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Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

Type1 Diabetes Mellitus

The goal of this longitudinal clinical trial is to measure variability of interstitial glucose levels with a user-friendly real-time continuous glucose monitoring (CGM) technology at regular intervals in normo- and dysglycemic multiple autoantibody-positive individuals (age 5-39 years), in comparison with single autoantibody-positive individuals in the same age range. Participants will asked to undergo repeated oral glucose tolerance tests (OGTTs) (age 5-39 years) and hyperglycemic clamp tests (age 12-39 years) in parallel for a period of at least 2-3 years. In case of confirmed dysglycemia, we propose to perform CGM and OGTT every 3 months. The main questions the study aims to answer are: 1. Do the amplitude and time trends of CGM-derived glycemic variability indices and OGTT- and clamp-derived variables differ between the intermediate, high and very high risk groups? 2. Can (changes in) CGM-derived glycemic variability indices predict/detect dysglycemia in initially normoglycemic (single or multiple autoantibody-positive) individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables? 3. Can (changes in) CGM-derived glycemic variability indices predict clinical onset in (stage 1 or 2) multiple autoantibody-positive individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables? 4. Can correlating (changes in) CGM-derived indices with (changes in) OGTT- and clamp-derived variables help to better understand the sequence of events leading to dysglycemia and clinical onset, as well as the relative contribution of beta cell function and insulin action to glycemic variability according to disease stage and biological and phenotypical characteristics of the individuals?

LiΓ¨ge5–39 yrsAll genders
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SCENAR Therapy in Chronic Non-specific Neck Pain

Cervicalgia Β· Neck Pain Β· Chronic Pain

Shifting away from a medication-centered approach is a major public health priority, particularly in chronic pain management, where non-pharmacological therapies are recommended despite barriers such as limited evidence and low prescriber awareness. SCENAR (Self-Controlled Energo-Neuro Adaptive Regulation), an electrotherapy device, lacks robust randomized controlled trial data. A prior study showed effects in both active and placebo groups after a single session, supporting further investigation. This study aims to assess whether repeated SCENAR sessions improve disability, mobility, and pain in patients with chronic neck pain.

Suresnes18–80 yrsAll genders
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Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.

Carcinoma, Non-Small-Cell Lung

The purpose of this study is to assess percentage reduction in the of urine NTX and serum CTX , in patients with NSCLC and bone metastases 1) with actionable driver oncogene on standard of care (SOC) TKI at 3 months post treatment and 2) without actionable mutations on standard of care therapy (chemotherapy/immunotherapy) treated with zoledronic acid or denosumab at the same time period.

Aurora, CO18–100 yrsAll genders
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Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder (ASD) Using Transcranial Magnetic Stimulation (TMS)

Autism Spectrum Disorder

The goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. The main question it aims to answers is can stimulation of the right temporoparietal junction can change brain activity related to mentalizing during social interaction in the stimulation area and other brain areas connected to it. Researchers will compare results to a group of individuals without autism to see if the patterns of neural activity change are similar between the groups. Participants will undergo assessment of their clinical traits and social skills and baseline MRI scan. They will attend three additional visits that include TMS session and functional MRI scans before and right after TMS.

Hartford, CT18–35 yrsAll genders
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Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer

Symptom Cluster Β· Breathlessness Β· Coughing

Lung cancer is the leading cause of cancer mortality, posing a critical public health challenge in both Hong Kong and global populations. Patients with lung cancer frequently experience a distressing symptom cluster characterized by breathlessness-driven respiratory distress, accompanied by persistent cough and fatigue, which collectively impose a substantial disease burden. While our research team leader previously developed and validated a multi-component Respiratory Distress Symptom Intervention (RDSI) in England, demonstrating clinical efficacy for lung cancer management, its impact on psychological distress (anxiety and depression) proved limited. This limitation may reflect insufficient integration of psychological components, a crucial consideration given the well-established bidirectional relationship between respiratory symptoms and psychological distress. Emerging evidence indicates that mindfulness interventions provide dual therapeutic benefits by improving patient adherence and effectively addressing both physical symptoms, such as breathlessness and fatigue, as well as psychological distress, including anxiety and depression. Meanwhile, current evaluation methodologies have mainly focused on behavioral data collection, such as self-reported questionnaires, to reflect the effect before and after the intervention. Neuroimaging data can help understand the brain mechanisms underlying breathlessness and elucidate the effectiveness of interventions, thereby improving intervention strategies.

Multiple locations18+ yrsAll genders
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Photobiomodulation With REd vs BluE Light (REBEL)

Dry Eye Syndromes Β· Meibomian Gland Dysfunction Β· Blepharitis

The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye has been limited. Hence, the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome, as well as conventional ocular surface measures of patients with dry eye disease and blepharitis (inflammation of the eyelids). Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group.

