There are about 20717 clinical studies being (or have been) conducted in Spain. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.
Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses. For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis. Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward. Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism. The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling. With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis.
The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.
The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge. The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge. Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientific principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home (Ballester et al., 2017; Ballester et al., 2019; Maier et al, 2020) There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature and, in particular, the results of Maier et al. (2020), the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In the study by Maier et al., the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales. The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience. We will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke. Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. the participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks.
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment. Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.
This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.
This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia. The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial. Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES (intervention group) or to continue their usual treatment (control group).
BACKGROUND AND CURRENT STATUS: Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising questions about the necessity of subsequent surgery, especially for those undergoing adjuvant radiotherapy. While Magnetic Resonance Imaging (MRI) remains the most effective imaging technique for assessing neoadjuvant treatment response, surgery is still required to confirm pCR in cases of almost complete or complete MRI response (iCR). To safely avoid surgery in these BC "exceptional responders," a technique with high negative predictive value is imperative. OBJECTIVE: This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after NST in HER2 positive or TN breast cancer subtypes, particularly those showing post NST-MRI complete or almost complete response. METHODS: A prospective study was conducted at "Hospital Universitario 12 de Octubre de Madrid" from June 25, 2018, to October 25, 2029. Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtype, at stages cT1-3/N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI, were enrolled. Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST. Pathological representativeness of the VAB sample was ensured. pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma.