Children's National Research Institute — Biomedical Watch V2

Traitements5programmes

Essais2liés

Publications2liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Development of a Therapeutic Endpoint in Pediatric Rheumatologic ConditionsThe overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.	Lupus	À vérifier	Traitement symptomatique	United States	À vérifier
Lyso-thermosensitive Liposomal DoxorubicinThis is a pilot study of LTLD with MR-HIFU hyperthermia followed by ablation in subjects with refractory/relapsed solid tumors.	Cancer	Phase 2	À vérifier	United States	À vérifier
Magnetic Resonance-Guided High Intensity Focused UltrasoundThis is a pilot study of LTLD with MR-HIFU hyperthermia followed by ablation in subjects with refractory/relapsed solid tumors.	Cancer	Phase 2	À vérifier	United States	À vérifier
Development of a Therapeutic Endpoint in Pediatric Rheumatologic ConditionsThe overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.	Lupus	À vérifier	Traitement symptomatique	United States	À vérifier
Magnetic Resonance-Guided High Intensity Focused UltrasoundThis is a pilot study of LTLD with MR-HIFU hyperthermia followed by ablation in subjects with refractory/relapsed solid tumors.	Cancer	Phase 2	À vérifier	United States	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Magnetic Resonance-Guided High Intensity Focused Ultrasound	Cancer	Phase 2	NCT04791228	A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors	WITHDRAWN
Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions	Lupus	À vérifier	NCT04833465	Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions	RECRUITING

Publications

2

Molécule	Indication / population	Titre	Journal	Date
Lyso-thermosensitive Liposomal Doxorubicin		Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in stage IV breast cancer patients: study protocol of the i-GO study.	BMJ open
Lyso-thermosensitive Liposomal Doxorubicin		Hyperthermia-targeted rectal delivery of thermosensitive liposomal doxorubicin via intra-arterial and intravenous administration.	Frontiers in pharmacology