There are about 20806 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.
Bladder cancer is a malignant disease that affects a large number of people worldwide. An increase in the incidence of this type of cancer has been observed in recent decades, leading to a growing interest in understanding its risk factors, clinical evolution, and possible treatment approaches. This retrospective study aims to retrospectively analyze a cohort of patients diagnosed with muscle-invasive bladder cancer, in whom, after presentation at multidisciplinary oncology committees, the goal of curing the oncological disease while preserving the bladder is considered. Trimodal therapy (TMT) is the most studied bladder preservation strategy, with oncological outcomes superior to those of isolated therapies (or monotherapies) such as transurethral resection of the bladder tumor (TURBT), radiotherapy, or chemotherapy. TMT consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent. Objectives The main objective is to retrospectively analyze the effectiveness and safety of the trimodal approach in our setting. Collecting and analyzing data from patients treated in our service will provide valuable insight into clinical outcomes and treatment tolerability in this context. Materials and Methods - Study Design A retrospective study will be conducted using data from medical records of patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected. - Study Population The study population will include all patients with confirmed diagnoses of non-metastatic muscle-invasive bladder cancer.
The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.
This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma to determine if ARV-393 may be a possible treatment option. ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.
Management of risk factors is the primary approach to prevent cardiovascular disease (CVD). In this regard the accurate scoring of disease risk is fundamental. Non-alcoholic fatty liver disease (NAFLD) has emerged recently as a potential mediator of CVD onset and progression. The hypothesis is that NAFLD can be a predictive CVD risk factor, independent of other classical and well-known risk factors. Preliminary epidemiological studies suggested that the fat infiltration in the liver mirrored the cardiometabolic status of the patient. But recent studies postulate that NAFLD could be a potential independent predictor of vascular injury. The mechanisms that link liver function and endothelial damage include modulation of adipose tissue function, lipid metabolism regulation or glycemic homeostasis, among others. But new mechanisms that could link NAFLD and ECV are emerging. The synthesis of ketone bodies in the liver is closely related to the cardiovascular system function. Ketone bodies can provide up to 50% of energy required by specific tissues. Plasma concentration of β-hydroxybutyrate is a biomarker of NAFLD. Plasma β-hydroxybutyrate and acetoacetate levels are also inversely associated with endothelial injury. Other biomarkers on endothelial damage like von Willebrand factor, ICAM, VCAM or coagulation factors (Factor VIII) can be used to stratify patients according to the risk of CVD. The improvement in the sensitivity, specificity and accuracy of scores such as FLI, HIS and FIB-4 and non-invasive techniques such as elastography allow the study of the relationship between liver disease and other comorbidities. The aim is to evaluate the potential of NAFLD to stratify patients according to the risk of CVD and to investigate the molecular mechanisms linking NAFLD and CVD.
Background: Stroke is the second leading cause of death worldwide and the primary medical cause of disability. It is estimated that 45% of affected individuals will continue to have moderate or severe functional disabilities throughout their lives. According to the American Stroke Association, telerehabilitation has the potential to provide timely and efficient care to stroke survivors, improving patients' functional outcomes while reducing long-term disability and associated costs. Hypothesis: Through the developed application (Muvity), the study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals in the post-stroke sequelae phase. Objectives: To evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation for patients who have experienced a stroke more than 6 months ago. Methodology: Prospective longitudinal study with single blinding. The control group undergoes a conventional intervention, while the experimental group undergoes an innovative intervention (n=25). Variables: The collected variables and measurement tools include upper extremity functionality (Fugl-Meyer scale), balance (Berg), functional independence (Barthel), pain (Brief Pain Inventory), post-stroke quality of life (ECVI-38), emotional health (UCLA Self-Rating Depression Scale), treatment expectations (Expectation for Treatment Scale), treatment adherence (through an APP), and satisfaction (Telehealth Usability Questionnaire). Statistical Analysis: Data will be analyzed per protocol (PP); the normality distribution of the data will be assessed, and results will be analyzed using parametric or non-parametric techniques depending on normality. A bivariate analysis will compare results between the control and intervention groups, considering a statistically significant result when p < 0.05. Expected Results: Similar results are expected between groups or slightly favorable outcomes in the experimental group for the different variables. Applicability and Relevance: The application would facilitate access to motor rehabilitation treatments in an enjoyable and engaging manner, promoting physical activity and contributing to a healthy lifestyle. Upon obtaining the results of this study, a trial implementation of the application in five socio-sanitary or associative centers is planned to verify its final applicability.
We present a research project in the form of a controlled clinical trial with the aim of analyzing and demonstrating whether the surgical treatment of upper limb spasticity is an effective and efficient measure to improve dependence and quality of life perceived by patients with sequelae of stroke and therefore, should be included in the therapeutic protocols, in which it is not usually contemplated, as a complement or alternative to traditional treatment with botulinum toxin, rehabilitation and occupational therapy.
The study aims to validate naevia medical, a knowledge-based clinical decision support system (CDSS), for clinical benefit and safety in cases of cardiac valvulopathies. Using a series of retrospective clinical cases of heart valve disease, the research will evaluate the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation.
Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer. Participants will receive either GEN1055 alone, GEN1055 with pembrolizumab, or GEN1055 with pembrolizumab and chemotherapy. All participants will receive active drug; no one will receive placebo. This trial has 2 parts. The purpose of the first part is to find out if GEN1055 is safe and to find out the doses of GEN1055 to use alone and to use with pembrolizumab. The purpose of the second part is to give GEN1055 to more participants to see how well the doses of GEN1055 that were selected in the first part work against cancer alone and how well they work with pembrolizumab (with or without other chemotherapy). A participant will receive trial treatment up to a maximum of 24 months for pembrolizumab-containing regimens, or until: - the cancer progresses. - there are side effects requiring that treatment be stopped. - the participant decides to not participate further in this trial. - the doctor believes it is in the participant's best interest to stop treatment. Participation in the trial will require visits to the site. For the first 12 weeks there will be weekly visits and after that, visits will be every 3 weeks. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography (CT) scans) to monitor whether the treatment is safe and effective. The trial duration (including screening, treatment, and follow-up) for each participant will be about 39 months.
The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy.