Search

Background: Although previous studies have showed that epidural morphine can be used as a complement to local anesthetics for analgesia after postcesarean delivery under spinal anesthesia, there is little known about the analgesic dosage of epidural morphine and hydromorphone for hemorrhoidectomy. Therefore, we conducted this study to examine the potency ratio of hydromorphone to epidural morphine as well as effective analgesic dose for 50% patients (ED50) undergoing elective hemorrhoidectomy. Methods: 80 patients under elective hemorrhoidectomy with combined spinal and epidural anesthesia(CSEA) in department of anesthesia, Dongguan Tungwah hospital. To assess the ED50, patients were treated with epidural morphine or epidural hydromorphone randomly using a biased coin method-determined dose with a sequential allocation procedure. Following surgery, standardized multimodal analgesia was administered to all patients. A pain response score of ≤ 3 (on a scale of 0–10) was determined to be the effective dose after 24 h following CSEA. The ED50 in both groups were determined using the probit regression and isotonic regression method. We also measured pain intensity by patient interview using a 10 point verbal numeric rating scale prospectively at 6, 12 and 24 h after CSEA, and adverse effects were also noted. Results: The ED50 was 0.350 mg (95% CI, 0.259–0.376 mg) in hydromorphone group and 1.129 mg (95% CI, 0.903–1.187 mg) in morphine group, respectively, estimated by isotonic regression method. Regression analysis with the probit, the ED50 of epidural hydromorphone was 0.366 mg (95% CI, 0.276–0.388 mg) and epidural morphine was 1.138 mg (95% CI, 0.910–1.201 mg). Exploratory findings showed that there was no difference between the most frequent dosages of epidural hydromorphone or epidural morphine in the occurrence of nausea, vomiting and pruritus. When administered with epidural opioids at ED50 doses or higher, 97.5% (39/40) of epidural morphine patients and 97.5% (39/40) epidural hydromorphone of patients were satisfied with their analgesia. Conclusion: Effective hemorrhoidectomy analgesia requires a 3:1 ratio of epidural morphine to epidural hydromorphone. Both drugs provide excellent patient satisfaction. [ABSTRACT FROM AUTHOR]

Background: Procedural sedation is essential for optimizing upper gastrointestinal endoscopy, particularly in high-risk patients with multiple underlying diseases. Respiratory and circulatory complications present significant challenges for procedural sedation in this population. This non-inferiority randomized controlled trial aims to investigate the safety and comfort of remimazolam compared to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients. Methods: A total of 576 high-risk patients scheduled to undergo upper gastrointestinal endoscopy are planned to be enrolled in this study and randomly allocated to either the remimazolam or propofol group. The primary outcome measure is a composite endpoint, which includes (1) achieving a Modified Observer's Alertness/Sedation scale (MOAA/S) score ≤ 3 before endoscope insertion, (2) successful completion of the endoscopic procedure, (3) the absence of significant respiratory instability during the endoscopy and treatment, and (4) the absence of significant circulatory instability during the examination. The noninferiority margin was 10%. Any adverse events (AEs) that occur will be reported. Discussion: This trial aims to determine whether remimazolam is non-inferior to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients, regarding success rate, complication incidence, patient comfort, and satisfaction. Trial registration {2a and 2b}: Chinese Clinical Trial Registry ClinicalTrials.gov ChiCTR2200066527. Registered on 7 December 2022. [ABSTRACT FROM AUTHOR]

Background: In Traditional Chinese Medicine (TCM) theory, cold dampness obstruction is one of the common syndromes of osteoarthritis. Therefore, in clinical practice, the main treatment methods are to dispel wind, remove dampness, and dissipate cold, used to treat knee osteoarthritis (KOA). This report describes a mulitercenter clinical study to assess Zhuifeng Tougu Capsule's efficacy and safety in the treatment of patients who are cold dampness obstruction syndrome in KOA, and to provide evidence-based medical for the rational use of Zhuifeng Tougu Capsules in clinical practice. Methods: This randomized, parallel group controlled, double-blind, double dummy trial will include a total of 215 KOA patients who meet the study criteria. 215 patients underwent 1:1 randomisation, with 107 cases assigned the experimental group (Zhuifeng Tougu Capsules + Glucosamine Sulfate Capsules Simulator) and 108 assigned the control group (Glucosamine Sulfate Capsules + Zhuifeng Tougu Capsules Simulator). After enrolment, patients received 12 weeks of treatment. The main efficacy measure is the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score. Visual analogue scale (VAS) pain score, Self-condition assessment VAS score, WOMAC KOA score, TCM syndrome score and TCM syndrome efficacy, ESR level, CRP level, suprapatellar bursa effusion depth, use of rescue drugs, and safety indicators are secondary efficacy indicators. Results: Compared with before treatment, WOMAC pain score, VAS pain score, Self-condition assessment VAS score, WOMAC KOA score, and TCM syndrome score decreased significantly in both groups (P < 0.01). Also, the experimental group showed significant differences in the above indicators compared to control (P < 0.01). However, after treatment, no significant differences were showed in the ESR level, CRP level, and suprapatellar bursa effusion depth between the two groups (P > 0.05). No any serious adverse effects showed in the experimental group and control group. Conclusions: Zhuifeng Tougu Capsules can effectively improve knee joint function and significantly alleviate the pain of KOA. Trial registration: Clinical trial registration was completed with the China Clinical Trial Registration Center for this research protocol (No. ChiCTR2000028750) on January 2, 2020. [ABSTRACT FROM AUTHOR]

Background: Numerous interventions for irritability in autism spectrum disorder (ASD) have been investigated. We aimed to appraise the magnitude of pharmacological and non-pharmacological interventions for irritability in ASD without any restrictions in terms of eligible interventions. Methods: We systematically searched PubMed/MEDLINE, Scopus, and Web of Science until April 15, 2023. We included randomized controlled trials (RCTs) with a parallel design that examined the efficacy of interventions for the treatment of irritability in patients of any age with ASD without any restrictions in terms of eligible interventions. We performed a random-effects meta-analysis by pooling effect sizes as Hedges' g. We classified assessed interventions as follows: pharmacological monotherapy, risperidone plus adjuvant therapy versus risperidone monotherapy, non-pharmacological intervention, and dietary intervention. We utilized the Cochrane tool to evaluate the risk of bias in each study and the GRADE approach to assess the certainty of evidence for each meta-analyzed intervention. Results: Out of 5640 references, we identified 60 eligible articles with 45 different kinds of interventions, including 3531 participants, of which 80.9% were males (mean age [SD] = 8.79 [3.85]). For pharmacological monotherapy, risperidone (Hedges' g − 0.857, 95% CI − 1.263 to − 0.451, certainty of evidence: high) and aripiprazole (Hedges' g − 0.559, 95% CI − 0.767 to − 0.351, certainty of evidence: high) outperformed placebo. Among the non-pharmacological interventions, parent training (Hedges' g − 0.893, 95% CI − 1.184 to − 0.602, certainty of evidence: moderate) showed a significant result. None of the meta-analyzed interventions yielded significant effects among risperidone + adjuvant therapy and dietary supplementation. However, several novel molecules in augmentation to risperidone outperformed risperidone monotherapy, yet from one RCT each. Limitations: First, various tools have been utilized to measure the irritability in ASD, which may contribute to the heterogeneity of the outcomes. Second, meta-analyses for each intervention included only a small number of studies and participants. Conclusions: Only risperidone, aripiprazole among pharmacological interventions, and parent training among non-pharmacological interventions can be recommended for irritability in ASD. As an augmentation to risperidone, several novel treatments show promising effects, but further RCTs are needed to replicate findings. Trial registration PROSPERO, CRD42021243965. [ABSTRACT FROM AUTHOR]

Background: Severe acute respiratory syndrome coronavirus 2 will coexist with humans for a long time, and it is therefore important to develop effective treatments for coronavirus disease 2019 (COVID-19). Recent studies have demonstrated that antiviral therapy is a key factor in preventing patients from progressing to severe disease, even death. Effective and affordable antiviral medications are essential for disease treatment and are urgently needed. Azvudine, a nucleoside analogue, is a potential low-cost candidate with few drug interactions. However, validation of high-quality clinical studies is still limited. Methods: This is a multicentre, randomized, double-blind, placebo-controlled phase III clinical trial involving 1096 adult patients with mild-to-moderate symptoms of COVID-19 who are at high risk for progression to severe COVID-19. Patients will be randomized to (1) receive azvudine tablets 5 mg daily for a maximum of 7 days or (2) receive placebo five tablets daily. All participants will be permitted to use a standard treatment strategy except antiviral therapy beyond the investigational medications. The primary outcome will be the ratio of COVID-19-related critical illness and all-cause mortality among the two groups within 28 days. Discussion: The purpose of this clinical trial is to determine whether azvudine can prevent patients at risk of severe disease from progressing to critical illness and death, and the results will identify whether azvudine is an effective and affordable antiviral treatment option for COVID-19. Trial registration: ClinicalTrials.gov NCT05689034. Registered on 18 January 2023. [ABSTRACT FROM AUTHOR]

Background: Rectovaginal fistula (RVF) is an abnormal channel formed by epithelial tissue between the anterior wall of the rectum and the posterior wall of the vagina, which manifests as vaginal gassing and defecation. It is one of the common complications of female pelvic surgeries. With the increased number of proctectomies for rectal cancer, the number of postoperative rectovaginal fistulas also increases. Once RVF occurs, the failure rate is still high with various treatments available. RVF causes great suffering to women and is still a major problem in treatment. Therefore, it is significant for female rectal cancer patients to prevent RVF after rectal cancer surgery. In this study, we introduce a new method to prevent RVF during rectal cancer radical operation. Methods: In this randomized controlled trial (RCT), all operations are performed according to the principle of total mesorectal excision (TME) radical resection in rectal cancer surgery. All eligible participants will be divided into two groups: the experimental group and the control group. Experimental group: the anterior rectal wall of about 1 cm distal to the anastomosis was dislocated. Before the anastomosis of the rectal end, a fat flap (usually left side) containing the ovarian vascular pedicle was dislocated, measured by 10–15 cm in length and 2 cm in width. The fat flap containing the ovarian vascular pedicle was packed and fixed anterior to the anastomotic stoma with fibrin glue. Control group: surgery will be carried out in accordance with the TME principle. Participants will be compared on several variables, including the incidence of RVF after operation (primary outcomes), the occurrence time of postoperative RVF, the occurrence time of RVF after stoma closure, and other postoperative complications, such as anastomotic leakage, chylous leakage, and intestinal obstruction (secondary outcomes). The follow-up data collection will be conducted according to the follow-up time point, and the baseline data will also be collected for follow-up analysis. By comparing the incidence of rectovaginal leakage between the experimental group and the control group, we aim to explore the feasibility of this method for the prevention of postoperative RVF. Discussion: This RCT will explore the feasibility of packing with a laparoscopic dislocated fat flap containing an ovarian vascular pedicle anterior to the anastomotic stoma after rectal cancer surgery to prevent RVF. Trial registration: Chinese Clinical Trial Registry (ChiCTR) registration ChiCTR2000031449. Registered on June 26, 2019. All items of the WHO Trial registration data set can be found within the protocol. [ABSTRACT FROM AUTHOR]

Background: Minimally invasive direct coronary artery bypass (MIDCAB) surgery offers an effective option for coronary artery disease (CAD) patients with the avoidance of median sternotomy and fast postoperative recovery. However, MIDCAB is still associated with significant postoperative pain which may lead to delayed recovery. The erector spinae plane block (ESPB) is a superficial fascial plane block. There have not been randomized controlled trials evaluating the effects of ESPB on analgesia and patient recovery following MIDCAB surgery. We therefore designed a double-blind prospective randomized placebo-controlled trial, aiming to prove the hypothesis that ESPB reduces postoperative pain scores in patients undergoing MIDCAB surgery. Methods: The study protocol has been reviewed and approved by the Ethical Review Committee of Peking University People's Hospital. Sixty adult patients of either sex scheduled for MIDCAB surgery under general anesthesia (GA) will be included. Patients will be randomly allocated to receive either a preoperative single-shot ESPB with 30 mL of ropivacaine 0.5% (ESPB group) or normal saline 0.9% (control group). The primary outcomes are the difference between the two groups in numeric rating scale (NRS) scores at rest at different time points (6, 12, 18, 24, 48 h) after surgery. The secondary outcomes include NRS scores on deep inspiration within 48 h, postoperative hydromorphone consumption, and quality of patient recovery at 24 h and 48 h, using the Quality of Recovery-15 (QoR-15) scale. The other outcomes include intraoperative fentanyl requirements, the need for additional postoperative rescue analgesics, time to tracheal extubation and chest tube removal after surgery, incidence of postoperative nausea and vomiting (PONV) and postoperative cognitive dysfunction (POCD), intensive care unit (ICU) length of stay (LOS), hospital discharge time, and 30-day mortality. Adverse events will be also evaluated. Discussion: This is a novel randomized controlled study evaluating a preoperative ultrasound-guided single-shot unilateral ESPB on analgesia and quality of patient recovery in MIDCAB surgery. The results of this study will characterize the degree of acute postoperative pain and clinical outcomes following MIDCAB. Our study may help optimizing analgesia regimen selection and improving patient comfort in this specific population. Trial registration: The study was prospectively registered with the Chinese Clinical Trial Registry (trial identifier: ChiCTR2100052810). Date of registration: November 5, 2021. [ABSTRACT FROM AUTHOR]

Background: Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. Within that research field, at least two important research paths have been explored in the past years. On the one hand, the anxiolytic effect of casual video games has been tested as such gaming activity may distract away from anxious thoughts through the induction of flow and redirection of attention toward the game and thus away of anxious thoughts. On the other hand, the bidirectional link between weak attentional control and higher anxiety has led to the design of interventions aiming at improving attentional control such as working memory training studies. Taking stock that another genre of gaming, action video games, improves attentional control, game-based interventions that combines cognitive training and action-like game features would seem relevant. This three-arm randomized controlled trial aims to evaluate the feasibility and the efficacy of two video game interventions to document how each may potentially alleviate adolescent anxiety-related symptoms when deployed fully on-line. Methods: The study aims to recruit 150 individuals, 12 to 14 years of age, with high levels of anxiety as reported by the parents' online form of the Screen for Child Anxiety Related Disorders questionnaire. This trial contrasts a child-friendly, "action-like" video game designed to improve attentional control abilities in a progressive and stepwise manner (Eco-Rescue), a casual puzzle video game selected to act as a positive distraction tool (Bejeweled) and finally a control group with no assigned training intervention to control for possible test-retest effects (No-training). Participants will be assigned randomly to one of the three study arms. They will be assessed for main (anxiety) and secondary outcomes (attentional control, affective working memory) at three time points, before training (T1), one week after the 6-week training (T2) and four months after completing the training (T3). Discussion: The results will provide evidence for the feasibility and the efficacy of two online video game interventions at improving mental health and emotional well-being in adolescents with high levels of anxiety. This project will contribute unique knowledge to the field, as few studies have examined the effects of video game play in the context of digital mental health interventions for adolescents. Trial registration: The trial is registered on ClinicalTrials.gov (NCT05923944, June 20, 2023). [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) have traditionally been considered the gold standard for medical evidence. However, in light of emerging methodologies in data science, many experts question the role of RCTs. Within this context, experts in the USA and Canada came together to debate whether the primacy of RCTs as the gold standard for medical evidence, still holds in light of recent methodological advances in data science and in the era of big data. The purpose of this manuscript, aims to raise awareness of the pros and cons of RCTs and observational studies in order to help guide clinicians, researchers, students, and decision-makers in making informed decisions on the quality of medical evidence to support their work. In particular, new and underappreciated advantages and disadvantages of both designs are contrasted. Innovations taking place in both of these research methodologies, which can blur the lines between the two, are also discussed. Finally, practical guidance for clinicians and future directions in assessing the quality of evidence is offered. [ABSTRACT FROM AUTHOR]

Background: High ambient air temperatures in Africa pose significant health and behavioral challenges in populations with limited access to cooling adaptations. The built environment can exacerbate heat exposure, making passive home cooling adaptations a potential method for protecting occupants against indoor heat exposure. Methods: We are conducting a 2-year community-based stratified cluster randomized controlled trial (cRCT) implementing sunlight-reflecting roof coatings, known as "cool roofs," as a climate change adaptation intervention for passive indoor home cooling. Our primary research objective is to investigate the effects of cool roofs on health, indoor climate, economic, and behavioral outcomes in rural Burkina Faso. This cRCT is nested in the Nouna Health and Demographic Surveillance System (HDSS), a population-based dynamic cohort study of all people living in a geographically contiguous area covering 59 villages, 14305 households and 28610 individuals. We recruited 1200 participants, one woman and one man, each in 600 households in 25 villages in the Nouna HDSS. We stratified our sample by (i) village and (ii) two prevalent roof types in this area of Burkina Faso: mud brick and tin. We randomized the same number of people (12) and homes (6) in each stratum 1:1 to receiving vs. not receiving the cool roof. We are collecting outcome data on one primary endpoint - heart rate, (a measure of heat stress) and 22 secondary outcomes encompassing indoor climate parameters, blood pressure, body temperature, heat-related outcomes, blood glucose, sleep, cognition, mental health, health facility utilization, economic and productivity outcomes, mosquito count, life satisfaction, gender-based violence, and food consumption. We followed all participants for 2 years, conducting monthly home visits to collect objective and subjective outcomes. Approximately 12% of participants (n = 152) used smartwatches to continuously measure endpoints including heart rate, sleep and activity. Discussion: Our study demonstrates the potential of large-scale cRCTs to evaluate novel climate change adaptation interventions and provide evidence supporting investments in heat resilience in sub-Saharan Africa. By conducting this research, we will contribute to better policies and interventions to help climate-vulnerable populations ward off the detrimental effects of extreme indoor heat on health. Trial registration: German Clinical Trials Register (DRKS) DRKS00023207. Registered on April 19, 2021. [ABSTRACT FROM AUTHOR]

Background: Patients with mental disorders have a higher prevalence of sleep problems than the general population. Sleep problems may include insomnia, circadian rhythm disorders, or hypersomnia. A transdiagnostic approach combining cognitive behavioral therapy for insomnia (CBT-I) with chronotherapy addressing a broad range of sleep problems has shown promising results in a limited number of studies. The aim of the study is to investigate the efficacy of a transdiagnostic sleep intervention for patients with sleep problems comorbid to bipolar disorder, unipolar depression, or attention deficit disorders. The primary hypothesis is that the intervention improves sleep quality compared with a control group. The secondary hypotheses are that the intervention increases subjective and objective sleep efficiency, reduces sleep onset latency, wake after sleep onset, number of awakenings, and severity of insomnia; and that it improves well-being, personal recovery, work ability, and consumption of sleep medication compared with a control group. Methods: The study is a randomized controlled trial enrolling 88 outpatients with bipolar disorder, major depression, or attention deficit disorder with symptoms of various sleep problems (insomnia, circadian rhythm disorders, or hypersomnia). Patients are allocated to either an intervention group receiving six sessions of transdiagnostic sleep treatment or to a control group receiving a single session of sleep hygiene education. Assessments are made at baseline, at week two, and after 6 weeks in both groups. Actigraphy is performed continuously throughout the 6-week study period for all patients. The primary outcome is changes in the subjective appraisal of sleep quality (Pittsburgh Sleep Quality Index). The secondary outcomes are changes in sleep efficiency, sleep onset latency, wake after sleep onset, number of nocturnal awakenings (based on actigraph and sleep diary data), changes in insomnia severity (Insomnia Severity Index), well-being (WHO-5 Well-Being Index), personal recovery (INSPIRE-O), work ability (Work Ability Index), and consumption of sleep medication (sleep-diaries). Discussion: The study was initiated in 2022 and the inclusion period will continue until mid-2024. The results may have implications for the development and implementation of additional treatment options for patients with mental disorders and comorbid sleep problems. Trial registration: ClinicalTrials.gov. NCT05406414. Registered on June 6, 2022. [ABSTRACT FROM AUTHOR]

Background: Cystic fibrosis is an inherited disease, which is caused by the CFTR protein defects due to mutations in the CFTR gene. Along with CFTR dysfunction, exocrine pancreatic insufficiency plays a key role in persistent fat malabsorption in CF patients; therefore, deficiency of fat-soluble vitamins (A, D, E, and K) is still a therapeutic challenge. Even with efficient pancreatic enzyme medication and CF-specific vitamins, many patients with CF have fat-soluble vitamins deficiency. The present study aims to evaluate the efficiency of nanomicelle formulation of fat-soluble vitamins in children with CF in order to achieve the appropriate serum levels of these vitamins. Methods: This prospective, single-blind control trial will be conducted at the Akbar Children's Hospital in Mashhad, Iran. Patients with CF will be enrolled based on the eligibility criteria. The control group will receive the standard formulation of fat-soluble vitamins similar to the routine CF treatment, and for the intervention group, the nanomicelle formulation of fat-soluble vitamins will be administered for 3 months. The primary outcome of this study is the measurement of serum levels of fat-soluble vitamins. The secondary outcomes are clinical assessment by the Shwachman-Kulczycki score, anthropometrics, and quality of life. Outcomes will be assessed before and after 3 months. Discussion: Due to persistent fat-soluble vitamin deficiency in CF disease, the nanomicelle formulation could be proposed as a new delivery method of fat-soluble vitamins in the treatment of cystic fibrosis. Trial registration: Iranian Registry of Clinical Trials IRCT20220415054541N1. Registered on July 23, 2022. [ABSTRACT FROM AUTHOR]

Background: For complete revascularization, patients with diffuse coronary artery disease should have a coronary endarterectomy and a coronary artery bypass graft (CE-CABG). Sadly, CE can lead to a lack of endothelium, which raises the risk of thrombotic events. Even though daily dual antiplatelet therapies (DAPT) have been shown to reduce thrombotic events, the risk of perioperative thrombotic events is high during the high-risk period after CE-CABG, and there is no consistent protocol to bridge DAPT. This trial aims to compare safety and efficacy between tirofiban and heparin as DAPT bridging strategies after CE-CABG. Methods: In phase I, 266 patients undergoing CE-CABG will be randomly assigned to tirofiban and heparin treatment groups to compare the two treatments in terms of the primary safety endpoint, chest tube drainage in the first 24 h. If the phase I trial shows tirofiban non-inferiority, phase II will commence, in which an additional 464 patients will be randomly assigned. All 730 patients will be studied to compare major cardiovascular and cerebrovascular events (MACCEs) between the groups in the first 30 days after surgery. Discussion: Given the possible benefits of tirofiban administration after CE-CABG, this trial has the potential to advance the field of adult coronary heart surgery. Trial registration: chictr.org.cn, ChiCTR2200055697. Registered 6 January 2022. https://www.chictr.org.cn/com/25/showproj.aspx?proj=149451. Current version: 20,220,620. [ABSTRACT FROM AUTHOR]

Objectives: Non-adherence to tuberculosis (TB) treatment is the leading cause of the increase in drug resistance cases. This study will determine the effectiveness of pharmaceutical-care-based interventions coupled with short messages delivered by a pharmacist on treatment outcomes and adherence among TB patients. Methods: The study will be conducted in TB Control Center of Pakistan Institute of Medical Sciences Hospital, Islamabad and District Bannu TB Control Center time period will be from August 2019 to September 2021. The patients will be included into the control group (usual care) or the intervention group pharmaceutical care and SMS reminder. The primary outcome includes a change in mean score from baseline in treatment outcomes and adherence, measured by Morisky Medication Adherence Scale, and clinic appointment attendance registration. Secondary outcomes include health-related quality of life of patients, disease knowledge, and patient satisfaction with the intervention. Result: The major issues in patients with TB are cure rate and medication adherence. The method anticipated in this manuscript could set the foundation of pharmaceutical care and mobile SMS for the future provision of care to improve TB treatment outcomes. Conclusion: The study will make available fundamental information about the influence of the patient centered program on the adherence and clinical outcomes of patients with TB. [ABSTRACT FROM AUTHOR]

Background: Patients with hematological malignancies received multiple hypodermic injections of recombinant human granulocyte colony-stimulating factor. Procedural pain is one of the most common iatrogenic causes of pain in patients with hematological malignancies. It is also identified as the most commonly occurring problem in clinical care in the Department of Hematology and Oncology at Shenzhen University General Hospital. However, providing immediate relief from pain induced by hypodermic injection of recombinant human granulocyte colony-stimulating factor remains a major challenge. This trial aims to evaluate the safety and analgesic efficacy of a fixed nitrous oxide/oxygen mixture for patients with hematological malignancies and experiencing procedural pain caused by hypodermic injection of recombinant human granulocyte colony-stimulating factor in the department. Methods: The nitrous oxide/oxygen study is a single-center, randomized, double-blind, placebo-controlled trial involving patients with hematological malignancies who require hypodermic injections of recombinant human granulocyte colony-stimulating factor for treatment. This trial was conducted in the Hematology and Oncology Department of Shenzhen University General Hospital. A total of 54 eligible patients were randomly allocated to either the fixed nitrous oxide/oxygen mixture group (n = 36) or the oxygen group (n = 18). Neither the investigators nor the patients known about the randomization list and the nature of the gas mixture in each cylinder. Outcomes were monitored at the baseline (T0), immediately after hypodermic injection of recombinant human granulocyte colony-stimulating factor (T1), and 5 min after hypodermic injection of recombinant human granulocyte colony-stimulating factor (T2) for each group. The primary outcome measure was the score in the numerical rating scale corresponding to the highest level of pain experienced during hypodermic injection of recombinant human granulocyte colony-stimulating factor. Secondary outcomes included the fear of pain, anxiety score, four physiological parameters, adverse effects, total time of gas administration, satisfaction from both patients and nurses, and the acceptance of the patients. Discussion: This study focused on the safety and analgesic efficacy during hypodermic injection of recombinant human granulocyte colony-stimulating factor procedure. Data on the feasibility and safety of nitrous oxide/oxygen therapy was provided if proven beneficial to patients with hematological malignancies during hypodermic injection of recombinant human granulocyte colony-stimulating factor and widely administered to patients with procedural pain in the department. Trial registration: Chinese Clinical Trial Register, ChiCTR2200061507. Registered on June 27, 2022. http://www.chictr.org.cn/edit.aspx?pid=170573&htm=4 [ABSTRACT FROM AUTHOR]

Background: The management of small gastric submucosal tumors (SMTs) originating from the muscularis propria layer (SMT-MPs) remains a subject of debate. Endoscopic submucosal dissection (ESD) is currently considered the optimal treatment for resection. However, high expenses, complex procedures, and the risk of complications have limited its application. Our previously proposed novel operation, precutting endoscopic band ligation (precutting EBL), has been demonstrated in a long-term, single-arm study to be an effective and safe technique for removing small gastric SMTs. However, the absence of a pathological examination and the potential for delayed perforation have raised concerns. Thus, we modified the precutting EBL by adding endoscopic resection to the snare after ligation and closure, yielding the precutting endoscopic band ligation-assisted resection (precutting EBLR). Moreover, the initial pilot study confirmed the safety and efficacy of the proposed approach and we planned a randomized controlled trial (RCT) to further validate its clinical feasibility. Methods: This was a prospective, single-center, open-label, parallel group, and randomized controlled trial. Approximately 40 patients with SMT-MPs will be included in this trial. The patients included were allocated to two groups: ESD and precutting EBLR. The basic clinical data of the patients were collected in detail. To better quantify the difference between ESD and precutting EBLR, the primary outcome was set as the operation duration. The secondary outcomes included total operation cost and hospitalization, intraoperative adverse events, and postoperative recurrence. The primary outcome was tested for superiority, while the secondary outcomes were tested for noninferiority. SPSS is commonly used for statistical analysis. Discussion: This study was designed to validate the feasibility of a novel operation for removing gastric SMT-MPs. To intuitively assess this phenomenon, the operation durations of precutting EBLR and ESD were compared, and other outcomes were also recorded comprehensively. Trial registration: Chinese Clinical Trial Registry ChiCTR2200065473. Registered on November 5, 2022. [ABSTRACT FROM AUTHOR]

Background: Anhedonia, which is defined as the inability to feel pleasure, is considered a core symptom of major depressive disorder (MDD). It can lead to several adverse outcomes in adolescents, including heightened disease severity, resistance to antidepressants, recurrence of MDD, and even suicide. Specifically, patients who suffer from anhedonia may exhibit a limited response to selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT). Previous researches have revealed a link between anhedonia and abnormalities within the reward circuitry, making the nucleus accumbens (NAc) a potential target for treatment. However, since the NAc is deep within the brain, repetitive transcranial magnetic stimulation (rTMS) has the potential to modulate this specific region. Recent advances have enabled treatment technology to precisely target the left dorsolateral prefrontal cortex (DLPFC) and modify the functional connectivity (FC) between DLPFC and NAc in adolescent patients with anhedonia. Therefore, we plan to conduct a study to explore the safety and effectiveness of using resting-state functional connectivity magnetic resonance imaging (fcMRI)-guided rTMS to alleviate anhedonia in adolescents diagnosed with MDD. Methods: The aim of this article is to provide a study protocol for a parallel-group randomized, double-blind, placebo-controlled experiment. The study will involve 88 participants who will be randomly assigned to receive either active rTMS or sham rTMS. The primary object is to measure the percentage change in the severity of anhedonia, using the Snaith-Hamilton Pleasure Scale (SHAPS). The assessment will be conducted from the baseline to 8-week post-treatment period. The secondary outcome includes encompassing fMRI measurements, scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17), the Montgomery Asberg Depression Rating Scale (MADRS), the Chinese Version of Temporal Experience of Pleasure Scale (CV-TEPS), and the Chinese Version of Beck Scale for Suicide Ideation (BSI-CV). The Clinical Global Impression (CGI) scores will also be taken into account, and adverse events will be monitored. These evaluations will be conducted at baseline, as well as at 1, 2, 4, and 8 weeks. Discussion: If the hypothesis of the current study is confirmed, (fcMRI)-guided rTMS could be a powerful tool to alleviate the core symptoms of MDD and provide essential data to explore the mechanism of anhedonia. Trial registration: ClinicalTrials.gov NCT05544071. Registered on 16 September 2022. [ABSTRACT FROM AUTHOR]

Background: Combined antihypertensive therapy has obvious advantages over single drug therapy. Hypertension guidelines fully affirm the efficacy of dual combination in initial antihypertensive therapy. Recent studies have also pointed out that the quadruple combination of very low-dose antihypertensive drugs is superior to single drugs. However, whether low-dose quadruple therapy is better than dual combination is unknown. Methods/design: A randomized double-blind crossover clinical trial will be conducted to compare the efficacy and safety of low-dose quadruple antihypertensives (irbesartan 75 mg + metoprolol 23.75 mg + amlodipine 2.5 mg + indapamide 1.25 mg) with standard-dose dual antihypertensives (irbesartan 150 mg + amlodipine 5 mg) in the initial treatment of patients with mild to moderate hypertension (140–179/90–109 mmHg). Ninety patients are required and will be recruited and randomly assigned in a 1:1 ratio to two crossover groups. Two groups will receive a different combination therapy for 4 weeks, then switch to the other combination therapy for 4 weeks, with a 2-week wash-out. Antihypertensive effects and related adverse effects of the two antihypertensive combination treatments will be compared. The primary outcome, i.e., mean 24-h systolic blood pressure in ambulatory blood pressure monitoring, will be assessed via linear mixed-effects model. Discussion: This statistical analysis plan will be confirmed prior to blind review and data lock before un-blinding and is sought to increase the validity of the QUADUAL trial. Trial registration: ClinicalTrials.gov, NCT05377203. Registered May 11, 2022, https://clinicaltrials.gov/study/NCT05377203. [ABSTRACT FROM AUTHOR]

Background: Patients with obsessive–compulsive disorder (OCD) suffer from repetitive fearful intrusions which they try to neutralize by performing compulsions. OCD is considered to be the most resistant anxiety disorder with a remission rate of only 53% after a year of an evidence-based treatment. Therefore, it remains an obligation to develop and investigate more effective treatment interventions. This study aims to compare personalized exposure with response prevention (ERP) using experience sampling methodology-based feedback to ERP as usual in patients with OCD. Personalized exposure will be provided screen-to-screen in an ecologically valid (real time and real place) context by means of a smartphone application. This app will also be used to collect both objective and subjective data by means of experience sampling methodology (ESM). This ESM data will be used to identify triggers and protective factors for symptom severity, provide personalized feedback and optimize the effect of ERP. The primary goal of this RCT is to compare the effectiveness of personalized ERP to ERP as usual in the traditional context of a therapist's room in patients with OCD in OCD symptom severity, as well as differences in quality of life, depressive symptoms and anxiety states. Since both self-efficacy and experiential avoidance are known to influence symptom severity in OCS, a secondary goal is to examine if a possible treatment effect is mediated by self-efficacy or experiential avoidance. Methods: This study involves a randomized controlled trial with 20 weekly sessions by 2 groups (ERP as usual versus personalized ERP), repeated measurements at baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3), posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7) and a year follow-up (T8). A hundred and sixty patients with an OCD diagnosis according to DSM-5 criteria will participate. Half of the group will receive exposure with response prevention as usual, the other half will receive personalized exposure with response prevention with a smartphone application and personalized feedback sessions based on experience sampling data. Multilevel mixed modelling analysis will be used to investigate differences in treatment effect, as well as differences in quality of life, depressive symptoms and anxiety states. We will use the macro of Preacher and Hayes and apply bootstrapping methods to assess the possible mediating effect of changes in self-efficacy and experiential avoidance on subsequent treatment effects. Discussion: This randomized controlled trial is the first to assess the influence of delivering ERP through video-calling and the use of an ESM intervention on the symptom severity of OCD. Since the global pandemic COVID-19, the use of video-calling to deliver psychological treatments has become more common, increasing the relevance of this study. Trial registration: ICTRP Trial NL8254. Registered on 2019–12-24. [ABSTRACT FROM AUTHOR]

Background: Patients undergoing carotid endarterectomy (CEA) have a high restenosis rate, which increases the risk of stroke, and there is still a lack of effective treatment for restenosis. The cause of stenosis is related to local inflammatory reactions. Some basic studies have shown that the inflammatory response causing arterial stenosis is closely related to the nerve axons distributed in its outer membrane, and that removal of the nerve is effective in reducing the inflammatory response to prevent arterial stenosis. Therefore, we propose to design a randomized controlled trial to study whether disconnecting the carotid sinus nerve during a CEA operation can reduce carotid arterial restenosis. Method/design: This study is a randomized, double-blind, single-center study. We will recruit 276 patients, who will be randomly divided into the experimental group and the control group. Based on the standard CEA operation, the operator will search for the carotid sinus nerve on the surface of the internal carotid artery and will entirely transect it in the experimental group. Both groups will be guided with the same postoperative treatment and will be followed up every 3 months for 3 years after the operation. The main indices observed will be the carotid restenosis rate, incidence and nature of carotid plaque, and carotid blood flow velocity. Other indices will be arrhythmia, blood pressure variability, and biomarkers of atherosclerosis, such as blood lipids, hypersensitive C-reactive protein (hs-CRP), homocysteine, and total bilirubin. Discussion: It is expected that carotid sinus nerve transection will significantly reduce the occurrence of restenosis after CEA, decrease the incidence of ischemic stroke, and realize the effective primary prevention of stroke. Trial registration: ChiCTR2300073652. Registered on July 18, 2023. [ABSTRACT FROM AUTHOR]

Background: Research on intermittent fasting has shown that it can improve a variety of health outcomes, including blood sugar control, blood lipid levels and blood pressure. Only few studies document longer periods of fasting, especially in rehabilitation participants. Cardiac inpatient rehabilitation follows a multidisciplinary approach including change of health behaviour to reduce patients' risk of future cardiovascular events. To date, evidence suggests that intermittent fasting can be an effective way to improve health and well-being, but more research is needed to fully understand its long-term effects and factors that promote the implementation. Therefore, the aim of the ongoing InterVFast trial is to investigate the effectiveness of intermittent fasting amongst cardiac rehabilitation patients after 4-week inpatient rehabilitation as well as 3 and 12 months subsequently including patients' perspective. Methods: This single-centre randomized controlled trial evaluates the effectiveness of the InterVFast intervention in weight loss (primary outcome). We also examine patients' acceptance and the effect on relevant outcomes as blood glucose and triglyceride levels, cholesterol and high-sensitivity C-reactive protein. Weight, blood samples and clinical data are collected as part of the initial and final examination during inpatient rehabilitation. During inpatient rehabilitation, participants daily note fasting intervals and meals eaten as well as practicability in a fasting diary. In addition, interviews about perceived advantages and disadvantages and acceptance are carried out with the participants in the IG. A standardized follow-up examination (weight, blood samples) will be carried out by the family doctor after 3 and 12 months (t2 and t3). Discussion: Compared to other weight-loss intervention studies, our study addresses patients with coronary heart disease and includes patients' acceptance as well as long-term maintenance. It is hypothesized that participation in the InterVfast intervention will improve relevant health outcomes in a sample of cardiac rehabilitation patients and thus constitute a behavioural prevention strategy to reduce the risk of future cardiac events and improve overall health and quality of life. Trial registration: ClinicalTrials.gov DRKS00023983. Registered on February 17, 2022. [ABSTRACT FROM AUTHOR]

Background: Preprints are increasingly used to disseminate research results, providing multiple sources of information for the same study. We assessed the consistency in effect estimates between preprint and subsequent journal article of COVID-19 randomized controlled trials. Methods: The study utilized data from the COVID-NMA living systematic review of pharmacological treatments for COVID-19 (covid-nma.com) up to July 20, 2022. We identified randomized controlled trials (RCTs) evaluating pharmacological treatments vs. standard of care/placebo for patients with COVID-19 that were originally posted as preprints and subsequently published as journal articles. Trials that did not report the same analysis in both documents were excluded. Data were extracted independently by pairs of researchers with consensus to resolve disagreements. Effect estimates extracted from the first preprint were compared to effect estimates from the journal article. Results: The search identified 135 RCTs originally posted as a preprint and subsequently published as a journal article. We excluded 26 RCTs that did not meet the eligibility criteria, of which 13 RCTs reported an interim analysis in the preprint and a final analysis in the journal article. Overall, 109 preprint–article RCTs were included in the analysis. The median (interquartile range) delay between preprint and journal article was 121 (73–187) days, the median sample size was 150 (71–464) participants, 76% of RCTs had been prospectively registered, 60% received industry or mixed funding, 72% were multicentric trials. The overall risk of bias was rated as 'some concern' for 80% of RCTs. We found that 81 preprint–article pairs of RCTs were consistent for all outcomes reported. There were nine RCTs with at least one outcome with a discrepancy in the number of participants with outcome events or the number of participants analyzed, which yielded a minor change in the estimate of the effect. Furthermore, six RCTs had at least one outcome missing in the journal article and 14 RCTs had at least one outcome added in the journal article compared to the preprint. There was a change in the direction of effect in one RCT. No changes in statistical significance or conclusions were found. Conclusions: Effect estimates were generally consistent between COVID-19 preprints and subsequent journal articles. The main results and interpretation did not change in any trial. Nevertheless, some outcomes were added and deleted in some journal articles. [ABSTRACT FROM AUTHOR]

Background: Intensive care unit (ICU) patients often experience significant physiological stress. This study evaluated the effect of a defined family visitation protocol on physiological responses in the ICU. Methods: A randomized, block-randomized clinical trial was conducted on 78 ICU patients at Imam Reza Hospital between February 8, 2017, and August 8, 2017. The intervention group received protocol-based visits, and the control group continued with standard visitation. Block randomization was utilized for group assignments. The primary outcome was the measurement of physiological signs using designated monitoring devices. Data were analyzed using SPSS version 22, employing independent t-tests, Mann-Whitney U test, repeated measures analysis, and Friedman's test. Results: The results showed no significant differences in systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, and arterial blood oxygen levels between the two groups. However, heart rate in the intervention group was significantly lower in three stages before, during, and after the meaningful visiting (P = 0.008). Conclusion: Protocol-based scheduled family visits in the ICU may reduce physiological stress, as evidenced by a decrease in patients' heart rate. Implementing tailored visitation protocols sensitive to patient preferences and clinical contexts is advisable, suggesting the integration of family visits into standard care practices for enhanced patient outcomes. Trial Registration: IRCT20161229031654N2; 25/01/2018; Iranian Registry of Clinical Trials (https://en.irct.ir). [ABSTRACT FROM AUTHOR]

Background: Dietary sulfur amino acid restriction (SAAR) improves metabolic health in animals. In this study, we investigated the effect of dietary SAAR on body weight, body composition, resting metabolic rate, gene expression profiles in white adipose tissue (WAT), and an extensive blood biomarker profile in humans with overweight or obesity. Methods: N = 59 participants with overweight or obesity (73% women) were randomized stratified by sex to an 8-week plant-based dietary intervention low (~ 2 g/day, SAAR) or high (~ 5.6 g/day, control group) in sulfur amino acids. The diets were provided in full to the participants, and both investigators and participants were blinded to the intervention. Outcome analyses were performed using linear mixed model regression adjusted for baseline values of the outcome and sex. Results: SAAR led to a ~ 20% greater weight loss compared to controls (β 95% CI − 1.14 (− 2.04, − 0.25) kg, p = 0.013). Despite greater weight loss, resting metabolic rate remained similar between groups. Furthermore, SAAR decreased serum leptin, and increased ketone bodies compared to controls. In WAT, 20 genes were upregulated whereas 24 genes were downregulated (FDR < 5%) in the SAAR group compared to controls. Generally applicable gene set enrichment analyses revealed that processes associated with ribosomes were upregulated, whereas processes related to structural components were downregulated. Conclusion: Our study shows that SAAR leads to greater weight loss, decreased leptin and increased ketone bodies compared to controls. Further research on SAAR is needed to investigate the therapeutic potential for metabolic conditions in humans. Trial registration: ClinicalTrials.gov identifier: NCT04701346, registered Jan 8th 2021, https://www.clinicaltrials.gov/study/NCT04701346 [ABSTRACT FROM AUTHOR]

Background: Globally, women with disabilities are less likely to have access to family planning services compared to their peers without disabilities. However, evidence of effective interventions for promoting their sexual and reproductive health and rights remains limited, particularly in low- and middle-income settings. To help address disparities, an inclusive sexual and reproductive health project was developed to increase access to modern contraceptive methods and reduce unmet need for family planning for women of reproductive age with disabilities in Kaduna city, Nigeria. The project uses demand-side, supply-side and contextual interventions, with an adaptive management approach. This protocol presents a study to evaluate the project's impact. Methods: A pragmatic cluster-randomized controlled trial design with surveys at baseline and endline will be used to evaluate interventions delivered for at least 1 year at health facility and community levels in comparison to 'standard' state provision of family planning services, in the context of state-wide and national broadcast media and advocacy. Randomization will be conducted based on the health facility catchment area, with 19 clusters in the intervention arm and 18 in the control arm. The primary outcome measure will be access to family planning. It was calculated that at least 950 women aged 18 to 49 years with disabilities (475 in each arm) will be recruited to detect a 50% increase in access compared to the control arm. For each woman with disabilities enrolled, a neighbouring woman without disabilities in the same cluster and age group will be recruited to assess whether the intervention has a specific effect amongst women with disabilities. The trial will be complemented by an integrated process evaluation. Ethical approval for the study has been given by the National Health Research Ethics Committee of Nigeria and London School of Hygiene & Tropical Medicine. Discussion: Defining access to services is complex, as it is not a single variable that can be measured directly and need for family planning is subjectively defined. Consequently, we have conceptualized 'access to family planning' based on a composite of beliefs about using services if needed. Trial registration: ISRCTN registry ISRCTN12671153. Retrospectively registered on 17/04/2023. [ABSTRACT FROM AUTHOR]

Background: Motivation and a therapeutic alliance are crucial for successful therapy. It is assumed that dogs can increase motivation and help support therapeutic relationships. This is one of the reasons for including dogs in psychotherapy. While the positive effects of psychotherapy with dogs have been documented over the past years, little is known about the underlying mechanisms of animal-assisted psychotherapy. This study therefore aims to investigate whether and how the presence of a dog affects motivation and the therapeutic alliance in child and adolescent psychotherapy. Methods: The study is a randomized controlled trial assessing motivation and the therapeutic alliance during the first five sessions of psychotherapy attended by children and adolescents with different psychiatric disorders. We will recruit 150 children and adolescents and randomly assign them to one of three conditions: (a) a dog is present but not integrated in the therapeutic narrative, (b) a dog is actively integrated in the therapeutic narrative, and (c) no dog is present. The children's and adolescents' evaluations of the therapeutic alliance and of their motivation will be assessed as the primary outcomes using standardized questionnaires before and after the first five therapy sessions as well as at follow-up. Further outcomes include the therapists' evaluations of the therapeutic alliance and their motivation, treatment adherence of the children and adolescents, and treatment satisfaction of the children and adolescents, their parents, and of the therapists. Interventions are conducted by experienced therapists who regularly work with their dogs. Outcomes will be analyzed using general linear models, with the treatment group as a fixed factor and the baseline values as covariates. Discussion: This study provides information on the possible motivation and alliance-enhancing effects of integrating a dog into child and adolescent psychotherapy. This is relevant for practice, as these two components are strong predictors of therapy outcome. Moreover, the study will contribute to a better understanding of how a dog should be incorporated into psychotherapeutic settings. This can lead to a more purposeful inclusion of dogs in psychotherapy for children and adolescents. Trial registration: The trial was registered on ClinicalTrials.gov, NCT05384808, on 20 May 2022. [ABSTRACT FROM AUTHOR]

Background: Individuals with wrist osteoarthritis (OA) can suffer from pain, muscular weakness, and impaired motion of the wrist, which can reduce the quality of life. While there is strong evidence that all patients with OA should receive first-line treatment with education and exercises, this approach has not yet been proposed for individuals with wrist OA. Therefore, this trial aimed to evaluate the effectiveness of a first line neuromuscular joint-protective exercise therapy program compared to a training program with range of motion (ROM) exercises in patients with wrist OA. Methods: In this randomized controlled trial (RCT), 48 patients with symptomatic and radiographically confirmed wrist OA were randomly allocated to a 12-week self-management program with either a neuromuscular joint-protective exercise therapy program (intervention group) or a training program with ROM exercises only (control group). Our primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) with secondary outcome measures of grip strength, range of wrist motion, the Numerical Pain Rating, Scale (NPRS), the Disabilities of the Arm, Shoulder, and Hand (DASH) and the Generalized Self-Efficacy Scale (GSES). The outcome measures were evaluated by a blinded assessor at baseline and 12 weeks. Between-groups differences were analyzed using the Mann–Whitney U test and within-group differences were analyzed with the Wilcoxon signed-rank test. Results: A total of 41 participants were analyzed at 12 weeks. There were no significant differences in PRWE between the groups at 12 weeks (p = 0.27). However, DASH improved significantly in the intervention group compared to the control group (p = 0.02) and NPRS on load within the intervention group (p = 0.006). The difference in DASH should be interpreted with caution since it could be due to a non-significant increase (worsening) from baseline in the control group in combination with a non-significant decrease (improvement) in the intervention group. Conclusions: This RCT showed that the novel neuromuscular joint-protective exercise therapy program was not superior in reducing pain and improving function compared to a training program with ROM exercises at 12 weeks. Future research is warranted to evaluate the effectiveness of forthcoming exercise therapy treatment programs for patients with wrist OA. Trial registration: ClinicalTrials.gov, NCT05367817. Retrospectively registered on 10/05/2022. https://clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Background: Although the risk of gastric cancer can be stratified according to Helicobacter pylori (H. pylori) IgG antibody titer and pepsinogen levels (ABC classification), a population-based gastric cancer screening system combining serological tests and endoscopy has not been introduced. This study aimed to compare the total testing cost per participant between the ABC classification method and the existing protocol. Methods: Using the minimization method with sex and age as allocation factors, 1206 participants were randomly assigned to the following two methods for a 5-year intervention: barium photofluorography as primary examination followed by detailed examination with upper gastrointestinal endoscopy (Ba-Endo) and risk-based upper gastrointestinal endoscopy by ABC classification (ABC-Endo). The primary endpoint was the total testing cost per participant over a 5-year period. The secondary endpoint was the expense required to detect one gastric cancer. Results: The total testing cost per participant was 39,711 yen in Ba-Endo (604 participants) and 45,227 yen in ABC-Endo (602 participants), with the latter being significantly higher (p < 0.001). During the intervention period, gastric cancer was found in 11 and eight participants in Ba–Endo and ABC-Endo, respectively. The expenses required to detect one gastric cancer were 2,240,931 yen in Ba-Endo and 3,486,662 yen in ABC-Endo. Conclusions: The testing cost per participant turned out to be higher in the ABC-Endo group than in the Ba-Endo group. This superiority trial, based on the hypothesis that the cost of testing is lower for ABC-Endo than for Ba-Endo, was rejected. [ABSTRACT FROM AUTHOR]

Mothers of children with autism spectrum disorder (ASD) face considerable psychological distress. Cognitive behavioral therapy (CBT) has shown promise in reducing caregiver burden, but evidence in the Arab world is lacking. Problem-solving appraisal training may optimize CBT's benefits. This study evaluated a tailored CBT program emphasizing the role of problem-solving appraisal in managing distress through the process of CBT. Sixty mothers were randomly allocated in a 1:1 ratio to either the CBT intervention group or the control group. The CBT group received 3-month sessions incorporating problem-solving appraisal training within a CBT curriculum from October 2022 to April 2023. Problem-solving techniques are focused on equipping individuals with the skills to identify, approach, and effectively resolve problems, leading to a reduction in stress levels and an improved capacity to cope with difficult situations. All mothers completed assessments of socio-demographics such as age, level of education, marital status, occupation, and adequacy of family income, the Depression Anxiety Stress Scale (DASS-21) and the Problem-Solving Inventory (PSI) before and after the program. The CBT group showed significant pre-to-post reductions in depression, anxiety, stress, and general psychological distress compared to controls (all p < 0.05). They also exhibited significant improvements in problem-solving confidence, approach-avoidance style and personal control (all p < 0.05). The customized CBT program markedly improved psychological well-being for mothers of children with ASD in Egypt. Incorporating problem-solving techniques may optimize CBT's benefits cross-culturally. These findings have implications for the implementation of evidence-based support programs for families impacted by ASD worldwide. [ABSTRACT FROM AUTHOR]

Background: Polycystic ovary syndrome (PCOS), an incidence of 10–15% in women of reproductive age, shows sex hormone disorders, luteal insufficiency, and the tendency of placental villus space thrombus. The incidence of early pregnancy loss in women with PCOS is three to eight times higher than that in non-PCOS women. PCOS women were reported in a pre-thrombotic state, which was manifested by accelerated thrombin production, increased PAI-1 activity, and fibrinogen. Other research also found an over-activated state of women with PCOS in immune system. Therefore, changing the prethrombotic state of PCOS through anticoagulation may be a new way to improve the adverse pregnancy outcome of PCOS. Low-molecular-weight heparin (LMWH) is the most common used anticoagulant drug in pregnancy, and it also was proposed for the prevention of recurrent abortion, although the application of LMWH in PCOS population during early pregnancy has not been reported. The objective of this study is to investigate the effect of LMWH on pregnancy outcomes after invitro fertilization-frozen embryo transfer (IVF-FET) in patients with polycystic ovary syndrome. Methods: A total of 356 PCOS women aged between 20 and 38 years which prepared for IVF followed with FET will be enrolled in the study. The patients, from four different hospitals stratified by age and body mass index (BMI), will be randomly divided into the study group who will be treated with LMWH started on the day of progesterone transformation (hormone therapy) during FET cycle and the control group without additional medicine. Serum or urine hCG test will be given 14 days after embryo transfer to confirm biochemical pregnancy. If pregnancy is positive, LMWH+ hormone therapy/hormone therapy will be continued for another 2 weeks. Transvaginal ultrasonography will be performed 14 days later to confirm intrauterine pregnancy. The primary outcome is the ongoing pregnancy, which is defined as intrauterine live fetus with ultrasound after 12 weeks of gestation. Discussion: This is the first study protocol to investigate the efficacy of LMWH as an adjuvant drug for IVF-FET outcomes in PCOS women, by comparing differences in ongoing pregnancy rate, clinical pregnancy rate, live birth rate, and early pregnancy loss rate between LMWH group and the control group. Trial registration: ClinicalTrials.gov ChiCTR2000036527. Registered on August 24, 2020 [ABSTRACT FROM AUTHOR]

Background: Disseminated intravascular coagulation (DIC) occurs in 30–50% of septic patients and contributes to high mortality in the intensive care unit (ICU). However, there are few proven interventions for coagulation disorder management in sepsis. Experimental and clinical data have demonstrated that sepsis could benefit from unfractionated heparin (UFH) treatment. To date, there are no large multicenter trials to determine the safety and efficacy of UFH in septic patients with suspected DIC. Methods: A multicenter, double-blinded, placebo-controlled randomized trial is designed to recruit 600 patients who met sepsis 3.0 criteria and suspected DIC. Participants will be randomized (1:1) to receive UFH or saline via continuous intravenous administration for 7 days within 6 h of enrolment. The primary outcome is ICU mortality. The secondary outcome includes 28-day all-cause mortality, the improvement of Sequential Organ Failure Assessment scores, and the incidence of major hemorrhage. Investigators, participants, and statisticians will be blinded to the allocation. Discussion: The HepSIC trial is to evaluate the efficacy and safety of UFH on sepsis-related DIC across different areas of China. The small dosage of UFH administration would offer a new potential approach for treating sepsis-related coagulation disorders. Ethics and dissemination: Ethical approval was granted by all the ethics committees of 20 participant centers. Results will be disseminated via peer-reviewed publications and presented at conferences. Trial registration: ClinicalTrials.gov NCT02654561. Registered on 13 January 2016. [ABSTRACT FROM AUTHOR]

Objective: Borderline personality disorder (BPD) is a serious public health problem. Dialectical Behavior Therapy (DBT) is a program that has provided encouraging results for its treatment. However, scientific evidence about its efficacy is scarce. Therefore, we aimed to describe the scientific production on the components of the DBT program and its therapeutic efficacy in the treatment of people with BPD. Method: A systematic review with relevant keywords was conducted based on studies available in Scopus, Web of Science, and PubMed until June 2023, including studies in English, research on therapeutic intervention, studies with a randomized controlled trial (RCT) design that included people with the diagnosis of BPD. Results: We found 18 RCTs, most of which supported the effectiveness of DBT for BPD. There were a total of 1,755 participants in these studies, most of whom were women. These studies looked for treating self-injurious behaviors, suicidal thoughts or ideations, number of visits to emergency services, and frequency of hospital admissions. Most studies revealed that both short-term DBT and standard DBT improved suicidality in BPD patients with small or moderate effect sizes, lasting up to 24 months after the treatment period. Furthermore, these studies showed that DBT can significantly improve general psychopathology and depressive symptoms in patients with BPD. Improvement of compliance, impulsivity, mood instability, as well as reduction in hospitalization rate are other findings observed in the trials following DBT. Conclusion: Although DBT shows efficacy in the treatment of BPD, heterogeneity in the methodologies employed is highlighted. Therefore, it is necessary to design studies from a homogeneous theoretical and methodological framework. [ABSTRACT FROM AUTHOR]

Background and aims: Tobacco use has posed a tremendous public health problem for China. The Chinese government has taken great efforts to curb the tobacco epidemic. However, the existing smoking cessation services available in China are underused and have some limitations. Our research team intends to develop a smartphone smoking cessation application (SSC APP) and integrate it with the existing smoking cessation services. This study aims to assess the efficacy of the SSC APP developed by our research team through a randomized controlled trial (RCT). Methods: Current smokers who are motivated to quit within 1 month (n = 1000) will be recruited both online and offline, and all potential participants will register and complete the prescreening assessment online. Participants will be randomly assigned to either the intervention group (receiving the SSC APP and a self-help smoking cessation manual) or the control group (receiving a self-help smoking cessation manual only) using a block randomization method. This study will be a two-arm, single-blind, parallel-group RCT. Participants will be followed up after enrollment through online questionnaires or by phone call. The primary outcome is self-reported 6-month continuous abstinence. The main secondary outcomes include self-reported 7-day point-prevalence abstinence at each follow-up; self-reported 3-month continuous abstinence; reduction in the number of cigarettes smoked per day; and the number of recent quit attempts. Discussion: If this SSC APP proves to be effective, it could be integrated with the existing smoking cessation services and further facilitate smoking cessation at the population level in China. Trial registration: Chinese Clinical Trial Registry: ChiCTR2200062097, Registered July 22, 2022. [ABSTRACT FROM AUTHOR]

Background: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. Methods: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. Discussion: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. Trial registration: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022). [ABSTRACT FROM AUTHOR]

Background This clinical study aims to evaluate the efficacy and safety of alcoholcontaining and alcohol-free mouth rinses in a controlled setting. With oral hygiene being a crucial aspect of overall health, it is essential to determine which type of mouth rinse is more effective and safer for daily use. Materials and Methods A randomized, double-blind, parallel-group study was conducted with 150 adult participants. They were divided into two groups: one using an alcohol-containing mouth rinse, and the other using an alcohol-free alternative. Participants followed a standardized oral hygiene regimen for four weeks, using their respective mouth rinses twice daily. Key parameters such as plaque reduction, gingival health, and adverse effects were assessed at baseline and after the study period. Results The results indicated a significant reduction in plaque accumulation in both groups, with the alcohol-containing mouth rinse group showing a mean reduction of 25.4% and the alcohol-free group showing a mean reduction of 23.1%. In terms of gingival health, both groups demonstrated improvement, with the alcohol-containing mouth rinse group showing a mean reduction of gingival inflammation by 19.2%, while the alcohol-free group exhibited a reduction of 18.5%. Importantly, the alcohol-free mouth rinse group reported fewer cases of adverse effects such as dry mouth and irritation compared to the alcohol-containing group. Conclusion This clinical study suggests that both alcohol-containing and alcoholfree mouth rinses are effective in reducing plaque accumulation and improving gingival health when used as part of a daily oral hygiene routine. However, the alcohol-free mouth rinse demonstrated a lower incidence of adverse effects, making it a potentially safer choice for individuals with sensitivity or a history of irritation. Further long-term studies are needed to confirm these findings. [ABSTRACT FROM AUTHOR]

Introduction: This study assessed the safety, tolerability, and PK/PD of HSK7653 tablets in Chinese patients with type 2 diabetes mellitus (T2DM). Methods: This was a Phase IIa, multicenter, randomized, double-blind, placebo-controlled, and dose-increasing study with 48 Chinese diabetes patients. Subjects were randomly assigned to placebo and 10/25/50 mg dose groups, and they received oral administration once every two weeks for a total of six times. Safety and tolerability were assessed throughout this study, and PK/PD parameters were analyzed using non-compartment model with WinNonlin. Results: The three doses of HSK7653 were well tolerated, and the incidence of TEAE and ADR was not significantly increased compared with the placebo group. Cmax increased linearly with the increasing dose, and the mean t1/2 was 64.0–87.0 h. The first dose and last dose PK parameters were similar. After oral administration of 10–50 mg HSK7653 every two weeks, the average Rac_Cmax and Rac_AUC were 0.9–1.0 and 1.0–1.1 respectively; therefore, HSK7653 was not accumulated in vivo. All three doses significantly inhibited DPP-4 activity and increased plasma GLP-1 level and serum insulin levels. When the plasma concentration of HSK7653 was ≥ 20.0 ng/mL, the DPP-4 inhibition rate in all subjects was maintained at > 80.0%. In 10 and 25 mg dose groups, the HbA1c levels maintained a downward trend compared with the placebo group. Discussion: HSK7653 showed desirable pharmacokinetic and pharmacodynamic properties with good safety and tolerability in Chinese T2DM patients. DPP-4 inhibition rate and plasma GLP-1 levels were higher in each dose group than in placebo group. Trial Registration Number: CTR20182505 (Drug Clinical Trial Registration and Information Disclosure Platform, www.chinadrugtrials.org.cn). [ABSTRACT FROM AUTHOR]

Aim: To assess the incremental cost-effectiveness ratio (ICER) of group transdiagnostic cognitive-behavioural therapy (tCBT) added to treatment as usual (TAU) for anxiety disorders compared to TAU only from the healthcare system perspective over a 1-year time horizon. Methods: Data from a pragmatic multisite randomized controlled trial where adults (18–65 years) with an anxiety disorder were randomized to tCBT + TAU (n = 117) or TAU (n = 114). Group tCBT is a 12-week (2h weekly sessions) community-based intervention. Health service utilization and related costs were captured from medico-administrative data and included those for the intervention, ambulatory visits, hospitalizations and medications. Effectiveness was based on quality-adjusted life years (QALYs). The study included measures at baseline, 4, 8, and 12 months. Intention-to-treat and complete case analyses were carried out. Missing data were imputed using multiple imputation analyses. Seemingly unrelated regression analyses were used to assess the effect of the intervention on total costs and QALYs while also adjusting for baseline confounders. The probability of cost-effectiveness of the intervention was assessed according to different willingness-to-pay (WTP) thresholds using the net benefit regression method. Results: The ICER of tCBT + TAU as compared to TAU in the intention-to-treat analysis was $6,581/QALY. Complete case analyses showed a similar ICER of $6,642/QALY. The probability at a WTP threshold of $20,000 and $40,000 that tCBT + TAU as compared to TAU is cost-effective is 93.0% and 99.9%. Conclusion: tCBT added to TAU appears to be cost-effective from the healthcare system perspective for treating adult patients with anxiety disorders. Larger trials including young and older adults as well as a range of anxiety disorders are needed to further investigate the cost-effectiveness of tCBT in different patient populations. [ABSTRACT FROM AUTHOR]

Background: Dengue fever, a globally significant mosquito-borne viral illness, imposes a substantial burden on tropical regions. Thrombocytopenia, characterized by reduced platelet counts, is a critical complication of dengue, often leading to bleeding complications and increased morbidity and mortality. Vitamin E and vitamin C, with their anti-inflammatory and antioxidant properties, have garnered interest as potential interventions to address this issue. Materials and Methods: A rigorous prospective, double-blind, randomized controlled trial (RCT) was conducted across multiple healthcare facilities. Adult dengue fever patients with thrombocytopenia were randomly assigned to receive either vitamin E, vitamin C, or a placebo in addition to standard dengue management. Platelet counts, time to recovery, duration of hospitalization, bleeding complications, adverse events, and adherence were assessed. Results: Vitamin E and vitamin C supplementation significantly increased platelet counts compared to the placebo group. Participants in the vitamin E group exhibited a mean increase of +25.6 ×10^3/μL, while the vitamin C group showed +28.3 ×10^3/μL compared to +7.2 ×10^3/μL in the placebo group. Time to platelet count recovery was shorter in supplemented groups (3.8 and 3.6 days) compared to the placebo group (4.5 days). Bleeding complications were reduced in supplemented groups (6% and 4.5%) compared to the placebo group (12%). Adverse events did not significantly differ among groups. Conclusion: Vitamin E and vitamin C supplementation, as adjunctive therapies in dengue management, improved platelet counts, expedited recovery, and reduced bleeding complications without a notable increase in adverse events. Gender-based variations in treatment response warrant further investigation. These findings emphasize the potential role of vitamin supplementation in enhancing dengue fever outcomes, underlining the significance of evidence-based interventions in resource-constrained settings. [ABSTRACT FROM AUTHOR]

Background: This study aimed to evaluate the efficacy of pulsed radiofrequency applied using transcutaneous electrodes in carpal tunnel syndrome (CTS). Methods: After randomization, the patients received two cycles of noninvasive pulsed radiofrequency (NiPRF), once weekly, or splinting (the control group) for three months. Clinical evaluations were recorded at baseline and weeks 4 and 8. The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) was used to determine the functional status and symptom severity. Results: Sixty-two patients were followed up for three months. There was no difference between the groups in the BCTQ scores before and after treatment. The NiPRF group found a significant difference between the BCTQ measurements at all time intervals (paired sample t -test; P < 0.001). In the splint group, there was a significant difference only between the basal-1st month and basal-3rd month (paired samples t -test; P < 0.001). The main effect of the time variable was statistically significant (ANOVA; P < 0.001), but the group variable was not. There was no correlation between the BCTQ results measured at any time and the electroneuromyelogragphy findings in either group. Conclusions: NiPRF effectively improves symptoms and functionality in patients with CTS for up to 3 months. Thus, NiPRF can be considered an easy, safe, and useful alternative treatment modality for CTS. [ABSTRACT FROM AUTHOR]

Background: Orthodontic treatment planning involves the precise assessment of dental and skeletal anomalies, which can be facilitated by AI-enhanced diagnostic tools. Materials and Methods: A total of 100 orthodontic cases were included in this RCT. Patients were randomly assigned to two groups: an AI-enhanced diagnostic group and a traditional diagnostic group. The AI-enhanced diagnostic group underwent orthodontic assessment with the aid of AI-powered software, which provided automated cephalometric analysis, 3D model evaluations, and treatment suggestions. The traditional diagnostic group received conventional diagnostic assessments by orthodontists. The primary outcome measures included treatment planning accuracy, treatment time, and patient satisfaction. Secondary outcomes included the number of appointments required and treatment cost. Results: The AI-enhanced diagnostic group demonstrated a significantly higher accuracy in treatment planning compared to the traditional diagnostic group (P < 0.05). The AI group also required fewer appointments (mean ± SD: 10.2 ± 2.1 vs. 12.8 ± 3.4) and had a shorter treatment time (mean ± SD: 14.6 ± 3.2 months vs. 18.9 ± 4.5 months) (P < 0.001 for both comparisons). Additionally, patient satisfaction scores were higher in the AI group (mean ± SD: 9.2 ± 0.6 vs. 8.1 ± 0.8) (P < 0.001). However, the AI-enhanced diagnostic group had a slightly higher treatment cost. Conclusion: AI-enhanced diagnostic tools significantly enhance the accuracy of treatment planning in orthodontic cases, leading to reduced treatment time, fewer appointments, and increased patient satisfaction. [ABSTRACT FROM AUTHOR]

The randomized controlled trial (RCT) is considered the gold standard for evaluating the effectiveness of interventions or treatments across fields of physical and psychological medicine. While the RCT is well-placed for issues best addressed with a medical model approach—its origin story, the study and treatment of scurvy, an ideal exemplar—its stature and use must be challenged in cases of experiential phenomena, such as posttraumatic stress disorder (PTSD), where there is no one answer, treatment, or approach that suits all persons. Uncontested, its evidentiary superiority threatens to have deleterious effects on determining best practices for the treatment of PTSD. [ABSTRACT FROM AUTHOR]

Background: Periodontal disease, characterized by inflammation and infection of the supporting structures of teeth, poses a significant oral health challenge. Traditional periodontal surgery and non-surgical therapy, such as scaling and root planing, are established treatment approaches for addressing periodontal disease. Materials and Methods: The study enrolled 120 adult patients diagnosed with moderate to severe periodontal disease. Participants were randomly allocated to one of two groups: the traditional surgery group (TSG) or the non-surgical therapy group (NSTG). In the TSG, patients underwent traditional periodontal surgery, which included flap surgery and grafts when deemed necessary. The surgical procedures were performed by experienced periodontal surgeons. In contrast, the NSTG received non-surgical therapy in the form of scaling and root planing administered by trained dental hygienists. Outcome measures encompassed clinical parameters and patient-centered outcomes. Periodontal pocket depth and clinical attachment level, both measured in millimeters, were assessed at baseline, 3 months, and 6 months. Patient-reported outcomes, including pain, discomfort, and satisfaction, were collected through standardized questionnaires at each follow-up visit. Results: Patients in the TSG experienced a notable reduction in pocket depth from a baseline of 6.8 mm to 3.7 mm at the 6-month mark, resulting in a change of -3.1 mm. Conversely, the NSTG exhibited a reduction from 6.7 mm to 4.0 mm, with a change of -2.7 mm. In the TSG, the baseline attachment level of 7.2 mm decreased to 5.1 mm at 6 months, indicating a change of -2.1 mm. In the NSTG, the attachment level decreased from 7.1 mm to 5.5 mm, resulting in a change of -1.6 mm. Patients in the TSG reported an average pain score of 3.6 on a 1–10 scale, discomfort of 4.2, and satisfaction of 7.8. In contrast, patients in the NSTG reported lower pain (2.1) and discomfort (2.9) scores but similar satisfaction levels (8.4). Conclusion: In this randomized controlled trial (RCT), both traditional periodontal surgery and non-surgical therapy demonstrated improvements in clinical parameters and patient-reported outcomes. Traditional surgery resulted in greater reductions in periodontal pocket depth and clinical attachment loss at the 6-month follow-up. [ABSTRACT FROM AUTHOR]

Background: Dental restorations play a crucial role in preserving the structural integrity and function of posterior teeth. However, wear resistance remains a significant concern for these restorations. Materials and Methods: In this RCT, 120 participants with posterior tooth restoration needs were randomly assigned to two groups. Group A received conventional composite restorations, while Group B received NanoFilled Composite restorations. The restorations were placed according to standardized protocols. Wear resistance was assessed using a custom-designed chewing simulator, and the material wear was quantified using a profilometer. Patient-reported outcomes and clinical evaluations were also recorded at regular intervals over a 24-month follow-up period. Results: The wear resistance of the NanoFilled Composite restorations (Group B) was significantly higher than that of the conventional composite restorations (Group A) after 24 months of follow-up (P < 0.05). Profilometer measurements revealed that Group B had an average wear depth of 0.15 mm, while Group A had an average wear depth of 0.25 mm. Patient-reported outcomes indicated higher satisfaction and comfort in Group B. Clinical evaluations also demonstrated that Group B restorations had better retention and marginal integrity. Conclusion: This RCT demonstrates that NanoFilled Composite restorations exhibit superior wear resistance compared to conventional composite restorations when used in posterior teeth. [ABSTRACT FROM AUTHOR]

Background: Dental caries is a prevalent oral health issue, often diagnosed through intraoral radiographs. The accuracy of Artificial Intelligence (AI) in diagnosing dental caries from these radiographs is a subject of growing interest. Materials and Methods: In this RCT, 200 intraoral radiographs were collected from patients seeking dental care. These radiographs were independently evaluated by both AI-based software and experienced human dentists. The software utilized deep learning algorithms to analyze the radiographs for signs of dental caries. The performance of both AI and human interpretations was compared by calculating sensitivity, specificity, and overall accuracy. Arbitrary values of 85% sensitivity, 90% specificity, and 88% overall accuracy were set as benchmarks. Results: The AI-based software demonstrated a sensitivity of 88%, a specificity of 91%, and an overall accuracy of 89% in diagnosing dental caries from intraoral radiographs. Human interpretation, however, yielded a sensitivity of 84%, a specificity of 88%, and an overall accuracy of 86%. The AI-based software performed consistently close to or above the predefined benchmarks, while human interpretation showed slightly lower accuracy rates. Conclusion: This RCT suggests that AI-based software is a valuable tool for diagnosing dental caries from intraoral radiographs, with performance comparable to or exceeding that of experienced human dentists. The consistent accuracy of AI in this context highlights its potential as an adjunctive diagnostic tool, which can aid dental professionals in more efficient and precise caries detection. [ABSTRACT FROM AUTHOR]

Background: The interaction between type 2 diabetes and periodontal disease underscores the importance of exploring dietary interventions that could mitigate inflammation and improve periodontal health in diabetic patients. Materials and Methods: This randomized controlled trial included 100 patients with type 2 diabetes who were equally divided into two groups: Group A (low-carbohydrate diet) and Group B (control group). Patients in Group A followed a low-carbohydrate diet for 12 weeks, while Group B maintained their regular dietary habits. Periodontal health was assessed using clinical parameters such as probing depth (PD) and clinical attachment level (CAL), and inflammation was measured by analyzing levels of C-reactive protein (CRP) and interleukin-6 (IL-6). Statistical analyses were performed using appropriate tests. Results: After 12 weeks, Group A exhibited significant improvements in periodontal health compared to Group B. The mean PD reduction was 0.5 mm in Group A and 0.1 mm in Group B, with a corresponding mean CAL gain of 0.3 mm in Group A and no significant change in Group B. Inflammatory markers also showed favorable outcomes in Group A, with a decrease of 1.2 mg/L in CRP levels and 20% reduction in IL-6 levels. In contrast, Group B demonstrated minimal changes in inflammatory markers. The differences in PD, CAL, CRP, and IL-6 levels between the two groups were statistically significant (P < 0.05). Conclusion: The adoption of a low-carbohydrate diet for 12 weeks demonstrated significant improvements in periodontal health and reduction of inflammation in patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Evaluate and compare the efficacy and safety of molnupiravir and favipiravir in outpatients with mild to moderate COVID-19 and at risk of severe COVID-19. In an open-label, parallel-group, multicenter trial in Thailand, participants with moderate COVID-19 and at least one factor associated with severe COVID-19 were randomly assigned 1:1 to receive oral molnupiravir or oral favipiravir (standard of care). Phone calls for remote symptom assessment were made on Days 6, 15, and 29. Participants with worsening symptoms were instructed to return to the hospital. The primary endpoint was pulmonary involvement by Day 29, as evidenced by ≥2 of the following: dyspnea, oxygen saturation <92% or imaging. Nine hundred seventy-seven participants (487 molnupiravir, 490 favipiravir) were enrolled from 8 July 2022 to 19 January 2023. 98% had received ≥1 dose of COVID-19 vaccine and 83% ≥3 doses. By Day 29, pulmonary involvement occurred in 0% (0/483) in molnupiravir arm versus 1% (5/482) in favipiravir arm (−1.0%; Newcombe 95.2% CI: −2.4% to −0.0%; P = 0.021); all-cause death in 0% (0/483) and <1% (1/482); COVID-19 related hospitalization in <1% (1/483) and 1% (3/482); treatment-related adverse event in 1% (5/483) and 1% (4/486); and serious adverse event in 1% (4/483) and 1% (4/486). Favipiravir and molnupiravir had a similar efficacy and safety profile. Whether either of the two reduced the risk of complications during the omicron era in this population with a low risk of pulmonary involvement and a high vaccine coverage remains unclear. There were no differences in any of the safety endpoints. TCTR20230111009. [ABSTRACT FROM AUTHOR]

Abrocitinib is a highly selective Janus kinase 1 (JAK1) inhibitor that can block a multitude of inflammatory signaling pathways that underlie atopic dermatitis (AD). In addition, abrocitinib inhibits JAK1 signaling in sensory neurons to alleviate acute and chronic pruritus during AD. However, substantial variations in efficacy and safety risks remain due to variations in doses applied in clinical use. Therefore for the present study, differences in the efficacy and tolerability of 100 and 200 mg abrocitinib for treating pruritus and eczema symptoms in patients with moderate-to-severe AD were evaluated compared with placebo. Specifically, randomized controlled trials (RCTs) of abrocitinib compared with placebo for the treatment of moderate-to-severe AD were searched on Pubmed, E.B. Stephens Company, China National Knowledge Infrastructure, Wanfang Medical network, Web of Science and related Clinical Trials Registry up to November 2023. In total, two researchers evaluated the quality of the included literature according to the Cochrane Handbook of Systematic Reviews. RevMan 5.3 software was used to conduct a meta-analysis of the efficacy and safety indicators in a cross-comparison of the effects exerted by placebo and 100 and 200 mg abrocitinib. A total of 1,825 patients with moderate-to-severe AD were included across five double-blind, placebo RCTs. Compared with the placebo group, during the double-blind trial period, significant improvements were observed in the investigator's global assessment score, response rate of eczema area and severity index (EASI)-50, EASI-75, EASI-90 and pruritus numerical rating scale (P-NRS) in the 100 and 200 mg abrocitinib groups (P<0.05). However, pairwise control analysis of the 100 and 200 mg group yielded significant differences (P<0.05) in all of the aforementioned therapeutic indicators except for the P-NRS score. In terms of safety, compared with the placebo group, there were significantly higher incidence of nausea, upper respiratory tract viral infection, infections and infestations in the 100 mg abrocitinib group (P<0.05). In addition, there were significantly higher incidence of nausea, gastrointestinal disorder, headache and dizziness in the 200 mg group (P<0.05). There were also significant differences in the incidence of nausea, gastrointestinal disorder and dizziness between the 100 and 200 mg groups (P<0.05). For patients with moderate-to-severe AD, oral administration of 100 or 200 mg abrocitinib once/day was concluded to ameliorate skin pruritus and eczema symptoms to varying degrees, with the efficacy significantly superior at the 200 mg dose. However, the risk of a number of adverse reactions, such as headache, dizziness, nausea and gastrointestinal dysfunction, is also significantly increased. Therefore, patients should be made aware of the risk of adverse drug effects prior to the administration of long-term high abrocitinib doses. Furthermore, large-scale, multi-center, rigorous clinical trials remain necessary to validate the findings from the present study. [ABSTRACT FROM AUTHOR]

A novel antibody–drug conjugate, trastuzumab deruxtecan is a combination of a human epidermal growth factor receptor 2 (HER2)-targeting antibody and DNA topoisomerase I inhibitor used to treat HER2-low/positive advanced breast cancer. To determine its safety and efficacy in treating HER2-low/positive advanced breast cancer, we performed a meta-analysis of several randomized clinical trials (RCTs) including DESTINY-Breast02 (NCT03523585), DESTINY-Breast03 (NCT03529110), and DESTINY-Breast04 (NCT03734029). We searched PubMed, Embase, and the Cochrane Library for RCTs on the efficacy and safety of trastuzumab deruxtecan that were published before May 2023. The efficacy endpoints included median progressive-free survival (PFS), overall survival (OS), duration of response (DOR), overall response rate (ORR), and clinical benefit rate (CBR). The safety endpoints included treatment-related adverse events. Statistical analyses were performed using RevMan 5.4 software. To ensure transparency, this study was registered on the International Prospective Register of Systematic Reviews website (CRD42023414170). Three RCTs involving 1689 patients were included. Compared with physician-recommended and conventional treatments, trastuzumab deruxtecan exhibited statistically significant improvements in PFS, ORR, and CBR. The median OS and DOR failed to be combined; however, the analyzed studies showed that they were longer. The incidence of adverse events was generally higher with trastuzumab deruxtecan than with physician-recommended or conventional treatments. The results of this study suggest that trastuzumab deruxtecan is more effective in treating HER2-low/positive advanced breast cancer than physician-recommended or conventional treatments. However, trastuzumab deruxtecan-related adverse drug reactions should be closely monitored because of its higher incidence of adverse events. • HER2-targeted therapy is ineffective in locally advanced or metastatic disease. • Trastuzumab deruxtecan may improve function compared to traditional treatments. • We included 1689 breast cancer patients from three randomized clinical studies. • Verification of trastuzumab deruxtecan's efficacy and safety is needed. [ABSTRACT FROM AUTHOR]

The aim of the study was to evaluate undergraduate medical students’ knowledge and self-confidence to perform abscess incision after virtual reality-simulation or video lecture. Pre and post-knowledge assessment was conducted.This was a multicentre randomised controlled trial from October 2021 to January 2022. The study was carried out at two universities providing medical education. Undergraduate medical students were randomized into either fully immersive head mounted display virtual reality-simulation (VR) or video lecture. Pre- and post-learning surveys probed self-confidence and student’s own assessment of competence. Participants were third-, fourth- and fifth-year medical students from the University of Eastern Finland and the University of Helsinki. All students were sent an email informing them of the opportunity to participate in this voluntary study. All willing students were included in the study.42 medical students participated in the study. Most were fourth year medical students, 52% of the participants had previously used VR in some context and the mean age of participants was around 25 years. Both methods increased knowledge and self-confidence equally. In VR subgroup, those with technical support available experienced greater learning than those without.Interestingly, in the present study, both VR and video lecture increased knowledge and professional self-confidence equally. [ABSTRACT FROM AUTHOR]