Birmingham18+ yrsAll genders
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An Ecological Momentary Assessment Based Program to Support Self-Management for Post-stroke Patients

Stroke Β· Post Stroke

The goal of this feasibility study is to test whether a new approach that combines real-time symptom tracking (Ecological Momentary Assessment) with machine learning can help people recovering from a stroke to better manage depression, thinking difficulties, and daily functioning. The main questions it aims to answer are: Is this combined approach practical and acceptable for post-stroke survivors? Does the program improve mood, cognitive function, or functional ability to carry out daily activities? Participants will: Use a smartphone app called RehabCare Companion for a period of time Answer brief daily surveys about their mood, thoughts, and activities for one week Receive personalized self-care suggestions generated by machine learning based on their responses Complete assessments of depression, cognition, and functioning before and after the program Take part in a group interview to share their experiences

Hong Kong18+ yrsAll genders
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At-Home tDCS as Maintenance Therapy

MDD Β· Severe Depression Β· Major Depressive Episode

The primary purpuse of this pilot study is to find out whether a home-based transcranial direct current stimulation (tDCS) program is feasible and well tolerated as maintenance therapy and whether there are early signs that it helps maintain the clinical clinical benefits achieved during successful acute inpatient treatment. Participant population: Adults (18+) with depressive disorder who had already improved/stabilized after acute treatment at our clinic (esketamine, repetitive transcranial magnetic stimulation , or electroconvulsive therapy). Main questions: Feasibility: Do participants reliably complete the home program and stay in the study? Preliminary effectiveness: Do improvements of depressive symptoms hold up over the 4-week treatment and 2-week follow-up (based on self-report and clinician-rated scales)? Participants receive standardized instruction from trained staff and a portable tDCS device (with cap and small sponge electrodes) and complete 20 home sessions over 4 weeks (5 per week), each 30 minutes at a very low current (2 mA); the device gently ramps current up/down for comfort. During treatment, participants use a smartphone app with step-by-step guidance and reminders; sessions are automatically logged. They will also fill out short weekly self-rating questionnaires and join brief phone check-ins every 2 weeks. Where: Department and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich Safety \& data privacy: The device monitors electrode contact and pauses automatically if contact is poor. Typical sensations can include mild tingling or redness. The app stores anonymized session data so the care team can track progress; no personal data are exchanged between the app and the stimulator, and access is via a secure clinical portal.

MΓΌnchen18+ yrsAll genders
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Evaluation of a Neuropsychological Tool to Assess Temporal Processing Abilities in Alzheimer's Disease

Alzheimer's Disease (AD) Β· Time Perception

Perceiving and representing the passage of time allows us to temporally organize perceptions and memories for the coordination of actions, planning, and the mobilization of cognitive processes toward a goal. This innovative project aims to clarify the profile of time impairment associated with normal aging and the progression of age-related pathologies. This project proposes to develop a new neuropsychological tool for quantifying and preventing changes in the relationship to time associated with Alzheimer's disease. Four aspects of time are distinguished, which are measured separately and distributed along a continuum between perception and memory: (a) perception of simultaneity and order; (b) processing of durations; (c) subjective sense of the passage of time; and (d) mental time travel. Crucially, many neurological and psychiatric disorders are associated with impairment in one or more aspects of time. However, time remains largely unexplored in clinical practice. Patients with Alzheimer's disease will complete the CHRONOS battery. This battery allows for a rapid assessment (approximately ten minutes) of the four aspects of time. This new battery will enable the identification of behavioral markers aimed at improving prognosis and prevention regarding individual cognitive trajectories of aging. The relationship to time is closely linked to each person's personal experience. This project will help to put into words difficulties that are not always expressed in terms of time. Thus, considering these pathologies from the perspective of time aims to better understand and prevent their difficulties and to guide the identification of new markers and new avenues for remediation.

Multiple locationsAll agesAll genders
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ROTEM in Sepsis Trauma Outcome in Intensive Care

Sepsis - to Reduce Mortality in the Intensive Care Unit Β· Trauma Coagulopathy

This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.

Multiple locations18+ yrsAll genders
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Comparison of Conventional Impressions, Intraoral Scanners and Digital Photogrammetry for Full-arch Implant Prosthesis.

Dental Implant Failed

The aim of this clinical trial is to compare implant-supported definitive impressions in edentulous patients (mandible or maxilla) with 4 to 8 osseointegrated implants. The main questions it aims to answer are : The primary outcome of this prospective clinical comparative study is to analyse the precision of a complete-arch impression. The secondary aim is to obtain patient satisfaction with these new types of impression. The different impressions (conventional, intraoral scanner and photogrammetry) will be taken twice on the same patient.

