Clinical Trial Study Research Articles

Dietary fat quality indices and risk of pre-diabetes and type 2 diabetes mellitus: Tehran Lipid and Glucose Study.

To assess associations between dietary fat quality indices (FQI) and risk of pre-diabetes and type 2 diabetes mellitus (T2DM) among Iranian adults. Daily intakes of fatty acids were estimated using a validated food frequency questionnaire with 168 food item. Adjusted hazard Ratios (HRs) and 95% confidence intervals (CIs) of pre-diabetes and T2DM were calculated in tertile categories of dietary FQI including atherogenic index (AI), thrombogenic index (TI), health promoting index (HPI), ratio of poly-unsaturated fatty acids to saturated fatty acids (PUFA/SFA) and ratio of hypo and hypercholesterolemia (h/H). Tehran Lipid and Glucose Study. Iranian men and women. Mean (±SD) age of the 2042 pre-diabetes-free participants in pre-diabetes analysis was 38.84 (12.97), and 55.2% were women. In T2DM analysis, mean (±SD) age of the 2295 T2DM-free participants was 40.06 (13.42), and 54.6% of them were women. In the crude model, PUFA/SFA ratio was positively associated with T2DM incidence (HR=1.43, 95% CI: 1.04-1.98). However, after adjustment for confounding variables, there were no significant associations between dietary FQI and risk of pre-diabetes and T2DM. We found no significant association between FQI and risk of pre-diabetes and T2DM. Further prospective and clinical trial studies are needed to clarify the issue.

Comparison Effect of Clonidine and Magnesium Sulfate on Bleeding Volume during Septorhinoplasty: A Double-Blind, Randomized Clinical Trial

Background: Control of hemodynamic changes and blood loss is a daily challenge in general anesthesia for patients undergoing septorhinoplasty. This study aimed to evaluate the effects of magnesium sulfate and clonidine on the control of hemodynamic factors and bleeding volume during this procedure. Methods: This double-blind, randomized clinical trial study was conducted on 60 patients undergoing septorhinoplasty at 5th Azar Medical & Educational Centre of Gorgan in 2021-2022. Patients were divided into two intervention groups (50 mg/kg of magnesium sulfate) and control group (5 μg/kg of clonidine) with permutation random block allocation. All patients underwent induced hypotension. Before induction of anesthesia and every 5 minutes afterwards, blood pressure was recorded. Blood loss volume was calculated at the end of the surgery. Results: In the magnesium group, 36 individuals were evaluated, while in the clonidine group, 24 individuals were examined. There were no statistically significant differences in baseline characteristics of patients in the two groups and the duration of surgery. Both drugs were equally effective in inducing hypotension, however blood pressure changes in magnesium group were more trivial than clonidine group. The bleeding volume in the magnesium sulfate and clonidine groups was 139.44 ml and 141.25, respectively and this difference was not statistically significant (p-value=0.634). Conclusion: The results of this study showed that magnesium sulfate can be effectively used as an alternative to clonidine in controlling hemodynamic changes and ultimately reducing blood loss volume during septorhinoplasty surgery. In addition, magnesium is at least as effective as clonidine in stabilizing hemodynamic changes.

The effect of computer-based Stress Inoculation Training (SIT) approach on the pelvic pain, depression, and anxiety in students with primary dysmenorrhea: a clinical trial study

