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NCT ID: NCT05499546 Completed - Polyp of Colon Clinical Trials

Virtual Scale Function SCALE EYE: Variability and Systematic Differences

SCALE-EYE
Start date: October 11, 2022
Phase: N/A
Study type: Interventional

Size of colorectal polyps is important to decide on appropriate surveillance intervals and treatment modality, as well as carrying out optical diagnosis strategies. However, polyp size measurement is often prone to inter-observer variability. An easy and accurate tool to assist in polyp size measurement is required. Recently, a virtual scale function for size measurement during endoscopy (SCALE EYE), operating in real-time without the use of any additional devices, has been developed. The aim of this study is to assess whether use of the SCALE EYE for polyp size measurement can reduce inter-observer variability.

NCT ID: NCT05498051 Completed - Clinical trials for Colorectal Neoplasms

Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.

IBIZA-1
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using peritumoral submucosal injections

NCT ID: NCT05497726 Completed - Clinical trials for Colorectal Neoplasms

Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Intravenous Bevacizumab-800CW

IBIZA-2
Start date: January 27, 2023
Phase: N/A
Study type: Interventional

This prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using intravenous administration.

NCT ID: NCT05491785 Completed - Pain Clinical Trials

Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain.

Start date: July 29, 2022
Phase: Phase 1
Study type: Interventional

Opioids are potent painkillers but come with serious adverse effects ranging from addiction to potentially lethal respiratory depression via activation of μ-opioid receptors (MOP) at specific sites in the central nervous system. Cebranopadol is a first-in-class investigational drug to treat patients with acute and chronic pain. The molecule dually activates the Nociceptin/Orphanin FQ peptide (NOP) receptor and the classical MOP receptor. This is a unique mechanism of action and has demonstrated efficacy in multiple Phase 2 and Phase 3 clinical studies across several nociceptive and neuropathic indications as well as a superior safety profile, low potential for abuse and minimal risk of physical dependence. In animal studies, cebranopadol produced considerably less respiratory depression at comparably analgesic doses of oxycodone and fentanyl and appeared to have a ceiling to its respiratory effects. Preliminary clinical trials have suggested that these results will be similar in humans. The present study is designed to investigate if: 1) cebranopadol produces less respiratory depression than oxycodone 2) cebranopadol respiratory effects have a ceiling at very high doses and 3) cebranopadol does not produce significant respiratory depression, as measured in this study design with 30 subjects, at any dose in the VRH model.

NCT ID: NCT05491239 Completed - Lung Cancer Clinical Trials

Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Adequate pain control after video-assisted thoracoscopic surgery (VATS) for lung resection is important to improve postoperative mobilisation, recovery, and to prevent pulmonary complications. So far, no consensus exists on optimal postoperative pain management after VATS anatomic lung resection. Thoracic epidural analgesia (TEA) is the reference standard for postoperative pain management following VATS. Although the analgesic effect of TEA is clear, it is associated with patient immobilisation, bladder dysfunction and hypotension which may result in delayed recovery and longer hospitalisation. These disadvantages of TEA initiated the development of unilateral regional techniques for pain management. The most frequently used techniques are continuous paravertebral block (PVB) and single-shot intercostal nerve block (ICNB). The investigators hypothesize that using either PVB or ICNB is non-inferior to TEA regarding postoperative pain and superior regarding quality of recovery (QoR). Signifying faster postoperative mobilisation, reduced morbidity and shorter hospitalisation, these techniques may therefore reduce health care costs and improve patient satisfaction.

NCT ID: NCT05489406 Completed - Hiv Clinical Trials

Relative Bioavailability Study to Investigate a Potential Interaction Between DTG DT and F/TAF TOS.

UNIVERSALRBA
Start date: October 6, 2022
Phase: Phase 1
Study type: Interventional

This relative bioavailability (RBA) study will be conducted to investigate whether there is a potential pharmacokinetic effect when paediatric DTG and F/TAF are taken together as dispersible formulations. This study will be performed in healthy volunteers instead of HIV-infected patients.

