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NCT ID: NCT04935983 Recruiting - Energy Metabolism Clinical Trials

Maximal Fat Oxidation During Exercise

FatMaxx
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

It is well known that, even in quite homogenous populations, inter-individual variability in fat oxidation during exercise, in particular MFO, is quite large. Individual factors like gender, body composition (lean mass) and fitness level do explain a substantial part of this variation. In addition, genetic factors do underlie differences between individuals. But also 'external factors' like nutritional status, i.e. a low or high carbohydrate (CHO) availability, and exhaustion are likely linked to maximal fat oxidation, due to alterations in substrate availability. The contribution of these external factors to alterations in substrate utilization is, as of yet, unknown. This study aims to establish the impact of pre-exercise CHO availability and exhaustion on maximal fat oxidation (MFO & FATmax) during exercise

NCT ID: NCT04935788 Not yet recruiting - Sarcopenia Clinical Trials

Postprandial Amino Acid Response After Protein Consumption

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

Increasing muscle protein synthesis via protein-based nutrition, with or without exercise, maintains a strong, healthy muscle mass, which in turn leads to improved health, independence and functionality in older adults. There is increased interest in plant-based proteins, but these have in general a lower anabolic effect than animal proteins. Various strategies have been suggested to augment the anabolic properties of plant proteins, including using plant-animal protein blends. However, only little is known yet about the anabolic properties of such an approach. As the peripheral metabolic availability of proteins is an important aspect that has to be taken into account when screening the anabolic properties of protein sources/blends, it is the aim of this study to investigate the postprandial AA response of milk protein, micellar casein, pea protein, and a milk protein-pea protein blend in healthy older adults.

NCT ID: NCT04935359 Active, not recruiting - Clinical trials for Metastatic Pancreatic Ductal Adenocarcinoma

Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

NCT ID: NCT04935255 Completed - Testicular Cancer Clinical Trials

Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe

TANNED
Start date: August 11, 2021
Phase:
Study type: Observational

Rationale: In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of CYP3A4 activity. Etoposide is metabolised by CYP3A4. Objective: to investigate the absence of a clinical relevant interaction between aprepitant and etoposide in TC patients treated with (B)EP. Study design: A single centre, prospective, paired observational pharmacokinetic study in 12 patients with TC who are treated with etoposide during 5 days in combination with cisplatin with or without bleomycin conform the standard BEP or EP-protocol and who will be treated with aprepitant from day 3 until day 7 according to the routine antiemetic protocol. The effect of aprepitant on etoposide will be investigated within the same patient. In this study the patient will serve as its own control.

NCT ID: NCT04934670 Terminated - Clinical trials for Steroid-Refractory Acute Graft Versus Host Disease

A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)

2002
Start date: June 16, 2022
Phase: Phase 3
Study type: Interventional

This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.

NCT ID: NCT04934501 Completed - Clinical trials for Peripheral Arterial Disease

Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry

EchoPIV in SFA
Start date: August 8, 2018
Phase:
Study type: Observational

Peripheral arterial disease (PAD) in the lower extremity is the third leading cause of atherosclerotic cardiovascular morbidity. Endovascular treatment has become the principal surgical strategy in femoro-popliteal lesions. Stent placement induces significant changes in the arterial geometry and thereby in the hemodynamic environment. Visualization of local blood flow patterns (around stents) is challenging, but clinically relevant. Blood flow has a significant influence on the development of atherosclerosis and therefore stent patency. In vivo blood flow characterization might enable the recognition, prediction and explanation of (in-stent) restenosis. This study will therefore aim to investigate the feasibility of a novel ultrasound technique (echoPIV) to quantify spatiotemporal blood flow near stented femoral artery lesions. Furthermore, the blood flow information obtained during the echoPIV measurements will be used as patient-specific boundary conditions in a computational fluid dynamics (CFD) simulation. The tested hypothesis is that blood flow quantification using echoPIV is feasible in and around stents in the femoral artery and that it will improve CFD simulations.

NCT ID: NCT04933695 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment

CodeBreaK201
Start date: January 28, 2022
Phase: Phase 2
Study type: Interventional

The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation.

NCT ID: NCT04931862 Terminated - ALS Clinical Trials

Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)

FOCUS-C9
Start date: June 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of intrathecal (IT) WVE-004 in adult patients with C9orf72-associated ALS or FTD. To participate in the study, patients must have a documented mutation (GGGGCC [G4C2] repeat expansion) in the first intronic region of the C9orf72 gene and be diagnosed with ALS or FTD.

NCT ID: NCT04931771 Recruiting - Clinical trials for Coronary Artery Disease

Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization

FAST III
Start date: November 9, 2021
Phase: N/A
Study type: Interventional

The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization. Patients will be consented prior to the procedure and then followed up to 12 (+1) months after randomization. The primary endpoint is analyzed at 12 months after randomization. Approximately 35 sites in 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France).

NCT ID: NCT04931654 Recruiting - Gastric Cancer Clinical Trials

A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer

Start date: September 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.