Subjects In Intervention Group Research Articles

The effect of web-based education on self-care behaviors in cardiovascular patients: application of the pender’s health promotion model

BackgroundCoronary artery disease is the most common cardiovascular disease, the mortality rate of which is increasing significantly. The most important way to prevent a second attack in patients undergoing angioplasty is self-care, which can be influenced by several factors such as the patient’s beliefs. Thus, the present study aimed to determine the effect of a web-based intervention based on the Pender’s health promotion model in patients with cardiovascular disease.MethodsThe present clinical trial study was conducted with 99 patients undergoing angioplasty treatment referring to Bushehr Heart Specialist Center. Random sampling was done and the participants were divided into two groups (50 subjects in intervention group and 49 subjects in control group). The data collection tool was a three-part questionnaire (including demographic information, a researcher-made questionnaire based on the health promotion model constructs, and self-care behaviors), which was completed in three stages (before, two weeks, and three months after the intervention). In addition to routine hospital services, the intervention group received multimedia training based on the constructs of the Pender’s health promotion model from the website. The control group received usual hospital services. Data were analyzed with chi-square, independent T-test and repeated measure ANOVA using SPSS-22 software.ResultsThe results showed that 2 weeks and 3 months after the intervention, the mean scores of perceived benefits, perceived self-efficacy and perceived social support had a significant increase in the intervention group compared to the control group, but the mean score of perceived barriers had a significant decrease in the intervention group (p < 0.001). Regarding self-care behaviors, after the intervention, the mean scores of self-care behaviors, physical activity, healthy diet, medication adherence and stress management had a significant increase in the intervention group compared to the control group (p < 0.001), but no significant was observed between the two groups in terms of changes in the non-smoking (p = 0.38).ConclusionThe results of the study showed that the web-based educational intervention based on the health promotion model is useful in improving the self-care behaviors of cardiac patients undergoing angioplasty. Nursing education and care have a great role in improving the self-care behaviors of cardiovascular patients.Trial registrationRegistration number: IRCT2017080635429N2. Registration date: 09/03/2017 (https://en.irct.ir/trial/26775).

AG-920 (Articaine) Ophthalmic Solution: A Masked, Active-Controlled Evaluation of Its Local Anesthetic Efficacy and Safety in Pediatric Patients.

Purpose: The safety and efficacy of a novel topical ocular anesthetic (AG-920 sterile ophthalmic solution, 8%) was previously evaluated in adults. For both clinical and regulatory purposes, this new agent was evaluated in children. Methods: This was a Phase 3, randomized, active-controlled, single-masked, parallel-group design study in healthy pediatric subjects performed at a private practice retina clinic in the United States. The safety and anesthetic efficacy of AG-920 was compared with proparacainehydrochloride ophthalmic solution 0.5% in 60 children undergoing ophthalmic examinations. The primary efficacy endpoint was whether the investigator was able to perform the eye examination. Results: In all subjects in each treatment group, the investigator was able to perform the eye examination without additional local anesthetic. There were no adverse events reported in this study. In both the study eye and fellow eye, there were no notable changes after dosing, and both treatment groups were similar. All external eye exams in all subjects in both treatment groups were normal. Conclusions: In this pediatric population aged 7 months to >11 years, AG-920 was therapeutically equivalent to marketed proparacaine with respect to having an ophthalmic examination performed without needing additional local anesthetic. Further, AG-920 was well tolerated, and there were no clinically significant safety findings.

549 - Laboratory parameters in adolescent patients aged 12–17 with moderate-to-severe atopic dermatitis treated with tralokinumab up to week 52: results from the phase 3 ECZTRA 6 trial

Abstract Introduction/Background Tralokinumab, a high-affinity, monoclonal antibody that targets IL-13, is approved in the EU and Canada for adolescents (aged ≥12 years) with inadequately controlled moderate-to-severe atopic dermatitis (AD), and it does not require laboratory monitoring. The phase 3 ECZTRA 6 (NCT03526861) clinical trial demonstrated efficacy and safety up to 52 weeks in that population. Objectives To further characterize the safety profile of tralokinumab by evaluating laboratory parameters of adolescents in the ECZTRA 6 trial. Methods ECZTRA 6 subjects received tralokinumab 150mg (n=98), 300mg (n=97) or placebo (n=94) every 2 weeks (Q2W) from week 0–16 after a loading dose at week 0 (twice the subsequent dose), and then randomized to maintenance [original tralokinumab dose either Q2W or every 4 weeks (Q4W) or placebo Q2W] or open-label (tralokinumab 300mg Q2W) until week 52. Laboratory parameters included hematology, serum biochemistry, and urinalysis throughout the trial (weeks 0, 8, 16, 28, and 52). Results Overall (n= 289 subjects), laboratory baseline parameters were similar across treatment groups. Mean and median changes of most hematology parameters showed minor fluctuations within the normal ranges through week 52, except for eosinophils. At baseline, elevated mean eosinophil counts (&amp;gt;0.5 109/L) were observed for 40.8% (tralokinumab 150mg), 48.5% (tralokinumab 300mg), and 43.6% (placebo) of subjects in each respective treatment group. Some tralokinumab-treated patients had small transient increases in eosinophils (maximum mean change from baseline 0.2×109/L) before week 16. Continued treatment with tralokinumab or placebo did not correspond with further increase in eosinophil levels over time, and no adverse events of eosinophilia were reported. Mean levels of most biochemistry parameters, including electrolytes, renal and liver function parameters, and lipid panel, were within normal range at baseline, and mean and median changes showed minor fluctuations within normal ranges in all treatment arms. Mean lactate dehydrogenase levels were around or above the upper limit of normal at baseline and decreased to within the normal ranges during the trial across all groups. Overall, no clinically meaningful differences were observed in hematology, biochemistry, or urinalysis parameters between active treatment groups or placebo. Conclusions Similar to findings in adult trials, no meaningful changes in laboratory parameters were observed in adolescents through week 52 with tralokinumab treatment. No routine laboratory monitoring is needed for adult or adolescent AD patients treated with tralokinumab.

Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial

ObjectiveTo determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus (cCMV(-associated sensorineural hearing loss (SNHL). Study designWe conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at United States (n=12) and United Kingdom (n=9) sites. Patients ages1 month through 3 years with baseline SNHL were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in CMV viral load in blood, saliva, and urine. ResultsOf 54 participants enrolled, 35 were documented to have cCMV infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) versus 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (p= 0.09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome. ConclusionsIn this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with cCMV-associated SNHL.

A study on the impact of Magnesium on the Glycemic regulation

Objectives: The present study was to evaluate the impact of magnesium on glycemic regulation and also evaluate the changes of glycemic control indicators in type 2 diabetes mellitus patients. Methods: A total of 50 subjects aged 30–60 years with the FBS of more than 126 mg/dL who had been recently diagnosed with T2D (maximum one year) and were being treated with antidiabetic drugs were enrolled in the present study. All the subjects were instructed to follow a prescribed diet plan for one week to stabilize their serum glucose level (30% of total energy as fat, 15% of energy as protein, and 55% of energy as carbohydrate-focused, from complex carbohydrates). Both groups were instructed to consume a healthy diet of fruits and vegetables (five serving per day), legumes, nuts and whole grains. The intervention group consisted of 25 participants who were on Mg supplementation for three months. The control group (25 participants) were not received any type of supplement throughout the intervention period. Body weight and height were measured to calculate body mass index (BMI). All measurements and indicators were taken at the base line (Pre) and after three months of intervention (post changes). Results: Mean age group of intervention and control group was not significant (p=0.118). In both group, males were more preponderance than females. When we compared the mean BMI, HbA1C, C-peptide (ng/mL), HOMA.?%, and Mg (mg/dL) between intervention and control group subjects respectively. P-value was found to be 0.512, 0.588, 0.117, 0.606, 0.317, and 0.235 respectively. Mean FBS of interventional group patients was significantly (p=0.011) reduced in post intervention as compared to pre intervention. While in control group, mean FBS was not significant differences (p=0.184). Mean Ca of interventional group subjects was extreme significantly (p&lt;0.0001) decreased in post intervention as compared to preintervention. While in control group subjects, mean Ca was not significantly decreased in post-test as compared to pre-test. In interventional group subjects, mean Mg was highly significantly (p=002) increased in post intervention as compared to pre intervention. While in control group subjects, mean Mg level was extreme significantly (p&lt;0.0001) reduced in post-test as compared to pre-test. Conclusions: Oral magnesium supplement significantly decreases the fasting blood sugar level. And it reduces the insulin resistance and improves the glycaemic control indicators in type 2 diabetes mellitus patients. Key words: Magnesium, glycaemic control indicators, type 2 diabetes mellitus.

Laboratory Parameters in Adolescent Patients Aged 12–17 with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Up to Week 52: Results from the Phase 3 ECZTRA 6 Trial

Introduction: Tralokinumab, a high-affinity, monoclonal antibody that targets IL-13, is approved in the EU and Canada for adolescents (aged ≥12 years) with inadequately controlled moderate-to-severe atopic dermatitis (AD), and it does not require laboratory monitoring. The phase 3 ECZTRA 6 (NCT03526861) clinical trial demonstrated efficacy and safety up to 52 weeks in that population.&#x0D; Objective/Purpose: To further characterize the safety profile of tralokinumab by evaluating laboratory parameters of adolescents in the ECZTRA 6 trial.&#x0D; Methods: ECZTRA 6 subjects received tralokinumab 150mg (n=98), 300mg (n=97) or placebo (n=94) every 2 weeks (Q2W) from week 0–16 after a loading dose at week 0 (twice the subsequent dose), and then randomized to maintenance [original tralokinumab dose either Q2W or every 4 weeks (Q4W) or placebo Q2W] or open-label (tralokinumab 300mg Q2W) until week 52. Laboratory parameters included hematology, serum biochemistry, and urinalysis throughout the trial (weeks 0, 8, 16, 28, and 52).&#x0D; Results: Overall (n= 289 subjects), laboratory baseline parameters were similar across treatment groups. Mean and median changes of most hematology parameters showed minor fluctuations within the normal ranges through week 52, except for eosinophils. At baseline, elevated mean eosinophil counts (&gt;0.5 109/L) were observed for 40.8% (tralokinumab 150mg), 48.5% (tralokinumab 300mg), and 43.6% (placebo) of subjects in each respective treatment group. Some tralokinumab-treated patients had small transient increases in eosinophils (maximum mean change from baseline 0.2×109/L) before week 16. Continued treatment with tralokinumab or placebo did not correspond with further increase in eosinophil levels over time, and no adverse events of eosinophilia were reported. Mean levels of most biochemistry parameters, including electrolytes, renal and liver function parameters, and lipid panel, were within normal range at baseline, and mean and median changes showed minor fluctuations within normal ranges in all treatment arms. Mean lactate dehydrogenase levels were around or above the upper limit of normal at baseline and decreased to within the normal ranges during the trial across all groups. Overall, no clinically meaningful differences were observed in hematology, biochemistry, or urinalysis parameters between active treatment groups or placebo.&#x0D; Conclusions: Similar to findings in adult trials, no meaningful changes in laboratory parameters were observed in adolescents through week 52 with tralokinumab treatment. No routine laboratory monitoring is needed for adult or adolescent AD patients treated with tralokinumab.

Changing electronic use behavior in adolescents while studying: An interventional psychology experiment

In an increasingly technological world, electronic distractions are ubiquitous and make focused studying difficult. Students surround themselves with technology while studying, despite a plethora of evidence that cell phones, television, and social media negatively impact academic performance. Thus, it seems that theoretical knowledge of the negative effects of electronic distraction on academic performance alone is insufficient to change students’ study habits. In this paper, we hypothesized that if high school students observed the change in their academic performance due to electronic distractions, they would be more likely to change their study habits. We conducted an interventional psychology experiment to test the verbal and visual memory of high school students with various distractions present. The students performed these tests while listening to instrumental music, lyrical music, television, or in silence. After the interventions, subjects were asked if they would change their study habits based on their interventions. All students were then surveyed two weeks after the interventions to determine if they had changed their study habits. A higher percentage of the control group changed their habits, but several treatment group subjects were found to have ruminated on their interventions and ultimately changed their habits despite initially not committing to. This prompts further exploration into this method of habit-breaking for students.

Effects of modified hybrid resistance training on dynamic control ratio of knee joint in untrained healthy subjects

Background: Increased physical inactivity due to the COVID-19 pandemic has the potential to cause leg muscle strength decline due to the decrease in muscle mechanical loading. The hybrid training method uses the force generated by an electrically stimulated antagonist muscle to provide resistance to a voluntarily contracting agonist muscle. This exercise might be an effective choice for strengthening exercises during a pandemic because it does not require external resistance or stabilization devices. In addition, engaging the eccentric contraction of the antagonist muscle while the agonist is contracting concentrically may reduce agonist-antagonist muscle imbalance and reduce the risk of injury. Because the hybrid training system device was difficult to replicate, modifications were carried out using conventional stimulation tools. Methods: The research was conducted at the Medical Rehabilitation Installation of Dr. Soetomo General Academic Hospital Surabaya. The research subjects were 24 untrained healthy men aged 18-40 years divided into two groups: the treatment group who received modified hybrid strengthening exercises and the control group who received Russian protocol neuromuscular electrical stimulation (Russian NMES), 3 times per week for 4 weeks. Statistical tests were carried out on 12 treatment group subjects and 12 control group subjects who were able to complete the study. Results: There was a decrease in non-dominant 60o/sec DCR (p-value 0.002) and non-dominant 120o/sec DCR (p-value 0.019) in the treatment group. There was no significant difference in 60o/sec and 120o/sec DCR on both sides of the leg in the control group. There is a significant difference in ΔDCR between the two groups at non-dominant DCR 120o/sec (p-value 0.036). Conclusion: There was a greater reduction of knee joint DCR in the modified hybrid resistance training compared to the Russian NMES in untrained healthy subjects.

Treatment of Chin Retrusion With Botulinum Toxin Plus Hyaluronic Acid Filler in Comparison With Hyaluronic Acid Filler Alone: A Randomized, Evaluator-Blinded, Controlled Study.

