Controlled Trial Research Articles

The Effects of Cognitive Remediation on Negative Symptoms in Schizophrenia-Spectrum Illness: A Meta-analytic Investigation of Efficacy.

The number of clinical efficacy trials of Cognitive Remediation (CR), a behavioral intervention consisting of cognitive task practice and/or strategy training to improve cognitive skills in schizophrenia, has increased substantially over the past 25 years. While recent reviews have highlighted the effects of CR on cognition and function, CR effects on negative symptoms remain understudied. Given the overlap between negative symptoms and cognition, CR effects might be expected. Electronic databases were evaluated up to September 2023 using a broad range of search terms. Sixty-nine unique, controlled trials that used negative symptoms as an outcome were meta-analyzed. Data were independently extracted with excellent (>98%) reliability. Random effects models assessed the effects of CR on summary and expressive vs. experiential negative symptoms. Moderator analyses evaluated a broad array of treatment and participant factors. The meta-analysis (5319 participants) revealed that CR produced a small effect size improvement on summary negative symptoms (Hedge's g = 0.179). Sample differences in age, duration of illness, symptoms, and antipsychotic dosage did not serve as a barrier to treatment benefit. CR also produced small-to-moderate improvements in alogia (Hedge's g = 0.312) but not experiential negative symptoms. Programs of CR that utilized bridging activities that relate training of cognitive skills to activities of daily living produced greater improvement in negative symptoms (g = 0.281 vs 0.055). Longer CR programs also produce larger effects on negative symptoms. CR produces small, consistent reductions in negative symptoms in people with schizophrenia. Variations in CR effects may be linked to different treatment ingredients.

The effect of next-generation, dual-active-ingredient, long-lasting insecticidal net deployment on insecticide resistance in malaria vectors in Benin: results of a 3-year, three-arm, cluster-randomised, controlled trial

The effect of next-generation, dual-active-ingredient, long-lasting insecticidal net deployment on insecticide resistance in malaria vectors in Benin: results of a 3-year, three-arm, cluster-randomised, controlled trial

Comparison between local-made and imported porous polyethylene orbital implant: a randomized controlled equivalence trial and multicenter study.

To compare the exposure rate, infection rate, percentage of enhancement, and success rate between Medpor and the three-dimensional printed polyethylene (3DP-PE) orbital implant in a preliminary report. This prospective, randomized, equivalence, controlled trial was conducted at two institutes. The equivalent margin was ±10%. The sample size for the equivalence trial was 174 participants per group. Patients who were eligible for enucleations received either Medpor or 3DP-PE implants based on a randomized block of six. The surgeries were performed by five oculoplastic surgeons. The assessor and patients were masked. The magnetic resonance imaging (MRI) of the orbit was performed at least 6mo after operation and the fibrovascular ingrowth was analyzed using the Image J software. Follow-up continued at least 1y after surgery. The intention to treat and per protocol approaches were used. Totally 128 patients met the criteria in the report. Fifty Medpor and 55 3DP-PE cases completed the trial. The most common cause of blindness was trauma. The mean follow-up times of Medpor and 3DP-PE were 33 and 40mo respectively. The exposure rate was not statistically significant between two groups (6.0% and 7.3%), P<0.05, 95%CI (-9.8%, +12.0%). The success rates were 94% (Medpor) and 92.7% (3DP-PE). No postoperative infection was reported. Nine patients had MRI tests and two had implant exposures with 66.3% enhancement at 75mo (Medpor) and 58% enhancement at 57mo (3DP-PE) postoperatively. There is no statistically significant difference in exposure rate and success rate between Medpor and 3DP-PE in enucleation in the report. However, we cannot conclude that they are equivalent in terms of the exposure rate and success rate because the 95%CI is wider than ±10%. The infection rate is equivalent in both groups.

