scholarly journals Brachystemma calycinumD. Don Effectively Reduces the Locomotor Disability in Dogs with Naturally Occurring Osteoarthritis: A Randomized Placebo-Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Maxim Moreau ◽  
Bertrand Lussier ◽  
Jean-Pierre Pelletier ◽  
Johanne Martel-Pelletier ◽  
Christian Bédard ◽  
...  
Keyword(s):  
Locomotor Activity ◽  
Controlled Trial ◽  
Reaction Force ◽  
Locomotor Disability ◽  
Naturally Occurring ◽  
New Information ◽  
Limb Loading ◽  
Whole Plant ◽  
Specific Outcome ◽  
To Receive

Objective. The aim of this randomized placebo-controlled trial was to evaluate the beneficial effect of a whole plant extract ofBrachystemma calycinumD. Don (BCD) in naturally occurring osteoarthritis (OA) in dogs.Methods. Dogs had stifle/hip OA and poor limb loading based on the peak of the vertically oriented ground reaction force (PVF) measured using a force platform. At baseline, PVF and case-specific outcome measure of disability (CSOM) were recorded. Dogs (16 per group) were then assigned to receive BCD (200 mg/kg/day) or a placebo. The PVF was measured at week (W) 3 and W6. Locomotor activity was recorded throughout the study duration using collar-mounted accelerometer, and CSOM was assessed biweekly by the owner.Results. BCD-treated dogs had higher PVF at W3 and W6 when compared to Baseline (P<0.001) and at W6 when compared to placebo-treated dogs (P=0.040). Higher daily duration (P=0.024) and intensity (P=0.012) of locomotor activity were observed in BCD-treated dogs compared to baseline. No significant change was observed in either group for CSOM.Conclusions. Treatment with BCD improved the limb impairment and enhanced the locomotor activity in dogs afflicted by naturally-occurring OA. Those preclinical findings provide interesting and new information about the potential of BCD as an OA therapeutic.

Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

2017 ◽  
Vol 1 (3) ◽  
pp. 117-127
Author(s):  
Yasaman Mansouri ◽  
Yasmin Amir ◽  
Michelle Min ◽  
Raveena Khanna ◽  
Ruiqi Huang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Subcutaneous Administration ◽  
Open Label ◽  
Post Dose ◽  
Subcutaneous Injections ◽  
Pain Scores ◽  
Observational Cohort ◽  
Vas Scores ◽  
Pre Treatment ◽  
To Receive

Background: Adherence to subcutaneous biologic agents for the treatment of psoriasis can be negatively influenced by injection pain.Objective: To explore the differences in injection site pain when patients are pre-treated with heat or cold, versus no pre-treatment prior to administration of a subcutaneous biologic agent.Methods: In an observational cohort study, patients receiving subcutaneous injections of ustekinumab were randomly assigned to receive pretreatment with ice, heat, or no intervention over three visits. Post-dose, patients rated pain on a 100 mm visual analogue scale (VAS).Results: There was an increase in the VAS score for both heat (2.51, P=0.30) and ice (3.33, P=0.16), compared to no intervention. No differences were found between the two intervention groups (-0.83, P=0.73). On average, females had the same VAS scores with ice compared to that of no intervention (-0.12, P=0.97) and a non–significant decrease of 3.29 points (P=0.38) with heat. Males had increased pain scores by 5.65 points (P=0.07) with ice and by 6.39 points (P=0.04) with heat.Limitations: Pain is a subjective measurement and objective quantification is difficult.Conclusions: On average, neither heat nor cold application reliably reduced pain. Our results do not support the application of heat or cold prior to ustekinumab injection.

Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the “ItaVision” Randomized Controlled Trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Manuel Zorzi ◽  
Cesare Hassan ◽  
Jessica Battagello ◽  
Giulio Antonelli ◽  
Maurizio Pantalena ◽  
...  
Keyword(s):  
Screening Program ◽  
Controlled Trial ◽  
Withdrawal Time ◽  
Adenoma Detection ◽  
Organized Screening Program ◽  
Immunochemical Test ◽  
Medical Design ◽  
Standard Colonoscopy ◽  
To Receive ◽  
Screening History

Objective Endocuff Vision (EV, Arc Medical Design Ltd., Leeds, England) has shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicentre study assessed possible benefits and harms of implementing EV in a Faecal Immunochemical Test (FIT)-based screening program. Design Patients undergoing colonoscopy after a FIT+ test were randomised 1:1 to receive colonoscopy with EV or standard colonoscopy, stratified by gender, age, and screening history. Primary outcome was ADR, Secondary outcomes were ADR stratified by endoscopists’ ADR, advanced ADR (AADR), adenoma per colonoscopy (APC), withdrawal time (WT), and adverse events (AE). Results Overall, 1,864 patients were enrolled in 13 centres. After exclusions, 1,813 (males: 53.7%; mean age: 60.1 years) were randomised, 908 in the EV arm and 905 in the control. ADR was significantly higher in the EV arm (47.8% vs 40.8%; RR 1.17, 95%CI 1.06-1.30) with no differences between arms regarding size or morphology. When stratifying for endoscopists’ ADR, only low detectors (ADR< 33.3%) showed a statistically significant ADR increase (EV = 41.1%, 95%CI 35.7-46.7 vs control = 26%, 95%CI 21.3-31.4 . AADR (24.8% vs 20.5%, RR 1.21; 95%CI 1.02-1.43) and APC (0.94 vs. 0.77, p=0.001) were higher in the EV arm. WT and AE were similar between arms. Conclusion EV increased ADR in a FIT-based screening program, supporting a complete exploration of colonic mucosa. Its utility was highest among endoscopists with a low ADR. ClinicalTrial.gov NCT03612674

Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

2020 ◽  
pp. 1-3
Author(s):  
Maximilian Jorczyk
Keyword(s):  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Double Blind ◽  
Mechanically Ventilated ◽  
Before And After ◽  
Anti Inflammatory ◽  
To Receive ◽  
Therapeutic Possibilities ◽  
Inflammatory Effect

<b>Introduction:</b> Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. <b>Objective:</b> The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. <b>Methods:</b> This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for <i>Ureaplasma</i>. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). <b>Results:</b> Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O<sub>2</sub> dependency at 28 days/death in azithromycin-treated patients regardless of the detection of <i>Ureaplasma</i> in blood. <b>Conclusions:</b> Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O<sub>2</sub> dependency at 28 days/death in mechanically ventilated preterm neonates.

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

scholarly journals Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Statistical Power ◽  
Controlled Trial ◽  
Treatment Options ◽  
Cognitive Remediation ◽  
Negative Effects ◽  
Metacognitive Training ◽  
To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

scholarly journals Conceptual and Practical Issues in the Pharmacological Treatment of Brain Injury

1993 ◽  
Vol 4 (3) ◽  
pp. 227-237 ◽  
Author(s):  
Donald G. Stein ◽  
Marylou M. Glasier ◽  
Stuart W. Hoffman
Keyword(s):  
Central Nervous System ◽  
Brain Injury ◽  
Time Course ◽  
Chemical Activity ◽  
Behavioral Testing ◽  
Naturally Occurring ◽  
New Information ◽  
Definition Of ◽  
Injury And Repair ◽  
The Brain

It is only within the last ten years that research on treatment for central nervous system (CNS) recovery after injury has become more focused on the complexities involved in promoting recovery from brain injury when the CNS is viewed as an integrated and dynamic system. There have been major advances in research in recovery over the last decade, including new information on the mechanics and genetics of metabolism and chemical activity, the definition of excitotoxic effects and the discovery that the brain itself secretes complex proteins, peptides and hormones which are capable of directly stimulating the repair of damaged neurons or blocking some of the degenerative processes caused by the injury cascade. Many of these agents, plus other nontoxic naturally occurring substances, are being tested as treatment for brain injury. Further work is needed to determine appropriate combinations of treatments and optimum times of administration with respect to the time course of the CNS disorder. In order to understand the mechanisms that mediate traumatic brain injury and repair, there must be a merging of findings from neurochemical studies with data from intensive behavioral testing.

Auricular Acupuncture for Pre-Exam Anxiety in Medical Students: A Prospective Observational Pilot Investigation

2016 ◽  
Vol 34 (2) ◽  
pp. 90-94 ◽  
Author(s):  
Catharina Klausenitz ◽  
Thomas Hesse ◽  
Henriette Hacker ◽  
Klaus Hahnenkamp ◽  
Taras Usichenko
Keyword(s):  
Medical Students ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Final Analysis ◽  
Auricular Acupuncture ◽  
Before And After ◽  
Pilot Investigation ◽  
Exam Anxiety ◽  
Randomised Controlled ◽  
To Receive

Objective Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. Methods Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students’ recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. Results Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. Conclusions AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.

scholarly journals Effectiveness of Measures to Eradicate Staphylococcus aureus Carriage in Patients with Community-Associated Skin and Soft-Tissue Infections: A Randomized Trial

2011 ◽  
Vol 32 (9) ◽  
pp. 872-880 ◽  
Author(s):  
Stephanie A. Fritz ◽  
Bernard C. Camins ◽  
Kimberly A. Eisenstein ◽  
Joseph M. Fritz ◽  
Emma K. Epplin ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Soft Tissue ◽  
Controlled Trial ◽  
Control Group ◽  
Open Label ◽  
Intention To Treat ◽  
Intranasal Mupirocin ◽  
Mupirocin Ointment ◽  
Hygiene Education ◽  
To Receive

Background.Despite a paucity of evidence, decolonization measures are prescribed for outpatients with recurrent Staphylococcus aureus skin and soft-tissue infection (SSTI).Objective.Compare the effectiveness of 4 regimens for eradicating S. aureus carriage.Design.Open-label, randomized controlled trial. Colonization status and recurrent SSTI were ascertained at 1 and 4 months.Setting.Barnes-Jewish and St. Louis Children's Hospitals, St. Louis, Missouri, 2007–2009.Participants.Three hundred patients with community-onset SSTI and S. aureus colonization in the nares, axilla, or inguinal folds.Interventions.Participants were randomized to receive no therapeutic intervention (control subjects) or one of three 5-day regimens: 2% mupirocin ointment applied to the nares twice daily, intranasal mupirocin plus daily 4% chlorhexidine body washes, or intranasal mupirocin plus daily dilute bleach water baths.Results.Among 244 participants with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 38% of participants in the education only (control) group, 56% of those in the mupirocin group (P = .03 vs controls), 55% of those in the mupirocin and chlorhexidine group (P = .05), and 63% off those in the mupirocin and bleach group (P = .006). Of 229 participants with 4-month colonization data, eradication rates were 48% in the control group, 56% in the mupirocin only group (P = .40 vs controls), 54% in the mupirocin and chlorhexidine group (P = .51), and 71% in the mupirocin and bleach group (P = .02). At 1 and 4 months, recurrent SSTIs were reported by 20% and 36% of participants, respectively.Conclusions.An inexpensive regimen of dilute bleach baths, intranasal mupirocin, and hygiene education effectively eradicated S. aureus over a 4-month period. High rates of recurrent SSTI suggest that factors other than endogenous colonization are important determinants of infection.Trial Registration.ClinicalTrials.gov identifier: NCT00513799.

Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Yafang Guo ◽  
Hong Lu ◽  
Jing Gan ◽  
Dongdong Li ◽  
Jiandong Gao ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Serum Uric Acid Level ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
To Receive ◽  
Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

Adding a Low Dose of Fentanyl to Propofol in Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Trial

2021 ◽  
Vol 104 (10) ◽  
pp. 1692-1697
Keyword(s):  
Blood Pressure ◽  
Electroconvulsive Therapy ◽  
Low Dose ◽  
Controlled Trial ◽  
Optimal Dose ◽  
Hemodynamic Response ◽  
Mean Difference ◽  
Seizure Duration ◽  
American Society ◽  
To Receive

Objective: To evaluate the effects of low-dose fentanyl combined with a reduced dose of propofol on seizure duration and hemodynamic response during electroconvulsive therapy (ECT). Materials and Methods: Twenty-two patients with the American Society of Anesthesiologist Physical Status II to III undergoing ECT were enrolled in the present study. One hundred and five bilateral ECT sessions randomized to receive thiopental 2 mg/kg, propofol 1 mg/kg, and fentanyl 0.3 mcg/kg, followed by propofol 0.5 mg/kg. Succinylcholine 0.5 mg/kg was used for muscle paralysis. Seizure duration, awakening time and hemodynamic changes were compared between groups. Results: One hundred and five bilateral ECT treatments were randomized into thiopental group (n=35), propofol group (n=35), and fentanyl plus propofol group (n=35). The thiopental and fentanyl plus propofol groups had longer EEG and motor seizure durations than the propofol group, but the differences were not statistically significant. There was no difference in stimulus intensity across groups. However, fentanyl plus propofol group had statistically significant prolonged awakening time compare with thiopental group [mean difference 2.71, (95% CI 0.37 to 5.06, p=0.019)] and propofol group (mean difference 2.77, 95% CI 0.42 to 5.12, p=0.016). Only systolic blood pressure in propofol group was significantly lower than thiopental group [mean difference –10.4, (95% CI –19.4 to –1.38, p=0.018)]. There were no significant differences in diastolic blood pressure (df=2, F=2.546, p=0.083), heart rate (df=2, F=0.596, p=0.553), or oxygen saturation across group (df=2, F=2.914, p=0.059). Conclusion: Using a combination of low-dose fentanyl and low-dose propofol during ECT could be beneficial. Further investigation is needed to establish the optimal dose of propofol and fentanyl. Keywords: Electroconvulsive therapy; Fentanyl, Hemodynamic response; Propofol; Thiopental; Seizure duration

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