Parallel Randomized Clinical Trial Research Articles

Influence of digital media in the oral health education of mother-child pairs: study protocol of a parallel double-blind randomized clinical trial

BackgroundDental caries is the most common non transmissible chronic disease in childhood and the control of dental biofilm in children is one of the greatest challenges in oral disease prevention. Digital media applications can help patients in improving their oral hygiene performance and reducing the number of appointments due to pain and discomfort reasons. This study aims to investigate the use of an smartphone application (WhatsApp) to deliver oral health education to mother-child pairs, with the ultimate goal of controlling dental biofilm and caries through digital activities focused on oral hygiene.MethodsThis study was designed as a randomized, double-blind, parallel clinical trial involving 100 pairs of mothers and children (6–12 years old). The mothers and children will be randomly allocated to the control group (n = 50 pairs), who will receive a single visit conventional oral health education, or to the experimental group (n = 50 pairs), who will receive both a single visit conventional oral health education and educational videos through WhatsApp Messenger, twice a week. Before randomization of the groups and after the intervention, pairs will be evaluated regarding to plaque index (VPI), gingival bleeding index (GBI), and number of decayed, missing and filled permanent or primary teeth (DMF-T) modified by the inclusion of active non-cavitated carious lesions (Nyvad criteria). Socioeconomic data, dental history, and oral health literacy will obtained using questionnaires (Oral Health Literacy Assessment Task for Paediatric Dentistry; BOHLAT-P). Chi-square, Student’s t-test, paired Student’s t-test, Mann-Whitney, and Friedman tests will be used with a 5% significance level.DiscussionThis intervention proposal is designed to motivate behavioral change in mother-child pairs. We hypothesize that adding digital media to traditional oral health programs will provoke improvements in oral hygiene behavior and health outcomes. To our knowledge, this is the first study evaluating the effect of educational videos communicated by digital media (WhatsApp) on the oral health of mother-child pairs evaluated by long-term dental examinations. In addition, we will assess the maternal level of comprehension of the provided information via a literacy assessment tool. The clinical trial is registered at the Brazilian Registry of Clinical Trials (No. RBR-7s8bw6m).

The effects of magnesium supplementation on abnormal uterine bleeding, alopecia, quality of life, and acne in women with polycystic ovary syndrome: a randomized clinical trial

BackgroundAbnormal uterine bleeding (AUB), alopecia, low quality of life, and acne are considered as complications of polycystic ovary syndrome (PCOS). We hypothesized that magnesium supplementation would yield beneficial effects on PCOS related complications.ObjectiveTo examine the effects of magnesium supplementation on AUB, alopecia, quality of life, and acne.MethodsIn this parallel randomized clinical trial, we randomly assigned 64 women with PCOS to the magnesium group (n = 32) or placebo group (n = 32) for 10 weeks. AUB, alopecia, quality of life, and acne were assessed by the International Federation of Gynecology and Obstetrics criterion, the Sinclair Scale, the Health Survey Quality of Life Questionnaire, and the Global Acne Grading System, respectively. This randomized clinical trial was registered at IRCT.ir (IRCT20130903014551N9).ResultsMagnesium supplementation significantly improved the components of quality of life including physical functioning (p = 0.011), role limitations due to physical health (p = 0.012), role limitations due to emotional problems (p < 0.001), energy/fatigue (p = 0.005), emotional wellbeing (p < 0.001), social functioning (p = 0.002), general health (p = 0.013), and total quality of life (p < 0.001), compared with placebo. No significant effect was observed on acne, alopecia, and AUB.ConclusionMagnesium supplementation in women with PCOS had a significant positive effect on improving total quality of life.Trial registrationThis randomized clinical trial was registered at IRCT.ir on 2020–10-18 (Registration Code: IRCT20130903014551N9).

Speed of Processing (SoP) Training Plus α-tACS in People With Mild Cognitive Impairment: A Double Blind, Parallel, Placebo Controlled Trial Study Protocol.

Several cognitive training programs, alone or in combination with non-invasive brain stimulation have been tested in order to ameliorate age-related cognitive impairments, such as the ones found in Mild Cognitive Impairment (MCI). However, the effects of Cognitive Training (CT)—combined or not—with several forms of non-invasive brain stimulation have been modest at most. We aim to assess if Speed of Processing (SoP) training combined with alpha transcranial alternating current stimulation (α-tACS) is able to increase speed of processing as assessed by the Useful Field of View (UFOV), when comparing to SoP training or active α-tACS alone. Moreover, we want to assess if those changes in speed of processing transfer to other cognitive domains, such as memory, language and executive functioning by using the NIH EXAMINER. We also want to test the mechanisms underlying these interventions, namely brain connectivity and coherence as assessed by electroencephalography (EEG). To that purpose, our proposal is to enroll 327 elders diagnosed with MCI in a double-blinded, parallel randomized clinical trial assessing the effects of combining SoP with alpha endogenous tACS (either active or sham) in people with MCI. Participants will perform an intervention that will last for 15 sessions. For the first 3 weeks, participants will receive nine sessions of the intervention, and then will receive two sessions per week (i.e., booster) for the following 3 weeks. They will then be assessed at 1, 3, and 6 months after the intervention has ended. This will allow us to detect the immediate, and long-term effects of the interventions, as well as to probe the mechanisms underlying its effects.Clinical Trial Registration: Clinicaltrials.gov, Identifier: NCT05198726.

Estimation of alpha amylase, cortisol, and pH level in saliva of patients wearing conventional and Biofunctional Prosthetic System complete dentures: A parallel randomized clinical trial

Statement of problemBiofunctional Prosthetic System (BPS) complete dentures have been reported to maintain a harmonious relationship with the surrounding oral structures and provide improved adaptation compared with conventional complete dentures. However, an evaluation of salivary changes and its constituents between BPS and conventional dentures is lacking. PurposeThe purpose of this parallel randomized clinical trial was to evaluate the alpha amylase, cortisol, and pH levels in saliva in participants provided with conventional and BPS complete dentures. Material and methodsSixteen completely edentulous participants were recruited for providing with conventional and BPS dentures (n=8). The levels of alpha amylase, cortisol, and pH in their saliva were evaluated by using an enzyme-linked immunosorbent assay (ELISA), colorimetric, and pH meter before insertion and 1 week and 1 month after denture insertion. The data were analyzed with repeated measure ANOVA and the Student t test (α=.05). ResultsThe mean ±standard deviation for pH was 6.94 ±0.22 in conventional complete dentures and 7.04 ±0.12 in BPS dentures; for alpha amylase, it was 206.75 ±14.64 and 210.88 ±15.72 IU/mL; and for cortisol, it was 0.29 ±0.05 and 31 ±0.04 nmol/L before insertion and 1 week and 1 month after denture insertion. From the repeated measures ANOVA, the mean pH and salivary cortisol were not statistically different (P>.05), but salivary amylase was statistically different (P<.05). The Student t test showed no significant difference in pH (P>.05), but a statistically significant difference in alpha amylase and salivary cortisol levels was found between the 2 groups (P<.05). ConclusionsNo significant difference in salivary pH was found in completely edentulous patients provided with conventional or BPS dentures, but significant differences were found in levels of alpha amylase and salivary cortisol.

Uneven Treadmill Training for Rehabilitation of Lateral Ankle Sprains and Chronic Ankle Instability: Protocol for a Pragmatic Randomized Controlled Trial.

BackgroundLateral ankle sprains (LASs) are common injuries among military service members. Approximately 40% of individuals with an LAS progress to develop chronic ankle instability (CAI), a condition that results in substantial mechanical and neurophysiological impairment and activity limitation. Since proprioceptive and balance training improve functional outcomes and prevent secondary injury following LAS, they are recommended in clinical practice. Uneven treadmills are an innovative modality that challenge the sensorimotor system while performing an ecologically valid task simulating environments frequently encountered by service members with LAS and CAI.ObjectiveThe aim of this study is to evaluate whether the inclusion of uneven treadmill training in standard rehabilitation can improve clinical, functional, biomechanical, and patient-reported outcomes compared with the standard of care alone in service members with LAS and CAI. The prophylactic effects of treatment on secondary injury and identification of any contributing or mediating factors that influence outcomes following treatment will also be evaluated. We hypothesize that service members receiving uneven treadmill training will demonstrate greater improvements in clinical and instrumented measures of impairment, patient-reported function, and lower risk of injury recurrence than the control group immediately post and 18 months following treatment.MethodsA multisite, parallel randomized clinical trial will be performed among service members aged 18-49 years being treated for LAS and CAI in military treatment facilities in the United States. Participants randomly assigned and allocated to receive the experimental intervention will be provided up to 12 sessions of training on an uneven terrain treadmill over a 6-week treatment course to supplement standard rehabilitation care. Treatment intensity of the rehabilitation exercises and treadmill training will be progressed on the basis of patient-perceived intensity and treatment responses. Outcome measures will include patient-reported outcomes, functional assessments, performance measures, and biomechanical measures. Investigators collecting outcome measures will be blinded to treatment allocation. Reinjury rates and patient-reported outcomes of function will be tracked over 18 months following treatment.ResultsThe project was funded in September 2020. Patient recruitment began in November 2021, with 3 participants enrolled as of February 2022. Dissemination of the main study findings is anticipated in 2024.ConclusionsThis study will assess the impact of an innovative uneven-terrain treadmill on treatment outcomes in the rehabilitation of service members with LAS and CAI. The results of this study will be used to inform rehabilitation practices and to potentially improve functional outcomes and secondary prevention in this patient population.Trial RegistrationClinicalTrials.gov NCT04999904; https://clinicaltrials.gov/ct2/show/NCT04999904?term=NCT04999904International Registered Report Identifier (IRRID)DERR1-10.2196/38442

