Single-blind Controlled Trial Research Articles

A single session of slow-paced breathing improved cognitive functions and postural control among middle-aged women: a randomized single blinded controlled trial.

The aim of the study was to explore the immediate effects of slow-paced breathing (SPB) on cognitive performance and postural control in middle-aged postmenopausal women. Thirty-four middle-aged women were recruited and assigned to either an experimental group (EG), who practiced SPB, or a control group (CG), who watched an educational video. Both groups had their cognitive functions and postural control assessed using validated tools during both pre-intervention and post-intervention sessions. Simple reaction time, congruent reaction time, incongruent reaction time, and incongruent reaction accuracy improved (P ≤ 0.01) in the EG in the post-intervention compared to the pre-intervention. The incongruent reaction time improved (P ≤ 0.05) among the EG compared to the CG in the post-intervention session. Postural control improved (P ≤ 0.05) post-intervention compared to pre-intervention in the EG, on a firm surface in the eyes closed condition. On the foam surface, postural control improved (P ≤ 0.001) in the post-intervention compared to pre-intervention in the EG irrespective of the vision conditions. Our findings highlight the potential benefits of SPB as a nonpharmacological, cost-effective, and easily accessible intervention to improve cognitive performance and postural control among postmenopausal women. Hence, this technique should be taken into consideration when designing preventive and therapeutic strategies for these women. Additionally, women are encouraged to incorporate this exercise into their daily activities to enhance their quality of life.

Efficacy of diclofenac transdermal patch versus injection as post-cesarean analgesia: A clinical, comparative, single-blind randomized control trial

Objectives: Post-operative pain is a common problem following cesarean delivery. The efficacy of topical application of diclofenac in alleviating pain has not been well established. We aim to evaluate the analgesic effect of transdermal diclofenac patch and compare it with the injectable form. Material and Methods: This is a prospective, randomized, single-blind, and placebo-controlled study. The study protocols and ethical considerations were adhered fully. Parturient women (n = 90) undergoing cesarean section were randomized into two equal groups: the transdermal diclofenac patch (Group A) and the injectable diclofenac (Group B). The surgery was performed under spinal anesthesia. The participant’s demographic data, clinical data, pain relief data collected, compiled, and analyzed using the Statistical Package for the Social Sciences 20. The post-operative pain was scored using Visual Analog Scale. Pain relief scores were compared between the groups using Mann–Whitney U-test and Wilcoxon matched-pair test. Results: The participants match in demographic and clinical characters. The pain relief scores at 12 h was – 3.10 ± 0.74 and 3.04 ± 0.21 respectively while at 24 hours was – 2.48 ± 0.51 and 2.09 ± 0.29 respectively in Group A and Group B. The difference between Group A and Group B was statistically significant (P = 0.0022). The pain relief scores in both groups match was statistically significant at 6–24 h and 6–48 h (P = 0.0001, 0.0001). Conclusion: Diclofenac transdermal patch gives equal pain relief as that of routine injectable formulation.

A multidisciplinary weight management intervention for adults with severe mental illness in forensic psychiatric inpatient services (Motiv8): a single blind cluster-randomised wait-list controlled feasibility trial.

People with severe mental illness experience physical health inequalities and a 15-20-year premature mortality rate. Forensic inpatients are particularly affected by restrictions on movement, long admissions, and obesogenic/sedative psychotropic medication. We aimed to establish the feasibility and acceptability of Motiv8, a multidisciplinary weight management intervention co-produced with service users for forensic inpatients. A randomised waitlist-controlled trial of Motiv8(+Treatment-As-Usual) vs.TAU was conducted in medium-secure forensic services in Greater Manchester. Motiv8 is a 9-week programme of exercise sessions, diet/cooking classes, psychology, physical health/sleep education, and peer support. Physical and mental health assessments were conducted at baseline/10-weeks/3-months. A nested qualitative study captured participant experiences. A staff sub-study explored ward environment. We aimed to recruit 32 participants (four cohorts). The trial met recruitment targets (n=29, 90.9%; 4 cohorts, 100%), participants were randomised to Motiv8+TAU (n=12) or waitlist (control) (n=17). Acceptable retention rates were observed (93.1%, 10-weeks; 72.4%, 3-months), and participants engaged well with the intervention. The blind was maintained, and no safety concerns raised. Assessment completion was high suggesting acceptability (>90% for people retained and engaged in the study). Participants reported high levels of satisfaction. The trial was not powered to detect group differences. However, data suggests it is feasible to conduct a rigorous, methodologically robust study of Motiv8 vs.TAU for adults on forensic inpatient units. Motiv8 was acceptable with potential promise providing evidence to proceed to a definitive trial for males. A larger trial is needed to explore potential effectiveness and reduce physical health inequalities for people with SMI. https://doi.org/10.1186/ISRCTN13539285, identifier ISRCTN13539285.

Comprehensive assessment of heavy slow resistance training and high-dose therapeutic ultrasound in managing patellar tendinopathy, a randomized single-blind controlled trial

BackgroundPatellar tendinopathy (PT) is a common sport injury prone to recurrence. Heavy Slow Resistance Training (HSR) and High-Dose Therapeutic Ultrasound (TUS) are frequently used interventions for PT. However, the combined effectiveness of these therapies remains unclear. This study investigated the impact of combination therapy on functional outcomes in patients with PT.MethodsFifty-one college students aged 18–25, diagnosed with PT via musculoskeletal ultrasound, were randomly assigned to one of three groups (n = 17 per group): combined HSR and high-dose TUS, HSR training alone, or high-dose TUS alone. The eight-week intervention included assessments using the Victorian Institute of Sport Assessment-Patella (VISA-P), Visual Analogue Scale (VAS), Y-balance Test (YBT), Modified Thomas Test (MTT), Horizontal Jumping Distance, Maximum Isometric Muscle Strength Test, and musculoskeletal ultrasound for patellar tendon thickness and blood flow. Assessments were conducted at baseline and post-intervention, with a follow-up VISA-P assessment at week 16. This randomized, single-blind controlled trial was registered on ISRCTN11447397 (www.ISRCTN.com) on February 17, 2024 (retrospectively registered).ResultsAll groups demonstrated significant improvements in VISA-P scores at the end of the intervention compared to baseline (p < 0.01), with the combined group showing the greatest improvement (21 points). Follow-up at week 16 revealed continued improvement in VISA-P scores for the combined and HSR groups, while the TUS group showed a slight decrease (from 74 to 70). All groups displayed significantly reduced VAS scores post-intervention (p < 0.01) compared to baseline, indicating decreased pain. While no significant between-group differences were observed in pre-intervention VAS scores, post-intervention results revealed significant differences between the combined and HSR groups (p < 0.05), as well as between the combined and TUS groups (p < 0.01).ConclusionBoth exercise intervention and high-dose TUS appear effective in reducing pain and improving motor function in individuals with PT. However, the therapeutic effect of high-dose TUS alone seems limited compared to exercise intervention. The combined application of both methods yielded the most significant improvements in pain relief and motor function enhancement.

Effect of herbal soup on immunological parameters of people living with HIV, Kenya - a parallel single blind randomized control trial

Effect of herbal soup on immunological parameters of people living with HIV, Kenya - a parallel single blind randomized control trial

Comparative evaluation of various biomaterials as pulpotomy agents in molars with symptomatic irreversible pulpitis: A randomized single-blinded single-center control trial.

Untreated tooth decay in mature permanent dentition is a prevalent global issue, affecting 34.1% of people with 2.5 billion cases annually. Extensive decay often leads to irreversible pulpitis, characterized by pulp inflammation and pain. Pulpectomy, the standard treatment, involves complex procedures with potential complications. Modern endodontics favors minimally invasive treatment such as pulpotomy, which preserves pulp vitality. This study aims to compare the clinical as well as radiographic outcomes of different pulpotomy agents: Biodentine, mineral trioxide aggregate (MTA), Bio-C repair, and Endosequence Bio-ceramic root repair material (BCRRM) in mature permanent molars. This single-blind, single-center study involved 80 participants randomly assigned to four groups, each receiving one of the biomaterials. Ethical approval was obtained. Participants aged 14-60 years with symptomatic irreversible pulpitis were selected. Pulpotomy procedures were performed, and follow-up evaluations occurred at 24 h, 1 week, 4 weeks, 3, 6, and 12 months. Clinical success was measured by the absence of pain, sensitivity, and tenderness. Radiographic evaluation used the periapical index (PAI) scoring system. Pulpotomy significantly reduced postoperative pain in all groups. Endosequence BCRRM showed the maximum pain reduction at 24 h with a statistically significant difference from all the groups (at 1% probability level), followed by Bio-C repair, Biodentine, and MTA. At 1 week, Bio-C repair led in pain reduction with statistically nonsignificant results. All groups reported no pain at 3, 6, and 12 months. Endosequence BCRRM had the highest improvement in periapical findings at 1 year. Sensitivity to hot and cold improved significantly in all groups, with Endosequence BCRRM performing best. Endosequence BCRRM provided the best overall outcomes, emphasizing the importance of material choice in pulpotomy treatments. Further research on biomaterials' long-term clinical and radiographic outcomes is needed to enhance treatment efficacy.

The evaluation of nightshade elimination diet (NED) on inflammatory and rheumatologic markers of rheumatoid arthritis patients: study protocol for a randomized controlled trial

BackgroundRheumatoid arthritis (RA) is a chronic disease with a global prevalence rate of 1%. Patients with RA often associate specific foods like tomatoes and eggplants with adverse symptoms. These plants contain solanine, which could potentially contribute to bone and joint damage. Despite patient reports, there is a lack of randomized controlled trials (RCTs) investigating the effects of nightshades on patients with RA. This study aims to assess the effect of nightshade elimination diet (NED) on inflammatory and rheumatologic marker levels in rheumatoid arthritis patients for the first time.MethodsA single-blinded controlled trial will be conducted to evaluate the effect of an NED on 40 participants over 8 weeks (2 months). Participants will be equally divided into intervention and placebo groups. Both groups will receive general anti-inflammatory dietary recommendations, with the intervention group undergoing an NED during the study. Clinical symptoms will be assessed using questionnaires, and blood samples will be collected to measure relevant indicators.DiscussionThis RCT signifies a groundbreaking exploration into NED effects on RA markers, potentially initiating crucial discussions in the field. Its outcomes could serve as a cornerstone for larger and more robust trials, offering pivotal insights to nutritionists and physicians for the nuanced management of patients with RA.Trial registrationIranian Registry of Clinical Trials IRCT20230220057465N1 (https://irct.behdasht.gov.ir/trial/68959). Registered on 8 April 2023.

Clinical and neurophysiological effects of bilateral repetitive transcranial magnetic stimulation and EEG-guided neurofeedback in Parkinson’s disease: a randomized, four-arm controlled trial

BackgroundRepetitive Transcranial Magnetic Stimulation (rTMS) and EEG-guided neurofeedback techniques can reduce motor symptoms in Parkinson’s disease (PD). However, the effects of their combination are unknown. Our objective was to determine the immediate and short-term effects on motor and non-motor symptoms, and neurophysiological measures, of rTMS and EEG-guided neurofeedback, alone or combined, compared to no intervention, in people with PD.MethodsA randomized, single-blinded controlled trial with 4 arms was conducted. Group A received eight bilateral, high-frequency (10 Hz) rTMS sessions over the Primary Motor Cortices; Group B received eight 30-minute EEG-guided neurofeedback sessions focused on reducing average bilateral alpha and beta bands; Group C received a combination of A and B; Group D did not receive any therapy. The primary outcome measure was the UPDRS-III at post-intervention and two weeks later. Secondary outcomes were functional mobility, limits of stability, depression, health-related quality-of-life and cortical silent periods. Treatment effects were obtained by longitudinal analysis of covariance mixed-effects models.ResultsForty people with PD participated (27 males, age = 63 ± 8.26 years, baseline UPDRS-III = 15.63 ± 6.99 points, H&Y = 1–3). Group C showed the largest effect on motor symptoms, health-related quality-of-life and cortical silent periods, followed by Group A and Group B. Negligible differences between Groups A-C and Group D for functional mobility or limits of stability were found.ConclusionsThe combination of rTMS and EEG-guided neurofeedback diminished overall motor symptoms and increased quality-of-life, but this was not reflected by changes in functional mobility, postural stability or depression levels.Trial registrationNCT04017481.

Mechanisms of neurodynamic treatments (MONET): a protocol for a mechanistic, randomised, single-blind controlled trial in patients with carpal tunnel syndrome

BackgroundPhysiotherapeutic management is the first-line intervention for patients with entrapment neuropathies such as carpal tunnel syndrome (CTS). As part of physiotherapy, neurodynamic interventions are often used to treat people with peripheral nerve involvement, but their mechanisms of action are yet to be fully understood. The MONET (mechanisms of neurodynamic treatment) study aims to investigate the mechanisms of action of neurodynamic exercise intervention on nerve structure, and function.MethodsThis mechanistic, randomised, single-blind, controlled trial will include 78 people with electrodiagnostically confirmed mild or moderate CTS and 30 healthy participants (N = 108). Patients will be randomly assigned into (1) a 6-week progressive home-based neurodynamic exercise intervention (n = 26), (2) a steroid injection (= 26), or (3) advice (n = 26) group. The primary outcome measure is fractional anisotropy of the median nerve at the wrist using advanced magnetic resonance neuroimaging. Secondary outcome measures include neuroimaging markers at the wrist, quantitative sensory testing, electrodiagnostics, and patient reported outcome measures. Exploratory outcomes include neuroimaging markers at the cervical spine, inflammatory and axonal integrity markers in serial blood samples and biopsies of median nerve innervated skin. We will evaluate outcome measures at baseline and at the end of the 6-week intervention period. We will repeat questionnaires at 6-months. Two-way repeated measures ANCOVAs, followed by posthoc testing will be performed to identify differences in outcome measures among groups and over time.DiscussionThis study will advance our understanding of the mechanisms of action underpinning neurodynamic exercises, which will ultimately help clinicians to better target these treatments to those patients who may benefit from them. The inclusion of a positive control group (steroid injection) and a negative control group (advice) will strengthen the interpretation of our results.Trial registrationNCT05859412, 20/4/2023.

The effects of mouth rinsing and gargling with mouthwash containing povidone-iodine and hydrogen peroxide on the cycle threshold value of Severe Acute Respiratory Syndrome Coronavirus 2: A randomized controlled trial of asymptomatic and mildly symptomatic patients.

Coronavirus disease 2019 can spread rapidly. Surgery in the oral cavity poses a high risk of transmission of severe acute respiratory syndrome coronavirus 2. The American Dental Association and the Centers for Disease Control and Prevention recommend the use of mouthwash containing 1.5% hydrogen peroxide (H 2O 2) or 0.2% povidone iodine (PI) to reduce the viral load in the upper respiratory tract and decrease the risk of transmission. The aim of the present study was to analyze the effect of mouth rinsing and gargling with mouthwash containing 1% PI, 0.5% PI, 3% H 2O 2, or 1.5% H 2O 2 and water on the cycle threshold (CT) value obtained by real-time reverse transcription polymerase chain reaction (RT-PCR). This study is a randomized single blind controlled clinical trial which has been registered in the International Standard Randomized Controlled Trial Number (ISRCTN) registry on the 3 rd February 2022 (Registration number: ISRCTN18356379). In total, 69 subjects recruited from Persahabatan General Hospital who met the inclusion criteria were randomly assigned to one of four treatment groups or the control group. The subjects were instructed to gargle with 15 mL of mouthwash for 30 s in the oral cavity followed by 30 s in the back of the throat, three times per day for 5 days. CT values were collected on postprocedural days 1, 3, and 5. The results of the Friedman test significantly differed among the groups (n=15). The CT values increased from baseline (day 0) to postprocedural days 1, 3, and 5. Mouth rinsing and gargling with mouthwash containing 1% PI, 0.5% PI, 3% H 2O 2, or 1.5% H 2O 2 and water increased the CT value.

Safety and Efficacy of Oral Mifepristone for Cervical Ripening and Induction of Labor.

Background Labor induction, a common practice to prevent maternal and fetal complications from prolonged labor, involves stimulating contractions before they begin naturally. This can be achieved through medications, mechanical methods, or surgical interventions. Cervical ripening is crucial for successful delivery. When the cervix is not sufficiently ripe, drugs are often used to augment this process chemically. Objective To evaluate the safety and efficacy of mifepristone for cervical ripening and induction of labor. Method A sample size of 200 was used in this single-blind randomized control trial. Primarily, pregnant women with term pregnancies, Bishop scores <6, and cephalic fetal presentation were included in the study. The study population was randomly divided into test and control groups. The test group (n=100) was administered 200 mg of mifepristone orally, while the control group (n=100) received a placebo. The Bishop score was reassessed 24 hours after mifepristone administration. Patients were taken for labor induction if their Bishop score was >6. For individuals with a Bishop score of <6, 1 mg of dinoprostone gel was administered intracervically once every six hours. Safety and efficacy were assessed by analyzing several parameters associated with labor progression, maternal outcomes, and fetal outcomes. Results The mean age of patients in the test group was 26±4.5 years, while in the control group, it was 26±5 years. The induction-to-delivery interval was notably shorter in the test group (18.8±2.3 hours) than in the control group (19.24±1.8 hours, p<0.0001). After the administration of 200 mg mifepristone, the mean Bishop score in the test group was 5.74±0.8, compared to 5.13±0.76 in the control group. The increase in the Bishop score after mifepristone treatment was significantly higher in the test group than in the control group (p-value=0.013). In the study, 73 (73%) patients in the test group had a normal vaginal delivery (NVD), whereas NVD accounted for 64 (64%) patients in the control group. Instrumental deliveries were less frequent in the test group, accounting for 14 (14%) patients, compared to 16 (16%) patients in the control group. The frequency of lower segment cesarean section (LSCS) was also lower in the mifepristone-treated group at 13 (13%) compared to the control group at 20 (20%). Fetal distress in five (38%) patients and non-progression of labor in 11 (55%) patients were the most frequent indications for LSCS in the test and control groups, respectively. There was no significant difference in neonatal outcomes between the test and control groups. Meconium-stained liquor was the most frequent complication in both the test group(10, 10%) and the control group (5, or 5%). Conclusion Administration of mifepristone effectively increased the Bishopscores and reduced the induction-to-delivery interval compared to controls, highlighting its potential as a cervical ripening agent.

Comparison of Milrinone with Sildenafil for the Treatment of Persistent Pulmonary Hypertension of the Newborn

Objective: To compare milrinone with sildenafil for the treatment of persistent pulmonary hypertension of the newborn. Methodology: A single blinded randomized control trial was conducted in Department of Pediatrics, Aziz Fatima Hospital Faisalabad from October 2022 to September 2023. 160 infants of persistent pulmonary hypertension were included through non probablity consecutive sampling. Group 1 infants (n = 80) received a loading dose of milrinone intravenously administered over a 60-minute period at a dose of 50 µg/kg. Group 2 infants (n = 80) received sildenafil (2mg per kg per dose three times a day). The medication was continued until extubation. The primary outcome variables were the mortality and duration of hospital stay. Results: Ninety two(57.5%) of the one hubdred &amp; sixty newborns in total were male. 111(69.4%) of the total, were full-term babies. In 114(71.2%) infants, the mode of delivery was C-section. Mortality was observed in 7 (8.8%) patients in milrinone group and 17 (21.2%) patients in sildenafil group with p-value = 0.027. Duration of hospital stay was less in milrinone group as compared to sildenafil group (14.22±3.75 days vs 17.72±5.7 days) with p-value = 0.0001. Conclusion: Milrinone has been proven to be a promising therapeutic choice for persistent pulmonary hypertension in neonates, and it is effective in doing so in low resource settings.

Effect of Curcuma longa Extract as Adjuvant Therapy on IL-6 Serum Levels in Leprosy Type 1 Reaction Patients

Type 1 leprosy reaction / Reversal reaction (RR) is an inflammatory episode in existing leprosy lesions and aggravates the pain rate. Long-term therapy with steroids causes a variety of side effects, so an adjuvant therapy alternative is needed to alleviate steroid use. Curcuma longa rhizome extract has become an anti-inflammatory therapy choice in various previous inflammatory diseases. This study aims to determine the anti-inflammatory effect of Curcuma longa rhizome extract as an adjuvant therapy for reversal reaction patients by analyzing serum levels of IL-6 as a marker of inflammation. The pre and post-test randomized single-blinded controlled trial was conducted on two groups, namely control (RR patients with steroid therapy &amp; placebo) and treatment (steroid therapy &amp; Curcuma longa rhizome extract 1 gram/day). IL-6 serum levels were analyzed from sampling before and after the intervention for one month. The serum levels of IL-6 post-test in the control group were significantly higher than those of the pre-test. The treatment group showed lower serum levels of IL-6 post-test compared to pre-test, although there was no significant difference. Curcuma longa rhizome extract 1 gram/day for one month as adjuvant therapy for patients with type 1 leprosy reaction did not significantly reduce serum IL-6 levels.

Impact of Tai Chi and Aerobic Exercise on Cognitive Function, Balance, Cardiovascular Fitness, and Quality of Life in Older Adults: Randomized Control Trial.

Introduction Tai chi, an ancient Chinese martial art, was originally developed for combat and self-defense. Over time, it has evolved into both a sport and a form of exercise. This gentle, low-impact exercise involves performing a series of deliberate, flowing motions while focusing on deep, slow breaths. This study investigates the effects of chen tai chi and aerobic exercises on cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Methodology This study employed a single-blinded randomized control trial design, enrolling 60 participants aged between 60 and 75 years. Participants were divided into three groups: Group A (aerobics), Group B (chen tai chi), and Group C (control). Exercise sessions were held four days per week over a period of four weeks. Evaluations included the Montreal Cognitive Assessment for cognition, a one-leg stand test for static balance, a Timed Up and Go Test for dynamic balance, a six-minute walk test for cardiopulmonary fitness, and a health-related quality-of-life scale. Assessments were conducted at baseline, immediately after the intervention, and at follow-up was taken after eight weeks. Results Post-intervention, improvements were observed in cognition and static balance across all groups. Within-group analysis revealed that the aerobics group experienced statistically significant enhancements in cognition (p = 0.0001) and static balance (p = 0.01). Although no statistically significant differences were found between groups in terms of dynamic balance, cardiopulmonary fitness, and quality of life, the within-group analysis showed significant improvements in the aerobics group in dynamic balance (p = 0.0009), cardiopulmonary fitness (p = 0.03), and quality of life (p = 0.0001). Conclusion Compared to chen tai chi and no intervention, the study concludes that aerobic exercise has a more pronounced effect on improving cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Aerobic exercise is recommended as an effective method to prevent frailty and promote independence among the elderly.

Effects of peer-education training on cardiopulmonary resuscitation knowledge and skill retention of secondary school students: a feasibility study

ObjectivesThe need for cardiopulmonary resuscitation (CPR) training dissemination in the community could be resolved by mass school training programmes. However, the availability of instructors remains an unsolved problem. Our purpose...

#2430 Comparison of the efficacy of gentamicin-citrate and gentamicin-citrate/Taurolock-urokinase locks for non-tunneled catheters in hemodialysis patients

Abstract Background and Aims Catheter-related complications, such as dysfunction, thrombosis and infection, are associated with significant morbidity and mortality in patients on hemodialysis (HD) receiving dialysis through temporary non-tunneled double-lumen central venous catheters (CVC). Catheter lock solutions containing antibiotics and antitrombolytics are commonly used to prevent such complications. The aim of the present study was to compare impact of a different prophylactic catheter lock solutions on the incidence of catheter-related complications (catheter-related bloodstream infection (CRBSI) and catheter thrombosis) and mortality compared with heparin catheter locks. Method We performed a single-centre prospective, randomized, single-blinded controlled trial of 96 adult patients undergoing HD in our institution from Jun 2018 to Jun 2023. Patients were randomized 1:1:1 to receive either a lock solution combining gentamicin-citrate twice a week with taurolidine-citrate (Taurolock)/urokinase at the end of the third hemodialysis session before the end of the week (TAURO group) or gentamicin-citrate at the end of all hemodialysis sessions (GENTAM group) or unfractionated heparin 5000 U/mL thrice weekly as control (HEPARIN group). Catheter lock solutions were administered for 3 months after insertion of CVC and patients were followed for at least 6 months after insertion of CVC. Demographic, clinical and laboratory parameters, as well as used medications, were analyzed. Episodes of acute catheter thrombosis and incidence of CRBSI were recorded, along with dialysis adequacy (Kt/V) and adverse events. Results The study population (96 patients, 32 in each group) had a median age of 60 years (range 19–85 years), 56.3% man. In the majority of patients (88.5%) the indication for placement of the CVC was the initiation of dialysis, while in the remaining patients indication was thrombosis of the existing vascular access. The most important baseline clinical and laboratory values are presented in Table 1. The catheter median length of stay was of 125.94 ± 87.48 (from 50 to 535) days in TAURO group, 113.44 ± 35.68 (from 54 to 233) days in GENTAM group and 108.59 ± 37.84 (from 42 to 212) days in HEPARIN group (p = 0.831). There was no difference between groups with regard to catheter thrombosis (3.3 events/1000 catheter-days in all groups). The CRBSI rate of 3.2 episodes/1000 catheter-days in TAURO group was slightly lower than the rate of 5.3 episodes/1000 catheter-days in GENTAM group (p = 0.479) and 4.3 episodes/1000 catheter-days in control HEPARIN group (p = 0.705). The CRBSI-free survival time in TAURO group was 197 ± 220 (from 28 to 447) days, longer than in the GENTAM group (38 ± 33 days, from 8 to 86) and HEPARIN group (37 ± 35 days, from 4 to 86), p = 0.21. Impact of catheter lock solution on dialysis adequacy as measured by Kt/V in time is presented in Fig. 1. No significant differences were found between study groups in survival after 6 months (p = 0.810) and at the end study period (p = 0.096)-presented in Fig. 1. Conclusion We observed no difference in the incidence of catheter thrombosis and mortality rate in groups with prophylactic catheter lock solutions and control group. The use of Gentamicin-citrate/Taurolock-urokinase as a dialysis catheter lock solution, as compared with gentamicin-citrate or heparin administered three times a week, led to a nonsignificant reduction of CRBSI incidence and longer CRBSI-free survival time in patients on HD receiving dialysis through temporary non-tunneled double-lumen CVC.

Effectiveness of medication self-management, self-monitoring and a lifestyle intervention on hypertension in poorly controlled patients: The MEDICHY randomized trial.

Uncontrolled hypertension is a common problem worldwide, despite the availability of many effective antihypertensive drugs and lifestyle interventions. We assessed the efficacy of a multi-component intervention in individuals with uncontrolled hypertension in a primary care setting. This study was a randomized, multicenter, parallel, two-arm, single-blind controlled trial performed in primary healthcare centers in Mallorca (Spain). All participants were 35 to 75-years-old and had poorly controlled hypertension. Patients were randomly assigned in a 1:1 ratio to a control group (usual care) or an intervention group (self-monitoring of blood pressure, self-titration of hypertensive medications, dietary interventions, and physical activity interventions). The primary outcome was decrease in the mean SBP at 6 months relative to baseline. A total of 153 participants were randomized to an intervention group (77) or a control group (76). After 6 months, the intervention group had a significantly lower systolic blood pressure (135.1 mmHg [±14.8] vs. 142.7 mmHg [±15.0], adjusted mean difference: 8.7 mmHg [95% CI: 3.4, 13.9], p < 0.001) and a significantly lower diastolic blood pressure (83.5 mmHg [±8.8] vs. 87.00 mmHg [±9.0], adjusted mean difference: 5.4 [95% CI: 2.9, 7.8], p < 0.0001). The intervention group also had significantly more patients who achieved successful blood pressure control (<140/90 mmHg; 54.4% vs. 32.9%, p = 0.011). Self-monitoring of blood pressure in combination with self-management of hypertensive medications, diet, and physical activity in a primary care setting leads to significantly lower blood pressure in patients with poorly controlled hypertension.Clinical Trial Registration: ClinicalTrials.gov, identifier ISRCTN14433778.

Neurofeedback training can increase the effectiveness of neuromuscular training on balance and limit of stability of athletes with chronic ankle instability: three arms and single-blind randomized control trial

Neurofeedback training can increase the effectiveness of neuromuscular training on balance and limit of stability of athletes with chronic ankle instability: three arms and single-blind randomized control trial

EFFECT OF ADDITION OF DEXAMETHASONE TO ROPIVACAINE ON POST-OPERATIVE ANALGESIA IN ULTRASOUND-GUIDED TRANSVERSE ABDOMINIS PLANE BLOCK FOR ANTERIOR ABDOMINAL WALL HERNIA REPAIR

Objective: The objective of the present study was to evaluate the adjuvant effect of dexamethasone to Ropivacaine in ultrasound-guided transverse abdominal plan block for anterior abdominal wall hernia repair. Methods: A single-blind randomized control trial was conducted by selecting patients undergoing anterior abdominal wall hernia and dividing them into two groups with Group A: received a total of 50 mL of 0.2% Ropivacaine (48 mL) with normal saline (2 mL) and Group B received a total 50 mL of 0.2% Ropivacaine (48 mL) with 8 mg dexamethasone (2 mL). Outcome was assessed on the basis of visual analog scale (VAS), the requirement of rescue analgesia, and adverse events. Results: Twenty-seven patients were recruited in each group, Group A and Group B had an average pain-free interval of 11.85±2.82 and 8.07±2.51, respectively (p&lt;0.001). Mean VAS was lower in Group B at the end of 2 h (p&lt;0.05). Both the groups had similar side effects with no significant difference. Total analgesia dose required in Groups B and A was 75 and 96 mg, respectively (p&lt;0.001). Conclusion: A combination of 0.2% Ropivacaine (48 mL) with 8 mg dexamethasone (2 mL) significantly reduces the VAS in post-operative pain along with reduced quantity and frequency of rescue analgesia.

Randomized controlled trial of the CMR immersive virtual reality (IVR) headset training compared to e-learning for operating room configuration of the CMR versius robot

Robotic surgery offers potential advantages over laparoscopic procedures, but the training for configuring robotic systems in the operating room remains underexplored. This study seeks to validate immersive virtual reality (IVR) headset training for setting up the CMR Versius in the operating room. This single-blinded randomized control trial randomised medical students with no prior robotic experience using an online randomiser. The intervention group received IVR headset training, and the control group, e-learning modules. Assessors were blinded to participant group. Primary endpoint was overall score (OS): Likert-scale 1–5: 1 reflecting independent performance, with increasing verbal prompts to a maximum score of 5, requiring physical assistance to complete the task. Secondary endpoints included task scores, time, inter-rater reliability, and concordance with participant confidence scores. Statistical analysis was performed using IBM SPSS Version 27. Of 23 participants analysed, 11 received IVR and 12 received e-learning. The median OS was lower in the IVR group than the e-learning group 53.5 vs 84.5 (p < 0.001). VR recipients performed tasks independently more frequently and required less physical assistance than e-learning participants (p < 0.001). There was no significant difference in time to completion (p = 0.880). Self-assessed confidence scores and assessor scores differed for e-learning participants (p = 0.008), though not IVR participants (p = 0.607). IVR learning is more effective than e-learning for preparing robot-naïve individuals in operating room set-up of the CMR Versius. It offers a feasible, realistic, and accessible option in resource-limited settings and changing dynamics of operating theatre teams. Ongoing deliberate practice, however, is still necessary for achieving optimal performance. ISCRTN Number 10064213.