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NCT ID: NCT05532566 Not yet recruiting - Allergic Reaction Clinical Trials

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

NCT ID: NCT05530395 Not yet recruiting - Clinical trials for Prostate Cancer Metastatic

BAseLine TEstosterone as a Prognostic and/or Predictive bioMARKer in mHSPC

Start date: January 1, 2023
Phase:
Study type: Observational

Despite large amounts of basic-science data supporting a role for androgens in PCa pathogenesis, there are conflicting clinical data on the role of endogenous testosterone in human de novo PCa pathogenesis. The investigators hypothesize that lower baseline serum testosterone is significantly associated with worse clinical outcomes in mHSPC patients undergoing continuous medical castration

NCT ID: NCT05527743 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

Effectiveness of an Invasive Physical Therapy Protocol in Carpal Tunnel Syndrome: Randomized Controlled Clinical Trial

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Carpal Tunnel Syndrome (CTS) is the most common peripheral neuropathy due to entrapment, caused by compression of the median nerve as it passes under the transverse carpal ligament at the wrist. The prevalence of CTS is between 5% and 20% in the general population, according to the criteria used. It stands at 10% when following the criteria established by the National Institute for Occupational Safety and Health. Within the prevalence, 1% are men and 7% women, with an incidence per year of 105 cases per 100,000 people. In 2019, the external consultant "statista" indicated that approximately 924,000 cases of CTS were registered in Spain. CTS generates large saturations in rehabilitation in primary care and in preoperative lists, for example, in 2008 there were 4,109 hospital admissions with a rate of 0.18 hospital discharges per thousand. Risk factors for the development of CTS include female sex, older age, diabetes, menopause, hypothyroidism, obesity and pregnancy. Smoking appears to be a risk factor in the development of CTS. As well as wrist hyperflexion and hyperextension movements. The number of risk factors present progressively increases the prevalence of CTS. CTS is characterized by the presence of neuropathic pain, nocturnal paresthesias and dysesthesia. It can be combined with loss of strength and atrophy of the tenar muscles. Therefore, the most severe cases produce very notable physical, psychological and economic consequences. For example, in the United States, CTS generates an annual primary care expenditure of $2 billion. Currently, the most recent clinical guidelines recommend the use of orthoses, exercises and manual therapy in the management of CTS, although there is no consensus on the most effective option. On the other hand, surgery is one of the most used therapeutic options. However, there is a great collapse of the health system and the waiting list for the intervention and it can take a long time. The conservative therapeutic options used to date focus on the local approach to CTS at the wrist, and a recent systematic review has shown a high rate of surgical need (around 60%) at 3-year follow-up. This need for surgery may be reduced in the long term to 15% if the conservative approach includes maneuvers focused on desensitization of the central nervous system, performing an approach to the entire upper extremity. Current evidence suggests that CTS is a complex disorder, which presents sensitization mechanisms of the nervous system, and not only a peripheral nerve compression at the carpal tunnel level. Therefore, approaches and therapies with a central effect are hypothesized to be of future interest, in accordance with current nociceptive theories of CTS. In the field of physiotherapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electrical current are applied through solid needles. Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of the descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization. Invasive electrolysis and neuromodulation techniques have been applied in other studies at the nerve level, especially in the sciatic nerve at the piriformis and hamstrings level, in the popliteal fossa and in the foot. However, there is no study performed in patients with CTS. To date, there is no clear consensus on the therapeutic approach to CTS, and the application of these invasive physiotherapy techniques is a novel approach that encompasses the local effect of treatment by means of local ultrasound-guided insertion of the needle in the carpal tunnel and the central neurophysiological effect produced by the current when it is applied. Taking into account the good empirical results found in private clinics and the precedents of studies carried out in other nerves, this treatment approach for outpatient application in primary care centers could relieve the demand for hospital care for patients referred for surgical treatment.

NCT ID: NCT05527340 Not yet recruiting - Multiple Myeloma Clinical Trials

Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

Start date: September 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, phase II, national, and open-label study to evaluate the efficacy and safety of two different combinations, iberdomide-dexamethasone (IBERDEX) and iberdomide-dexamethasone in combination with daratumumab (IBERDARADEX) in transplant ineligible newly diagnosed multiple myeloma (NDMM) patients. It will be ensured that at least 30% of the patients are frail in order to evaluate the feasibility of these combinations in this special population. Patients will receive treatment with either iberdomide + dexamethasone (IBERDEX) or iberdomide + daratumumab + dexamethasone (IBERDARADEX), until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study or death, whichever comes first. This is not a randomized trial so eligible patients will be sequentially allocated to receive iberdomide-dexamethasone or iberdomide-dexamethasone plus daratumumab.

NCT ID: NCT05526274 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Clinical Epidemiology of NAFLD in Children and Adolescents

LiverKids
Start date: October 2022
Phase:
Study type: Observational

Background: Non-alcoholic fatty liver disease (NAFLD) is rapidly increasing alongside overweight and obesity, not only in adults but also in children and adolescents. It is unknown what impact the development of NAFLD in childhood may have in later life. The importance of early detection and treatment lies in its potential for progression to cirrhosis, liver cancer and liver-related death, as well as its associated extrahepatic comorbidities. Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP) is an effective, non-invasive and safe diagnostic method to estimate the degree of fibrosis and steatosis in the liver, but little is known about its applicability in the paediatric population. Objectives: 1) To assess the prevalence of significant liver fibrosis (LSM≥6,5kPa) using VCTE, and that of non-alcoholic fatty liver disease (≥225dB/m) using CAP in children and adolescents. 2) To determine the optimal cut-off points of the CAP to achieve maximum concordance with the Magnetic Resonance Imaging (MRI) findings in the diagnosis of mild, moderate and severe NAFLD in children and adolescents. Methods: cross-sectional population-based study which will include 2.866 subjects aged ≥9 to ≤16 years. Participants will undergo: anamnesis, physical examination, blood extraction, VCTE, MRI and questionnaires on socio-demographic data, personal and family medical history and lifestyle assessment. Applicability and relevance: the study aims to establish the foundations for the use of VCTE in children and adolescents in order to achieve early diagnosis of NAFLD. Moreover, it will serve to understand in further detail the disease and to identify the risk groups of children and adolescents who may be at risk of developing it. Ultimately, this will help determine to which subgroups of the population we need to target resources for prevention and early detection of this entity, as well as possible intervention for its treatment.

NCT ID: NCT05498987 Not yet recruiting - Ultrasonography Clinical Trials

Ultrasound Achilles Tendon Assessment

Start date: May 14, 2023
Phase: N/A
Study type: Interventional

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

NCT ID: NCT05497661 Not yet recruiting - Ultrasonography Clinical Trials

Ultrasound Patellar Tendon Assessment

Start date: October 14, 2022
Phase: N/A
Study type: Interventional

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

NCT ID: NCT05489185 Not yet recruiting - Hip Fractures Clinical Trials

Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.

Start date: May 30, 2023
Phase: Phase 4
Study type: Interventional

Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality. Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis. It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.

NCT ID: NCT05485506 Not yet recruiting - Exercise Training Clinical Trials

Multimodal Exercises on Sprint Performance of Rugby Players

Start date: August 8, 2022
Phase: N/A
Study type: Interventional

This study is designed to evaluate the effects of a multimodal exercise program in the sprint performance and kinematics of adolescent rugby players. For this, an experimental study with an intervention group (IG) and a control group (CG) is designed. During 6 weeks of the 2022-2023 preseason of rugby seven, IG will include a multimodal exercise program in their training routine. Meanwhile, CG will maintain their training routine. The study will be developed in the Sport High Performance Centre of Balearic Islands during the season of rugby seven (from August to September, 2022). All rugby athletes from under-16 and under-18 autonomic rugby teams will be invited to participate in this study throughout an email invitation from their regional rugby federation. Prior to the beginning of the study, all participants will sign the inform consent, or their legal tutors in case of minors. The Ethical Committee of the local university approved this study (278CER22) according to the Declaration of Helsinki. One week before intervention period, sociodemographic and sportive data will be registered (age, sex, body mass, height, and sport experience). Body mass and height will be evaluated with a ±100-g precision digital weight scale (Tefal, France) and a t201-t4 adult height scale (Asimed, Spain), respectively. Also, the rugby players will complete a familiarization process consisting on a standardized warm up and 3 progressive sprints (i.e. 30 m at 50%, 70% and 90% of maximal effort). All testing procedure (pre-test and post-test) will be completed at a similar daytime (between 17h and 19h) on the same natural grass field. The test procedure listed in our study will consist on two maximal 30-m sprints to obtain mechanical variables of horizontal force-velocity profile and kinematics during sprinting. Players from IG will perform a multimodal exercise program two days per week during six weeks. This program will include running technical drills, exercises for lumbopelvic stabilization and resisted sprints. This program will be supervised by two experts in this field. The investigators hypothesize that those rugby players who add the multimodal exercise program to their training routine will increase mechanical and kinematics variables of sprint performance.

NCT ID: NCT05477953 Not yet recruiting - Chagas Disease Clinical Trials

An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health

Start date: June 30, 2024
Phase:
Study type: Observational

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: - Birth defects (abnormal and problematic structures or functions, a child is born with) - Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) - Certain health problems of the child up to 12 months of age - Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.