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.
The objective of this study to evaluate the seroprevalence of anti-bodies against C. difficile toxins A and B and the asymptomatic carriage of C. difficile in IBD patients according to the need and type of immunosuppressive therapy. The ultimate goal is to identify, among IBD patients, those with the highest risk of CDI.
Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups: - In patients with follicular lymphoma (FL) grade 1-3a *1,2 - In patients with diffuse large B-cell lymphoma (DLBCL) *1,2 - In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy. - In patients with marginal zone lymphoma (MZL) *1 - In patients with other B-NHL subtypes *1 Secondary objectives are: - To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by: - ORR according to the Lugano Classification and as assessed by local investigator evaluation - Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review - Progression-free survival (PFS)*3 - Overall survival (OS) - Duration of response (DOR)*3 - Disease control rate (DCR)*3 - To evaluate the safety and tolerability of odronextamab - To assess the pharmacokinetics (PK) of odronextamab - To assess the immunogenicity of odronextamab - To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) - 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy - 2 including an anti-CD20 antibody and an alkylating agent - 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation
Approximately 300 patients presenting orbital blow-out fracture will be enrolled prospectively in this registry. All patients, surgically and nonsurgically treated as per standard (routine) of care will be followed-up (FU) within the registry for a period of 6 months.
Centres: Three university hospitals and the primary care centres in their area in Madrid (Clínico San Carlos, La Paz, 12 de Octubre) Type of study: Randomized, multicentric, placebo-controlled, single-blind pilot study Main outcome: Nighttime blood pressure in type 2 diabetic patients Objective: To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to the addition of placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients withalbuminuria levels ≥ 30 and < 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2.. Patients: 225 patients with a previous diagnosis of type 2 diabetes and eGFR> 30mL/min x1,73m2, office BP above 140/70 mmHg, HbA1C 7.5-10%, albuminuria levels between 30 mg/g creatinine and 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2. Intervention: 10 mg once daily of dapagliflozin or placebo resembling dapagliflozin.
Introduction The promotion of physical activity among older adults is considered to be one of the main actions that can result in more successful aging. Currently, there are few studies focusing on the effects of long-duration physical activity interventions in older adults. Thus, the purpose of the following study was to analyze the effects of an 8-month multicomponent intervention program on cardiorespiratory capacity, body composition, and strength in a group of nonagenarians. A secondary objective was to determine if the impact of the program differed according to the participants' way of life (institutionalized vs. community dwelling). Methods Participants Participants in this research represent a subset from an ongoing study aimed at collecting baseline and follow-up data over three years, to evaluate the health-related changes observed in a cohort of older adults f The present research was carried out on the basis of data obtained from the individuals in this sample who participated in a multicomponent intervention program offered to the inhabitants of the said region and who met the following inclusion criteria: a) being ninety years of age or older; and b) holding a medical certificate confirming their suitability for sport. The exclusion criteria were a) lack of independent ambulation (walking with an assistive device); b) recent upper or lower limb injuries; c) neurological or orthopedic diagnosis in upper or lower-extremities. Intervention A multicomponent intervention program was developed consisting of two 60-minute sessions per week, held on non-consecutive days, for a period of 8 months. The sessions consisted of a warm-up phase (10') in which individuals performed joint mobility exercises and walked at a rate of 3 km/h. Afterwards, muscular strength work was carried out on the upper and lower limbs, including calisthenic exercises, and the use of dumbbells or medicine balls (1-3kg). Generally, the exercises were organized in two sets of 10-15 repetitions, resting for two minutes between sets. Communal ball games and relay games were then practiced (over a distance of 30 meters). Finally, 10 minutes were devoted to relaxation and stretching exercises. multicomponent intervention program was designed and monitored by a specialist in gerontogymnastics. Evaluations Two weeks before the start and after the end of the exercise program, a series of assessments were