BackgroundPrimary dysmenorrhea (PD) is one of the most common pains experienced by women. Stress Inoculation Training (SIT) is a cognitive-behavioral technique that immunizes them against future periods of stress. The purpose of this research is to investigate the effectiveness of a computer-based stress inoculation approach on pelvic pain, depression, and anxiety symptoms in students with PD.MethodsThe present study is a clinical trial conducted on 100 students with PD. The SIT intervention consisted of eight consecutive sessions. The content of the sessions was created as multimedia on a computer platform of a site. In each session, several interactive questions were asked about the topics of that session, and participants answered them, with responses recorded in the system. Then, each individual session, lasting about 50 min, was sent as a link (offline) to a participant. Data collection tools included the demographics Checklist, McGill Pain Questionnaire (MPQ), Moos Menstrual Distress Questionnaire (MMDQ), Hospital Anxiety and Depression Scale (HADS), Pain Self-Efficacy Questionnaire (PSEQ), and Perceived Stress Scale (PSS-14), which were completed on the second menstrual day of the cycle before the study and for three consecutive cycles after the intervention by each student. The data were analyzed using chi-square, generalized linear mixed models (GLMM), and multiple linear regression tests. The significance level was set at P < 0.05.ResultsThe results of the GLMM test showed that the SIT intervention decreased depression (p = 0.002), anxiety (p = 0.001), menstrual distress (p = 0.001), pain intensity (p = 0.003), and perceived stress (p = 0.002), while it increased pain self-efficacy (p = 0.001). Based on multiple linear regression analysis, the main predictors of depression were the student’s age and residence in a dormitory (β=-0.255, p = 0.047 and β=-0.376, p = 0.005, respectively). The factors influencing pain self-efficacy were birth rank and the type of university admission (β=-0.351, p = 0.027 and β=-0.249, p = 0.030, respectively). In the presence of confounding variables, increasing age and living in a dormitory were risk factors that increased depression, while studying with tuition fees and a higher birth rank were associated with decreased self-efficacy.ConclusionThe computer-based SIT was effective in reducing pelvic pain, and psychological factors, and in increasing pain self-efficacy in students with primary dysmenorrhea. Therefore, it can be used as a useful solution to manage complications associated with primary dysmenorrhea.Trial registrationIRCT20230130057274N5Date of registration: 2024-04-29Retrospectively registered

Investigating the Effect of Bromelain Capsules on Stress, Anxiety and Depression in Patients with Diabetic Foot Ulcers

Depression and stress are common among individuals with diabetic foot ulcers. The purpose of this study was to find whether bromelain can alleviate these symptoms. This single blind, two-group clinical trial study was conducted in 2023. Eighty people with diabetic foot ulcers in specialised wound clinics of Tehran University of Medical Sciences were selected and randomly assigned to the test and control groups. The test group received capsules containing 500mg of bromelain twice a day for four weeks, and the control group received the same amount and number of placebos. After the intervention, the DASS-21 was completed again by the participants. The mean scores of depression, anxiety and stress of people with diabetic foot ulcers in the test group before taking bromelain were 16.02 ± 1.44, 11.62 ± 1.25 and 13.65 ± 1.81 respectively. After the intervention, they were 10.45 ± 1.44, 7.25 ± 1.17 and 10.80 ±1.72 respectively. The mean of this index in the control group before the intervention was 15.50 ± 3.25, 11.55 ± 3.43 and 13.22 ± 3.33. After the intervention, it reached 15.15 ± 1.87, 12.22 ± 2.15 and 13.17 ± 2.34. There was a statistically significant difference between the mean indices of depression (p=0.00), anxiety (p=-0.02) and stress (p˂0.001) in the test group before and after the intervention. However, this difference in the control group was not significant (p ≥ 0.05). The core of caring for patients with chronic diseases involves using safe and low-complication treatment methods. The study findings show that bromelain capsules can effectively alleviate depression, anxiety and stress. Therefore, it is recommended that healthcare providers, especially nurses, consider using bromelain for patients with diabetes and other acute and chronic diseases.

A natural history study of pediatric patients with early onset of GM1 gangliosidosis, GM2 gangliosidoses, or gaucher disease type 2 (RETRIEVE)

BackgroundThe GM1 and GM2 gangliosidoses and type 2 Gaucher disease (GD2) are inherited lysosomal storage disorders with most cases having symptom onset in infancy and reduced life expectancy. The conditions are rare, and there is therefore a need for accurate and up to date information concerning the disease course and survival to assist in the design of clinical trials. RETRIEVE is a natural history study aiming to: (1) collect data on the survival of patients with early-onset (onset of first neurological manifestation before 24 months of age) GM1, GM2, or GD2; (2) collect data that could constitute a historical control group for future clinical trials; and (3) evaluate whether the conditions can be assessed together in a single interventional clinical trial. Group A included patients who were deceased or with unknown survival status at enrollment and was thus limited to retrospective data. Group B included patients who were alive at enrollment, who were followed prospectively with additional retrospective data collection.ResultsGroup A included 185 patients (60 with GM1, 78 with GM2, and 47 with GD2), and Group B included 40 patients (18 with GM1, 16 with GM2, and 6 with GD2). Mean and median age at diagnosis and age at onset of first neurological manifestation were youngest in patients with GD2 and oldest in patients with GM2 in both groups. In Group A, median (95% CI) survival was 19.0 (18.0, 22.0), 44.0 (37.0, 51.9) and 14.0 (10.0, 16.0) months in patients with GM1, GM2 and GD2, respectively. In Group B, hypotonia was experienced by most patients with GM1 (17/18, 94.4%), and was less common in patients with GM2 (12/16, 75.0%) and GD2 (4/6, 66.7%). Strabismus and splenomegaly were reported in all six patients with GD2.ConclusionsRETRIEVE is one of the largest natural history studies of GM1, GM2, and GD2. Results were generally consistent with the published literature, with differences potentially due to variation in inclusion criteria. The difference in median survival between patients with early-onset GM1, GM2, and GD2 reported in this study suggests that the three diseases should not be pooled for study in clinical trials.

The Effect of Combined Exercises with and Without Blood Flow Restriction and Vitamin D Supplementation on Serum Levels of Alkaline Phosphatase in Elderly Women: A Randomized Clinical Trial Study

The Effect of Combined Exercises with and Without Blood Flow Restriction and Vitamin D Supplementation on Serum Levels of Alkaline Phosphatase in Elderly Women: A Randomized Clinical Trial Study

Comparing the Effect of Poppy Seed Oil Consumption and the Educational Approach on Consumption Based on Bandura Cognitive-Social Theory on Self-Efficacy of Pain Management in the Elderly with Knee Osteoarthritis in Babol City; 2022-2023

Introduction:This study was aimed at comparing the effect of poppy seed consumption and educational approach on how to use Bandura's cognitive-social theory on self-efficacy of elderly pain management with knee osteoarthritis in Babol city; 2022-2023. Methods: This randomized clinical trial study of three parallel and double-blind groups was conducted on 129 elderly people with osteoarthritis of the knee referred to the Babol city pain clinic. The participants were placed in three groups A, B and C using the 6 block randomization method using Excel software. Group A received oil consumption along with training based on the Bandura model , group B received oil without training, and group C as control group received routine treatments. Demographic, PSEQ (pain self efficacy questioner VAS (visual analogue scale) were used to collect data. Ethical considerations were observed. Data was analyzed using SPSS23 statistical software and compared of the primary characteristics of the group Chi-square test was used for qualitative variables and analysis of variance was used for quantitative variables. (If the data does not follow the normal distribution, the non-parametric equivalent of Kruskal-Wallis was used). Results: The elderly were mostly female(102 n, 77.9. No significant difference was observed in the visual score of pain between groups A and B before and 4 weeks after the intervention, before and 8 weeks after the intervention and 4 and 8 weeks after the intervention (P&lt;0.05). However, there were significant differences between groups C and B before and 4 weeks after the intervention and before and 8 weeks after the intervention (P&lt;0.05). There is no significant difference between the PSEQ pain management self-efficacy scores 8 weeks after the implementation of the intervention between groups A and B (P = 0.331). But a significant difference was observed between groups A and C (P=0.001). Conclusion: The results of the present study showed that the consumption of poppy seed oil alone can improve pain and self-efficacy in pain management. Using Bandura's learning theory produces little change in pain and pain management self-efficacy. Also, it is necessary to repeat the training program to improve the training effect.

Uterus transplantation: A bibliometric review of six-decade study from 1960 to 2024.

Some women are unable to become pregnant because they do not have a functional uterus. Over the last decade, it has become possible for these women to get pregnant through uterus transplantation, which has been the subject of numerous research studies. Therefore, the purpose of this study is to review published articles in the uterus transplantation area. We conducted a cross-sectional bibliometric review to study the 100 highly cited papers in the Web of Science and Scopus databases from 1960 to 2024. Our research applied bibliometric analysis to these top 100 highly cited papers. Document citation and co-occurrence analysis were used for the data study. VOSviewer along with Bibliometrix® software was used to design the maps. The trend of uterus transplantation publications increased exponentially after 2010. Sweden is the leading country, followed by the USA and Spain. Fertility and Sterility, Lancet, American Journal of Transplantation, and Human Reproduction were the highly cited journals. Collaboration among countries showed that the most collaboration took place between Sweden and Spain (18), Sweden and the USA (14), the USA and Spain (8), Sweden and Australia (6), and the USA and the United Kingdom (6). Furthermore, the results found that more than one-third of the highly cited papers were review papers (39%) and 27% were clinical trial studies. This bibliometric review provides a valuable contribution to the literature on uterine transplantation by synthesizing and analyzing existing research findings. It offers insights into current trends, key themes, geographic distribution, and potential areas for future research within this rapidly evolving field.

Long-term cognitive effects of menopausal hormone therapy: Findings from the KEEPS Continuation Study.

Findings from Kronos Early Estrogen Prevention Study (KEEPS)-Cog trial suggested no cognitive benefit or harm after 48 months of menopausal hormone therapy (mHT) initiated within 3 years of final menstrual period. To clarify the long-term effects of mHT initiated in early postmenopause, the observational KEEPS Continuation Study reevaluated cognition, mood, and neuroimaging effects in participants enrolled in the KEEPS-Cog and its parent study the KEEPS approximately 10 years after trial completion. We hypothesized that women randomized to transdermal estradiol (tE2) during early postmenopause would show cognitive benefits, while oral conjugated equine estrogens (oCEE) would show no effect, compared to placebo over the 10 years following randomization in the KEEPS trial. The KEEPS-Cog (2005-2008) was an ancillary study to the KEEPS (NCT00154180), in which participants were randomized into 3 groups: oCEE (Premarin, 0.45 mg/d), tE2 (Climara, 50 μg/d) both with micronized progesterone (Prometrium, 200 mg/d for 12 d/mo) or placebo pills and patch for 48 months. KEEPS Continuation (2017-2022), an observational, longitudinal cohort study of KEEPS clinical trial, involved recontacting KEEPS participants approximately 10 years after the completion of the 4-year clinical trial to attend in-person research visits. Seven of the original 9 sites participated in the KEEPS Continuation, resulting in 622 women of original 727 being invited to return for a visit, with 299 enrolling across the 7 sites. KEEPS Continuation participants repeated the original KEEPS-Cog test battery which was analyzed using 4 cognitive factor scores and a global cognitive score. Cognitive data from both KEEPS and KEEPS Continuation were available for 275 participants. Latent growth models (LGMs) assessed whether baseline cognition and cognitive changes during KEEPS predicted cognitive performance at follow-up, and whether mHT randomization modified these relationships, adjusting for covariates. Similar health characteristics were observed at KEEPS randomization for KEEPS Continuation participants and nonparticipants (i.e., women not returning for the KEEPS Continuation). The LGM revealed significant associations between intercepts and slopes for cognitive performance across almost all domains, indicating that cognitive factor scores changed over time. Tests assessing the effects of mHT allocation on cognitive slopes during the KEEPS and across all years of follow-up including the KEEPS Continuation visit were all statistically nonsignificant. The KEEPS Continuation study found no long-term cognitive effects of mHT, with baseline cognition and changes during KEEPS being the strongest predictors of later performance. Cross-sectional comparisons confirmed that participants assigned to mHT in KEEPS (oCEE and tE2 groups) performed similarly on cognitive measures to those randomized to placebo, approximately 10 years after completion of the randomized treatments. These findings suggest that mHT poses no long-term cognitive harm; conversely, it provides no cognitive benefit or protective effects against cognitive decline. In these KEEPS Continuation analyses, there were no long-term cognitive effects of short-term exposure to mHT started in early menopause versus placebo. These data provide reassurance about the long-term neurocognitive safety of mHT for symptom management in healthy, recently postmenopausal women, while also suggesting that mHT does not improve or preserve cognitive function in this population.

Efficacy of the maxillary anterior segmental distraction osteogenesis in patients with cleft lip and palate.

Cleft lip and palate (CLP) is one of the most common birth defects worldwide. It typically results in significant maxillary dysplasia, causing severe oral function problems and substantially affecting the patient's facial aesthetics. Maxillary anterior segmental distraction osteogenesis (MASDO) has gained popularity in recent years as an effective treatment for correcting maxillary dysplasia. However, the evaluation of its effectiveness in patients with CLP varies across different studies. Our research was aimed at providing evidence of the effects of MASDO among CLP patients. A meta-analysis covered Medline, Web of Science, Embase, Scopus, and Cochrane Library. Controlled clinical trial studies published before February 2024 and analyzed changes in maxillary cephalometric landmarks before and after MASDO among patients with maxillary hypoplasia and CLP were included. Our meta-analysis included 10 papers in total. One study was at low risk of bias, seven were at medium risk, and two were at serious risk. MASDO significantly increased the maxillary length. The mean SNA angle increased by 6.43° (95% CI, 4.11° to 8.74°) and A-McNamara rose by 7.29mm (95% CI, 6.21mm to 8.37mm). The maxilla also showed a slight counterclockwise rotation; however, this reached no statistical significance. The mandibular position did not vary remarkably. Moreover, a significant increase in upper anterior tooth tipping and overjet, a decrease in overbite, and an improvement in nasolabial soft tissue were observed. MASDO might be a valid therapy option for CLP patients. It causes a significant increase in the maxillary length, anterior tooth crossbite, and nasolabial soft tissue were also greatly improved.

Allergens Causing Allergic Contact Dermatitis in Cosmetic Products: A Systematic Review

Background: The increasing use of cosmetics worldwide has led to a rise in allergic reactions, particularly due to inadequate risk assessment. Identifying common allergens in cosmetic products causing dermatitis is crucial for effective prevention and management strategies. Objectives: This systematic review aims to determine the list of allergens that most commonly cause allergic contact dermatitis in cosmetic products and to find the patch test positivity rate for cosmetic products. Methods: This systematic review, following the PRISMA guidelines, investigated patch test results on cosmetic-induced contact dermatitis from January 2013 to September 2023 on PubMed, Cochrane, and Medline databases. Inclusion criteria comprised retrospective cohort and clinical trial studies reporting patch test positivity rates and positive allergens in cosmetics, with eligibility determined through independent screening, full-text evaluation, and data extraction. Exclusion criteria comprised abstract-only publications, non-English or Indonesian languages, review articles, and studies with incomplete text. Result: 13 studies were included out of 2,162 initially screened articles, involving 111,097 participants. The selected studies encompassed ten retrospective studies and three clinical trials conducted in various locations, including India, Brazil, North America, Korea, Sweden, and the Czech Republic. The patch test positivity rate ranged from 13% to 100%. The predominant allergens identified in cosmetics were nickel sulfate, fragrance mix I, cobalt chloride, para-phenylenediamine base, potassium dichromate, and balsam of Peru. Conclusion: This systematic review highlights the diversity in patch test positivity rates and identifies key allergens responsible for allergic contact dermatitis in cosmetic products, emphasizing the need for comprehensive evaluation and awareness of cosmetic safety.

Combined office-based and home-based orthoptic training in the management of intermittent exotropia in children: a randomized clinical trial

ABSTRACT Purpose: To compare the effect of combinational office-based and home-based orthoptic training regimens with part-time patching in participants with intermittent exotropia. Methods: In a randomized clinical trial study, patients with a diagnosis of IXT were involved and randomly assigned to three groups. Patients in the control group were followed with part-time patch therapy. For the Intervention 1 group, in-office and home-based orthoptic training was prescribed along with playing with a video game software (PIVOT). For Intervention 2 group the same management protocol was incorporated except using the video game software. Evaluation of the control scale and degree of deviation, accommodation, convergence, and stereopsis was performed at baseline and at 1.5 months, 3 months, and 6 months follow-ups. Results: A total of 53 patients (21 males and 32 females) with a mean age of 10.15 ± 3.80 years (range 5–18 years) completed the treatment and follow-up visits. The angle of deviation at distance decreased significantly in all groups (p < .05). No significant reduction of near angle of deviations was found in the control group (p = .38). In the intervention groups, positive fusional vergence (PFV), stereopsis, near point of convergence (NPC), and control scale of deviation at distance improved significantly compared to the control group (all, p < .05). At six months follow-up, patients in the Int 1. group showed significantly increased amplitude of accommodation and positive relative accommodation (PRA) compared to the patients in the Int 2. and control groups (all, p < .05). Conclusion: Compared to part-time patch therapy, orthoptic training is more effective in the management of children with IXT. Using video games as a home-based therapy can improve accommodative abilities in these patients.

Effects on tricuspid regurgitation by different techniques for passing permanent pacemaker leads through the tricuspid valve: a randomized, open-label, superiority clinical trial study protocol

BackgroundIn recent years, lead-induced tricuspid regurgitation (LITR) has attracted increasing attention. At present, there are two commonly used transvalvular methods for pacing lead wires to enter the right ventricle. The first transvalvular approach involves placing the tip of the pacing lead directly through the tricuspid valve into the right ventricle, including “direct-crossing” and “drop-down.” The second transvalvular approach is to bend the pacing lead so that the reflexed lead body crosses the tricuspid valve and then enters the right ventricle, which is “prolapsing.” However, there are no clinical trials to evaluate or compare the effects of the above two different pacing lead transvalvular approaches on tricuspid regurgitation. In this study, we will perform a randomized clinical trial to understand the effect of different transvalvular lead wire transversal techniques on the incidence of tricuspid regurgitation.MethodsThree hundred seventy-six subjects with right ventricular single-chamber pacemaker implantation or dual-chamber pacemaker implantation were recruited in the First Affiliated Hospital of Shantou University Medical College. Participants will be randomized into the direct group (“direct-crossing” and “drop-down”) or the bending group (“prolapsing”). The primary objective will be new tricuspid regurgitation or exacerbation of existing tricuspid regurgitation within 1 year of follow-up.DiscussionThis study aims to verify whether different transvalvular approaches influence the incidence of LITR, and is expected to provide an optimized method for routine pacemaker surgery and improve the long-term prognosis and quality of life of patients.Trial registrationChinese Clinical Trials Registry ChiCTR2100045558. Registered on April 19, 2021.

A comparison of the effects of ENTONOX inhalation and spinal anesthesia on labor pain reduction and apgar score in vaginal delivery: a clinical trial study

A comparison of the effects of ENTONOX inhalation and spinal anesthesia on labor pain reduction and apgar score in vaginal delivery: a clinical trial study

The Effect of Lifestyle Interventions on Anxiety, Depression and Stress: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Depression, anxiety, and stress are common mental health issues that affect individuals worldwide. This systematic review and meta-analysis examined the effectiveness of various lifestyle interventions including physical activity, dietary changes, and sleep hygiene in reducing the symptoms of depression, anxiety, and stress. Using stress as an outcome and conducting detailed subgroup analyses, this study provides novel insights into the differential effects of lifestyle interventions across diverse populations. Five databases were systematically searched: PubMed, Web of Science, Scopus, Cochrane Library, and Google Scholar, for gray literature searches. Keywords were used to search each database. The search period was from the conception of the databases until August 2023 and was conducted in English. For each analysis, Hedges' g was reported with a 95% confidence interval (CI) based on the random-effects method. Subgroups were analyzed and heterogeneity and publication bias were examined. Ninety-six randomized clinical trial studies were included in this meta-analysis. Lifestyle interventions reduced depression (Hedges g -0.21, 95% confidence interval -0.26, -0.15; p < 0.001; I2 = 56.57), anxiety (Hedges g -0.24, 95% confidence interval -0.32, -0.15; p < 0.001; I2 = 59.25), and stress (-0.34, -0.11; p < 0.001; I2 = 61.40). Lifestyle interventions offer a more accessible and cost-effective alternative to traditional treatments and provide targeted benefits for different psychological symptoms.

Use of long-acting injectable cabotegravir/rilpivirine in people with HIV and adherence challenges.

Recent changes in US Department of Health and Human Services and International AIDS Society USA guidelines now endorse use of long-acting injectable cabotegravir and rilpivirine (LA-CAB/RPV) in people with HIV (PWH) who have adherence challenges, including those with viremia. We sought to summarize clinical trial and real-world study data on outcomes and implementation strategies, highlight key unanswered questions, and provide recommendations for best practices. Studies of LA-CAB/RPV in PWH with adherence challenges demonstrate excellent virologic outcomes, although the rate of virologic failure is higher than that in registrational trials conducted in PWH with stable viral suppression. However, viral suppression is attainable on alternate antiretroviral regimen, including those that employ lenacapavir, another long-acting injectable antiretroviral drug, even after virologic failure on LA-CAB/RPV. Successful implementation strategies for long-acting programs include centralized multidisciplinary clinic teams (ideally with pharmacist/pharmacy technician involvement), small incentives to promote patient retention on injections, allowing for drop-in injections, outreach after late injections, and partnerships with home nursing, street medicine, and harm reduction sites. Creating programs that can support PWH with adherence challenges, their providers, and their clinics to use LA-CAB/RPV in service of sustained viral suppression is an urgent priority, particularly for PWH with CD4+ cell count <200 cells/mm3.

A Randomized Controlled Trial on the Effect of Zucchini Seed Oil on Nipple Pain Among Lactating Women

Objective:Nipple pain is one of the most common reasons for early termination of breastfeeding; thus, effective treatment of this condition is very important. Previous studies have proposed the anti-inflammatory and analgesic properties of theCucurbita pepoplant. The present study was conducted to determine the effects ofC. peposeed oil on the severity of nipple pain in lactating women.Methods:In this randomized clinical trial study, 60 lactating women with nipple pain were randomly assigned to either the intervention group (zucchini seed oil) or the control group (breast milk). In the intervention group, 0.5 mL of zucchini seed oil was applied to the nipples and areola three times a day after each breastfeeding session to ensure the absence of an allergy to zucchini compounds. In the control group, three to four drops of breast milk were applied to the nipples and areola after each breastfeeding session. Pain score was recorded using a visual analog scale before the intervention and on the third and eighth day after the intervention. Data analysis was done using the Statistical Software for Social Sciences software (version 24). Apvalue of less than .05 was considered statistically significant.Results:Before the intervention, there was no significant difference between the intervention and control groups with regard to mean pain severity (p= .330). On the third day, the mean pain intensity in the intervention group significantly decreased compared with the control group (p= .023). On the eighth day, the mean pain severity was significantly lower in the intervention group compared with the control group (p= .016).Conclusions:The findings of this study indicate that zucchini seed oil extract was effective in reducing the severity of nipple pain in lactating women. Therefore, use of this oil extract is suggested for treatment of nipple pain in lactating women.

Investigating the Effects of Nintendo Wii on Ankle Spasticity in Patients with Stroke: A Randomized Clinical Trial

Introduction: Stroke is one of the most common causes of disability. Spasticity is a common clinical impairment that occurs after a stroke. This study investigates the effect of Nintendo Wii games on the outcomes of spasticity, functional mobility, and quality of life in patients with stroke. Materials and Methods: In this single-blind clinical trial study, 30 patients with stroke were randomly assigned to one of the experimental and control groups. Subjects of both groups received conventional physiotherapy. In addition, the experimental group also received Nintendo Wii games for 30 min, three times a week for a total of 12 sessions. The primary outcomes spasticity and functional mobility that respectively evaluated using the modified modified Ashworth scale (MMAS) and the timed up-and-go test before and after the treatment. The assessor was blind about group assignment. Meanwhile, the secondary outcome included quality of life. All statistical analyses were performed using the SPSS software, version 20. Results: The intragroup results showed that in the experimental group, spasticity was significantly reduced (P=0.001), functional mobility improved (P=0.001), and the quality of life increased significantly (P&lt;0.001); however, in the control group, only a significant improvement in functional mobility (P=0.04) was observed. The comparison between the two groups showed that there is no statistically significant difference in the results between the experimental and control groups (P&gt;0.05). Conclusion: Considering these results, the use of Nintendo Wii can be suggested as a treatment modality alongside the usual treatments to achieve more and faster effectiveness in patients with stroke.

