The Cleveland Clinic — Biomedical Watch V2

Traitements22programmes

Essais13liés

Publications17liées

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Traitements

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
CAVS-MS — Central Vein Sign: a Diagnostic Biomarker in Multiple SclerosisThe need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease. This is highly consequential, as more than two-thirds of misdiagnosed patients are unnecessarily exposed to risks from disease-modifying therapies, which in rare cases can be life-threatening. Moreover, the current standard in MS diagnosis - the McDonald criteria, which combine clinical symptoms and MRI findings - were developed from studies in people with typical clinical presentations of MS. This reduces the specificity of these criteria, rendering them uninformative for the nearly half of MS patients who present to neurologists with atypical or nonclassical symptoms. Timeliness of MS diagnosis is also key, as diagnostic delay is common in cases of relapsing-remitting MS and can carry severe and lifelong consequences. The CentrAl Vein Sign in MS (CAVS-MS) study has been designed to assess whether Central Vein Sign (CVS) criteria can help address some of these unmet diagnostic needs. It will specifically explore the role of presentation type by enrolling a mixed population of patients with typical clinical presentations (n = 200) and those with atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms (n = 200) across North America.	SEP	À vérifier	Traitement symptomatique	United States, Canada	À vérifier
CREXONT ERThe purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.	Parkinson	Phase 4	Traitement symptomatique	United States	À vérifier
CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)The overall goal of the CYCLE-AD trial is to determine the role of long-term, high intensity exercise in slowing or delaying the onset of cognitive and AD-related brain changes in e4 carriers. Successful translation and demonstration of the effectiveness of a scalable home-based exercise intervention capable of slowing or delaying disease onset will transform AD treatment, improve patient outcomes and quality of life, and reduce health care costs.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's DiseaseThe purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.	Parkinson	Non applicable	Traitement symptomatique	United States	À vérifier
Early Highly Effective Therapies GroupThe DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.	SEP	Phase 4	À vérifier	United States, United Kingdom	À vérifier
Escalation Therapies GroupThe DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.	SEP	Phase 4	À vérifier	United States, United Kingdom	À vérifier
GalcanezumabThe main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.	Migraine	À vérifier	À vérifier	United States	À vérifier
Multiple Tip ThermoablationThe purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.	Cancer	Non applicable	À vérifier	China, El Salvador	À vérifier
Single Tip ThermoablationThe purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.	Cancer	Non applicable	À vérifier	China, El Salvador	À vérifier
Standard C02 CryotherapyThe purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.	Cancer	Non applicable	À vérifier	China, El Salvador	À vérifier
Early Highly Effective Therapies GroupThe DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.	SEP	Phase 4	À vérifier	United States, United Kingdom	À vérifier
GalcanezumabThe main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.	Migraine	Phase 3	À vérifier	United States, Argentina, Canada, Czechia, Germany, Israel, Italy, Mexico, Netherlands, Puerto Rico, Spain, Taiwan, United Kingdom	À vérifier
CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)The overall goal of the CYCLE-AD trial is to determine the role of long-term, high intensity exercise in slowing or delaying the onset of cognitive and AD-related brain changes in e4 carriers. Successful translation and demonstration of the effectiveness of a scalable home-based exercise intervention capable of slowing or delaying disease onset will transform AD treatment, improve patient outcomes and quality of life, and reduce health care costs.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
GalcanezumabThe main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.	Migraine	À vérifier	À vérifier	United States	À vérifier
GalcanezumabThe main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.	Migraine	Phase 3	À vérifier	United States, Denmark, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Spain	À vérifier
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's DiseaseThe purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.	Parkinson	Non applicable	Traitement symptomatique	United States	À vérifier
GalcanezumabThe main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.	Migraine	Phase 3	À vérifier	United States, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Spain	À vérifier
GalcanezumabThe main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.	Migraine	Phase 4	À vérifier	United States	À vérifier
GalcanezumabThe main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.	Migraine	Phase 3	À vérifier	China, India, Russia	À vérifier
CAVS-MS — Central Vein Sign: a Diagnostic Biomarker in Multiple SclerosisThe need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease. This is highly consequential, as more than two-thirds of misdiagnosed patients are unnecessarily exposed to risks from disease-modifying therapies, which in rare cases can be life-threatening. Moreover, the current standard in MS diagnosis - the McDonald criteria, which combine clinical symptoms and MRI findings - were developed from studies in people with typical clinical presentations of MS. This reduces the specificity of these criteria, rendering them uninformative for the nearly half of MS patients who present to neurologists with atypical or nonclassical symptoms. Timeliness of MS diagnosis is also key, as diagnostic delay is common in cases of relapsing-remitting MS and can carry severe and lifelong consequences. The CentrAl Vein Sign in MS (CAVS-MS) study has been designed to assess whether Central Vein Sign (CVS) criteria can help address some of these unmet diagnostic needs. It will specifically explore the role of presentation type by enrolling a mixed population of patients with typical clinical presentations (n = 200) and those with atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms (n = 200) across North America.	SEP	À vérifier	Traitement symptomatique	United States, Canada	À vérifier
Standard C02 CryotherapyThe purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.	Cancer	Non applicable	À vérifier	China, El Salvador	À vérifier
CREXONT ERThe purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.	Parkinson	Phase 4	Traitement symptomatique	United States	À vérifier

