Clinical Trial Study Research Articles

I Pack Block versus Adductor Canal Block for Post-Operative Pain Management in Total Knee Arthroplasty

Abstract Background Total knee arthroplasty (TKA) is a highly distressful major surgery, with a significant potential for complications, not only because of the surgical and anesthetic impact of the procedure, but also because of the demographic and clinical characteristics of the target population. Careful pain management is necessary post-operative to achieve early post-operative mobilization while ensuring patient comfort throughout and preventing post-operative complications. Objective we aim to compare postoperative pain management and post- operative analgesic consumption between IPACK block and Adductor canal block in total knee arthroplasty cases. Methods After obtaining approval from the medical ethical committee in Ain Shams University, this Prospective randomized controlled double-blind clinical trial study was conducted in the operating theatres of Ain shams University Hospitals. Study period March 2022 to August 2022. Physical status: ASA 1 or 2 and candidates for spinal anaesthesia undergoing total knee arthroplasty. Age group: 40-65 years. Sample sizes of 30 patients in total; 15 in group I (group I) and 15 in group II (group A). Results As for the comparison between effect of IPACK block and Adductor canal block as regard post-operative pain in total knee arthroplasty, it showed that there is significance regarding the numeric version of the visual analogue scale (VAS) that was used to assess postoperative pain and its intensity with range 1-3 for Adductor canal block and 2-4 for IPACK block. Conclusion The comparison between effect of IPACK block and Adductor canal block as regard post-operative pain in total knee arthroplasty showed significant difference regarding the numeric version of the visual analogue scale (VAS) that was used to assess postoperative pain and its intensity with range 1-3 for Adductor canal block and 2-4 for IPACK block. These findings with our study primary and secondary outcomes showed that Adductor canal block has more analgesic effect with respect to IPACK block regarding pain assessment but with no significant difference regarding the by the time till first analgesia postoperative and Total analgesics consumption (in mg.) over 24-hour period post-operative.

Comparison of Cambridge vision stimulator (CAM) therapy with passive occlusion therapy in the management of unilateral amblyopia; a randomized clinical trial

ABSTRACT Introduction There are limited studies on the effectiveness of Cambridge vision stimulator (CAM) therapy as a management strategy in amblyopic patients. In addition, all these studies have a low sample size. The main purpose of this study was to compare the effect of CAM therapy with passive occlusion therapy in the management of unilateral amblyopia. Methods In this randomized clinical trial study, 110 cooperative amblyopic children, who had not been managed previously, were randomly divided into two groups of CAM therapy (n = 55) and passive occlusion therapy (n = 55). In the CAM procedure, five discs with different spatial frequencies (SF) (2, 6, 15, 20, 30 cycles/degree) were presented to the patient (30 minutes a day, twice a week). Plates with SF equal to the two lines better than the measured corrected distance visual acuity (CDVA) were chosen. During the training, the non-amblyopic eye was occluded. The standard occlusion therapy protocols were performed in the occlusion therapy group. The CDVA for all patients was measured at baseline and then at one, two, and three months after the treatment. Results The mean age of patients in CAM and occlusion therapy groups was 7.0 ± 2.1 and 6.9 ± 1.9 years, respectively (p = .721). There was no significant difference in the mean CDVA between CAM and occlusion therapy groups after one (0.30 ± 0.16 vs. 0.25 ± 0.14, p = .079), two (0.15 ± 0.10 vs. 0.15 ± 0.11, p = .732) and three months (0.05 ± 0.08 and 0.05 ± 0.06, p = .919) from baseline. However, the mean amount of CDVA increased significantly in each follow-up in both groups (all p < .001). Regarding the amblyopia type and severity, the mean improvement of CDVA from baseline in the anisometropic patients and in moderate amblyopia was significantly higher in the CAM group than the occlusion group after two and three months (p < .05). Discussion CAM and conventional occlusion therapies significantly improved CDVA in children with amblyopia, and the difference was not significant; therefore, they could be used as alternatives. CAM therapy requires cost and time for the amblyopic patient and parents. Thus, it can be considered as a second treatment option in amblyopic patients, especially anisometropic type and moderate amblyopia, with poor compliance to patching.