NCT ID: NCT05489341 Completed - Prostate Cancer Clinical Trials

Artificial Intelligence and Radiologists at Prostate Cancer Detection in MRI: The PI-CAI Challenge

Start date: February 1, 2022
Phase:
Study type: Observational

The PI-CAI challenge aims to validate the diagnostic performance of artificial intelligence (AI) and radiologists at clinically significant prostate cancer (csPCa) detection/diagnosis in MRI, with respect to histopathology and follow-up (≥ 3 years) as reference. The study hypothesizes that state-of-the-art AI algorithms, trained using thousands of patient exams, are non-inferior to radiologists reading bpMRI. As secondary end-points, it investigates the optimal AI model for csPCa detection/diagnosis, and the effects of dynamic contrast-enhanced imaging and reader experience on diagnostic accuracy and inter-reader variability.

NCT ID: NCT05483179 Completed - Colorectal Cancer Clinical Trials

Association Between New Effort-independent Cardiopulmonary Exercise Test Variables and Postoperative Complications After Elective Colorectal Surgery

Start date: April 15, 2022
Phase:
Study type: Observational

A cardiopulmonary exercise test (CPET) is increasingly used for preoperative risk assessment. Oxygen uptake (VO2) at peak exercise (VO2peak) and VO2 at the ventilatory anaerobic threshold (VO2VAT) are the most commonly used preoperative CPET variables that are associated with postoperative outcomes following colorectal cancer surgery. The aim of this study is to investigate the association between two relatively new preoperative submaximal and effort-independent CPET variables, the cardiopulmonary optimal point (COP) and the Oxyen uptake efficiency plateau (OUEP) and postoperative outcomes in colorectal cancer surgery. In additiion, the association between the oxygen uptake at the COP en OUEP and postoperative outcomes wil be explored.

NCT ID: NCT05481216 Completed - COVID-19 Clinical Trials

HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV

HIV CoCo
Start date: March 29, 2022
Phase:
Study type: Observational

HIV CoCo is a European multi-centre, multi-country, retrospective, observational case-control study that will aim to describe clinical outcomes and identify risk factors for People Living With HIV (PLWHIV) who are co-infected with the SARS-CoV-2 coronavirus. The study will address two central questions: 1. Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases? 2. Are there particular factors, within the group of PLWHIV, which put them at risk for a more severe COVID-19 disease course? The study will address these questions by recruiting patients co-infected with both HIV and SARS-CoV-2 and comparing them to two control groups - one group infected with SARS-CoV-2 only and another group infected with HIV only. Only deidentified, real-world retrospective data will be used for the study, collected as part of standard, routine clinical care. Additionally, this study will also look to: 1. Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls 2. Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy 3. Describe the co-morbidities in PLWHIV and controls with COVID-19 4. Compare the severity of COVID-19 between PLWHIV and the COVID-19 only controls at diagnosis and hospital admission. Data will be collected about patient outcomes from COVID-19 (including hospitalisation for COVID-19, length of stay in hospital, critical care admission, ventilation/oxygenation requirements, and need for kidney replacement therapy), as well as pre-existing health conditions, and relevant blood results at COVID-19 diagnosis.

NCT ID: NCT05479916 Completed - Clinical trials for Protein Digestion & Absorption

The Impact of Milk Protein Glycation on Protein Digestion and Absorption

VerLys
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

Rationale: Protein intake is an essential stimulus for muscle protein anabolism. The muscle protein synthetic response to protein ingestion is mainly determined by the post-prandial plasma amino acid response. Milk protein often undergoes glycation during commonly applied milk processing procedures (Maillard reaction). We have previously shown that glycated protein results in lower postprandial amino acid levels. The level of protein glycation in processed dairy products might therefore be an important modulator of the overall protein quality of a product, and its ability to stimulate protein metabolism. However, it has not yet been investigated if the glycation level of dietary protein modulates its appearance in plasma as amino acids. Objective: To compare the appearance of dietary protein-derived amino acids in plasma after ingestion of a milk protein powder with different levels of protein glycation in healthy young men. Study design: Double blinded, randomized cross-over study. Study population: 15 healthy young males, aged 18-35 years. Intervention (if applicable): All subjects will perform two experiments in a double-blinded, randomized order: ingest 40 g of milk protein with 5% glycation level in 600 mL water, or 40 g of milk protein with 50% glycation level in 600 mL water. After ingestion, blood samples will be taken at regular intervals during a 6 hour period. Main study parameters/endpoints: The primary endpoint will be the appearance of milk protein-derived amino acids in plasma over the full assessment period (6 h), as determined using stable isotope tracer methodology.