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.
Multicenter observational prospective registry, Spanish nationwide-based, of consecutive patients diagnosed with Spontaneous Coronary Artery Dissection (SCAD)
Aim. To evaluate the efficacy of optimizing hydration during labor in nulliparous women with respect to reducing the duration of dilation and the second stage of labor, lowering the incidence of Cesarean sections and fever, and also with respect to changes in sodium and osmolarity in blood and urine, and 24 hour diuresis. Background. In the international scientific community there is a lack of consensus regarding the most suitable hydration strategies to be used in the attention of nulliparous women during low risk birth. Insufficient hydration during labor is associated with increased maternal and neonatal morbidity. Design. A randomized, controlled clinical trial with allocation concealment and masking during the evaluation of the results. Methods. A study of nulliparous women whose births and newborn are attended in the Obstetric Service of a University Hospital. The women will be randomized to two groups: the "optimal hydration" group, that will be guaranteed 300 ml/h (intravenous crystalloids and water) with a minimum diuresis of 400 ml/24h; and the "variability in hydration" group, comprised of the administration of intravenous and clear liquid volumes, without any established perfusion rate, based on criteria established by the healthcare professional attending the birth, and without established minimum diuresis. Mother outcomes: duration of labor, Cesarean section, fever, dehydration. Newborn outcomes: distress, hypoglycemia, hyponatremia, jaundice, weight loss in 48h, breastfeeding difficulties. Analysis will be per-protocol. Statistical significance will be set at p<0.05 Discussion. The findings obtained in this study will provide new evidence for considering the benefits of providing women with suitable optimized hydration during labor. Diminishing the clinical practice variability related to hydration strategies applied to nulliparous women attended during labor through the use of a decision-making algorithm to administer optimal hydration, would imply improved health and safety for mothers and their newborn together with reduced maternal and neonatal morbidity. Funding granted in 2015 by the Spanish Health Research Fund (PI 15/00897, Ministry of Health). Keywords: hydration; dehydration; adverse events; labor; Cesarean section, fever.
The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.
Background: Although Drug- related Problems (DRPs) in polimedicated patients are a major public health problem in western countries and many of them have been considered avoidable, secondary and primary prevention policies have not been systematized, beyond pharmaceutical care programs in certain settings and on specific patients. Objectives: The main objective of this study is to evaluate the impact of implementing the Medication Code (CM) on patients who consult the emergency department for a DRP (secondary prevention of DRP). It is also intended to draw conclusions, based on the knowledge obtained in terms of DRP that will allow the establishment of future actions to reduce its prevalence (primary prevention actions). Method: A single-centre clinical trial is proposed in which adult patients will be selected to consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for a primary or secondary diagnosis of DRP and will be randomised with a 1:1 distribution to be included in the medication code (intervention group) or to receive usual care (control group). The intervention will be evaluated in terms of health outcomes (ED consultations and hospital readmission).
Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.
This is an observational, multicentre epidemiological study with a longitudinal cohort in which information will be retrieved from medical records of patients with advanced metastatic or unresectable melanoma at first diagnosis.
The objectives of this study are to characterize MPS VII disease presentation and progression and assess long-term effectiveness and safety, including hypersensitivity reactions and immunogenicity of vestronidase alfa.
Descriptive prospective study carried out to compare the results obtained by self-administered IPSS (International Prostate Symptom Score), Sanitary staff-supervised IPSS and directed medical interview and its correlation with clinical parameters in the assessment of lower urinary tract symptoms in males.
Levodopa-carbidopa intestinal gel (LCIG) infusion has demonstrated to improve motor fluctuations. The aim of this study is to assess the long-term safety and effectiveness of LCIG infusion in advanced Parkinson's disease (PD) patients with motor fluctuations and its effect in non-motor symptoms.
This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with multiple myeloma (MM) having progressed within 18 months of initial treatment with autologous stem cell transplantation (ASCT) (Cohort 2a) and without ASCT (Cohort 2b) or, in participants with inadequate response post ASCT during initial treatment (Cohort 2c) and the efficacy and safety of bb2121 used in combination with lenalidomide maintenance in participants with suboptimal response post ASCT (Cohort 3). Approximately 264 participants will be enrolled into one of three cohorts. Cohort 1 (including cohort 1b) will enroll approximately 126 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.