Comparing the effect of warmwater footbath with effleurage and petrissage massages on fatigue of patients undergoing hemodialysis

Background: Few comparative studies have been carried out into the effects of nonpharmacological interventions on reducing fatigue in hemodialysis patients. This study compared the effect of warm footbath with effleurage and petrissage massages on fatigue in hemodialysis patients. Materials and Methods: Seventy patients undergoing hemodialysis referring to two dialysis centers in 2016 were included in this clinical trial study. However, 62 hemodialysis patients finally completed the study. The patients were selected through a nonrandom sampling method, but were later assigned to one of the three groups of warmwater footbath, effleurage, and petrissage massages based on randomized blocked allocation. Using a multidimensional inventory, fatigue was assessed before the commencement of the interventions, at the end of the first and the 2nd month of the interventions. The data were analyzed using statistical software of SPSS, version 25, through descriptive statistics by running median and Friedman tests with considering 95% confidence interval. Results: Warmwater footbath, effleurage, and petrissage resulted in a significant reduction or improvement in global fatigue and types of fatigue of patients undergoing hemodialysis at the end of the first and 2nd month of the interventions (P = 0.001). The results of the between-groups comparison showed that there was no significant difference (P &gt; 0.05) in fatigue reduction among the three groups of warmwater footbath, effleurage, and petrissage massages in terms of the median index of fatigue scores. Conclusion: Warmwater footbath, effleurage, and petrissage massages have similar positive effects on fatigue in patients undergoing hemodialysis.

Single-drug Chemotherapy Plus Immunotherapy as First-line Treatment for Stage Ⅳ Non-small Cell Lung Cancer Elderly Patients: A Phase II Clinical Trial UNICORN Study

IntroductionLung cancer remains the most common malignancy and the leading cancer-related death among the elderly in China, which deserves more research attention. Immunotherapy combined with platinum-based doublet chemotherapy has been approved as the standard treatment for advanced non-small cell lung cancer (NSCLC) patients who are devoid of specific gene mutations or fusions. Given that patients with NSCLC over the age of 65 typically exhibit declining organ function and physical condition, they often showed reduced tolerance for this rigorous treatment regimen. However, the KEYNOTE-042 study illuminated a promising pathway: in patients testing positive for programmed death-ligand 1 (PD-L1), immunotherapy alone has demonstrated a superior overall survival (OS) compared to platinum-based doublet chemotherapy. This suggests that moderating the intensity of chemotherapy and prioritizing immunotherapy may be a gentler alternative in elderly demographic. Patients and MethodsThis multicenter phase II clinical trial named UNICORN aimed to enroll 49 patients aged 65 and older, utilizing paclitaxel or nab-paclitaxel for those with squamous NSCLC, and pemetrexed for those diagnosed with lung adenocarcinoma. The treatment protocol entails 4 cycles of serplulimab plus chemotherapy followed by an extended regimen of serplulimab maintenance, spanning a total of 35 cycles. Primary endpoints of this study are progression-free survival (PFS), disease control rate (DCR) and the secondary endpoints are OS, objective control rate (ORR) and safety metrics. ConclusionThis is the first study to evaluate the efficacy and safety of serplulimab combined with either paclitaxel or pemetrexed in elderly treatment-naïve patients with stage IV NSCLC whose PD-L1 are positive.

Non-pharmacological Interventions for Muscle Cramps and Pain in Patients With Cirrhosis: A Systematic Review.

