Effectiveness of Two Moisturizers in the Treatment of Foot Xerosis

2018 ◽  
Vol 108 (6) ◽  
pp. 458-465 ◽  
Author(s):  
Justin C. Parker ◽  
Rolf W. Scharfbillig ◽  
Sara Jones
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Confidence Interval ◽  
Effect Size ◽  
Clinical Care ◽  
Data Entry ◽  
Parallel Design ◽  
Sum Score ◽  
Urea Group ◽  
Mean Differences

Background: Xerosis (dryness) of the foot is commonly encountered in clinical care and can lead to discomfort, pain, and predisposition to infection. Many moisturizing products are available, with little definitive research to recommend any particular formulation. Methods: We compared two commonly prescribed moisturizing products from different ends of the price spectrum (sorbolene and 25% urea cream) for their effectiveness in reducing xerosis signs using the Specified Symptom Sum Score. A randomized clinical trial of parallel design was conducted over 28 days (February–May 2015) on 41 participants with simple xerosis. Participants, therapists, assessors, and data entry personnel were blinded to treatment, and allocation was determined via a randomization table. Results: Thirty-four participants completed the study (19 urea and 15 sorbolene), with one reporting minor adverse effects. There were statistically significant improvements in both groups after 28 days. Mean differences between pre and post scores were 3.50 (95% confidence interval [CI], 2.80 to 4.20) for the urea group and 2.90 (95% CI, 2.00 to 3.80) for the sorbolene group. There was a slightly lower mean posttreatment score in the urea group (1.16; 95% CI, 0.67 to 1.64) than in the sorbolene group (1.80; 95% CI, 1.25 to 2.35), but this difference was not significant (P ≤ .09). Effect size of difference was –0.48 (95% CI, –1.16 to 0.22). Conclusions: In this study, there was no difference between using sorbolene or 25% urea cream to treat symptoms of foot xerosis. A recommendation, therefore, cannot be made based on efficacy alone; however, sorbolene treatments are invariably cheaper than urea-based ones.

Barriers to Deferoxamine Adherence for Adults with Sickle Cell Disease.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3760-3760 ◽  
Author(s):  
Marsha Treadwell ◽  
Jennifer Sung ◽  
Eileen Murray ◽  
Robert Hagar ◽  
Kimberly Major ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sickle Cell Disease ◽  
Adverse Effects ◽  
Iron Overload ◽  
Sickle Cell ◽  
Serum Ferritin ◽  
Chelation Therapy ◽  
Clinical Care ◽  
Cell Disease ◽  
Transfusion Therapy

Abstract Background: The barriers to adherence with chelation therapy for chronically transfused and iron overloaded patients with sickle cell disease (SCD) have been described only anecdotally. Objectives: To describe barriers to home deferoxamine (DFO) administration adherence among adults with SCD. It was hypothesized that barriers would include limited patient education on the importance of chelation and perceived aversiveness of the regimen. Methods: Medical records were reviewed for 189 adult patients seen at a comprehensive sickle cell center. Patients with transfusion induced hemosiderosis, defined as a serum ferritin ≥ 1500 ng/ml, were administered a four item interview asking if iron overload had ever been discussed with them; if they had been informed they were iron over loaded; if chelation therapy had been offered; and if not currently home chelating, why not. Patients not interviewed were deceased (3); unavailable (10); or declined (3). A study coordinator who did not provide clinical care conducted the interviews. Results: 54 of the 189 patients (29%) had a history of intermittent or chronic transfusion, or pheresis. 45 of these patients were iron overloaded. 29 of these patients agreed to complete the interview; 22 (76%) were female. Average age was 41.5 years (range 22.4 – 58.4 years) and average serum ferritin was 4240.8 (range 1547 – 9420). 23 of the 29 patients (79%) reported that their physician or nurse had discussed iron overload and chelation with them. 16 of these (55%) reported that they were currently receiving home DFO therapy. Reasons given for not administering home DFO included: Reason Number (%) “Don’t want to stick self” 3 (23) No longer being transfused or being exchanged 3 (23) Awaiting clinical trial for oral chelator 2 (15) Home situation too complex 2 (15) Don’t want to (no further explanation) 2 (15) Too many adverse effects 1 (8) Discussion: Life threatening levels of iron overload were observed in intermittently transfused adult sickle cell patients. Contrary to expectations, iron overload and its treatment had been discussed with most patients. However, just over half were currently chelating at home. Toxicity of DFO and misunderstanding that iron overload is no longer a problem if chronic transfusion therapy stops are the most common reasons for non-compliance. Repeated patient counseling are essential in order to prevent progressive iron toxicity in sickle cell disease. Reason Number (%) “Don’t want to stick self” 3 (23) No longer being transfused or being exchanged 3 (23) Awaiting clinical trial for oral chelator 2 (15) Home situation too complex 2 (15) Don’t want to (no further explanation) 2 (15) Too many adverse effects 1 (8)

Enasidenib: First Mutant IDH2 Inhibitor for the Treatment of Refractory and Relapsed Acute Myeloid Leukemia

2019 ◽  
Vol 18 (14) ◽  
pp. 1936-1951 ◽  
Author(s):  
Raghav Dogra ◽  
Rohit Bhatia ◽  
Ravi Shankar ◽  
Parveen Bansal ◽  
Ravindra K. Rawal
Keyword(s):  
Clinical Trial ◽  
Bone Marrow ◽  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Adverse Effects ◽  
Blood Cells ◽  
Myeloid Leukemia ◽  
White Blood Cells ◽  
Phase Iii ◽  
Acute Myeloid

Background: Acute myeloid leukemia is the collective name for different types of leukemias of myeloid origin affecting blood and bone marrow. The overproduction of immature myeloblasts (white blood cells) is the characteristic feature of AML, thus flooding the bone marrow and reducing its capacity to produce normal blood cells. USFDA on August 1, 2017, approved a drug named Enasidenib formerly known as AG-221 which is being marketed under the name Idhifa to treat R/R AML with IDH2 mutation. The present review depicts the broad profile of enasidenib including various aspects of chemistry, preclinical, clinical studies, pharmacokinetics, mode of action and toxicity studies. Methods: Various reports and research articles have been referred to summarize different aspects related to chemistry and pharmacokinetics of enasidenib. Clinical data was collected from various recently published clinical reports including clinical trial outcomes. Result: The various findings of enasidenib revealed that it has been designed to allosterically inhibit mutated IDH2 to treat R/R AML patients. It has also presented good safety and efficacy profile along with 9.3 months overall survival rates of patients in which disease has relapsed. The drug is still under study either in combination or solely to treat hematological malignancies. Molecular modeling studies revealed that enasidenib binds to its target through hydrophobic interaction and hydrogen bonding inside the binding pocket. Enasidenib is found to be associated with certain adverse effects like elevated bilirubin level, diarrhea, differentiation syndrome, decreased potassium and calcium levels, etc. Conclusion: Enasidenib or AG-221was introduced by FDA as an anticancer agent which was developed as a first in class, a selective allosteric inhibitor of the tumor target i.e. IDH2 for Relapsed or Refractory AML. Phase 1/2 clinical trial of Enasidenib resulted in the overall survival rate of 40.3% with CR of 19.3%. Phase III trial on the Enasidenib is still under process along with another trial to test its potency against other cell lines. Edasidenib is associated with certain adverse effects, which can be reduced by investigators by designing its newer derivatives on the basis of SAR studies. Hence, it may come in the light as a potent lead entity for anticancer treatment in the coming years.

scholarly journals 4494 Predictors of Reintubation After Cardiac Surgery

2020 ◽  
Vol 4 (s1) ◽  
pp. 50-50
Author(s):  
Robert Edward Freundlich ◽  
Gen Li ◽  
Jonathan P Wanderer ◽  
Frederic T Billings ◽  
Henry Domenico ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
High Risk ◽  
Query Language ◽  
Risk Estimation ◽  
Clinical Care ◽  
Model Development ◽  
Calibration Plot ◽  
Iterative Model ◽  
Strong Candidate

OBJECTIVES/GOALS: We modeled risk of reintubation within 48 hours of cardiac surgery using variables available in the electronic health record (EHR). This model will guide recruitment for a prospective, pragmatic clinical trial entirely embedded within the EHR among those at high risk of reintubation. METHODS/STUDY POPULATION: All adult patients admitted to the cardiac intensive care unit following cardiac surgery involving thoracotomy or sternotomy were eligible for inclusion. Data were obtained from operational and analytical databases integrated into the Epic EHR, as well as institutional and departmental-derived data warehouses, using structured query language. Variables were screened for inclusion in the model based on clinical relevance, availability in the EHR as structured data, and likelihood of timely documentation during routine clinical care, in the hopes of obtaining a maximally-pragmatic model. RESULTS/ANTICIPATED RESULTS: A total of 2325 patients met inclusion criteria between November 2, 2017 and November 2, 2019. Of these patients, 68.4% were male. Median age was 63.0. The primary outcome of reintubation occurred in 112/2325 (4.8%) of patients within 48 hours and 177/2325 (7.6%) at any point in the subsequent hospital encounter. Univariate screening and iterative model development revealed numerous strong candidate predictors (ANOVA plot, figure 1), resulting in a model with acceptable calibration (calibration plot, figure 2), c = 0.666. DISCUSSION/SIGNIFICANCE OF IMPACT: Reintubation is common after cardiac surgery. Risk factors are available in the EHR. We are integrating this model into the EHR to support real-time risk estimation and to recruit and randomize high-risk patients into a clinical trial comparing post-extubation high flow nasal cannula with usual care. CONFLICT OF INTEREST DESCRIPTION: REF has received grant funding and consulting fees from Medtronic for research on inpatient monitoring.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

Effects of electromyographic biofeedback interventions for shoulder pain and function: Systematic review and meta-analysis

2021 ◽  
pp. 026921552199095
Author(s):  
Danilo Harudy Kamonseki ◽  
Letícia Bojikian Calixtre ◽  
Rodrigo Py Gonçalves Barreto ◽  
Paula Rezende Camargo
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Shoulder Pain ◽  
Meta Analysis ◽  
Quality Of Evidence ◽  
Electromyographic Biofeedback ◽  
Mean Differences ◽  
And Function

Objective: To systematically review the effectiveness of electromyographic biofeedback interventions to improve pain and function of patients with shoulder pain. Design: Systematic review of controlled clinical trials. Literature search: Databases (Medline, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and SCOPUS) were searched in December 2020. Study selection criteria: Randomized clinical trials that investigated the effects of electromyographic biofeedback for individuals with shoulder pain. Patient-reported pain and functional outcomes were collected and synthesized. Data synthesis: The level of evidence was synthesized using GRADE and Standardized Mean Differences and 95% confidence interval were calculated using a random-effects inverse variance model for meta-analysis. Results: Five studies were included with a total sample of 272 individuals with shoulder pain. Very-low quality of evidence indicated that electromyographic biofeedback was not superior to control for reducing shoulder pain (standardized mean differences = −0.21, 95% confidence interval: −0.67 to 0.24, P = 0.36). Very-low quality of evidence indicated that electromyographic biofeedback interventions were not superior to control for improving shoulder function (standardized mean differences = −0.11, 95% confidence interval: −0.41 to 0.19, P = 0.48). Conclusion: Electromyographic biofeedback may be not effective for improving shoulder pain and function. However, the limited number of included studies and very low quality of evidence does not support a definitive recommendation about the effectiveness of electromyographic biofeedback to treat individuals with shoulder pain.

scholarly journals Increase in recruitment upon integration of trial into a clinical care pathway: an observational study

2021 ◽  
Vol 8 (1) ◽  
pp. e000967
Author(s):  
Kay Por Yip ◽  
Simon Gompertz ◽  
Catherine Snelson ◽  
Jeremy Willson ◽  
Shyam Madathil ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hospital Admissions ◽  
Care Pathway ◽  
Clinical Care ◽  
Intensive Therapy ◽  
Respiratory Support ◽  
Trial Recruitment ◽  
Recruitment Process ◽  
Support Unit ◽  
Clinical Care Pathway

IntroductionMany respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers.MethodsA respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP.ResultsOn integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence.DiscussionIntegrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.

Clinical Trial Management and Remote Data Entry on the Internet

1999 ◽  
Vol 33 (4) ◽  
pp. 1061-1065 ◽  
Author(s):  
Roberto Scognamillo ◽  
Carlo Strozzi ◽  
Beatrice Vincenzi ◽  
Giuseppe Recchia
Keyword(s):  
Clinical Trial ◽  
Data Entry ◽  
The Internet ◽  
Trial Management ◽  
Clinical Trial Management ◽  
Remote Data

scholarly journals Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

2017 ◽  
Vol 77 (08) ◽  
pp. 870-878 ◽  
Author(s):  
Markus Wallwiener ◽  
Felix Heindl ◽  
Sara Brucker ◽  
Florin-Andrei Taran ◽  
Andreas Hartkopf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Cancer Registry ◽  
Data Entry ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Patient Reported ◽  
Trial Staff ◽  
Breast Cancer Registry

Abstract Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patientsʼ compliance was better with some questionnaires, but others may present difficulties.

Evaluating the effectiveness of interventions to reducing screen time in children: meta-analysis of randomized controlled trials

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Duygu Akçay ◽  
Nuray Barış
Keyword(s):  
Effect Size ◽  
Subgroup Analysis ◽  
Screen Time ◽  
Meta Analysis ◽  
Intervention Group ◽  
Evidence Base ◽  
Control Group ◽  
Content Type ◽  
Mean Differences ◽  
The Impact

Purpose The purpose of this paper is to evaluate the impact of interventions focused on reducing screen time in children. Design/methodology/approach Studies that aim to investigate the effects of interventions aimed at reducing the time spent in front of the screen (i.e. screen time). A Random-effects model was used to calculate the pooled standard mean differences. The outcome was to evaluate the screen time in children in the 0–18 age range. A subgroup analysis was performed to reveal the extent to which the overall effect size varied by subgroups (participant age, duration of intervention and follow). Findings For the outcome, the meta-analysis included 21 studies, and the standard difference in mean change in screen time in the intervention group compared with the control group was −0.16 (95% confidence interval [CI], −0.21 to −0.12) (p < 0.001). The effect size was found to be higher in long-term (=7 months) interventions and follow-ups (p < 0.05). Originality/value Subgroup analysis showed that a significant effect of screen time reduction was observed in studies in which the duration of intervention and follow-up was =7 months. As the evidence base grows, future researchers can contribute to these findings by conducting a more comprehensive analysis of effect modifiers and optimizing interventions to reduce screen time.

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