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.
This is a non-randomized, open label study to assess the reduction of Human Papillomavirus (HPV) infectivity and transmission in women positive for HPV16 and/or 18 in a cervical, oral and anal sample and vaccinated with 9vHPV/Gardasil-9™. The primary objective of the study is to demonstrate that vaccination with a 3-dose regimen of 9vHPV will reduce viral infectivity in HPV 16/18/16+18-positive women. This objective rests upon the hypothesis that, since vaccination with 9vHPV triggers the production of type-specific HPV antibodies which are exudated to the cervical and other infected mucosae, these antibodies adhere to and neutralize newly produced HPV 16/18 viral particles also present in the mucosae, thus reducing HPV's infective capacity and transmission to sexual partners. Secondary objectives of the study are: - To determine HPV antibody levels before and after vaccination for each of the 9vHPV-covered HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58), to distinguish an induced antibody production due to 9vHPV vaccination from a natural response to an HPV infection (when antibody production is expected to be lower). - To demonstrate viral infectivity reduction in HPV 16/18/16+18 after vaccination with 1-dose or 2-dose regimen of 9vHPV. Since antibody production after administration of 2 vaccine doses is not inferior to 3 doses, infectivity reduction is expected to be detected after 2 doses, and at least partially after one dose. The main endpoint of the study is the evaluation of the HPV infective capacity in cervical, anal and oral samples from HPV 16, 18 or 16+18-positive women, using a cellular assay that models in-vitro the cervical mucosa. In brief, the specific HPV biomarker E1^E4 is measured in HaCaT keratinocytes after being cultured with study samples and thus, exposed to HPV16/18 viral particles. A reduction in E1^E4 expression is expected for keratinocytes exposed to samples taken after vaccination with 9vHPV, since the specific HPV antibodies also present in these samples would bind HPV viral particles and prevent infection of cultured keratinocytes. Other endpoints included in the study are: - Detection of antibodies against HPV types covered by 9vHPV (6/11/16/18/31/33/45/52/58) by specific immunoassays (ELISA, cLIA). - HPV16/18 virion detection using ELISA and electronic microscopy. - HPV DNA detection and genotyping, using Anyplex HPV28. These endpoints are performed in cervical, anal and oral samples from HPV 16, 18 or 16+18-positive women - Titration of antibodies against HPV types covered by 9vHPV in serum samples from HPV 16, 18 or 16+18-positive women using ELISA or cLIA. A minimum of 39 and 30 women will be enrolled in two different study population cohorts, respectively: - RIFT-HPV 1 cohort: non-vaccinated adult women aged 35 years or older, positive for HPV16-, 18-, or double positive for 16 and 18, without lesion or with cervical intraepithelial neoplasia (CIN) 1/2 lesion eligible for conservative treatment. - RIFT-HPV 2 cohort: non-vaccinated adult women aged 27 years or older, positive for HPV16-, 18-, or double positive for 16 and 18, with multiple cervical, vulvar and/or anal lesions, with cervical lesions eligible for conservative treatment. Candidates to participate in the study are selected according to the HPV DNA test result in a cervical sample taken in their routine cervical cancer screening visit or in their routine gynaecological follow-up visit. There is no control group in this study: all participants are expected to complete all the per-protocol procedures in a total of 4 study visits within an average of 7 months' duration: Visit 1/ Day1, Visit 2/Month 2, Visit 3/Month 6, and Visit 4/Month 7. The study procedures are the following: - Pregnancy test on a urine sample in Visit 1 (pregnant women are excluded from the study). - Completion of a questionnaire about the participant's health status, use of oral contraception and sexual activity in Visits 1 and 4. - Cervical, anal oral and blood sample collection Visits 1, 2 and 3 before receiving 9vHPV vaccination, and in Visit 4. - Intramuscular administration of 9vHPV in a three-dose regimen in Visits 1, 2 and 3. Regarding data analysis for primary objective assessment, differences in the infectivity rate before (Day 1/ Visit 1) and after vaccination with 3 doses of 9vHPV (Month 7/ Visit 4) will be compared in cervical, anal and oral samples using non-parametric Wilcoxon signed rank test. The same assessment will be done in 1- or 2-dose vaccination scenario. Antibody production before and after vaccination will be summarized for each of the 9vHPV-covered HPV types.
This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.
Objectives: The primary objective is to identify and characterize the relevant subgroups ( clusters ) in type 2 diabetes (T2DM) at the time of diagnosis in our region. This objective will be addressed using the six main variables (see Methodology) used so far in previous studies in other populations to develop the clustering of diabetes. Therefore, this is a study in diagnostic precision medicine in diabetes. In addition, as secondary objectives, other phenotypic characteristics of these subgroups (clinical, metabolic, and associated comorbidities) will be evaluated. Methodology: This project will establish a prospective observational cohort study of 1200 subjects newly diagnosed with T2DM in primary care centers in the healthcare areas of Barcelona city and the territory of Lleida. All newly diagnosed cases of T2DM will be identified and evaluated. Participants will undergo a comprehensive phenotypic evaluation, including the six variables that will allow the characterization of T2DM subgroups: age, antibodies against glutamic acid decarboxylase (GAD), body mass index, glycated hemoglobin, and sensitivity indices ( HOMA-IR) and insulin secretion (HOMA beta), based on the determination of C-peptide. The latest generation cluster analysis (k- means and hierarchical clustering ) will be performed, following the method described in previous studies using the six variables mentioned above. Onset diabetes subgroups and their association with secondary outcome variables will be assessed. The initial prescription of antidiabetic medication will be evaluated. Other procedures of this project include: clinical (including complications) and biochemical evaluation, advanced lipoprotein profile, and validated questionnaires to evaluate diet and physical activity.
The study aims to examine the effect of nurse-led education program on quality of life, atrial fibrillation (AF) risk factors, AF symptomatology, arrhythmia recurrence rate, and readmission rate after AF catheter ablation.
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.
INTRODUCTION The practice of yoga in recent years is becoming more common. Originating in India, yoga combines physical postures with a philosophy of life and breathing (pranayama). One of the breaths used during yoga practice is the so-called ujjayi or victorious breath. It consists of the voluntary contraction of the muscles of the larynx both in inspiration and expiration. This reduces the diameter of the larynx, reducing airflow and thus increasing intrathoracic pressure, as well as increasing expiratory/inspiratory time and reducing respiratory rate and dead space. It also increases oxygen saturation in healthy subjects, increasing respiratory effort. Several studies have verified the relationship between ujjayi breathing and increased BRS (cardiovagal baroreflex sensitivity), by stimulation of the parasympathetic system at the glottis level. This would favor a decrease in heart rate, as well as better control of stress and anxiety. The cardiovascular and respiratory effects studied with ujjayi breathing have not evaluated the effect that this breath has on the activation of the respiratory muscles, mainly the diaphragm. The diaphragm is the main inspiratory muscle and as such, lung volumes and intrathoracic pressures created during respiration depend on its activation and position. In recent years, ultrasound has become a technique widely used by pulmonologists and intensivists. It is an easy technique to perform, reproducible, non-ionizing, allows bilateral comparison, non-invasive and non-painful and whose results can broaden the information from other techniques such as spirometry and radiography. There are standardized protocols to measure the diaphragmatic excursion, the thickness of the diaphragm HYPOTHESIS: ujjayi breathing is capable of generating greater activation of the diaphragm in subjects healthy with respect to spontaneous or pursed-lip breathing. OBJECTIF: study and compare the activation and work of the diaphragm in different type of breathing (ujjayi, pursed lips and at rest) in healthy subjects who practice yoga or not. DESIGN: cross over study experimental, analytical and prospective. METHODOLOGY: 80 healthy subjets (40 yoga practitioners and 40 non yoga practitioners) participated at this study. All of them volunteers will undergo an ultrasound study of their diaphragm. To do this, following the stipulated protocol, three variables will be analyzed: diaphragm thickness, its rate of contraction, and diaphragmatic excursion, all of them at rest, ujjayi breathing, and pursed-lip breathing. The ultrasound measurements will be taken by a single researcher, who is not the main one, and who will not know which group each of the subjects belongs to, thus avoiding an evaluation bias. To avoid bias and according to the RUSI regulations, the researcher will take 3 measurements of each of the explorations with the average of the 3.
The present study aims to investigate the therapeutic potential of a high definition transcranial direct current stimulation protocol, stimulating frontal and cerebellar areas boosting the cognitive and motor recovery of stroke population.
Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention.
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).