Single-blind Study Research Articles

Efficacy and Safety of Balneotherapy using Diverse Natural Resources in Lithuania: A Multicenter Study

Background: Balneotherapy or spa therapy, with its multimodal effects, has shown clinical efficacy in treating various pathological conditions. However, further studies are needed to assess its impact on mental health and to evaluate treatment safety. This study aimed to evaluate the effectiveness of different natural resources of the Lithuanian medical spa for stress-related disorders and skin health and to disclose the safety profile of using natural resources. Methodology. We performed a multicenter randomized controlled single-blinded study in 6 Lithuanian medical spas. The 1- 2-week treatment combining mineral water, therapeutic mud, and salt procedures was provided for the 364 participants with moderate stress levels and the effect was evaluated using surveys, instrumental, and laboratory measures. Results. The findings highlighted that the effects of BT using different natural resources significantly improve mental and skin health, as well as contribute to overall health status for up to 6 months. A significant reduction of anxiety, depression, and fatigue as well as improvement in sleep, skin moisture, subjective skin state, and integrative outcomes was achieved in all centers after treatment, while stress and saliva cortisol, working speed, skin oiliness, and elasticity improved in a few centers. A positive result was related to the duration of the treatment, and possibly- to the features of natural resources. Mineral water most commonly caused side effects; it varied among centers, however, they were predominantly local, mild, and transient. Conclusions. Balneotherapy using natural resources is effective for the enhancement of mental and skin health. Further research is necessary for a better understanding of the role of different natural resources on health status and safety profile. Keywords: balneotherapy, health, mental state, mineral water, natural resources, peloids, peloi-dotherapy, safety, spa therapy, skin

Scenting serenity: influence of essential-oil vaporization on dental anxiety - a cluster-randomized, controlled, single-blinded study (AROMA_dent)

Dental fear and anxiety (DFA) is known as an immense challenge in oral healthcare, which can result in compromised oral health, pain, and uncomfortable treatment. The objective of this study was to analyze the effect of essential-oil vaporization on acute anxiety of patients in dental practices. Four dental practices used five weekly cycles of vaporization with each scent: Orange (Citrus sinensis), Swiss Pine (Pinus cembra), Good Mood (blended essential oils: Citrus sinensis, Citrus aurantifolia, Citrus limon, Osmanthus fragrance (5%)), Forest Walk (blended essential oils: Abies grandis, Pinus cembra, Myrtus communis c. t. 1,8-cineol, Abies alba, Citrus paradisi, Abies sibirica, Pseudotsuga menziesii, Vetiveria zizanoides), and water. Acute anxiety was the primary outcome (state-trait-anxiety inventory (STAI-S)). Secondary outcomes were trait anxiety (STAI-T), dental anxiety (Kleinknecht dental fear survey), and pain perception in treatment (numeric rating scale). Across all patients (n = 486), STAI-S was slightly higher in the control group (40.7 ± 11.6) than in the intervention groups (38.4 ± 10.5). Post-hoc analyses revealed that the effect is only robust for the subgroup of female patients (n = 296, p = 0.044). We also conducted a post-hoc additional analysis on a subpopulation with an increased level of STAI-T ≥ 42 (n = 131 patients). For this group the difference in acute anxiety between the control group (51.1 ± 11.9, n = 30) vs. the intervention groups (46.8 ± 9.6, n = 118) was significant (T = 4.39, p = 0.0379). The results of the study indicate a promising potential of essential-oil vaporization to alleviate dental anxiety, particularly in the subgroups of patients with a high level of trait anxiety, and particularly in female patients. The calming effects of the essential-oil vaporization were also highlighted by the anecdotical statements of the dental-practice staff. The anxiety-reducing role of essential-oil vaporization alone and as one part of combined techniques to counter DFA should be further explored using multi-perspective methodological approaches in research.

Development of Novel High and Low Emulsifier Diets Based upon Emulsifier Distribution in the Australian Food Supply for Intervention Studies in Crohn's Disease.

The aims of this study were to develop and evaluate a high/low-emulsifier diet and compare emulsifier content with preclinical studies that have associated Crohn's disease with emulsifiers. Supermarkets were audited with a seven-day high- (HED) and low-emulsifier diet (LED) meal plan developed. The emulsifier content of food was sought from food manufacturers, compared to acceptable daily intake (ADI), and doses were provided in trials. Nutritional composition analysis was completed. Healthy adults ate these diets for seven days in a randomized single-blinded cross-over feeding study to assess palatability, tolerability, satiety, food variety, dietary adherence, blinding and the ease of following the meal plan via visual analogue scale. A database of 1680 foods was created. There was no difference in nutritional content between the HED and LED, except HED had a higher ultra-processed food content (p < 0.001). The HED contained 41 emulsifiers, with 53% of the products able to be quantified for emulsifiers (2.8 g/d), which did not exceed the ADI, was similar to that in observational studies, and was exceeded by doses used in experimental studies. In ten participants, diets were rated similarly in palatability-HED mean 62 (5% CI 37-86) mm vs. LED 68 (54-82) mm-in tolerability-HED 41 (20-61) mm vs. LED 55 (37-73) mm-and in satiety HED 57 (32-81) mm vs. LED 49 (24-73) mm. The combined diets were easy to follow (82 (67-97) mm) with good variety (65 (47-81)) and excellent adherence. Nutritionally well-matched HED and LED were successfully developed, palatable and well tolerated.

Characterizing the accuracy of robotic bronchoscopy in localization & targeting of small pulmonary lesions.

Considering the recent implementation of lung cancer screening guidelines, it is crucial that small pulmonary nodules are accurately diagnosed. There is a significant need for quick, precise, and minimally invasive biopsy methods, especially for patients with small lung lesions in the outer periphery. Robotic bronchoscopy (RB) has recently emerged as a novel solution. The purpose of this study was to evaluate the accuracy of RB compared to the existing standard, electromagnetic navigational bronchoscopy (EM-NB). A prospective, single-blinded, and randomized-controlled study was performed to compare the accuracy of RB to EM-NB in localizing and targeting pulmonary lesions in a porcine lung model. Four operators were tasked with navigating to four pulmonary targets in the outer periphery of a porcine lung, to which they were blinded, using both the RB and EM-NB systems. The dependent variable was accuracy. Accuracy was measured as a rate of success in lesion localization and targeting, the distance from the center of the pulmonary target, and by anatomic location. The independent variable was the navigation system, RB was compared to EM-NB using 1:1 randomization. Of 75 attempts, 72 were successful in lesion localization and 60 were successful in lesion targeting. The success rate for lesion localization was 100% with RB and 91% with EM- NB. The success rate for lesion targeting was 93% with RB and 80% for EM-NB. RB demonstrated superior accuracy in reaching the distance from the center of the lesion, at 0.62mm compared to EM-NB at 1.28mm (p = 0.001). Accuracy was improved using RB compared to EM- NB for lesions in the LLL (p = 0.025), LUL (p < 0.001), and RUL (p < 0.001). Our findings support RB as a more accurate method of navigating and localizing small peripheral pulmonary targets when compared to standard EM-NB in a porcine lung model. This may be attributed to the ability of RB to reduce substantial tissue displacement seen with standard EM-NB navigation. As the development and application of RB advances, so will the ability to accurately diagnose small peripheral lung cancer nodules, providing patients with early-stage lung cancer the best possible outcomes.

A prospective study to evaluate the role of repetitive trans-cranial magnetic stimulation in treatment of chronic low back pain

Introduction: Chronic Low Back Pain (CLBP) is a disabling musculoskeletal condition with a high prevalence in developing and developed countries. There are many treatment modalities but none of them provides a satisfactory and consistent cure. Recently focus has shifted to neuromodulation to cure chronic pains. The U.S. Food and Drug Administration (FDA) approved the use of Repetitive TMS (rTMS) in the management of Pain in 2013. Since then, centres across the world have been using Transcranial Magnetic Stimulation (TMS) as a noninvasive modality for the treatment of various pain conditions. rTMS is a variation of TMS where stimulation is provided in sessions to create long-term excitation in the brain cortex. Evidence on the effectiveness of rTMS for CLBP is scarce due to limited rigorous clinical trials. This study is the first of its kind undertaken in India to critically analyze the role of rTMS in the treatment of CLBP. Materials &amp; Methods: In this single institutional prospective, single-blind study, we enrolled 40 patients of CLBP sharing similar clinical profiles. They were divided into a test group and a sham group. In the test group patients were given rTMS in addition to conventional treatment while in the sham group, patients were taken through the procedure of rTMS without actually being administered it. A figure-of-eight-shaped coil was used focusing on the Left M1 area and Dorsolateral prefrontal cortex to administer the rTMS by a trained physician. Visual Analogue Scores (VAS) were noted before and after the procedure. Each patient was continuously monitored during the procedure for any side effects. Subsequently, they were interviewed and followed up for 6 months. At the end of 6 months, data was compiled and conclusions were drawn. Result: In our study, we found that 90 per cent of patients in the test group reported a reduction in VAS score by 30 per cent reduction while the remaining had a 20 per cent reduction in pain scores. 90 per cent of subjects in the sham group reported a marginal improvement in VAS score which can be attributed to the placebo effect. Most patients in the test group reported an improvement in quality of life at the end of six months. None of the patients suffered any untoward side effects during or after the procedure. Conclusion: Based on our study we conclude that rTMS is a safe procedure and it can be used as a modality in treating CLBP with satisfactory outcomes. Although the sample size was small, it is the first study of its kind undertaken in India to evaluate the role of rTMS-based neuromodulation in treating this chronic disabling condition. However, to be accepted as a standard of care for CLBP it will require further multi-institutional robust clinical trials with long-term follow-up.

