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NCT ID: NCT06375967 Not yet recruiting - Clinical trials for Biliary Tract Neoplasms

EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

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

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.

NCT ID: NCT06375954 Not yet recruiting - Pancreatic Cancer Clinical Trials

EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

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

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.

NCT ID: NCT06375928 Not yet recruiting - Clinical trials for Biliary Tract Neoplasms

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

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

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.

NCT ID: NCT06374875 Not yet recruiting - Obesity Clinical Trials

Fibrosis Lessens After Metabolic Surgery

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

Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment. Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.

NCT ID: NCT06374394 Not yet recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above

Start date: April 29, 2024
Phase: Phase 3
Study type: Interventional

This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.

NCT ID: NCT06369753 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome

Visible Abdominal Distension

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

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers. Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

NCT ID: NCT06367790 Not yet recruiting - Basketball Players Clinical Trials

Plyometry and Tapping in the Functional Improvement of Non-professional Basketball Players

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Introduction. In basketball, the lower extremities have the highest prevalence of injury, regardless of gender and professional category. Objective. To analyse the efficacy of a physiotherapy intervention using a protocol of plyometric exercises and dry needling in non-professional basketball athletes. Methods. Randomised clinical study. 20 players will be randomised to an experimental group (plyometric exercises and dry needling of the gastrocnemius muscles) and a control group (plyometric exercises). The intervention will include 8 sessions over 4 weeks. The study variables will be: range of motion in dorsal flexion in loading (Leg Motion®) and unloading (goniometer) and vertical jump (MyJump2®). Expected results. An intervention of plyometric exercises and dry needling produces significant differences in range of motion and vertical jump in basketball players, compared to the isolated administration of plyometric exercises.

NCT ID: NCT06365853 Not yet recruiting - Clinical trials for Recurrent Ovarian Cancer

A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer [PSOC] or platinum-resistant ovarian cancer [PROC]) with high folate receptor alpha (FRĪ±) expression.

NCT ID: NCT06365320 Not yet recruiting - Metabolomics Clinical Trials

Association Between Training Load and Lactate and Other Metabolites Analyzed by Metabolomic and Proteomic Techniques

PROTEOMET
Start date: April 2024
Phase: N/A
Study type: Interventional

Physical exercise induces numerous changes in the body in a complex signalling network caused by or in response to increased metabolic activity of contracting skeletal muscles. The application of omics analytical techniques such as proteomics and metabolomics in the field of sport allows us to understand how the human body responds to exercise and how sports results can be improved by optimising nutrition and training. Both omics techniques offer a quantitative measurement of the metabolic profiles associated with exercise and are able to identify metabolic signatures of athletes from different sports disciplines. Basketball is a high-intensity exercise modality interspersed with low-intensity. The performance requirements of basketball include aerobic and anaerobic metabolism, with anaerobic metabolism being considered the main energy system. Therefore, basketball players need great athletic ability to produce a successful performance during competition. For optimal sports performance it is important to adjust the training load, i.e. the degree of effort that the player can withstand in a single training session. Coaches require effective and objective load monitoring tools that allow them to make decisions about training plans based on the needs of each player. Microsampling systems emerge as an alternative to venipuncture by facilitating self-sampling, which can be carried out outside healthcare centres, in a comfortable and precise way from a small finger prick that the user can perform. These systems are less expensive and can be effective in measuring the levels of glucose metabolism products, such as lactate, through the application of metabolomics and proteomics. On the other hand, the use of non-invasive methods of measuring lactate levels is becoming increasingly popular in sports medicine. The use of saliva as an alternative fluid to the blood shows promise for identifying the concentrations of metabolites that occur during and after sports training.

NCT ID: NCT06364982 Not yet recruiting - Peri-Implantitis Clinical Trials

Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease.

Start date: April 5, 2024
Phase:
Study type: Observational

The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances.