University Hospital, Ghent — Biomedical Watch V2

Traitements9programmes

Essais3liés

Publications10liées

SourceDBlocale

Traitements

9

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin DefectsColorectal 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.	Cancer	À vérifier	À vérifier	Belgium	À vérifier
dehydroepiandrosteroneIn this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.	Cancer	Phase 4	À vérifier	Belgium	À vérifier
EstrogenIn this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.	Cancer	Phase 4	À vérifier	Belgium	À vérifier
Estrogen + probioticsIn this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.	Cancer	Phase 4	À vérifier	Belgium	À vérifier
MoisturizerIn this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.	Cancer	Phase 4	À vérifier	Belgium	À vérifier
NovaSure ablationHeavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified. The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications. An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia. The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours) This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout). The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.	Cancer	Non applicable	Immunomodulation + Traitement symptomatique	Belgium	À vérifier
EstrogenIn this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.	Cancer	Phase 4	À vérifier	Belgium	À vérifier
Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin DefectsColorectal 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.	Cancer	À vérifier	À vérifier	Belgium	À vérifier
NovaSure ablationHeavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified. The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications. An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia. The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours) This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout). The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.	Cancer	Non applicable	Immunomodulation + Traitement symptomatique	Belgium	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
NovaSure ablation	Cancer	Non applicable	NCT05856838	RAMBOS — NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding	RECRUITING
Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects	Cancer	À vérifier	NCT05660317	Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects	UNKNOWN
Estrogen	Cancer	Phase 4	NCT05562518	GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.	COMPLETED

Publications

10

Molécule	Indication / population	Titre	Journal	Date
Moisturizer		A film of tuberose polysaccharide supports normal epidermal keratinization by suppressing cytokine release induced by external stimuli.	International journal of cosmetic science
Moisturizer		Efficacy and safety of a novel anhydrous 0.1% retinal and 10% azelaic acid concentrate for blemish-prone skin: An eight-week randomized prospective split-face, vehicle-controlled study.	International journal of cosmetic science
Moisturizer		Tranexamic acid protects human dermal fibroblasts from D-galactose-induced senescence via the GPR30/MAPK pathway.	Annals of medicine
Estrogen + probiotics		Recent insights in pathogenesis of endometriosis with focus on gut microbiota.	Molecular biology reports
Estrogen + probiotics		Prospective efficacy of a novel dual-pronged strategy combining the probiotic Lactobacillus casei and Microalga Chlorella vulgaris in preventing postmenopausal bone loss in ovariectomized rats.	Archives of microbiology
Estrogen + probiotics		Polyphenol‑based interventions in breast cancer: Signaling pathways, molecular mechanisms and translational therapeutic strategies (Review).	Oncology reports
dehydroepiandrosterone		Investigating associations between allostatic load phenotypes and clinical impairment in youth with chronic pain.	Brain, behavior, & immunity - health
dehydroepiandrosterone		Changes in hormones and experimental pain sensitivity in healthy girls: an exploratory longitudinal pilot study.	Pain reports
dehydroepiandrosterone		DHEA model of PCOS selectively alters reproductive but not metabolic or behavioral phenotypes in female Long-Evans rats.	Physiology & behavior
Estrogen		Peripheral precocious puberty with unilateral ovarian agenesis in early childhood: a case report and review of literature.	Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology