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NCT ID: NCT06381648 Recruiting - Cholangiocarcinoma Clinical Trials

Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)

LyMIC
Start date: April 15, 2023
Phase:
Study type: Observational

Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC. This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients.

NCT ID: NCT06391970 Recruiting - COVID-19, Long Haul Clinical Trials

Digital Cognition Study During Long-COVID

DIGICOG
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

The persistence of the COVID-19 disease symptoms, such as extreme fatigue, shortness of breath, cardiovascular complications, depression and anxiety, pain, brain fog, loss of taste/smell, headaches as well as loss of memory has been evoked in many studies. This project aims at approaching the persistent symptomatology on cognition, more than 1 year after the infection. When we refer to cognition, we refer to everything associated with knowledge, that is, the accumulation of information we have acquired through learning or from our experience. We can define cognitive processes as the processes we use to incorporate new knowledge and make decisions based on it. Through these processes several cognitive functions intervene: perception, attention, memory, reasoning, language, learning, decision-making. All of these cognitive functions work together to integrate knowledge as a whole and create an interpretation of the world around us. Usually neuropsychological tests are used to evaluate cognitive problems, they consist in different exercises sometimes with words, figures to draw, images to remember, movement to repeat, numbers to link together etc. The DigiCog project here propose 1. to test and validate a very novel device, which uses the eyes movement during tasks to evaluate very quickly the cognitive functioning; 2. to study potential cognitive problems long-term after COVID-19; and 3. to explore how cognition could be preserved. Finally, this project will also help to bring the innovative device tested to the market, for accurately monitoring people with long COVID.

NCT ID: NCT06425354 Recruiting - Mechanical Power Clinical Trials

Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study

Start date: April 15, 2023
Phase:
Study type: Observational

The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage. The main questions it aims to answer are: 1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation? 2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power >17 J/min compared to <17 J/min? Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP <17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.

NCT ID: NCT04816006 Recruiting - Breast Cancer Clinical Trials

Breast Cancer, Reasoning, and Activity Intervention

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

This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.

NCT ID: NCT05617833 Recruiting - Clinical trials for Intraventricular Hemorrhage of Prematurity

Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage

SCEMPI
Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious are severe intraventricular hemorrhage (sIVH) and the subsequent progression to posthemorrhagic hydrocephalus (PHH). Currently, the only treatment for PHH is surgery, most commonly with shunts that are prone to malfunction across the lifespan. Preclinical data show that melatonin (MLT) and erythropoietin (EPO), when administered in a sustained dosing regimen, can prevent the hallmarks of progression from early postnatal sIVH to subsequent PHH. The investigators will perform a Phase I, single institution, randomized, double-blind trial for very preterm infants with sIVH to define a safe combination dose of MLT and EPO. A maximum of 60 very preterm neonates with sIVH will be enrolled, treated through 33w6/7d, and followed to 37w6/7d. Neonates will be randomized 3:1 between MLT+EPO and placebo, with all receiving standard of care. The primary endpoint is a composite serious adverse event (SAE)/dose limiting toxicity (DLT). The investigators hypothesize that the MLT+EPO SAE/DLT rate will not be higher than the placebo rate. Secondary outcomes will be rate of co-morbidities of preterm birth. Exploratory data, collected to guide design of future clinical trials for efficacy, will include serial neuro-imaging metrics acquired from clinical images, serial neonatal neurodevelopmental examinations, serum and urine MLT and EPO levels, and liquid biomarkers. Successful implementation of this initial safety trial will provide essential data to guide the next stage of clinical trials to test if sustained MLT+EPO treatment can reduce the need for surgical intervention, and avoid the lifelong burden of shunted hydrocephalus.

NCT ID: NCT05768087 Recruiting - Glioblastoma Clinical Trials

Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients

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

The goal of this phase 1 dose finding study is to to assess the clinical tolerability and safety of escalated dose proton therapy in glioblastoma patients treated with multimodality treatment, according to treatment volume. The main questions it aims to answer are: - what is the maximum tolerated proton dose in glioblastoma patients? - is the maximum tolerated proton dose in glioblastoma patients dependent on treatment volume? - what is the recommended phase 2 proton dose in glioblastoma patients? Patients will be asked to undergo radiotherapy to step-wise escalated doses using proton therapy as part of their multimodality treatment. Patients will be monitored closely for treatment effects.

NCT ID: NCT05776914 Recruiting - Clinical trials for Irritable Bowel Syndrome

Fecal Microbiota Transplantation for IBS

Start date: April 15, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with post-infection irritable bowel syndrome (PI-IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

NCT ID: NCT05804266 Recruiting - Clinical trials for Gastrointestinal Diseases

A Randomized Comparison of UnderwateR Versus Regular Coagulation in Endoscopic Submucosal DissectioN and Third Space Endoscopy

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

What the investigatorpropose in this protocol is a technique already used in clinical practice. It prevents the risk of bleeding and make third space endoscopy easier, quicker, safer and cheaper. Indeed, we noticed that preventive underwater coagulation of the candidate vessels during the submucosal dissection with the Hybrid Knife (HK), seal the wall of the vessel, resulting in a subsequent cut under CO2 without any bleeding. Such preventive coagulation is likely to be related with the conduction of the current underwater as it focalizes all the power on the interface between the vessel and the water, allowing a soft sealing of the vessel without cutting it. Despite widely used, there is no evidence up to know on the benefit and harm of such coagulation technique. The hypothesis is that the use of this approach in clinical practice, especially when used to coagulate a vessel, may lead to an increase in safety, feasibility and cost-effectiveness, reducing the procedural time, the rate of complications and the need for coagulation forceps in comparison with the conventional preventive coagulation technique under CO2 insufflation. Therefore, this randomized study compares the underwater coagulation technique with the conventional coagulation technique in the CO2 setting during the submucosal dissection in third space endoscopy.

NCT ID: NCT05805397 Recruiting - Schizophrenia Clinical Trials

Effectiveness of Motivation Skills Training (MST)

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

This study will take place at four outpatient clinics serving adults with serious mental illness. Informed consent will be obtained from N=80 individuals with a Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 diagnosis of schizophrenia or schizoaffective disorder meeting inclusion/exclusion criteria to participate in a randomized controlled trial comparing Motivation Skills Training (MST) to a Healthy Behaviors Control (HBC) group. Eligible participants will receive a baseline assessment including sociodemographic and psychosocial assessments, measures of motivation, goal attainment, and quality of life, as well as measures of executive skills, community functioning, and psychiatric symptoms severity. Both MST and HBC will be implemented as once weekly group therapies. The treatment phase is approximately 12-14 weeks. MST will focus on motivation knowledge and self-regulation skills while HBC will focus on physical health and health-related skills.

NCT ID: NCT05814913 Recruiting - Psychosis Clinical Trials

Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting

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

Primary Aims: To determine the clinical efficacy of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) compared to Treatment As Usual (TAU) on reducing overall symptoms of psychosis in patients with First Episode Psychosis (FEP) in Pakistan. Secondary Aims: 1. To determine the efficacy of CaCBT and CulFI compared to TAU on positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, general functioning, and insight in patients with FEP in Pakistan. 2. To determine the efficacy of CaCBT and CulFI compared to TAU on improving carer experience, carer wellbeing, carer illness attitudes and symptoms of depression and anxiety in family and carers of patients with FEP in Pakistan. 3. To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan. 4. To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings 5. To explore delivery and reach of each intervention, tolerability of intervention components, acceptability of interventions, understanding mechanism of change and developing an understanding of barriers and facilitators to future adoption using process evaluation. Study design and setting: This will be a multi-centre, assessor masked, individual, three-arm randomised controlled trial (RCT). Sample Size: The study aims to recruit a total of N=390 participants with FEP