Despite the high prevalence of pain and challenges associated with traditional pharmacological pain management in patients with cirrhosis, little is known about the safety and effectiveness of non-pharmacological management of pain in this patient population. A systematic literature search of published studies was conducted in nine databases from inception through January 11, 2023, including any clinical trial, cohort, or case-control study of non-pharmacological pain interventions in adult patients with cirrhosis. Studies using nutritional supplements were included. The primary and secondary outcomes for this review were pain/analgesic effect and safety, respectively. Two reviewers independently performed data extraction and risk of bias assessment. Of the 4,087 studies initially screened, 11 studies representing 340 patients ultimately met inclusion criteria, including seven observational and four randomized controlled trials. Five studies reported muscle cramp severity, four reported muscle cramp frequency, and two reported non-cramp pain. Oral zinc sulfate, L-carnitine, and taurine were reported to decrease cramp frequency. Oral vitamin E, oral zinc sulfate, L-carnitine, taurine, and pickle juice decreased cramp severity. Curcumin supplementation, resistance training, and stretching and walking programs improved non-cramp pain. Mild adverse events were reported in four studies. The risk of bias was moderate to high for all studies, largely due to missing data, study design, and a lack of blinding of participants. Numerous nutritional and non-pharmacological interventions have been reported to be safe and effective for the treatment of pain and painful muscle cramps in patients with cirrhosis. However, further research is needed to better determine the efficacy, safety, and optimal frequency and dosage of interventions.

The Effect of Yoga and Pelvic Floor Muscle Exercise on Sexual Function and Sexual Self-esteem of Reproductive-age Women: A Randomized Clinical Trial.

Sexual function is a part of sexual health which is an important aspect of the quality of life. Physical activity is one of the healthiest activities that can effectively reduce the risk of sexual disorders. Therefore, this study was conducted with the aim of evaluating the effect of yoga and pelvic floor muscle exercises on the sexual function and sexual self-esteem of reproductive-age women. This randomized clinical trial study was conducted from September to December 2023 on 46 women of reproductive age working in the Shahrekord University of Medical Sciences and its affiliated health centers. Multi-stage cluster sampling was used to select the subjects; later, they were randomly divided into two intervention groups A (N=21) and B (N=25). Participants in intervention groups A and B performed pelvic floor muscle exercises at home using an educational pamphlet 3 times a week for 6 weeks, with 3 times a day repetition. In addition, women in the intervention group A participated in a yoga training program for 2 sessions per week for 6 weeks. Data collection tools included a demographic information form, the Female Sexual Function Index, and Sexual Self-Esteem Inventory for women. Questionnaires were completed by both groups before, immediately, and one month after the intervention. The data were analyzed using the chi-square test, fisher's exact test, independent two-sample t-test, repeated measures test, and analysis of covariance in SPSS software version 16. A significance level of less than 0.05 was considered. The results showed no statistically significant difference between the two groups in sexual function (P=0.21) and sexual self-esteem (P=0.22) scores before the intervention. Also, the results showed no statistically significant difference between the two groups in terms of sexual function (P=0.35) and sexual self-esteem (P=0.59) scores one month after the intervention. However, the mean score of the sexual function index immediately after intervention showed a statistically significant difference between the intervention groups A (31.43±3.76) and B (29.41±2.38) (P<0.001). The mean score of the sexual self-esteem immediately after the intervention showed a statistically significant difference between the intervention groups A (181.19±19.90) and B (171.32±15.02) (P<0.001). Adding yoga exercises to pelvic floor muscle exercises can improve the sexual function and sexual self-esteem of women at their reproductive age. Trial Registration Number: IRCT20100524004015N1.

The Effect of a Happiness Education Program on the Expressed Emotion and Quality of Life of Mothers of Children with Autism Spectrum Disorder.

The mental health of the parents of Autism Spectrum Disorder (ASD), particularly the mothers, is poor due to the severity and complex nature of this condition, and they encounter numerous issues. This investigation aimed to determine whether happiness education affected mothers of children with ASD's Expressed Emotions (EE) and Quality of Life (QoL). A total of 70 mothers of children with ASD aged 3 to 13 years participated in this clinical trial study research. The experimental group received the Fordyce happiness training program once every 6 weeks via WhatsApp. In three stages, data were collected using a demographic form, the Family Questionnaire (FQ), and the World Health Organization Quality Of Life Instrument, Short Form (WHOQOL-BREF) (before the intervention, immediately afterward, and 1 month later). In the Statistical Package for Social Sciences (SPSS) software, the acquired data were analyzed using independent-sample t-tests, Chi-square tests, and repeated-measures Analysis of Variance (ANOVA). There was no significant difference in EE and QoL mean scores between the two groups before the intervention, but after, the intervention group's mean score of EE (20.91 (4.355)) was substantially lower than the control group's (44.74 (4.77)) (p < 0.001). In comparison, the intervention group's mean score of QoL and its dimensions was more significant than the control group's (p < 0.001). Given the efficacy of the happiness education program in reducing EE and enhancing QoL in mothers of children with ASD, such treatment strategies should be developed and used.

The Effect of Magnetic Therapy on Postoperative Urinary Retention in Patients Undergoing Surgery: A Randomized Clinical Trial.

Urinary retention is a postoperative problem that causes pain and discomfort for patients, even when catheters are used. The potential role of magnetic therapy in treating postoperative urinary retention through acupuncture points remains uncertain. This research aims to assess the impact of magnetic therapy on urinary retention in patients undergoing surgery. This single-blind clinical trial study was conducted in a recovery department within an operating room and subsequently in the Surgery Department of Amin Hospital. The study took place in Isfahan in 2022, with a sample of 64 patients selected using a simple random sampling method and divided equally into two groups. In the intervention group, magnet plates were applied, while the control group received iron plates at seven specific points for duration of 35 ± 5 minutes. Demographic information, the type of urinary excretion, the duration of urinary retention, and the volume of excreted urine were recorded using a researcher-made checklist for both intervention and control groups. These data were compared and subjected to descriptive and analytical statistical analysis. Among the participants (N = 64), the majority were male (N = 37, 57.80%), and the mean age was 40.17 years. The Chi-square analysis revealed no significant difference between the intervention and control groups in terms of the type of urinary excretion (p = 0.106). However, the Mann-Whitney U-test demonstrated significant difference between the two groups regarding the duration required to eliminate urinary retention and the volume of excreted urine (F2,41 = 62 and F1,76 = 62; p < 0.001). The use of a novel approach involving magnetic therapy applied to acupuncture and reflexology points has been shown to reduce the time required for the first urination and increase the volume of urine in post-surgery patients.

Effects of Oral Probiotic Supplements on the Rate of Vaginal Colonization of Group B Streptococcus in Pregnant Women: A Clinical Trial Study

Background: Management of Group B Streptococcus (GBS) infection in a pregnant woman is one of the serious challenges for gynecologists and infectious disease specialists. The present clinical trial study aimed to investigate the impact of oral probiotic supplements on the rate of vaginal colonization of GBS in pregnant women. Methods: Overall, 64 pregnant patients with vaginal GBS were selected to participate in this study. They were randomly divided into two groups (n=32/each). The intervention group received a probiotic supplement capsule at a dose of 500 mg daily for 30 days, and the control group received a placebo for 30 days. At the end of the study on day 30, the vaginal sample was retaken with a sterile swab, and all the steps performed at the beginning of the study to diagnose GBS were repeated. Results: The average mean gestation at the first vaginal sampling was 27.09±2.48 weeks. There was no meaningful difference in age between the two groups of patients (P=0.47). Moreover, no considerable difference was found in the body mass index (P=0.37), weeks of gestation (P=0.92), or number of pregnancies (P=0.89) between the two groups. A significant relationship was observed between positive GBS and BMI in pregnant women (P=0.001), but this meaningful relationship was not found between GBS and age of patients (P=0.86) and age of pregnancy (P=0.16). Finally, there was no significant difference between the probiotic and placebo groups in terms of secondary test results for GBS (P=0.07). Conclusion: In the present study, oral probiotic supplementation did not significantly alter GBS in pregnant women, but for a definite opinion, a study with a larger sample size, different vaginal sampling techniques, a higher dose of oral probiotics, and an increase in the length of the intervention period is essential.

