OBJECTIVES: To determine the safety and oncological advantages of en bloc resection of bladder tumour (ERBT) vs conventional transurethral resection of bladder tumour (cTURBT) in terms of resection quality, staging quality, and safety. PATIENTS AND METHODS: We conducted a single-blinded randomised controlled trial at seven European hospitals with the following inclusion criteria: first diagnosis of non-muscle-invasive bladder cancer, no singular carcinoma in situ, and tumour size >4.3 mm. Patients were randomised intraoperatively in a 1:1 ratio to either the ERBT or cTURBT group. Outcome analysis was performed using the chi-square test, t-test, and multivariate regression analysis. RESULTS: A total of 97 patients were randomised into the study (cTURBT = 40, ERBT = 57). A switch to cTURBT was necessary in two patients (3.5%) and 11.5% of the screened patients were preoperatively excluded for ERBT. There was no difference in the specimen presence of detrusor muscle with 73.7% in cTURBT and 67.3% in ERBT specimens (P = 0.69). There were no significant differences in mean operative time (ERBT 27.6 vs cTURBT 25.4 min, P = 0.450) or mean resection time (ERBT 16.3 vs cTURBT 15.5 min, P = 0.732). Overall the complication rate did not differ significantly (ERBT 18.2% vs cTURBT 7.5%, P = 0.142). Bladder perforations occurred significantly more often in the ERBT group (ERBT seven vs cTURBT none, P = 0.020). R0 status was reported more often after ERBT, whilst a second resection was significantly less frequent after ERBT (P = 0.018). Recurrence rates were comparable for both techniques after 6 months of follow-up. CONCLUSION: The feasibility of ERBT is higher than previously reported. Whereas other perioperative and safety parameters are comparable to cTURBT, bladder perforations occurred significantly more often in the ERBT group and raised safety concerns. This is why this trial was terminated.

• MeSH
• cystektomie * metody   škodlivé účinky   MeSH
• jednoduchá slepá metoda MeSH
• karcinom z přechodných buněk chirurgie   patologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory močového měchýře * chirurgie   patologie   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• transuretrální resekce močového měchýře MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

INTRODUCTION: This was a single-center pilot study that sought to describe an innovative use of 4DryField® PH (premix) for preventing the recurrence of intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis in patients with Asherman's syndrome (AS). MATERIAL AND METHODS: Twenty-three patients with AS were enrolled and 20 were randomized (1:1 ratio) to intrauterine application of 4DryField® PH (n = 10) or Hyalobarrier® gel (n = 10) in a single-blind manner. We evaluated IUAs (American Fertility Society [AFS] score) during initial hysteroscopy and second-look hysteroscopy one month later. Patients completed a follow-up symptoms questionnaire three and reproductive outcomes questionnaire six months later. RESULTS: The demographic and clinical characteristics, as well as severity of IUAs, were comparable in both groups. The mean initial AFS score was 9 and 8.5 in the 4DryField® PH and Hyalobarrier® gel groups, respectively (p = .476). There were no between-group differences in AFS progress (5.9 vs. 5.6, p = .675), need for secondary adhesiolysis (7 vs. 7 patients, p = 1), and the follow-up outcomes. CONCLUSION: 4DryField® PH could be a promising antiadhesive agent for preventing the recurrence of IUAs, showing similar effectiveness and safety to Hyalobarrier® gel. Our findings warrant prospective validation in a larger clinical trial. CLINICAL TRIAL REGISTRY NUMBER: ISRCTN15630617.

• MeSH
• adheze tkání prevence a kontrola   MeSH
• dospělí MeSH
• gely * MeSH
• gynatrézie prevence a kontrola   MeSH
• hysteroskopie * metody   MeSH
• jednoduchá slepá metoda MeSH
• kyselina hyaluronová aplikace a dávkování   MeSH
• lidé MeSH
• nemoci dělohy prevence a kontrola   chirurgie   MeSH
• pilotní projekty MeSH
• recidiva MeSH
• sekundární prevence metody   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

