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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: 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: NCT06299618 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism

ENIGMA-I
Start date: April 2024
Phase:
Study type: Observational

The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.

NCT ID: NCT06280885 Not yet recruiting - Cancer Clinical Trials

A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy

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

The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment.

NCT ID: NCT06232707 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

ALUMMINATE
Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT06200519 Not yet recruiting - Clinical trials for Gestational Diabetes

Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography

DiFuSE
Start date: January 2024
Phase:
Study type: Observational

The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function. The main question it aims to answer are: - What are the normal reference ranges for parameters of diastolic cardiac function in neonates? - How are these influenced by maternal, intrapartum and neonatal factors? - Do the diastolic changes noted during the first two days of life persist into infancy? Participants will have four echocardiographic assessments in total: - Two during the first 48 hours of life (prior to discharge home) - Two during infancy (as an outpatient)

NCT ID: NCT06149546 Not yet recruiting - Pancreatic Cancer Clinical Trials

Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)

FEED
Start date: January 2024
Phase: N/A
Study type: Interventional

The study will examine if a multi-modal nutritional care package, with or without resistance training delivered with neoadjuvant chemotherapy, is effective at preventing loss of muscle strength during neoadjuvant chemotherapy for pancreatic cancer. There are two arms in this study: Control Arm will receive standard dietetic care and be prescribed standard pancreatic enzyme replacement therapy and oral nutritional supplement drinks with their neoadjuvant chemotherapy. The intervention Arm will have 3 additional dietitian visits and 6 physiotherapist visits that the control group will not.

NCT ID: NCT06115629 Not yet recruiting - Gastric Cancer Clinical Trials

Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial

SARONG-II
Start date: November 2023
Phase: Phase 3
Study type: Interventional

Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most patients with cancer of the oesophagus and stomach are treated with surgery with or without additional chemotherapy or radiotherapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection. Despite these improvements, in around half of patients treated with surgery, the cancer will return, usually within the first three years. At present there is very little evidence as to how patients who have been treated for cancer of the oesophagus or stomach should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery. The SARONG-II study will investigate if regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive imaging surveillance (including regular radiological scans and a camera test (endoscopy)) or clinical follow-up. The study aims to recruit at least 952 participants in Europe over a 32-month period. Patients undergoing surgery for oesophageal or stomach cancer will be invited to participate in the study at around 4 to 8 weeks after their surgery. (i) The imaging surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months after randomisation. They will also receive endoscopy at 12 months after randomisation (ii) The clinical surveillance group will receive a review in clinic or by telephone at 6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year according to local practice The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with oesophagus or stomach cancer. The investigators anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for oesophagus and stomach cancer.

NCT ID: NCT06095648 Not yet recruiting - Thrombocytopenia Clinical Trials

Study Comparing Platelet Transfusion Volumes in Premature Babies

PlaNeT-3
Start date: October 28, 2023
Phase: N/A
Study type: Interventional

Platelet transfusions can help clotting but may also have risks. Currently when babies get platelet transfusions they get as much as three times (per kilogram of body weight) as much as adults do. The goal of this clinical trial is to to find out which volume of platelets should be transfused to premature babies with low platelets and no bleeding. The main question it aims to answer is if a smaller volume for platelet transfusion can help prevent death and severe bleeding and also have fewer side effects for the baby. Participants will be placed at random into one of two groups: In Group 1, babies will get a platelet transfusion based on the volume of 5mls/kg weight, in Group 2, babies will get a platelet transfusion based on the volume of 15mls/kg weight. Babies will remain in their allocated group during their stay on the neonatal unit so that they always receive the allocated volume unless a clinician decides otherwise.

NCT ID: NCT06093178 Not yet recruiting - Life Style, Healthy Clinical Trials

Assessing the Feasibility of a Coach-led Digital Platform

Connect5
Start date: May 1, 2024
Phase:
Study type: Observational

This research is taking place to find out if a smartphone app plus a health coach can support citizens of Athy, Co. Kildare Ireland to make healthy changes in your lifestyle - small changes for better health. This is the first study of its kind in Ireland; Athy is the first town to take part. Connect5 Athy smartphone app will have a health coach who will advise and support participants make new healthy lifestyle habits linked to sleep, managing stress, increasing physical activity, support healthy eating, cultivate positive local relationships, and help to avoid risky substances like tobacco and alcohol. This is a 6-month observational study that will be conducted between May and October 2024.