Clinical and radiological outcomes of direct anterior versus posterolateral total hip arthroplasty in ankylosing spondylitis: A propensity-matched study

Abstract: This study aims to compare the clinical and radiological outcomes of the direct anterior approach (DAA) and the traditional posterior-lateral approach (PLA) for total hip arthroplasty (THA) in patients with ankylosing spondylitis (AS). Between July 2001 and May 2024, a total of 137 patients (117 males, 20 females; mean age: 40.21 ± 13.28 years; range, 17 to 73 years) with AS who underwent THA using the DAA or PLA were retrospectively analyzed. Using propensity score-matching, we retrospectively analyzed data on 164 hips with AS for which THA was performed, with 41 and 123 hips in the DAA and PLA groups, respectively. Preoperative baseline characteristics, surgical data, clinical and radiological outcomes at follow-up were collected and compared between the two groups. The mean follow-up was 68.05 ± 38.09 months. There were no significant intergroup differences in terms of surgical data, postoperative complications, clinical scores, or patient satisfaction (p > 0.05). Compared to the PLA group, the DAA group had a significantly higher rate of achieving hip flexion over 90° (82.93% vs. 60.98%, p = 0.010), with fewer patients in the group reporting difficulty with putting on socks (p = 0.003). The DAA group exhibited a smaller acetabular anteversion (17.10 ± 6.60° vs. 20.68 ± 8.73°, p = 0.031), with a higher proportion of acetabular components positioned within the Lewinnek safe zone (82.93% vs. 60.16%, p = 0.008). Although both surgical approaches are effective for managing hip involvement in ankylosing spondylitis undergoing THA, the DAA may offer functional benefits and improved prosthetic alignment. These advantages support its consideration as a favorable surgical option in appropriately selected patients.

Wang X
Guo S
Chen D
Zhou Y
Bian T
Man S
Zhang L

Humans
Female
Spondylitis, Ankylosing
Arthroplasty, Replacement, Hip
Male
Middle Aged
Adult
Retrospective Studies
Aged
Treatment Outcome
Adolescent
Young Adult
Propensity Score
Hip Joint
Radiography
Range of Motion, Articular
Patient Satisfaction


Clinical efficacy and safety of closed reduction versus in situ internal fixation for valgus-impacted femoral neck fractures: A meta-analysis

Abstract: In this meta-analysis, we discuss the clinical efficacy of closed reduction with in situ fixation for valgus-impacted femoral neck fractures (VIFNFs) by contrasting postoperative functional recovery and complication profiles. We performed a systematic literature search in PubMed, Embase, Web of Science, the Cochrane Library, and ScienceDirect for publications up to October 2025. The search targeted original studies which directly compared the surgical outcomes of closed reduction and in situ internal fixation for valgus-impacted femoral neck fractures. Search terms included combinations of: valgus-impacted (or valgus impaction), femoral neck fracture, in situ, reduction, and internal fixation. Pooled data were analyzed using mean differences (MD) with 95% confidence intervals (CIs) for continuous outcomes and risk differences (RD) with 95% CIs for dichotomous outcomes. The final analysis included a total of 447 patients extracted from five studies that met the predetermined inclusion criteria. The meta-analysis demonstrated that the closed reduction group exhibited a statistically significant reduction in postoperative femoral neck shortening (FNS) compared with the in situ fixation group (MD: 4.05; 95% CI: 2.68 ~ 5.42; p < 0.00001). For the caput-collum-diaphysis (CCD) angle, the closed reduction group showed a borderline significant improvement relative to the in situ fixation group (MD: 9.79; 95% CI: 0.19 ~ 19.39; p = 0.05). The in situ fixation group was associated with a substantially lower reoperation rate (RD: -0.08; 95% CI: -0.16 ~ -0.01; p = 0.04). No statistically significant intergroup differences were detected for the Harris Hip Score (HHS) (MD: -4.13; 95% CI: -9.37 ~ 1.11; p = 0.12), incidence of femoral head necrosis (RD: -0.05; 95% CI: -0.14 ~ 0.05; p = 0.36), or fixation failure rate (RD: -0.05; 95% CI: -0.17 ~ 0.06; p = 0.37). Closed reduction yields a statistically significant advantage in reducing postoperative FNS and a borderline significant benefit in maintaining the CCD. In contrast, in situ fixation is associated with a lower reoperation rate. The two strategies show comparable outcomes for the HHS, femoral head necrosis incidence, and fixation failure rate. Thus, surgical approach should be individualized based on patient-specific profiles.

Humans
Femoral Neck Fractures
Fracture Fixation, Internal
Closed Fracture Reduction
Treatment Outcome
Postoperative Complications
Proximal Femoral Fractures

Journal Article
Meta-Analysis
Comparative Study
Systematic Review


Intercalary Allograft Reconstruction of the Femur: A Cadaveric Comparison of Intramedullary and Plate Fixation Techniques

Abstract: Intercalary reconstruction following diaphyseal tumor resection is advantageous in that they preserve the joint above and below. Recently, intramedullary devices such as intramedullary nails (IMN), photodynamic bone stabilizing system (PBSS), and intercalary endoprosthetic reconstruction (EPR) have become increasingly used. Understanding the tradeoffs associated with each construct as well as characterizing their mechanical stability is essential for making a patient-specific decision for reconstruction. The mechanical properties of four different constructs used in the reconstruction of segmental defects in a femur model were compared: Double plate (DP) allograft secured by 90-90 plating, allograft secured by IMN and plate fixation, allograft secured by PBSS and plate fixation, as well as an intercalary prosthesis (EPR). Samples were tested in axial, bending and torsional loading, and mechanical properties were compared. The EPR during anterior-posterior bending had 51.63% of the displacement compared to the DP (p = 0.0007), and 55% of the creep over 100 cycles (p = 0.0126) with a rigidity of 201.3% (p = 0.0067). This difference also exists for cyclic torsion where the EPR rotates 52.32% the amount of the DP (p = 0.0044) and has 4.44% of the creep (p < 0.0001). The PBSS and IMN constructs had comparable results across all tests (p > 0.05). Overall, the EPR has comparable or superior mechanical stability to the DP, while the PBSS and IMN have similar mechanical properties. Together, these results can be used as a guide for surgeons to choose different implants depending on individual patient needs.

Journal of orthopaedic research : official publication of the Orthopaedic Research Society

Kadkoy Y
Schneider GJ
Ippolito JA
Helbig TP
Subramanian V
Lopez JR
Paglia DN
Benevenia J

Humans
Bone Plates
Femur
Bone Transplantation
Cadaver
Biomechanical Phenomena
Allografts
Fracture Fixation, Intramedullary
Plastic Surgery Procedures


[The role of central vascular access in the management of patients receiving chemotherapy for non-hematological malignant tumors: PICC line versus implantable Ports]

Abstract: peripherally inserted central catheters (PICCs) and totally implantable ports (Ports) are used for chemotherapy administration. This study aimed to compare their morbidity, mortality, and complication rates. a prospective, randomised, comparative single-centre study with 6 months of follow-up included adult patients with non-hematological malignancies eligible for chemotherapy (palliative, curative, or adjuvant intent). Primary endpoints were the frequency of adverse events (minor/major), impact on quality of life (EORTC QLQ-C30), and medico-economic cost. out of 206 randomised patients, 192 were analysed (Port: 102; PICC: 90). The overall complication rate was 12.5% (n=24). Major complications were significantly more frequent with PICCs (17.8%; 16/90) than with Ports (4.9%; 5/102), with a relative risk of 3.6 (95% CI 1.3-9.9; p=0.041). For chemotherapy lasting less than 6 months, the mean total cost was significantly higher for Ports (160,123.41 DA) than for PICCs (43,259.69 DA) (p<0.001). No significant difference was observed in overall quality of life, with a modest trend favoring Ports for global health and pain at three months. Ports, although costlier, are associated with a significantly lower risk of major complications. They may be preferred as a safe and effective access for long-term chemotherapy. The optimal choice should integrate treatment duration, patient risk profile, and economic constraints.

Bendjaballah O
Chioukh S
Bensalem A
Makhloufi H
Karoune A
Lekhal A
Mouellef R

Humans
Female
Prospective Studies
Middle Aged
Antineoplastic Agents
Male
Neoplasms
Quality of Life
Adult
Catheters, Indwelling
Catheterization, Central Venous
Aged
Catheterization, Peripheral
Follow-Up Studies
Young Adult

Journal Article
Comparative Study
Randomized Controlled Trial
English Abstract


Effects of motivational music on sleep quality for caregivers of patients with advanced cancer: a randomized controlled trial

Abstract: To investigate the benefits of listening to pre-bedtime music on sleep quality and daytime sleepiness for family caregivers of palliative care patients at home. Multicenter, randomized controlled clinical trial. Seventy-six caregivers were randomly assigned to intervention (n = 38) and control (n = 38) groups. The intervention group listened to individually chosen music for 30 min before bedtime for 7 days, and the control group listened to pre-recorded basic nursing education messages. The primary endpoint was the change in global subjective sleep quality, evaluated via the global Pittsburgh Sleep Quality Index (PSQI) score. Secondary endpoints included daytime sleepiness (Epworth Sleepiness Scale [ESS]), accelerometer-derived sleep parameters, and client satisfaction (CSQ-8). Significant intergroup differences favoring the music intervention were observed in the mean changes from baseline for the primary endpoint of global sleep quality (PSQI Global Score: + 0.60 vs. + 2.05 points; p = 0.006). Descriptive intergroup differences favoring the intervention were observed for subjective nighttime sleep duration (+ 0.55 h; 95% CI 0.19 to 0.94) and daytime sleepiness (ESS: -2.74 points; 95% CI -4.11 to -0.56). Post-intervention satisfaction was significantly higher in the music group (CSQ-8: 27.61 vs. 24.63 points). Listening to pre-bedtime music maintains global subjective sleep quality for family caregivers in a home palliative care setting. Furthermore, exploratory signals suggest it may also prolong subjective sleep duration and reduce daytime sleepiness. The study is registered at Clinical Trials.gov, NCT04491110. Date: 29 July 2020.

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

Valero-Cantero I
Vázquez-Sánchez MÁ
Espinar-Toledo M
Corral-Pérez J
Casals-Sánchez JL
Casals C

Humans
Female
Caregivers
Male
Middle Aged
Sleep Quality
Neoplasms
Aged
Palliative Care
Adult
Music Therapy
Motivation
Sleep Duration
Sleep
Patient Satisfaction
Sleepiness

Journal Article
Randomized Controlled Trial
Multicenter Study


Effectiveness of online simulation-based versus face-to-face training on episiotomy skills among midwifery students in Turkey

Abstract: This study evaluated the effectiveness of synchronous online simulation compared with face-to-face instruction in teaching episiotomy repair skills to midwifery students. It also assessed learning satisfaction and self-confidence. A randomized controlled study was conducted with undergraduate students enrolled in a childbirth course. Participants were randomly assigned to either a synchronous online or face-to-face training group. Both groups received structured instruction using standardized simulation models. Outcomes were measured using the Student Satisfaction and Self-Confidence in Learning Scale and the Episiotomy Skill Evaluation Form. Both training formats resulted in similarly high levels of skill performance. The online group demonstrated significantly higher self-confidence and overall learning satisfaction, while skill outcomes were comparable between groups. No significant associations were found between demographic characteristics and study outcomes. Synchronous online simulation is a feasible and effective alternative to face-to-face training for developing procedural skills while also enhancing learner confidence and satisfaction.

Humans
Episiotomy
Female
Midwifery
Turkey
Clinical Competence
Simulation Training
Students, Nursing
Pregnancy
Young Adult
Adult

Journal Article
Randomized Controlled Trial


Effects of vitamin D supplementation on insulin resistance and lipid metabolic profiles in women with gestational diabetes mellitus: A randomized controlled trial

Abstract: Gestational diabetes mellitus (GDM) commonly presents as insulin resistance and altered lipid metabolism, with evidence linking vitamin D deficiency to its pathogenesis. In this randomized, double-blind, placebo-controlled trial, 120 pregnant women diagnosed with GDM were assigned to receive either vitamin D3 supplements (2000 IU/day) or a placebo for 3 months. Serum vitamin D status, glycemic control parameters, and lipid profiles were evaluated pre- and post-intervention, adjusting for dietary and exercise confounders. After the 3-month intervention, serum 25-hydroxyvitamin D levels in the vitamin D group were significantly higher than those in the placebo group. Vitamin D supplementation effectively reduced fasting plasma glucose, fasting insulin, and HOMA-IR scores. Simultaneously, it significantly decreased triglycerides and LDL-C levels while increasing HDL-C. Total cholesterol levels showed no statistically significant difference between the two groups. Supplementation with 2000 IU vitamin D per day for 3 months yields significant improvements in glucose homeostasis and lipid metabolism in the GDM population. Vitamin D holds promise as an effective auxiliary treatment to enhance maternal metabolic health.

Humans
Female
Diabetes, Gestational
Pregnancy
Insulin Resistance
Dietary Supplements
Vitamin D
Adult
Blood Glucose
Double-Blind Method
Vitamin D Deficiency
Lipids
Lipid Metabolism
Vitamins
Insulin


[Influence of acupotomy on postoperative musculoskeletal status following lumbar surgery and discussion on its theoretical mechanism in traditional Chinese medicine]

Abstract: To investigate the effects of acupotomy on the paraspinal muscle status via MRI and spinal pelvic parameters, as well as lumbar activity in patients with lumbar disc herniation (LDH) post-surgery, aiming to elucidate the relative correlation and the traditional Chinese medicine (TCM) theory "regulating tendons to treat bones". Between December 2019 and December 2021, a total of 104 patients with LDH who underwent percutaneous transforaminal endoscopic discectomy (PTED) were enrolled via a prospective case-control study. They were randomly assigned to the acupotomy group (52 cases, 3 cases lost to follow-up) and the control group (52 cases, 4 cases lost to follow-up). There were 49 patients in the acupotomy group, including 38 males and 11 females, aged from 30 to 70 years with a mean age of (57.21±11.19) years and disease course ranged from 1 to 12 month with a mean of (4.83±1.31) months. The affected segments were L3,4 in 3 cases, L4,5 in 35 cases and L5S1 in 11 cases. Patients in the acupotomy group received one acupotomy intervention within 24 hours after PTED, and additional interventions were performed on postoperative day 7 and day 14 respectively. A total of 48 patients were enrolled in the control group, including 32 males and 16 females, aged from 30 to 69 years with an average age of (53.03±12.37) years old and disease course ranged from 1 to 12 month with a mean disease course of (5.14±1.43) months. The lesioned segments involved L3,4 in 1 case, L4,5 in 37 cases and L5S1 in 10 cases. All patients underwent PTED following the identical surgical procedures without acupotomy intervention, and the remaining rehabilitation and nursing protocols were consistent with those in the acupotomy group. Relevant evaluations were performed on patients before surgery as well as at 6 and 12 months postoperatively. The spinal pelvic parameters included lumbar lordosis (LL), sacral slope (SS), pelvic tilt (PT) and pelvic incidence (PI). Indicators of lumbar mobility include the Oswestry Disability Index (ODI) and the Japanese Orthopedic Association Scores (JOA). Pearson correlation analysis was used to study the relationship between spinal muscle structure parameters, spinal pelvic parameters and lumbar mobility function for the patients with LDH after acupotomy, and generalized linear regression analysis was used to study the effects of spinal paravertebral muscle structure on the spinal joint force lines for the patients with LDH after acupotomy. All patients completed 12-month follow-up. At 6 and 12 months after surgery, the multifidus muscle IF values at L4,5 segment in the acupotomy group were (28.50±6.20)% and (26.43±8.80)%, which were significantly lower than the preoperative level of (45.16±10.45)% with statistically significant differences (P<0.01). Meanwhile, these values were obviously lower than those in the control group (40.14±15.16)% and (38.41±14.92)%, and the differences were statistically significant (P<0.01). At 12 months postoperatively, the LL of (47.48±6.49)° and SS of (35.10±7.01)° in the acupotomy group were higher than (43.06±4.22)° and (31.12±10.25)° in the control group respectively, with statistically significant differences (P<0.01). The PT of (13.73±4.66)° was lower than that of the control group (18.01±6.56)°, showing a statistically significant difference (P<0.05). There was no significant difference in PI between the two groups during the study period (all P>0.05). At 12 months postoperatively, IF was correlated with JOA and ODI (P<0.01), and PS was positively correlated with JOA (P<0.01). PT was correlated with JOA and ODI (both P<0.05), LL was positively correlated with JOA (P<0.01), SS was positively correlated with JOA (P<0.01), and SS was strongly positively correlated with JOA (r=0.91). IF was significantly correlated with LL, PT and SS (all P<0.01), PS was also significantly correlated with LL, PT and SS (all P<0.01), and PS was strongly positively correlated with LL (r=0.75). Regression studies showed that the degree of IF at L4,5 segments had statistically significant effects on PT, and SS had statistically significant effects on JOA. Acupotomy based on the theory of "regulating tendons to treat bones" can alleviate intramuscular fat infiltration of lumbar multifidus in post-PTED patients, thereby triggering favorable shifts in spinal-pelvic alignment and promoting lumbar functional recovery. Among them, the decrease in fat infiltration rate of multifidus(decreased by approximately 41% at the L4,5 level at 12 months postoperatively) and the increase in SS (increased by approximately 21% at 12 months postoperatively) were the most prominent factors for the changes of spinal paravertebral muscle structure and spinal-pelvic alignment. The relationship between "regulating tendons first" and "treating bones later" in the TCM theory of "regulating tendons to treat bones" can also be explained from an anatomical perspective.

Zhongguo gu shang = China journal of orthopaedics and traumatology

Zhong Y
Ding Y
Fu B
Ma G
Cui H
Chen T
Pan L
Liu Q
Xu H
Ma L
Guan L

Humans
Male
Female
Middle Aged
Adult
Aged
Intervertebral Disc Displacement
Lumbar Vertebrae
Medicine, Chinese Traditional
Case-Control Studies
Acupuncture Therapy
Prospective Studies

Journal Article
Randomized Controlled Trial
English Abstract


The effects of different velocity loss thresholds on post-activation performance enhancement in basketball players

Abstract: This study investigated the effects of different velocity loss (VL) thresholds during squat exercise at 80% of one-repetition maximum (1RM) on post-activation performance enhancement (PAPE) in basketball players. Nineteen male collegiate basketball players completed three familiarization sessions and four randomized crossover experimental sessions: control (passive rest), 5% VL, 10% VL, and 20% VL. Countermovement jump height (JH), peak power output (PPO), and reactive strength index modified (RSIm) were measured pre-test and at 3-min and 8-min post-squat. Linear mixed-effects models (LMMs) evaluated the effects of time, condition, and mean-centered relative strength on the outcome variables and repetition counts. To identify responders who exhibited meaningful improvements in jump height, the smallest worthwhile change (SWC) was calculated. At the group level, no significant condition × time interactions or main effects of condition were observed for JH, PPO, or RSIm (p > 0.05), indicating no uniform PAPE effect across protocols. Furthermore, no statistically significant strength × time × condition interaction effects were observed. Repetition counts did not differ between the 5% and 10% VL conditions but were significantly lower in both conditions compared to the 20% VL condition (p < 0.01). Individual analysis showed the 20% VL condition yielded the highest number of responders (n = 11; 58%). Squat protocols using 5-20% VL at 80% 1RM did not produce significant group-level CMJ performance improvements, suggesting that a comprehensive warm-up may create a performance ceiling. Furthermore, these responses were not moderated by relative strength. However, the high inter-individual variability and responder rates at higher VL thresholds highlight the importance of individualized PAPE programming.

Wu H
Jukic I
Xu K
Holmberg PM
Du B
Shan Z
Chen W
Jiang J
Guan G
Zhao Q

Humans
Male
Basketball
Athletic Performance
Cross-Over Studies
Muscle Strength
Young Adult
Resistance Training
Force Potentiation


Acute Effects of Varying Neuromuscular Electrical Stimulation Amplitude on Quadriceps Isometric Torque and Muscle Thickness in Healthy Young Adults: A Randomized Split-Limb Trial

Abstract: Despite the relevance of neuromuscular electrical stimulation (NMES) dosimetry, it is unclear whether increasing the self-reported tolerated amplitude enhances acute neuromuscular responses. To investigate the acute effects of varying NMES amplitude and type of induced contraction on quadriceps isometric torque (IT) and muscle thickness. A randomized split-limb within-subject repeated-measures design was employed in healthy young adults. IT and quadriceps muscle thickness were the outcomes. Bilateral measurements were obtained using participants seated at 60° (± 5°) of knee flexion. Muscle thickness was assessed via ultrasound and IT using a portable dynamometer. The Aussie current was applied at two doses: the self-reported tolerated amplitude (threshold) and 20% above this value (suprathreshold). Doses were randomly applied to dominant and non-dominant limbs across three assessment conditions in separate sessions: (1) IT at maximal voluntary effort without NMES, (2) IT during NMES alone, and (3) IT during NMES combined with maximal voluntary effort. Forty-one volunteers of both sexes participated. Isolated NMES (threshold = 0.49 and suprathreshold = 0.66 N m kg-1) elicited significantly lower IT than other conditions, whereas maximal voluntary IT (threshold = 2.82 and suprathreshold = 2.84 N m kg-1) did not differ from maximal voluntary IT performed concurrently with NMES (threshold = 3.03 and suprathreshold = 2.91 N m kg-1). The suprathreshold condition resulted in a greater increase in RF muscle thickness. Exploratory regression analysis showed that RF thickness was the only variable significantly associated with IT (R2 = 0.54). Acute Aussie NMES did not increase IT compared with maximal voluntary contraction, and isolated NMES elicited lower IT. However, suprathreshold stimulation acutely increased RF thickness.