Comparison of the efficacy of intradialytic core stabilization and aerobic exercises for hemodialysis patients: randomized controlled single-blind study

Purpose This study was performed to investigate and compare the effects of intradialytic core stabilization and aerobic exercises on physical performance, fatigue, quality of life and dialysis adequacy. Materials and methods The study involved 39 individuals on hemodialysis randomized into two groups: aerobic exercise (AE, n = 20) and core stabilization (CSE, n = 19). Over 8 weeks, the AE group performed pedal ergometer exercises, while the CSE group performed 4-phase core stabilization exercises. Physical performance (five times sit to stand test, 2-min step test), quality of life (Kidney Disease Quality of Life-36; KDQOL-36), fatigue levels (Piper Fatigue Scale), and dialysis adequacy (Kt/V and URR) were assessed. Results After training, a significant improvement was observed in the physical performance, fatigue levels, and some parameters of KDQOL-36 of the patients (p < 0.05). However, no significant changes were observed in dialysis adequacy indicators (Kt/V and URR) (p > 0.05). When the amount of development obtained in both treatment groups is compared, kidney disease burden only in the subparameter of KDQOL-36 was statistically significantly improved in the CSE group compared to the AE group (p < 0.05). Conclusions According to the results of the study, intradialytic core stabilization exercises appear to have similar effects to aerobic exercises and can be performed by HD patients.

The effect of preoperative botulinum toxin a injection on traction force during hernia repair: a prospective, single-blind study, intra-patient comparison using contralateral side as a control

PurposeVentral hernias are a common complication of laparotomy, posing challenges particularly when primary fascial closure is unattainable. Although chemical component separation using preoperative botulinum toxin A (BTX) injections has emerged as a promising adjunct, objective evidence of its efficacy remains limited. This study aimed to objectively assess the effect of preoperative BTX on traction force during ventral hernia repair.MethodsA prospective, single-blind study was conducted on patients with midline incisional hernias following liver transplantation. BTX was administered unilaterally, and the traction force required to medially advance the anterior rectus sheath was measured intraoperatively. Pre- and post-injection CT scans were analyzed for changes in hernia size and LAW muscle measurements. Statistical analyses were performed to evaluate traction force differences between BTX-injected and uninjected sides.ResultsTen patients underwent hernia repair with primary fascial closure achieved in all cases. Comparison of pre- and post-injection CT scans showed no significant changes in hernia size. LAW muscle length increased by 1.8 cm, while thickness decreased by 0.2 cm. Intraoperative traction force measurements revealed a significant reduction on the BTX-injected side compared to the uninjected side (p < 0.0001). The traction force ratio on the BTX-injected to the uninjected side averaged 57%, indicating the efficacy of BTX in reducing tension.ConclusionPreoperative BTX significantly reduces traction force during ventral hernia repair, highlighting its potential as an adjunctive therapy in complex cases. While challenges remain in patient selection and outcome assessment, BTX offers a promising avenue for enhancing abdominal wall reconstruction outcomes and reducing surgical complications.

Data-science-guided calibration curve prediction of an MLCT-based ee determination assay for chiral amines

Circular dichroism (CD) based enantiomeric excess (ee) determination assays are optical alternatives to chromatographic ee determination in high-throughput screening (HTS) applications. However, the implementation of these assays requires calibration experiments using enantioenriched materials. We present a data-driven approach that circumvents the need for chiral resolution and calibration experiments for an octahedral Fe(II) complex (1) used for the ee determination of α-chiral primary amines. By computationally parameterizing the imine ligands formed in the assay conditions, a model of the circular dichroism (CD) response of the Fe(II) assembly was developed. Using this model, calibration curves were generated for four analytes and compared to experimentally generated curves. In a single-blind ee determination study, the ee values of unknown samples were determined within 9% mean absolute error, which rivals the error using experimentally generated calibration curves.

Comparison of Postprocedure Cardiac Catheterization Recovery Instructions on Participant’s Perceived Comprehension and Satisfaction

PurposeThe purpose of this study was to evaluate the effect of education timing on patient satisfaction and perceived knowledge comprehension of recovery instructions in cardiac catheterization patients. DesignThis prospective quasi-experimental single-blinded study was blinded to the participant. MethodsThis study was conducted between January and August 2022 in the cardiac catheterization laboratory of a New York metropolitan community hospital. Seventy-seven cardiac catheterization participants were randomized into two groups. The intervention group (n = 40) received instructions preprocedurally, while the control group (n = 37) received instructions per standard of care postprocedurally. The study team designed a nine-question satisfaction and perceived comprehension survey, which was used as the primary data collection tool. Data were collected through telephone interviews conducted 24 to 48 hours postprocedure. Chi-square (χ2) analysis was used to determine associations between the two groups. FindingsResults revealed the participants in the intervention group (97.5%, n = 39) were more satisfied than those in the control group (83.8%, n = 31). Satisfaction with instructions about managing arterial bleeding was higher in the intervention group (100%, n = 40) than in the control group (83.8%, n = 31). There was a statistically significant difference in perceived comprehension of management of arterial bleeding (χ2 = 5.22, P < .05) and management difficulty urinating (χ2 = 5.69, P < .05), where the intervention group scored significantly higher than the control group. Major feedback from participants included recommendations to enhance written instructions for clarity. ConclusionsDelivering instructions preprocedurally compared to the standard of care revealed higher patient satisfaction and perceived comprehension of recovery instructions in cardiac catheterization patients. This study demonstrates how clinical nurses can translate nursing research into patient-centered outcomes, bridging research and practice gaps.

Acute effects of multi-ingredient pre-workout dietary supplement on anaerobic performance in untrained men: a randomized, crossover, single blind study

BackgroundMulti-ingredient pre-workout dietary supplements (MIPS), which are combinations of different ingredients acting on different physiological mechanisms, can have a synergistic effect and improve performance. The aim of the study was to determine the acute effects of a multi-ingredient pre-workout supplement containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on anaerobic performance.MethodsA randomized, crossover, single-blind study was designed. Twelve young, healthy, untrained men aged 22.4 ± 1.44 years participated in the study. The participants performed a supramaximal all-out test (20 s Wingate test) twice, day by day, in random order: test after placebo or MIPS consumption. In both trials, the following variables were measured in the exercise test: total work performed, peak power, mean power, time to reach peak power, and power decrease.ResultsMIPS was found to be effective in improving peak power (p = 0.009, ES = 0.77) and mean power (p = 0.04, ES = 0.62) in the Wingate test. However, the supplement consumption did not affect the amount of total work done (p = 0.10, ES = 0.48) in the test or power decrease (p = 0.07, ES = 0.53). The data indicate, that the improvement in anaerobic power was due to a significant improvement in pedaling speed, which was manifested in a significant improvement (i.e. shortening) in time to peak power (p = 0.003, ES = 0.88).ConclusionA multi-ingredient pre-workout dietary supplement was found to be effective in improving Wingate (anaerobic) performance.Trial registrationNCT06363669, retrospectively registered on 11.04.2024 (ClinicalTrials.gov).

Effectiveness of Intermittent Theta Burst Stimulation to Enhance Upper Extremity Recovery After Stroke: A Pilot Study

ObjectivesTo first investigate the effectiveness of modified constraint-ınduced movement therapy (mCIMT) in low-functioning patients with stroke (PwS). Second, we aimed to investigate the efficiency of intermittent theta-burst stimulation (iTBS), applied on intermittent days, in addition to the mCIMT in PwS. DesignA randomized, sham-controlled, single-blinded study. SettingOutpatient clinic. ParticipantsFifteen PwS (age [mean±SD]: 66.3±9.2 years; 53% female) who were in the first 1 to 12 months after the incident were included in the study. InterventionsPwS were divided into 3 groups: (1) mCIMT alone; (2) mCIMT + sham iTBS; (3) mCIMT + iTBS. Each group received 15 sessions of mCIMT (1 hour/session, 3 sessions/week). iTBS was applied with 600 pulses on impaired M1 before mCIMT. Main Outcome MeasuresUpper extremity (UE) impairment was assessed with the Fugl-Meyer Test (FMT-UE), whereas the motor function was evaluated with the Wolf-Motor Function Test (WMFT). Motor Activity Log-28 (MAL-28) was used to evaluate the amount of use and how well (How Well Scale) the impaired UE movements. ResultsWith-in-group analysis revealed that all groups had statistically significant improvements based on the FMT-UE and MAL-28 (p<.05). However, the performance time and arm strength variables of WMFT were only increased in the mCIMT + iTBS group (p<.05). The only between-group difference was observed in the intracortical facilitation in favor of the mCIMT + iTBS group (p<.05). The effect size of iTBS was f=0.18. ConclusionsOur findings suggest that mCIMT with and without the application of iTBS has increased the UE motor function in low-functioning PwS. iTBS applied on intermittent days may have additional benefits as an adjunct therapy for facilitating cortical excitability, increasing the speed and strength of the impaired UE as well as decreasing disability.

Efficacy of 10%,25% and 50% dextrose in the treatment of hypoglycemia in the emergency department – A randomized controlled study

IntroductionDocumented symptomatic hypoglycemia is defined as “event during which typical symptoms of hypoglycemia are accompanied by measured blood glucose of ≤70 mg/dL. Most of the studies and recommendations for the unconscious hypoglycemic adult advocate the use of 25 g of glucose as 50 mL of 50% dextrose solution intravenous or 1 mg of intramuscular glucagon. ObjectiveTo compare the efficacy and safety of 5 g boluses of 10%, 25% and 50% dextrose in the treatment of hypoglycemic patients presenting to our emergency department. MethodsThis was a randomized controlled single blinded study. Hypoglycemic patients in altered mental status were randomized into three treatment arms to be administered 10%, 25% or 50% dextrose. 5 g aliquots of intravenous 10%,25% or 50% dextrose were administered over 1 min. Time taken to achieve a Glasgow Coma Scale (GCS) of 15 and median total doses (g) were the primary outcomes. ResultsData of 204 patients were analysed in the study. There was no difference in the median time to achieve a GCS of 15 in all three treatment arms (6 min). Total median dose administered in the 10% and 25% groups was lower than 50% (10 g vs 15 g). Proportion of patients who received the maximum dose of 25 g was higher in the 50% group as compared to 10% and 25% groups (12%, 3%, 4%). ConclusionThere was no difference in 10% dextrose and 25% dextrose as compared to 50% dextrose in achieving the baseline mental status (or GCS 15) in the treatment of hypoglycemia in the ED.

Effect of surface-modified intraocular lenses on long-term postoperative inhibition of posterior capsule opacification

We compared the posterior capsule opacification incidences at 5 years postoperatively and the neodymium–yttrium–aluminum–garnet capsulotomy rates at 10 years postoperatively for two types of intraocular lenses with different optical properties and shapes. This randomized, controlled, prospective, single-blinded study with intra-individual comparisons was conducted between July 21, 2009, and August 31, 2011, at the Dokkyo Medical University Hospital, Tochigi, Japan. Thirty patients (60 eyes) underwent bilateral cataract surgery and received a XY1 intraocular lens in one eye and a FY-60AD intraocular lens in the other. Both intraocular lenses are acrylic and manufactured by HOYA. The XY1 lens is a single-piece, tinted intraocular lens featuring an ultraviolet/ozone treatment on the posterior surface of the lens optic, aimed at enhancing posterior capsule adhesion to prevent posterior capsule opacification. Conversely, the FY-60AD is a tinted intraocular lens with modified polymethylmethacrylate C-loops and no ultraviolet/ozone treatment of the optic. Scheimpflug images were taken using EAS-1000 (NIDEK Co., Ltd., Aichi, Japan), and the scattered light intensity (computer compatible tape) on the posterior surface of the intraocular lens was calculated and evaluated as the posterior capsule opacification. The scattered light values of the XY1 and FY-60AD groups were 6.50 ± 5.69 and 11.64 ± 5.30 computer compatible tape, respectively, at 5 years postoperatively. The cumulative survival incidence after neodymium–yttrium–aluminum–garnet laser capsulotomy was 74.8 % in the XY1 group and 13.8 % in the FY-60AD group at 10 years postoperatively. The surface-modified intraocular lens XY1 reduced the incidence of posterior capsule opacification even 10 years after surgery. Surface modification to increase the adhesion between the intraocular lens and the capsule effectively prevents posterior capsule opacification.

A prospective, randomized, single-blinded study evaluating the effect of frozen-section directed excision on positive surgical margins in high-grade vulvar dysplasia.

TPS5644 Background: Vulvar cancer accounts for 2-5% of gynecologic malignancies. As with many skin cancers, vulvar cancer is preceded by a dysplastic state. Currently, wide local excision (WLE) is the surgical treatment modality used to excise visually dysplastic tissue, with a 0.5 cm border. However, this methodology does not incorporate the risk of microinvasion and positive margins on the tissue sample. The significance in having positive margins is a 3-fold higher risk of recurrence when positive margins are present. Our study seeks to compare this current standard of care with a frozen section directed excision, which is similar to Mohs Surgery, a long-established surgical technique mainly used in dermatology. This technique allows for repeated pathologic evaluation to ensure negative margins are present before cessation of the surgery. The goal of this study is to show the superiority of Frozen-Section Directed Excision (FSDE) in conducting vulvectomies in reducing positive margin rates, thus potentially reducing recurrence rates. Methods: This is a prospective randomized, single-blinded study. The target population is adults ≥ 18 years of age with histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures. One group of subjects is assigned to the FSDE surgery arm and will undergo this procedure. The other group of subjects will be assigned to the WLE (standard of care) arm and will undergo that procedure. The randomization will be 1:1. This trial is designed as a group sequential study with two primary analysis timepoints. The interim analysis will occur after the surgical margin status is known for the first 56 evaluable subjects and the second after all (112 targeted) evaluable subjects. Information regarding the surgery procedure, the amount of time the surgery procedure takes, and total amount of pain medication required during surgery and while in the surgery recovery area will be collected. The study team will also look at recurrence rates in six months, if any other therapies are required, and subject satisfaction related to the surgery, recovery, and sexual function by using questionnaires before and after the procedure. Based on previously published cases and a review of cases of vulvar excision at our institution, it is anticipated that the rate of positive margins will exceed 50% with standard surgery. It is expected that FSDE will reduce the positive margin rate by at least 50%. Assuming 56% of standard surgeries result in positive margins and a two-tailed alpha of 0.05, 56 subjects per arm or a total of 112 evaluable subjects will provide 80% power to detect this difference. Clinical trial information: NCT05934851 .

Histological Properties of Adipose Tissue as an Autologous Tissue Filler Harvested from Different Donor Areas and Impact of Centrifugation.

As a burgeoning technique in reconstructive and aesthetic surgery, lipofilling's success is hindered by the unpredictability of graft integrity and quality. This study addresses the critical need to enhance consistency and reproducibility by exploring the clinical utility of adipose tissue from specific body areas, considering the influence of patient-specific factors and mechanical processing on fat graft integrity and morphology. In a prospective, randomized, single-blind study, 52 patients undergoing surgical reconstruction due to significant deformities were enrolled. Lipoaspiration from four areas was performed. Adipose tissue was compared using five parameters of tissue damage and 10 parameters of graft integrity, assessed immediately postcollection and after centrifugation. The study aimed to evaluate the structural integrity and clinical applicability of adipocytes. Morphological assessment revealed no significant differences in adipose tissue quality across donor sites, suggesting consistent graft quality regardless of the harvesting location. Centrifugation induced more morphological damage than noncentrifuged samples, but the overall graft integrity was maintained due to increased cell density. Higher graft acceptance parameters were noted in noncentrifuged samples compared with centrifuged ones. Despite centrifugation-induced morphological changes, adipose tissue integrity remains relatively unaffected, supporting a flexible approach to donor site selection. The consistent quality of adipose tissue underscores the potential for autologous fat transplantation across various clinical scenarios. Optimizing graft processing techniques is crucial for enhancing the predictability and efficacy of lipofilling.

Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial.

Constipation is an independent risk factor for poor bowel preparation. This study aimed to evaluate the bowel cleansing efficacy and safety of polyethylene glycol (PEG) combined with linaclotide (lin) for colonoscopy in patients with chronic constipation (CC). This single-blinded, randomized, controlled, and multicenter study was conducted from July 2021 to December 2022 at 7 hospitals. Patients with CC who underwent colonoscopies were enrolled and randomly assigned to 4 groups with split-PEG regimens: 4L-PEG group, 4L-PEG+1d-Lin group, 3L-PEG+1d-Lin group, and 3L-PEG+3d-Lin group. The primary outcome was rates of adequate bowel preparation, defined as a total BBPS score ≥6 and a score ≥2 for each segment. Secondary outcomes were adverse effects, sleep quality, willingness to repeat the colonoscopy, adenoma detection rate, and polyp detection rate. Five hundred two patients were enrolled. The rates of adequate bowel preparation (80.0% vs 60.3%, P < 0.001; 84.4% vs 60.3%, P < 0.001) and the total Boston Bowel Preparation Scale (BBPS) scores (6.90 ± 1.28 vs 6.00 ± 1.61, P < 0.001; 7.03 ± 1.24 vs 6.00 ± 1.61, P < 0.01) in the 4L-PEG+1d-Lin group and the 3L-PEG+3d-Lin group were superior to that in the 4L-PEG group. Compared with the 4L-PEG group, the 4L-PEG+1d-Lin group (66.7% vs 81.7%, P = 0.008) and the 3L-PEG+3d-Lin group (75.0% vs 81.7%, P = 0.224) had a lower percentage of mild adverse events. No statistically significant difference in willingness to repeat the colonoscopy, sleep quality, polyp detection rate, or adenoma detection rate was observed among groups. PEG combined with linaclotide might be an effective method for bowel preparation before colonoscopy in patients with CC.

Cancer associated macrophages in blood correlates with poor outcomes in patients with clinically resectable disease in gastrointestinal cancers.

e15052 Background: Gastrointestinal (GI) cancers, i.e., pancreatic (PC), colorectal (CC), and esophageal (EC), are known to be both highly aggressive and clinically underdiagnosed, resulting in high rates of relapse after standard neoadjuvant therapy with curative intent resection. While cancer biomarkers (i.e. CEA, CA19-9) can aid in identifying early relapse post-resection, they lack accuracy and do not aid in identifying underdiagnosed patients. Recently, a circulating phagocytic macrophage engorged to ≥50 µm, i.e. cancer-associated macrophage-like cells (CAMLs), were identified in GI cancers and associated with highly aggressive cancer subtypes. However, monitoring CAMLs pre- and post-surgery and their clinical value in minimal residual disease remains unexplored. In this pilot study, we prospectively evaluated the blood of n = 133 patients with GI cancer pre- and post-surgery to assess CAMLs in resectable disease, and their association with progression free survival (PFS), relapse free survival (RFS), and overall survival (OS). Methods: In a single-blind multi-institutional prospective pilot study, we recruited n = 133 GI patients with newly diagnosed clinically resectable disease (n = 118), or with metastatic disease scheduled for curative resection post systemic therapy (n = 15). Whole peripheral blood (7.5mL) was drawn prior to neoadjuvant chemotherapy and/or radiation therapy at T1, and a post-surgery sample (T2) was obtained. CAMLs were filtered, stained with cytokeratin &amp; CD45, and enumerated for CAML engorgement of ≥50 µm, as previously described. Cox proportional regression hazard ratios for PFS, RFS &amp; OS using univariate and multivariate analyses were run over 96 months. Results: Of the patients with clinically resectable EC (n = 36/133), PC (n = 75/133) or CC (n = 22/133), 32% of patients (n = 43/133) did not undergo curative resection. T1 samples drawn pre-surgery were available from n = 105 patients and T2 samples drawn post-surgery were available from = 52 patients. Engorged ≥50 µm CAMLs were found in 51% (n = 53/105) of T1 patients and were significantly associated with worse PFS (HR = 3.4 CI95% 2.0-5.8, p &lt; 0.001) and worse OS (HR = 63.5 CI95% 2.0-6.1, p &lt; 0.001), compared to patients with &lt; 50 µm CAMLs. Additionally, engorged ≥50 µm CAMLs were found in 60% (n = 31/52) of T2 patient samples and were associated with significantly worse RFS (HR = 5.7, CI95% 2.4-13.2, p &lt; 0.001) and OS (HR = 5.3, CI95% 2.2-13.3, p &lt; 0.001) compared to patients with &lt; 50 µm CAMLs. Conclusions: These data suggest that GI cancer patients with CAMLs ≥50µm prior to curative intent resection have high rates of progression, and their presence post surgery may identify patients with residual disease that are likely to relapse. Given these results, more refined studies should evaluate CAMLs ability to identify such at risk patients who may benefit from alternative therapeutic approaches.

Effect of Transcutaneous Electrical Nerve Stimulation on Gait Parameters in Dogs with Osteoarthritis.

Osteoarthritis is a common degenerative disease in dogs, often manifested as pain, joint swelling, and lameness. Despite the lack of scientific evidence for its treatment efficacy, transcutaneous electrical nerve stimulation (TENS) is used in dogs as a pain-relieving treatment. This randomised single-blinded cross-over study investigated the effect of TENS on gait parameters in fifteen dogs with osteoarthritis. Stance time, swing time, stride time, stride length, peak vertical force (%BW), vertical impulse (%BW*sec), and symmetry indices were obtained using a pressure-sensitive mat. TENS treatment of 80 Hz and 100 µs with an individually selected amplitude was conducted for 45 min once daily for a treatment period of seven or ten days. No significant differences were seen between TENS and placebo for any of the gait parameters. Hence, in this study, TENS did not affect gait parameters, compared to placebo. Further studies are needed to confirm the observations.

Scalp Nerve Block for Enhanced Pain Control and Analgesic Optimization in Elective Craniotomy: A Randomized Controlled Trial with Analgesia Nociception Index Monitoring

In patients who are candidates for craniotomy, scalp nerve blocks have been shown to be effective in relieving pain intensity as well as postoperative hemodynamic stability after surgery, but the results have been inconsistent. We aimed to assess the effect of scalp block on pain control, intraoperative drug use under Analgesia Nociception Index (ANI) monitoring, and postoperative pain in patients who were candidates for elective craniotomy. In this randomized, single-blinded clinical trial study, candidates for craniotomy were randomly (using the block randomization method) divided into 2 groups before entering the operating room. The first group received a scalp block with bupivacaine (intervention), and the second group did not receive a scalp block (control) besides the routine anesthetic procedure in these patients. ANI, hemodynamic parameters, and the amounts of received remifentanil were conducted and compared. Patients under scalp block received less dosage of fentanyl than the nonscalp block group (mean=57.14±15.59 mcg vs. 250.00±65.04 mcg, respectively). Similarly, the dose of remifentanil required in the scalp block group was less (mean=3.04±1.95mg and 5.54±2.57mg, respectively). No difference was observed in hemodynamic parameters such as blood pressure and heart rate (before, during, and after surgery). However, the group receiving scalp block had higher ANI means than the control group. Scalp nerve block has an effective role in pain control (increasing ANI), consequently reducing the need for analgesic drugs such as fentanyl and remifentanil following craniotomy without changing the hemodynamic condition.

Effects of different inspiratory muscle training protocols on functional exercise capacity and respiratory and peripheral muscle strength in patients with chronic kidney disease: a randomized study

BackgroundPathological changes were observed in the diaphragm due to abnormal renal function in chronic kidney disease (CKD). Inspiratory muscle training (IMT) has been suggested for patients with CKD; however, the most appropriate intensity for IMT has not been determined. Therefore, this study aimed to investigate the effects of different IMT protocols on respiratory muscle strength, quadriceps femoris muscle strength (QMS), handgrip muscle strength (HGS), functional exercise capacity, quality of life (QoL), pulmonary function, dyspnoea, fatigue, balance, and physical activity (PA) levels in patients with CKD.MethodsThis randomized, controlled, single-blind study included 47 patients and they were divided into three groups: Group 1 (n = 15, IMT with 10% maximal inspiratory pressure (MIP)), Group 2 (n = 16, IMT with 30% MIP), and Group 3(n = 16; IMT with 60% MIP). MIP, maximal expiratory pressure (MEP), 6-min walking test (6-MWT), QMS, HGS, QoL, pulmonary function, dyspnoea, fatigue, balance, and PA levels were assessed before and after eight weeks of IMT.ResultsIncreases in MIP, %MIP, 6-MWT distance, and %6-MWT were significantly higher in Groups 2 and 3 than in Group 1 after IMT (p < 0.05). MEP, %MEP, FEF25-75%, QMS, HGS, and QoL significantly increased; dyspnoea and fatigue decreased in all groups (p < 0.05). FVC, PEF, and PA improved only in Group 2, and balance improved in Groups 1 and 2 (p < 0.05).ConclusionsIMT with 30% and 60% MIP similarly improves inspiratory muscle strength and functional exercise capacity. IMT with 30% is more effective in increasing PA. IMT is a beneficial method to enhance peripheral and expiratory muscle strength, respiratory function, QoL and balance, and reduce dyspnoea and fatigue. IMT with %30 could be an option for patients with CKD who do not tolerate higher intensities.Trial registrationThis study was retrospectively registered (NCT06401135, 06/05/2024).