The effect of empowerment counseling on stress and self-esteem of mothers with hospitalized premature infants

ABSTRACT Background This study aimed to investigate the effect of counselling on stress and self-esteem of mothers with hospitalized premature infants. Materials and Methods This parallel randomized clinical trial was conducted on 80 primigravida mothers aged 18-40 years, gestational age of 28-34 weeks in 2021 in Iran. The women were randomly assigned to two groups by blocked randomization. The data were collected using a demographic information questionnaire, Paternal Stress Scale and Rosenberg self-esteem questionnaire. Individual counselling based on the GATHER model was carried out within two consecutive weeks in four sessions. Data were analyzed with SPSS 24. Results There was no significant difference between the two groups in demographic variables, stress, and self-esteem before the intervention (P>0.05). There was a substantial difference in the mean score of self – esteem 9.52±3.22 and 16.75±6.39 (P<0.001), stress 154.65±32.15and 61±10.98 (P<0.001) and different dimensions of stress between the control and intervention groups after the intervention. The most significant reduction occurred in the dimension of appearance and behaviour of the infant (cohen d=3.146). Conclusions The results show counselling with an empowerment approach based on the GATHER model is effective in reducing stress and increasing self-esteem of mothers of premature infants admitted to the intensive care unit.

A randomized phase III clinical trial of acupuncture for chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors.

TPS12145 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect in cancer survivors that can last long after completion of neurotoxic chemotherapy. Patients with CIPN often experience neuropathy symptoms such as pain, tingling, numbness, paresthesia, and dysesthesia, which can lead to significant functional decline and diminished quality of life (QoL). Our prior study showed that more than half of breast cancer survivors who received taxane-based chemotherapy experienced persistent peripheral neuropathy symptoms for a mean duration of 5.6 years after completing chemotherapy. This outcome highlights the importance of developing effective CIPN treatments to improve cancer survivors’ QoL. Identifying nonpharmacological approaches to reduce CIPN symptoms and improve cancer survivors’ outcomes is urgently needed. Acupuncture is a widely used, minimally invasive Traditional Chinese Medicine technique that has shown promising evidence as an effective and safe treatment for CIPN. We hypothesize that acupuncture may reduce CIPN pain and improve overall CIPN symptoms in cancer survivors. Methods: We are conducting a two-arm, parallel randomized clinical trial comparing electroacupunture (EA) versus sham acupuncture (SA) in cancer survivors at Memorial Sloan Kettering Cancer Center, New York, NY. The EA arm includes a total of ten sessions of EA over eight weeks using a standardized, semi-fixed protocol developed by our group based on the previously published pilot study (NCT03183037). The SA arm includes a sham technique that uses a combination of non-acupuncture points and a non-insertion procedure in ten sessions over eight weeks. The primary outcome of this study is the Brief Pain Inventory-Short Form (BPI-SF) average pain item. The secondary outcomes are quantitative sensory testing measures and additional patient-reported outcomes that include the BPI-SF pain interference subscale, Neuropathic Pain Scale (NPS), Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), CIPN-20, PROMIS Global Health Scale, and Patients’ Global Impression of Change (PGIC). The primary end point is week 12 and the secondary end point is week 24; treatment effects are assessed at baseline and at weeks 4, 8, 12, 18, and 24. Eligibility criteria includes: 1) Moderate-to-severe CIPN pain, defined by a score of 4 or greater on a 0–10 numeric rating scale; 2) completion of neurotoxic chemotherapy at least three months prior to enrollment; and 3) no changes in anti-neuropathy medications within three months of enrollment. We have accrued 30 participants as of February 2022, with a total accrual target of 250 participants. Accrual completion is anticipated by December 2024. Funding resource: NIH R37 CA248563. Clinical trial information: NCT04917796.

Markers of respiratory function response to high-carbohydrate and high-fat intake in patients with lung diseases: a systematic review with meta-analysis of randomized clinical trials.

Macronutrients can differently affect respiratory function markers such as VO2 , VCO2 , PaO2 , PaCO2 , and respiratory quotients (RQs), but systematic appraisal of the evidence on randomized clinical trials (RCTs) is lacking. The objective of this work is to compare the response of respiratory function markers with high-carbohydrate and high-fat intake in patients with lung diseases. Systematic review conducted according to Cochrane Collaboration recommendations, reported following Preferred Reporting Items for Systematic Reviews and Meta-Analysis for pairwise systematic reviews of interventions 2020. PubMed, EMBASE, Scopus, and Cochrane CENTRAL were searched up to July 2021. Two reviewers selected the RCTs and extracted the data. Risk of bias and the certainty of evidence were assessed by RoB 2 and Grading of Recommendations Assessment, Development, and Evaluation System criteria, respectively. Statistical and graphical data guided the publication bias investigation. Meta-analyses were conducted. We included 14 RCTs (362 participants), four of which were parallel. Most studies included patients with chronic obstructive pulmonary disease. High-fat intake decreased VCO2 (mean difference [MD] = -35.89 ml/min [95% confidence interval (CI), -45.24 to -26.21]); I² = 0%), VO2 (MD = -29.30 ml/min [95% CI, -40.94 to -17.66]; I² = 0%), PaCO2 mm Hg (MD = -4.62 [95% CI, -7.67 to -1.58]; I² = 84%), and RQ (MD = -0.08 [95% CI, -0.09 to -0.06]; I² = 0%) in the subset of parallel RCTs. In crossover RCTs, there was generally no evidence of effect except for a greater decrease in RQ (MD = -0.09 [95% CI, -0.12 to -0.02]; I² = 96%) in favor of high-fat intake. High-fat intake resulted in greater reductions of VCO2 , VO2 , PaCO2 , and RQ in adult patients with lung diseases. The certainty of the evidence is very low/low, and it precludes a specific recommendation on macronutrients contribution to energy intake of these patients.

The effectiveness of adapted group mindfulness-based stress management program on perceived stress and emotion regulation in midwives: a randomized clinical trial

BackgroundMidwives' stress can have negative consequences on their emotional state, burnout, and poor quality of midwifery care. This study aimed to determine the effectiveness of an adapted mindfulness-based stress management program on perceived stress and the emotional regulation of midwives.MethodsThe study was a parallel randomized clinical trial on the midwives working in general hospitals of Zanjan, Iran. In this study, 121 midwives registered to participate based on the census sampling method were screened using a cut point of ≥ 28 in the Perceived Stress Scale (PSS). From the initial sample, 42 subjects had inclusion criteria assigned to two groups of control (n = 21) and intervention (n = 21) using online random allocation. The intervention group received an 8-week adapted mindfulness-based stress management program. This program emanates from the Kabat-Zinn's MBSR program, which has been adjusted according to the Iranian culture. The ANCOVA and repeated measure analysis of variance test were used to compare groups over time.ResultsThe results showed that the group intervention effectively affected perceived stress (P = 0.001) and difficulty in emotion regulation during the post-intervention period (P = 0.001). Moreover, the interventions were effective in emotion regulation (P = 0.003), but it was not effective on perceived stress (P = 0.125) at the 3-month follow-up.ConclusionsThis adapted mindfulness-based program successfully reduced stress and increased emotion regulation strategies in midwives; however, the long-term outcomes of this treatment program need further consideration.

The effect of the combination of acupuncture and kinesiotherapy on upper cross syndrome based on mechanical balance principle – A randomized clinical trial: 浅析基于力学平衡原理针刺结合运动疗法治疗上交叉综合征疗效观察 -- 随机对照试验

ObjectiveTo observe the clinical effect of combined acupuncture and kinesiotherapy on upper cross syndrome (UCS) by a parallel randomized clinical trial. MethodsA total of 45 patients with UCS were recruited from the outpatients of Acupuncture-Moxibustion, Tuina and Rehabilitation Department of the First Affiliated Hospital of Hunan University of Chinese Medicine, the students of Hunan University of Chinese Medicine and the patients from the nearby communities in accordance with the inclusion criteria. Using the random number table method, they were divided into a combined treatment group (acupuncture plus kinesiotherapy, 23 cases) and a simple kinesiotherapy group (22 patients). Treatment for 4 weeks was one course, and two consecutive courses were required. The visual analog scale (VAS) score, the score of the assessment scale for cervical spondylosis, the value of surface electromyography (root mean square, RMS), and the cervical curvature value were used in the evaluation. The allocation scheme was concealed from the outcome assessors. ResultsThe data from 23 cases of the combined treatment group and 22 cases of the simple kinesiotherapy group were analyzed. Before treatment, the differences were not statistically significant in the general conditions, VAS score, assessment score of cervical spondylosis, cervical curvature value, and RMS in UCS patients between the two groups (all P > 0.05). After treatment, the VAS score was reduced compared with that before treatment in both groups (all P < 0.05). In two courses of treatment, the VAS score decreased as compared with that in one course of treatment in both groups (both P < 0.05), and the VAS score in the combined treatment group decreased more obviously after each course of treatment (both P < 0.05). The RMS decreased compared with that before treatment in each group (both P < 0.05), and the decrease in the combined treatment group was more obvious (P < 0.05). After treatment of each course, the assessment score was all increased as compared with that before treatment in two groups (all P < 0.05). In two courses of treatment, the assessment score was increased as compared with that in one course of treatment in both groups (both P < 0.05), and the score in the combined treatment group was increased more obviously in the two courses of treatment (P < 0.05). Regarding either the intra-group comparison or the inter-group comparison before and after treatment, the differences were not statistically significant (all P > 0.05), suggesting no obvious improvement of cervical curvature in the two courses of treatment in patients with UCS. However, cervical curvature tended to improve in the combined treatment group. The total effective rate was significantly different between the two groups (P < 0.05), indicating that the total effective rate in the combined treatment group was better than that in the simple kinesiotherapy group.No any adverse reactions occurred. ConclusionCombined treatment with acupuncture, kinesiotherapy, and kinesiotherapy alleviated pain, relieved the symptoms and physical signs, and improved the daily movement of the patients. However, the combined treatment of acupuncture and kinesiotherapy had a much better effect on UCS.

The effect of olive cream on pain and healing of caesarean section wounds: a randomised controlled clinical trial.

This study was performed to determine the effect of olive cream on the severity of pain and healing of caesarean section wounds. This study is a parallel randomised clinical trial that was conducted on women who had caesarean sections at Ayatollah Taleghani Hospital in Arak, Iran. Women were assigned to intervention, placebo and control groups by a block randomisation method. Women in the intervention and placebo groups were asked to use olive cream and placebo cream, respectively, twice a day from the second day after surgery to the tenth day. The wound healing score and pain intensity score were assessed using the REEDA and VAS scales, respectively, before and at the end of the intervention. The intervention group consisted of 34 women, the placebo group of 34 women and the control group of 35 women. We found a statistically significant difference between the intervention and placebo groups, intervention and control groups, and placebo and control groups in terms of the pain intensity (p<0.05 in all three cases). Also, we found a statistically significant difference between the intervention and placebo groups, and intervention and control groups in terms of the scores of wound healing on the tenth day after surgery (p<0.05 in both cases). Olive cream can be effective in relieving pain and enhancing caesarean section wound healing, and since no specific side effects were reported, the use of olive cream is recommended.

A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial.

BackgroundThe-Optimal-Lymph-Flow (TOLF) is a patient-centered, web- and mobile-based mHealth system that delivers safe, easy, and feasible digital therapy of lymphatic exercises and limb mobility exercises.ObjectiveThe purpose of this randomized clinical trial (RCT) was to evaluate the effectiveness of the web- and mobile-based TOLF system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference measured by infrared perometer, BMI, and quality of life (QOL) related to pain. We hypothesized that participants in the intervention group would have improved pain and symptom experiences, limb volume difference, BMI, and QOL.MethodsA parallel RCT with a control–experimental, pre- and posttest, and repeated-measures design were used. A total of 120 patients were recruited face-to-face at the point of care during clinical visits. Patients were randomized according to pain in a 1:1 ratio into either the arm precaution (AP) control group to improve limb mobility and arm protection or The-Optimal-Lymph flow (TOLF) intervention group to promote lymph flow and limb mobility. Trial outcomes were evaluated at baseline and at week 12 after the intervention. Descriptive statistics, Fisher exact tests, Wilcoxon rank-sum tests, t test, and generalized linear mixed effects models were performed for data analysis.ResultsAt the study endpoint of 12 weeks, significantly fewer patients in the TOLF intervention group compared with the AP control group reported chronic pain (45% [27/60] vs 70% [42/60]; odds ratio [OR] 0.39, 95% CI 0.17-0.90; P=.02). Patients who received the TOLF intervention were significantly more likely to achieve a complete reduction in pain (50% [23/46] vs 22% [11/51]; OR 3.56, 95% CI 1.39-9.76; P=.005) and soreness (43% [21/49] vs 22% [11/51]; OR 2.60, 95% CI 1.03-6.81; P=.03). Significantly lower median severity scores were found in the TOLF group for chronic pain (MedTOLF=0, IQR 0-1 vs MedAP=1, IQR 0-2; P=.02) and general bodily pain (MedTOLF=1, IQR=0-1.5 vs MedAP=1, IQR 1-3; P=.04). Compared with the AP control group, significantly fewer patients in the TOLF group reported arm/hand swelling (P=.04), heaviness (P=.03), redness (P=.03), and limited movement in shoulder (P=.02) and arm (P=.03). No significant differences between the TOLF and AP groups were found in complete reduction of aching (P=.12) and tenderness (P=.65), mean numbers of lymphedema symptom reported (P=.11), ≥5% limb volume differences (P=.48), and BMI (P=.12).ConclusionsThe TOLF intervention had significant benefits for breast cancer survivors to manage chronic pain, soreness, general bodily pain, arm/hand swelling, heaviness, and impaired limb mobility. The intervention resulted in a 13% reduction (from 40% [24/60] to 27% [16/60]) in proportions of patients who took pain medications compared with the AP control group, which had a 5% increase (from 40% [24/60] to 45% [27/60]). A 12% reduction (from 27% [16/60] to 15% [9/60]) in proportions of patients with ≥5% limb volume differences was found in the TOLF intervention, while a 5% increase in the AP control group (from 40% [24/60] to 45% [27/60]) was found. In conclusion, the TOLF intervention can be a better choice for breast cancer survivors to reduce chronic pain and limb volume.Trial RegistrationClinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226International Registered Report Identifier (IRRID)RR2-10.2196/resprot.5104

Effect of linagliptin plus insulin in comparison to insulin alone on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 infection

To evaluate the effect of the combination of linagliptin and insulin on metabolic control and prognosis in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and hyperglycemia. A parallel double-blind randomized clinical trial including hospitalized patients with SARS-CoV-2 infection and hyperglycemia, randomized to receive 5 mg linagliptin + insulin (LI group) or insulin alone (I group) was performed. The main outcomes were the need for assisted mechanical ventilation and glucose levels during hospitalization. Subjects were screened for eligibility at hospital admission if they were not with assisted mechanical ventilation and presented hyperglycemia, and a total of 73 patients with SARS-CoV-2 infection and hyperglycemia were randomized to the LI group (n = 35) or I group (n = 38). The average hospital stay was 12 ± 1 vs 10 ± 1 days for the I and LI groups, respectively (p = 0.343). There were no baseline clinical differences between the study groups, but the percentage of males was higher in the LI group (26 vs 18, p = 0.030). The improvements in fasting and postprandial glucose levels were better in the LI group that the I group (122 ± 7 vs 149 ± 10, p = 0.033; and 137 ± 7 vs 173 ± 12, p = 0.017, respectively), and insulin requirements tended to be lower in the LI group than the I group. Three patients in the LI group and 12 in the I group required assisted mechanical ventilation (HR 0.258, CI 95% 0.092–0.719, p = 0.009); 2 patients in the LI group and 6 in the I group died after a follow-up of 30 days (p = 0.139). No major side effects were observed. The combination of linagliptin and insulin in hospitalized patients with SARS-CoV-2 infection and hyperglycemia reduced the relative risk of assisted mechanical ventilation by 74% and improved better pre and postprandial glucose levels with lower insulin requirements, and no higher risk of hypoglycemia.This study is registered at clinicaltrials.gov, number NCT04542213 on 09/03/2020.

Effectiveness of systemic acupuncture in the control of urinary incontinence following radical prostatectomy: a randomized clinical trial.

To evaluate the effectiveness of acupuncture associated with pelvic floor muscle training for the control of urinary incontinence following radical prostatectomy. Open-label, parallel randomized clinical trial. The intervention group (n = 33) underwent eight sessions of systemic acupuncture associated with pelvic floor muscle training and the control group (n = 31) performed only pelvic floor muscle training. The outcome variable was urinary incontinence assessed by the Pad Test and Daily Pad Used, before treatment (T0), after four weeks (T1) and after eight weeks of treatment (T2). Data analysis was performed using a longitudinal model of Generalized Estimating Equations, significance level of 0.05. The control group showed greater urinary loss compared to the intervention group at T1 (p = 0.006) and at T2 (p < 0.001). Both groups showed improvement in the level of urinary incontinence over time, but the improvement was greater in the intervention group (p < 0.001). Acupuncture associated with pelvic floor muscle training was effective in reducing urinary incontinence in prostatectomized men.Brazilian Registry of Clinical Trials:RBR-3jm5y2.

Effect of fertility health awareness strategies on fertility knowledge and childbearing in young married couples (FertStart): study protocol for an effectiveness-implementation hybrid type I multicentre three-arm parallel group open-label randomised clinical trial

IntroductionBirth rates have been declining in many advanced societies including Singapore. We designed two interventions with vastly different resource requirements, which include fertility education, personalised fertility information and a behavioural...