An open-labeled randomized non-comparative clinical trial on the efficacy of fairfoot ointment in Vipadika

In Ayurveda, cracked or fissured feet are often associated with an imbalance in the Vata dosha. An excess of Vata in the body can lead to various skin issues, including dry and cracked skin, not only on the feet but on other parts of the body. Fairfoot ointment, a proprietary product, is an antifungal and antiseptic combination of Jathyadi Grutham, Jeevanthyadi Yamakam and Karanja Thailam, intended for external application of cracked feet and other skin conditions like chapped lips, anal fissures etc. An open-labeled randomized non-comparative clinical trial study was conducted on 30 patients presenting with cracked feet, fissures, dry scaly skin, pain, and itching to prove the efficacy in Vipadika. The associated symptoms of pigmentation and skin elasticity were also evaluated as part of this trial. A visual analog scale (VAS) was used to quantify pain. On a Likert scale of 1 to 5, dryness, wrinkles, scaling, itching, and skin laxity were scored. At each point of examination, the amount of cracking and pigmentation were counted. The study involved four evaluations of the participants. Following pairwise analysis using the SPSS 16.0 program, data were examined using Repeated Measure ANOVA. The results of the study showed a considerable reduction in the symptoms of dryness, cracking, pain, and itching. Additionally, there was a statistically significant decline in the symptoms of skin laxity, wrinkles, sealing, and pigmentation. No adverse events were observed during the course of the experiment, suggesting that the medication is safe. Clinical findings indicate that Fairfoot ointment could be used for the improvement and treatment of patients with Vipadika.

The effect of counseling based on health promotion awareness on self-care needs and reproductive and sexual health literacy of newly married women: a randomized controlled clinical trial study

BackgroundDespite the importance of health literacy and the self-care skills in improving individual and social health and health costs reduction, scientific evidence indicates women’s poor awareness of self-care needs and low health literacy concerning reproductive and sexual health in most societies. The present study was conducted to specify the effect of health awareness promotion on self-care needs and reproductive and sexual health literacy of newly married women.MethodsThis randomized controlled clinical trial was conducted on 64 newly married women aged 15–45 in Tehran, Iran from August 2021 to the end of December 2021. The participants were randomly assigned into the intervention (n = 32) and control (n = 32) groups. The intervention group received four individual health awareness-promotion education sessions. The reproductive and sexual self-care needs, and sexual health literacy questionnaires, were completed before and 4-week after the intervention through interview. The data were analyzed using SPSS26 software. The independent t-tests and ANCOVA were used to comparison the mean scores and a significance level of P < 0.05 was considered.ResultsThe results of this study indicated that after counseling, the average overall score of perceived reproductive and sexual self-care needs significantly decreased in the intervention group [Mean (standard deviation(SD)): 125.70 (24.70)] compared to the control group [Mean (SD): 87.1 (23.42)][P = 0.001]. Also, the mean score of sexual and reproductive health literacy significantly increased in the intervention group [Mean (SD): 125.50 (14.09)] compared to the control group [Mean (SD): 97.15 (14.90)] after intervention [P = 0.01].ConclusionsThe results indicated the positive effect of health promotion awareness educations on reproductive and sexual self-care needs and health literacy among newly married women. Therefore, health promotion interventions should be incorporated in health services provision programs for newly married women in comprehensive health centers to improve the health of women and families.Trial registrationIranian Registry of Clinical Trials (IRCT): IRCT20171007036615N7 Date of registration: 2021-09-21. URL: https://fa.irct.ir/trial/58597.

BI44 Latent tuberculosis reactivation in a patient with chronic plaque psoriasis treated with ustekinumab with a review of the literature