OBJECTIVES: To assess the diagnostic performance and interobserver agreement of CT pulmonary angiography (CTPA) in the detection of chronic thromboembolic pulmonary hypertension (CTEPH) and its features among radiologists of different levels of experience. MATERIALS AND METHODS: In this retrospective, single-center, single-blinded study, three radiologists with different levels of experience in CT imaging (R1:15 years, R2:6 years, and R3:3 years) evaluated CTPA of 51 patients ultimately diagnosed with CTEPH (European Society of Cardiology guidelines) and 49 patients without CTEPH in random order to assess the presence of CTEPH, its features in the pulmonary artery tree, proximal level of involvement, bronchial artery hypertrophy, mosaic perfusion, and right heart overload. RESULTS: CTPAs of 51 patients with CTEPH (median age, 66 years (IQR 56-72), 28 men) and 49 patients without CTEPH (median age, 65 years (IQR 50-74), 25 men) were evaluated. The sensitivity and specificity for the detection of CTEPH was 100% (all radiologists) and 100% (R1), 96% (R2), and 96% (R3) with almost perfect agreement (κ = 0.95). The sensitivity and specificity for detecting CTEPH by mosaic perfusion would be 89% (95%CI 83-93%) and 81% (74-87%). The level of pulmonary artery involvement was reported with moderate agreement (κ = 0.54, 95%CI 0.40-0.65). Substantial agreement was found in the evaluation of mosaic attenuation (κ = 0.75, 95%CI 0.64-0.84), right heart overload (κ = 0.68, 95%CI 0.56-0.79), and bronchial artery hypertrophy (0.71, 95%CI 0.59-0.82) which were the best predictors of CTEPH (p < 0.0001). CONCLUSIONS: CTPA has high sensitivity and specificity in detecting CTEPH and almost perfect agreement among radiologists of different levels of expertise. CLINICAL RELEVANCE: CT pulmonary angiography can be used as a first-line imaging modality in patients with suspected chronic thromboembolic pulmonary hypertension (CTEPH) even when interpreted by non-CTEPH experts. KEY POINTS: • CT pulmonary angiography has high sensitivity and specificity in detecting chronic thromboembolic pulmonary hypertension (CTEPH) and almost perfect interobserver agreement among radiologists of different levels of expertise. • Substantial agreement exists in the assessment of mosaic attenuation, right heart overload, and bronchial artery hypertrophy, which are the best predictors of CTEPH.

• MeSH
• angiografie metody   MeSH
• chronická nemoc MeSH
• hypertrofie MeSH
• jednoduchá slepá metoda MeSH
• lidé středního věku MeSH
• lidé MeSH
• plicní embolie * komplikace   diagnostické zobrazování   MeSH
• plicní hypertenze * komplikace   diagnostické zobrazování   MeSH
• počítačová rentgenová tomografie metody   MeSH
• retrospektivní studie MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a peripheral nerve disorder characterised by weakness and sensory loss. We assessed the neonatal Fc receptor inhibitor rozanolixizumab for CIDP management. METHODS: CIDP01 (NCT03861481) was a randomised, subject-blind, investigator-blind, placebo-controlled, phase 2a study. Adults with definite or probable CIDP receiving subcutaneous or intravenous immunoglobulin maintenance therapy were randomised 1:1 to 12 once-weekly subcutaneous infusions of rozanolixizumab 10 mg/kg or placebo, stratified according to previous immunoglobulin administration route. Investigators administering treatment and assessing efficacy, and patients, were blinded. The primary outcome was a change from baseline (CFB) to day 85 in inflammatory Rasch-built Overall Disability Scale (iRODS) score. Eligible patients who completed CIDP01 entered the open-label extension CIDP04 (NCT04051944). RESULTS: In CIDP01, between 26 March 2019 and 31 March 2021, 34 patients were randomised to rozanolixizumab or placebo (17 (50%) each). No significant difference in CFB to day 85 in iRODS centile score was observed between rozanolixizumab (least squares mean 2.0 (SE 3.2)) and placebo (3.4 (2.6); difference -1.5 (90% CI -7.5 to 4.5)). Overall, 14 (82%) patients receiving rozanolixizumab and 13 (76%) receiving placebo experienced a treatment-emergent adverse event during the treatment period. Across CIDP01 and CIDP04, rozanolixizumab was well tolerated over up to 614 days; no clinically meaningful efficacy results were seen. No deaths occurred. CONCLUSIONS: Rozanolixizumab did not show efficacy in patients with CIDP in this study, although this could be due to a relatively high placebo stability rate. Rozanolixizumab was well tolerated over medium-to-long-term weekly use, with an acceptable safety profile.

• MeSH
• chronická zánětlivá demyelinizační polyneuropatie * farmakoterapie   MeSH
• dospělí MeSH
• humanizované monoklonální protilátky * terapeutické užití   škodlivé účinky   aplikace a dávkování   MeSH
• intravenózní imunoglobuliny terapeutické užití   škodlivé účinky   MeSH
• jednoduchá slepá metoda MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

PURPOSE: Memory plays an essential role in daily life and is one of the first functions to deteriorate in cognitive impairment and dementia. Transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic method; however, its ability to enhance memory is underexplored, especially considering long-term stimulation. We aimed to investigate the effect of a 2-week course of auricular tVNS (taVNS) on memory in a non-clinical population. METHODS: This single-blind randomized placebo-wait-list controlled trial recruited 76 participants (30 men; mean age 48.32 years) and randomized them into four groups: early active/sham taVNS and late active/sham taVNS. Participation in the study lasted 4 weeks; early groups underwent 2 weeks intervention immediately following the first study site visit (days 0-13) and late groups 2 weeks after the first study site visit (days 14-27). Active and sham taVNS included 2 weeks of daily 4-h neurostimulation at the tragus or earlobe, respectively. To assess memory, we used the Rey Auditory Verbal Learning Test. RESULTS: Two weeks of active taVNS, but not sham taVNS, improved immediate recall and short-term memory score both in early and late groups. Furthermore, the improvements persisted over subsequent follow-up in early active taVNS. Importantly, the effect of active taVNS was superior to sham for immediate recall in both early and late groups. There were no statistical differences in delayed recall. CONCLUSION: Our findings suggest that taVNS has potential to improve memory, particularly immediate recall, and may be an effective method in preventing memory loss and mitigating cognitive aging.

• MeSH
• dospělí MeSH
• jednoduchá slepá metoda MeSH
• lidé středního věku MeSH
• lidé MeSH
• paměť * fyziologie   MeSH
• transkutánní elektrická neurostimulace * metody   MeSH
• vagová stimulace * metody   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .

• MeSH
• fibrilace síní * chirurgie   terapie   MeSH
• jednoduchá slepá metoda MeSH
• katetrizační ablace * metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• recidiva MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

PURPOSE: Gastric residual measurement is routinely performed in premature infants prior to feeding despite a lack of evidence of benefit. We aimed to evaluate if the exclusion of routine gastric residual measurement and evaluation has an impact on the time taken to achieve full enteral feeding in preterm neonates. METHODS: International multi-centre randomised controlled trial. Clinically stable, appropriate for gestational age infants between 26+0 and 30+6 weeks of gestation and less than 1.5 kg birth weight were eligible. Infants were randomised to the intervention arm (no monitoring of gastric aspirates) or control arm (routine care). Primary outcome was the achievement of enteral feeds of 100 ml/kg/day by day 5 of life. RESULTS: Ninety-five infants were recruited with 88 included in an intention-to-treat analysis, 45 in the intervention arm and 43 in the control arm. There was no imbalance in baseline characteristics. Thirty-three (73.3%) infants in the intervention group and 32 infants (74.4%) in the control group reached full feeds by day 5 of life (p = 0.91) with no difference in median time to full feeds. There were no statistically significant differences in survival or the major morbidities of prematurity. CONCLUSION: There was no difference in time to attainment of enteral feeds of 100 ml/kg/day in premature infants when gastric residuals were not monitored. In the absence of a clinical benefit to routine monitoring, it may be appropriate to discontinue this practice and only monitor residuals when clinical concern of feeding intolerance or gastrointestinal pathology arises in this group of patients. TRIAL REGISTRATION: NCT03111329- https://clinicaltrials.gov/ . Registered 06/04/2017. WHAT IS KNOWN: • Previous randomized trials have shown little benefit to the performance of routine assessment of gastric residuals in preterm infants. Despite this, they continue to be performed due to concerns from observational data regarding development of NEC. Meta-analysis to date has failed to answer the question regarding NEC. WHAT IS NEW: • In very low birth weight infants who are fed using modern feeding practice of faster feed advancement, to minimize use of central access and parenteral nutrition, exclusion of routine checks of gastric residuals did not increase the proportion of infants reaching full enteral feeds by day 5. No harm was seen when residual checks were not performed. • In the absence of a clinical benefit to the routine performance of gastric residuals in very low birth weight infants, it may be appropriate to discontinue their use and instead check residuals when clinical concern of pathology arises.

• MeSH
• časové faktory MeSH
• enterální výživa * metody   MeSH
• gestační stáří MeSH
• jednoduchá slepá metoda MeSH
• lidé MeSH
• novorozenec nedonošený * MeSH
• novorozenec MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

OBJECTIVE: The purpose of this study was to analyze short-term changes in dynamic and static balance after a manual therapy protocol in healthy participants and analyze any repercussions on mood and perception of change after applying articulatory techniques. METHODS: A single-blind, randomized, multicenter clinical trial was conducted. Participants were allocated to either a manual therapy group (MTG) (n = 101) or a control group (CG) without intervention (n = 99), and measures were taken before treatment, after the intervention, and 1 week after treatment. Assessments included the Star Excursion Balance Test, Unipedal Stance Test (UPST), Profile of Mood States (POMS), and Patient Global Impression of Change (PGIC) scale. RESULTS: Two hundred healthy participants completed the study (mean age, 22 [SD = 2.67]). There was a statistically significant interaction between groups and time measurements in the right leg for anterior (P = .003), posteromedial (P < .001), and posterolateral (P = .001) directions in favor of the MTG, as well as in the left leg for anterior (P < .001), posteromedial (P < .001), and posterolateral (P = .012) directions. The analysis failed to show statistically significant interactions between any of the factors for the UPST and POMS (P > .05). The MTG showed a significant improvement compared to the CG after treatment (P = .003) and at 1-week follow-up (P < .001) on the PGIC scale. CONCLUSION: The results suggest the MT intervention was effective on dynamic balance in post-intervention in healthy participants, and some of the directions maintained the results at 1-week follow-up. Perception of change in post-treatment and 1-week follow-up also significantly improved. The protocol did not seem to produce changes in static balance and mood states. Positive changes after manual therapy were maintained in the short term.

• MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• jednoduchá slepá metoda MeSH
• lidé MeSH
• mladý dospělý MeSH
• muskuloskeletální manipulace * MeSH
• posturální rovnováha * MeSH
• techniky fyzikální terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladý dospělý MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: Exercise-based interventions prevent or delay symptoms and complications of type 2 diabetes (T2D) and are highly recommended for T2D patients; though with very low participation rates. Τelerehabilitation (TR) could act as an alternative to overcome the barriers preventing the promotion of T2D patients' well-being. AIM: Determine the effects of a six-week TR program on glycemic control, functional capacity, muscle strength, PA, quality of life and body composition in patients with T2D. DESIGN: A multicenter randomized, single-blind, parallel-group clinical study. SETTING: Clinical trial. POPULATION: Patients with T2D. METHODS: Thirty T2D patients (75% male, 60.1±10.9 years) were randomly allocated to an intervention group (IG) and a control group (CG) with no exercise intervention. IG enrolled in a supervised, individualized exercise program (combination of aerobic and resistance exercises), 3 times/week for 6 weeks at home via a TR platform. Glycated hemoglobin (HbA1c), six-minute walk test (6MWT), muscle strength (Hand Grip Strength Test [HGS], 30-Second Chair Stand test [30CST] physical activity [IPAQ-SF]), quality of life (SF-36) and anthropometric variables were assessed. RESULTS: Two-way repeated-ANOVA showed a statistically significant interaction between group, time and test differences (6MWT, muscle strength) (V=0.33, F [2.17]=4.14, P=0.03, partial η2=0.22). Paired samples t-test showed a statistically significant improvement in HbA1c (Z=-2.7), 6MWT (Μean ∆=-36.9±27.2 m, t=-4.5), muscle strength (Μean ∆=-1.5±1.4 kg, t=-2.22). Similarly, SF-36 (mental health [Μean ∆=-13.3±21.3%], general health [Μean ∆=-11.4±16.90%]) were statistically improved only in IG. CONCLUSIONS: The findings of this study indicate that a 6-week supervised home-based TR exercise program induced significant benefits in patients with T2D, thus enabling telehealth implementation in rehabilitation practice as an alternative approach. CLINICAL REHABILITATION IMPACT: Home-based exercise via the TR platform is a feasible and effective alternative approach that can help patients with T2D eliminate barriers and increase overall rehabilitation utilization.

• MeSH
• diabetes mellitus 2. typu * MeSH
• glykovaný hemoglobin MeSH
• jednoduchá slepá metoda MeSH
• kvalita života MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• síla ruky MeSH
• telerehabilitace * MeSH
• terapie cvičením MeSH
• videokonferování MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: The administration of local anesthesia (LA) in dental practice requires an injection which is the leading cause of patients' fear and anxiety. Computer-controlled local anesthetic injector, designed to reduce the pain of performing local anesthesia by controlling the speed of injection. This single-blind randomised control trial aimed to compare the pain perception after computer-controlled local anesthesia (CCLA) and conventional LA. METHODS: Dental students were both test and operator group versus an experienced dentist as additional operator of the LA. Data were collected regarding gender, age, medical condition, smoking habits. Additionally, operator feedback about the handling, pain at insertion and during infiltration, excitement (Dental Anxiety Scale), and complications were assessed. RESULTS: Out of the 60 included participants, the majority were females (n = 41; 68.3%), medically healthy (n = 54; 90%), and did not receive medications (n = 54; 90%). While the participating students administered 62 (51.7%) injections, the experienced dentist administered 58 (48.3%) injections. The difference in pain perception on puncture between CCLA and conventional injections was not statistically significant (Sig. = 0.285); however, pain perception during injection was significantly different (Sig. = 0.029) between CCLA (1.65 ± 1.93) and conventional injections (2.49 ± 2.31). CONCLUSION: The professional experience influenced the pain perception while applying the LA. CCLA did not reduce pain on puncture significantly; however, pain perception during the injection was significantly reduced in the case of using CCLA devices compared to the conventional syringe.

• MeSH
• anestetika lokální * MeSH
• bolest MeSH
• jednoduchá slepá metoda MeSH
• lidé MeSH
• lokální anestezie MeSH
• percepce bolesti MeSH
• počítače MeSH
• zubní anestezie * škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH