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 goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Optimal diagnostic management and underlying pathophysiological mechanisms of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies have not been fully clarified. The current diagnostic classification system based on three different umbilical artery flow patterns has no increasing scale of severity and the predictive value is limited. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double fetal demise. Outcome prediction is furthermore important in the selection of cases that will be offered selective reduction (to provide the larger twin with better prospects), as well as determining monitor frequency and possible hospital admission. As outcome prediction is clinically challenging, patient counselling is too, and parents often encounter a great deal of uncertainty during the pregnancy. Furthermore, little is known about the brain development of sFGR children (both during pregnancy and after birth). Moreover, the psychological impact of an sFGR pregnancy of the future parent)s) has not been studied before. The impact of these factors should be taken into account during patient counseling, which is currently not the case. By our knowledge, this is the first international, multicenter, prospective cohort study on that will address the abovementioned questions and knowledge gaps in MCDA pregnancies complicated by selective fetal growth restriction.
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
The FLARE-RA study will have the following research objectives: A) To establish the cellular and molecular atlas of remission RA achieved with different therapeutics aimed to identify (i) cell clusters/pathways driving disease flare or maintaining remission and (ii) provide an evidence base for developing ML tools for predicting flares. B) To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study. C) To dissect the cellular and molecular mechanisms of remission maintenance and joint flares.
This is an exploratory therapeutic study (according to the terminology of the "ICH Harmonised Tripartite Guideline Topic E8. General Considerations for Clinical Trials". EMEA, March 1998. CPMP/ICH/291/95), open-label, non-randomized, multicenter study. It is considered phase I/II since the safety and efficacy of the infusion of allogeneic haploidentical NK cells in combination with chemotherapy and/or radiotherapy in the treatment of pediatric, adolescent and young adult patients with refractory sarcoma will be sought.
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
TrAVeRse is a multicentre, open-label, randomised, Phase II study of AVR in treatment naïve MCL participants. The primary objective will be to assess the rate of MRD-negative CR at end of induction after completing 13 cycles of AVR. Participants achieving an MRD-negative CR at the end of AVR induction will be randomised to continued acalabrutinib or observation. Participants who progress during observation may receive retreatment with acalabrutinib
The goal of this clinical trial is to analyze whether a physiotherapy protocol based on strengthening exercises to the shoulder girdle muscles carried on during anodal transcranial electrical stimulation (a-TES) is more effective on the symptoms and functionality of subjects with subacromial pain syndrome than an isolated strengthening program. The main questions it aims to answer are: - Is the strengthening + a-TES protocol effective on functionality? - Is the strengthening + a-TES protocol effective on quality of life? - Is the strengthening + a-TES protocol effective on pain? - Is the strengthening + a-TES protocol effective on muscle strength? - Is the strengthening + a-TES protocol effective on active range of movement? - Is the strengthening + a-TES protocol effective on proprioception? - Is the strengthening + a-TES protocol effective on posture? - Is the strengthening + a-TES protocol effective on glenohumeral and scapulothoracic kinematics? Participants will perform an 8 weeks-3 days/week shoulder strengthening protocol for the rotator cuff and scapulothoracic muscles using elastic bands and dumbbells. The rotator cuff exercises will be performed while they receive a-TES using a neoprene helmet with the electrodes placed in the opposite hemisphere to the affected side. The scapulothoracic exercises will be performed without the transcranial stimulation. The experimental group will receive real a-TES, and will be compared with a control group that will perform the same therapeutic exercises but with placebo a-TES to see the effectiveness of the a-TES on the outcomes cited above.
Sarcopenia (SAR) is the loss of strength and muscle mass caused by aging. It is accompanied by a progressive loss of physical and cognitive abilities, increasing the risk of falls. This loss of muscle mass leads to pathophysiological changes at the neuromuscular and tendon level as a consequence of, among others, alterations in the protein synthesis/degradation balance, inflammation (INF), or alterations in the anabolic/catabolic state (EAC). These alterations are caused by oxidative stress (OS), when reactive O2 species, toxic metabolites produced by cells using O2, exceed the defense capacity of the antioxidant mechanism. Therapeutic strategies to modulate SAR are based on exercise and nutrition programs. Multicomponent physical exercise program has shown improvements in sarcopenia-related parameters. Likewise, the use of nutritional supplements such as creatine (CRE) has shown improvements in muscle function in the elderly. CRE could reduce INF and EO in the general population. Guanidinoacetate (GAA, also known as guanidinoacetate acid or glucosamine) is a naturally occurring creatine precursor with advanced transportability and an innovative dietary supplement that may increase the rate of creatine turnover. The CRE-GAA mixture outperforms creatine in increasing brain and muscle performance in adult men and women, but whether this mixture improves muscle function and quality in people with sarcopenia has not been addressed so far. Similarly, whether this mixture may promote oxidative stress and inflammation in adults with sarcopenia has not been studied. Similarly, beta-hydroxy-beta-methylbutyrate (HMB) also appears to improve muscle function in older people by enhancing myogenesis. However, the effects of these supplements on the elderly have only been shown to be seen when used in isolation. In this regard, our research team observed that a 10-week combination of 3 g/day of CRE+3 g/day of HMB (CRE-HMB) improved muscle recovery (better EAC) and physical performance in athletes exposed to heavy muscle wasting. However, not aware that it has been addressed whether this mixture improves muscle function, EO, INF, and EAC in women with SAR. Therefore, the hypothesize would be that the CRE-HMB combination could improve muscle function and physical performance, as well as OE, INF, and EAC in people with high muscle wasting such as those with SAR. Therefore, a randomized double-blind study is proposed to analyze the effect of 12 weeks of co-supplementation of 3 g/day of CRE + 3 g/day of HMB (CRE-HMB) and 3 g/day of CRE and 3 g/day of GAA (CRE-GAA) with 3 sessions/week of multicomponent physical exercise on muscle function, EO, INF, and EAC in 81 women with SAR over 70 years of age. These 81 women will be divided into 3 groups of 27 (27 placebo group, 27 CRE-HMB group, and 27 CRE-GAA group). At the control points (at baseline and after 12 weeks) participants will have their body composition, nutritional intake, strength, and performance tests analyzed. Blood will also be drawn to determine biochemical values of EO, INF, and EAC. The expected results are that co-supplementation with CRE-HMB and CRE-GAA for 12 weeks together with multicomponent physical exercise in individuals diagnosed with SAR will improve muscle strength, muscle quantity, and performance. In addition, improved EO, INF, and EAC levels are expected.
To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).