Abstract Ustekinumab, a monoclonal antibody against interleukin (IL)-12 and IL-23, is used for the treatment of psoriasis and psoriatic arthritis. The IL-12 pathway also plays an important role in regulating immunity to Mycobacterium tuberculosis. A multicentre, double-blind, randomized clinical trial study of 121 Korean patients with moderate-to-severe psoriasis revealed at least 75% improvement in Psoriasis Area and Severity Index (PASI) score after 12 weeks of ustekinumab treatment. Ten cases of latent tuberculosis infection (LTBI) were reported. Lupea-Chilom et al. [Lupea-Chilom DS, Solovan CS, Farcas SS et al. Latent tuberculosis in psoriasis patients on biologic therapies: real-world data from a care center in Romania. Medicina (Kaunas) 2023; 59: 1015] conducted a retrospective observational study on a total of 97 patients with severe psoriasis who were on different biologics. That study showed that two of seven patients on monotherapy ustekinumab developed LTBI. In this abstract, we present the case of a 49-year-old White woman with resistant moderate-to-severe chronic psoriasis without psoriatic arthritis who developed LTBI while on ustekinumab. She was diagnosed with psoriasis in 2012 with involvement of the scalp, flexural, vulval and gluteal regions as well as the nails. She was started on ustekinumab in October 2013 following a satisfactory prebiologics screen (including a negative QuantiFERON test). Her PASI score was zero at week 12. In 2017, she developed a malar rash and positive antinuclear antibody test, which was not tested prior to starting biologics. As lupus is a potential adverse effect of this medication, the ustekinumab was stopped in April 2017. Further rheumatological investigations ruled out lupus and ustekinumab was restarted in November 2017. As part of the screening process prior to restarting treatment, she had a repeat QuantiFERON test, which was positive. The respiratory team reviewed the patient and issued a 3-month course of rifampicin and isoniazid to treat LTBI. Following a few months of monitoring, it was deemed safe to restart ustekinumab in December 2018 and her PASI improved. In February 2020, due to the COVID pandemic, this medication had to be stopped. She was started on acitretin as an alternative in 2021 with a resulting worsening of her condition. In December 2021, the patient was restarted on ustekinumab. In this abstract, we illustrate that ustekinumab has the potential to reactivate latent tuberculosis, a phenomenon that is infrequently reported and attributed to its impact on the IL-12 pathway. To address this concern, we recommend conducting repeated annual screening during treatment in addition to a comprehensive baseline evaluation, including a chest X-ray and QuantiFERON test. Additionally, it is advisable to consider initiating isoniazid chemoprophylaxis concurrently with ustekinumab treatment as a precautionary measure.

Reflections on the opportunities and challenges of applying experience-based co-design (EBCD) to phase 1 clinical trials in oncology.

Experience-Based Co-Design (EBCD) is a multi-stage participatory action research process which was developed originally to increase patient involvement in service improvement initiatives. This viewpoint article serves as a reflection on the researchers' experiences, focusing on the application and feasibility of participatory approaches, particularly co-design, in the specific context of early-phase clinical trials. We reflect on the opportunities and challenges of applying EBCD in a new context of early-phase clinical trials in oncology where experimental treatments are increasingly perceived as a therapeutic option and, in certain instances, their efficacy may lead to accelerated approval facilitating a swifter integration into standard care. We propose that the opportunity of applying EBCD in such trials lies in improving the delivery of person-centered care, care coordination, and support during the transition from experimental to standard care. Three potential challenges when applying EBCD in early-phase clinical trials are discussed related to: the need for standardization in trial processes; planning EBCD in a context of high uncertainty; and vulnerability of patient populations. Integrating EBCD into early-phase oncology trials presents an opportunity to enhance person-centered care and can lead to simultaneous improvements in care processes and therapeutic development. This article has been developed with the collaboration of a patient partner who serves on the advisory board of our ongoing EBCD study in early clinical trials.

An Efficient Combination Therapy with Lisdexamfetamine Dimesylate and Topiramate in Improving Binge Eating Scale & Metabolic Profile in Binge Eating Disorder: A Randomized Control Trial.

