random clinical trial

BACKGROUND: Chemical plaque control with mouthwashes as an adjunct to mechanical plaque control with a toothbrush and dental floss has been considered an effective method for controlling gingivitis. The anti-inflammatory effects of chemical plaque control benefit the oral tissues by reducing inflammation and bleeding. OBJECTIVES: The aim of the present study was to evaluate and compare the clinical efficacy of probiotic, Aloe vera, povidine-iodine, and chlorhexidine (CHX) mouthwashes in treating gingivitis patients by assessing changes in their clinical parameters...

OBJECTIVE: The aim of this study was to demonstrate whether lasofoxifene improves vaginal signs/symptoms of genitourinary syndrome of menopause. METHODS: Two identical, phase 3 trials randomized postmenopausal women with moderate to severe vaginal symptoms to oral lasofoxifene 0.25 or 0.5 mg/d, or placebo, for 12 week. Changes from baseline to week 12 in most bothersome symptom, vaginal pH, and percentages of vaginal parabasal and superficial cells were evaluated...

AIMS: The aim of this study was to examine the effect of Reiki in patients with cardiac disease. METHODS AND RESULTS: This study was a single-blind, pre-post-test, randomized, placebo-controlled study. Patients from the cardiology outpatient clinic of a training and research hospital were randomized into three groups: Reiki (n = 22), sham (placebo) (n = 21), and control (no treatment) (n = 22). Data were collected using a personal information form, biochemical parameters, cortisol levels, Beck Anxiety Inventory, and electrocardiography analysis...

Since the start of the COVID-19 pandemic, it has become increasingly clear that the disease can have relevant multisystemic and long-term effects, and several studies have attempted to identify key determinants of the disease course. Here we discuss recent evidence suggesting that, in long COVID patients, combined magnesium and vitamin D deficiencies associate with a higher number of clinical manifestations, as compared to patients with normal levels of both nutrients. We highlight the potential synergistic effects of these deficiencies and propose that future studies should explore a causal link with the risk of developing long COVID...

BACKGROUND: The different clinical presentations of fibromyalgia (FMS) may play independent roles in the unclear etiology of cognitive impairments and depressive symptoms seen in this population. Understanding how these clinical presentations are associated with FMS's clinical and neurophysiological aspects is important when developing effective treatments. AIM: To explore the relationship between memory complaints and depressive symptoms, and the different clinical and neurophysiological characteristics of FMS...

OBJECTIVES: Rheumatoid arthritis (RA) and atherosclerosis share many common inflammatory pathways. We studied whether a multi-biomarker panel for RA disease activity (MBDA) would associate with changes in arterial inflammation in an interventional trial. METHODS: In the TARGET Trial, RA patients with active disease despite methotrexate were randomly assigned to the addition of either a TNF inhibitor or sulfasalazine+hydroxychloroquine (triple therapy). Baseline and 24-week follow-up 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography scans were assessed for change in arterial inflammation measured as the maximal arterial target-to-blood background ratio of FDG uptake in the most diseased segment of the carotid arteries or aorta (MDS-TBRmax)...

OBJECTIVE: Ultrasound-guided tibial nerve pulsed radiofrequency (US-TN PRF) and fluoroscopy-guided intralesional radiofrequency thermocoagulation (FL-RFT) adjacent to the painful calcaneal spur are two interventions for pain management in painful calcaneal spur (PCS) and plantar fasciitis (PF). This study aimed to compare the effectiveness of the two procedures. DESIGN: A prospective, randomized, single-blind study. SETTING: Single-center pain clinic...

BACKGROUND: Repeated stigmatization due to group membership constitutes a recurrent stressor with negative impact on physical and mental health (minority stress model). Among European countries, Romania ranks low on LGBT+ (lesbian, gay, bisexual, and transgender people. The "+" represents individuals whose identities do not fit typical binary notions of male and female [nonbinary]) inclusion, with 45% of Romanian LGBT+ respondents reporting discrimination in at least 1 area of life in the year preceding the survey...

IMPORTANCE: Postoperative delirium is a common and impactful neuropsychiatric complication in patients undergoing coronary artery bypass grafting surgery. Cognitive training may enhance cognitive reserve, thereby reducing postoperative delirium. OBJECTIVE: To determine whether preoperative cognitive training reduces the incidence of delirium in patients undergoing coronary artery bypass grafting. DESIGN, SETTING, AND PARTICIPANTS: This prospective, single-blind, randomized clinical trial was conducted at 3 university teaching hospitals in southeastern China with enrollment between April 2022 and May 2023...

BACKGROUND: We aimed to compare the analgesic effects and incidence of urinary retention between ultrasound-guided intersphincteric space block combined with low-dose ropivacaine spinal anesthesia and conventional-dose ropivacaine spinal anesthesia post-hemorrhoidectomy. METHODS: Fifty patients aged 20-65 years who underwent elective hemorrhoidectomy were stochastically assigned to one of two groups. Spinal anesthesia was induced with 8 mg ropivacaine, combined with ultrasound-guided intersphincteric space block in the treatment group...