Hyaluronic acid (HA) has already been widely administered for chin augmentation. Patients with chin retrusion frequently present with increased chin hypertonia. Monotherapy with HA falls short in addressing the multifaceted cosmetic concerns associated with chin retrusion. This study aimed to investigate the clinical efficacy and safety of the combination therapy involving botulinum toxin (BTX) and HA in the treatment of chin retrusion. We enrolled patients with moderate to severe chin retrusion for 9 months of follow-up after they received either combined treatment with BTX plus HA or monotreatment with HA. We also calculated the surface-volume coefficient with 3-dimensional digital scanning technique, and evaluated outcomes based on the Allergan Chin Retrusion Scale (ACRS), the Global Aesthetic Improvement Scale (GAIS), and treatment-related adverse events (TRAEs). A total of 50 patients were recruited and randomized to the treatment group (BTX plus HA) or control group (HA alone) in a 1:1 ratio. Patients in the treatment group exhibited significantly higher surface-volume coefficients during the first 6 months (P < .05). ACRS scores and responder rates in the 2 groups remained similar throughout the follow-up (P > .05). Within the initial 3 months, the GAIS responder rate in the treatment group was significantly higher than that in the control group (P < .05). Mild TRAEs were observed in both groups, and subsided within 7 days. There was no increase in adverse effects with the combined treatment. In comparison to monotherapy, the combined treatment not only improved the surface-volume coefficient of hyaluronic acid but also achieved similar ACRS scores with less HA volume. Furthermore, the combination treatment yielded superior treatment outcomes for individuals with chin retrusion.

Evaluation of the effectiveness regarding the participation of pharmacists in perioperative blood glucose management via the iGMS: a pilot RCT

BackgroundExcellent blood glucose management is a key guarantee for successful progress of surgery. However, the impact of clinical pharmacists on blood glucose management of perioperative patients needs to be further investigated. To investigate the effectiveness regarding the participation of pharmacists in blood glucose management via the informatized glucose management system (iGMS) on perioperative patients with type 2 diabetes mellitus (T2DM).MethodsThe working mode of clinical pharmacists participating in blood glucose management of perioperative patients with diabetes was constructed. A total of 300 patients with T2DM who underwent elective surgery were recruited and divided into a clinical pharmacist management group (intervention group) of 150 patients (94 men and 56 women; mean age: 44.38 ± 14.03 years) and a control group of 150 patients (101 men and 49 women; mean age: 47.85 ± 12.26 years) between September 2019 to April 2020. The outcomes of perioperative blood glucose management, and healthcare indicators such as preoperative waiting time, total hospitalization time, postoperative infection rate and other indicators were analyzed statistically between the two groups.ResultIn the blood glucose management team of the whole hospital, the physicians, clinical pharmacists and nurses of blood glucose management in endocrinology department were the core members, and were responsible for perioperative blood glucose management of the participants in the intervention group. All subjects had lower blood glucose after 3 days of management compared to the time of admission, and blood glucose was significantly lower in the intervention group compared to the control group (P < 0.05). As compared with the control group, subjects in intervention group demonstrated significant differences in outcome measures. The relevant parameters included preoperative blood glucose compliance rate (60.67% vs. 35.33%, P<0.05), preoperative waiting time [(5.27 ± 3.34) vs. (7.45 ± 4.38), P<0.05], length of hospitalization [(11.11 ± 4.56) vs. (14.87 ± 5.39), P<0.05], incidence of hypoglycemia (8.67% vs. 18.00%, P<0.05), incidence of hyperglycemia (32.00% vs. 62.67%, P<0.05) and postoperative infection rate (18.00% vs. 24.67%, P > 0.05).ConclusionThe involvement of clinical pharmacists in blood glucose management utilizing the iGMS can control the blood glucose level of patients with T2DM in the perioperative period more stably and effectively, thereby leading to an improvement in the quality of healthcare.

Potential cardioprotective effects of acetylcholinesterase inhibitors in patients with Alzheimer's disease

Abstract Background In patients with mild to moderate Alzheimer's disease (AD), acetylcholinesterase inhibitors (AChE-I) are commonly employed to improve cognitive function. They increase the amount of acetylcholine (ACh) in the neuronal synapses, but bradycardia, cardiac electrical conduction blocks and hypotension due to muscarinic M2 receptor stimulation are potential side effects. However, whether these "side effects" could play a potential protective effect on cardiovascular (CV) events is not yet well defined. Purpuses To evaluate potential beneficial cardiac effects of AChE-Is in patients with AD, in terms of reduction of major adverse cardiovascular events (MACEs). Methods We conducted a retrospective, monocentric, observational cohort study in patients referred to our hospital. Two groups were considered: the interventional group included AD patients treated with AChE-I. The control group enrolled a cohort of subjects matched for age and comorbidities, recruited between caregivers of intervention group subjects that were cognitively unimpaired and not taking AchE-I. The primary endpoint was a composite of hospitalization for heart failure (HF), non-fatal acute myocardial infarction (AMI), myocardial revascularization, hospitalization for cardiovascular (CV) causes, cardiovascular mortality and occurrence of stroke and/or TIA during total 5 year follow-up period (MACEs). Secondary endpoints were each individual component of the primary end point, total deaths, non-cardiovascular death and incidence of pacemaker implant. Results 221 AD patients treated with AChE-I (91 with Donepezil, 130 with Rivastigmine) were included in intervention group and 221 non-AD patients in control group. Groups were homogeneous in terms of age, gender and main cardiovascular risk factors, except for family history of cardiovascular diseases (CVD), which was more frequent in control group. During a median follow-up of 3.1 years the primary endpoint occurred in 24 patients in intervention group (2.1 per 100 patient-years) compared to 56 patients in the control group (5.0 per 100 patient-years). Therefore, AChE-I therapy resulted a protective factor from primary endpoint (HR 0.48, 95% CI 0.24-0.95; p= 0.036). Even not significant, the difference was mainly driven by myocardial revascularization (3.2% in intervention group vs 6.8% in controls) and hospitalization for heart failure (4.5% in intervention group vs 14.5% in controls). Non-CVD mortality was significantly higher in treatment group (13,6% in intervention group vs 2,7% in controls). No significant difference was observed between groups in terms of other secondary outcomes. Conclusions Among patients with AD, use of AChE-I may be protective for CV outcomes, especially reducing HF hospitalisation and myocardial revascularization.Kaplan-Meier of cumulative MACEsNumber of Event/Years

Real-world effectiveness of an intranasal spray A8G6 antibody cocktail in the post-exposure prophylaxis of COVID-19

Previously, we identified an antibody combination A8G6 that showed promising efficacy in COVID-19 animal models and favorable safety profile in preclinical models as well as in a first-in-human trial. To evaluate the real-word efficacy of A8G6 neutralizing antibody nasal spray in post-exposure prophylaxis of COVID-19, an open-label, non-randomized, two-arm, blank-controlled, investigator-initiated trial was conducted in Chongqing, China (the register number: ChiCTR2200066416). High-risk healthy participants (18–65 years) within 72 h after close contact to COVID-19 patients were recruited and received a three-dose (1.4 mg/dose) A8G6 treatment daily or no treatment (blank control) for 7 consecutive days. SARS-CoV-2 infection occurred in 151/340 (44.4%) subjects in the blank control group and 12/173 (6.9%) subjects in the A8G6 treatment group. The prevention efficacy of the A8G6 treatment within 72 h exposure was calculated to be 84.4% (95% CI: 74.4–90.4%). Moreover, compared to the blank-control group, the time from the SARS-CoV-2 negative to the positive COVID-19 conversion was significantly longer in the AG86 treatment group (mean time: 3.4 days vs 2.6 days, p = 0.019). In the secondary end-point analysis, the A8G6 nasal treatment had no effects on the viral load at baseline SARS-CoV-2 RT-PCR positivity and the time of the negative COVID-19 conversion. Finally, except for 5 participants (3.1%) with general adverse effects, we did not observe any severe adverse effects related to the A8G6 treatment. In this study, the intranasal spray AG86 antibody cocktail showed potent efficacy for prevention of SARS-CoV-2 infection in close contacts of COVID-19 patients.

The Effect of Coffee Consumption on Acute Increased Blood Pressure in Normotensive Teens

Introduction: Caffeine has been known to elevate blood pressure. However, the effect of drinking coffee on blood pressure varied among studies. This study examines the impact of coffee on the acute response of blood pressure in a late adolescent with normal blood pressure. Method: This cross-sectional study with a cross-over design involving 16 male and late female adolescents. The intervention group subjects drank a glass of 200 ml of Robusta coffee (commercial brand), while the control group drank plain water. After a 7-day washout, the intervention group became the control group and vice versa. A paired t-test was applied to evaluate systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after the intervention. The significance was set at p&lt;0.05. Results: SBP and DBP in the control group were unchanged (Δ0.8 and 0.6 mmHg, p=0.237 and 0.584, respectively). SBP and DBP in the intervention group were significantly elevated (Δ8.4 and 8.1 mmHg, p&lt;0.01 and &lt;0.01, respectively). Discussion: Our findings demonstrated that coffee increases SBP and DBP significantly in the late adolescent with normal BP. Increased sympathetic tones and blocking adenosine receptors are suggested to increase BP. However, some limitations were also found, so the results should be interpreted carefully. Conclusion: A 200 ml coffee (Robusta) increased SBP and DBP in late adolescents with normal blood pressure. Keywords: Caffeine - Blood Pressure - Sympathetic Activity - Adenosine Receptor - Phosphodiesterase

