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.
Currently, both the American Thyroid Association and the European Thyroid Association recommend the use of Lugol Solution (LS) in the preparation of patients undergoing thyroidectomy for Graves' disease (GD), but their recommendations are based on a low level of evidence. This means that its use is not generalized among the different endocrine surgery units. Methods: Study population: 270 patients (135 patients in each arms) undergoing total thyroidectomy (TT) due to GD in Spanish hospitals, which perform a minimum of 100 thyroidectomies a year, at least 10 of them for GD. Variables: Preoperative variables - Demographic variables: birthdate, gender and ethnicity. - Drugs allergies. Allergy to iodine. - Personal history and usual treatment. - Aspects related to the GD: date of diagnosis, use of AT drugs and/or radioiodine, existence of ophthalmopathy, existence of cervical compression symptoms and indication of surgery. - Physical exploration: body mass index, pulse at rest and blood pressure and cervical palpation. - Laboratory tests: hematocrit, leukocytes, neutrophils, platelets, international normalized ratio(INR), creatinine, potassium, total calcium, albumin, total proteins, parathormone (PTH), 25-hydroxide-vitamin D, free T4 and / or free T3, TSH, thyroid stimulating immunoglobulin (TSI). - Classification of the anesthetic risk of ASA. - Cervical ultrasound: existence of thyroid nodules and volume of the thyroid. - Mobility of the vocal cords evaluated by laryngoscopy. - Compliance with assigned treatment: the patient assigned to the LS arm must have consumed at least 80% of the total dose indicated. Intraoperative variables - Surgical time. - Antibiotic prophylaxis - Intraoperative hemorrhage. - Thyroidectomy Difficulty Scale. - Loss of electromyographic signal during neural intraoperative monitorization. - Accidental parathyroidectomy. - Section or obvious lesion of the recurrent laryngeal nerve. - Trachea or esophagus perforation. - Weight of the gland. - Electrosurgical hemostasis system used during the intervention. - Maneuvers used to check hemostasis. - Hemostats used during the intervention. - Use of drainage. - Definitive surgical technique: TT, unilateral or bilateral subtotal thyroidectomy or hemithyroidectomy. Postoperative variables - Early complications: hypoparathyroidism, paralysis of the recurrent laryngeal nerve, postoperative hematoma, surgical site infection or death. - Debit for surgical drains. - Postoperative hospital long of stay. - Anatomopathological variables: histological diagnosis compatible with GD and existence of parathyroid glands in the surgical specimen. - Long-term complications: hypocalcemia and/or permanent vocal cord paralysis longer than 6 months
The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
Objectives: To analyze the number of sessions needed to achieve a positive impact after combining interferential current therapy and therapeutic exercise, compared with therapeutic exercise alone, on self-reported pain, disability and range of motion in subjects with chronic neck pain. Design: A randomized, single-blind, controlled trial. Subjects: Patients between 18 and 65 years old, with idiopathic chronic neck pain. Methods: The experimental group who will perform a combined treatment using Interferential current therapy and therapeutic exercise for two weeks. The control group will receive the same program of therapeutic exercise during the same period of time.
Given (1) the high volume of women on reproductive age that have a clinical diagnosis of endometriosis and (2) the poor management of symptoms that medical treatment usually achieves, new therapeutic interventions need to be evaluated in order to improve pain and quality of life in those patients. Therefore, 'Physio-EndEA' study has been designed to evaluate whether therapeutic exercise could help on the management of endometriosis-related symptoms
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
Alzheimer's disease (AD) neuropathology is characterized by deposits of insoluble amyloid β-peptide (Aβ) in extracellular plaques and aggregated tau protein, which is found largely in the intracellular neurofibrillary tangles. Current knowledge, has allowed a shift in the definition of AD from a syndromal to a biological construct, based on biomarkers that are proxies of pathology. However, little is known about mechanisms underlying the disease progression at its early stages. The loss of dendritic spines, the primary locus of excitatory synaptic transmission in the mammalian central nervous may be linked to cognitive and memory impairment in AD: A multimodal lifestyle change intervention (dietary, physical activity and cognition) combined with epigallocatechin gallate (EGCG) will slow down cognitive decline and improve brain connectivity in a population of participants with subjective cognitive decline (SCD). In humans, alterations in functional connectivity (FC) have been observed in early AD stages, subjective cognitive decline (SCD) and mild cognitive impairment (MCI). A hyper-synchronized anterior network and a posterior network characterized by a decrease in FC are the spatial features. These disruptions also seen in AD indicate that FC alterations appear very early in the course of the disease . Experimental research strongly suggests that in order to increase our cerebral reserves, we have to follow a lifestyle that takes into account many factors. Clinical studies provided evidence that individuals with more cerebral reserves are those who have a high level of education, who maintain regular physical activity and who eat in a healthy way. The environmental enrichment (EE) animal models confirmed that the experience plays a key role in increasing brain plasticity phenomena .There is a growing understanding that a valid therapeutic emerging approach in AD is prevention. A large number of modifiable risk factors for AD have been identified in observational studies, many of which do not appear to exert effects through amyloid or tau. This suggests that primary prevention studies focusing on risk reduction and lifestyle modification may offer additional benefits. The therapeutic approach proposed in the present project aims at improving synaptic plasticity and functional connectivity in early stages of AD, and specifically in SCD in the context of a personalized medicine approach that includes a multimodal intervention (nutritional, physical, cognitive and medical) looking at improving person-centered outcomes. In this context the proposed clinical trial design will evaluate the efficacy of EGCG in the context of a personalized medicine approach that includes a multimodal intervention (nutritional, physical, cognitive and medical) looking at improving person-centered outcomes. Early phase I studies in Down syndrome young adults showed that while subjects were under EGCG, improvements in cognition were observed but these vanished when treatment was discontinued. Phase II studies combining EGCG with cognitive training showed improvements in cognitive performance and adaptive functionality but interestingly sustained effects after treatment discontinuation. Observations made in humans are in agreement with preclinical studies showing that EGCG combined with environmental enrichment resulted in an improvement of age-related cognitive decline. These observations are in favor of the option of combining EGCG with a personalized multimodal intervention. The personalized multimodal intervention will take into account medical comorbidities (i.e. metabolic syndrome, T2DM), diet (including nutritional status), physical exercise, and will incorporate cognitive training and a behavioral intervention to aid subject's adherence and empowerment to the intervention proposed. This will be in-line with other clinical studies in AD showing the superiority of multimodal interventions vs. a single life style intervention (i.e. single nutrient, physical activity). Hypothesis: A multimodal lifestyle change intervention (dietary, physical activity and cognition) combined with epigallocatechin gallate (EGCG) will slow down cognitive decline and improve brain connectivity in a population of participants with subjective cognitive decline (SCD).
DESCRIPTION: The Investigational Product "A-Ce toughened TZP nanocomposite implant" is a Medical Device (MD) intended for the dental rehabilitation of edentulous sites with fixed prosthesis. The "G3®-coated NK2® abutment" is a MD intended for the prevention of peri-implant bone loss due to peri-implantitis. The MD are for dental use and will be used exclusively on subjects who have signed an informed consent form and by approved study investigators. OBJECTIVES: (a) To evaluate the safety and performance of the "A-Ce toughened TZP nanocomposite Implant" for its intended medical application purpose in the context of successful osseointegration of zirconia-based dental implants. (b) To evaluate the safety and performance of the "G3®-coated NK2® abutment" for its intended purpose in the context of peri-implantitis prevention. (c) To obtain the regulatory CE Mark Certification status for both medical devices. TYPE OF INVESTIGATION: Randomized double-blind (patient, appraiser) controlled study. CENTER/COUNTRY: Instituto de Cirugía Oral Avanzada (ICOA), Madrid, Spain GROUPS: Group A: 30 zirconia implants with 30 G3-coated abutments (test implant and abutment) Group B: 30 test implants with 30 uncoated (control) abutments Group C: 30 Ti implants (control) with 30 test abutments Group D: 30 control implants with 30 control abutments Group E: 3 test implants and 3 control implants, for histological/histomorphometric evaluation. COMPARATIVE DEVICE: Commercial Ti dental implant. STATISTICAL METHODOLOGY: H0 : INPERIO performs worse (with statistical significance) than the commercial devices. - Test implants achieve a higher failure rate than Ti implants. - The clinical osseointegration parameter values are worse with statistical significance for test implants than for control implants. - Histological and histomorphometric analysis shows worse quality and quantity of osseointegration for test implants than for Ti implants. H1: There is no statistical significance between INPERIO and the commercial solution or INPERIO performs better (with statistical significance) than the commercial Ti implants. - Test implants achieve the same failure rate or less than Ti implants. - The clinical osseointegration parameter values are no different or are better with statistical significance for test implants than for control implants. - The histological and histomorphometric analysis shows a similar or better quality and quantity of osseointegration for test implants than for Ti implants.
The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing comunication instrument: a Guide of Hosting for urogical scheduled patients for surgical intervention.