Radboud University Medical Center — Biomedical Watch V2

Traitements12programmes

Essais6liés

Publications10liées

SourceDBlocale

Traitements

12

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
EQuAL — Enhancement of Quality of Work And LifeWork participation is essential for quality of life, providing purpose, social interaction, financial security, and shaping social status. Work participation is increasingly compromised in people with slowly progressive chronic disorders (hereafter referred to as progressive disorders). This negatively impacts their quality of life. Early work-related support, focused on sustainable work-retention, has the potential to enhance work participation in people with progressive disorders. Therefore, this study investigates the (cost)effectiveness of the Preventive Participatory Workplace Intervention (PPWI), a personalized work intervention to enhance sustainable work participation. The investigators perform an 18-month randomized controlled trial (RCT). In addition, the investigators perform a process evaluation and an economic evaluation alongside the RCT. 124 Dutch working persons with three types of movement disorders (Parkinson's Disease (PD), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP)) and with slowly progressive neuromuscular and mitochondrial disorders will be included.	Parkinson	Non applicable	Remyélinisation indirecte / réparation	Netherlands	À vérifier
Magnetic Resonance Imaging and Ultrasound Comparison With Load EvaluationFacioscapulohumeral dystrophy (FSHD) is one of the most common hereditary neuromuscular disorders (NMD), with an estimated prevalence of 2000 patients in the Netherlands. Magnetic resonance imaging (MRI) and muscle ultrasound have contributed to an enhanced understanding of the pathophysiology of Facioscapulohumeral Muscular Dystrophy (FSHD). Previously, our group demonstrated the potential presence of an intermediate factor between muscle fiber loss and clinical weakness in FSHD. The influence of disrupted muscle architecture in FSHD on muscle contractile efficiency is a likely candidate for this factor, and remains relatively unexplored. In this study, we aim to assess the use of ultrasound-defined contractile performance, in comparison with current measures including structural MRI, for monitoring disease progression in FSHD.	Myopathies	À vérifier	Ralentissement de la progression	Netherlands	À vérifier
PD_Pal — Advance Care Planning and Care Coordination for People With Parkinson's DiseaseBackground: People with Parkinson's disease (PD), including parkinsonisms, experience complex motor and non-motor symptoms, which become more hindering in the advanced stages of PD. Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and serves to ensure that people receive treatment and care that is in line with their preferences during serious chronic illness. The effectiveness of ACP for PD is currently unknown. Methods: The investigators will evaluate the effectiveness of a multicenter, open-label randomized controlled trial, with a parallel group design in seven European countries (Austria, Estonia, Germany, Greece, Italy, Sweden and United Kingdom). The "PD\_Pal intervention" comprises (1) several consultations with a trained nurse who will perform ACP conversations and support care coordination and (2) use of a patient-directed "Parkinson Support Plan-workbook". The intervention group will be compared to a care-as-usual group. Documented ACP-decisions in the medical records/patient's central file assessed at 6 months after baseline will be the primary endpoint. Secondary endpoints include patients' and family caregivers' quality of life, perceived care coordination, patients' symptom burden, and cost-effectiveness. Assessments will take place at baseline, 6 months after baseline and 12 months after baseline. In parallel, we will perform a process evaluation, to understand the feasibility of the intervention. Hypothesis: The investigators hypothesize that the PD\_Pal intervention will result in an increased number of participants with ACP documentation in the medical records/patient's central file, as compared to care-as-usual. Secondly, the investigators expect that, due to the PD\_Pal intervention, patients and their FC will experience better care coordination, better quality of life, a reduced patient symptom burden and the FC will experience a reduction in caregiver burden.	Parkinson	Non applicable	Traitement symptomatique	Austria, Estonia, Germany, Greece, Italy, Sweden, United Kingdom	À vérifier
Personalised treatmentThis is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.	Cancer	Phase 1	À vérifier	Netherlands	À vérifier
The ParkCycle Study: Aerobic Exercise in PDThe primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.	Parkinson	Non applicable	Neuroprotection	United States, Netherlands	À vérifier
TIME-NL — Timing of Immunotherapy in MelanomaThe TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data from the randomized clinical trial will be combined with observational data.	Cancer	Non applicable	À vérifier	Netherlands	À vérifier
Magnetic Resonance Imaging and Ultrasound Comparison With Load EvaluationFacioscapulohumeral dystrophy (FSHD) is one of the most common hereditary neuromuscular disorders (NMD), with an estimated prevalence of 2000 patients in the Netherlands. Magnetic resonance imaging (MRI) and muscle ultrasound have contributed to an enhanced understanding of the pathophysiology of Facioscapulohumeral Muscular Dystrophy (FSHD). Previously, our group demonstrated the potential presence of an intermediate factor between muscle fiber loss and clinical weakness in FSHD. The influence of disrupted muscle architecture in FSHD on muscle contractile efficiency is a likely candidate for this factor, and remains relatively unexplored. In this study, we aim to assess the use of ultrasound-defined contractile performance, in comparison with current measures including structural MRI, for monitoring disease progression in FSHD.	Myopathies	À vérifier	Ralentissement de la progression	Netherlands	À vérifier
TIME-NL — Timing of Immunotherapy in MelanomaThe TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data from the randomized clinical trial will be combined with observational data.	Cancer	Non applicable	À vérifier	Netherlands	À vérifier
PD_Pal — Advance Care Planning and Care Coordination for People With Parkinson's DiseaseBackground: People with Parkinson's disease (PD), including parkinsonisms, experience complex motor and non-motor symptoms, which become more hindering in the advanced stages of PD. Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and serves to ensure that people receive treatment and care that is in line with their preferences during serious chronic illness. The effectiveness of ACP for PD is currently unknown. Methods: The investigators will evaluate the effectiveness of a multicenter, open-label randomized controlled trial, with a parallel group design in seven European countries (Austria, Estonia, Germany, Greece, Italy, Sweden and United Kingdom). The "PD\_Pal intervention" comprises (1) several consultations with a trained nurse who will perform ACP conversations and support care coordination and (2) use of a patient-directed "Parkinson Support Plan-workbook". The intervention group will be compared to a care-as-usual group. Documented ACP-decisions in the medical records/patient's central file assessed at 6 months after baseline will be the primary endpoint. Secondary endpoints include patients' and family caregivers' quality of life, perceived care coordination, patients' symptom burden, and cost-effectiveness. Assessments will take place at baseline, 6 months after baseline and 12 months after baseline. In parallel, we will perform a process evaluation, to understand the feasibility of the intervention. Hypothesis: The investigators hypothesize that the PD\_Pal intervention will result in an increased number of participants with ACP documentation in the medical records/patient's central file, as compared to care-as-usual. Secondly, the investigators expect that, due to the PD\_Pal intervention, patients and their FC will experience better care coordination, better quality of life, a reduced patient symptom burden and the FC will experience a reduction in caregiver burden.	Parkinson	Non applicable	Traitement symptomatique	Austria, Estonia, Germany, Greece, Italy, Sweden, United Kingdom	À vérifier
EQuAL — Enhancement of Quality of Work And LifeWork participation is essential for quality of life, providing purpose, social interaction, financial security, and shaping social status. Work participation is increasingly compromised in people with slowly progressive chronic disorders (hereafter referred to as progressive disorders). This negatively impacts their quality of life. Early work-related support, focused on sustainable work-retention, has the potential to enhance work participation in people with progressive disorders. Therefore, this study investigates the (cost)effectiveness of the Preventive Participatory Workplace Intervention (PPWI), a personalized work intervention to enhance sustainable work participation. The investigators perform an 18-month randomized controlled trial (RCT). In addition, the investigators perform a process evaluation and an economic evaluation alongside the RCT. 124 Dutch working persons with three types of movement disorders (Parkinson's Disease (PD), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP)) and with slowly progressive neuromuscular and mitochondrial disorders will be included.	Parkinson	Non applicable	Remyélinisation indirecte / réparation	Netherlands	À vérifier
The ParkCycle Study: Aerobic Exercise in PDThe primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.	Parkinson	Non applicable	Neuroprotection	United States, Netherlands	À vérifier
Personalised treatmentThis is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.	Cancer	Phase 1	À vérifier	Netherlands	À vérifier