Presenting JAK inhibitor safety information to dermatology patients

AbstractJanus Kinase (JAK) inhibitors are treatment options for dermatologic conditions such as atopic dermatitis, psoriasis, vitiligo, and alopecia areata. Guidance on how to counsel patients on these novel treatments is limited. The purpose of this review is to provide options providers can use to discuss JAK inhibitors with dermatology patients. The PubMed database was searched for terms including “dermatology JAK inhibitor safety” and “presenting information to patients.” Relevant literature was selected for inclusion. Black box warnings were placed on JAK inhibitors after a large, controlled trial in rheumatoid arthritis patients did not prove that tofacitinib was as safe as tumor necrosis factor inhibitors; in clinical trials for dermatologic conditions, JAK inhibitors had low risks of serious adverse events. Patient barriers to comprehending treatment information include conflicting information and limited time for discussion of risks. To address these barriers, suggested approaches have included speaking in simple phrases, providing reliable sources, and offering educational materials appropriate for different cultures. When discussing risks, physicians may use anecdotes and frame risks and side effects in ways that decrease anxiety. JAK inhibitors have uncommon severe side effects and related concerns that may be hard for patients to overcome, even when benefits exceed risks. Standard educational approaches can be complemented by anecdotes and framing to help diminish patients' anxiety.

Effectiveness, cost-effectiveness, and positive externalities of integrated chronic care for adults with major depressive disorder in Malawi (IC3D): a stepped-wedge, cluster-randomised, controlled trial

In low-income and middle-income countries, individuals with major depressive disorder often do not receive screening and treatment. We assessed effectiveness and cost-effectiveness of an integrated care model for treating major depressive disorder in Malawi, accounting for two sets of positive externalities: household benefits and improvements in comorbidities. In this stepped-wedge, cluster-randomised, controlled trial, 14 health facilities in Neno District, Malawi, introduced screening, diagnosis, and treatment for people with major depressive disorder, using a stepped-care model of group Problem Management Plus and antidepressant therapy. Adults (ie, aged ≥18 years) residing in facility catchment areas, newly diagnosed with major depressive disorder, and actively enrolled in an integrated chronic care clinic were eligible for inclusion. People identified with high suicidal risk or psychotic symptoms were excluded. Health facilities were categorised into two strata (ie, health centres or secondary hospitals) and randomly allocated to one of five trial sequences, with intervention initiation staggered across sequences in 3-month periods. Participants were masked to trial sequence, data collectors were masked to treatment assignment, and the chief statistician was masked to treatment assignment until analysis. Services were delivered by counsellors and clinical officers at integrated chronic care clinics, and assessments took place at 3-month intervals over 27 months. Primary outcomes were changes in depressive symptom severity (measured with the Patient Health Questionnaire-9 [PHQ-9]), current depressive episode (PHQ-9 score of >10), and functioning (measured with the WHO Disability Assessment Schedule 2.0) over the 27-month period. Longitudinal mixed-effects regression analyses assessed outcomes from an intention-to-treat perspective. The trial was registered with ClinicalTrials.gov (NCT04777006) and is completed. Between Sept 1, 2021, and April 28, 2022, we conducted 15 562 screenings, resulting in 506 (3%) adults identified with major depressive disorder and 487 (3%) enrolled (395 [81%] women and 92 [19%] men). Assignment to IC3D corresponded to a 2·60-point (95% CI -3·35 to -1·86; d -0·61) reduction in depressive symptoms and 1·69-point (-2·73 to -0·65; -0·27) improvement in functioning, reflecting a reduced odds of depression after treatment roll-out (adjusted odds ratio 0·62, 95% CI 0·51 to 0·74). Integrated care for people with major depressive disorder and chronic health conditions is effective at reducing depressive symptoms, improving functioning, and reducing the odds of depression, and facilitates expansion of services through existing infrastructure. National Institute of Mental Health.

Dexmedetomidine Nasal Spray on Emergence Agitation After Ear, Nose, and Throat Surgery: Protocol for a Randomized, Double-Blind, Controlled Trial.

Emergence agitation (EA) is a state of psychomotor hyperactivity following general anesthesia and is associated with postoperative complications. Patients undergoing ear, nose, and throat (ENT) surgery are at a high risk for EA. We aim to assess whether preoperative dexmedetomidine nasal spray reduces the occurrence of EA for patients undergoing ENT surgery. This is a protocol for a randomized, double-blind, controlled trial that will include 160 adults scheduled for ENT surgery. Patients will be randomly assigned, in a 1:1 ratio, to receive dexmedetomidine nasal spray (100μg) or a same volume of normal saline approximately 30min before general anesthesia induction. The primary endpoint is the incidence of EA, defined as a Riker sedation agitation scale (RSAS) score ≥5 from discontinuation of sevoflurane until 5min after tracheal extubation. Secondary endpoints include (1) the maximal RSAS score during emergence; (2) the incidence of agitation in the postoperative care unit (PACU); (3) pain at rest and while coughing in the PACU and at 24h postoperatively; (4) postoperative sleep disturbance on the first night after surgery; (5) anxiety within 24h postoperatively; and (6) postoperative delirium during the first 24h after surgery. All analyses will be performed on a modified intention-to-treat basis. For the primary endpoint, subgroup analysis will be conducted on sex, age, and type of surgery. We expect that preoperative dexmedetomidine nasal spray would reduce the incidence of EA after ENT surgery. Our results offer clinical evidence for improving anesthetic care for patients undergoing ENT surgery. Chinese Clinical Trial Registry (Identifier: ChiCTR2400086731).

Dexmedetomidine and Dexamethasone as Adjuvants to the Local Anesthetic Mixture in Rhomboid Intercostal and Sub-Serratus Block for Video-Assisted Thoracoscopic Surgery: A Randomized, Double-Blind, Controlled Trial.

The utilization of adjuvants such as dexamethasone and dexmedetomidine in combination with local anesthetics has proven effective in extending analgesia duration. We aimed to investigate the potential efficacy of combining dexmedetomidine and dexamethasone in rhomboid intercostal and sub-serratus (RISS) block for prolonging postoperative analgesia in patients undergoing video-assisted thoracoscopic surgery (VATS). We did this randomized, double-blind, controlled trial in two tertiary-care hospitals. A total of eighty-eight patients undergoing VATS under general anesthesia were enrolled in this study. They were randomly assigned into four groups: ropivacaine (R) group, ropivacaine + dexmedetomidine (RM) group, ropivacaine + dexamethasone (RS) group, or ropivacaine + dexmedetomidine + dexamethasone (RSM) group. The primary outcome measure was the duration of analgesia. Secondary outcomes included Numeric Rating Scale (NRS) scores, cumulative oxycodone consumption, and adverse effects. The RSM group exhibited a significantly prolonged duration of analgesia at 1073.5min (932.0-1283.3) compared to the R group with a duration of 154.5min (80.5-199.3) and the RS group with a duration of 282.0min (195.3-350.0, P < 0 0.001). The cumulative oxycodone consumption during the 0-12hours and 0-24-hours period was significantly reduced in the RSM group compared to the R group (P < 0.05). There was also a lower incidence of nausea at 48hours postoperatively in the RSM group compared to the RM group. However, there were no significant differences between the four groups regarding NRS pain scores. The combination of ropivacaine, dexmedetomidine, and dexamethasone in RISS block significantly prolongs the duration of postoperative analgesia following VATS.

Evaluating the Efficacy of a Novel Hemostatic Powder Compared to Traditional Treatments in Non-Variceal Upper Gastrointestinal Bleeding: A Multicenter, Randomized Non-inferiority Study

Hemostatic powders have been rapidly developed and used to treat gastrointestinal bleeding. We aimed to investigate the non-inferiority of the newly developed hemostatic powder (CEGP-003) compared to conventional endoscopic treatments for non-variceal upper gastrointestinal bleeding (NVUGIB). This prospective, multicenter, randomized, open-label, controlled trial was conducted at four referral institutions. We enrolled consecutive patients who underwent emergency endoscopy for NVUGIB. The patients were randomly assigned to either the CEGP-003 or the conventional treatment group. In the CEGP-003 group, the hemostatic powder was applied as a spray. Conventional endoscopic treatments included electrical coagulation and hemoclipping. Between November 2019 and June 2022, 218 patients were enrolled (CEGP-003, 108; conventional, 110). Initial hemostasis was achieved in 104 of 108 patients (96.3%) in the CEGP-003 group and 101 of 110 patients (91.8%) in the conventional treatment group. The CEGP-003 group exhibited a significantly higher re-bleeding rate than the conventional treatment group. Multivariate analysis that age, duodenum and middle 1/3 of stomach, and CEGP-003 use as the initial hemostatic treatment were independent risk factors for re-bleeding. No adverse events were associated with CEGP-003. CEGP-003 demonstrates promise as an initial endoscopic therapy for NVUGIB, however close monitoring is warranted due to the risk of re-bleeding (Cris.nih.go.kr, number: KCT0004655).

