Indiana University — Biomedical Watch V2

Traitements15programmes

Essais7liés

Publications0liées

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Traitements

15

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
ABCV — Aging Brain Care Virtual ProgramThe program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. The intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. Protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning.	Alzheimer	Non applicable	Traitement symptomatique	United States	À vérifier
Digital Detection of Dementia (D Cubed) Studies: D3The specific aim of the pragmatic trial is to evaluate the practical utility and effect of the PDM, the QDRS, and the combined approach (PDM + QDRS) in improving the annual rate of new documented ADRD diagnosis in primary care practices.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
EleviewEMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the area to be removed and healthy mucosal tissue. Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S. A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml). Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate. This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.	Cancer	Phase 4	À vérifier	United States	À vérifier
HetastarchEMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the area to be removed and healthy mucosal tissue. Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S. A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml). Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate. This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.	Cancer	Phase 4	À vérifier	United States	À vérifier
INCLUDE — Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And ResearchRecent studies have highlighted the potential use of electronic health record (EHR) data for scalable and less biased identification of people who may have or be at risk of developing MCI or ADRD at the population level.8,9 Using data from the EHR in advance of PC visits can systematically identify patients with undetected MCI and ADRD. At Indiana University (IU), researchers developed a Passive Digital Marker (PDM) to enable early detection of ADRD with an 80% accuracy for one-year and three-year prediction horizons.8,9 Despite the accuracy of the PDM, the feasibility, acceptability, and overall effectiveness of its use for early detection of ADRD in PC remains unclear. Building on this innovative tool and the ongoing engagement in IUH PC for early detection of ADRD, we propose a project to test the acceptability and feasibility of implementing the PDM in IUH PC to identify people with and at risk of MCI and ADRD and measure if we can increase patient engagement in research and evidence-based follow-up care with the IUH Brain Health Navigator (BHN). The BHN, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive ADRD screen to identify possible underlying causes of cognitive impairment and assist the PCP to facilitate the patient's next steps for diagnostic assessment.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
NCRAD — Alzheimer's Disease Genetics StudyThe purpose of the Alzheimer's Disease Genetics Study is to identify the genes that are responsible for causing Alzheimer's Disease (AD). One of the ways in which the risk factor genes for late onset AD can be investigated is by identifying and collecting genetic material from families with multiple members diagnosed with AD or dementia.	Alzheimer	À vérifier	À vérifier	United States	À vérifier
R2D2 — Reducing Risk of Dementia Through DeprescribingA cluster-randomized controlled trial (RCT) called "Reducing Risk of Dementia through Deprescribing" (R2D2) to evaluate the impact of a deprescribing intervention on important cognitive and safety outcomes.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
Sonatherm 600i ablation systemThe Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus, there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback could replace RF and Cryo for the treatment of small renal masses where the invasiveness of full resection partial nephrectomy is contraindicated due to patient comorbidities.	Cancer	Phase 1	À vérifier	United States	À vérifier
INCLUDE — Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And ResearchRecent studies have highlighted the potential use of electronic health record (EHR) data for scalable and less biased identification of people who may have or be at risk of developing MCI or ADRD at the population level.8,9 Using data from the EHR in advance of PC visits can systematically identify patients with undetected MCI and ADRD. At Indiana University (IU), researchers developed a Passive Digital Marker (PDM) to enable early detection of ADRD with an 80% accuracy for one-year and three-year prediction horizons.8,9 Despite the accuracy of the PDM, the feasibility, acceptability, and overall effectiveness of its use for early detection of ADRD in PC remains unclear. Building on this innovative tool and the ongoing engagement in IUH PC for early detection of ADRD, we propose a project to test the acceptability and feasibility of implementing the PDM in IUH PC to identify people with and at risk of MCI and ADRD and measure if we can increase patient engagement in research and evidence-based follow-up care with the IUH Brain Health Navigator (BHN). The BHN, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive ADRD screen to identify possible underlying causes of cognitive impairment and assist the PCP to facilitate the patient's next steps for diagnostic assessment.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
Digital Detection of Dementia (D Cubed) Studies: D3The specific aim of the pragmatic trial is to evaluate the practical utility and effect of the PDM, the QDRS, and the combined approach (PDM + QDRS) in improving the annual rate of new documented ADRD diagnosis in primary care practices.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
Sonatherm 600i ablation systemThe Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus, there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback could replace RF and Cryo for the treatment of small renal masses where the invasiveness of full resection partial nephrectomy is contraindicated due to patient comorbidities.	Cancer	Phase 1	À vérifier	United States	À vérifier
R2D2 — Reducing Risk of Dementia Through DeprescribingA cluster-randomized controlled trial (RCT) called "Reducing Risk of Dementia through Deprescribing" (R2D2) to evaluate the impact of a deprescribing intervention on important cognitive and safety outcomes.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
ABCV — Aging Brain Care Virtual ProgramThe program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. The intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. Protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning.	Alzheimer	Non applicable	Traitement symptomatique	United States	À vérifier
NCRAD — Alzheimer's Disease Genetics StudyThe purpose of the Alzheimer's Disease Genetics Study is to identify the genes that are responsible for causing Alzheimer's Disease (AD). One of the ways in which the risk factor genes for late onset AD can be investigated is by identifying and collecting genetic material from families with multiple members diagnosed with AD or dementia.	Alzheimer	À vérifier	À vérifier	United States	À vérifier
EleviewEMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the area to be removed and healthy mucosal tissue. Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S. A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml). Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate. This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.	Cancer	Phase 4	À vérifier	United States	À vérifier

Essais cliniques

7

Molécule	Indication / population	Phase	NCT	Titre	Statut
Eleview	Cancer	Phase 4	NCT03350217	A Comparison of Eleview Versus Hetastarch as Injectate for EMR	COMPLETED
NCRAD — Alzheimer's Disease Genetics Study	Alzheimer	À vérifier	NCT00064870	NCRAD — Alzheimer's Disease Genetics Study	RECRUITING
ABCV — Aging Brain Care Virtual Program	Alzheimer	Non applicable	NCT06245499	ABCV — Aging Brain Care Virtual Program	COMPLETED
R2D2 — Reducing Risk of Dementia Through Deprescribing	Alzheimer	Non applicable	NCT04270474	R2D2 — Reducing Risk of Dementia Through Deprescribing	COMPLETED
Sonatherm 600i ablation system	Cancer	Phase 1	NCT02248389	HIFU-KIDNEY — Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses	COMPLETED
Digital Detection of Dementia (D Cubed) Studies: D3	Alzheimer	Non applicable	NCT06224205	Digital Detection of Dementia (D Cubed) Studies: D3	COMPLETED
INCLUDE — Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research	Alzheimer	Non applicable	NCT07016178	INCLUDE — Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research	COMPLETED

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.