Physiotherapy research international : the journal for researchers and clinicians in physical therapy

Anjos JZD
Cenci OAC
Silva IGD
Albuquerque CE
Bertolini GRF
Carvalho AR

Humans
Male
Female
Quadriceps Muscle
Torque
Isometric Contraction
Young Adult
Adult
Ultrasonography
Muscle Strength
Electric Stimulation


[Compound Ciwujia Granules for chronic fatigue syndrome with syndrome of deficiency of both heart and spleen: a multicenter, randomized, double-blind, double-dummy, positive drug-controlled trial]

Abstract: This study aimed to evaluate the clinical efficacy and safety of Compound Ciwujia Granules in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen. It adopted a multicenter, double-blind, double-dummy, randomized controlled trial design and represented a pre-specified subgroup analysis regarding syndrome of deficiency of both heart and spleen from a registered clinical trial. A total of 224 patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen were randomized, among whom 222 were included in the full analysis set(FAS). Patients were assigned in a 1∶1 ratio to the treatment group(Compound Ciwujia Granules + Guipi Granules placebo, 111 cases) and the control group(Guipi Granules + Compound Ciwujia Granules placebo, 111 cases), and the course of treatment lasted for 6 weeks. The primary outcome was the improvement rate measured in the Chalder Fatigue Questionnaire-11(CFQ-11) after 6 weeks of treatment. The secondary outcomes included the improvement rate after 3 weeks of treatment, changes in CFQ-11 scores from baseline, changes in CFQ-11 physical and mental fatigue scores from baseline, and changes in TCM syndrome(deficiency of both heart and spleen) scores from baseline after 3 and 6 weeks of treatment. Safety was assessed by recording adverse events. The results showed that 222 patients were included in the FAS, 203 in the per-protocol set(PPS), and 224 in the safety set(SS). In terms of primary outcome, FAS analysis showed that after 6 weeks of treatment, the improvement rate in CFQ-11 scores in experimental group was 73.99%(95%CI[69.10%, 78.87%]), compared to 52.87%(95%CI[47.99%, 57.76%]) in control group, with a between-group difference of 21.11%(95%CI[14.19%, 28.04%], P<0.000 1). PPS analysis was consistent with FAS(difference of 20.54%, P<0.000 1). After treatment for 6 weeks, the decrease in CFQ-11 scores was-13.81 in treatment group, significantly greater than-9.87 in control group(difference of-3.95, 95%CI[-5.23,-2.66], P<0.000 1). Both physical fatigue and mental fatigue domain scores also favored the treatment group after 6 weeks of treatment(P<0.000 1). The reduction in TCM syndrome scores after treatment for 6 weeks was also significantly greater in the treatment group than in the control group(FAS difference of-1.30, P=0.001 4; PPS difference of-1.14, P=0.005 3). No serious adverse events occurred in either group. In conclusion, Compound Ciwujia Granules significantly improved clinical symptoms in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen, demonstrating definite efficacy and good safety.

Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

Ren J
Zhang XT
Xie CQ
Wang SJ
Kong LJ
Li JH
Liu LJ
Cui P
Hu ZG
Zhao WX
Zou R
Diwu YC
Fang H
Yang XJ
Li R
Ji G
Fang M
Yuan WA

Humans
Fatigue Syndrome, Chronic
Double-Blind Method
Female
Drugs, Chinese Herbal
Spleen
Adult
Male
Middle Aged
Heart
Treatment Outcome
Young Adult

Journal Article
Randomized Controlled Trial
Multicenter Study
English Abstract


Safety and feasibility of calcium sulfate/hydroxyapatite with zoledronic acid for the augmentation of helical blades in trochanteric fractures: A randomized pilot study

Abstract: This study aims to evaluate the feasibility, safety, and peri-implant bone formation of augmenting a proximal femoral nail (PFN) helical blade with a calcium sulfate/hydroxyapatite (CaS/HA) biomaterial combined with systemic zoledronic acid (ZA). This single-center, two-arm, parallel-group, randomized-controlled pilot study included a total of 20 patients with osteoporotic trochanteric fractures (TFs) between December 2023 and January 2025. The patients were randomized into a control group receiving standard PFN or an intervention group receiving PFN augmented with CaS/HA biomaterial. All patients received cefazoline and doxycycline for infection prophylaxis. On postoperative Day 7, both groups received a single intravenous infusion of ZA. The primary outcome was the change in bone mineral density (BMD) defined by previously published peri-implant regions-of-interest at one week and six months postoperatively. Secondary outcomes included tip-apex distance (TAD) for assessing blade migration and the Harris Hip Score (HHS) for functional evaluation. Of a total of 20 patients included in the study, 6 were male and 14 were female with a median age of 81 (range, 65 to 90) years. Regarding intervention delivery, all 10 randomly assigned patients received their intended treatment. While 19 of the 20 randomly assigned patients received the intended treatment; one patient died within the first week and did not receive ZA. The required data for clinical analysis (change in peri-implant BMD, TAD, fracture union, and HHS) could only be extracted for five patients in the control group and five patients in the intervention group. There were no intraoperative complications, and no adverse effects related to the CaS/HA biomaterial were reported. Ten patients were included for the outcome analysis. The intervention group demonstrated a more pronounced increase in peri-implant BMD compared to controls. Additionally, TAD changed more in the control group. Functional evaluation revealed that the intervention group demonstrated a slightly greater HHS improvement. Our study results suggest that augmentation using the CaS/HA and ZA is a feasible and safe procedure for patients with osteoporotic TF. Preliminary findings indicate a potential trend toward enhanced peri-implant bone formation in the intervention group.

Yolaçan H
Raina DB
Lidgren L
Tägil M
Tarasevičius Š
Güler S
Tolunay T
Markevičiūtė V
Sezgin EA

Humans
Female
Pilot Projects
Zoledronic Acid
Aged
Male
Calcium Sulfate
Durapatite
Proximal Femoral Fractures
Feasibility Studies
Aged, 80 and over
Bone Density Conservation Agents
Bone Nails
Bone Density
Hip Fractures
Osteoporotic Fractures
Fracture Fixation, Intramedullary


Investigating the effect of web-based education on positive mental health of family caregivers of breast cancer patients: a quasi-experimental study

Abstract: The increasing incidence of cancer and the fact that the family is an important factor in cancer care; attention to the positive mental health of cancer patients should be sought to provide solutions to improve the mental health of these caregivers. The present study aimed to investigate the effect of web-based education on positive mental health of family caregivers of breast cancer patients undergoing chemotherapy in educational and treatment centers of Zahedan University of Medical Sciences. This study is a semi-experimental study. The statistical population of the study included all family members of breast cancer patients undergoing chemotherapy who referred to Imam Ali Hospital in Zahedan in 1402. The samples included 70 people who were randomly assigned to two groups: the intervention group and the control group. Caregivers in the intervention group received the necessary training and education for 20 days through a website prepared by the researcher. Data collection was carried out using the demographic information formula and the 9-question positive mental health questionnaire of Lockett before the intervention and 30 days after the intervention. The data were analyzed using descriptive and analytical tests using SPSS 27 statistical software and independent t-tests, paired t-tests, and chi-square tests. Before the intervention, there was no significant difference between the two groups in terms of positive mental health (p = 0.43). However, after web-based training, the results of the analysis of covariance (ANCOVA) with adjustment for pre-test scores showed that the positive mental health score in the intervention group was 19.02 ± 3.05, compared to 15.94 ± 2.61 in the control group (p = 0.0001). The findings of this study suggest that web-based educational programs can enhance the positive mental health of family caregivers of breast cancer patients undergoing chemotherapy. Accordingly, such interventions may be considered an effective supportive approach for family caregivers in oncology care settings.

Rezaee N
Mohammadifard L
Khalilzadeh-Farsangi Z
Fallah-Karimi S

Humans
Female
Caregivers
Breast Neoplasms
Mental Health
Middle Aged
Adult
Internet
Surveys and Questionnaires
Male
Internet-Based Intervention
Iran
Aged


Pro-Con Debate for Thenar Tissue Oxygenation in Prone Position during Lumbar Discectomy

Abstract: AIM: To compare the regional tissue oxygen saturation under general, spinal, and epidural anesthesias during the posterior lumbar discectomy procedures performed in the prone position. MATERIAL and METHODS: A total of 90 patients with an American Society of Anesthesiologists score I-III were evaluated. Using the research randomizer program, the patients were split into three groups: group of general anesthesia (GA, Group I), group of spinal anesthesia (SA, Group II), and group of epidural anesthesia (EA, Group III). Each patient received non-invasive peripheral arterial oxygen saturation (SpO2), three-lead electrocardiography, non-invasive mean arterial blood pressure (MAP), and the in Spectra TM StO2 Spot Check device with near-infrared spectroscopy (NIRS) technology. The group GA also received end-tidal CO2 monitoring and tissue hemoglobin index (THI), and StO2 monitoring. RESULTS: The data of 90 patients showed that age, weight, height, American Society of Anesthesiologists score, amount of bleeding, duration of surgery, and anesthesia were not statistically significant. Tissue oxygen saturations were detected between groups at the 15th, 30th, 45th, and 60th minutes. The values of group EA at the 15th, 30th, and 45th minutes were higher than group SA (p=0.001; p<0.05). CONCLUSION: This study shows that general anesthesia, as opposed to spinal and epidural anesthesia, offers superior thenar tissue oxygenation in a prone position during posterior lumbar discectomy surgery, despite the ongoing debate over the pros and cons of this position.

Salih MN
Kazancioglu L
Batcik S
Salih O
Kanat A

Humans
Diskectomy
Prone Position
Female
Lumbar Vertebrae
Male
Anesthesia, General
Adult
Anesthesia, Epidural
Middle Aged
Oxygen
Anesthesia, Spinal
Oxygen Saturation
Spectroscopy, Near-Infrared


Improving Critical Appraisal of Cancer-Related Health Information: A Pilot Randomised Trial of the Informed Health Choices-Cancer Programme

Abstract: People impacted by cancer may be confronted with conflicting and misleading cancer-related information that is everywhere in daily life. The Informed Health Choices-Cancer (IHC-C) programme was developed to equip participants with the skills and knowledge necessary to think critically and make well-informed health choices. To assess the feasibility, acceptability, and preliminary outcomes of the IHC-C programme. We conducted an online pilot randomised trial to compare the IHC-C programme with a waitlist control within a prespecified recruitment window. Adults impacted by cancer (current patients, survivors, informal caregivers and loved ones) were recruited and randomised 1:1. The intervention was a 4-week, nine-unit online learning programme. Primary outcomes assessed feasibility (recruitment, retention, adherence, technical feasibility, and data-collection processes) and acceptability (participation rates, participation burden, and overall acceptability). Secondary outcomes included eHealth literacy, critical thinking and decision-making skills, which were assessed post-intervention. Forty-three participants were randomised (22 intervention; 21 waitlist control), achieving 72% of the recruitment target. In the intervention group, 91% accessed the platform and 64% completed all nine units. Outcome assessment completion was 64% (14/22) in the intervention group and 81% (17/21) in the control group. Acceptability was high among intervention completers, as indicated by both quantitative and qualitative measures. eHealth literacy scores were high in both groups, with ceiling effects and no between-group difference (Hodges-Lehmann median difference -1.0, 95% CI -5.0 to 1.0). Critical thinking and decision-making quiz scores were higher in the intervention group in exploratory analyses (median difference: 1.0, 95% CI: 1.0-2.0), although the distributions clustered near the upper range. The IHC-C programme was feasible to deliver and acceptable to participants within a defined recruitment period. These findings support progression to a fully powered trial, with refinements to engagement strategies and outcome measurement. This trial was registered on ISRCTN registry with ID ISRCTN17391470.

