A Prospective, Multicenter, Evaluator-Blinded, Randomized Study of Diluted Calcium Hydroxylapatite to Treat Decollete Wrinkles.

BACKGROUND: Calcium hydroxylapatite (CaHA) dermal filler is used for a variety of aesthetic treatments; however, the safety and effectiveness of diluted CaHA for the treatment of décolleté wrinkles have not been established. OBJECTIVE: To demonstrate the effectiveness and safety of diluted CaHA (Radiesse; 1:2 CaHA:saline) injection for the improvement of décolleté wrinkles in females. METHODS: Eligible females with moderate or severe ratings on the Merz Aesthetic Scale (MAS) Decollete Wrinkles - At Rest received up to 3 injection cycles of diluted CaHA either 8 weeks apart (3 injection cycles) or 16 weeks apart (2 injection cycles). Effectiveness was evaluated by improvement on the MAS. Adverse events were recorded over a 52 week period. RESULTS: Sixteen weeks after the last treatment, the response rate (1-point improvement or greater) on the MAS Decollete Wrinkles - At Rest was 73.5% (P<0.0001; pooled sample) for all patients. The use of diluted CaHA in the decollete also demonstrated a favorable safety profile. CONCLUSIONS: Diluted CaHA is a safe and effective treatment for the improvement of decollete wrinkles in females.J Drugs Dermatol. 2024;23(7):551-556.  doi:10.36849/JDD.8261.

Cerina: cognitive-behavioural therapy-based mobile application for managing GAD symptoms among Ulster University Students in Northern Ireland - a protocol for a pilot feasibility randomised controlled trial.

INTRODUCTION: University students are one of the most vulnerable populations for anxiety disorders worldwide. In Northern Ireland, anxiety disorders appear to be more common among the university student population due to the population demographics across the region. Despite the need, these students show less inclination to access the widely available on-campus well-being services and other external professional services. Digital cognitive-behavioural therapy (CBT) aims to bridge this gap between the need for psychological help and access to it. However, challenges such as limited reach, low adoption, implementation barriers and poor long-term maintenance are mainstay issues resulting in reduced uptake of digital CBT. As a result, the potential impact of digital CBT is currently restricted. The proposed intervention 'Cerina' is a scalable CBT-based mobile app with an interactive user interface that can be implemented in university settings if found to be feasible and effective. METHODS AND ANALYSIS: The study is a single-blind pilot feasibility randomised controlled trial aiming to test the feasibility and preliminary effects of Cerina in reducing Generalised Anxiety Disorder (GAD) symptoms. Participants are 90 Ulster University students aged 18 and above with self-reported GAD symptoms. They will be allocated to two conditions: treatment (ie, access to Cerina for 6 weeks) and a wait-list control group (ie, optional on-campus well-being services for 6 weeks). Participants in the wait-list will access Cerina 6 weeks after their randomisation and participants in both conditions will be assessed at baseline, at 3 (mid-assessment) and 6 weeks (postassessment). The primary outcome is the feasibility of Cerina (ie, adherence to the intervention, its usability and the potential to deliver a full trial in the future). The secondary outcomes include generalised anxiety, depression, worry and quality of life. Additionally, participants in both conditions will be invited to semistructured interviews for process evaluation. ETHICS AND DISSEMINATION: Ethical approval for the study has been granted by the Ulster University Research Ethics Committee (ID: FCPSY-22-084). The results of the study will be disseminated through publications in scientific articles and presentations at relevant conferences and/or public events. TRIAL REGISTRATION NUMBER: NCT06146530.

Description of the Dunning-Kruger effect in general surgery residents during laparoscopic cholecystectomy: a blinded prospective study.

PURPOSE: The purpose of this study is to assess whether the Dunning-Kruger effect occurs in surgical residents when performing laparoscopic cholecystectomy in a porcine model. METHODS: Prospective blinded study, which counted with forty PGY-1 general surgery residents who agreed to participate in the study were blindly recruited to perform a laparoscopic cholecystectomy in a porcine model. At the end of the procedure, the participants assigned a score of 0-10 for their own performance and the video of the operation was independently assessed by 2 experienced laparoscopic surgeons using a validated tool. RESULTS: Participants were divided into groups of 10 individuals according to objective performance and compared. The group with the worst objective result was inferior to the group with the best objective result (3.77 ± 0.44 vs. 8.1 ± 0.44, p < 0.001), but they were similar in self-perception of performance (5.11 ± 1.69 vs. 6.1 ± 1.79, p = 0.999). CONCLUSIONS: In the studied sample, it was possible to demonstrate the presence of the Dunning-Kruger effect.

Effectiveness of a mobile application for independent computerized cognitive training in patients with mild cognitive impairment: study protocol for the NeNaE Study, a randomized controlled trial.

BACKGROUND: Mild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass various cognitive domains as the causes of MCI are diverse. MCI as well as frequent comorbid neuropsychiatric conditions like depression and anxiety affect individuals' quality of life. Early interventions are essential, and computerized cognitive training (cCT) is an established treatment method. This paper presents the protocol for the NeuroNation MED Effectiveness Study, evaluating the self-administered mobile cCT intervention ("NeuroNation MED") in individuals with MCI to assess training effects on cognitive domains, health competence, neuropsychiatric symptoms, psychological well-being, and the general application usability. METHODS: This study protocol presents a single-blinded multicenter randomized controlled trial that will be carried out in six study centers in Germany and Luxembourg. We included adults with MCI (existing F06.7 ICD-10-GM diagnosis and TICS ≥ 21 and ≤ 32). The intervention group will use a mobile, multi-domain cCT ("NeuroNation MED") for 12 weeks. Meanwhile, the wait list control group will receive standard medical care or no care. The eligibility of volunteers will be determined through a telephone screening. After completion of the baseline examination, patients will be randomly assigned to one of the experimental conditions in a 2:1 ratio. In total, 286 participants will be included in this study. The primary outcome is the change of cognitive performance measured by the index score of the screening module of the Neuropsychological Assessment Battery. Secondary outcomes are changes in the Cognitive Failures Questionnaire, Hospital Anxiety and Depression Scale, Health-49, Health Literacy Questionnaire, among others. All of the primary and secondary outcomes will be assessed at baseline and after the 12-week post-allocation period. Furthermore, the intervention group will undergo an assessment of the System Usability Scale, and the training data of the NeuroNation MED application will be analyzed. DISCUSSION: This study aims to assess the effectiveness of a mobile self-administered cCT in enhancing cognitive abilities among individuals diagnosed with MCI. Should the findings confirm the effectiveness of the NeuroNation MED app, it may confer possible benefits for the care management of patients with MCI, owing to the accessibility, cost-effectiveness, and home-based setting it provides. Specifically, the cCT program could provide patients with personalized cognitive training, educational resources, and relaxation techniques, enabling participants to independently engage in cognitive training sessions at home without further supervision. TRIAL REGISTRATION: German Clinical Trials Register DRKS00025133. Registered on November 5, 2021.

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

BACKGROUND: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

PEMOCS: Evaluating the effects of a concept-guided, PErsonalised, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke-study protocol for a randomised controlled trial.

BACKGROUND: Many stroke survivors remain with residual cognitive and motor impairments despite receiving timely acute and sub-acute rehabilitation. This indicates that rehabilitation following stroke should be continuous to meet the needs of individual stroke patients. Both cognitive and motor functions are essential for mastering daily life and, therefore, should be aimed at with rehabilitation. Exergames, motor-cognitive exercises performed using video games, are an auspicious method to train both motor and cognitive functions and at the same time may foster the long-term motivation for training. This study aims to assess the effect of concept-guided, personalised, motor-cognitive exergame training on cognitive and motor functions in chronic stroke survivors. METHODS: This study is a single-blinded, randomised controlled trial. Assessments are performed at baseline, after a 12-week intervention, and at a 24-weeks follow-up. Chronic stroke patients (≥ 18 years old, ≥ 6 months post-stroke) able to stand for 3 min, independently walk 10 m, follow a two-stage command, and without other neurological diseases apart from cognitive deficits or dementia are included. Participants in the intervention group perform the exergame training twice per week for 30 (beginning) up to 40 (end) minutes additionally to their usual care programme. Participants in the control group receive usual care without additional intervention(s). Global cognitive functioning (total Montreal Cognitive Assessment (MoCA) score) is the primary outcome. Secondary outcomes include health-related quality of life, specific cognitive functions, single- and dual-task mobility, and spatiotemporal gait parameters. The target sample size for this trial is 38 participants. Linear mixed models with the post-outcome scores as dependent variables and group and time as fixed effects will be performed for analysis. DISCUSSION: Superior improvements in global cognitive functioning and in the abovementioned secondary outcomes in the intervention group compared to the control group are hypothesised. The results of this study may guide future design of long-term rehabilitation interventions after stroke. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05524727). Registered on September 1, 2022.

The short-term effects of Jin's three needles in conjunction with mirror therapy on brain function in patients with upper limb disability following an ischemic stroke were evaluated using ReHo analysis.

BACKGROUND: Jin's three needle (JTN) is a commonly utilized treatment for ischemic stroke in China. Mirror therapy (MT) is also gradually transitioning from treating limb discomfort to restoring motor function in the damaged limb. Investigations into the 2 treatments' mechanisms of action are still ongoing. We used functional magnetic resonance imaging (fMRI) technique in this study to examine the effects of JTN combined with mirror therapy MT on brain function in patients with upper limb dysfunction in ischemic stroke, as well as potential central mechanisms. The goal was to provide a solid evidence-based medical basis to support the continued use of JTN combination MT. METHODS: This study will be a single-blind, randomized, and controlled experiment. Randomization was used to assign 20 patients who met the study's eligibility requirements to the JTN + MT treatment group or the JTN control group. Each intervention will last for 4 weeks, with 6 days of treatment per week. The JTN acupuncture points are 3 temporal acupuncture points on the opposite side of the wounded limb, 3 hand acupuncture points on the injured upper limb, 3 shoulder acupuncture points, Renzhong and Baihui, The (JTN + MT) group simultaneously takes MT for 30 minutes. fMRI of the brain using BOLD and T1-weighted images was done both before and after therapy. Brain areas exhibiting changes in regional homogeneity during the pre and posttreatment periods were analyzed. RESULTS: By the end of the treatment course, Jin three-needle therapy plus MT activated more relevant brain functional regions and increased cerebral blood oxygen perfusion than Jin three-needle therapy alone (P <.05). CONCLUSION: In patients with upper limb impairment following an ischemic stroke, JTN with MT may improve brain function reconstruction in the relevant areas.

The impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients: A randomized controlled trial.

BACKGROUND AND OBJECTIVES: Dysphagia is a common complication following stroke. It corresponds to the development of pneumonia, which is always associated with bad prognosis, longer hospital stays and increased mortality. The aim of the study was to assess the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients. METHODS: A single-blind randomized controlled trial was carried out on 70 ischemic stroke patients with oropharyngeal dysphagia, age ranged from 49 to 65 years. They were randomly assigned to two groups (control and study) of equal number. Patients in the control group received oral care and nasogastric tube feeding, while patients in the study group received the same program in addition to the designed physical therapy program (exercises and neuromuscular electrical stimulation). The intervention program was applied for 40 min/session, 1 session/day, and 5 days/week for 4 weeks. Gugging swallowing screen (GUSS), and stroke associated pneumonia (SAP) control and prevention criteria were used to assess dysphagia and incidence of pneumonia at baseline, after two and 4 weeks of intervention for both groups. RESULTS: Before treatment, all patients were susceptible to pneumonia after two and 4 weeks of intervention; there were a significant increase in GUSS score in both groups with more improvement in favor of the study group (p < 0.05) and a statistically significant increase in incidence of SAP after 2 weeks of intervention only in the control group (p < 0.05). The results also showed a significant negative correlation between GUSS score and SAP (r = - 0.3662, p = 0.0018) IMPLICATIONS FOR PHYSIOTHERAPY PRACTICE: adding physical therapy (exercise therapy and neuromuscular electrical stimulation) to oral care and nasogastric tube feeding is effective in improving oropharyngeal dysphagia and decreasing the incidence of aspiration pneumonia in acute ischemic stroke patients.

Effect of in-line filtration in newborns: study protocol of the Intravenous Neonatal Central Access Safety (INCAS) randomized controlled trial.

BACKGROUND: Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICUs). This particulate consists of metals, drug crystals, glass fragments, or cotton fibers and can be generated by drug packaging, incomplete reconstitution, and chemical incompatibilities. In-line filters have been shown to remove micro-organisms, endotoxin, air, and particles in critically ill adults and older infants, but its benefits in newborn remain to be demonstrated. Moreover, 50% of inflammatory episodes in the setting of NICUs are blood culture-negative. These episodes could be partly related to the presence of particles in the infusion lines. METHODS: A multicenter randomized single-blind controlled trial was designed. All infants admitted to NICUs for which prolonged infusion therapy is expected will be enrolled in the study and randomized to the Filter or Control arm. All patients will be monitored until discharge, and data will be analyzed according to a "full analysis set." The primary outcome is the frequency of patients with at least one sepsis-like event, defined by any association of suspected sepsis symptoms with a level of c-reactive protein (CRP) > 5 mg/L in a negative-culture contest. The frequency of sepsis, phlebitis, luminal obstruction, and the duration of mechanical ventilation and of catheter days will be evaluated as secondary outcomes. The sample size was calculated at 368 patients per arm. DISCUSSION: This is the first multicenter randomized control trial that compares in-line filtration of parenteral nutrition and other intravenous drugs to infusion without filters. Sepsis-like events are commonly diagnosed in clinical practice and are more frequent than sepsis in a positive culture contest. The risk of these episodes in the target population is estimated at 30-35%, but this data is not confirmed in the literature. If the use of in-line filters results in a significant decrease in sepsis-like events and/or in any other complications, the use of in-line filters in all intravenous administration systems may be recommended in NICUs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05537389, registered on 12 September 2022 ( https://classic. CLINICALTRIALS: gov/ct2/show/results/NCT05537389?view=results ).

Improving Lower Limb Function and Frailty in Frail Older Patients with Acute Myocardial Infarction After Percutaneous Coronary Intervention: A Randomized Controlled Study of Neuromuscular Electrical Stimulation.

Background: A global public health problem, frailty is closely associated with poor prognosis after percutaneous coronary intervention (PCI) in older patients with acute myocardial infarction (AMI). Although exercise intervention is the most commonly used method to reverse and alleviate frailty, its application is restricted in patients with acute myocardial infarction following PCI due to cardiovascular instability and autonomic imbalance. Consequently, there is a need for a new practical intervention to address frailty syndrome in these patients. Purpose: This study aimed to investigate the effect of neuromuscular electrical stimulation in frail older AMI patients post-PCI. Patients and Methods: A single-blind, randomized controlled trial was carried out in the Department of Cardiovascular Medicine from March to October 2023. A total of 100 eligible participants were randomly divided into two groups: experimental (n = 50) and control (n = 50) groups, respectively. Both groups received usual care. The experimental group underwent neuromuscular electrical stimulation (NMES) on bilateral quadriceps and gastrocnemius muscles for 30 minutes daily from day 1 to day 7 after surgery. The primary outcomes measured included the frailty score, lower limb muscle strength, and lower limb muscle quality. Secondary outcomes included the activities of daily living score, inflammatory markers, and length of hospital stay. All participants were included in an intention-to-treat analysis after the study ended. Results: The frailty scores of the two groups exhibited a gradual decrease over time, and the scores of the experimental group were lower than those of the control group at 4 and 7 days after surgery (P<0.001). Concurrently, the lower limb muscle strength showed an increasing trend over the time in the experimental group and a decreasing trend in the control group, and the scores of the experimental group surpassed those of the control group (p<0.001). Moreover, a statistical difference was observed in the lower limb muscle mass across the groups after 7 days postoperatively compared with baseline on both sides (p<0.05). Conclusion: Neuromuscular electrical stimulation has the potential to enhance lower limb function and alleviate frailty in elderly patients with acute myocardial infarction after PCI. These findings introduce a novel intervention approach for frailty management in the elderly population.

Deconstructing Fitbit to Specify the Effective Features in Promoting Physical Activity Among Inactive Adults: Pilot Randomized Controlled Trial.

BACKGROUND: Wearable activity trackers have become key players in mobile health practice as they offer various behavior change techniques (BCTs) to help improve physical activity (PA). Typically, multiple BCTs are implemented simultaneously in a device, making it difficult to identify which BCTs specifically improve PA. OBJECTIVE: We investigated the effects of BCTs implemented on a smartwatch, the Fitbit, to determine how each technique promoted PA. METHODS: This study was a single-blind, pilot randomized controlled trial, in which 70 adults (n=44, 63% women; mean age 40.5, SD 12.56 years; closed user group) were allocated to 1 of 3 BCT conditions: self-monitoring (feedback on participants' own steps), goal setting (providing daily step goals), and social comparison (displaying daily steps achieved by peers). Each intervention lasted for 4 weeks (fully automated), during which participants wore a Fitbit and responded to day-to-day questionnaires regarding motivation. At pre- and postintervention time points (in-person sessions), levels and readiness for PA as well as different aspects of motivation were assessed. RESULTS: Participants showed excellent adherence (mean valid-wear time of Fitbit=26.43/28 days, 94%), and no dropout was recorded. No significant changes were found in self-reported total PA (dz<0.28, P=.40 for the self-monitoring group, P=.58 for the goal setting group, and P=.19 for the social comparison group). Fitbit-assessed step count during the intervention period was slightly higher in the goal setting and social comparison groups than in the self-monitoring group, although the effects did not reach statistical significance (P=.052 and P=.06). However, more than half (27/46, 59%) of the participants in the precontemplation stage reported progress to a higher stage across the 3 conditions. Additionally, significant increases were detected for several aspects of motivation (ie, integrated and external regulation), and significant group differences were identified for the day-to-day changes in external regulation; that is, the self-monitoring group showed a significantly larger increase in the sense of pressure and tension (as part of external regulation) than the goal setting group (P=.04). CONCLUSIONS: Fitbit-implemented BCTs promote readiness and motivation for PA, although their effects on PA levels are marginal. The BCT-specific effects were unclear, but preliminary evidence showed that self-monitoring alone may be perceived demanding. Combining self-monitoring with another BCT (or goal setting, at least) may be important for enhancing continuous engagement in PA. TRIAL REGISTRATION: Open Science Framework; https://osf.io/87qnb/?view_only=f7b72d48bb5044eca4b8ce729f6b403b.

The effect of mandala coloring on anxiety and quality of life of women in the climacteric period: a randomized controlled study.

OBJECTIVE: This study was conducted to determine the effect of mandala coloring on anxiety and quality of life of women in the climacteric period. METHODS: This research was conducted as an experimental study based on a randomized controlled pre-test and post-test model (single-blind). The study was conducted with women in the climacteric period who presented to a training and research hospital in a western city of Turkey between November 1, 2022, and April 28, 2023. Participants were divided into mandala coloring (n=38) and control groups (n=38). RESULTS: According to the women's socio-demographic and descriptive characteristics, mean age, body mass index, and frequency of menopausal symptoms were similar in both groups. The mean post-test scores of the women in the mandala coloring group on the state-trait anxiety inventory and menopause-specific quality of life questionnaire vasomotor, psychosocial, physical, and sexual subscales (29.71±5.22, 0.86±0.97, 0.53±0.61, 0.79±0.84, and 0.92±1.24, respectively) were lower than the mean post-test scores of the women in the control group on the same scales (41.02±1.20, 1.79±1.76, 1.49±1.39, 1.72±1.38, and 1.95±1.82, respectively) (p=0.000). CONCLUSION: Mandala coloring reduces menopause-related anxiety levels and improves quality of life effectively.

EFFECT OF VISCERAL MANIPULATION ON CHILDREN WITH REFRACTORY CHRONIC FUNCTIONAL CONSTIPATION: A RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: Functional constipation (FC) is a common global high prevalence issue in children. OBJECTIVE: The purpose of the present study is to evaluate the effect of visceral manipulation (VM) on children with chronic interacble FC unresponsive to the standard treatment. METHODS: This study was conducted as a randomized, single-blind controlled trial. Fifty-two children with refractory chronic functional constipation unresponsive to the standard medical treatment were randomly allocated to two groups of 26 control (standard medical care (SMC)) and 26 intervention (SMC with VM) for 4 weeks. Abdominal pain, painful defecation, stool consistency, defecation frequency, and the dose of oral laxative were evaluated before and after the treatment period using the Pain Rating Scale, Bristol stool form scale, and patient/parents report. RESULTS: At the end of treatment, except for the dose of oral laxative in the control group, all of the results showed a significant difference in both groups (P<0.05). The dose of oral laxative in the intervention group decreased significantly (P<0.05), however, no significant change was observed in the control group (P>0.05). In the intervention group comparison, statistically significant differences were found in all va-riables except the Bristol stool form scale (P<0.05). The Bristol stool form scale after treatments was not different when the groups were compared (P=0.32), but the number of subjects who had normal stool consistency was significantly increased in the intervention group than in the control group (P<0.05). CONCLUSION: VM can be considered as a possible treatment without side effects besides SMC for the management of chronic FC. Further studies are needed to investigate the long-term effect of VM.

Efficacy of linaclotide in combination with polyethylene glycol for bowel preparation in Chinese patients undergoing colonoscopy polypectomy: protocol for a randomised controlled trial.

BACKGROUND: Adequate bowel preparation is essential for successful colonoscopy and polypectomy procedures. However, a significant proportion of patients still exhibit suboptimal bowel preparation, ranging from 18% to 35%. The effectiveness of bowel preparation agents can be hampered by volume and taste, adversely affecting patient compliance and tolerance. Therefore, exploring strategies to minimise laxative volume and improve patient tolerance and adherence is imperative to ensure optimal bowel preparation quality. METHODS AND ANALYSIS: This study is a two-arm, single-blinded, parallel-group randomised controlled trial designed to compare the efficacy of 2 L polyethylene glycol (PEG) combined with linaclotide with 4 L PEG in bowel cleansing. A total of 422 participants will be randomly assigned in a 1:1 ratio to either the intervention group (2 L PEG combined with 580 µg linaclotide) or the control group (4 L PEG). The primary outcome measure is bowel cleansing efficacy, which is assessed using the Boston Bowel Preparation Scale. Secondary outcomes include evaluating the tolerability and safety of the bowel preparation regimens, bowel diary assessments, postpolypectomy complications (such as bleeding and perforation) and the size and number of removed polyps. ETHICS AND DISSEMINATION: The study has received approval from the Clinical Research Ethics Committee of The First Affiliated Hospital, Zhejiang University School of Medicine. The findings of this trial will serve as a valuable resource for clinicians and patients undergoing colonoscopy polypectomy by guiding the selection of appropriate bowel preparation regimens. Study findings will be disseminated to participants, presented at professional society meetings, and published in peer-reviewed journals. This trial was registered on the Chinese Clinical Trial Registry with registration number ChiCTR2300075410.

Effects of broadband music and audible band music on relaxation states and cognitive function in young adults: a randomized controlled trial.

BACKGROUND: Although broadband music with inaudible high-frequency components may benefit human well-being, this research area is largely unexplored and lacks sufficient studies on the topic. This study aimed to investigate and compare the effects of broadband and audible band music on relaxation states and cognitive function in young adults. METHODS: A single-blind randomized controlled trial was conducted in a professional soundproof laboratory from December 22, 2022, to January 18, 2023 with 32 participants randomly assigned to two groups, "Day 1 broadband + Day 2 audible band" (n = 16) and "Day 1 audible band + Day 2 broadband" (n = 16), listening to either broadband or audible band music (the same music piece played on the piano and harp) for two sessions of 15 min each on two consecutive days. Cognitive function was measured using CNS Vital Signs at pre-listening, after the 1st session, and after the 2nd session, while heart rate was monitored throughout the experiment. Visual Analog Scale was also administered for self-reported arousal, stress, thinking ability, and attention following each listening session. RESULTS: No significant differences were found in heart rate, cognitive flexibility, and executive function between the broadband listening group and the audible band-listening group (p > 0.05). However, the broadband group exhibited significant differences in mean heart rate at several time points, as well as a significant improvement in VAS stress level during the 2nd listening session compared to the 1st (p < 0.05). On the other hand, significant improvements in cognitive flexibility and executive function were observed in the audible band group across different time points (p < 0.05). CONCLUSION: Comparative analysis showed that broadband and audible band music influenced cognitive function differently. Short-term audible band music listening significantly improved cognitive flexibility and executive function, while short-term broadband music listening significantly reduced reaction time in cognitive tests. Additionally, broadband music consistently resulted in lower mean heart rates compared to audible band music at all time points, suggesting that it may be more effective in promoting relaxation and reducing stress, although these differences were not statistically significant. Since the cognitive enhancing effects of broadband music may be counteracted by the drowsy effect of the selected relaxing music, using different types of music may be necessary to confirm its effects in future studies.

Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study.

INTRODUCTION: Physical activity (PA) protects the cardiovascular system and reduces the risk of stroke recurrence. However, most stroke survivors have significantly lower daily PA levels than those recommended. Adapted PA programmes provide a useful means of increasing the daily PA levels of this population. PA programmes designed to encourage people walking have been found to be more effective than no intervention. Some programmes have been applied in institutional settings while others are done on an independent basis. The aim of this study will be to compare the two methods in terms of their impact on the daily walking rates of subjects with spastic hemiparesis following a chronic stroke. Secondary outcomes will include effects on walking ability, endurance, balance, quality of life and motivation for exercise. METHODS AND ANALYSIS: This French single-centre randomised (1:1), controlled, two-arm, parallel, single-blind study will include 40 adults with chronic stroke spastic hemiparesis who are able to walk for 6 min. The primary outcome will be the participants' daily activity measured via the number of steps performed per day using a Stepwatch device. We expect to establish that the institution-based programme will be more effective than a self-managed programme as a means of increasing the PA of chronic stroke subjects. ETHICS AND DISSEMINATION: The protocol was approved by an independent National Ethics Committee (Comité de Protection des personnes Est IV). Participants will be asked to provide their signed informed consent prior to the study. The results will be disseminated via publications in the scientific literature, oral and poster presentations by partners at international scientific meetings and associations of patients. TRIAL REGISTRATION: NCT06061770.

Safety and pharmacokinetics of subcutaneous administration of broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs), given to HIV-1 exposed, uninfected neonates and infants: study protocol for a phase I trial.

BACKGROUND: The ambitious goal to eliminate new pediatric HIV infections by 2030 requires accelerated prevention strategies in high-risk settings such as South Africa. One approach could be pre-exposure prophylaxis (PrEP) with broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs). The aim of our study is to define the optimal dose(s), the ideal combination(s) of bNAbs in terms of potency and breadth, and timing of subcutaneous (SC) administration(s) to prevent breast milk transmission of HIV. METHODS: Two bNAbs, CAP256V2LS and VRC07-523LS, will be assessed in a sequential and randomized phase I, single-site, single-blind, dose-finding trial. We aim to investigate the 28-day safety and pharmacokinetics (PK) profile of incrementally higher doses of these bNAbs in breastfeeding HIV-1 exposed born without HIV neonates alongside standard of care antiretroviral (ARV) medication to prevent (infants) or treat (mothers) HIV infection. The trial design includes 3 steps and 7 arms (1, 2, 3, 4, 5, 6 and 6b) with 8 infants in each arm. The first step will evaluate the safety and PK profile of the bNAbs when given alone as a single subcutaneous (SC) administration at increasing mg/kg body weight doses within 96 h of birth: arms 1, 2 and 3 at doses of 5, 10, and 20 mg/kg of CAP256V2LS, respectively; arms 4 and 5 at doses of 20 and 30 mg/kg of VRC07-523LS, respectively. Step two will evaluate the safety and PK profile of a combination of the two bNAbs administered SC at fixed doses within 96 h of birth. Step three will evaluate the safety and PK profile of the two bNAbs administered SC in combination at fixed doses, after 3 months. Arms 1 and 6 will follow sequential recruitment, whereas randomization will occur sequentially between arms (a) 2 & 4 and (b) 3 & 5. Before each randomization, a safety pause will allow review of safety data of the preceding arms. DISCUSSION: The results of this trial will guide further studies on bNAbs to prevent breast milk transmission of HIV. PROTOCOL VERSION: Version 4.0 dated 15 March 2024. TRIAL REGISTRATION: Pan African Clinical Trial Registry (PACTR): PACTR202205715278722, 21 April 2022; South African National Clinical Trial Registry (SANCTR): DOH-27-062022-6058.

Effect of Using Mouthwash Containing Cibotium barometz J. Smith on Cariogenic Bacteria and Acid-producing Ability of Saliva: A Randomised Blinded Clinical Trial.

PURPOSE: To examine the anti-caries effect of mouthwashes containing Cibotium barometz J. Smith (CB), a natural substance, and compare it with chlorhexidine and saline solution. MATERIALS AND METHODS: A randomised, blinded clinical trial was conducted on 76 study participants. The differences between the 3 gargle groups (saline gargle: SAL; chlorhexidine gargle: CHX; CB gargle group: CB) and the differences over time (baseline, after 1 week, after 2 weeks) were compared. To this end, ANOVA was performed on caries-related clinical indicators (e.g. O'Leary plaque index, caries activity, and satisfaction). RESULTS: The O'Leary index, caries activity, and saliva tests, gradually improved in group CB at one and two weeks. In the case of bacterial tests, unlike SAL and CHX, only in group CB did the decrease occur one and two weeks later. The caries-related indicators decreased significantly over time in group CB compared to SAL and CHX groups, and there was also a statistically significant difference in interaction between groups and time (p<0.05). CONCLUSIONS: The mouthwash containing CB extract showed statistically significant improvement in biofilm adhesion as well as the saliva and bacterial tests compared to SAL and CHX. However, since there were differences in the initial oral conditions of the three groups, additional long-term research is needed through crossover clinical trials to supplement these.

The effect of histopathologic analysis and tissue cultures on inpatient management of cellulitis: a randomized control trial.

BACKGROUND: In the absence of a gold-standard diagnostic modality for cellulitis, sterile inflammatory disorders may be misdiagnosed as cellulitis. OBJECTIVE: To determine the utility of skin biopsy and tissue culture for the diagnosis and management of patients admitted with a diagnosis of presumed cellulitis. DESIGN: Pilot single-blind parallel group randomized controlled clinical trial in 56 patients with a primary diagnosis of presumed cellulitis. In the intervention group only, skin biopsy and tissue culture results were made available to the primary care team to guide diagnosis and management. Length of hospital stay and antibiotic use were evaluated as outcome measures. RESULTS: Length of stay showed the greatest opportunity for further study as a primary outcome (intervention: 4, IQR (2-6) vs. control: 5 IQR (3-8) days; p = 0.124). LIMITATIONS: The COVID-19 pandemic placed limitations on participant enrollment and study duration; in addition, data was collected from a single medical center. CONCLUSION: This study demonstrates that length of stay and anti-pseudomonal antibiotic de-escalation are endpoints that may be influenced by biopsy and tissue culture results in presumed cellulitis patients; these outcomes warrant further study.

Using patients' oral photographs for oral hygiene motivation promotes periodontal health: a prospective randomized controlled trial.

OBJECTIVES: The aim of this prospective, randomized, controlled, single-centered, examiner-blinded clinical trial was to evaluate the effectiveness of a personalized and visual oral health education program in addition to conventional oral hygiene education. MATERIALS AND METHODS: Fifty-six non-smoker, right-handed participants (aged 30.34 ± 11.46 years) without clinical signs of periodontitis were randomly grouped: the intervention group (n = 28) received a personalized visualized oral health education combined with conventional oral hygiene education, and the control group (n = 28) received conventional oral hygiene education only. All participants were assessed for improved periodontal parameters (PI, GI, BOP, and PPD) at baseline, first month, and third month. RESULTS: A significant reduction (p < 0.001) was observed in PI, GI, and BOP during two follow-up sessions compared to the baseline for the two groups. No differences were found for inter-group (p > 0.05) or intra-group (p = 1) comparison of PPD. PI (p = 0.012), GI (p = 0.032), and BOP (p = 0.024) scores were significantly reduced at the third-month follow-up assessment in the intervention group compared to the control group. CONCLUSIONS: Clinical outcomes of periodontal health were significantly enhanced by the personalized and visual oral health education program applied in this study compared to the conventional oral hygiene education program. CLINICAL RELEVANCE: Numerous studies reported additional interventions to the oral hygiene education program. However, we did not find any published studies investigating the role of patients' intra-oral photographs in oral care. This study's results demonstrated that a visually aided education program for oral hygiene motivation may help improve oral health. CLINICAL TRIAL REGISTRATION: Registration number is "NCT06316505" and date of registration is 18/03/2024.