scholarly journals The Ineffective Role of Cathodal tDCS in Enhancing the Functional Motor Outcomes in Early Phase of Stroke Rehabilitation: An Experimental Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Augusto Fusco ◽  
Federica Assenza ◽  
Marco Iosa ◽  
Simona Izzo ◽  
Riccardo Altavilla ◽  
...  
Keyword(s):  
Early Phase ◽  
Inpatient Rehabilitation ◽  
Functional Improvement ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Noninvasive Technique ◽  
Subacute Phase ◽  
Cathodal Tdcs ◽  
Manual Force

Transcranial direct current stimulation (tDCS) is a noninvasive technique that could improve the rehabilitation outcomes in stroke, eliciting neuroplastic mechanisms. At the same time conflicting results have been reported in subacute phase of stroke, when neuroplasticity is crucial. The aim of this double-blind, randomized, and sham-controlled study was to determine whether a treatment with cathodal tDCS before the rehabilitative training might augment the final outcomes (upper limb function, hand dexterity and manual force, locomotion, and activities of daily living) in respect of a traditional rehabilitation for a sample of patients affected by ischemic stroke in the subacute phase. An experimental group (cathodal tDCS plus rehabilitation) and a control group (sham tDCS plus rehabilitation) were assessed at the beginning of the protocol, after 10 days of stimulation, after 30 days from ending of stimulation, and at the end of inpatient rehabilitation. Both groups showed significant improvements for all the assessed domains during the rehabilitation, except for the manual force, while no significant differences were demonstrated between groups. These results seem to indicate that the cathodal tDCS, provided in an early phase of stroke, does not lead to a functional improvement. To depict a more comprehensive scenario, further studies are needed.

scholarly journals Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 626
Author(s):  
Ángela Rodríguez-Padilla ◽  
Germán Morales-Martín ◽  
Rocío Pérez-Quintero ◽  
Juan Gómez-Salgado ◽  
Rafael Balongo-García ◽  
...  
Keyword(s):  
Colorectal Carcinoma ◽  
Postoperative Ileus ◽  
Loop Ileostomy ◽  
Bowel Function ◽  
Ileostomy Closure ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Colorectal Cancer Surgery ◽  
Stimulation Of

Loop ileostomy closure after colorectal surgery is often associated with Postoperative ileus, with an incidence between 13–20%. The aim of this study is to evaluate the efficacy and safety of preoperative stimulation of the efferent loop with probiotics prior to ileostomy closure in patients operated on for colorectal carcinoma. For this, a prospective, randomized, double-blind, controlled study is designed. All patients who underwent surgery for colorectal carcinoma with loop ileostomy were included. Randomized and divided into two groups, 34 cases and 35 controls were included in the study. Postoperative ileus, the need for nasogastric tube insertion, the time required to begin tolerating a diet, restoration of bowel function, and duration of hospital stay were evaluated. The incidence of Postoperative ileus was similar in both groups, 9/34 patients stimulated with probiotics and 10/35 in the control group (CG) with a p = 0.192. The comparative analysis showed a direct relationship between Postoperative ileus after oncological surgery and Postoperative ileus after reconstruction surgery, independently of stimulation. Postoperative ileus after closure ileostomy is independent of stimulation of the ileostomy with probiotics through the efferent loop. There seem to be a relationship between Postoperative ileus after reconstruction and the previous existence of Postoperative ileus after colorectal cancer surgery.

CHRONIC ASTHMA IN CHILDHOOD: DOUBLE-BLIND CONTROLLED STUDY OF TREATMENT WITH GAMMA-GLOBULIN

PEDIATRICS ◽  
1958 ◽  
Vol 21 (6) ◽  
pp. 980-993
Author(s):  
Rosalind S. Abernathy ◽  
Edward L. Strem ◽  
Robert A. Good
Keyword(s):  
Gamma Globulin ◽  
Normal Population ◽  
Physical Growth ◽  
Controlled Study ◽  
Control Group ◽  
Chronic Asthma ◽  
Blood Proteins ◽  
Double Blind ◽  
Chemical Determination ◽  
Complete Blood Counts

To evaluate the effect of injections of gamma-globulin upon the course of asthma, observations were made with 22 asthmatic children ranging in age from 1½ to 5½ years. They had suffered from asthma from 1 to 13 years and were selected as subjects because they had not made satisfactory improvement under allergic management over an average of 2.4 years. They were placed in two groups by random assignment, one of which received injections of gamma-globulin. Without knowledge of the treatment being given, one author examined each child at the time of each injection and one month after the last injection. Roentgenograms, vital capacity, complete blood counts and chemical determination of the blood proteins were performed at the initial and final visits. Fifteen of the twenty-two patients improved clinically, eight in the treatment group and seven in the control group. No significant differences between the groups were noted in the amount of asthma, physical growth, hemoglobin value or eosinophilia. The concentration of gamma-globulin in the serum increased in the treated patients. Nevertheless, there was no difference in the incidence of infection in the two groups and in both it was equal to that in a normal population. This double-blind controlled study offers no evidence to support the view that treatment with gamma-globulin has a beneficial effect on the course of chronic asthma in children.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

