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NCT ID: NCT05900609 Active, not recruiting - Clinical trials for Microbial Colonization

Gut Health Enhancement by Eating Favourable Food

GEEFomjebuik
Start date: May 22, 2023
Phase: N/A
Study type: Interventional

Within the GEEF om je buik study the effect of 8 weeks intervention with either a diet rich in fiber or fermented food on the gut microbiota will be investigated.

NCT ID: NCT05896982 Active, not recruiting - Clinical trials for Myocardial Infarction

Optimizing Patient Experience During Myocardial Perfusion Imaging

OPTIMIZE
Start date: November 2, 2022
Phase: N/A
Study type: Interventional

The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI). The diagnostic procedure consists of two days of MPI using SPECT: day 1 of MPI involves obtaining a resting image and day 2 (typically 3 or 4 days later) a stress MPI following exercise or pharmacological challenge with adenosine. The diagnostic procedure can result in undesirable effects on psychological wellbeing, such as anxiety or psychological distress. These effects can be related to anticipatory anxiety (day 1 of MPI) and/or responses to the exercise or adenosine stress testing (day 2 of MPI). The present investigation aims to develop methods to further improve patients' experiences and wellbeing during the diagnostic process for the presence of inducible myocardial ischemia. This research project will compare four groups to establish the effect of providing information and supportive coaching: (1) care as usual, (2) information support using video materials, (3) supportive coaching during the diagnostic testing procedure, and (4) a combination of both interventions. The video-based information and supportive coaching are aimed at reducing feelings of anxiety, uncertainty and psychological distress during the diagnostic testing procedure. In addition to standardized self-report questionnaires, this project will utilize facial expression analysis software to measure emotional states during CST as well as 24- hour ambulatory assessments to evaluate autonomic nervous system activity, cardiac symptoms and psychological wellbeing during everyday life activities in the period between the two days of MPI. It is hypothesized that additional video-based information and supportive coaching during the diagnostic process for the inducibility of myocardial ischemia will result in improved psychological wellbeing (reduced acute negative emotions; primary outcome) as well as less cardiac and other physical symptoms and improved patient satisfaction (secondary outcomes) of the diagnostic clinic visit. The innovative aspect of the present proposal is its focus on emotional expression during evaluation for myocardial ischemia using FaceReader software in combination with self-reported momentary mood and perceived stress assessments. Knowledge about the interaction between psychological wellbeing and cardiac function obtained in this project will strengthen the development of future interventions aimed to reduce symptom burden and psychological distress in patients undergoing diagnostic evaluations for heart disease.

NCT ID: NCT05891067 Active, not recruiting - Child Behavior Clinical Trials

The Effectiveness of a Classroom-based Intervention Promoting a Prosocial Classroom Climate in Children

Start date: May 11, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether a classroom-based program promoting a prosocial classroom climate is more effective than treatment-as-usual (control condition).

NCT ID: NCT05886387 Active, not recruiting - Surgery Clinical Trials

a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

Start date: September 22, 2022
Phase:
Study type: Observational

The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.

NCT ID: NCT05871515 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

3D Ultrasound of Abdominal Aortic Aneurysm Characteristics

3D US - EVAR
Start date: December 27, 2022
Phase:
Study type: Observational

AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. This enables 3D visualization of the AAA and its thrombus without the need for harmful radiation and nephrotoxic contrast agents, as opposed to CTA. In in vitro measurements, 3D US has already been shown to have clinically acceptable error rate with AAA diameter and volume measurement. However, it is unclear whether this is also applicable to in vivo measurements. Therefore, the aim of this prospective study is to compare preoperative 3D US AAA characteristics as measured by 3D US with contrast enhancement (3D CEUS), 3D US without contrast enhancement (3D non-CEUS) and CTA.

NCT ID: NCT05869669 Active, not recruiting - Clinical trials for Dementia With Lewy Bodies

RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies

Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether neflamapimod can improve learning skills, problem solving skills, and memory loss in people diagnosed with DLB. More specifically, improvement in verbal learning, memory, and attention, as well as cognitive and functional performance will be measured.

NCT ID: NCT05849922 Active, not recruiting - Clinical trials for Hidradenitis Suppurativa

A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa

HS OBTAIN
Start date: June 6, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.

NCT ID: NCT05845814 Active, not recruiting - Clinical trials for Metastatic Urothelial Carcinoma

A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)

Start date: June 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study.

NCT ID: NCT05845632 Active, not recruiting - Skin Cancer Clinical Trials

Time to Treatment and Disease-free Survival of Patients With High-risk Head-neck Cutaneous Squamous Cell Carcinoma

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

The purpose of this study is to investigate the association between time to treatment (defined as date of pathological diagnosis to date of start treatment) and disease free survival in patients with high risk cutaneous squamous cell carcinoma in the head-neck region.

NCT ID: NCT05836623 Active, not recruiting - Clinical trials for Advanced and/or Metastatic Solid Tumours

A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions

Start date: December 20, 2022
Phase: Phase 1
Study type: Interventional

CB307 is a trispecific Humabody® targeting CD137; PSMA; and human serum albumin (HSA) undergoing Phase 1 assessment in patients with PSMA+ solid tumours. This sub study will assess the biodistribution of radiolabelled CB307 in patients with advanced and/or metastatic solid tumours that are PSMA+.