Liège18+ yrsAll genders
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Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes

Type 2 Diabetes (Adult Onset)

The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.

San Antonio, TX18–75 yrsAll genders
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NAsal MEthicillin-resistant Staphylococcus (NAMES): a Prospective Study to Assess the Impact of Antibiotic Therapy on Nasal Colonization with Methicillin-resistant Staphylococcus Aureus (MRSA) Inhospitalized Children

NAsal MEthicillin-resistant Staphylococcus

Antimicrobial resistance (AMR) is recognized as one of the major threats to global health \[1\], causing up to 25.000 deaths in the European Union every year, longer hospitalizations and increased healthcare costs. It is well known that antimicrobial use is the main driving force towards AMR and up to 50% of antimicrobial prescriptions are either inappropriate or unnecessary \[2\]. It is then important to understand how to optimize antimicrobial usage not only in adults but also in infants, as they show different resistance patterns and have peculiar characteristics that may lead to incorrect administration and alteration of the pharmacokinetic and pharmacodynamic properties of the drug \[3\]. Antimicrobials are the most prescribed drugs in children \[4\]\[5\] and this excessive usage has been recorded not only in developed countries, but also in low-income and middle-income ones \[6\]. In Europe, Italy reported one of the highest prescriptions rates, four times higher than the UK and six times higher than the Netherlands \[7\]\[8\]. 84% of Italian infants in the community have already received at least one course of antibiotics at 2 years of age \[9\]. A point-prevalence survey (PPS) showed that 38.9% of hospitalized Italian infants received at least one antibiotic prescription both for treatment and prophylaxis; in children, the most commonly used antibiotic classes were third generation cephalosporins and penicillins plus enzyme inhibitors, with a high prescription rates of carbapenems and quinolones as well, often off-label \[10\]. In order to limit misuse and overuse of antibiotics in children, the joint SHEA-IDSA-PIDS position paper states the importance of introducing antimicrobial stewardship programs (ASPs) in all healthcare institutions \[11\]. Antimicrobial stewardship has been defined as "the optimal selection, dosage, and duration of antimicrobial therapy that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance" \[12\]. So far, little progress has been made with developing pediatric ASPs, especially outside the United States healthcare system. One of the most important studies conducted in Europe in this field, the ARPEC project, was designed as a PPS: this type of strategy is very useful if repeated regularly, as it allows to monitor prescription trends over time and to identify the problem of inappropriate antibiotic usage \[13\]. However, it has been shown that PPSs are not sufficient by themselves to change the clinical practice if not combined with other methods \[14\], such as pre-prescription authorization, prospective audit and feedback, educational and training programmes or technological means of support. In USA, methicillin-resistant Staphylococcus aureus (MRSA) in children mainly causes skin and soft tissue infections but invasive diseases were increasingly reported in 1995-2010 \[15\]. Studies on MRSA carriage in healthy children showed great geographic variation (from less than 1% in Belgium to 15% in Taiwan) that depend on many local differences \[16\]. Nevertheless, very few studies have been performed on the influence of antibiotic prescription in the acquisition of resistant microorganism such MRSA in pediatric population. The aim of this study is to estimate the incidence of MRSA nasal colonization and invasive disease and to investigate the impact of antibiotic treatment during hospitalization on the acquisition of MRSA nasal colonization in children.

Pavia1–16 yrsAll genders
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The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction

Addiction Nicotine

This clinical trial evaluates the VapeAway system, a novel, multi-modal intervention designed to address the multifaceted nature of vaping addiction. VapeAway combines progressive nicotine tapering via proprietary filters, behavioral substitution with a sensory device (Fix Bar), and structured digital support. The purpose of this research is to evaluate the efficacy and safety of the investigational VapeAway system, a multi-component behavioral and nicotine-reduction intervention, for promoting cessation of nicotine-containing e-cigarette use in motivated adults. The primary objective is to determine if the VapeAway program can achieve a Continuous Abstinence Rate (CAR) of at least 25% at 30 days post-intervention completion, a rate which will be statistically compared to the historical spontaneous cessation rate of approximately 7%. Secondary objectives include assessing reductions in biochemical nicotine exposure (cotinine), vaping frequency, withdrawal symptoms, and electronic cigarette dependence, as well as characterizing the safety and tolerability profile of the intervention. Participants will be asked to follow the VapeAway system (filters, Fix Bar and timeout periods) as prescribed by the protocol for about 42 days. During this time, participants should keep track of vaping sessions throughout the trial.

New York, NY21+ yrsAll genders
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