Comprehensive evaluation of lisedexamfetamine dimesylate (LDX) alone and in combination with topiramate (TPM) was done for treatment of binge eating disorder (BED) in adults aged 18-55 years. In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48 and 45 using the permuted block randomization method. This study was conducted from January to September 2022 in Shiraz, Iran. Patients received LDX (n = 48) or LDX plus TPM. Average dose of LDX was 37.5 mg/day and 38 mg/day in the first and second group respectively. The second group (n = 45) also received TPM with average dose of 77.7 mg/day. Twelve weeks treatment caused significant higher mean reduction in level of triglyceride (73.68 vs. 58.97 respectively, p = 0.024), low density lipo-protein (LDL) (9.66 vs. 5.16 respectively, p < 0.001) and body mass index (5.48 vs. 3.41 respectively, p < 0.001) with TPM plus LDX and also greater significant improvement (p < 0.001) in binge eating scale compared to use of LDX alone. Combination therapy with TPM and LDX had better tolerability and lower adverse events such as insomnia (p < 0.001), paresthesia (p = 0.001), confusion (p = 0.035) and ataxia (p = 0.009) compared to monotherapy in BED. The combinative treatment was more effective than single drug in terms of higher tolerability, safety and causing lesser adverse events for BED patients. However, more studies with larger samples are needed.

Data Flow Construction and Quality Evaluation of Electronic Source Data in Clinical Trials: Pilot Study Based on Hospital Electronic Medical Records in China.

The traditional clinical trial data collection process requires a clinical research coordinator who is authorized by the investigators to read from the hospital's electronic medical record. Using electronic source data opens a new path to extract patients' data from electronic health records (EHRs) and transfer them directly to an electronic data capture (EDC) system; this method is often referred to as eSource. eSource technology in a clinical trial data flow can improve data quality without compromising timeliness. At the same time, improved data collection efficiency reduces clinical trial costs. This study aims to explore how to extract clinical trial-related data from hospital EHR systems, transform the data into a format required by the EDC system, and transfer it into sponsors' environments, and to evaluate the transferred data sets to validate the availability, completeness, and accuracy of building an eSource dataflow. A prospective clinical trial study registered on the Drug Clinical Trial Registration and Information Disclosure Platform was selected, and the following data modules were extracted from the structured data of 4 case report forms: demographics, vital signs, local laboratory data, and concomitant medications. The extracted data was mapped and transformed, deidentified, and transferred to the sponsor's environment. Data validation was performed based on availability, completeness, and accuracy. In a secure and controlled data environment, clinical trial data was successfully transferred from a hospital EHR to the sponsor's environment with 100% transcriptional accuracy, but the availability and completeness of the data could be improved. Data availability was low due to some required fields in the EDC system not being available directly in the EHR. Some data is also still in an unstructured or paper-based format. The top-level design of the eSource technology and the construction of hospital electronic data standards should help lay a foundation for a full electronic data flow from EHRs to EDC systems in the future.

The Impact of Loving-Kindness Meditation on Job-Related Burnout of Nurses Working in Neonatal Intensive Care Unit: A Randomized Clinical Trial Study.

Job-related burnout is one health outcome in nurses working in neonatal intensive care units (NICUs) due to the heavy workload, which results in negative physical and psychological consequences. One newly introduced approach to improve coping is loving-kindness meditation (LKM). Some studies have shown the effectiveness of the LKM on the mental health of nurses, though more evidence is required to support them. This study aimed to investigate the effectiveness of the LKM on job-related burnout of nurses working in NICU. This clustered controlled randomized clinical trial assessed job-related burnout before and after a month of practicing LKM guided through a virtual method. A total of 66 eligible NICU nurses from 2 referral children hospitals in Tehran were randomly assigned to 2 control (n = 33) and intervention (n = 33) groups. The intervention was performed 3 times a week for 1 month in the form of 20-minute audio files of LKM for the intervention group, and educational files on mental health during the COVID-19 pandemic were sent to the control group. The instruments used in this study were the demographic information questionnaire and the Maslach Burnout Inventory, which participants completed before and after the intervention. The mean difference in the overall scores of burnout before and after the intervention in the intervention group was significantly reduced (P = .003), but no significant difference was observed in the control group (P = .018). These findings support the benefit of LKM in NICU nurses in reducing burnout.

Characterization of an expanded set of assays for immunomodulatory proteins using targeted mass spectrometry

Immunotherapies are revolutionizing cancer care, but many patients do not achieve durable responses and immune-related adverse events are difficult to predict. Quantifying the hundreds of proteins involved in cancer immunity has the potential to provide biomarkers to monitor and predict tumor response. We previously developed robust, multiplexed quantitative assays for immunomodulatory proteins using targeted mass spectrometry, providing measurements that can be performed reproducibly and harmonized across laboratories. Here, we expand upon those efforts in presenting data from a multiplexed immuno-oncology (IO)-3 assay panel targeting 43 peptides representing 39 immune- and inflammation-related proteins. A suite of novel monoclonal antibodies was generated as assay reagents, and the fully characterized antibodies are made available as a resource to the community. The publicly available dataset contains complete characterization of the assay performance, as well as the mass spectrometer parameters and reagent information necessary for implementation of the assay. Quantification of the proteins will provide benefit to correlative studies in clinical trials, identification of new biomarkers, and improve understanding of the immune response in cancer.

Evaluating an Integrated Approach to Improve the Couple Sexual Desire Disorders: A Randomized Clinical Trial Study

Background: Treating and changing patterns of low sexual desire and dysfunctions can be done in various ways. However, it is important to recognize the value of integrated approaches when it comes to addressing these issues. To this end, we conducted a randomized clinical trial study to compare the effectiveness of an integrated approach with that of Masters-Johnson Sex Therapy (MJST) for treating hypoactive sexual desire disorder (HSDD) in Iranian couples from Mar 2016 to May 2018. Methods: We conducted a clinical trial on 24 couples who were experiencing HSDD. The couples were randomly divided into two groups. The intervention group was given an integrative approach, while the control group received MJST for ten sessions. We collected data using standard questionnaires before, immediately after, and eight weeks after the intervention. Results: There was no significant difference in sexual desire and function among men between the MJST and integrative approach groups. However, women in the integrative approach group showed more improvement in sexual desire and dysfunction compared to those in the MJST group. The improvement in sexual function for women and sexual desire for both men and women were maintained at the eight-week follow-up in the integrative approach. Conclusion: Our study found that using an integrative approach effectively treated HSDD in couples.

Association between cadmium exposure and risk of endometrial cancer; a systematic review and meta-analysis of clinical trial and observational studies

Association between cadmium exposure and risk of endometrial cancer; a systematic review and meta-analysis of clinical trial and observational studies

Effect of vertical implant position on marginal bone loss: a randomized clinical trial

ObjectivesOne of the most important factors that has influence on dental implants success rate is marginal bone loss. The purpose of this study is to investigate the effect of the implant’s vertical position and the soft tissue’s thickness on the rate of marginal bone loss of the dental implant.Materials and methodsIn this single-blind randomized clinical trial study, 56 implants placed in the posterior region of mandible of 33 patients (19 women, 14 men) were divided into two groups. The group of crestal (28 implants) and subcrestal (28 implants) implants, each group was divided into two sub-groups with soft tissue thickness of 2 mm and less than 2 mm (14 implants) and more than 2 mm (14 implants). The amount of marginal bone loss was measured by Scanora 5.2 program with radiographs Digital parallelism based on the effect of the vertical position of the implant, soft tissue thickness, three months after placement, and three months after loading implants (six months after implant placement).ResultsThe results showed that marginal bone loss in subcrestal implants is significantly more than crestal implants (p-value = 0.001), and also marginal bone loss in the soft tissue thickness group of 2 mm and less is significantly more than the group of soft tissue thickness more than 2 mm (p-value < 0.001). The amount of marginal bone loss three months after implant loading was significantly higher than three months after implant placement (p-value < 0.001).ConclusionThe implant’s vertical position and the soft tissue’s thickness around the implant are effective factors in the amount of marginal bone loss. Marginal bone loss is more in subcrestal implants and in cases with less soft tissue thickness. The time factor significantly affects the amount of marginal bone loss.Trial registrationthis clinical trial was registered at Iranian Registry of Clinical Trials, registration number IRCT20120215009014N415, registration date 20,220,110, (https//en.irct.ir/trial/60,991)