Scharding Innere Stadt, Austria

Consolidation Therapy with Cladribine in Relapsing Multiple Sclerosis Patients

Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)

This is a prospective, multicenter, all-comers observational study. Primary endpoint was procedural success (defined as a combination of successful primary target lesion crossing, residual stenosis of ≤30% following vessel preparation and before definite treatment) and absence of procedural complications (defined as target vessel perforation or rupture, acute occlusion, and distal embolization).

Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

Feasibility and Cost of Robot-assisted Upper Limb Rehabilitation with Different Levels of Supervision

The ReHandyBot is a platform for hand rehabilitation with two degrees of freedom, namely forearm pronation/supination and finger flexion/extension. This device allows performing exercises targeting somatosensation and motor functions. Different exercises are implemented using virtual reality and haptic feedback; the interaction forces between subjects and ReHandyBot are measured by force sensors in the handles, allowing the control of a virtual hand and the physical interaction with the virtual environment. Mechanical properties (e.g., size, stiffness) of the objects displayed in the virtual environment are rendered by the motion/force of the instrumented handles. The type and difficulty level of the exercises are patient-specific and are automatically adapted throughout the therapy. The duration and frequency of the therapy sessions with ReHandyBot depend on the specific patient's needs and are set according to the therapist's instructions. The main goals of this study are to: (i) Evaluate the feasibility of integrating ReHandyBot into the routine of rehabilitation clinics and ambulatories. (ii) Perform a cost-benefit analysis of supervised, minimally supervised, and unsupervised therapy with the device. The secondary goals are to investigate: (iii) The intensity of use of ReHandyBot by the facilities. (iv) The increase in therapy dose for the patients using the device minimally or unsupervised compared to usual care. (v) The quantity and characteristics of patients who can train supervised, minimally, or unsupervised with the device. (vi) Usability and user experience. All the patients admitted to the clinic or ambulatory will be screened for participation in this study. Eligible patients will receive robot-assisted therapy sessions with the ReHandyBot in parallel to their conventional therapy program. During therapy with ReHandyBot, the patient sits comfortably on a chair in front of a screen and places the fingers of the impaired hand on the handles of the device. The eligibility of the patients will be checked during the admission visit, after which, for eligible patients, a trial session with ReHandyBot will be scheduled. During the trial session, the supervising therapist will decide if the patient can really benefit from training with ReHandyBot, and if yes, the therapist will integrate supervised therapy sessions with the device into the therapy schedule of the patient. Then, during the supervised sessions, the therapist will use a checklist to decide if a patient can train minimally supervised (i.e., group sessions) or unsupervised. If this will be the case, the minimally or unsupervised therapy sessions will be added to the therapy schedule of the patient. The therapy sessions with ReHandyBot (e.g., frequency, duration) will be scheduled based on the therapist's instruction and may vary between patients, depending on their specific needs. On the day of the last session with ReHandyBot, patients will fill in questionnaires to rate its usability and user experience. For each recruited patient, data regarding demographics, medical condition, clinical and cognitive assessments, therapy dose, and device data will be recorded on the CRF. Medical and assessment data will be data routinely collected at the clinic and ambulatory. We will not perform evaluations specifically for this study. At the end of the study, data regarding costs, intensity of use, and device retention will be recorded.

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Fibroblast Growth Factor 23 and Risk of Cardiac Arrhythmias in Hemodialysis Patients

This is an exploratory, observational, prospective, mono-center study that aims to elucidate the pathogenesis of cardiac repolarization and arrhythmias in subjects with CKD receiving maintenance dialysis. This exploratory research project aims to confirm the link between FGF23 and ECG abnormalities (QTc as a proxy for cardiac arrhythmias) in a well-characterized sample of HD patients and expand our understanding of the molecular mechanisms by which FGF23 may trigger arrhythmias. Previous works suggest that FGF23 cardiac toxicity may be mediated by the activation of FGFR4 and that modulation of FGF23-FGFR4 signaling through monoclonal antibodies can attenuate the toxic effects of FGF23 on the CM. Although these preliminary data warrant clinical and molecular confirmation, they also suggest FGF23-FGFR4 modulation as a novel potential therapeutic target in CKD to improve morbidity and mortality. During a standard dialysis session, FGF23 is acutely removed while Ca2+ is provided to the patients. However, shortly after the HD session completion, it was documented that FGF23 serum levels rebound. The investigators hypothesize that acute reduction and subsequent rebound of circulatory levels of FGF23 coupled with calcium loading induced by HD may favour a Ca 2+ influx in the CM and trigger cardiac arrhythmias. This exploratory study aims to determine the independent association between variations in serum levels of FGF23 and QTc (msec) during and after dialysis. In particular, the primary endpoint of the study is defined as the association between QTc variations (msec) defined as the difference between QTc pre-dialysis and QTc 1 hour after dialysis session completion and variations of serum levels of FGF23 defined as the difference between serum levels of FGF23 at dialysis session completion and after 1-hour form dialysis session completion. The investigators hypothesize that these time points should maximize the chance of detecting a significant association between the exposure variable (FGF23) and the outcome of interest (QTc). All study procedures are non-invasive, and they will be carried out between the beginning of the last HD of the week and the beginning of the first HD of the following week (long interdialytic interval) to allow for the maximum variation of serum levels of FGF23 between dialysis sessions. All study-related procedures are performed on top of standard clinical practice, and guidelines are performed non-invasively. Study participants will undergo the following procedures: - ECG: A standard 12-leads ECG will be recorded at the beginning, at the end as well as 60 minutes after the end of the last HD session of the week and at the beginning of the first HD session of the following week. All readings will be performed will be centralized and read by a single investigator blinded to clinical information at EOC. - Laboratory assessment: a blood sample will be taken at the beginning, at the end, and 60 minutes after the end of the last HD session of the week and at the beginning of the first HD session of the following week. Laboratory investigations will check the serum values of cardiovascular biomarkers (including FGF23) associated with QTc and volume expansion (OH: overhydration). Venous blood samples for measurement of cardiovascular biomarkers will be drawn at each time point and stored in the biobank at Ente Ospedaliero Cantonale (EOC) according to the standard procedures. These aliquotes will be used to assess FGF23 and for subsequent in-vitro evaluation of the cardiac arrhythmogenicity of patients' sera in relation to the homeostasis variation induced by HD. - Volume assessment: total body weight will be measured at dialysis session, to calculate the net body weight increase during the long interval. Overhydration (OH) will be quantitatively assessed with a portable whole-body bioimpedance spectroscopy device (Fresenius Medical Care GmbH, Bad Homburg, Germany). The total body water (TBW), the extracellular water (ECW), the intracellular water (ICW), and the OH are calculated as previously defined - Applanation tonometry: Central blood pressure (BP) values and aortic pressure waveforms will be obtained non-invasively directly from the common carotid artery using a validated high fidelity PulsePen tonometer (DiaTecne, San Donato Milanese, Italy). In particular, the subendocardial viability ratio (SEVR) will be calculated during the first HD session of the week according to the central BP wave form as previously reported - Echocardiogram: If no echocardiogram exam within 12 months from study inception is available in the patient's chart, a two-dimensional echocardiographic study will be performed before the first HD session of the week utilizing a standard equipment as per standard clinical practice. Digital images will be acquired in the long axis and short axis parasternal views and the apical four and two chamber views and three-cycle clips will be stored on magnetic optical disks for future review. The presence of valvular calcification (aortic and mitral valve) as well as systolic and diastolic function assessment will be performed. Adverse event: The occurrence of any adverse events (AE) will be recorded for the occurrence of any event from study inception until the end of the following week This exploratory study will be carried out at the Division of Nephrology, Ente Ospedaliero Cantonale (EOC), Ticino, Switzerland.

Outcomes of Low-Risk Endometrial Cancer with Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective, Multicenter, Cohort Study

PRIMARY OBJECTIVE: I. Evaluate whether patients with low-risk endometrial cancer and isolated tumor cells (ITC) will have worse recurrence-free survival (RFS) than a historical cohort of similar patients with negative nodes. OUTLINE: This is an observational study. Patients undergo tissue sample collection and have their medical records reviewed on study.

Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine

AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance

Migraine affecting approximately 1 in 7 individuals globally, significantly impacts quality of life and economic productivity due to its associated healthcare and social burdens. Despite its prevalence, awareness and understanding of migraine remain limited, contributing to misdiagnosis, inadequate treatment, and the perpetuation of stigmatization. Artificial Intelligence (AI) may advance migraine management by improving diagnosis, prediction, and educational outreach. AI applications are currently being employed in diagnosing migraines more accurately by analyzing comprehensive patient data, thus differentiating migraine from other types of headaches. Additionally, AI algorithms predict migraine episodes, enabling preemptive measures. They also streamline medication management through reminders and monitor patient adherence, which is crucial for preventing medication overuse and optimizing treatment outcomes. Moreover, AI can bridge the educational gap in migraine understanding. By using adaptive learning technologies, AI platforms can deliver personalized educational content, tailored to an individual's knowledge level and learning pace, enhancing understanding and engagement. This approach not only facilitates better management of the condition but also promotes a broader societal awareness essential for destigmatizing migraine. The primary objective of this study is to ascertain if the addition of AI-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition.