at baseline and the end of follow-up. Adherence to the assigned treatment, and changes in PACs, serum magnesium concentration, glucose and blood pressure were assessed.ResultsA total of 59 participants, 73% women and average age 62 years, were randomized. 98% of participants completed follow-up. Those assigned to the magnesium supplement took 75% of tablets as compared to 83% for those in the placebo group. Change in magnesium concentrations was significantly greater for those given magnesium supplement compared to placebo (0.07; 95% confidence interval (CI): 0.03, 0.12 mEq/L; p = 0.002). ZioPatch was worn for an average of 13.0 of the requested 14 days at baseline; at the end of follow-up, the average number of days of monitoring was 13.0 days for the magnesium supplement group and 12.7 days for the placebo group. For log PAC burden (episodes per hour), the average change from baseline was −0.05 (95% CI: −0.31, 0.20) for those randomized to magnesium supplement and 0.04 (95% CI: −0.24, 0.31) for those randomized to placebo (p=0.79 for difference). Gastrointestinal problems were reported by 50% of participants in the magnesium supplement group and 7% in the placebo group. Only one person in the magnesium supplement group and none in the placebo group experienced adverse events which led to treatment discontinuation.ConclusionsIn this pilot randomized clinic trial, although gastrointestinal side effects to the magnesium supplement were common, adherence, measured by pill counts, was very good and, as a consequence, magnesium concentrations were greater for those randomly assigned to the magnesium supplement compared to placebo. Participant acceptance of the planned monitoring with ZioPatch was also very good. While the difference in the change in PACs was not significant, this pilot study was small, short-term, and did not include participants at high risk of AF. Thus, we could not reliably evaluate the effect of magnesium supplementation on PACs.Clinicaltrials.gov registrationNCT02837328

scholarly journals The CANNA-TICS Study Protocol: A Randomized Multi-Center Double-Blind Placebo Controlled Trial to Demonstrate the Efficacy and Safety of Nabiximols in the Treatment of Adults With Chronic Tic Disorders

2020 ◽  
Vol 11 ◽  
Author(s):  
Ewgeni Jakubovski ◽  
Anna Pisarenko ◽  
Carolin Fremer ◽  
Martina Haas ◽  
Marcus May ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alternative Treatment ◽  
Tic Disorders ◽  
Driving Ability ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Psychiatric Comorbidities ◽  
Double Blind Placebo ◽  
Cannabis Extract ◽  
Chronic Tic Disorders

Background: Gilles de la Tourette syndrome (TS) is a chronic neuropsychiatric disorder characterized by motor and vocal tics. First-line treatments for tics are antipsychotics and tic-specific behavioral therapies. However, due to a lack of trained therapists and adverse events of antipsychotic medication many patients seek alternative treatment options including cannabis. Based on the favorable results obtained from case studies on different cannabis-based medicines as well as two small randomized controlled trials using delta-9-tetrahydrocannabinol (THC), we hypothesize that the cannabis extract nabiximols can be regarded as a promising new and safe treatment strategy in TS.Objective: To test in a double blind randomized clinical trial, whether treatment with the cannabis extract nabiximols is superior to placebo in patients with chronic tic disorders.Patients and Methods: This is a multicenter, randomized, double-blind, placebo controlled, parallel-group, phase IIIb trial, which aims to enroll 96 adult patients with chronic tic disorders (TS or chronic motor tic disorder) across 6 centers throughout Germany. Patients will be randomized with a 2:1 ratio into a nabiximols and a placebo arm. The primary efficacy endpoint is defined as tic reduction of at least 30% (compared to baseline) according to the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) after 13 weeks of treatment. In addition, several secondary endpoints will be assessed including changes in different psychiatric comorbidities, quality of life, driving ability, and safety assessments.Discussion: This will be the first large, controlled study investigating efficacy and safety of a cannabis-based medicine in patients with TS. Based on available data using different cannabis-based medicines, we expect not only a reduction of tics, but also an improvement of psychiatric comorbidities. If the cannabis extract nabiximols is proven to be safe and effective, it will be a valuable alternative treatment option. The results of this study will be of high health-economic relevance, because a substantial number of patients uses cannabis (illegally) as self-medication.Conclusion: The CANNA-TICS trial will clarify whether nabiximols is efficacious and safe in the treatment of patients with chronic tic disorders.Clinical Trial Registration: This trial is registered at clinicaltrialsregister.eu (Eudra-CT 2016-000564-42) and clinicaltrials.gov (NCT03087201).

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals Zinc supplementation improves body weight management, inflammatory biomarkers and insulin resistance in individuals with obesity: a randomized, placebo-controlled, double-blind trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Hoda Khorsandi ◽  
Omid Nikpayam ◽  
Reyhaneh Yousefi ◽  
Maryam Parandoosh ◽  
Nima Hosseinzadeh ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Clinical Trial ◽  
Body Weight ◽  
Placebo Group ◽  
Zinc Supplementation ◽  
Energy Requirement ◽  
Anthropometric Measurements ◽  
Model Assessment ◽  
Double Blind ◽  
Calorie Diet

Abstract Background The present study was designed to determine whether zinc supplementation would increase the effects of restricted calorie diet (RCD) on obesity. Methods and materials A randomized, double-blind clinical trial was performed on 40 obese subjects who were randomly assigned to receive zinc supplements (30 mg/day) or placebo for a period of 15-weeks. Both groups were under a restricted calorie diet (~ 300 kcal lower than the estimated energy requirement). Anthropometric measurements, biochemical markers, appetite, and dietary intakes were determined during the study period. Results The reductions of body weight, body mass index, waist circumference, and hip circumference were significantly higher in the zinc group compared to the placebo group (P = 0.032, 0.025, 0.003, and 0.0001, respectively). Lower levels of high sensitivity C-reactive protein, apelin, homeostatic model assessment of insulin resistance (HOMA-IR), and appetite score were observed in the zinc group in comparison with the placebo group (P = 0.0001, 0.001, 0.031 and 0.001 respectively). Conclusion This study indicates that Zn supplementation with a restricted calorie diet has favorable effects in reducing anthropometric measurements, inflammatory markers, insulin resistance and appetite in individuals with obesity, and may play an effective role in the treatment of obesity. Trial registration This clinical trial was registered at clinicaltrials.gov at the U.S. National Library of Medicine (NCT02516475).

A DOUBLE BLIND RANDOMIZED TRIAL OF ORG 10172 LOW MOLECULAR WEIGHT HEPARINOID IN THE PREVENTION OF DEEP VEIN THROMBOSIS IN PATIENTS WITH THROMBOTIC STROKE

1987 ◽  
Author(s):  
A G G Turple ◽  
M N Levin ◽  
J Hirish ◽  
C J Carter ◽  
R M Jay ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Deep Vein Thrombosis ◽  
Placebo Group ◽  
Venous Thrombosis ◽  
Randomized Trial ◽  
Thrombosis Prophylaxis ◽  
Low Molecular Weight ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Deep Vein

The optimal method of venous thrombosis prophylaxis in patients with stroke is uncertain. ORG 10172 is a low molecular weight heparinoid consisting principally of heparan and dermatan sulphates. In animal studies, ORG 10172 is as effective as unfractionated heparin in preventing venous thrombosis but produces less bleeding. There have been a limited number of descriptive studies on its use in humans, but to date randomized efficacy trials of ORG 10172 in the prevention of venous thrombosis have not been reported. A double blind randomized trial was carried out to compare ORG 10172 with placebo in the prevention of deep vein thrombosis in patients with thrombotic stroke. Seventy-five patients were randomized to receive ORG 10172 (50 patients) in a loading dose of 1,000 anti-Xa units intravenously followed by 750 anti-Xa units subcutaneously 12 hourly or placebo (25 patients). Prophylaxis was commenced within 7 days of stroke onset, continued for 14 days or until discharge from hospital, if earlier. Venous thrombosis surveillance was carried out with 125-1 fibrinogen leg scanning and impedance plethysmography. Venous thrombosis was confirmed by venography which occurred in 2 of 50 (4%) in the ORG 10172 group and 7 of 25 (28%) in the placebo group (p=0.005). The corresponding rates for proximal vein thrombosis were 0% and 16%, respectively (p=0.01). There was one major haemorrhage in the treated group and one minor haemorrhage in the placebo group. The anti-factor Xa levels (units/ml; mean ± SE) gradually rose from 0.18 ± 0.001 and 0.06 ± 0.01 six and 12 hours after injection on the first day to 0.24 ± 0.02 and 0.12 ± 0.01 after 11 days treatment. The results of this study indicate that ORG 10172 heparinoid is effective prophylaxis against deep vein thrombosis in patients with acute thrombotic stroke.

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