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| Name | Class |
|---|---|
| Moleac Pte Ltd. | INDUSTRY |
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The NeST registry is a pro-active industry-academic collaboration to assess the use and safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy data entry and retrieval of clinical information.
The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional, and cognitive state, compliance, concomitant medications and side effects if any, among patients on NeuroAiD. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialization of NeuroAiD) and during subsequent visits. The follow up visits are timed with clinical appointments. Anonymized data will be extracted and collectively analyzed. Initial target sample size for the registry is 2000.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroAiD | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients experiencing adverse events | Adverse events categorized according to individual events, organ system, severity (mild, moderate, severe), and relatedness (based on WHO-World Health Organization - Uppsala Monitoring System as 'possibly' 'probably' or 'definitely' related) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status based on modified Rankin Scale | 0 No symptoms at all
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients complying to prescribed dosage of NeuroAiD | Compliance assessed as "since last visit, taking NeuroAiD..." never, 'rarely,' 'sometimes,' 'often,' 'always.' | 1, 2, 3 months |
| Glasgow Outcome Scale Extended (GOS-E) |
Inclusion Criteria:
Exclusion Criteria:
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The NeST Registry is a product-specific and safety outcome registry that includes patients who are taking NeuroAiD. Participation is entirely voluntary and an agreement will be obtained before inclusion. The decision on the use of NeuroAiD should be made following a discussion between participant and physician and only then will the option of participation in the registry be considered.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Lim | Contact | +6562113710 | 3184 | emily.lim@moleac.com |
| Sylvain Durrleman, PhD | Contact | sylvain.durrleman@moleac.com |
| Name | Affiliation | Role |
|---|---|---|
| Narayanaswamy Venketasubramanian, FRCP | Raffles Neuroscience Centre, Raffles Hospital, Singapore | Study Chair |
| Ramesh Kumar, FRCS | Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Brain Center Hospital | Recruiting | Jakarta | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26567259 | Derived | Venketasubramanian N, Kumar R, Soertidewi L, Abu Bakar A, Laik C, Gan R. The NeuroAiD Safe Treatment (NeST) Registry: a protocol. BMJ Open. 2015 Nov 13;5(11):e009866. doi: 10.1136/bmjopen-2015-009866. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| C546417 | Neuroaid |
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| 1, 2, 3 months |
| Neurological status based on Glasgow Coma Scale | to assess level of consciousness: eye opening, Eye opening 4, Eye Opening Response
| 1, 2, 3 months |
| Neurological status based on National Institute of Health Stroke Scale | Quantify impairment caused by stroke 0- no stroke, 1-4 Minor stroke, 5-15 Moderate,16-20 Moderate to Severe stroke, 21-42 severe stroke | 1, 2, 3 months |
| Cognitive status based on Short Orientation-Memory-Concentration Test | test involves 6 items test -1.what year is it now?2.What month is it now?3.Repeat phrase, about what time is it ? (within one hour),Count backwards 20 to 1,Say months in reversw order,repeat phrase just given, | 1, 2, 3 months |
| Cognitive status based on Mini-Mental State Examination (MMSE) | Orientation, Registration,Attention and Calculation,Recall, Language, Copying, | 3, 6,9, 12 months |
| Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog) | World recall, Naming of objects and fingers,Commands,Constructional Praxis,Ideational Praxis,Orientation, World Recognition,Language,Comprehension of spoken language,Word finding difficulty, Remembering test instructions | 3, 6, 9, 12 months |
| Cognitive status based on Montreal Cognitive Assessment (MoCA) | Visio spatial /executive,naming, memory ,attention , language,abstraction, delayed recall | 3, 6, 9, 12 months |
| Functional outcome based on Bristol Activities of Daily Living (BADL) | Preparing Food 3 Eating 3 Preparing Drink 3 Drinking 3 Dressing 3 Hygiene 3 Teeth 3 Bath/Shower 3 Toilet/Commode 3 Transfers 3 Mobility 3 Orientation - Time 3 Orientation - Space 3 Communication 3 Telephone 3 Housework/Gardening 3 Shopping 3 Finances 3 Games/Hobbies 3 Transport 3 | 3, 6, 9, 12 |
For Traumatic Brain injury cohort:This clinical scale is the most widely used outcome measure after TBI. The extended version is rated from 0 (dead) to 8 (full recovery)
| 1, 2, 3 months, additional visit |
| Rivermead Post-Concussion Symptom Questionnaire (RPQ) | For Traumatic Brain Injury Cohort. This questionnaire is a simple, 10-item measure of outcome mainly used with patients with mild to moderate head injuries. This questionnaire explores the occurrence of 16 post-concussive symptoms such as headaches, fatigue, and restlessness | 1, 2, 3 months, additional visit |
| Modified Barthel Index | For Traumatic Brain Injury cohort. This scale assesses functional disability by quantifying patient performance in 10 activities of daily life (ADLs). This scale measures performance and patient independence with respect to self-care, sphincter management, transfers and locomotion. The score is calculated by summing the response value to each item. | 1, 2, 3 months, additional visit |
| Lyna Soertidewi, MD | Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia | Principal Investigator |
| University Kebangsaan Malaysia Medical Centre | Recruiting | Kuala Lumpur | Malaysia |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |