Cerebrovascular DiseaseBIG-MENTINCT05925699
National Database of the Virtual Institute of Cerebrovascular Diseases
An observational study of Cerebrovascular Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. Secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- Collection of clinical, radiological, and biological data from patients' medical records
- How many people
- 285,600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 1 Sep 2052
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with cerebrovascular diseases occuring between January 1, 2016 and July 1, 2049 who consented to partecipate in the study
Who may be able to join
- Diagnosis of cerebrovascular pathology defined according to the NINDS special report of 1990 as "all disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding and/or in which one or more blood vessels of the brain are mainly altered by a pathological process", falling within the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438;
- Informed consent provided by the patient or his legal representative in the case of mental incapacity or by the parents/guardians in the case of minors.
Who cannot join
- The patient, his legal representative in the case of mental incapacity or his parents/guardians in the case of minors clearly state their will to leave the study;
- Onset of cerebrovascular disease before January 1, 2016.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Paolo Calabresi, Prof, MD, +390630154459, paolo.calabresi@policlinicogemelli.it
Irene Scala, MD, +393519746393, irene.scala01@icatt.it
About this study
The primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. Secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases and the onset of complications related to therapeutic procedures, and to calculate predictive prognostic scores composed of multiple variables.
Each participating center will collect clinical, radiological, and biological data from the medical records of the study participants. Patients included in the study will not undergo any additional medical procedures to those of normal clinical practice.
- Conditions
- Cerebrovascular Disease
- Being tested
- Collection of clinical, radiological, and biological data from patients' medical records
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of clinical, radiological, and biological data from patients' medical recordsOther
Collection of clinical, radiological, and biological data from patients' medical records
| Study group | Role | What they receive |
|---|---|---|
| All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049 | Not described Receives: Other: Collection of clinical, radiological, and biological data from patients' medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.
Identification and definition of the various subtypes of each cerebrovascular disease (International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438) associated with poor prognosis.
Measured: July 1, 2023 - July 1, 2053
Secondary outcomes (20)
Identification of clinical variables of each cerebrovascular disease correlated with its prognosis
Identification of the clinical variables of each cerebrovascular disease correlated with its prognosis
Measured: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease correlated with its prognosis
Identification of the radiological variables of each cerebrovascular disease correlated with its prognosis
Measured: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease correlated with its prognosis
Identification of the biomarkers of each cerebrovascular disease correlated with its prognosis
Measured: July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis
Identification of the neurophysiological variables of each cerebrovascular disease correlated with its prognosis
Measured: July 1, 2023 - July 1, 2053
Identification of prognostic scores for each cerebrovascular disease
Identification of prognostic scores for each cerebrovascular disease, based on the combination of clinical, radiological, neurophysiological and biomarker variables
Measured: July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease helping in differential diagnosis
Identification of clinical variables of each cerebrovascular disease that help the clinician in early differential diagnosis
Measured: July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease capable of predicting the development of complications
Identification of clinical variables of each cerebrovascular disease capable of predicting the development of spontaneous complications or complications related to therapeutic procedures
Measured: July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Measured: July 1, 2023 - July 1, 2053
Identification of the clinical variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Identification of the clinical variables of each cerebrovascular disease useful for the purpose of personalizing the rehabilitation treatment and able to predict the good functional outcome following the same rehabilitation treatments
Measured: July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease helping in differential diagnosis
Identification of neurophysiological variables and biomarkers of each cerebrovascular disease helping in differential diagnosis
Measured: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis
Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis
Measured: July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications
Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications
Measured: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications
Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications
Measured: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis
Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis
Measured: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease capable of predicting the development of complications
dentification of biomarkers of each cerebrovascular disease capable of predicting the development of complications
Measured: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Measured: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Measured: July 1, 2023 - July 1, 2053
Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Measured: July 1, 2023 - July 1, 2053
Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Measured: July 1, 2023 - July 1, 2053
Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Measured: July 1, 2023 - July 1, 2053
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2052 (estimated)
- Study completion1 Sep 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 285,600 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS National Neurological Institute "C. Mondino" Foundation, I.R.C.C.S. Fondazione Santa Lucia, Ospedale Policlinico San Martino, IRCCS San Camillo, Venezia, Italy, Istituto Di Ricerche Farmacologiche Mario Negri, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Ospedale Pediatrico Bambin Gesù, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS Fondazione Stella Maris, Istituto Neurologico Mediterraneo Neuromed S. R. L, IRCCS San Raffaele Roma, Fondazione Don Carlo Gnocchi ETS, Ospedale San Raffaele, IRCCS Centro Neurolesi Bonino Pulejo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Auxologico Italiano, Istituti Clinici Scientifici Maugeri SpA, Fondazione IRCCS San Gerardo dei Tintori
- Responsible party
- Principal investigator, Calabresi Paolo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925699
- Sponsor's protocol ID
- 5832
- Acronym
- BIG-MENTI
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All the data collected in the registry will be available, upon reasonable request, for all the PIs and Sub-Is of the study of the various participating centers
Publications
Special report from the National Institute of Neurological Disorders and Stroke. Classification of cerebrovascular diseases III. Stroke. 1990 Apr;21(4):637-76. doi: 10.1161/01.str.21.4.637. No abstract available.
PubMed 2326846Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
PubMed 35016208GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PubMed 34487721Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.
PubMed 21557809Ozpinar A, Mendez G, Abla AA. Epidemiology, genetics, pathophysiology, and prognostic classifications of cerebral arteriovenous malformations. Handb Clin Neurol. 2017;143:5-13. doi: 10.1016/B978-0-444-63640-9.00001-1.
PubMed 28552158Ferro JM, Aguiar de Sousa D. Cerebral Venous Thrombosis: an Update. Curr Neurol Neurosci Rep. 2019 Aug 23;19(10):74. doi: 10.1007/s11910-019-0988-x.
PubMed 31440838
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Database of the Virtual Institute of Cerebrovascular Diseases
- ClinicalTrials.gov ID
- NCT05925699
- Acronym / sponsor ID
- BIG-MENTI / 5832
- Conditions
- Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 285,600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS National Neurological Institute "C. Mondino" Foundation, I.R.C.C.S. Fondazione Santa Lucia, Ospedale Policlinico San Martino, IRCCS San Camillo, Venezia, Italy, Istituto Di Ricerche Farmacologiche Mario Negri, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Ospedale Pediatrico Bambin Gesù, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS Fondazione Stella Maris, Istituto Neurologico Mediterraneo Neuromed S. R. L, IRCCS San Raffaele Roma, Fondazione Don Carlo Gnocchi ETS, Ospedale San Raffaele, IRCCS Centro Neurolesi Bonino Pulejo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Auxologico Italiano, Istituti Clinici Scientifici Maugeri SpA, Fondazione IRCCS San Gerardo dei Tintori
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2052 (estimated)
- Study completion
- 1 Sep 2052 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. Secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases and the onset of complications related to therapeutic procedures, and to calculate predictive prognostic scores composed of multiple variables.
Each participating center will collect clinical, radiological, and biological data from the medical records of the study participants. Patients included in the study will not undergo any additional medical procedures to those of normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049 | – | Other: Collection of clinical, radiological, and biological data from patients' medical records |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with cerebrovascular diseases occuring between January 1, 2016 and July 1, 2049 who consented to partecipate in the study
Key inclusion criteria (2 listed)
- Diagnosis of cerebrovascular pathology defined according to the NINDS special report of 1990 as "all disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding and/or in which one or more blood vessels of the brain are mainly altered by a pathological process", falling within the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438;
- Informed consent provided by the patient or his legal representative in the case of mental incapacity or by the parents/guardians in the case of minors.
Key exclusion criteria (2 listed)
- The patient, his legal representative in the case of mental incapacity or his parents/guardians in the case of minors clearly state their will to leave the study;
- Onset of cerebrovascular disease before January 1, 2016.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of clinical, radiological, and biological data from patients' medical recordsCollection of clinical, radiological, and biological data from patients' medical records | Other | All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049 |
Primary outcome
Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.
Time frame: July 1, 2023 - July 1, 2053
Identification and definition of the various subtypes of each cerebrovascular disease (International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438) associated with poor prognosis.
20 secondary outcomes
Identification of clinical variables of each cerebrovascular disease correlated with its prognosis
Time frame: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease correlated with its prognosis
Time frame: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease correlated with its prognosis
Time frame: July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis
Time frame: July 1, 2023 - July 1, 2053
Identification of prognostic scores for each cerebrovascular disease
Time frame: July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease helping in differential diagnosis
Time frame: July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease capable of predicting the development of complications
Time frame: July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Time frame: July 1, 2023 - July 1, 2053
Identification of the clinical variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Time frame: July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease helping in differential diagnosis
Time frame: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis
Time frame: July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications
Time frame: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications
Time frame: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis
Time frame: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease capable of predicting the development of complications
Time frame: July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Time frame: July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Time frame: July 1, 2023 - July 1, 2053
Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Time frame: July 1, 2023 - July 1, 2053
Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Time frame: July 1, 2023 - July 1, 2053
Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Time frame: July 1, 2023 - July 1, 2053
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Results publication: PubMed 2326846Special report from the National Institute of Neurological Disorders and Stroke. Classification of cerebrovascular diseases III. Stroke. 1990 Apr;21(4):637-76. doi: 10.1161/01.str.21.4.637. No abstract available.
- Results publication: PubMed 35016208Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
- Results publication: PubMed 34487721GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Results publication: PubMed 21557809Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.
- Results publication: PubMed 28552158Ozpinar A, Mendez G, Abla AA. Epidemiology, genetics, pathophysiology, and prognostic classifications of cerebral arteriovenous malformations. Handb Clin Neurol. 2017;143:5-13. doi: 10.1016/B978-0-444-63640-9.00001-1.
- Results publication: PubMed 31440838Ferro JM, Aguiar de Sousa D. Cerebral Venous Thrombosis: an Update. Curr Neurol Neurosci Rep. 2019 Aug 23;19(10):74. doi: 10.1007/s11910-019-0988-x.
- Individual participant dataSharing planned: Undecided. All the data collected in the registry will be available, upon reasonable request, for all the PIs and Sub-Is of the study of the various participating centers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Calabresi, Prof, MD (+390630154459, paolo.calabresi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis. (time frame: July 1, 2023 - July 1, 2053). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925699, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.