carried out, which were monitored by specialists in physical exercise and sport, who did not know whether those evaluated were institutionalized or not. Body composition Weight was measured to the nearest 0.1 kg using a Tefal digital scale (type PP1200VO) with the participants wearing light clothing and no shoes. Height was measured to the nearest millimeter with a field stadiometer (Seca 220). The body mass index (BMI) was calculated taking the body weight in kilograms and dividing it by the height in meters squared (BMI: kg/m2). Densitometry Bone mineral density content (BMD) of the femoral neck was measured using a dual energy X-ray absorptiometry (DEXA) machine (Hologic QDR 1000®), which reported BMD in grams per square centimeter (g/cm2). This method was used to ensure better reproducibility, a lower radiation dose and better image resolution (Watts 2004). The minimum significant alteration, with a 95% confidence interval, was 4.7%. Muscular strength Upper limb muscle strength was assessed with the Handgrip Test (HG) on the right hand using a dynamometer (SH5001, SAEHAN Corporation, South Korea). For each measurement, patients were asked to perform their maximum voluntary contraction for 5s. Each measurement was repeated three times with patients resting for 30s between trials. The best performance was recorded for further analysis. Lower limb muscle strength was assessed with the Isometric Knee Extension Test (KNEE), performed three times on the right leg with participants seated on a custom-built chair with a load cell (Vetek VZ101BS, Vaddo, Sweden). For each measurement, participants were asked to perform their maximum voluntary contraction for 5 s. The test was repeated 3 times and participants rested for 2 min between trials. The best performance from the three trials was considered for further analysis. Cardiorespiratory fitness In order to assess the effect of the program on the participants' cardiorespiratory fitness, the six-minute walk test (6MWT), was performed, following standard procedure. The subjects were instructed to walk at their own pace from one end to the other of a 100-foot-long measured distance in an enclosed, level, corridor, and to cover as much ground as possible in 6 min. They were allowed to stop and rest during the test, but were instructed to resume walking as soon as they felt able to do so.
Prospective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab, ustekinumab and tofacitinib will be made at the discretion of the clinician. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.
Alcohol and/or drug abuse problems (ADAPs) have been consistently identified in the scientific literature as a risk factor of intimate partner violence against women (IPVAW). Around 50% of IPVAW offenders referred to batterer intervention programs (BIPs) have ADAPs. ADAPs are also one of the main predictors of BIPs dropout. In Spain, the majority of BIPs do not fit the intervention to specific needs or characteristics of IPVAW offenders, such as those with ADAPs. The aim of this research is to assess the effectiveness of a new motivational strategy adapted to IPVAW offenders with ADAPs, aiming to increase treatment adherence and to improve BIPs outcomes. The motivational strategy will include an individualized motivational plan (IMP) developed for each participant with ADAPs (IMP-ADAPs). In these IMPs one of the main aims will be to reduce alcohol and/or drug consumption. The current study will use a randomized control trial. Participants with ADAPs will be allocated to one of two treatment conditions: experimental condition: Standard batterer intervention program (SBIP) plus individualized motivational plan focused in ADAPs (SBIP+ ADAPs-IMP), and control condition: Standard batterer intervention program plus individualized motivational plan (SBIP+IMP). Primary/final outcomes will be recidivism and ADAPs reduction. Secondary/proximal outcomes will include treatment adherence related variables, violence related attitudes and attributions, self-control and psychological adjustment. Outcome variables will be assessed at baseline, at the end of the intervention, and at six months after the intervention will be finished.
The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment. The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.
The goal of this study is to evaluate the role that high-flow nasal cannulas (HFNC) have on respiratory drive, work of breathing and neuromuscular efficiency after lung resection surgery. The main question the investigators aim to answer is whether HFNC decrease respiratory drive by at least 15% in these patients, assessed by a special diaphragmatic electromyography (EMG) device (NAVA catheter). In order, to perform this study, the investigators will perform a physiological study in 40 patients. These patients will be assessed in the immediate postoperative period and HFNC will be compared to conventional face-mask therapy.
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.