Online Mindfulness-Based Intervention (eMBI) in management of dyspnea in patients with interstitial lung disease: A randomized clinical trial

Dyspnea and cough are frequent symptoms in ILD patients. The management of these symptoms is challenging, and evidence-based therapies are lacking. To evaluate the effect of an online Mindfulness-Based Intervention (eMBI) on reducing dyspnea in patients affected by different ILDs. This study was a prospective, open-label, controlled trial that included patients ≥18 years and a modified Medical Research Council (mMRC) dyspnea scale score of ≥ 1. Patients were randomized into either the eMBI or the control group (CG) for 8 weeks. The primary outcome was the change in the dyspnea mMRC scale. The Leicester Cough Questionnaire (LCQ), King's Brief Interstitial Lung Disease (K-BILD) questionnaire, and Depression, Anxiety, and Stress Scale (DASS-21) were performed before and after the eight weeks. All analyses were conducted on an intention-to-treat basis. The study was registered at the Brazilian Registry of Clinical Trials (ReBEC), RBR-3s4mf9y. 24 patients in the eMBI and 25 in the CG completed the intervention. In the eMBI group, compared to the control group, there was a greater proportion of patients with a reduction in dyspnea according to the mMRC scale score (48.9% versus 15.4%, p = 0.001). There was no significant difference between the groups in the LCQ (p = 0.666), or in the K-BILD (p = 0.108), depression (p = 0.08), or anxiety (p = 0.869 or stress (p = 0.789). No moderate or severe adverse events were observed in either group. Eight weeks eMBI is a potentially viable and safe approach, that can help manage dyspnea in ILD patients.

The effect of upper- and lower-body exercise on next-day postprandial triglycerides in healthy young men.

High non-fasting triglycerides (TG) concentration is linked to the development of atherosclerosis, and physical activity is commonly recommended to reduce postprandial TG concentration and cardiovascular diseases. Previous studies have demonstrated that acute whole-body (walking and running) or lower-body (leg cycling) aerobic exercise reduces postprandial TG. However, it is unclear whether upper-body exercise (i.e. arm-cranking) with sufficient energy expenditure lowers postprandial TG. Therefore, this study aimed to evaluate the effects of energy-matched upper- and lower-body exercises on postprandial TG concentrations the next day in healthy young men. Fifteen healthy young men (age 22.5 ± 1.7years, height 173.8 ± 5.7cm, body mass 68.2 ± 8.5kg, peak oxygen uptake 48.0 ± 5.5mL/min/kg and physically active) participated in a three-arm crossover trials: 1) arm-cranking, 2) leg-cycling exercise at 70% of mode-specific peak oxygen uptake to induce a net energy expenditure of 1,255kJ, or 3) rested between 16:00 and 17:00h on day 1 and consumed two standardised meals for breakfast (10:00h) and lunch (13:00h) on day 2. The mean macronutrient content of the breakfast was 44.9 ± 5.6g fat, 104.8 ± 13.0g carbohydrate, and 29.4 ± 3.6g protein, which provided 3.95 ± 0.49MJ energy (43% fat, 45% carbohydrate, and 12% protein), and that of the lunch was 45.2 ± 5.6g fat, 106.7 ± 13.2g carbohydrate, and 33.9 ± 4.2g protein, which provided 4.06 ± 0.50MJ energy (42% fat, 44% carbohydrate, and 14% protein). Time-averaged postprandial serum TG concentrations over 8h differed among trials (main effect of trial p < 0.001) and were lower in the upper- and lower-body exercise trials than in the control trial (1.46 ± 0.54 vs. 1.50 ± 0.69 vs. 1.79 ± 0.83mmol/L, respectively). The incremental TG area under the curve (AUC) (main effect of trial, p = 0.012) was 39% and 37% higher in the control trial than in the upper- and lower-body exercise trials (p = 0.025 and p = 0.033, respectively). There were no significant differences in incremental TG AUC between the upper- and lower-body exercise trials. An acute bout of energy-matched upper- and lower-body exercises similarly lowered postprandial TG concentrations the following day in healthy young men.Trial registration number: UMIN000045449.Date of registration: 10 September 2021.

Effects of online high-definition transcranial direct current stimulation over left dorsolateral prefrontal cortex on predominant negative symptoms and EEG functional connectivity in patients with schizophrenia: a randomized, double-blind, controlled trial.

Schizophrenia, a debilitating mental disorder, is characterized by persistent negative symptoms such as avolition and anhedonia. Currently, there are no effective treatments available for these symptoms. Thus, our study aims to assess the efficacy of online high-definition transcranial direct current stimulation (online HD-tDCS) in addressing the negative symptoms of schizophrenia, utilizing a double-blind, randomized, sham-controlled trial design. Fifty-nine patients with schizophrenia were randomized to receive either active HD-tDCS or sham stimulation, targeting the left dorsolateral prefrontal cortex. Outcomes were measured by changes in the Positive and Negative Syndrome Scale Factor Score for Negative Symptom (PANSS-FSNS). Exact low-resolution electromagnetic tomography was used to assess the functional connectivity. All 59 participants, including 50.84% females with an average age of 43.36 years, completed the trial. In the intention-to-treat analysis, patients receiving active HD-tDCS showed greater improvement in PANSS-FSNS scores compared to those receiving the sham procedure. The differences were 2.34 (95% confidence interval [CI], 1.28-3.40), 4.28 (95% CI, 2.93-5.62), and 4.91 (95% CI, 3.29-6.52) after the intervention, as well as at 1-week and 1-month follow-ups, respectively. A tingling sensation on the scalp was more common in the active group (63.3%) compared to the sham group (10.3%). Additionally, HD-tDCS was associated with a decrease in delta-band connectivity within the default mode network. High-definition transcranial direct current stimulation was effective and safe in ameliorating negative symptoms in patients with schizophrenia when combined with online functional targeting.

An agroecological approach to preparation and use of a milk protein production baseline.

Commercial dairy production occurs in a complex management environment, but increasingly, the dairy manager is expected to provide detailed reporting of productivity and environmental outcomes, for which conventional research methods double-blind crossover or case:control trials are inappropriate. This paper demonstrates the development of a milk protein production monitoring tool using a temporal (baseline) control in longitudinal, census-type investigations of modulation of system performance in response to factor change. It utilises farm-derived current and historical data, and contrasts seasonal responses with those achieved on neighbouring farms in a 2×2 contingency table. The approach is then shown to be useful in assessing the effect of two approaches to moderating milk urea concentration. Firstly, milk urea content can be monitored as it falls due to reduced feed protein content, and this fall can be arrested when milk protein content starts to decline relative to the value expected for the herd at any lactation stage. Secondly, by providing a dietary intervention aimed at increasing the availability of metabolic energy in the last month before calving, udder development can be augmented, leading to greater protein secretion capacity, meaning greater utilisation of circulating amino acids, and thus more limited substrate for urea synthesis. Thus, the changing impact of differing nutrition practices on dairy herd nitrogen excretion to environment can be followed with daily precision. In principle this approach can provide useful insights into a wide range of practical management interventions.

The application of intravenous general anesthesia under nasopharyngeal airway assisted ventilation undergoing ureteroscopic holmium laser lithotripsy: A prospective, single-center, controlled trial

Abstract To observe the effect of intravenous general anesthesia under nasopharyngeal airway-assisted ventilation on patients undergoing ureteroscopic holmium laser lithotripsy. One hundred and twenty patients who underwent ureteroscopic holmium laser lithotripsy in our hospital were selected and randomly divided into nasopharyngeal airway group (research group) and laryngeal mask group (control group). These patients, respectively, received intravenous anesthesia under nasopharyngeal airway and laryngeal mask-assisted ventilation. The following evaluation indexes were compared and analyzed between the two groups, including anesthetic effect, hemodynamics, stress response, postoperative recovery, adverse reactions, etc. There were no significant differences in Visual Analog Scale, hemodynamics, and stress response between the two groups at each time point (P &gt; 0.05). There were no significant differences in residence time and postoperative recovery time between the two groups (P &gt; 0.05). The difference in airway establishment time between the two groups was statistically significant (P &lt; 0.05), and cases with blood in the research group was significantly lower than those in the control group (P &lt; 0.05). Patient satisfaction in research group was significantly higher than those in the control group (P &lt; 0.05). The clinical effect of intravenous general anesthesia under nasopharyngeal airway-assisted ventilation in ureteroscopic holmium laser lithotripsy is significant, which helps to stabilize patients’ hemodynamics, reduce their stress response and adverse reactions, and improve the satisfaction rate of patient.

Creative puppet therapy reduces hallucinations in patients diagnosed with schizophrenia: Preliminary findings

Anomalous experiences and hallucinations characterize schizophrenia. This study aimed at determining the efficacy of creative puppet therapy (CPT; creation of a puppet with malleable DAS) to reduce severe anomalous experiences and hallucinations among patients diagnosed with schizophrenia. Double-blinded, controlled trials were performed on a convenience sample of 24 patients from a mental health center. The intervention group of 12 patients (who created puppets) and the pseudo-treatment group of 12 patients (who were involved in outdoor leisure trips) were compared to the control group of 12 control participants (who created puppets). Cardiff Anomalous Perceptions Scale (CAPS) assessed hallucinations; Emotional Expression Inventory (EEXI) assessed the emotional expression of one's own puppet. Puppet facial features were measured. Results showed that CPT effectively reduced (d = –4.00) hallucination frequency in patients. Hallucination reduction occurred across all sensory modalities, but touch and bodily interoception. Exteroceptive vs. interoceptive hallucinations was the most valuable classification in patients. Compared to controls, puppets created by patients expressed more negative emotions and had larger eye diameters, shorter noses, and larger whole face width. Eye diameter was correlated with fear, sadness, anger, and disgust, and whole face width with boredom. Fragmented-self integration of schizophrenia through CPT treatment might exploit aggregative dominance of the patient's own body.

Comparison of ustekinumab, infliximab and combination therapy in moderately to severely active ulcerative colitis - a study protocol of a randomized, multicenter, head-to-head COMBO-UC trial.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease with a complex etiology that affects the large intestine. Characterized by chronic, bloody diarrhea, UC can lead to severe complications, including an increased risk of colorectal cancer. Despite advancements in conservative treatment, including biologics like anti-TNF agents and ustekinumab (UST), many patients do not achieve full remission. Dual targeted therapy (DTT) combining infliximab (IFX) and UST is a promising approach to improve treatment outcomes. This prospective, randomized, multicenter, head-to-head controlled trial will evaluate the efficacy and safety of UST, IFX, and combination therapy (UST + IFX) in 172 patients with moderate to severe active UC across eight gastroenterology centers in Poland. The study includes a 14-16 week remission induction period followed by a 52-week maintenance phase. Patients will be randomly assigned to one of three treatment arms: IFX monotherapy, UST monotherapy, or IFX + UST combination therapy. Primary endpoint is clinical and endoscopic remission post-induction. Secondary endpoints include clinical response, biochemical remission, histological remission, and quality of life assessments using the Inflammatory Bowel Diseases Questionnaire and 36-Item Short Form Survey. Safety will be monitored through adverse event and serious adverse event reporting. This trial aims to determine whether combining IFX and UST can achieve higher remission rates and better long-term outcomes compared to monotherapy. The results could provide crucial insights into the optimal use of biologic agents in UC treatment, potentially establishing DTT as a standard therapy. The study's design, including extensive follow-up and robust endpoint measures, will contribute to understanding the therapeutic potential and safety profile of this combination therapy.

Effect of probiotics on glycemic control and lipid profiles in patients with type 2 diabetes mellitus: a randomized, double blind, controlled trial.

This double-blind, placebo-controlled, randomized (1:1) clinical trial was conducted at the West China Hospital, Sichuan University, from March to September 2017. Eligible participants included adults aged 18 years and older, living in the community, diagnosed with type 2 Diabetes Mellitus according to ADA guidelines, capable of self-managing their diabetes, and able to visit the study site for follow-up. The intervention group received 25 ml of a probiotic beverage containing with over 10^8 CFU/mL of Lactobacillus, administered four times daily. An equal volume of inactivated Lactobacillus was administered to the control group and the control group was administered the same volume of inactivated Lactobacillus. This study aimed to evaluate the effectiveness of probiotics on glycemic control and other diabetes-related outcomes in patients with type 2 diabetes patients. The primary outcomes were changes in HbA1c and FBG levels post-intervention. Investigators, participants, and study site personnel were blinded to the treatment allocation until the conclusion of the study. This double-blind, randomized, placebo-controlled clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR-POR-17010850). Of the 490 participants screened, 213 were randomized to either the probiotics group (n = 103) or the placebo group (n = 110). After 16 weeks of follow-up, the probiotic group showed reductions in HbA1c [-0.44 (-0.66 to -0.22)] and FBG [-0.97 (-1.49 to 0.46)] post-intervention, similar to the placebo group with reductions in HbA1c [-0.33 (-0.52 to -0.15)] and FBG [-0.90 (-1.32 to -0.47)], but these changes were not statistically significant in PP and ITT analyses (P>0.05). Adverse events were similarly distributed among groups, indicating comparable safety profiles. Overall, 16-week probiotic supplementation showed no beneficial effects on glycemic control, lipid profiles, or weight. https://www.chictr.org.cn/showproj.html?proj=18421, identifier ChiCTR-POR-17010850.

The effect of social care nurses on health related quality of life in patients with advanced cancer: A non-randomized, multicenter, controlled trial.

The effect of social care nurses on health related quality of life in patients with advanced cancer: A non-randomized, multicenter, controlled trial.

Decompressive nerve surgery associated with low diabetic foot ulcer rate and high-risk bias: A systematic review and meta-analysis.

Diabetic sensorimotor polyneuropathy (DSPN) occurs in 50% of diabetes mellitus (DM) patients. Up to 70% of DM patients incur diabetic foot ulcer(s) (DFU). Of those with DSPN, 20% develop DFU and medical therapy remains challenging. Decompression nerve surgery (DNS) purportedly improves DSPN and DFU. Currently, there is no accurate, pooled DFU incidence post-DNS. Thus, this systematic review meta-analyses DFU incidence post-DNS. Given the 60% global DFU incidence, we hypothesised a lower, pooled DFU incidence following DNS. Two authors searched six databases (MEDLINE/PubMed/Web of Science/Embase/Scopus/Cochrane/Google Scholar) to July 2023 for DNS clinical studies. Primary tracked outcomes were new and recurrent DFU incidence post-DNS. Inclusion criteria: clinical studies, adult DM patients, DNS of tibial nerve(s) at minimum, three-month minimum follow-up, and reported new/recurrent DFU incidence post-DNS. Exclusion criteria: non-clinical, non-human studies. GRADE and MINORS instrument(s) evaluated evidence. With random-effects model, DFU incidence was meta-analysed. For inclusion, 1074 studies were identified and 208 screened. Thirteen studies yielded 2466 and 540 new and recurrent patients with DFU incidence(s) of 1% and 5%, respectively. Primary studies had low-level evidence and high-risk bias, including selection bias using Cochrane Collaboration Bias Risk Tool. A sub-analysis of sample size (new:0% and recurrent:2%) and follow-up length (new:1% and recurrent:7%) produced similar results. Additional analyses based on further co-variables was precluded because of incomplete primary study data. Overall, despite low DFU incidence post-DNS, clinical studies provide too low-level evidence and high-risk bias for any recommendations. Future randomized, control trials may validate DNS for DFU management.

Observations on the efficacy of edaravone dexborneol in preventing post-stroke depression and its inflammatory mechanism: a prospective, randomized, control trial.

This study aimed to observe the effect of edaravone dexborneol (EDB) on the incidence of early post-stroke depression (PSD) and explore its inflammatory mechanisms. A prospective, randomized controlled study was conducted from January 2022 to June 2023, involving patients with acute ischemic stroke (AIS) at the Neurology Department of the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine. The control group received routine treatment, while the experimental group received routine combined EDB treatment. The main outcome measures included PSD incidence, Patient Health Questionnaire (PHQ-9) and Hamilton Depression Scale (HAMD) scores on days 14 and 30, and inflammatory factor levels on day 14. A total of 93 patients were included in the study, 51 in the experimental group and 42 in the control group. On day 14, the PSD incidence was 13.7% in the experimental group, lower than 31.0% in the control group (95%CI 0.127-0.996; p = 0.044). Compared to the control group, the experimental group showed significantly lower concentrations of pro-inflammatory cytokines IL-1β (95%CI 3.353-5.184), IL-6 (95%CI 2.694-3.426), TNF-α (95%CI 4.985-12.196), IFN-γ (95%CI 0.163-0.451), MCP-1 (95%CI 0.335-0.787), IL-17A (95%CI 0.543-1.024), and IL-23p19 (95%CI 1.677-1.959) (all p < 0.001), and higher levels of anti-inflammatory cytokines IL-4 (95%CI -1.087 to -0.941), IL-10 (95%CI -6.125 to -1.662), and IL-13 (95%CI -6.078 to -2.953) (all p ≤ 0.001). On day 30, the PSD incidence in the experimental group was 15.7%, lower than 40.5% in the control group (95%CI 0.103-0.725; p = 0.007). Compared with the control group, the experimental group had lower PHQ-9 scores on day 14 (95%CI 0.034-1.577; p = 0.041) and day 30 (95%CI 0.018-1.573; p = 0.045), and also had lower HAMD scores on day 14 (95% CI 0.281-2.856; p = 0.018) and day 30 (95% CI 0.647-3.482; p = 0.005). EDB could reduce the incidence of early PSD, reduce pro-inflammatory cytokine levels, and elevate anti-inflammatory cytokine levels, which was possibly related to the anti-inflammatory mechanism of EDB. http://www.chictr.org.cn/, identifier [ChiCTR2300067750].

Effects of Single-Joint Type Hybrid Assistive Limb in Knee Rehabilitation on Reduction of Pre-motor Time and Increased Rate of Fast Muscle Activation for Anterior Cruciate Regiment (ACL) Reconstruction.

Changes in muscle characteristics after post-anterior cruciate regiment (ACL) reconstruction are common. Knee robotic-assisted therapy using hybrid assistive limb (HAL) single-joint training for recovery from ACL injury has the potential to optimize muscle activity; however, its neurophysiological effects remain unclear. Thus, this study aimed to explore the electrophysiological parameters. This prospective, nonrandomized, controlled trial was conducted between December 2021 and January 2024. The patients were divided into two groups: the HAL group and the control group, each including five patients who underwent arthroscopic ACL reconstruction. Knee HAL single-joint training was conducted once weekly for three sessions. Three electrophysiological measures were examined related to knee neuromuscular responses pre-motor time, peak amplitude time, and neuromuscular rate of electromyography rise (RER) using surface electromyography (EMG). The pre-motor time and peak amplitude time were assessed in both groups at each session pre- and post-intervention.Bothgroups were evaluated for RERat postoperative weeks 17 and 21. Regarding the interaction of pre-motor time within each group, the interaction of pre-motor time within each group, the effect size of vastus medialis (VM) was larger in the HAL group. The peak amplitude time of EMG, the overall estimated marginal means, and the HAL group exhibited a significant difference in the VM (p=0.019), while vastus lateralis (VL) showed no significant difference but a larger effect size (d=0.61). The RERrevealed a significant difference in semitendinosus-RER30ms in the HAL group (p=0.044). Theknee HAL training for post-ACL reconstruction patients may influence neurophysiological outcomes.