Evaluating the effect of educational intervention based on the health belief model on the lifestyle related to premenstrual syndrome and reduction of its symptoms among the first-grade high school girls

IntroductionA healthy lifestyle can reduce the rate and symptoms of premenstrual syndrome. Thus, the present study evaluates the effect of educational intervention based on the Health Belief Model on the lifestyle related to premenstrual syndrome and reduction of its symptoms among the first-grade high school girls.MethodsThis quasi-experimental study was conducted on 80 first-grade high school girls. They were divided into two intervention and control groups (40 people in each group). The data collection tools included the participants’ demographic information questionnaire, premenstrual symptoms screening tool, and a researcher-made questionnaire based on the constructs of the health belief model about PMS and the behaviors reducing its symptoms. Data were collected in two phases (before and three months after the educational intervention) via WhatsApp. Educational sessions were held in the form of four 45-min sessions for intervention group subjects regarding PMS and the behaviors that reduce its symptoms during one month via WhatsApp.ResultsAccording to the results of this study, the mean scores of knowledge about PMS and health belief model constructs (including perceived susceptibility), perceived severity, perceived benefits, perceived self-efficacy, cues to action, lifestyle/behaviors that reduce PMS symptoms) and the percentage of people who did not have PMS symptoms or had a mild type of PMS increased significantly after implementing the educational intervention in the intervention group compared to before the intervention and compared to the control group. Also, the perceived barriers construct score PMS decreased significantly.ConclusionsThe health belief model education focused on a healthy lifestyle was effective in reducing PMS symptoms. It is recommended to use the educational intervention designed in this study, along with other health care in schools and during puberty as an easy, low-cost, and effective intervention.

Moderate-to-high Intensity Group Exercise Improves Function of Stroke Survivors (P12-8.009)

<h3>Objective:</h3> The aim of this study is to investigate the effect and feasibility of moderate-to-high intensity exercise in stroke survivors. <h3>Background:</h3> Post-stroke exercise need to be encouraged to facilitate optimal recovery and to improve both physical and mental health. However, stroke survivors are easily predisposed to sedentary lifestyle due to physical impairment and functional compromise. Moreover, many clinicians as well as patients tend to be discouraged by exercise-related risk of injury of falls or comorbidities. <h3>Design/Methods:</h3> This study is a randomized controlled trial. Subjects were randomly assigned to either intervention or control group. Subjects in intervention group completed 16 sessions of 90-minute moderate-to-high intensity group-based exercise for 8 weeks. Isometric muscle strength and grip strength of the affected and unaffected side, 10 repetition sit-to-stand test (STS10), 60 second sit-to-stand test (STS60), Short Physical Performance Battery (SPPB), multidirectional reach test, Berg’s Balance scale (BBS), 10-meter walk test, 6 minute walk test, Timed-up-and-go test, physiological cost index, Korean version of modified Barthel index, and Korean version of Montreal Cognitive Assessment (MoCA-K) were measured at baseline and postintervention. <h3>Results:</h3> Total 30 stroke survivors were enrolled in the study and 22 were randomized to group-based moderate-to-high exercise and 8 were randomzied to home-based low intensity exercise. Intervention group showed high compliance as well as high attendance rate. Adverse event was only 2 uneventful falls in 1 subject. After 8 weeks of moderate-to-high intensity group exercise, subjects showed significant improvement in isometric muscle strength of hip extensors and knee flexors and grip strength both in affected and unaffected limbs, and isometric muscle strength of affected shoulder abductor. Also, STS60, SPPB, BBS, and MoCA-K were significantly improved in the intervention group after 8-week of moderate-to-high intensity exercise. <h3>Conclusions:</h3> Moderate-to-high intensity group-based exercise is feasible and safe and improves physical and cognitive function of chronic stroke survivors. <b>Disclosure:</b> The institution of Prof. Jung has received research support from National Rehabilitation Center, Ministry of Health and Welfare, South Korea. Miss Cho has nothing to disclose. Mr. Yoon has nothing to disclose.