A Randomized Clinical Trial of the Effect of Zinc Supplement on Depression and Anxiety in the Elderly

Background: Anxiety and depression in the elderly are considered important mental disorders. Objective: This study was designed to determine the effect of zinc Supplementation on depression and anxiety in the elderly. Methods: This study was a parallel randomized clinical trial. A total of 150 elderly aged 60 years and older were allocated into intervention and control groups by using the quadruple blocking method. The elderly in the intervention group received a daily dose of 30 mg zinc supplementation pill for 70 days and the elderly in the control group did not receive this supplement. Depression and anxiety in the elderly were measured using the Geriatric Depression Scale and the Beck Anxiety Inventory, respectively. A significance level of 0.05 was considered for all statistical tests. Results: After the intervention, the mean scores of depression and anxiety in the elderly were significantly decreased in the intervention group, as compared with the control group. Moreover, after the intervention, the serum zinc level in the elderly was significantly increased in the intervention group, as compared with the control group (P&lt;0.05). Conclusion: The use of zinc supplements improved depression and anxiety in the elderly. Therefore, it is recommended to use zinc supplements as a new therapeutic strategy for the prevention and treatment of depression and anxiety in the elderly. Registration No: This research was registered in the Iranian clinical trial system with code IRCT2017071635110N1.

Left Ventricular End-Diastolic Pressure and B-Type Natriuretic Peptide Levels Guidance of Low-Dose Furosemide Treatment to Prevent Contrast-Induced Nephropathy in Patients with Percutaneous Coronary Intervention: A Randomized Controlled Trial

Objective. We aimed to explore the preventive effect of low-dose furosemide administration guided by left ventricular end-diastolic pressure (LVEDP) and B-type natriuretic peptide (BNP) based on adequate hydration on contrast-induced nephropathy (CIN) in patients with percutaneous coronary intervention (PCI). Methods. This parallel randomized clinical trial was conducted at a tertiary hospital in China. A total of 1053 consecutive patients (71.98% men) who underwent PCI at our hospital were enrolled. Pre-PCI plasma BNP levels were recorded. Patients enrolled received a continuous intravenous infusion of normal saline starting 4 h before PCI until 24 h after surgery. LVEDP was measured immediately after surgery. Patients in the control group received intravenous furosemide injection (20 mg). Patients in the experimental group received furosemide if they showed LVEDP ≥15 mmHg, a post-PCI BNP level ≥100 pg/mL, and/or a post-PCI BNP value &gt; 150% of the pre-PCI value. The primary and secondary outcome measures were serum creatinine levels, glomerular filtration rate, and creatinine clearance rate measured before and after PCI. CIN incidence was compared between the two groups. Logistic regression analysis was used to study the risk factors for CIN. Results. CIN incidence was significantly higher in the control group than in the experimental group ( P &lt; 0.05 ). Logistic regression analysis showed that elevated LVEDP and BNP levels were risk factors. As LVEDP increased, the CIN incidence also increased (odds ratio (OR) 1.038, 95% confidence interval (CI) 1.006–1.070). The OR of BNP was 1.001 (95% CI 1.000–1.002). Conclusions. Low-dose furosemide administration guided by LVEDP or BNP is superior to direct low-dose administration on the basis of adequate hydration during PCI. This trial is registered with ChiCTR-IOR-14005250

The effect of metformin and myoinositol on metabolic outcomes in women with polycystic ovary syndrome: role of body mass and adiponectin in a randomized controlled trial.

To compare the effects of insulin sensitizers metformin (MET) and myo-inositol (MI) on adiponectin levels and metabolic characteristics in women with polycystic ovary syndrome (PCOS) with respect to their body mass index (BMI). In this open label, parallel randomized clinical trial, 66 women with PCOS (33 normal-weight and 33 overweight/obese) were randomized to either MI (4g/day) or MET (1500mg/day) for a period of 6months. Serum concentration of adiponectin, hormonal and metabolic laboratory outcomes and clinical assessment of BMI, body composition and Ferriman-Gallwey score (FG score) were evaluated before and after treatment. After the 6-month intervention, comparison between MET and MI in time to treatment analysis showed no significant differences between the two treatments for all analyzed parameters. Only borderline significantly lower AUC glucose was found in the MET group in comparison to the MI group (p = 0.071). The main effect of treatment was shown for glucose concentration at 120min OGTT (p = 0.032) and testosterone (p = 0.002). The main effect of time was shown for body mass (p = 0.004), waist circumference (p < 0.001), BMI (p = 0.003), body fat mass (p = 0.001), adiponectin (p = 0.020), fasting glucose (p = 0.001), testosterone (p = 0.015), SHBG (p = 0.013), 17OH progesterone (p = 0.008), LH (p = 0.004) and estradiol (p = 0.014). Our study showed similar effects of MET and MI on BMI, body composition, hormonal profile, metabolism of glucose and insulin, and adiponectin level. The two insulin sensitizers, MET and MI, were useful in reducing BMI and improving body composition without significant differences between the two treatments in PCOS women. ISRCTN13199265. Trial registration date: 14.04.2021. (ISRCTN Registry), retrospectively registered.

Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision

The conventional 2.2-mm clear corneal incision is relatively narrow compared with the sleeves of Phaco handpieces, resulting in friction at the incision site and increased risk of incision-related Descemet membrane detachment (DMD). The modified 2.2-mm incision only enlarged internal width to 3.0 mm, forming a trapezoid incision shape, which may reduce the friction of surgical instruments and decrease the risk of incisional DMD. To compare the incidence of incision-related DMD between eyes undergoing modified vs conventional 2.2-mm incision phacoemulsification for hard nuclear age-related cataract. This double-masked, parallel randomized clinical trial was conducted from July 22, 2019, to January 22, 2020, at Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. The study included patients with age-related cataract and nuclear opalescence grade of 4.0 or greater based on the Lens Opacities Classification System III. Patients were enrolled in this study according to the following inclusion criteria: (1) age between 65 to 90 years; (2) pupil size of 6 mm or greater after dilation; (3) Lens Opacities Classification System III nuclear opalescence grade of 4.0 or more; and (4) corneal endothelial cell density greater than 1500 cells/mm2. Modified (enlarged internal width to 3.0 mm) or conventional 2.2-mm incision phacoemulsification with intraocular lens implantation. Incidence of incision-related DMD at postoperative day 1. A total of 130 eyes of 130 patients were randomized into the conventional group (n = 65) or the modified group (n = 65). The mean (SD) age of participants was 74.5 (5.9) years and 74.3 (6.0) years in the conventional and modified groups, respectively. A total of 26 participants in the conventional group (40%) and 27 in the modified group (42%) were men. Compared with eyes in the conventional group, the incidence of DMD in eyes in the modified group was significantly lower at postoperative day 1 (difference, 26.15; 95% CI, 9.60-42.71; P = .003). The difference at postoperative day 7 was 16.92 (95% CI, 2.91-30.94; P = .02). The length of DMD (postoperative day 1: difference, 0.188; 95% CI, 0.075-0.301; P = .002) and maximal corneal thickness at incision site (postoperative day 1: difference, 0.032; 95% CI, 0.006-0.057; P = .02; postoperative day 7: difference, 0.019; 95% CI, 0.003-0.035; P = .02) were lower in the modified group, while visual quality parameter modulation transfer function (postoperative day 1: difference, -0.033; 95% CI, -0.064 to -0.001; P = .04) was higher. No difference was observed between the 2 groups in best-corrected visual acuity, central corneal endothelium loss, or surgically induced astigmatism at any follow-up time. There were no intraoperative complications in the 2 groups. These findings suggest that modified 2.2-mm trapezoid incision phacoemulsification reduces the incidence of DMD for hard nuclear age-related cataract at postoperative day 1 and might be considered in patients at high risk of incision-related DMD, although the clinical relevance cannot be determined with certainty from this trial. ClinicalTrials.gov identifier: NCT04014699.

The Potential Role of Aerosolized Colistin in the Ventilator-Associated Pneumonia Management Caused by Multidrug-Resistant Gram-Negative Bacteria: A Randomized Clinical Trial

Background: Infections caused by multidrug-resistant (MDR) pathogen have caused a resurgence of interest in colistin. To date, information about the effectiveness of Aerosolized Colistin (AS) is very limited in the treatment of Ventilator-Associated Pneumonia (VAP). The aim of this study is to evaluate the efficacy and safety of AS in conjunction with intravenous (IV) colistin in patients with VAP, caused by MDR Gram-Negative Bacteria (GNB).&#x0D; Methods: This parallel randomized clinical trial was conducted on patients with VAP in the Intensive Care Unit (ICU) ward. 27 patients allocated to the intervention or the control group. Patients in the intervention group received IV Colistin based on glomerular filtration rate along with aerosolized Colistin, 2 million units three times a day. In the control group, only IV Colistin was administered. For all patients, Procalcitonin (PCT), sputum culture, and Clinical Pulmonary Infection Score (CPIS) were evaluated and compared as outcome measures at the specified period of time.&#x0D; Results: Negative sputum culture was achieved in 9 (80%) out of 11 patients in the AS-IV Colistin group after seven days of therapy versus 9 (56.25%) out of 16 in the control group (P= 0.01). PCT and CPIS scores were not significantly different between two groups (P=0.21, P= 0.62). Furthermore, nephrotoxicity and neurotoxicity were not seen.&#x0D; Conclusion: AS Colistin lead to earlier negative sputum culture without increasing risk of nephrotoxicity and neurotoxicity, and could potentially be a beneficial adjunctive approach in the management of MDR-VAP.