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NCT ID: NCT06466031 Not yet recruiting - Clinical trials for Glioblastoma Multiforme

Application of MET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Glioblastoma multiforme (GBM IV WHO) is the most common, primary neoplasm of brain in the adults. Simultanously it is the most agressive one of all primary brain tumors. Despite the treatment the outcome in that group of patients is poor. In case of the optimal therapy the estimated median of survival ranges between 12 and 16 months. The present standard of treatment embraces the gross total resection with the preserved neurological functions and the posoperative management according to the Stupp's protocol (fractionated radiotherapy of 60 Gy dose and the chemotherapy with Temozolamide). Annually the incidence rate of GBM is 5/100.000 of population. According to the National Tumor Registry 2494 people went down to the malignant neoplasmatic disease of brain classified as C71 (ICD-10) in 2020. The evaluation indicates that it is 600 new patients with the diagnosis of GBM. The disease becomes the 9th cause of death among males and the 13th one among females. The peak of incidence appears in the 5th decade of life and concerns the most productive population. Routinely the management embraces the planning of the resection surgery based on the preoperative magnetic resonance investigation (MRI) with contrast. The common image of the tumor allows to put the preliminary diagnosis with the high probability rate. The GBM occurs as the enhanced tumor with the central necrosis and the circumferential brain edema visible in T2 and Flair sequences of MRI. Commonly the border of tumor becomes the line of contrast enhancement. The enhances area is the aim of surgical treatment. The lack of the preoperative enhanced area in the postoperative MRI is assumed as the gross total resection (GTR). It has been proved that the range of the resection translates into the overall survival (OS) and the progression free survival (PFS). Despite the resection classified as GTR the relapse in the operated area often occurs. It can be explained by the presence of the glioma stem cells in the surrounding neuronal tissue. They are responsible for the early relapse of GBM. Notably, it is evident that the MRI with contrast becomes the method which does not reveal the proper range of resection with the relevant sensitivity so as to extend PFS and OS. The positron emission tomography (PET) is one of the diagnostic methods having been clinically evaluated. PET assesses the metabolic demand of the neoplasm for the biochemical substrates. That methodology is commonly used in case of severity of the solid tumors. The fluorodeoxyglucose (18-FDG) is the most frequently used. However the high metabolism of glucose within the brain, particularly in the grey matter, 18-FDG has the limitation in the process of planning of the tumor resection. The higher specificity and sensitivity are elicited among the markers including aminoacids, praticularly 11-C methionine (11C-MET). Within the gliomas the higher uptake is observed than in the healthy brain. The range of the contrast enhancement in the MRI covers only 58% of the higher 11C-MET metabolism. Comparing these results with a tumor resection beyond the enhancement area, indicates the necessity of the precise assessment of the proposed method in the routine planning of the glioma resection. Current body of literature lacks in high quality research concerning that issue. The articles regarding the glioma resection beyond the GTR may be found instead. The surgery is limited to the resection of brain area with the incorrect signal in the FLAIR sequence, suspected of the presence of glioma stem cells. The described technique allows to extend PFS by for about 2 months. In that case the resection is based mainly on the FLAIR sequence which does not determine the presence of the neoplasm therein. The fusion of the MRI and the MET-PET images would allow to plan the resection so as to cover the area of incorrectly increased marker uptake.

NCT ID: NCT06460233 Recruiting - Obesity Clinical Trials

Blood Pressure Changes After Bariatric Surgery

Start date: September 21, 2021
Phase:
Study type: Observational

The aim of the study is to assess changes in blood pressure, cardiac function and selected laboratory measurements after bariatric surgery and to find most important factors associated with blood pressure reduction after weight loss. Description of the study Patients: consecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities, admitted for sleeve gastrectomy Methods: bedside and 24-hour blood pressure measurement, cardiac ultrasound and laboratory tests performed before surgery and at 1 week, 4 weeks, 6 months and 12 months after bariatric surgery

NCT ID: NCT06459765 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)

Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant. The main question it aims to answer is, whether the device is able to improve speech perception compared to the pre-operative score. Participants will undergo cochlear implantation and fitting, and will be asked to perform the following tests pre- and post-operatively: - Word test in quiet - Sentence test in noise - Audiograms - Health Utilities Index 2 and 3 (HUI2&3), a generic quality-of-life questionnaire - Nijmengen Cochlear Implant Questionnaire (NCIQ), a disease specific quality-of life questionnaire - Speech, Spatial and Qualities of Hearing Scale (SSQ12), a disease specific questionnaire - Hearing Implant Sound Quality Index (HISQUI19), a sound quality questionnaire

NCT ID: NCT06459050 Completed - Resistance Training Clinical Trials

Effects of Isometric Conditioning Activity on Subsequent Jumping Performance in Volleyball Players

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

The pairing of high-effort exercise, called conditioning activity, with a biomechanically similar high-velocity power movement is considered a valid method to effectively facilitate muscle power adaptations. Research has mainly focused on using this method in exercises performed by both limbs, even though sports tasks are often executed through motion sequences produced by a single limb alternately. However, available studies have focused solely on the dominant leg, leaving it unclear if the effectiveness is similar in both legs and how it transfers between them. Therefore, this study aims to evaluate the immediate effects of the isometric split squat exercise on single-leg drop jump performance in volleyball players, considering their training status.

NCT ID: NCT06458140 Recruiting - Syncope, Vasovagal Clinical Trials

Cardioneuroablation and Ventricular Proarrhythmia

Roman4
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

Cardioneuroablation (CNA) is a promising tool to treat patients with asystolic reflex syncope. CNA acts through complete or near complete abolition of vagal nerve chronotropic and dromotropic effects on the heart, resulting in sinus node acceleration and improved atrio-ventricular conduction, which in turn prevents vagally-mediated reflex asystole. However, lack of parasympathetic protection may potentially be proarrhythmic, especially on the ventricular level. Whether this is a real threat is not known. Therefore, the aim of our study is to assess acute effects of CNA-induced total vagal denervation, measured by extracardiac vagal stimulation, on ECG and electrophysiological parameters as well as vulnerability to ventricular arrhythmias. The study group will consist of 50 consecutive patients undergoing CNA in our institution. Cardioneuroablation will be performed in standard manner. The following parameters will be assessed at baseline and after CNA (directly after CNA, after atropine injected after CNA and after isoproterenol bolus injected at the very end of the procedure): QTc interval, QT dispersion, right ventricular action potential duration, right ventricular effective refractory period and susceptibility to complex ventricular arrhythmias using programmed ventricular stimulation.

NCT ID: NCT06455449 Not yet recruiting - Clinical trials for Polymyositis, Dermatomyositis

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

JASMINE
Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

NCT ID: NCT06452758 Not yet recruiting - Clinical trials for Endothelial Dysfunction

Relative Energy Deficiency in Rowers

Start date: June 20, 2024
Phase:
Study type: Observational

This study aims to learn about relative energy deficiency in male and female rowers at the end of the direct sport preparation phase of the annual training cycle. The main questions: - How will energy intake influence leptin, cortisol levels, mood, gut discomfort, and permeability? The observational study involves male and female rowers from the Polish rowing team. Participants will perform 2000 meter ergometer test and 6000 ergometer test in annual training cycle. Researchers will compare outcomes from both tests.

NCT ID: NCT06452277 Not yet recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

SOHO-02
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: - BAY 2927088 twice every day as a tablet by mouth, or - Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment. During the study, the doctors and their study team will: - take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer - check the overall health of the participants by performing tests such as blood and urine tests, and checking - heart health using an electrocardiogram (ECG) - perform pregnancy tests for women - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06451146 Recruiting - Safety Issues Clinical Trials

Lower Silesian Orbital Atherectomy Registry (LOAR)

LOAR
Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

The Lower Silesian Orbital Atherectomy Registry (LOAR), is an observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of the Orbital Atherectomy Device due to the presence of calcified lesion in coronary arteries. Data will be collected in two cooperating cardiac centers (Department of Cardiology, The Copper Health Center, Lubin, Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).

NCT ID: NCT06448767 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children

PROBAUT
Start date: June 2024
Phase: N/A
Study type: Interventional

In this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200, on the severity of autism symptoms and the quality of life in children with Autism Spectrum Disorder aged 7 to 15.