Essais cliniques

Molécule	Indication / population	Phase	NCT	Titre	Statut
Ubrogepant	Migraine	À vérifier	NCT06212661	Migraine Medication Effects on Urinary Symptoms	ENROLLING_BY_INVITATION
CREXONT ER	Parkinson	Phase 4	NCT07138560	BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease	RECRUITING
Standard C02 Cryotherapy	Cancer	Non applicable	NCT03429582	Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device	COMPLETED
CAVS-MS — Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis	SEP	À vérifier	NCT04495556	CAVS-MS — Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis	ACTIVE_NOT_RECRUITING
Galcanezumab	Migraine	Phase 3	NCT03963232	PERSIST — A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine	COMPLETED
Galcanezumab	Migraine	Phase 4	NCT05127486	CHALLENGE-MIG — A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine	COMPLETED
Galcanezumab	Migraine	Phase 3	NCT04616326	REBUILD-2 — A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine	ACTIVE_NOT_RECRUITING
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease	Parkinson	Non applicable	NCT07748962	Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease	NOT_YET_RECRUITING
Galcanezumab	Migraine	Phase 3	NCT03432286	REBUILD-1 — A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine	ACTIVE_NOT_RECRUITING
Galcanezumab	Migraine	À vérifier	NCT06085144	Emgality for Migraine in Breastmilk	RECRUITING
CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)	Alzheimer	Non applicable	NCT04748861	CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)	ACTIVE_NOT_RECRUITING
Galcanezumab	Migraine	Phase 3	NCT02614261	REGAIN — Evaluation of Galcanezumab in the Prevention of Chronic Migraine	COMPLETED
Early Highly Effective Therapies Group	SEP	Phase 4	NCT03535298	DELIVER-MS — Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS	ACTIVE_NOT_RECRUITING

Publications

Molécule	Titre	Journal
Galcanezumab	Case Report: Anodal DLPFC-tDCS for refractory post-traumatic cognitive fatigue in the hypometabolic brain.	Frontiers in human neuroscience
Escalation Therapies Group	Safety and immunogenicity of an investigational mRNA-lipid nanoparticle-based monovalent influenza vaccine: Results from a phase 1, randomized, dose-escalation study.	Human vaccines & immunotherapeutics
Escalation Therapies Group	Intravenous immunotherapy with Der p 1-containing nanoparticles alleviates the allergic responses in a murine allergic rhinitis model.	Human vaccines & immunotherapeutics
Escalation Therapies Group	type B (Hib) necrotizing soft tissue infection (NSTI) in a vaccinated 16-month-old Inuit boy: a case report.	International journal of circumpolar health
Early Highly Effective Therapies Group	Psychiatric Outcomes of Antiseizure Medications in Newly Diagnosed Focal Onset Epilepsy: From the Human Epilepsy Project Cohort Study.	Neurology. Clinical practice
Early Highly Effective Therapies Group	Management of moderate-to-highly exuding leg ulcers with polyacrylate superabsorbent wound dressings versus foam dressings in spanish settings: an early-stage cost-effectiveness and budget-impact analysis.	Journal of medical economics
Early Highly Effective Therapies Group	Impact of infrared moxibustion for patients with mild hyperlipidemia: a protocol for a randomized controlled trial.	Annals of medicine
Escalation Therapies Group	Time-Dependent Bias and Prognostic Confounding in Exposure-Response Analysis of Targeted Therapies: Lessons from Sunitinib in Metastatic Renal Cancer.	Clinical pharmacology and therapeutics
Escalation Therapies Group	Beyond Weight Loss: Gut Microenvironment Modulation to Enhance Cardiometabolic Outcomes and Long-Term Adherence During Incretin-Based Therapy.	Journal of clinical medicine
Early Highly Effective Therapies Group	Mentalisation-Based Treatment (MBT) in youth at Clinical High-Risk for Psychosis (CHR-P): study protocol for a randomised controlled trial (MBT-Psychosis).	BMJ open
Early Highly Effective Therapies Group	Bacterial Outer Membrane Vesicle-Based Versatile In Situ Nanovaccine Enhancer Synergized With Radiofrequency Ablation Against Hepatocellular Carcinoma.	Advanced healthcare materials
Galcanezumab	CGRP-pathway exposure during the pre-EBP interval in spontaneous intracranial hypotension: an exploratory retrospective case series.	BMC neurology
Galcanezumab	Comparing synthetic and biological therapy for the treatment of cluster headache: what is needed and when?	Expert review of neurotherapeutics
Escalation Therapies Group	Improved Outcomes with Early Aggressive Therapy in Pediatric Pulmonary Hypertension.	The European respiratory journal
Escalation Therapies Group	Adaptive, Stepped-Care for Cancer-Related PTSD Symptoms in HCT Survivors: Results From a SMART Trial.	Psycho-oncology
Early Highly Effective Therapies Group	Piloting a Digital App Based on the Friendship Bench for Depression and Anxiety in Palestine: Mixed Methods Study.	JMIR mental health
Early Highly Effective Therapies Group	User Acceptance of a Virtual Reality Beer Pong Intervention in Postoperative Rehabilitation: Exploratory Mixed Methods Study.	JMIR XR and spatial computing