Li M
Tierney M
Beecher C
Dowling M
Duffy AG
Duggan C
Grimes DR
Kennan A
Kilty C
Nsangi A
Oxman AD
Stewart DC
Toomey E
Devane D

Humans
Pilot Projects
Female
Middle Aged
Male
Neoplasms
Adult
Aged
Feasibility Studies
Health Literacy
Decision Making
Choice Behavior
Patient Education as Topic
Health Knowledge, Attitudes, Practice
Consumer Health Information


Polygenic risk scores predict blood pressure changes independent of dietary intervention: a secondary analysis of the NUPRESS trial

Abstract: This study aimed to investigate whether genetic variability, assessed through polygenic risk scores (PRSs), predicts blood pressure (BP) changes in individuals with systemic arterial hypertension (SAH), and to explore potential interactions between genetic risk and dietary interventions. This study represents a secondary analysis of data from the Brazilian multicentre trial (NUPRESS), which compared a Dietary Approach to Stop Hypertension (DASH) diet (control group) with a multicomponent intervention (intervention group) over 180 days in adults with SAH. Participants underwent anthropometric assessment, cardiovascular risk evaluation, dietary assessment, and genotyping using a genomic microarray. Single nucleotide polymorphisms (SNPs) associated with BP changes were identified and used to construct PRSs. Multiple linear regression models were employed to examine associations between PRSs, dietary interventions, and changes in systolic (ΔSBP) and diastolic BP (ΔDBP). A total of 114 SNPs were associated with ΔSBP and 101 with ΔDBP. The resulting PRSs showed strong correlations with both ΔSBP (r = 0.85; p < 0.0001) and ΔDBP (r = 0.84; p < 0.0001). No significant effect of dietary intervention on BP changes was observed, and no interaction was identified between PRSs and dietary approach for ΔSBP (p = 0.98) or ΔDBP (p = 0.13). PRSs derived from BP-associated SNPs were strong predictors of BP changes over six months, independent of dietary intervention. These findings support the potential utility of genetic profiling in predicting individual variability in BP response, although replication in independent cohorts is warranted. Main study trial registration number NCT03793881 on ClinicalTrials.gov.

Holzbach LC
Marcadenti A
Bersch-Ferreira AC
Machado RHV
Carvalho APPF
Pinto SL
Penafort AM
Coelho ASG
Cominetti C

Humans
Genetic Risk Score
Blood Pressure
Polymorphism, Single Nucleotide
Hypertension
Female
Male
Middle Aged
Brazil
Dietary Approaches To Stop Hypertension
Adult

Journal Article
Multicenter Study
Randomized Controlled Trial


Effects of Intensive Early Physiotherapy Intervention After Myocardial Infarction on Quality of Life, Anxiety and Depression Scores: A Controlled Clinical Trial

Abstract: Early mobilisation after myocardial infarction (MI) is strongly recommended. However, evidence regarding the benefits of structured physiotherapy during the acute in-hospital phase remains limited. This controlled clinical trial (CCT) aimed to evaluate whether an intensive early physiotherapy programme could improve health-related quality of life (HRQoL) and psychological well-being. This CCT included 172 adults hospitalised after MI and treated with primary percutaneous coronary intervention (PCI). The participants were quasi-randomly allocated (1:1) to the intervention or control group based on the hospital room number. They received either an intensive physiotherapy programme (daily supervised mobilisation, education and graded activity) or standard medical care and an informational flyer. Primary outcomes included HRQoL (MacNew) and psychological well-being (Hospital Anxiety and Depression Scale, HADS-D). Clinically important changes were evaluated using the standardised response mean (SRM, which reflects the clinical relevance of observed changes), and the minimal clinically important difference (MCID, the smallest change in an outcome perceived as important by patients). Statistical analysis was conducted to assess group-by-time and pre-post interaction effects. Clinical significance metrics: The intervention group showed less deterioration in overall HRQoL (SRM: 0.04 vs. 0.1) and an enhancement in the MacNew emotional subscale (SRM: 0.22 vs. 0.09) compared with the control group. The HADS-D improved to a greater extent in the intervention group, exceeding the MCID (1.7 points). There were no statistically significant interaction effects between groups by time (interaction factor group * factor time; HRQoL p = 0.68 and anxiety/depression p = 0.15) or between the time points (pre-post, main effect factor time; HRQoL p = 0.35 and anxiety/depression p = 0.4). Clinically, intensive early in-hospital physiotherapy may lead to improved psychological outcomes and an attenuation of HRQoL decline. Although the change in HADS-D in the intervention group did not reach statistical significance, it exceeded the MCID, indicating a clinically meaningful improvement from the patients' perspective. The implementation of structured early mobilisation protocols may provide clinically relevant benefits during the acute post-PCI hospitalisation period and warrants further investigation. Ethical approval was first submitted in January 2023, then resubmitted after minor revision in March 2023, and was then accepted on 15 March 2023 (Reg.Nr. K-2023-001).

Humans
Quality of Life
Male
Myocardial Infarction
Female
Middle Aged
Anxiety
Physical Therapy Modalities
Depression
Aged
Treatment Outcome
Percutaneous Coronary Intervention
Early Ambulation


Assessment and Comparison of Efficacy and Safety of Monotherapy With Topical 50% Urea Cream and Combination Therapy With Topical 50% Urea Cream and Carboxytherapy in Treatment of Recalcitrant Common Wart: A Randomized, Single-Blinded, 2-Split Clinical Trial

Abstract: The treatment of common warts can occasionally be a challenge in recalcitrant cases, either recurrent ones or non-responders to treatment. In the current study, the efficacy and safety of monotherapy with topical 50% urea cream and combination therapy with topical 50% urea cream and carboxytherapy were assessed and compared in the treatment of recalcitrant common wart. Twenty subjects with recalcitrant common warts in the extremities (excluding the plantar surface) were selected. For the lesions of one side of the body, topical 50% urea cream was used 2 times a day (group A), while for the other side, combination of topical 50% urea cream and carboxytherapy was administered (group B). Carboxytherapy was done weekly, and both treatments were continued until complete resolution. The lesion count and size were assessed until 2 weeks after the fifth session of carboxytherapy. Recurrence rate was evaluated 6 months after complete resolution. Regarding the lesion count, no statistically significant difference was seen between the 2 groups. In group B, decrease of lesion size was significantly greater than that in group A. The time for complete resolution was significantly shorter in the group B. No significant adverse event was reported in either treatment group. No recurrence of lesions was reported 6 months after complete resolution in either group. Our findings demonstrated that both monotherapy with topical 50% urea cream and combination therapy with topical 50% urea cream and carboxytherapy were effective in the treatment of recalcitrant recurrent common warts, although the effectiveness of combination therapy was statistically more.

Bagherani N
Rafiei M
Smoller BR
Yaghoobi R
Moradzade R
Mirnezami M
Rafie Z

Humans
Urea
Treatment Outcome
Warts
Female
Adult
Administration, Topical
Male
Young Adult
Single-Blind Method
Drug Therapy, Combination
Adolescent
Middle Aged
Recurrence

Journal Article
Randomized Controlled Trial
Comparative Study


Safety and Efficacy of Oliceridine Combined with Propofol for Painless Gastroscopy: A Single-Center, Randomized, Parallel Controlled Clinical Trial

Abstract: To explore the safety and efficacy of the novel G protein-biased μ-opioid receptor agonist oliceridine for painless gastroscopy. This study is a single-center randomized controlled clinical trial. One hundred and eighty-eight patients scheduled for painless gastroscopy were randomly assigned to four groups: Group L (oliceridine 10 μg/kg + propofol 2mg/kg), Group M (oliceridine 20 μg/kg + propofol 2mg/kg), Group H (oliceridine 30 μg/kg + propofol 2mg/kg) and Group C (sufentanil 0.1 μg/kg + propofol 2mg/kg). The primary outcome was the incidence of respiratory depression. Secondary outcomes included the incidence of respiratory arrest, bradypnea (respiratory rate<8 bpm) and hypoxemia (pulse oxygen saturation (SpO2) < 90%). Other outcomes included procedure and sedation-related outcomes, perioperative vital signs and adverse effects were recorded. Among the 184 patients, 46, 46, 45 and 47 patients were randomly assigned to the L, M, H and C groups, respectively, and completed the trial. The incidence of respiratory depression in Group C (55.32%) and Group H (46.67%) was significantly higher than that in Group L (15.22%) and Group M (17.39%) (P<0.05). The incidence of respiratory arrest was higher in group H (42.22%) and group C (51.06%) compared to group L (13.04%) and group M (15.22%) (P < 0.05). The incidence of bradypnea and hypoxemia in group C (31.90% and 14.89%) was higher than that in group M (6.5% and 0) (P < 0.05). The sedation success rate was significantly lower in Group L than in Group M (71.74% vs 93.48%; P < 0.05). No significant differences were observed in the incidence of postoperative adverse effects. 10 μg/kg and 20 μg/kg oliceridine is associated with a reduced risk of respiratory depression when co-administered with propofol for painless gastroscopy in adults, and the 20 μg/kg oliceridine exhibits superior sedative efficacy.

Hu X
Yang C
Li J
Wang F
You H
Chen C
Jiang L

Humans
Female
Propofol
Male
Gastroscopy
Middle Aged
Adult
Aged

Journal Article
Randomized Controlled Trial
Case Reports
Clinical Trial


The Effect of a Brief Psychologically Informed Education Intervention for Improving Function in Adolescents With Atraumatic Leg Pain: A Randomized Controlled Trial

Abstract: OBJECTIVE: To assess whether adding psychologically informed education (PIE) videos to usual care physical therapy (PT) improved function (primary outcome) and pain-related beliefs, pain intensity, and physical activity (secondary outcomes) in adolescents with atraumatic leg pain. DESIGN: Double-blinded randomized controlled trial. METHODS: Eighty-three adolescents (mean age, 14.7 ± 1.6 years; 62% female) with atraumatic leg pain (including patellofemoral pain, apophyseal injuries, tendinopathy) were randomized to view 3 PIE or control videos. All participants completed 6 weeks of PT. The PIE videos targeted kinesiophobia, fear avoidance, and catastrophizing; the control videos addressed anatomy and biomechanics. Outcomes were assessed at baseline, 1 month, and 12 months. The primary outcome was change in function (Lower Extremity Functional Scale). Secondary outcomes were pain-related beliefs, pain intensity, and physical activity. RESULTS: There was no between-group difference in function over time (P = .40), with similar changes at 1 month (PIE: 12.5 [95% CI: 7.4, 17.5]; control: 8.9 [95% CI: 5.1, 12.8]) and 12 months (PIE: 17.1 [95% CI: 11.8, 22.5]; control: 14.9 [95% CI: 10.3, 19.5]). Adolescents in the PIE group had a greater reduction in pain-related beliefs after 1 month (fear avoidance: PIE, 50% vs control, 23%; kinesiophobia: PIE, 50% vs control, 8%; catastrophizing: PIE, 27% vs control, 19%; P = .01). There were no between-group differences in pain (P = .82) or physical activity (P = .50). At 12 months, 34% (n = 26) reported persistent pain. CONCLUSION: Brief PIE did not improve function, pain intensity, or physical activity when added to usual PT care for adolescents with atraumatic leg pain. Adolescents who received the PIE videos reduced pain-related beliefs. J Orthop Sports Phys Ther 2026;56(8):555-562. Epub 26 May 2026. doi:10.2519/jospt.2026.14057.