BACKGROUND: The role of current pharmacological treatment after laparoscopic sleeve gastrectomy (LSG) is limited. The incidence of postoperative nausea and vomiting (PONV) after LSG remains high. Auricular acupressure (AA) is believed to relieve PONV after laparoscopic surgeries, but its role in patients with obesity after LSG has yet to be confirmed. METHODS: Ninety-five female patients who underwent LSG were randomized into two groups: AA combined with conventional anti-nausea medication (AA group, 47 patients) or conventional anti-nausea medication group (control group, 48 patients)...

OBJECTIVES: Effective management of neck in oral squamous cell carcinoma (OSCC) is pivotal for oncological outcomes. Although consensus exists for ipsilateral neck dissection (ND), the necessity for contralateral ND remains controversial. This study aimed to assess the prevalence and implications of bilateral/solely contralateral (B/SC) lymph node metastases (LNMs) to determine the need for contralateral elective ND. Additionally, it examined the prevalence and implications of occult B/SC metastases...

INTRODUCTION: Benign paroxysmal positional vertigo (BPPV) is one of the commonest causes of peripheral vertigo. It is treated with various canalolith repositioning manoeuvres by changing the head positions to allow the otoconial debris to fall back from the affected canal back to the utricle. The present study has compared the rate of recovery of vertigo with modified Epley's manoeuvres as compared to Semont's manoeuvre in patients with posterior canal BPPV. MATERIALS AND METHODS: One hundred and seventy patients diagnosed by positive Dix-Hallpike test as posterior canal BPPV were included in this clinical trial...

BACKGROUND: Accurate prediction of successful sphincter-preserving resection (SSPR) for low rectal cancer enables peer institutions to scrutinize their own performance and potentially avoid unnecessary permanent colostomy. The aim of this study is to evaluate the variation in SSPR and present the first artificial intelligence (AI) models to predict SSPR in low rectal cancer patients. STUDY DESIGN: This was a retrospective post hoc analysis of a multicenter, noninferiority randomized clinical trial (LASRE, NCT XXXXXX) conducted in 22 tertiary hospitals across China...

OBJECTIVE: To investigate the potential impacts of optimizing coronavirus disease 2019 (COVID-19) rapid antigen test (RAT) self-testing diagnostic accuracy information. DESIGN: Online randomized experiment using hypothetical scenarios: in scenarios 1 to 3 (RAT result positive), the posttest probability was considered to be very high (likely true positives), and in scenarios 4 and 5 (RAT result negative), the posttest probability was considered to be moderately high (likely false negatives)...

OBJECTIVE: To systematically review the literature and analyze clinical outcomes and return-to-sport after surgical management of cartilage injuries in football players. DESIGN: A systematic literature review was performed in August 2023 on PubMed, WebOfScience, and Cochrane Library to collect studies on surgical strategies for cartilage lesions in football players. Methodological quality and risk of bias were assessed with the modified Coleman Methodology score and RoB2 and RoBANS2 tools...

This study aimed to evaluate the pharmacokinetics (PKs), safety, and immunogenicity of the biosimilar HEC14028 compared to reference Trulicity® (dulaglutide) in healthy male Chinese subjects. This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period. A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0...

OBJECTIVE: his study aimed to systematically evaluate the clinical efficacy of gabapentin and pregabalin in the treatment of acute herpes zoster neuralgia, including pain control and the occurrence of adverse effects. METHOD: A systematic computerized search was conducted in October 2023 in PubMed, Embase, Web of Science, Cochrane Library, VIP, CNKI, and Wanfang databases. Data from randomized controlled trials comparing gabapentin analogs for the treatment of acute herpes zoster neuralgia were searched...

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) may act as a driver or propagator of systemic inflammation. In turn, cytokine release can modify thromboelastographic (TEG) tests which are commonly used for anticoagulation monitoring. In this context, antithrombin (AT) supplementation might further modify TEG. METHODS: This is a pre-specified sub-study of the "Randomized Controlled Trial of Antithrombin Supplementation During Extracorporeal Membrane Oxygenation" study (investigator-initiated, randomized, single-blind, two-arm trial) conducted in two Italian ECMO referral ICUs...

BACKGROUND: The impact of mechanical ventilation on the survival of patients supported with veno-venous extracorporeal membrane oxygenation (V-V ECMO) due to severe acute respiratory distress syndrome (ARDS) remains still a focus of research. METHODS: Recent guidelines, randomized trials, and registry data underscore the importance of lung-protective ventilation during respiratory and cardiac support on ECMO. RESULTS: This approach includes decreasing mechanical power delivery by reducing tidal volume and driving pressure as much as possible, using low or very low respiratory rate, and a personalized approach to positive-end expiratory pressure (PEEP) setting...