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 phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level [DL] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).
The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)
The purpose of this study is to test whether adding a treatment using pain neuroscience education (PNE) and multimodal physiotherapy to usual care, in subjects with knee osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty (TKA), is more effective than only usual care. There is a high evidence level of different systematic reviews, which support the efficacy of physiotherapy treatments combined with behavioural/educational techniques aimed to reduce pain catastrophism, pain and disability in other pathologies. The primary aim of that kind of interventions is to help the subjects to reconceptualise its own pain understanding and its role on the recovery process, as well as promoting an increase of activity and encourage the subject to resume its usual activity instead of continuing to avoid it.
Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).
Alzheimer's disease (AD) is the leading cause of dementia and its prevalence is estimated to exceed 100 million affects by 2050, becoming the main public health problem worldwide. Classically, AD has been considered a clinicopathological entity characterized by a progressive cognitive decline with early memory impairment followed by other cognitive domains, and an underlying neuropathological pattern characterized by extracellular accumulation of β-amyloid protein (Aβ) in the form of neuritic plaques, intracellular deposits of tau protein in the form of neuritic strands and neurofibrillary tangles, neuronal and synaptic loss and glial proliferation. In this context, a "probable" AD diagnosis was based on determining the presence of dementia and ruling out other potential aetiologies while a definite one required confirmation by post-mortem examination. In the last 15 to 25 years, progress in imaging and cerebrospinal fluid (CSF) biomarkers has enabled a change of the AD conceptualization from a clinical-pathological entity to a clinical-biological one. These new diagnostic criteria also divides the course of AD into 3 stages: (1) a preclinical phase, which would include persons with positive AD biomarkers and normal cognitive performance (the subjective perception of cognitive decline [SCD] is also part of this stage); (2) a phase of mild cognitive impairment (MCI), characterized by cognitive performance lower than expected by age and educational level; and (3) a dementia phase, once cognitive deficits interfere with the activities of daily living. This new conceptualization brings the opportunity of identifying the disease in very early symptomatic pre-dementia stages or even before symptoms appear, creating a window of opportunity for dementia prevention. The lack of positive results in the different clinical trials performed to date in patients with AD dementia has redirected the focus of therapeutic strategies towards preventing the development of dementia. For this reason, a detailed characterization of risk factors is of vital importance for identifying the persons who could benefit from a possible preventive strategy, as well as the optimal moment to carry out the intervention. A recent effort by the Lancet Commission on Dementia Prevention, Intervention, and Care reported the relative risk for incident dementia of the main modifiable risk factors (low education in early life; hypertension, obesity, and hearing loss in midlife; smoking, depression, physical inactivity, social isolation, and diabetes in late life). In addition, the Framingham Heart Study has shown that age, marital status, BMI, stroke, diabetes, ischemic attacks, and cancer are independent predictors of event risk in the final multivariate model and were used to construct a risk algorithm. These set of risk factors associated with an increased risk of incident dementia can be coupled with well-known genetic risk factors such as APOE genotype and with the presence of very mild symptoms, like self-perception of cognitive decline to create individual estimates of risk for dementia, taking also into account the presence of cognitive decline or impairment. The possibility of creating individual estimates of risk of dementia implies a personalised medicine approach and results in a change from the traditional diagnostic paradigm to a new one in which people at risk are attended in order to disclose risk factor estimates and offer them personalised solutions. This paradigm shift brings important consequences. On one hand, disclosing medical information may potentially generate emotional impact, psychological burden or harm. Although current experience with both disclosing APOE-e4 genetic status and amyloid status reveals that it is safe, one still needs to understand the potential risks and benefits of disclosing risk estimates for developing dementia. On the other hand, newly designed infrastructures that are focused in the assessment and follow-up of pre-dementia patients at high risk to develop dementia are needed, since they clearly represent a distinct population from the one attending dementia clinics. These "prevention infrastructures" would offer individual risk profiling accompanied by personalised risk reduction plans including, but not limited to, primary prevention advice and secondary prevention approaches (e.g. inclusion in prevention clinical trials). With the ultimate aim of assessing and understanding the value of these "dementia prevention infrastructures", several research questions need to be beforehand addressed such as the following: - Is disclosing risk factor estimates safe from the emotional and psychological point of view? - Is there any benefits derived from the personalised plans received by subjects? - Would the creation of Dementia Prevention Clinics be cost efficient? The BBRC-DevPrev-2018 study aims at answering the questions stated above.
Ageing is clearly the most important risk factor for AD and other dementias but, despite the amount of evidence supporting this fact, the exact mechanism that link ageing and AD is still unknown and, up to now, potential therapies for AD by targeting ageing have been poorly explored. This study aims to provide a better understanding of the link between ageing and AD by means of measuring in human blood those factors that have been found to be 'pro-youthful' (GDF-11, CSF2, TIMP-2, oxytocin) or 'pro-aging' (CCL2, CCL11, CCL19, Haptoglobine, B2-microglobuline) in experimental animal models, but have not been comprehensively studied in humans. In this proof-of-concept study these blood factors in extreme groups of age, namely young adults (18-25 yo) and old adults (≥70 yo) will be measured and the hypothesis of whether the 'pro-youthful' and 'pro-ageing' blood factors change throughout age tested. In order to include a wider range of age, human umbilical cord blood and plasma from teenagers (which is already available from a previous study) will also be included. The ultimate goal of this study is to select the more promising blood factors and obtain data on the effect size of the differences that may allow us in the future to design a larger study.
The main goal of the T1rho/BBRC2017 study is to assess the capability of the MRI sequences T1rho + multicomponent T2 relaxation analysis of detecting abnormal cerebral protein deposition in AD patients in comparison with an age-matched cognitively healthy control group. Both the AD and control groups will had previously undergone amyloid PET imaging to confirm/discard cerebral proteinopathy in the context of other research studies.
This study assesses the effect of adjusting the occlusal surface of a custom-made mouthguard on the degree of satisfaction with a mouthguard among water polo players. Twenty-four water polo players will wear a custom-made conventional mouthguard and a custom-made mouthguard with occlusal adjustment, two weeks per mouthguard. They will wear it during training sessions and for competing. The sequence will be randomized to obtain one-half of the participants starting the first week wearing the conventional mouthguard, and the other half wearing the mouthguard with occlusal adjustment. The participants will rate the degree of interference with oral functions or discomfort in reference to speech, breathing, swallowing, gag reflex, fits too tight, fits too loose, aesthetics and athletic performance, in a 10-point scale, considering 0 no discomfort/interference and 10 maximum discomfort/interference. After each session, players also rated the perception of protection, the degree of improvement on athletic performance and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.
The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter of iVascular. An expected total of 150 patients will be treated. Infrapopliteal lesions will be treated during this trial. The Paclitaxel eluting balloon Luminor-14 is designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation. The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure. The primary efficacy endpoint is defined as freedom from major adverse limb events, defined as above the ankle target limb amputations or major reintervention to the target lesions at 6 months. The primary safety endpoint is freedom from major adverse limb event at 30 days. The secondary endpoints consist of functional flow in target vessel, freedom from clinically driven target lesion revascularisation, above the ankle amputation free survival and limb salvage at 6 and 12 months, and also procedural success, wound healing status and wound healing time.
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.