The Journal of orthopaedic and sports physical therapy

Selhorst M
Hoehn J
Benedict J
Joshi S
Yang J

Humans
Adolescent
Female
Kinesiophobia
Double-Blind Method
Male
Patient Education as Topic
Catastrophization
Fear
Pain Measurement
Physical Therapy Modalities
Exercise


Evaluation of microscopically quantitative loads of bacilli as early predictors of TB treatment outcome

Abstract: <sec><title>BACKGROUND</title>Two-month smear conversion has been adopted instead of cultures to predict unfavourable bacteriological outcomes in TB treatment. However, this approach is limited by lower sensitivity and specificity.</sec><sec><title>OBJECTIVE</title>In absence of early-stage biomarkers of treatment response, we investigated the association between bacteriological outcome and microscopy data with auramine and fluorescein diacetate stains at baseline and during the first 2 weeks of treatment in the context of the OneRIF trial. This is a secondary analysis of data collected during the OneRIF trial.</sec><sec><title>RESULTS</title>Failure or relapse occurred in 15 patients of 321 treated with double-dose R. Only quantitative baseline auramine significantly predicted failure or relapse: for every 100 bacilli per field increase, there was 5% higher odds of having an unfavourable bacteriological outcome.</sec><sec><title>CONCLUSION</title>While quantitative baseline auramine predicted having an unfavourable bacteriological outcome, considering our small data we could not identify any added value in implementing quantitative bacillary load in the first 2 weeks of treatment. These findings should be interpreted with caution as we were limited by the relatively low number of failure and relapse.</sec>.

The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease

Vellere I
Jacobs BK
Maug AKJ
Hossain MA
De Jong BC
Lynen L
Lorent N
Decroo T

Humans
Antitubercular Agents
Benzophenoneidum
Bacilloscopy
Predictive Value of Tests
Mycobacterium tuberculosis
Bacterial Load
Treatment Outcome
Time Factors
Sputum
Recurrence


Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study

Abstract: Idiopathic pulmonary fibrosis (IPF) is a fatal interstitial lung disease with limited treatment options. LTI-03 promotes alveolar epithelial cell survival and reduces profibrotic protein expression in experimental models of IPF. In this Phase 1b, randomized, double-blind, placebo-controlled dose-escalation study, 24 participants with IPF were randomized 3:1 to inhaled LTI-03 5 mg/day (N = 9), LTI-03 10 mg/day (N = 9) or placebo (N = 6) for 14 days and included in all analyses (ClinicalTrials.gov: NCT05954988). The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs). Exploratory analyses included pharmacokinetics and disease-related biomarkers. LTI-03 was well-tolerated, with no treatment-related discontinuations, no severe TEAEs, and no evidence of airway obstruction by spirometry and associated symptoms. In deep bronchial brushings, both LTI-03 doses significantly reduced interleukin-11 (p = 0.0406 at 5 mg/day; p = 0.044 at 10 mg/day) and thymic stromal lymphopoietin (p = 0.0256 at 5 mg/day; p = 0.0128 at 10 mg/day) versus placebo. The 10 mg/day dose suppressed collagen type 1 alpha chain 1 (p = 0.0248), CXC chemokine ligand 7 (p = 0.0248) and galectin-7 (p = 0.0332). Other measured biomarkers were not significantly changed. The favorable safety profile and reductions in disease-related biomarkers support further evaluation of inhaled LTI-03 for IPF. This study was fully funded by Rein Therapeutics, Inc.

Molyneaux PL
Hirani NA
Chia CCK
Kulkarni T
Zaman T
Kaner RJ
Coelho AL
Jannini-Sa YAP
Windsor B
Kruger S
Christensen DJ
Shoemaker SA
Hogaboam CM
MacKenzie B
Günther A

Humans
Idiopathic Pulmonary Fibrosis
Female
Male
Double-Blind Method
Aged
Middle Aged
Administration, Inhalation
Cytokines
Biomarkers
Thymic Stromal Lymphopoietin
Dose-Response Relationship, Drug
Interleukin-11
Treatment Outcome

Journal Article
Randomized Controlled Trial
Clinical Trial, Phase I


Testing neuromuscular feedback therapy in patients with chronic spinal cord injury with residual motor function in the lower extremities compared to 'conventional' therapy: protocol for a multicentre randomised controlled trial

Abstract: Multicentre randomised controlled trial. Eight spinal cord injury (SCI) centres and 15 rehabilitation centres in Germany. To demonstrate the superiority of neuromuscular feedback therapy using an exoskeleton compared to conventional therapy in terms of improving walking ability in patients with chronic SCI. A total of 180 patients with chronic complete or incomplete SCI and residual motor function in the lower extremities are to be included. Baseline examination will be carried out at the recruiting SCI centres, followed by 1:1 randomisation at the rehabilitation centre allocating patients to the control group (conventional therapy) or the intervention group (Hybrid Assistive Limb therapy). Both interventions take place to the same extent (5×/week, 60 min) over a period of 12 weeks at the rehabilitation centres. After the 12-week intervention phase, the primary (therapy response defined as relevant improvement in at least one of the following: 6 min walk test, 10 m walk test and Walking Index for Spinal Cord Injury II score) and secondary endpoints (quality of life, pain, bladder and bowel function) are recorded by blinded observers at the SCI centres or via patient app. The effects of the intervention will be evaluated in the middle and at the end of the 6-month follow-up period. The study is approved by the ethics committee of the Medical Association of Westphalia-Lippe (register no. 2025-2014 f-S). The participants were informed about the aims and procedures of the study and gave their written consent. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. The study results will be published in accordance with the Consolidated Standards of Reporting Trials (CONSORT), regardless of whether the results are positive or negative. The datasets belong to the Joint Federal Committee of Germany and are available there on request. DRKS 00035487.

Aach M
Brinkemper A
Grasmücke D
Zhivotovskaya A
Königshausen M
Schildhauer TA
Uphues C
Schäkermann M
Pogoreuz M
Mai A
Timmesfeld N

Humans
Spinal Cord Injuries
Lower Extremity
Walking
Germany
Female
Quality of Life
Adult
Male
Chronic Disease
Recovery of Function
Treatment Outcome
Middle Aged
Research Design

Journal Article
Multicenter Study
Randomized Controlled Trial
Comparative Study


Exploring patient and NHS staff acceptability of artificial intelligence-supported surgical wound monitoring within the WISDOM feasibility study: a multi-centre qualitative interview study

Abstract: Artificial intelligence (AI) is beginning to be used within digital surgical wound monitoring to facilitate implementation at scale. AI acceptability is essential to its success. This study aimed to explore patient and staff acceptability of an AI-based digital surgical wound monitoring platform. Qualitative interviews SETTING: Two hospitals performing cardiac surgery in England. 20 patients undergoing cardiac surgery and 10 clinical staff participating in a randomised feasibility trial of surgical wound monitoring with AI. Semi-structured interviews were conducted focusing on participants' experiences or perceptions of AI-based digital surgical wound monitoring. Data were analysed, guided by the theoretical framework of acceptability. Patient and staff acceptability of AI within surgical wound monitoring. Patients and staff were supportive of the use of AI within surgical wound monitoring and felt safety was improved, access was increased and efficiency was improved. AI monitoring was perceived to allow the early detection and treatment of surgical wound complications and facilitate the implementation of monitoring at scale for all patients. Some participants were concerned about data security risks, staff over-reliance on AI and the loss of human interaction. AI-supported digital surgical wound monitoring appeared acceptable to participants within this feasibility study. Further research is needed to evaluate implementation in broader settings. ISRCTN16900119 and NCT06475703.

Tanner J
Rochon M
Cariaga K
Harris R
Beckhelling J
Bouttell J
Bolton S
Wilson K
Jurkiewicz J
Dhoonmoon L
Mostafa N
Dummer J
Basilio K
Magboo R
Procter K
McMillan C

Humans
Artificial Intelligence
Feasibility Studies
Female
Male
Qualitative Research
Surgical Wound
Attitude of Health Personnel
Middle Aged
Cardiac Surgical Procedures
Aged
England
State Medicine
Interviews as Topic
Monitoring, Physiologic
Digital Health
Adult


Racial outcomes in patients with diabetic cardiomyopathy treated with an aldose reductase inhibitor: the ARISE-HF trial

Abstract: Racial and ethnic differences in diabetic cardiomyopathy (DbCM) exist, with black and Hispanic participants showing poorer health status. It remains unclear whether these differences affect the natural progression of the disease. We aimed to evaluate disease progression in individuals with DbCM, as well as racial differences in the response to AT-001. A total of 625 participants with DbCM were randomised to either placebo or AT-001 and followed for 15 months. The primary outcome was change in peak oxygen uptake (peak VO2) and secondary outcomes included Kansas City Cardiomyopathy Questionnaire (KCCQ) and Physical Activity Scale for the Elderly scores. Analyses were stratified by race and ethnicity (black, Hispanic, white). Black and Hispanic participants who received placebo experienced greater declines in peak VO2 (-0.74 and -1.67 mL/kg/min, respectively) compared with white participants (-0.23 mL/kg/min, p=0.005). AT-001 demonstrated a non-statistically significant trend towards slower declines in peak VO2 in black and Hispanic participants (-0.31 and -0.62 mL/kg/min, p=0.29, respectively). Black participants who received placebo had the largest declines in most KCCQ scores. Black and Hispanic participants with DbCM experienced faster disease progression, with black participants showing the most pronounced functional and quality of life declines. The effect of AT-001 on peak VO2 changes was not statistically significant with similar effects between racial and ethnic groups (NCT04083339). NCT04083339.

Batista JL
Liu Y
Butler J
Del Prato S
Ezekowitz JA
Lam CSP
Marwick TH
Rosenstock J
Tang WHW
Perfetti R
Urbinati A
Zannad F
Ilonze O
Januzzi JL

Aged
Female
Humans
Male
Middle Aged
Black or African American
Diabetic Cardiomyopathies
Disease Progression
Double-Blind Method
Enzyme Inhibitors
Hispanic or Latino
Oxygen Consumption
Time Factors
Treatment Effect Heterogeneity
Treatment Outcome
United States
White

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial


Autologous impaction bone grafting of a cemented acetabular component in primary total hip arthroplasty in young patients: a randomized controlled trial

Abstract: This randomized controlled trial (RCT) aimed to compare clinical and radiological outcomes of cemented acetabular component in primary total hip arthroplasty (THA) in patients aged under 60 years with and without autologous impaction bone grafting (IBG). A single-centre, triple-blinded RCT was conducted in patients aged 18 to 59 years undergoing primary THA without acetabular defects. Patients were randomized to receive either IBG or no IBG. Noninferiority of IBG was assessed for the primary endpoint, the Hip disability and Osteoarthritis Outcome Score (HOOS) sub-scale for activities of daily living (ADL) at one-year follow-up. Secondary outcomes included other patient-reported outcome measures (PROMs), perioperative outcomes, complications, and radiological outcomes. Radiographs assessed acetabular component and centre of rotation positioning, offset changes, and the presence of radiolucent lines in the bone-cement interface. A total of 131 patients were randomized. No significant group differences were found for the HOOS-ADL sub-scale at one year (mean difference 1.9 points (95% CI -4.85 to 8.7); p = 0.578), meeting the criteria for noninferiority. Furthermore, there was no effect of group on the scores for other PROMs. Surgery duration (+ 7.5 minutes; p < 0.001) and blood loss (+ 100 ml; p = 0.001) were significantly higher in the IBG group. Complication and revision rates were comparable. Radiologically, the IBG group had significantly fewer radiolucent lines in the bone-cement interface than the control group at one-year follow-up (p < 0.001). Compared with preoperatively, the postoperative position of the centre of rotation was less superior and medial in the IBG group (p = 0.024). The use of autologous IBG with a cemented acetabular component in primary THA in young patients is noninferior to standard cemented fixation regarding short-term clinical outcomes. IBG improves vertical position of the centre of rotation and early radiological fixation by reducing radiolucent lines around the cup, suggesting potential benefits for long-term acetabular component survival.

de Boer DR
Pasman P
Munnik-Hagewoud R
Steinweg MJQ
Edens MA
van Driel PBAA
Ettema HB

Humans
Arthroplasty, Replacement, Hip
Female
Middle Aged
Adult
Bone Transplantation
Male
Acetabulum
Adolescent
Bone Cements
Young Adult
Treatment Outcome
Hip Prosthesis
Osteoarthritis, Hip
Transplantation, Autologous

Journal Article
Randomized Controlled Trial
Equivalence Trial


Efficacy and Safety of Shatavari Root Extract in Managing Peri-Menopausal Symptoms-A Randomized, Double-Blind, Placebo Controlled Clinical Trial

Abstract: CTRI/2025/06/088470 (https://ctri.nic.in).

