Controlled Trial Research Articles

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.

Effect of combined treatment with transcranial direct current stimulation and repetitive transcranial magnetic stimulation compared to monotherapy for the treatment of chronic insomnia: a randomised, double-blind, parallel-group, controlled trial

Effect of combined treatment with transcranial direct current stimulation and repetitive transcranial magnetic stimulation compared to monotherapy for the treatment of chronic insomnia: a randomised, double-blind, parallel-group, controlled trial

Effect of intravenous lidocaine on catheter‑related bladder discomfort, postoperative pain and opioid requirement in complex fusion lumbar spinal surgery: a randomized, double blind, controlled trial.

Catheter-related bladder discomfort (CRBD) and pain commonly arises postoperatively in patients who undergo intra-operative urinary catheterization. The study aims to demonstrate the effectiveness of intravenous lidocaine to prevent CRBD and postoperative pain in complex lumbar spinal surgery. Eighty male patients, aged 20-79 years, scheduled for elective fusion spine surgery at least two levels were randomly assigned to receive either intravenous lidocaine (1.5mg/kg followed by 2mg/kg/h) (Group L) or a parallel volume of normal saline (Group C). The primary outcome was incidence of moderate to severe CRBD in a postanesthetic care unit (PACU) between the two groups. Secondary outcomes included postoperative pain, 24-hour post operative opioid requirement, mild and moderate to severe CRBD at 1, 2, 6 and 24h postoperatively, patient satisfaction on Global Perceived Effect Scale (GPES), and the adverse effects of lidocaine and surgical complications. Group L showed a significantly lower incidence of moderate-to-severe CRBD compared to Group C in the PACU (P = 0.002) and at 1h postoperatively (P = 0.039). Additionally, Group L experienced a significantly lower average pain scores compared to Group C at all time points (P < 0.001, P < 0.001, P = 0.001, P < 0.001 and P < 0.001 at 0, 1, 2, 6 and 24h, respectively) and demonstrated a significantly reduced postoperative morphine requirement across all time intervals (P < 0.05). Group L also reported significantly higher satisfaction on GPES compared to group C (P < 0.001). No adverse outcome was observed in either group. Intravenous lidocaine administration significantly reduced the incidence of moderate-to-severe CRBD at PACU and at 1h postoperatively. Additionally, its use in complex spine surgery led to reductions in postoperative pain, opioid requirement, and improved patient satisfaction, without any observed side effects.

Final Results of the GRECCAR-6 Trial on Waiting Period Following Neoadjuvant Radiochemotherapy for Locally Advanced Rectal Cancer: 5 Years of Follow-up.

The potential oncological benefit of extending the waiting period between neoadjuvant radiochemotherapy and surgical resection for rectal cancer is debated. To evaluate the impact of prolonging this waiting period on the 5-year oncological prognosis and 2-year functional result of locally advanced rectal adenocarcinoma. Phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients were enrolled from 24 colorectal centers. Patients with non-metastatic mid or lower cT3-4 or TxN+ rectal adenocarcinoma who had received radio-chemotherapy (45 to 50 Gy with fluorouracil or capecitabine). Patients were randomly assigned to undergo total mesorectal excision either 7 weeks (W7) or 11 weeks (W11) after radiochemotherapy. Overall survival and disease-free survival at 5 years of follow-up and low anterior resection syndrome score assessed after 2 years of follow-up. Among 265 patients enrolled, 133 were randomized in the 7-week group and 132 in the 11-week group. Twelve patients were excluded as they did not undergo resection. Among 253 patients analyzed, 5-year overall survival was not different between the two groups (81.6% in 7-week group versus 82.6% in 11-week group, p = 0.827), as well as for the 5-year disease-free survival (70.4% in 7-week group versus 69.5% in 11-week group, p = 0.856). No difference was observed between the two groups for distant recurrence (27.4% in 7-week group versus 25.7% in 11-week group, p = 0.777) or local recurrence (8.4% in 7-weeks group versus 10.2% in 11-week group, p = 0.543). Low anterior resection syndrome score was similar between the 7-week (25.0 IQR [15.0-34.0]) and 11-week groups (23.0 IQR[14.2-32.0], p = 0.743). The response rate to the LARS questionnaire was only 52%. Extending the waiting period between radiochemotherapy and resection from 7 to 11 weeks does not modify the 5-year oncological prognosis in rectal cancer and the 2-year low anterior resection occurrence.

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

Insecticide resistance among malaria vector species now occurs in 84 malaria-endemic countries and territories worldwide. Novel vector-control interventions, including long-lasting insecticidal nets (LLINs) that incorporate new active ingredients with distinct modes of action, are urgently needed to delay the evolution and spread of resistance and to alleviate reversals in malaria-control gains. We aimed to assess the longitudinal effect of two dual-active-ingredient LLINs on insecticide resistance during a cluster-randomised, controlled trial in Benin. This 3-year, three-arm, cluster-randomised, controlled trial was conducted between Oct 17, 2019, and Oct 24, 2022, in three districts in southern Benin, to compare the effects of LLINs containing chlorfenapyr-pyrethroid or pyriproxyfen-pyrethroid with LLINs containing pyrethroid only. In 19 292 mosquitoes (Anopheles gambiae sensu lato) collected over 36 months-3 months of baseline followed by 3 years post-intervention-we measured longitudinal phenotypic insecticide resistance profiles using bioassays and genotypic resistance profiles using quantitative, real-time, reverse transcriptase PCR of metabolic resistance genes in two clusters per trial group. The trial was registered with ClinicalTrials.gov, NCT03931473. In all three trial groups, a significant effect of LLINs on insecticide resistance selection was evident, with the median lethal dose (LD50) of α-cypermethrin approximately halving between baseline and 12 months post-LLIN distribution (pyrethroid-only LLIN cluster 21: LD50 78·78 μg/ml [95% CI 65·75-94·48] vs 35·93 [29·41-43.86] and cluster 31: 79·26 [65·40-96·44] vs 38·71 [30·88-48·53]; chlorfenapyr-pyrethroid LLIN cluster 43: 104·30 [82·97-133·58] vs 43·99 [35·30-54·86]; and pyriproxyfen-pyrethroid LLIN cluster 36: 63·76 [52·14-77·75] vs 37·96 [30·88-46·69] and cluster 53: 77·67 [57·63-104·56] vs 39·72 [29·26-53·97]). Over the subsequent 2 years, the LD50 of α-cypermethrin increased past baseline values in all three trial groups (year 3 pyrethroid-only LLIN cluster 21: 141·01 [111·70-181·90] and cluster 31: 115·15 [93·90-143·09]; chlorfenapyr-pyrethroid LLIN cluster 43: 97·00 [77·24-123·54] and cluster 55: 126·99 [102·34-161·26]; and pyriproxyfen-pyrethroid LLIN cluster 36: 142·29 [112·32-184·84] and cluster 53: 109·88 [79·31-157·70]). We observed minimal reductions in chlorfenapyr susceptibility and variable but significant reductions in fertility after pyriproxyfen exposure, with an overall trend of increasing susceptibility across trial years. Several metabolic genes were implicated in resistance selection, including CYP6P4 in the pyriproxyfen-pyrethroid LLIN group, which encodes an enzyme known to metabolise pyriproxyfen in vitro, and CYP6P3 and CYP9K1 in the chlorfenapyr-pyrethroid LLIN group, both of which encode enzymes that are involved in pro-insecticide activation. After 24 months of use, chlorfenapyr-pyrethroid LLINs no longer mitigated pyrethroid resistance selection in this area of southern Benin, which has high malaria transmission dominated by highly resistant A gambiae sensu lato. This finding raises issues for current net-procurement schedules, which are based on an operational net lifespan of 3 years. Knowledge of the effects of next-generation LLINs on insecticide-resistance selection is crucial for the pragmatic design of prospective resistance-management strategies. UNITAID and The Global Fund to Fight AIDS, Tuberculosis and Malaria.

Oxygen extraction–guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial

IntroductionIn critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion...

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.

Effects of aerobic training on brain architecture, hippocampal volume, cardiorespiratory parameters, and health-related quality of life among patients with schizophrenia: A systematic review

Background: Schizophrenia is considered to be a condition that usually manifests at any age but commonly seen in young people and is associated with a genetic propensity in brain development. Aim: The study explores the impact of aerobic training on brain architecture, hippocampal volume, cardiorespiratory parameters, and quality of life in young individuals with schizophrenia. The investigation focuses on the correlation between genetic predisposition, hippocampal atrophy, and diminished cardiorespiratory fitness, aiming to discern potential benefits of aerobic exercise on both physical and mental health outcomes. Methods: A systematic search was conducted in major online databases, such as Cochrane, Embase, PEDro, Web of science and PubMed (Medline). Two authors independently evaluated possibilities of bias, retrieved data and decided which trials should be included in the analysis. Total of 13 published articles (randomized clinical and controlled trials) with 656 patients was included from January 2010 to December 2020. Results: Following aerobic exercise training, people with schizophrenia presented with an increased hippocampus volume and enhanced cardiorespiratory endurance (P ˂0.05). Due to a lack of information, we rated the majority of the studies’ risk of bias in relation to random sequence creation, allocation concealment, and selective reporting as uncertain. Conclusion: Findings from the present review propose aerobic exercise program as a meaningful therapeutic intervention for schizophrenia patients in terms of maintaining appropriate brain architecture, increasing the hippocampal volume, improving cardiorespiratory parameters and health related quality of life.

Danning tablets for the treatment of multiple gallbladder polyps: Study protocol of multicentre, randomised, open-labelled, controlled trial

IntroductionGallbladder polyps (GPs) are protrusions of the gallbladder wall into the lumen, and are commonly detected during ultrasound examinations. Traditional management of multiple GPs (MGPs) has been conservative, including lifestyle interventions, regular monitoring, and surgical intervention in certain cases, but this approach poses risks of polyps enlargement and increase of number, as well as patients’ psychological burdens. Danning Tablets, a traditional Chinese medicine, have emerged as a potential non-surgical treatment for GPs, showing promise in reducing polyp size and alleviating symptoms, backed by their anti-inflammatory and antitumor properties demonstrated in preclinical studies. This suggests the need for further research into Danning Tablets as an alternative treatment for MGPs. Methods and analysisThe study is designed as a prospective, randomized, controlled, open-label trial. The study will be conducted across multiple centres specializing in gastroenterology and hepatology. Participants will be recruited from these centres, ensuring a diverse patient demographic. Adult patients diagnosed with MGPs, based on ultrasound findings, will be included. Exclusion criteria include patients with a history of gallbladder cancer, previous gallbladder surgery, or serious comorbid conditions. The control group will receive standard care, including dietary and lifestyle advice, while the intervention group will receive Danning Tablets and standard care. The dosage and administration of Danning Tablets will follow established clinical guidelines. The primary outcome will be the change in size of the largest gallbladder polyps on week 24 ​± ​1, measured by ultrasound. The secondary outcomes will include symptom improvement and recording of any adverse events. The study will span over a period of 6 months, with periodic assessments at baseline, 4, 8, 12, and 24 weeks.

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.

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.

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).

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.

A Single Sauna Session Does Not Improve Postprandial Blood Glucose Handling in Individuals with Type 2 Diabetes Mellitus: A Cross-Over, Randomized, Controlled Trial.

Passive heat treatment has been suggested to improve glycemic control in individuals with type 2 diabetes mellitus (T2DM). Previous studies have focused predominantly on hot water immersion and traditional sauna bathing, as opposed to the more novel method of infrared-based sauna bathing. Here, the impact of a single infrared sauna session on post-prandial glycemic control was assessed in older individuals with T2DM. In this randomized controlled crossover trial, 12 participants with T2DM (male/female: 10/2, age: 69±7 y, BMI: 27.5±2.9 kg/m2) rested in an infrared sauna twice: once in a heated (60°C) and once in a thermoneutral (21°C) condition for 40 min, immediately followed by a 2-h oral glucose tolerance test (OGTT). Venous blood samples were obtained to assess plasma glucose and insulin concentrations and to determine the whole-body composite insulin sensitivity index. Body core and leg skin temperature were higher following the heated condition compared to the thermoneutral condition (38.0±0.3 vs. 36.6±0.2°C and 39.4±0.8 vs. 31.3±0.8°C, respectively; P<0.001 for both). The incremental area under the curve (iAUC) of plasma glucose concentrations during the OGTT was higher after the heated condition compared to the thermoneutral condition (17.7±3.1 vs. 14.8±2.8 mmol/L/120 min; P<0.001). No differences were observed in plasma insulin concentrations (heated: 380±194 vs. thermoneutral: 376±210 pmol/L/120 min; P=0.93) or whole-body composite insulin sensitivity indexes (4.5±2.8 vs. 4.5±2.1; P=0.67). A single infrared sauna session does not improve postprandial blood glucose handling in individuals with T2DM. Future studies should assess the effect of more prolonged application of infrared sauna bathing on daily glycemic control.

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.