Essais cliniques

6

Molécule	Indication / population	Phase	NCT	Titre	Statut
Personalised treatment	Cancer	Phase 1	NCT07485569	REPOTHYROID-II — Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial	ACTIVE_NOT_RECRUITING
The ParkCycle Study: Aerobic Exercise in PD	Parkinson	Non applicable	NCT01562496	The ParkCycle Study: Aerobic Exercise in PD	COMPLETED
EQuAL — Enhancement of Quality of Work And Life	Parkinson	Non applicable	NCT06573866	EQuAL — Enhancement of Quality of Work And Life	ACTIVE_NOT_RECRUITING
PD_Pal — Advance Care Planning and Care Coordination for People With Parkinson's Disease	Parkinson	Non applicable	NCT05954013	PD_Pal — Advance Care Planning and Care Coordination for People With Parkinson's Disease	COMPLETED
TIME-NL — Timing of Immunotherapy in Melanoma	Cancer	Non applicable	NCT07696715	TIME-NL — Timing of Immunotherapy in Melanoma	RECRUITING
Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation	Myopathies	À vérifier	NCT06227182	Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation	RECRUITING

Publications

10

Molécule	Indication / population	Titre	Journal	Date
EQuAL — Enhancement of Quality of Work And Life		Digital transformation of home-based care: a narrative review of nursing, technology, and management synergies.	Frontiers in public health
EQuAL — Enhancement of Quality of Work And Life		[Far more than a dress code: more women, new leadership styles : Rethinking leadership in medicine-perspectives of the German Medical Women's Association].	Urologie (Heidelberg, Germany)
PD_Pal — Advance Care Planning and Care Coordination for People With Parkinson's Disease		Advance Care Planning and Care Coordination for People With Parkinson's Disease and Their Family Caregivers-Study Protocol for a Multicentre, Randomized Controlled Trial.	Frontiers in neurology
Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation		Quantitative susceptibility mapping of the brain is associated with inflammatory changes in Alzheimer's disease related areas.	Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism
Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation		Diffusion-weighted magnetic resonance imaging as a promising technique for detection and follow-up of liver metastases from neuroendocrine tumors: a retrospective and prospective study from the NETTARE task force.	Journal of endocrinological investigation
TIME-NL — Timing of Immunotherapy in Melanoma		Advanced Metastatic Melanoma With C-KIT (CD117) Immunohistochemical Expression: A Case Report and Therapeutic Considerations.	Cureus
TIME-NL — Timing of Immunotherapy in Melanoma		Political determinants of melanoma: Global inequities in skin cancer care.	JAAD international
TIME-NL — Timing of Immunotherapy in Melanoma		Acral lentiginous melanoma metastases to the vitreous masquerading as uveitis: A case report.	American journal of ophthalmology case reports
Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation		The relationship between cerebellar functional connectivity alterations and hand dexterity impairment in multiple sclerosis.	Journal of neurology
Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation		Pilot feasibility study of intraprocedural transcranial Doppler monitoring to assess Heal coating thrombogenicity in flow diversion.	Frontiers in neurology