Co-exposure of iron oxide nanoparticles with glyphosate herbicides in Poecilia reticulata: Fish liver damages is reversible during iron accumulation and elimination period

Iron oxide nanoparticles (IONPs) are advanced materials for water remediation technologies. It is therefore relevant to evaluate the cellular and tissue behavior of fishes in response to IONPs and their associations with agrochemicals such as glyphosate (GLY) and glyphosate-based herbicides (GBHs). Iron accumulation, tissue integrity and lipid distribution in the hepatocytes of Poecilia reticulata (guppy) were investigated in a control group and in groups exposed to soluble iron ions, namely IFe (0.3 mgFe/L), IONPs (0.3 mgFe/L), and IONPs, associated with GLY (0.65 mg/L), GBHs 0.65 mgGLY/L (IONPs + GBH1), and 1.30 mgGLY/L (IONPs + GBH2), for 7, 14, and 21 days, followed by an equal period of postexposure in clean reconstituted water. The results showed that the accumulation of iron was greater in the subjects in the IONP treatment group when compared to that in the Ife group. In addition, the subjects in the mixtures with GBHs had a greater accumulation of iron than those in the IONP + GLY treatment group. Tissue integrity assessments demonstrated an intense accumulation of lipids, formation of necrotic zones and leukocyte infiltrates in all the treated groups, with a greater quantity of lipids in the animals treated with IONP + GLY and IFe. During postexposure, the results indicated an elimination of iron in all treated groups, reaching the same level as the control group, throughout the 21 days postexposure. Thus, the damage caused to animal livers by IONP mixtures is reversible, providing promising results for the development of safe environmental remediation practices using nanoparticles.

MP37-08 PATIENT SATISFACTION AND QUALITY OF LIFE IN A MULTICENTER PROSPECTIVE STUDY OF SINGLE INCISION MINI-SLING (ALTIS®) IN THE MANAGEMENT OF FEMALE STRESS URINARY INCONTINENCE

You have accessJournal of UrologyCME1 Apr 2023MP37-08 PATIENT SATISFACTION AND QUALITY OF LIFE IN A MULTICENTER PROSPECTIVE STUDY OF SINGLE INCISION MINI-SLING (ALTIS®) IN THE MANAGEMENT OF FEMALE STRESS URINARY INCONTINENCE Craig Hanson, Ty Erickson, and Rebecca Mccrery Craig HansonCraig Hanson More articles by this author , Ty EricksonTy Erickson More articles by this author , and Rebecca MccreryRebecca Mccrery More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To compare the non-inferiority of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic sling, including an evaluation of patient satisfaction, improvement in quality of life, return to normal, and pain at 6 months post surgery. METHODS: Prospective, nonrandomized FDA 522 cohort study comparing the Altis SIS to FDA cleared transobturator and/or retropubic slings for the treatment of stress urinary incontinence (SUI) through 36 months. Surgical Satisfaction Questionnaire (SSQ-8) for patient satisfaction at 6 months post surgery, Incontinence Impact Questionnaire (IIQ-7), Urodynamic Distress Inventory (UDI-6), and Visual Analog Scale (VAS) for pain were assessed at baseline and 6 months post surgery. RESULTS: 355 women underwent the sling procedure (Altis n=184 vs Comparator n=171). Subjects in both treatment groups had a high degree of satisfaction with their surgery as indicated on the SSQ-8 at 6 months Altis (n=165) 28.1±4.9 vs Comparator (n=148) 28.7±4.3 (p=0.257). There was no difference in satisfaction between groups in the amount of time to return to daily activities (p=0.877) and return to work (p=0.939). The IIQ-7 at 6 months indicated a trend of improvement in quality of life in both groups, of an average of 50%, with a mean change from baseline Altis (n=164) 50.6±25.3 vs Comparator (n=146) 49.9±27.9 (p=0.816). The UDI-6 at 6 months indicated an improvement in quality of life in both groups with a mean change from baseline Altis (n=164) 40.9±20.2 vs Comparator (n=145) 43.0±22.7 (p=0.387). Dyspareunia, de Novo, related to the procedure and/or device, was similar between groups (Altis 1.6% vs Comparator 1.2%, p=1.00). Pelvic/Urogenital Pain (Groin) was also similar between groups for all events (Altis 6.0% vs Comparator 2.9%, p=0.205). CONCLUSIONS: The patients had a high degree of satisfaction with their surgery and pain decreased similarly following either SIS or standard midurethral slings for treatment of SUI. Improvement in Quality of Life and Return to Normal increased similarly at 6 months following either SIS or Midurethral slings for treatment of SUI. Source of Funding: Coloplast funding for this FDA 522 required comparative trial. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e516 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Craig Hanson More articles by this author Ty Erickson More articles by this author Rebecca Mccrery More articles by this author Expand All Advertisement PDF downloadLoading ...

