There are about 21071 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.
Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces and eliminates tremor which reduces learning curve and it may have a reduction of complications. During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC). In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP). However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection. Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
The general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. The recruitment will be carried out from July 2023 and will be carried out until December 2023, the analysis of the information will be carried out from January to March 2024.
Pelvic floor dysfunctions (PFD) are especially prevalent among females. As conservative management, strengthening pelvic floor (PF) musculature under health supervision, regard an important research line. However, embarrassment of female athletes limits healthcare demands. New technologies could facilitate an autonomous but supervised tele-rehabilitation programs. This study will evaluate the effects of a 6-weeks strengthening PF program by using tele-rehabilitation, with or without intracavitary biofeedback, in the PF anatomo-functional characteristics, quality of life and sports performance of female athletes with PFD. To this end, 45 female athletes with self-reported PFD who train and compete in athletic in Spain will be recruited and randomly distributed in three groups of the experimental study. During 6 weeks, all participants will use an specifically developed Smartphone application (named ACTITUD): the control group (CG) will have access to information about PF and direct communication with healthcare team; experimental group 1 (EG1) will have access to the same information and communication, and will perform a strengthening program for PF, which will be instructed by 3D avatars, while using an intracavitary biofeedback device that will inform about vaginal pressure; the experimental group 2 (EG2) will be similar to EG1, but they will not use the intracavitary biofeedback device. Before and after these 6 weeks, anatomo-functional PF characteristics, quality of life, PFD symptoms and sports performance of all participants will be evaluated. As an additional outcome, the level of engagement of the athletes from experimental groups to complete the training program will be registered.
The goal of this clinical trial is to evaluate the effectiveness of a novel intervention that involved contact interaction with a simulated healthcare space to reduce medical fear in children in infant class. The main question it aims to answer is: • Will the Health Friendly Program, based on the interaction with a simulate healthcare space, reduce medica fear among children in infant class? Participants will participate in the Health Friendly Program that will consist of showing the children different scenarios that simulated various medical contexts, letting them experiment with the material and ask questions. Researchers will compare two groups (intervention group and control group) to see if there exist differences between both groups in their responses to the Child Medical Fear Scale.
The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way. With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon, thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal conic segment and simultaneously inflated, making a tight connection with the aortic stent, as if they were molded together, thus simulating a new bifurcation. This minimal invasive endovascular technique using covered stents, was developed in order to optimize endovascular mimicking the anatomical configuration of the aortic bifurcation and in an attempt to overcome the disadvantages of kissing stents influenced by geometric factors such as radial mismatch, protrusion mismatch and stent conformation. The use of BeGraft (balloon-expandalbe covered stent) and Solaris (self-expandable covered stent) fro this technique is revised.
This study aims to assess the safety and tolerability of the individual highest tolerated zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in Pulmonary Arterial Hypertension (PAH) disease.
This study aimed to evaluate the effect of a vegan diet (supplemented with vitamin B12) and an mediterranean diet on performance, cardiorespiratory fitness, metabolic health, immune status, and environmental impact in healthy adults.
Severe trauma is one of the leading causes of morbidity, mortality, and disability worldwide. Currently, it is the primary cause of death among individuals under 45 years of age. This disease, considered a "silent pandemic," exhibits heterogeneous physiopathology and unequal geographic distribution in terms of the type of injuries. The prognosis of subjects who have suffered severe trauma is uncertain, especially in patients with traumatic brain injury. The epidemiology of severe trauma has undergone changes in recent years due to the global aging of society, resulting in different populations with older ages and more associated comorbidities. These factors are frequently linked to the use of chronic treatments such as antiplatelet agents or anticoagulants, which could worsen traumatic hemorrhage-the leading preventable cause of death following severe trauma. Despite efforts for primary prevention, such as road safety campaigns and occupational risk prevention, the annual incidence of severe trauma cases worldwide remains high. Enhancing the management of trauma patients would significantly influence the final clinical outcomes. Given the aforementioned, it is of vital importance to understand the local epidemiology of severe trauma for the development of clinical research. This constitutes an effective tool to investigate changes in clinical practices, improve prevention strategies, and determine the global burden of the disease. The hypothesis of the IcuTrauma Project is to create a territorial Registry of adults with severe trauma admitted to the ICU to understand the local epidemiology in Tarragona (Spain). This initiative would facilitate new lines of clinical research aimed at improving outcomes and the quality of care for trauma patients.
Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence (5%) with associated difficulties and worse prognosis if undetected. Multimodal treatment is the treatment of choice, however, sometimes it can be insufficient or have some drawbacks. Objective: To demonstrate the effectiveness of cognitive training through the video game 'The Secret Trail of Moon' (MOON) in improving emotional regulation of ADHD in people aged 7 to 18 years. Hypotheses: H1: ADHD patients using MOON improve their emotional regulation more than the control group; H2: ADHD patients using MOON improve in symptomatology with respect to the control group; H3: ADHD patients using MOON improve their cognitive abilities than the control group; H4: ADHD patients using MOON improve in academic performance with respect to the control group; H5: The change of platform (face-to-face, online) does not entail differences in emotional regulation; H6: There are no side effects associated with the video game. Methods: Design: prospective, unicenter, randomized, unblinded, PRE-POST intervention study. Randomization of the groups (MOON vs. Control) will be performed by electronic CRD. The MOON intervention will be performed 2 times/week for 10 weeks (30 minutes/session). The first five weeks (10 sessions) will be conducted face-to-face; the remaining weeks will be conducted online at the participants' home. Sample: 152 patients with a clinical diagnosis of ADHD (CGI between 3 and 6) with pharmacological treatment. Evaluation: a data collection notebook will be used to obtain demographic and clinical data. The data will be recorded with electronic CRD (REDCap). Measures to answer the hypotheses will be made through clinical scales for parents and objective tests of cognitive abilities in patients. Additional information on academic performance will be collected. Statistical power analysis: The study has a power greater than 80% to detect differences. Statistical analysis: Classical statistics: T student, 2-factor ANOVA and Mann Whitney analyses will be performed according to the characteristics of each variable. Ethics: The study was approved by the Research Ethics Committee of the Hospital Universitario Puerta de Hierro on December 14th, 2022. The authorization of the Spanish Agency of Medicines and Health Products was February 14th, 2023. Informed consent will be requested from legal guardians and minors protecting their personal data to the provisions of the Organic Law 3/2018 of 5 December, on Personal Data Protection and guarantee of digital rights.
Non-randomized study with control group (CG) with the objective of analyzing the non-pharmacological analgesic efficacy of the "Painless Vaccine" protocol for the reduction of pain during vaccination in the population aged 2 months to 14 years participating in the experimental group (EG) versus traditional vaccination (CG).