Clinical Research Directory

Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App

The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes. The main questions this study aims to answer are: * Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia? * Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment? * Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information? Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.

Analysis of the Etiopathogenesis of Postoperative Complications in Orthopedic Patients Using Knee and Hip Arthroplasty as an Example

Relevance and Rationale Due to the widespread development of high-tech medical care in traumatology and orthopedics for patients with severe forms of hip and knee osteoarthritis and aseptic necrosis, and the increasing number of knee and hip arthroplasties, there is a proportional increase in serious complications after arthroplasty, the most serious and costly of which is the development of peri-implant infection. Today, the prevalence of peri-implant infection is close to epidemic. It is worth noting that peri-implant infection is not always associated with poor surgical technique or the quality of prostheses. Often, the causes of this life-threatening complication are not fully understood. Currently, no large-scale prospective or retrospective study of the causes of peri-implant infection has been conducted in Russia or in Moscow. The pathogenesis of peri-implant infection remains unexplored, and methodological approaches to its prevention and treatment have not been developed, making this topic relevant and promising. The project's results will establish the key links in the pathogenesis of peri-implant infection, define the risk spectrum for this complication, identify individual patient characteristics that increase the risk of developing this complication, determine the underlying mechanisms underlying its development, and identify alternative treatment options for these patients. Based on the data obtained, diagnostic algorithms and recommendations will be developed for treatment strategies and preoperative preparation for patients with severe forms of hip and knee osteoarthritis, femoral head fractures, and aseptic necrosis. Guidelines for the antemortem and postmortem diagnosis of peri-implant infection will also be developed. These guidelines will be used by general practitioners, rheumatologists, orthopedic traumatologists, pathologists, rehabilitation physicians, general practitioners, and endocrinologists. The program's implementation and implementation of its results are aimed at reducing the share of peri-implant infection in morbidity and mortality. 2. Objective and Tasks Project Objective: To establish the etiopathogenesis and morphological tissue changes following complications of large joint arthroplasty (PJI, aseptic instability, etc.) in patients of different age groups, assessing their somatic and immune status, calcium mineral metabolism, and its metabolism, and to develop guidelines for preoperative examination. List of tasks to be addressed within the Project: 1. Develop a clinical study protocol; 2. Recruit a cohort of at least 600 patients for the study to conduct a comprehensive assessment of the patient's baseline status: assessment of mineral metabolism (total calcium, serum magnesium, inorganic phosphorus, 25OH, vitamin D, osteocalcin, BetaCross laps, P1NP bone matrix formation marker, parathyroid hormone); Immune status assessment (Interleukin 10 (IL-10), Interleukin 1 beta (IL-1beta, IL-1b), Interleukin 6 (IL-6), Interleukin 8 (IL-8), Complement Component C4, TNF (Tumor Necrosis Factor alpha, TNFalpha, sachectin), Lymphocyte phenotyping (main subsets panel): CD3, CD4, CD8, CD19, CD16, 56); Microbiological and PCR testing, as well as somatic status (therapist, rheumatologist) and analysis of the results of instrumental examinations (MRI, CT, densitometry, radiography). 3. The study includes a single, less often twice-time examination of each patient from the group of above-mentioned indicators at the preoperative stage. 4. Conducting a study of each patient with complications of osseointegration of the endoprosthesis from the group of above-mentioned indicators at the postoperative stage. 5. Endoprosthetics/revision endoprosthetics of the knee and hip joint. 6. Collection of tissue samples and metal structures (their fragments) from peri-implant areas for an intravital pathological examination of the patient, scanning electron microscopy, sonication, followed by microbiological examination (at least 5 samples) to characterize the microbiota in patients with developed complications.; 7. Evaluation of the obtained results of the correlation between the patient's somatic, immune, and homeostatic (mineral) status and the development of postoperative complications, statistical analysis of the data, and creation of a database.; 8. Implementation of the results of the work into clinical practice at least at the State Budgetary Healthcare Institution "City Clinical Hospital No. 31 named after Academician G.M. Savelyeva"

Clinical Risk Score Prediction for Risk of Dementia Among Late-life Population With Depression

The goal of this observational study is to learn about the ability of a point risk score prediction model, developed using electronic medical record data, to predict the risk of progression from geriatric depression to dementia in older Chinese adults. The main questions it aims to answer are: Does a higher point risk score increase the risk of developing dementia in older adults with depression? What is the accuracy of the point risk score prediction model in identifying individuals at high risk of dementia among older adults with depression? Participants will receive their usual medical care as they normally would. No new treatments, tests, or procedures will be performed specifically for this study. The research team will collect data from their electronic medical records, including depression diagnoses, dementia diagnoses, comorbidities, medication records, and follow-up information. The point risk score will be calculated based on these routinely collected clinical data.

A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression

This is a multicentre retrospective and prospective cohort study with the goal to develop a well-characterised multimodal image database of eyes with intermediate AMD with and without early atrophy. The main objectives are: 1. Develop a collaborative well-characterised database on intermediate AMD with or without early atrophy. 2. Grading of these images to explore imaging markers of progression. 3. Develop predictive models as a secondary analysis of our dataset. This study will recruit around 1.000 eyes in 6 months. All consenting patients who have had at least 3 clinic visits with multimodal imaging done at least at 6 months interval between 2 visits and meet the inclusion and exclusion criteria will be included in the study for retrospective data collection. Those with one visit remaining to complete 2 years, images will be acquired prospectively. In addition to the images, routine demographic data (age and sex) and available visual acuity (VA) (BCVA if possible, VA with Pinhole or VA with patient's glasses) will be collected. Multimodal imaging includes mandated macular OCT with or without enhanced depth imaging and infrared imaging. Fundus autofluorescence (AF) and multicolor imaging are optional. All imaging must be done on Heidelberg Spectralis system.

Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du Hospital, and Air Force 986 Hospital. All patients will undergo HRV monitoring at baseline, Week 2, Week 6, and Week 14. The HRV monitoring results will be blinded to both physicians and patients. Based on the efficacy assessment at Week 14, patients will be divided into response and non-response groups for comparison, to analyze the strength of association between baseline HRV parameters and the achievement of clinical response. The study plans to enroll 100 IBD patients, with 50 in the IFX treatment group and 50 in the VDZ treatment group.

Infrared Thermography for Prediction of Successful Erector Spinae Plane Block in Unilateral Inguinal Hernia Surgery in Paediatric Patients

This study aims to evaluate the accuracy of temperature change (ΔT) measurements using infrared thermography to predict a successful erector spinae plane block in pediatric patients undergoing inguinal hernia repair under general anesthesia.

Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study

This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.