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NCT ID: NCT05666141 Recruiting - Dysphagia Clinical Trials

The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition

PES
Start date: June 7, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to clarify which biomechanical aspects of swallowing are altered by Pharyngeal Electrical Stimulation (PES) in stroke patients and healthy volunteers. The peripheral effect of PES intervention on the biomechanics of swallowing will be evaluated with High Resolution Manometry Impedance (HRMI).

NCT ID: NCT05665400 Recruiting - Fetal Monitoring Clinical Trials

A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

Start date: July 13, 2022
Phase: N/A
Study type: Interventional

Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes. In this study, Bloomlife Lovelace FT is used to collect the dataset needed for the development of a future product (Bloomlife Lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.

NCT ID: NCT05660967 Recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

EPCORE DLBCL-3
Start date: March 6, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

NCT ID: NCT05660330 Recruiting - Well-being at Work Clinical Trials

Well-being at Work: Research Into Happiness at Work

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Organizations are becoming increasingly aware that employees are an important factor in gaining and maintaining competitive advantage. Based on the current evidence, a holistic approach, in which different well-being factors and different levels are addressed simultaneously, is needed. However, given the scarcity of this approach in studies, a significant gap in knowledge is demonstrated. This paper tries to address these shortcomings. A partially randomised preference trials design is used to evaluate the impact of an intervention package that focusses on both the individual and organizational level and addresses 3 different domains to improve well-being: psychosocial, ergonomic and lifestyle. The data collection of the research outcomes will be conducted at several points in time. Therefore, a online self-administered questionnaire is developed en will be administered before the start of the intervention. Six and twelve months after the intervention, the short and long term impact of the intervention will be measured. The intervention itself consists of a basic intervention package that will be spread over 3 different days that take place over a time period of maximum 2 weeks. Between 20 and 30 companies will be recruited from a data pool with clients from the Flemish side of Belgium. The sample size of the participating employees should be at least 2000. A stratified random sampling method will be used based on sector type while company size (small-medium-large) will be taken into account

NCT ID: NCT05660317 Recruiting - Colorectal Polyp Clinical Trials

Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects

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

Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer related death with approximately 880 792 deaths every year (9,2% of the global yearly 9.6 million cancer deaths). Screening for polyps is done by colonoscopy, which is considered the gold standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly. Endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness, and safety in comparison to surgery. Endoscopic tip control is a fundamental component of high quality endoscopy. Endoscopic procedures are complex processes where cognitive processing and motoric output need to be perfectly aligned. This is reflected in endoscopic tip control. It is indispensable in every step of endoscopy: during insertion of the endoscope, where the tip of the endoscope needs to reach the caecum/terminal ileum/duodenum, without discomfort for the patient if under light sedation, during withdrawal of the endoscope in order not to miss any lesions, and also during every endoscopic treatment whether it is a simple polypectomy or a complex therapeutic procedure performed by expert endoscopists. However, there is currently no tool available to assess endoscopic tip control. And very little is known about educating it. The investigators developed a new, web-based scoring system to assess tip control. The intent of this study is to validate this novel tool so it can be used to assess endoscopists and evaluate their progress when training in endoscopy. This study takes place at the University Hospital Ghent, which is a tertiary care center for gastrointestinal endoscopy. The investigators will validate the tool in this study, through assessment of endoscopists of varying experience while they use a technique of snare tip soft coagulation on the margin of a polypectomy defect. This technique has proven its use in preventing recurrence after polypectomy. The technique uses the tip of a snare (used to resect polyps) to deliver thermal energy to the margin of a polypectomy, also called margin ablation. Thermal energy is applied by a hit on a pedal (operated with the foot), every hit needs to be exactly on the margin of the defect (not in the defect, not on normal mucosa around the defect). This requires a very steady and controlled handling of the endoscope and is an ideal technique to assess endoscopist's tip control. The score system will calculate the accuracy (number of correct hits over number of wrong hits) of tip control per second.

NCT ID: NCT05656976 Recruiting - Cervical Cancer Clinical Trials

Efficacy of Offering a Self-sampling Device by the GP to Reach Underscreened Women

ESSAG
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 65 who did not have a smear taken during the last 6 years. In order to assess the effect of a) providing the SSD, and b) the intervention of the general practitioner (GP) (either face-to-face, either by sending the SSD by letter), a randomized control trial is set up with three arms. The ESSAG trial evolves from a collaboration between Universiteit Gent and Vrije Universiteit Brussel, Katholieke Universiteit Leuven, Universiteit Antwerpen, Sciensano, het Centrum voor Kankeropsporing en het Belgisch Kankerregister, and is funded by "Kom Op Tegen Kanker".

NCT ID: NCT05654623 Recruiting - Clinical trials for Advanced Breast Cancer

A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

VERITAC-2
Start date: March 3, 2023
Phase: Phase 3
Study type: Interventional

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

NCT ID: NCT05653349 Recruiting - Clinical trials for Primary Immune Thrombocytopenia (ITP)

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

VAYHIT1
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

NCT ID: NCT05653219 Recruiting - Clinical trials for Primary Immune Thrombocytopenia

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

VAYHIT2
Start date: January 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

NCT ID: NCT05652335 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Start date: November 22, 2022
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).