Protocol for Comparing Benzodiazepine-Ketamine and Benzodiazepine-Fentanyl Sedation in Phacoemulsification (BEKEF): A Double-Blind Crossover Non-Inferiority Clinical Trial Study.

Cataract surgery, particularly phacoemulsification, often requires sedation alongside topical anesthesia to manage patient anxiety and discomfort. This protocol proposes a study comparing the efficacy of ketamine and fentanyl, both combined with benzodiazepine, as sedation options for patients undergoing bilateral phacoemulsification. In a randomized, double-blind, crossover clinical trial, at least 48 patients scheduled for bilateral cataract surgery will receive fentanyl with midazolam for one eye and ketamine with midazolam for the other. Sedation levels will be assessed using the Ramsay Sedation Scale, and the SURG-TLX Scale will measure intraoperative difficulties. Secondary outcomes include anesthesia-related complications, pain scores, and patient satisfaction. The primary outcomes, utilizing the Ramsay Sedation Scale, will determine if ketamine combined with a benzodiazepine is non-inferior to fentanyl combined with a benzodiazepine for sedation during phacoemulsification. Secondary outcomes will provide insight into complications, patient and surgeon comfort, and overall satisfaction. This trial will evaluate whether ketamine offers a safe and effective alternative to fentanyl for sedation in cataract surgery, potentially optimizing sedation protocols to enhance patient and surgeon experiences.

Investigating the effect of Iaraj Fiqra capsule and dry cupping on knee osteoarthritis: A clinical trial study

Background: Knee arthritis is a joint disease caused by the destruction of the underlying cartilage and bone. Common symptoms of this disease are stiffness and pain. Dry cupping and Iaraj Fiqra capsules are used in Persian medicine to treat knee arthritis. Therefore, the present study aimed to assess the effect of the Iaraj Fiqra capsule and dry cupping on arthritis and compare their effects. Materials and Methods: This randomized, single-blind trial was conducted on 61 subjects aged 60 to 69 years old with knee osteoarthritis after obtaining informed consent. Patients were randomly assigned to two groups. One group received 500 mg/day of Iaraj Fiqra capsules for four weeks (n=31), and the other group received dry cupping on the knee for 10 min twice a week for four weeks (n=30). Patients completed the Knee Injury and Osteoarthritis Outcome Score questionnaire, which assessed five areas: pain, symptoms, daily activities, sports and recreation function, and knee-related quality of life, both before and after the study. Independent and paired t-tests, Fisher's exact test, and the Chi-square test were used to evaluate the data in GraphPad software (version 8). Results: The results demonstrated that Iaraj Fiqra capsules and dry cupping for four weeks improved pain (Iaraj Fiqra capsule: before: 92.1±1.3 and after: 73.1±1.4, p=0.002, dry cupping: before: 96.6±2.3 and after: 83.0±3.1; P=0.02), symptoms (Iaraj Fiqra capsule: before: 84.12±3.1 and after: 73.23±1.5; P=0.005, dry cupping: before: 82.11±1.2 and after: 67.31±1.1; P=0.001), daily activities (Iaraj Fiqra capsule: before: 32.22±2.5 and after: 76.21±0.6; P=0.002, dry cupping: before: 34.15±1.4 and after: 72.12±1.2; P=0.001), sports performance (Iaraj Fiqra capsule: before: 92.1±1.3 and after: 73.1±1.4; P=0.002, dry cupping: before: 96.6±2.3 and after: 83.0±3.1; P=0.001,) and recreational (Iaraj Fiqra capsule: before: 24.21±1.2 and after: 68.11±0.5; P=0.002, dry cupping: before: 28.95±1.2 and after: 62.25±2.7; P=0.001), and knee-related quality of life scores (Iaraj Fiqra capsule: before: 31.11±0.6 and after: 82.32±11.4; P=0.002, dry cupping: before: 11.6±33.11 and after: 81.21±1.4; P=0.002). Furthermore, the results demonstrated that the pain score of patients improved significantly compared to the dry cupping group (P&lt;0.05). Conclusion: As evidenced by the obtained results, Iaraj Fiqra capsules and dry cupping can be used to improve the pain, symptoms, daily activities, sports and recreation function, and knee-related quality of life of individuals with knee osteoarthritis.