Needle contact test in auricular acupuncture for shoulder pain and where effective auricular acupoints identified are positioned on the map: A controlled study

Active Points Test on auricle was renamed Needle Contact Test (or NCT), considered an extremely effective method to select most efficient auricle acupoint for Auricular Acupuncture (or AA) therapy. Our aims were to evaluate NCT efficiency as viable diagnostic option to identify the most appropriate AA acupoints to be selected for SupraSpinatus Tendinopathy (SST) associated shoulder pain treatment and to evaluate which auricle area has greater concentration of NCT positive acupoints in subjects with SST shoulder pain, comparing results with available AA ear maps. 45 subjects with SST diagnosis were enrolled. On 30 subjects in treatment group, NCT was performed on acupoints of the auricle shoulder representation areas (i.e., Scaphoid Fossa), while in 15 subjects of control group, NCT was performed on auricle areas not shoulder associated. Statistically significant lower Numeric Pain Rating Scale scores were seen for study group over time and compared to control. A small sample showed statistically significant increase of SST shoulder maximum abduction range of Movements. NCT identified best SST shoulder pain AA acupoints in Scaphoid Fossa (or SF1 and SF2). In conclusion NCT is a viable tool to efficiently identify the best AA acupoints in SST shoulder pain treatment.

The Uniformed Services Constipation Action Plan: An effective tool for the management of children with functional constipation.

To implement and to evaluate the effectiveness of the Uniformed Services Constipation Action Plan (USCAP) in our gastroenterology clinic for children with functional constipation. This implementation science study included toilet-trained subjects aged 4years and older who met the Rome IV criteria for functional constipation. Children were block randomized to receive either the USCAP or control. All clinic functional constipation plans recommended subjects continue pharmacotherapy for 4months. Endpoints measured were clinical outcomes (resolution of functional constipation and achievement of a Pediatric Bristol Stool Form Scale [PBSFS] score of 3 or 4), patient-related outcomes (health-related quality of life [HRQoL] total scale score), and health confidence outcomes (Health Confidence Score [HCS]). Fifty-seven treatment group subjects (44%) received a USCAP (52% male; mean age, 10.9 [4.9] years) compared with 73 controls (56%; 48% male; mean age,10.9 [5.3] years). A PBSFS score of 3 or 4 was achieved by 77% of the treatment group compared with 59% of controls (P=.03). Subjects from the treatment group were more likely than the controls to endorse adherence to the 4-month course of pharmacotherapy (P<.001). Subjects who received a USCAP had greater improvements in HRQoL total scale score by the end of the project (P=.04). The USCAP is a simple, inexpensive tool that has the potential to improve global outcomes for functional constipation in children and should be recommended as standard clinical practice.

Effect of unsaturated fat and protein intake on liver fat in people at risk of unhealthy aging: 1-year results of a randomized controlled trial

BackgroundShort-term trials indicate improvement of intrahepatic lipids (IHLs) and metabolism by dietary protein or unsaturated fatty acids (UFAs) beyond weight loss. ObjectivesWe aimed to assess the effect of a dietary intervention high in protein and UFAs on IHLs and metabolic outcome after 12 mo, as long-term effects of such a combined intervention are unknown. MethodsWithin a 36-mo randomized controlled trial, eligible subjects (aged 50 to 80 y, ≥1 risk factor for unhealthy aging) were randomly assigned to either intervention group (IG) with high intake of mono-/poly-UFAs [15–20 percent of total energy (%E)/10%–15%E, respectively], plant protein (15%–25%E), and fiber (≥30 g/d), or control group [CG, usual care, dietary recommendations of the German Nutrition Society (fat 30%E/carbohydrates 55%E/protein 15%E)]. Stratification criteria were sex, known cardiovascular disease, heart failure, arterial hypertension, type 2 diabetes, and cognitive or physical impairment. Nutritional counseling and supplementation of foods mirroring the intended dietary pattern were performed in the IG. Diet-induced effects on IHLs, analyzed by magnetic resonance spectroscopy, as well as on lipid and glucose metabolism were predefined secondary endpoints. ResultsIHL content was analyzed in 346 subjects without significant alcohol consumption at baseline and in 258 subjects after 12 mo. Adjusted for weight loss, sex, and age, we observed a comparable decline of IHLs in IG and CG (−33.3%; 95% CI: −49.3, −12.3%; n = 128 compared with -21.8%; 95% CI: −39.7, 1.5%; n = 130; P = 0.179), an effect that became significant by comparing adherent IG subjects to adherent CG subjects (−42.1%; 95% CI: −58.1, −20.1%; n = 88 compared with -22.2%; 95% CI: −40.7, 2.0%; n = 121; P = 0.013). Compared with the CG, decline of LDL cholesterol (LDL-C) and total cholesterol (TC) was stronger in the IG (for LDL-C P = 0.019, for TC P = 0.010). Both groups decreased in triglycerides and insulin resistance (P for difference between groups P = 0.799 and P = 0.124, respectively). ConclusionsDiets enriched with protein and UFAs have beneficial long-term effects on liver fat and lipid metabolism in adherent older subjects.This study was registered at the German Clinical Trials Register, https://www.drks.de/drks_web/setLocale_EN.do, DRKS00010049. Am J Clin Nutr 20XX;xx:xx–xx.