Humans
Plant Extracts
Double-Blind Method
Female
India
Plant Roots
Perimenopause
Phytotherapy
Middle Aged
Hot Flashes


User Experience of a Web-Based Mobile Health App Supporting Low-Income Pregnant Individuals With Diabetes: Mixed Methods Study

Abstract: Diabetes mellitus management requires considerable patient self-efficacy, knowledge, and support for social determinants of health. These needs become particularly acute during pregnancy. Mobile health (mHealth) tools are a promising approach to enhance patient engagement with the health care system, education, and health promotion and may be particularly helpful during the period of rapid skills acquisition, which is a hallmark of experiencing diabetes during pregnancy. Therefore, we developed SweetMama, a web-based mHealth app designed to support and provide information to low-income pregnant individuals with gestational diabetes mellitus (GDM) or type 2 diabetes mellitus (T2DM). This study aimed to understand the user experiences of low-income pregnant people who were randomized to use SweetMama during a feasibility trial. This mixed methods secondary analysis of data from a feasibility randomized controlled trial (RCT) included participants randomized to SweetMama, an interactive, web-based mHealth app with multiple motivational and educational features that help reduce barriers to care, offer health education, and aim to improve diabetes self-care for low-income pregnant people. In the parent trial, English-speaking pregnant individuals with GDM or T2DM were randomized to use SweetMama during pregnancy or usual care. SweetMama users experienced an individualized curriculum from enrollment through 6 weeks postpartum. Upon exit, users completed 2 qualitative interviews (during the delivery hospitalization and at the postpartum visit) and surveys assessing standardized usability metrics. The surveys included the System Usability Scale (SUS), the Usefulness, Satisfaction, Ease of Use (USE) scale, and the mHealth App Usability Questionnaire (MAUQ) to assess usability. Qualitative data were analyzed using constant comparative techniques. Of 30 SweetMama users, 60% (n=18) had GDM, 83.3% (n=25) had publicly funded prenatal care, and the majority identified as non-Hispanic Black (n=17, 56.7%) or Hispanic (n=11, 36.7%). Scores on the SUS (median 85.0/100, IQR 70.0-88.8; ≥71% indicates acceptable or higher usability), USE (overall median 84.5/100, IQR 81.0-91.4), and MAUQ (median 84.1/100, IQR 79.0-91.3) indicated favorable usability assessments, particularly for the "ease of learning" domain. Qualitative interviews supported these findings: participants described the app as easy to navigate, well organized, and helpful for staying on track, citing features such as clear visual design, timely text reminders, and actionable tips. Users valued motivational elements and content specificity, while recommending increased customization and enhanced esthetics. In this user experience evaluation of a web-based mHealth app for low-income pregnant individuals with diabetes, participants found the tool to be user-friendly, visually appealing, informative, and motivating. Constructive feedback for application improvement for use in a future larger trial of clinical effectiveness was collected.

Raucher SL
Lu L
Merchant T
Soyemi E
Niznik C
Saber R
Yeh C
Yee LM

Humans
Female
Pregnancy
Adult
Poverty
Mobile Applications
Diabetes Mellitus, Type 2
Diabetes, Gestational
Telemedicine
Feasibility Studies
Internet
Digital Health
Self Care


Evaluating strategies to reduce the effects of pro-e-cigarette social media posts in young adults

Abstract: Examine how sponsorship disclosures and nicotine warning labels (NWLs) affect responses to proe-cigarette Instagram posts among Mexican young adults. In a 2 x 2 online experiment, Mexicans aged 18-24 (N= 699; 53% users and 47% nonusers of cigarettes or e-cigarettes who were susceptible to future use) were randomly assigned to view one of four Instagram posts: 1) control, 2) disclosure-only, 3) NWL-only, or 4) combination. Participants reported susceptibility to e-cigarettes, positive expectancies, and risk perceptions. Outcomes were analyzed via logistic regression (ref=control). Compared to the control, participants exposed to the NWL alone or combined were less likely to be curious to try the e-cigarette (OR= 0.54, 95%CI 0.35,0.83; OR= 0.54, 95%CI 0.34,0.84), try it if offered by a friend (OR= 0.59, 95%CI 0.39,0.90; OR= 0.55, 95%CI 0.36,0.85), or expect to enjoy use (OR= 0.64, 95%CI 0.42,0.97; OR= 0.65, 95%CI 0.43,1.00). Risk perceptions did not differ; disclosures had no effect. The disclosure-only condition (vs control) increased willingness to try e-cigarettes among people who currently smoked or were susceptible to smoking (β= 0.84, p <0.05). NWLs, but not sponsorship disclosures, reduce Mexican youth susceptibility and positive expectancies toward e-cigarettes.

Cruz-Jiménez L
Kim M
Vidaña-Pérez D
Khemkar A
Sun Y
Leal DF
Barrientos-Gutiérrez I
Thrasher JF

Humans
Electronic Nicotine Delivery Systems
Adolescent
Young Adult
Social Media
Female
Male
Mexico
Product Labeling
Media Exposure


Clinical observation of opioid-sparing anesthesia combined with QLB in patients undergoing gynecological laparoscopic surgery: A randomized controlled trial

Abstract: Laparoscopic surgery has become the mainstream approach for gynecological procedures. However, postoperative pain, particularly visceral pain, remains a major obstacle to achieving enhanced recovery after surgery. Therefore, this study aimed to observe the clinical effects of opioid-sparing anesthesia combined with a quadratus lumborum block (QLB) in patients undergoing gynecological laparoscopic surgery to provide a reference for clinical practice. A total of 80 female patients (aged 18 to 65 years, body mass index 18 to 28 kg/m2, American Society of Anesthesiologists I-II) scheduled for elective gynecological laparoscopic surgery under general anesthesia were enrolled and randomly assigned to 2 groups (n = 40 each): the control group (Group C) and the treatment group (Group T). All patients received general anesthesia. In Group T, a bilateral QLB was additionally performed under ultrasound guidance after the induction of general anesthesia. The following parameters were recorded for both groups: general demographic data and perioperative parameters; total intraoperative remifentanil consumption; postoperative analgesic pump consumption at 0 to 24 hours and 24 to 48 hours; the number of effective presses and total presses of the analgesic pump during 0 to 24 hours and 24 to 48 hours postoperatively; numerical rating scale (NRS) scores at rest and during movement at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours postoperatively; the rescue analgesia rate within 48 hours postoperatively; and the incidence of adverse reactions (hypotension, respiratory depression, postoperative nausea and vomiting [PONV], somnolence). Compared with Group C, patients in Group T had significantly reduced the following parameters: total intraoperative remifentanil consumption (P < .05); analgesic pump consumption at 0 to 24 hours and 24 to 48 hours postoperatively (P < .05); the number of effective presses and total presses of the analgesic pump during 0 to 24 hours and 24 to 48 hours postoperatively (P < .05); resting NRS scores at 12 hours, 24 hours, and 48 hours postoperatively (P < .05); and movement NRS scores at 6 hours, 12 hours, 24 hours, and 48 hours postoperatively (P < .05). Furthermore, the rescue analgesia rate within 48 hours postoperatively was significantly lower in Group T compared to Group C (P < .05). Regarding adverse reactions, the incidence of PONV in Group T was considerably lower than that in Group C (P < .05). For gynecological patients undergoing laparoscopic surgery, the application of opioid-sparing anesthesia combined with a QLB provides effective analgesia, reduces intraoperative opioid consumption, prolongs the duration of postoperative analgesia, lowers the incidence of PONV, and promotes enhanced postoperative recovery.

Humans
Female
Laparoscopy
Gynecologic Surgical Procedures
Adult
Middle Aged
Postoperative Pain
Analgesics, Opioid
Nerve Block
Anesthesia, General
Remifentanil
Young Adult
Aged
Adolescent


Application of gastric tube removal strategy based on the combination of Gugging Swallowing Screen (GUSS) and National Institutes of Health Stroke Scale (NIHSS) scores in patients following acute stroke: A randomized controlled trial

Abstract: Dysphagia is a common, serious complication in acute stroke patients, often requiring indwelling gastric tubes. Prolonged tube use increases risks of aspiration pneumonia and other adverse events. Current assessment methods often lack the sensitivity needed to guide safe extubation. To investigate the effect of combined Gugging Swallowing Screen (GUSS) and National Institutes of Health Stroke Scale (NIHSS) scores on the gastric tube removal in acute stroke patients. Between November 2021 and November 2022, 110 patients were admitted to our hospital with acute stroke and fitted with an indwelling gastric tube. We collated clinical data, performed the Kubota Water Swallowing Test, and determined the NIHSS and GUSS scores. Patients were then divided randomly into experimental and control groups. In the experimental group, gastric tubes were removed based on an NIHSS score < 15 and a GUSS score ≥ 15, while in the control group, extubation followed the Kubota Water Swallowing Test. Adverse events related to the 2 strategies were analyzed. No significant differences were detected between the 2 groups in terms of baseline clinical characteristics. When compared to the traditional extubation strategy based on the Kubota Water Swallowing Test, the incidence of aspiration pneumonia, indwelling time for the gastric tube, and the secondary indwelling rate associated with the combination of GUSS and NIHSS scores were significantly (P < .05) reduced. Cox and Kaplan-Meier curves demonstrated that the extubation strategy applied in the experimental group significantly (P < .05) reduced the risk of adverse events. An NIHSS score < 15 and a GUSS score ≥ 15 can be used to approve the removal of a gastric tube from acute stroke patients; this represents a reliable and safe strategy that reduces the risk of adverse events.

Peng X
Li N
Zeng F
Zhang M
Liu Y
Zhang L

Humans
Stroke
Deglutition Disorders
Female
Male
Aged
Pneumonia, Aspiration
Deglutition
Intubation, Gastrointestinal
Middle Aged
Device Removal
Aged, 80 and over
United States


Mechanical vs. sutureless aortic valve replacement: clinical outcomes and the contribution of preoperative multislice CT

Abstract: Heart valve disease is a significant cause of morbidity and mortality, and aortic valve replacement (AVR) is a common treatment option. Recently, sutureless biological valves have gained increasing use. This study aimed to evaluate the concordance between preoperative computed tomography-derived annulus measurements and valve sizes implanted during surgery rather than the direct clinical impact of imaging on prosthesis selection. A total of 40 patients with aortic valve stenosis who underwent elective open-heart surgery and preoperative multislice computed tomography between February 20 and May 20, 2024, were included and were randomly allocated into two groups: sutureless biological valve (n = 20) and mechanical valve (n = 20). Data were obtained from patient records and the hospital's data system and analysed statistically. A total of 40 patients were included in the study: 20 received sutureless, rapidly implantable biological valves, and 20 underwent mechanical AVR. The mean age of the cohort was 61.5 ± 9.1 years, with 45% females and 55% males. Compared with the sutureless group, the mechanical valve group had significantly longer cross-clamp (73.5 vs. 53.0 minutes, p < 0.001) and cardiopulmonary bypass times (102 vs. 92 minutes, p = 0.011), as well as smaller sinotubular junction diameters (30.2 vs. 32.3 mm, p = 0.025). In contrast, the sutureless group demonstrated a significantly greater optimal effective orifice area index (1.58 vs. 0.77, p < 0.001). Preoperative computed tomography is a reliable tool for planning AVR. Sutureless biological valves provide shorter cross-clamp and bypass times and favourable haemodynamic performance, whereas mechanical valves are more often associated with smaller valve sizes and longer procedures. Early postoperative outcomes were comparable between groups.

Humans
Female
Male
Multidetector Computed Tomography
Heart Valve Prosthesis Implantation
Heart Valve Prosthesis
Aortic Valve
Aortic Valve Stenosis
Treatment Outcome
Prosthesis Design
Aged
Sutureless Surgical Procedures
Middle Aged
Predictive Value of Tests
Bioprosthesis
Time Factors

Journal Article
Comparative Study
Randomized Controlled Trial


Protocol for the mesh matters project: evaluating the efficacy of suture mesh vs. planar mesh in small ventral hernia repair - a randomized, blinded multicenter study

Abstract: Small ventral hernia repair is among the most performed general surgical procedures. Despite the routine use of planar polypropylene mesh, surgical site occurrences (SSO) remain a frequent cause of morbidity, readmission, and patient dissatisfaction. A novel mesh-suture integrates mesh reinforcement with suture-like implantation and may reduce subcutaneous dissection and tissue trauma. The aim of this randomized trial is to investigate differences in SSO, patient-reported outcomes (PROMs) and operation time among patients operated for small ventral hernias either with this novel mesh-suture or planar mesh as well as evaluate potential influence of mesh-suture on wider socio-economic parameters such as return to work and contact with family physician/primary sector as well as long-term occurrence. A prospective, parallel-group, patient- and assessor-blinded, randomized controlled superiority trial conducted across Danish regional hospitals. Eligible patients undergoing elective repair of small ventral hernias are randomized 1:1 to mesh-suture or planar polypropylene mesh. The primary endpoint is SSO. Secondary endpoints include operative time, patient-reported quality of life (EQ-5D-5L, Abdominal Hernia Q), long-term recurrence, reoperation rates, and socio-economic outcomes. Analysis follows the intention-to-treat principle. This trial evaluates whether mesh-suture reduces wound morbidity while maintaining equivalent durability. Results may inform future standards in ventral hernia repair and device selection. The study is registered at clinicaltrials.gov om March 16th, 2026 (NCT07476560).

Hernia : the journal of hernias and abdominal wall surgery

Gameza V
Brandenburger N
Leutscher P
Holte K

Humans
Surgical Mesh
Hernia, Ventral
Herniorrhaphy
Prospective Studies
Suture Techniques
Polypropylenes
Operative Time
Patient Reported Outcome Measures
Sutures
Female
Recurrence
Quality of Life
Denmark
Reoperation
Treatment Outcome

Journal Article
Multicenter Study
Randomized Controlled Trial
Equivalence Trial


Safety and reproductive performance in sows after vaccination: a randomized controlled trial

Abstract: Although reproductive vaccines are essential in swine herd health programs, evidence on their safety across different physiological stages remains limited. This study evaluated the clinical and reproductive safety of Porcilis® EPL in sows and gilts under commercial field conditions. In a randomized, blinded, controlled trial, 200 females were allocated to treated or control groups within five physiological categories, of which 190 completed the study. Sows received a single dose and gilts a two-dose protocol. Clinical parameters (body condition, rectal temperature, general health, feed intake) and injection-site reactions were monitored for 14 days post-vaccination. Reproductive outcomes, including conception, litter size, stillbirths, mummification, and neonatal viability, were recorded. PCR testing for PCV2, PCV3, and PPV was performed on non-viable piglets. The vaccine was well tolerated, with no systemic adverse reactions and only mild, self-limiting injection-site swellings in some treated females. Body condition and temperature profiles remained within physiological limits. Reproductive performance did not differ between groups (p > 0.05). Pathogen detection frequencies were similar across treatments, indicating that vaccination did not measurably alter fetal susceptibility to endemic PCV2, PCV3, or PPV. Porcilis® EPL showed excellent clinical and reproductive safety when administered during different physiological stages in sows and gilts. The vaccine did not affect fertility, gestational outcomes, or perinatal survival and did not measurably alter pathogen detection under field conditions with natural pathogen exposure, supporting its safe integration into breeding herd vaccination programs. PCR detection of PCV2, PCV3, and PPV was included as an exploratory epidemiological assessment to distinguish vaccine-specific effects from endemic pathogen circulation. No differences were observed between groups, supporting that Porcilis® EPL did not influence susceptibility to non-target pathogens.

da Silva DF
Matias DR
Soto FRM
de Oliveira LL
de Castro AMMG

Animals
Female
Swine
Vaccination
Reproduction
Viral Vaccines
Pregnancy
Swine Diseases
Circovirus
Circoviridae Infections


The Effects of Remote Ischemic Preconditioning on the Inflammatory Cytokine Response to Free Flap Head and Neck Reconstruction: A Randomized Controlled Trial

Abstract: Ischemia-reperfusion injury due to vascular pedicle occlusion is one of the most common causes of free flap failure in head and neck cancer reconstruction. Remote ischemic preconditioning (RIPC) has been proposed as an experimental, non-invasive intervention to attenuate flap ischemia-reperfusion injury; however, the tissue-protective mechanisms remain unclear. RIPC may have multiple effects on the inflammatory system, which plays a central part in the pathophysiology of ischemia-reperfusion injury. The aim of the present study was to evaluate the effect of RIPC on inflammatory cytokine plasma levels during free flap reconstruction. Head and neck cancer patients (n = 60) undergoing tumor resection and subsequent free flap reconstruction between August 2015 and November 2017 at Aarhus University Hospital, Denmark were randomized 1:1 to RIPC or sham intervention in a single-center, single-blinded, randomized controlled trial (RCT) (ClinicalTrials.gov: NCT02548377). The study was approved by The Central Denmark Region Committees on Health Research Ethics (journal no. 1-10-72-140-15) and reported following the CONSORT guidelines. RIPC was administered intraoperatively as four 5-min cycles of upper extremity occlusion and reperfusion with an inflatable tourniquet. Blood samples were collected before surgery, 6 h after RIPC/sham intervention, and on the 1st postoperative day. Tumor necrosis factor (TNF)-α, interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and interferon (IFN)-gamma were analyzed using a multiplex immunoassay. The average age of the RIPC group was 67 years (±10) and 64 years (±12) in the sham group. Plasma levels of the pro-inflammatory cytokines changed significantly between preoperative measures to 1st postoperative day between RIPC and sham; TNF-α (p < 0.001), IL-6 (p < 0.001), IL-8 (p < 0.001), IL-12p70 (p < 0.001), and IFN-γ (p < 0.001). No significant differences in cytokine levels were shown between groups at any specific time points. RIPC does not attenuate pro-inflammatory cytokine release in head and neck cancer patients undergoing free flap reconstruction. ClinicalTrials.gov identifier: NCT02548377.

Nanthan KR
Larsen JB
Hvas CL
Kiil BJ
Krag AE

Humans
Ischemic Preconditioning
Free Tissue Flaps
Male
Middle Aged
Female
Head and Neck Neoplasms
Cytokines
Aged
Reperfusion Injury
Single-Blind Method
Plastic Surgery Procedures
Adult


Transspinal stimulation preceding step training reorganizes spinal locomotor circuits in human spinal cord injury: a randomized sham-controlled clinical trial

Abstract: Activity-based rehabilitation, such as locomotor training, is commonly used to induce positive systemic physiological adaptations and restore locomotion in individuals with chronic spinal cord injury (SCI). Restoration of locomotion with activity-based rehabilitation alone is not optimal and may require augmentation with neuromodulation strategies. We characterized the excitability of spinal locomotor circuits during stepping in humans with SCI who underwent transspinal stimulation before locomotor training, within the same session. A total of 14 participants with chronic SCI received an average of 40 sessions of 30 Hz transspinal stimulation delivered for 30 min during standing (active or sham) or in the supine (active) position, followed by 30 min of robotic-assisted step training. Before and after the completion of all training sessions, we assessed the soleus H-reflex phase-dependent amplitude modulation and reciprocal Ia and presynaptic inhibition in response to a conditioning stimulus delivered to the common peroneal nerve. Transspinal stimulation administered before locomotor training promoted soleus H-reflex depression during the swing phase in the active standing group (n = 5; F 1, 309 = 4.52, p = 0.034), stabilized soleus H-reflex excitability during the stance phase in the active supine group (n = 5; F 1, 327 = 18.44, p < 0.001), and promoted reduced ankle co-contraction during assisted stepping in all groups. Reciprocal inhibition between ankle flexors and extensors after treatment was reduced at mid-stance and during the swing-to-stance transition phase in the active standing group (n = 4; F 1, 81 = 7.4, p = 0.008), while it was markedly potentiated through the swing phase in the sham standing group (n = 3; F 1, 108 = 22.46, p < 0.001). Finally, generalized soleus H-reflex depression after the intervention in the active (n = 4; F 1, 150 = 42.32, p < 0.001) and sham (n = 3; F 1, 64 = 13.19, p < 0.001) standing groups supported potentiation for presynaptic inhibition. This study demonstrated that transspinal stimulation preceding locomotor training was associated with modulation of the spinal reflex pathways. These neurophysiological adaptations suggest increased responsiveness of spinal circuits, although further studies are needed to determine whether these changes translate into functional improvements in people with chronic SCI.

Pulverenti TS
Sayed Ahmad AM
Harel NY
Knikou M

Humans
Spinal Cord Injuries
Male
Adult
Female
H-Reflex
Middle Aged
Muscle, Skeletal
Locomotion
Electromyography
Spinal Cord Stimulation
Exercise Therapy
Spinal Cord


Assessing the relationship between body mass index and influenza-like illness risk and symptom severity among military health system beneficiaries vaccinated against influenza: a pooled prospective cohort study from a randomized trial

Abstract: Obesity prevalence is rising globally and associated with increased influenza mortality. The relationship between obesity and influenza-like-illness (ILI) incidence and symptom severity is less clear. US Military Health System (MHS) beneficiaries enrolled in a randomized influenza vaccine trial received one of three influenza vaccines and were followed for ILI via weekly surveys throughout one influenza season. Participants were pooled across vaccine arms into a prospective cohort. We compared ILI risk and ILI symptom severity (Flu-PRO) across body mass index (BMI) categories using multivariable regression models. Among the 8,334 participants with >50% response rates to weekly ILI surveys, 42% had an overweight-range BMI and 24% had an obesity-range BMI. The median age was 36.2, and 86% had no baseline comorbidities. Over one quarter of the participants (27%) reported at least one ILI during follow-up, with a median duration of 11 days. Participants with an overweight and obesity-range BMI were more likely to report ILIs [adjusted incidence rate ratio (aIRR) 1.18 (95% confidence interval (CI): 1.05-1.33) and 1.59 (95% CI: 1.37-1.84), respectively]. Participants with obesity also had higher risks of reporting moderate-to-severe symptoms in four Flu-PRO domains: gastrointestinal, respiratory, systemic, and throat [adjusted risk ratio (aRR) of 1.64 (95% CI: 1.01-2.70), 1.33 (95% CI: 1.05-1.67), 1.32 (95% CI: 1.06-1.63), and 1.20 (95% CI 1.02-1.40) respectively]. Higher BMI was associated with ILI incidence and severity. These findings prompt further research into optimal strategies to reduce the impact of ILI in MHS settings and the general population.

Gu M
Richard SA
Colombo RE
Schmidt K
Ganesan A
Campbell WR
Mende K
Seshadri S
Saperstein A
Hrncir DE
Maves RC
O'Connell RJ
Spooner CE
Simons MP
Housel LA
Williams A
Powers JH 3rd
Fries A
Coles CL
Burgess TH
Pollett SD

Humans
Body Mass Index
Female
Influenza, Human
Adult
Influenza Vaccines
Prospective Studies
Male
Obesity
Military Personnel
Severity of Illness Index
United States
Middle Aged
Risk Factors
Incidence
Military Health
Young Adult


The effect of oral magnesium supplementation on glycemic control and metabolic parameters in type 2 diabetes mellitus: a double-blind randomized controlled trial

Abstract: This randomized controlled trial (RCT) assessed the effect of oral magnesium (Mg) supplementation on glycated hemoglobin (HbA1c) and metabolic biomarkers in adults with Type 2 Diabetes Mellitus (T2DM). This was a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial with intention-to-treat (ITT) and per-protocol (PP) analyses. Adults (≥18 years) with T2DM were randomized 1:1 to receive magnesium oxide (500 mg; 302 mg elemental) or placebo. Eligibility criteria included a glycated hemoglobin (HbA1c) level ≥7.0% and a creatinine clearance >30 mL/min. Simple randomization was performed using a sealed-envelope method. Biochemical and clinical parameters were assessed at baseline and at three follow-up visits over 12 months. A total of 247 participants were included in the ITT analysis (Mg-oxide, n=118; placebo, n=129). Median age was 58 (50-65) years, and median diabetes duration was 16 (10-22) years. Hypomagnesemia was present in 7.3% by ionized magnesium (iMg) and 8.1% by total magnesium (tMg). Mg-oxide supplementation significantly reduced fasting blood glucose in a subgroup of the cohort (FBG; p = 0.039) and resulted in a modest, non-significant reduction in HbA1c (-0.30% vs. -0.05%; p = 0.145), with a higher proportion achieving goal attainment/controlled HbA1c (<7%) compared with placebo (14.0% vs. 6.0%; p = 0.043). HbA1c reductions were more pronounced among participants with baseline hypomagnesemia (-0.60% vs. +0.25%; p = 0.074), or diabetes duration ≤15 years (-0.40% vs. 0.00%; p = 0.085). No differences were observed in other metabolic parameters, clinical outcomes or adverse drug reactions between groups. Although median HbA1c reduction did not reach statistical significance, Mg-oxide supplementation improved Mg status and showed favorable trends in glycemic control without compromising safety. These findings support Mg supplementation as a safe adjunct to long-term T2DM management, particularly among selected subgroups, given the study's limitations. https://clinicaltrials.gov/, identifier NCTO5774015.

Al-Maqbali JS
Al Alawi AM
Osman A
Al-Farqani A
Kumar S
Al Futisi A
Al-Mamari A
Al-Zakwani I
Al Za'abi M

Humans
Diabetes Mellitus, Type 2
Double-Blind Method
Middle Aged
Female
Male
Magnesium
Dietary Supplements
Glycated Hemoglobin
Glycemic Control
Blood Glucose
Aged
Administration, Oral
Prospective Studies
Biomarkers
Magnesium Oxide

Journal Article
Randomized Controlled Trial
Clinical Trial


The effect of mindfulness-based cognitive therapy on non-suicidal self-injury in hospitalized adolescents with depressive disorders: a randomized controlled trial

Abstract: Nonsuicidal self-injury (NSSI) in adolescents with depressive disorder is characterized by recurrent impulsivity and is a predictor of future suicidal behavior, necessitating effective and feasible interventions. Mindfulness-based cognitive therapy for adolescents (MBCT-A), a first-line treatment for depression, was evaluated in this trial for its efficacy in reducing NSSI in this population. In this randomized, single-blind, controlled trial, 94 hospitalized adolescents diagnosed with depressive disorder and engaging in NSSI were allocated to either MBCT-A plus treatment-as-usual (TAU) or TAU alone. The primary outcome was the severity of NSSI, measured by the Adolescent Self-Harm Scale (ASHS) at baseline, post treatment (4 weeks), and at 1-month follow-up. Secondary outcomes encompassed symptoms of anxiety, depression, emotion regulation, risk behaviors, life satisfaction, resilience, rumination, coping styles, and mindfulness. Both intention-to-treat (ITT) and per-protocol (PP) analyses were conducted. Both ITT and PP analyses revealed significant between-group differences in NSSI severity at 4 weeks. Compared to the control group, the MBCT-A group showed significant improvements in mindfulness awareness, nonreactivity, emotional awareness, depressive symptoms, emotion regulation, and rumination (all P < 0.05). At the 1-month follow-up, the intervention group maintained a significant reduction in NSSI severity (interaction effect: F = 9.454, P < 0.001). MBCT-A is effective in reducing NSSI behavior and improving mindfulness, emotion regulation, and depressive symptoms among adolescents with depressive disorder and NSSI. These findings support the clinical application of MBCT-A for this high-risk population.

Humans
Self-Injurious Behavior
Adolescent
Mindfulness
Single-Blind Method
Female
Depressive Disorder
Male
Cognitive Behavioral Therapy
Emotional Regulation
Hospitalization
Treatment Outcome
Coping Skills


The Effect of a Probiotic on Gut Microbiota Stability and Systemic Well-Being during Short-Term Travel

Abstract: Short-term travel, particularly to new environments, can disrupt gut microbiota homeostasis and induce a range of physical and psychological symptoms. While probiotics are proposed to mitigate these effects, evidence from well-controlled trials during domestic travel, especially along unique routes like China's Silk Road, remains limited. This study investigated the efficacy of a multi-strain Bifidobacterium probiotic in maintaining gut microbiota stability and alleviating travel-related symptoms. In a randomized, double-blind, placebo-controlled trial, 74 healthy adults traveling to Xinjiang were assigned to receive either a probiotic (n = 39; B. longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536, 1.5 × 109 CFU/day) or a placebo (n = 35) for five days during travel. Gut microbiota was profiled via metagenomic sequencing (pre- and post-travel), and symptoms were recorded daily. Primary outcomes were changes in gut microbiota composition and function (KEGG pathways). Secondary outcomes included respiratory, gastrointestinal, and systemic symptom scores. Data were analyzed on an intention-to-treat basis. While alpha and beta diversity remained stable in both groups, the probiotic group exhibited a distinct post-travel microbiota enriched with beneficial taxa, including Bifidobacterium breve and Intestinibacillus at the genus level, and Lacticaseibacillus rhamnosus, Lacticaseibacillus paracasei, and other Lacticaseibacillus species. qPCR confirmed significant increases in administered strains B. longum subsp. infantis (p < 0.001) and B. breve (p < 0.001). KEGG analysis revealed that the probiotic group maintained a metabolically focused profile (e.g., peptidoglycan biosynthesis, histidine metabolism), whereas the placebo group showed increased abundance of microbial pathways associated with host disease-related signaling (e.g., Huntington disease, various cancers) and inflammatory signaling (e.g., PI3K-Akt signaling pathway). Symptomatically, the probiotic group demonstrated a significantly greater reduction than the placebo in irritability (-92% vs. -31%; p = 0.033) and fatigue (-24% vs. +43%; p = 0.024) post-travel, and reported less dizziness (-100% vs. -35%; p = 0.024). Supplementation with a multi-strain Bifidobacterium probiotic during short-term travel promoted the colonization of beneficial bacteria, stabilized gut microbial function against travel-induced dysregulation, and may contribute to supporting systemic well-being during travel.

Journal of microbiology and biotechnology

Yang K
Yang M
Yu Q
Liong MT
Chen D
Cai M

Humans
Probiotics
Bifidobacterium
Gastrointestinal Microbiome
Double-Blind Method
Adult
Travel
Male
China
Female
Feces
Young Adult
Bacteria


Dialogic Book-Sharing intervention in an Italian multicentre randomized controlled trial: effects on parental mood

Abstract: This randomized controlled trial (RCT) was conducted in 10 Italian health and maternal-child Centres to evaluate the effects of a Dialogic Book-Sharing (DBS) intervention on parental symptoms of anxiety and depression. Sixty-eight parents of 14-20-month-old infants were recruited. ANOVA analysis revealed a greater reduction in anxiety and depression symptoms in the intervention group (N = 36) compared to controls (N = 32). DBS is a simple, cost-effective programme that benefits parental mood, making it a valuable intervention for perinatal populations.

Primary health care research & development

Cena L
Trainini A
Belluardo M
Buizza C
Cooper H
Murray L

Humans Italy Female Infant Parents Anxiety Depression Male Books Affect Adult


Electrodermal activity during dental procedures: effects of procedure type, age, and audiovisual interventions

Abstract: Dental anxiety affects roughly 15% of the general population, yet the relative contribution of procedure type, patient age, and distraction interventions to objective autonomic arousal during dental treatment remains poorly characterised. This study investigated the effects of these three factors on electrodermal activity (EDA) in a clinical dental setting. Skin conductance was continuously recorded in 65 adult patients (age 18-29: n=23; 30-55: n=19; ≥56: n=23) undergoing dental procedures under local anaesthesia at a walk-in dental clinic. Patients were randomly assigned to audiovisual intervention (n=30) or control (n=35), and EDA was measured with a wrist-worn sensor and analyzed in STATISTICA 13.0 using nonparametric tests. Extractions produced significantly elevated mean EDA (mean (M)=10.85 μS, standard deviation (SD)=5.00) compared with non-extraction procedures (M=5.20 μS, SD=5.60; Z=4.25, P<0.001, η2=0.28). Older patients (≥56 years: median (Mdn)=2.49 µS) showed lower EDA than middle-aged patients (30-55 years: Mdn=7.81 µS; H=7.96, P=0.019, η2=0.09), consistent with physiological aging and stress resilience. Procedure duration did not correlate with EDA (r(s)=0.15, P=0.23). Anti-stress ball users showed elevated EDA during extractions (Mdn=13.12 vs. 8.60 μS, Z=-2.22, P=0.026), most plausibly attributable to bilateral hand immobilisation imposed by the study protocol. Among non-extraction procedures, augmented reality glasses (AR) were associated with the lowest median EDA (Mdn=2.35 μS, n=12), followed by music glasses (Mdn=2.73 µS, n=4) and headphones (Mdn=4.01 µS, n=3), though group differences were non-significant (H=1.42, P=0.49). Autonomic arousal was more strongly determined by procedure invasiveness (η2=0.28) than by patient age (η2=0.09), with the invasiveness effect driven primarily by the extraction subgroup. AR glasses were well tolerated and associated with the lowest EDA in non-extraction procedures, warranting evaluation in an adequately powered trial. Adequately powered randomised controlled trials restricted to single procedure types and incorporating validated anxiety scales are required before clinical recommendations can be made.

Journal of physiology and pharmacology : an official journal of the Polish Physiological Society

Bereziewicz J
Bereziewicz W
Gorski B
Kowalski J

Humans
Galvanic Skin Response
Adult
Female
Middle Aged
Adolescent
Young Adult
Male
Dental Anxiety
Age Factors
Tooth Extraction