Logroã±o, Spain
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Phase
N/ASpan
53 weeksSponsor
Hospital Universitario de ValmeElche
Recruiting
Healthy Volunteers
Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
Phase
3Span
213 weeksSponsor
Instituto de Investigación Sanitaria y Biomédica de AlicanteElche
Recruiting
Healthy Volunteers
Integrated Approach in Frail Older People with Atrial Fibrillation
Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition. AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care. Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.
Phase
N/ASpan
95 weeksSponsor
Heart Care FoundationElche
Recruiting
Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI
Phase
N/ASpan
603 weeksSponsor
Jorge Sanz SanchezElche
Recruiting
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Phase
3Span
218 weeksSponsor
Astellas Pharma Global Development, Inc.Elche
Recruiting
Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
This is a prospective, multicenter, randomized, observational study involving multiple hospitals across Spain. At each site, patients will ingest both the Pillcam SB3 and Navicam capsules in a randomized order. Reading times, transit times, and diagnostic yield will be compared between the two devices. A central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria. The primary endpoint is the diagnostic concordance between Navicam's AI-driven ProScan™ system and the conventional reading of Pillcam SB3, measured by Cohen's kappa index. The secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events. The sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6. This study aims to establish that the AI-based Navicam capsule is at least as effective as the conventional Pillcam SB3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.
Phase
N/ASpan
84 weeksSponsor
Hospital Clinic of BarcelonaElche
Recruiting
Registry of Patients in Shock Treated With Vasopressin
The main objective is to characterise the routine clinical practice of vasopressin use in the context of shock in a multicentre observational study. By collecting clinical, analytical and echocardiographic data in a uniform manner, describing the time sequence of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline. The secondary objectives are: - to assess what motivated the decision to initiate AVP: type of shock, perfusion parameters, noradrenaline dose; - to define the impact of initiating AVP on noradrenaline dose (whether the dose can be reduced or not), on cardiac function (whether echocardiographic data improve or worsen) and on perfusion data (whether laboratory and clinical data such as lactate, capillary refill time, mottling score or diuresis improve or worsen); - estimate what is the dose range of AVP used and what is the maximum dose used in routine clinical practice; - observe when AVP is stopped, how (abruptly or progressively); - describe the incidence of side effects of AVP, whether it is related to the dose of AVP and the comorbidities of the patients; - assess medium/long-term outcomes: 28- and 90-day mortality, ICU and hospital stay, days of vasopressor support, days of mechanical ventilation, days of renal replacement.
Phase
N/ASpan
103 weeksSponsor
Hospital Universitario 12 de OctubreElche
Recruiting
Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU
The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh videolaryngoscope vs the hyperangulated videolaryngoscope during tracheal intubation in ICU patients.The hypothesis of the study is that tracheal intubation using the hyperangulated videolaryngoscope will improve the frequency of successful intubation on the first attempt in ICU patients requiring intubation in the intensive care unit.
Phase
N/ASpan
57 weeksSponsor
Hospital Clinico Universitario de SantiagoElche
Recruiting
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Phase
3Span
455 weeksSponsor
Gilead SciencesElche
Recruiting
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Phase
3Span
387 weeksSponsor
GlaxoSmithKlineElche
Recruiting