2018 ◽  
Vol 2018 ◽  
pp. 1-15
Author(s):  
Ranran Chen ◽  
Dianrong Song ◽  
Wei Zhang ◽  
Guanwei Fan ◽  
Yingqiang Zhao ◽  
...  
Keyword(s):  
Drug Withdrawal ◽  
Endometrial Thickness ◽  
Vaginal Epithelium ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vulvovaginal Atrophy ◽  
Normal Ranges ◽  
And Control

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.

Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

1992 ◽  
Vol 17 (1) ◽  
pp. 69-70 ◽  
Author(s):  
M. A. LAMBERT ◽  
R. J. MORTON ◽  
J. P. SLOAN
Keyword(s):  
Local Anaesthetic ◽  
Steroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Controlled Study ◽  
Control Group ◽  
Methylprednisolone Acetate ◽  
Double Blind ◽  
Local Steroid Injection ◽  
Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

scholarly journals 2838. Safety and Immunogenicity of a gp120-CD4 Chimeric Subunit Vaccine: A Phase 1a Randomized Controlled Trial

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S65-S66
Author(s):  
Joel V Chua ◽  
Charles Davis ◽  
Amy Nelson ◽  
Ka Wing J Lam ◽  
Lydiah Mutumbi ◽  
...  
Keyword(s):  
Subunit Vaccine ◽  
Vaccine Development ◽  
Controlled Trial ◽  
Chimeric Protein ◽  
Controlled Study ◽  
Control Group ◽  
Single Chain ◽  
Double Blind ◽  
Humoral Responses ◽  
Hiv 1

Abstract Background A primary challenge for HIV vaccine development is to raise antiviral antibodies capable of recognizing highly variable viral antigens. The full-length single chain (FLSC) gp120-CD4 chimeric protein was designed to present a highly conserved CD4-induced HIV-1 envelope structure that evokes cross-reactive humoral responses (Figure 1). IHV01 is an FLSC subunit vaccine formulated in alum adjuvant. The safety and immunogenicity of IHV01 was evaluated in this first-in-human phase 1a trial. Methods This randomized, double-blind placebo-controlled study involved three dose-escalating cohorts (75 µg, 150 µg, and 300 µg doses). Eligible participants were HIV-1 uninfected healthy volunteers aged 18 to 45 years. Participants in each cohort were block randomized in groups of four in a 3:1 ratio to receive either vaccine or placebo. Intramuscular injections were given on weeks 0, 4, 8, and 24. Participants were followed for an additional 24 weeks after the last immunization. Crossreactive antibody binding titers against diverse HIV envelopes and antigens and specific CD4i epitopes on gp120 were assessed. Results Sixty-five volunteers were enrolled—49 vaccine and 16 placebo. Majority (81%) of vaccinations with IHV01 produced no localized or systemic reactions; no different from the control group. The overall incidence of adverse events (AEs) was not significantly different between groups. Majority (89%) of vaccine-related AEs were mild in severity. The most common vaccine-related AEs were injection site pain (31%), pruritus (10%), and headache (10%). There were no vaccine-related serious AE, discontinuation due to AE, or intercurrent HIV infection. By the final vaccination, all subjects in all cohorts had developed antibodies against IHV01; all placebo recipients were negative. The antibodies induced by IHV01 reacted with envelope antigens from diverse HIV-1 strains (Figure 2). Conclusion IHV01 vaccine was safe, well tolerated, and immunogenic in all doses tested. The vaccine raised broadly reactive humoral responses against multiple gp120 domains, transition state structures, and CD4i epitopes. Disclosures All Authors: No reported Disclosures.

scholarly journals Acupuncture and Postoperative Vomiting in Day-Stay Paediatric Patients

1996 ◽  
Vol 24 (6) ◽  
pp. 674-677 ◽  
Author(s):  
K. L. Schwager ◽  
D. B. Baines ◽  
R. J. Meyer
Keyword(s):  
Adult Population ◽  
Acupuncture Point ◽  
Controlled Study ◽  
Control Group ◽  
Postoperative Vomiting ◽  
Double Blind ◽  
Paediatric Patients ◽  
Transcutaneous Stimulation ◽  
Significant Difference ◽  
Stimulation Of

The stimulation of the acupuncture point P6 has been used to prevent nausea and vomiting in the adult population. It has, however, been subject to limited comparative evaluation in children. We proposed that stimulation of P6 and the analgesic point Li4 would reduce the incidence of postoperative vomiting. Eighty-four unpremedicated paediatric patients having day-stay surgery (circumcision or herniotomy/orchidopexy) were included in a randomized, double-blind, placebo-controlled study of transcutaneous stimulation of P6 and Li4 or no stimulation. The incidence of vomiting was recorded for 24 hours postoperatively. There was no statistically significant difference in total postoperative vomiting in those patients who were stimulated, compared with the control group (P=0.909), or between any group for postoperative vomiting in the recovery ward, day-stay ward or at home. For all groups, vomiting was more common within the first four hours and more likely to occur in the day-stay ward.

The efficacy of multidisciplinary rehabilitation in stable multiple sclerosis patients

2006 ◽  
Vol 12 (2) ◽  
pp. 235-242 ◽  
Author(s):  
L K Storr ◽  
P S Sørensen ◽  
M Ravnborg
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Bodily Pain ◽  
Intervention Group ◽  
Inpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Multidisciplinary Rehabilitation ◽  
Upper Limb Function ◽  
Multiple Sclerosis Patients

Objective To evaluate the short-term efficacy of multidisciplinary, inpatient rehabilitation of multiple sclerosis (MS) patients. Methods A double-blind, randomized, parallel group design was used. The intervention group were offered comprehensive, multidisciplinary inpatient rehabilitation at the Haslev MS Hospital for an average of 35.5 days, while the control group received no treatment related to the study. All patients were examined in their homes twice with a 10-week interval. The rehabilitation of the intervention group started 2-3 weeks after the first examination and ended 2-3 weeks before the second examination. Impairment was assessed by the Multiple Sclerosis Impairment Scale and the Expanded Disability Status Scale. Disability was assessed by means of Guy’s Neurological Disability Scale. Two specific scales were used to assess upper limb function and ambulation: The Nine-Hole Peg Test and timed 10-metre walking. Patients’ own perception of bodily pain, bladder symptoms, spasticity, fatigue, impaired walking and transfers were recorded using visual analogue scales. Finally, quality of life was assessed using the Life Appreciation and Satisfaction Questionnaire and the Functional Assessment in Multiple Sclerosis. Patients Two hundred and thirty-three patients were screened and of those 38 were included for treatment and 52 as controls. Results We found no statistically significant differences between the two groups in any of the outcome measures. Conclusion Although the study was underpowered, the negative outcome exposes the difficulties in quantitative analyses of the efficacy of multidisciplinary rehabilitation, which is liable to confounding factors such as variation in the indication for treatment, in the placebo effect, and in the reliability and responsiveness of the outcome measures.

scholarly journals Efficacy of dexamethasone in reducing the incidence of postoperative sore throat: a double blind randomized study

2018 ◽  
Vol 5 (1) ◽  
pp. 10-15 ◽  
Author(s):  
Sujita Manandhar ◽  
Kishor Manandhar ◽  
Sharad Khakrel
Keyword(s):  
Endotracheal Tube ◽  
Sore Throat ◽  
Randomized Study ◽  
Saline Group ◽  
Controlled Study ◽  
Control Group ◽  
Lower Grade ◽  
Postoperative Sore Throat ◽  
Double Blind ◽  
Dexamethasone Group

Introductions: Postoperative sore throat (POST) is a commonly seen adverse event after general anesthesia with endotracheal intubation. Dexamethasone, a potent corticosteroid with anti-inflammatory action is the most popular steroid studied in this regard with positive results. Methods: This randomized, prospective, double-blinded, placebo-controlled study was conducted on one hundred and ten adult patients of either sex, American Society of Anesthesiologists physical status I & II, undergoing elective surgeries requiring endotracheal tube intubation. After obtaining written informed consent, they were randomly divided into Control (A, n=55) and Dexamethasone (B, n=55) groups and received either an injection of Dexamethasone (Group B) 8 mg intravenously or an equivalent volume of Normal Saline (Group A) just before entering the operating theatre. All the patients received a similar anesthesia with endotracheal tube intubation and at the end of surgery, extubated and transferred to the post-anesthesia care unit. The incidence and severity of sore throat were assessed at 1, 6 and 24 hours post-extubation. Severity of sore throat were graded on a 4 point scale, p <0.05 was considered significant. Results: Incidence of POST in Dexamethasone group was found significantly low compared to the control group up to six hours (p<0.05) but was comparable at 24 hours post extubation. Severity of POST in the study group was of lower grade in compare to control group. Conclusions: Prophylactic intravenous Dexamethasone 8 mg administered to patients undergoing elective surgeries requiring endotracheal tube intubation significantly reduces the incidence and severity of POST up to six hours post-extubation.

Efficacy and safety of prophylaxis with once-weekly BAY 79–4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients

2012 ◽  
Vol 108 (11) ◽  
pp. 913-922 ◽  
Author(s):  
Uri Martinowitz ◽  
Jerzy Windyga ◽  
Giovanni Di Minno ◽  
Andrzej Hellmann ◽  
Ingrid Pabinger ◽  
...  
Keyword(s):  
Controlled Study ◽  
Control Group ◽  
Investigational Drug ◽  
Haemophilia A ◽  
Double Blind ◽  
Investigational Treatment ◽  
Joint Health ◽  
Secondary Endpoints ◽  
Recombinant Fviii ◽  
Randomised Controlled

SummaryThe benefits of prophylaxis of haemophilia A patients regarding joint health and quality-of-life are well established. However, adherence to an up to every-other-day infusion regimen is a barrier to widespread adoption of prophylaxis. BAY 79–4980 is an investigational drug consisting of rFVIII-FS (sucrose-formulated recombinant FVIII) reconstituted with liposome solvent. Previous clinical studies showed extended protection from bleeding after a single injection of BAY 79–4980 (13.3 ± 6.2 days) compared with rFVIII-FS (7.2 ± 1.7 days). The effect of once-a-week prophylaxis with BAY 79–4980 (35 IU/kg) compared with three times-per-week rFVIII-FS (25 IU/kg) in previously treated, severe haemophilia A patients was evaluated in a 52-week, double-blind, two-arm, randomised, controlled study. The primary and secondary endpoints were protection from total bleeds and joint bleeds, respectively. Short- and long-term safety and tolerability of BAY 79–4980 including effects on lipid levels were assessed. A total of 139 and 131 subjects were evaluable for safety and efficacy analyses, respectively. A large difference in efficacy between treatment groups was observed with 72.1% (49/68) in the rFVIII-FS control group demonstrating <9 bleeds/year compared with 38.1% (24/63) of BAY 79–4980-treated subjects. A similar difference was seen in annualised joint bleeds, with 43 subjects (63.2%) in the control group demonstrating <5 joint bleeds/year compared with 24 subjects (38.1%) treated with BAY 79–4980. The distribution of bleeds seven days post-prophylactic treatment with BAY 79–4980 showed that 61% of bleeds occurred after day 4 post dosing. There were no safety concerns identified. The investigational treatment arm was prematurely discontinued due to failure to achieve the primary endpoint.

scholarly journals Comparison of Lignocaine and Esmolol in attenuating cardiovascular response to laryngoscopy and endotracheal intubation

2015 ◽  
Vol 1 (1) ◽  
pp. 29-35
Author(s):  
Anil Shrestha ◽  
Subhash Prasad Acharya ◽  
Roshna Amatya
Keyword(s):  
Blood Pressure ◽  
Tracheal Intubation ◽  
Elective Surgery ◽  
Cardiovascular Response ◽  
Cerebrovascular Disorders ◽  
Study Drug ◽  
Controlled Study ◽  
Saline Control ◽  
Control Group ◽  
Double Blind

Background: Laryngoscopy and tracheal intubation induces cardiovascular stress response characterized by tachycardia and hypertension, which are well tolerated in normotensive individuals but are of greater significance in patients with cardiovascular and cerebrovascular disorders. The quest for an effective suppression of these responses continues.Materials and Methods: A randomized, prospective, double blind, placebo controlled study was conducted in which the efficacy of Lignocaine 1.5 mg/kg and Esmolol 1.5 mg/kg were compared in attenuating the cardiovascular response to laryngoscopy and tracheal intubation in sixty patients undergoing elective surgery under general endotracheal anaesthesia. Patients were divided into three groups receiving Lignocaine, Esmolol or Normal saline (control). Anaesthesia was induced with intravenous Thiopental Sodium 5 mg/kg and intubation was facilitated with Vecuronium 0.12 mg/kg after administering the study drug. Blood pressure and heart rate were compared among the three groups.Results: The increase in Systolic blood pressure was not significant, but Diastolic and Mean Arterial Pressures increased significantly in control group whereas it was attenuated more effectively in Esmolol group (p<0.05) compared to lignocaine group. The increase in HR was significantly lower (p<0.05) in Esmolol group compared with lignocaine and control group.Conclusion: Esmolol is more effective than lignocaine in attenuating cardiovascular response to laryngoscopy and tracheal intubationJournal of Society of Anesthesiologists 2014 1(1): 29-35

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