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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
| Assaf-Harofeh Medical Center | OTHER_GOV |
| University of Wisconsin, Madison | OTHER |
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An urgent need exists to identify effective interventions to arrest or reverse dementia and cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen therapy effects on cognition in diabetes. The potential to preserve, or even enhance, cognition in elderly at high risk of cognitive decline and dementia has major implications for the affected individuals and their support systems that bear the social and financial burdens of long-term caregiving.
This resubmission responds to "PAR-16-365-Pilot Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)". It will examine the efficacy of hyperbaric oxygen therapy (HBOT) in improving cognitive functioning in cognitively impaired elderly with diabetes (T2D), who have high risk for dementia. It is a collaboration of the Icahn School of Medicine at Mount Sinai, NY, the University of Wisconsin, the Sagol Center for Hyperbaric Medicine and Research at Asaf Harofeh Medical Center, Israel-one of the world's largest and busiest hyperbaric units-and the Sheba Medical Center, Israel.
HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure above the ambient atmosphere. The combined action of hyperoxia and hyperbaric pressure leads to significant improvements in tissue oxygenation, resulting in cerebrovascular benefits with improved ischemic damage and cerebral blood flow. Recently, the researchers of this group published compelling evidence from clinical trials indicating HBOT neurotherapeutic effects in stroke, with better cognitive function and elevated brain activity in SPECT. New preliminary data suggests potential neurotherapeutic effects of HBOT on T2D elderly with mild cognitive impairment (MCI), showing better cognitive performance and brain activity. The researchers propose a randomized controlled clinical trial examining the short (12 weeks) and long-term (12 months) efficacy of HBOT. The researchers will test hypotheses that HBOT compared to a sham condition improves cognitive function and increases cerebral blood flow and glucose utilization in MCI patients with T2D. Such patients are at high dementia risk and enriched in cerebrovascular disease, and thus have high potential for benefitting from HBOT. Aim 1 examines the potential beneficial effects of HBOT on cognition (with a primary composite measure of executive functions and episodic memory, both affected by T2D). Aim 2 examines effects of HBOT on ischemic injury which will be measured by CBF at the level of capillaries in gray matter (by MRI arterial spin labeling), and in macrovessels (by a novel 4D Flow MRI technology developed by the researchers of this group). Aim 3 focuses on effects of HBOT on cerebral glucose utilization using [F18]FDG-PET. Finally, Aim 4 investigates mediation by the biomarkers, i.e. whether their inclusion in a mediation model will attenuate the effect of HBOT on cognition, suggesting them as underlying mechanisms. This study will be performed in Israel, where there is optimal infrastructure and expertise for all the study components at significantly lower costs. HBOT can be widely deployed in the US so if successful, this pilot study will provide the basis for a multi-center large-scale clinical trial for definitive evidence of its benefits to cognition in T2D patients at high dementia risk. Despite advances in the understanding of risk factors and the pathologic basis for dementia, treatments are of very limited effects. As the proportion of elderly increases, the accelerating prevalence of T2D and dementia amplifies this application's public health impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBOT intervention | Experimental | The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 30 minutes. |
|
| Sham intervention | Sham Comparator | Except for pressure, all the conditions of the HBOT intervention are provided in the sham intervention (nurse measures vitals and asks about health before entering the chamber, time in the chamber, number of sessions per week and overall, nurse in the chamber at all times, mask on the face, etc.). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBOT intervention | Device | HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure. HBOT intervention arm - 3 months of HBOT treatment, 9 months observation all participants receive HBOT treatment for 3 months at year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Cognition Score | This analysis involves 11 cognitive performance variables, each measuring a specific aspect of cognition. In general, higher scores indicate better performance (Digit Symbol measures processing speed, Semantic Fluency measures verbal fluency, Word Recall Task measures immediate verbal memory, Delayed Word Recall Test measures delayed verbal memory, and Recall Unit measures immediate and delayed story recall), except for two variables (Trail Making Test Part A measures processing speed, Trail Making Test Part B measures cognitive flexibility) that measure time (where higher values indicate worse performance). These variables are standardized using Z-scores, which allow for combining and comparing values across different scales. The standardized values (Z-scores) of all 11 measures are averaged to create the composite score. Full range of composite score is -1 to 1. Higher composite Z-score reflects better cognitive performance and more favorable outcomes. | baseline, 12, weeks, 6 months and 12 months |
| Cerebral Blood Flow | Cerebral blood flow (CBF) via arterial spin labeling magnetic resonance imaging (ASL-MRI). CBF is defined as the blood volume that flows per unit mass per unit time in brain tissue. | baseline, 3 months, and 12 months |
| Whole Brain SUVr (FDG-PET) | Measures how actively the brain uses glucose, highlighting areas with abnormal activity that may signal diseases like Alzheimer's. Dimmer areas suggest reduced activity seen in disorders like dementia. | Baseline, 12 weeks, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Computerized Cognitive Test | The sum z-scores for 3 computer-based tests (not language dependent), developed through NIH; EXAMINER assessing executive abilities: http://examiner.ucsf.edu). Early in the study, it became clear that participants-older adults with significant frailty, multiple chronic conditions (average >4 per participant), and high medication burden (mean >5 medications)-were finding the assessment protocol burdensome. The protocol already required repeated cognitive testing, MRI, FDG-PET imaging, and other assessments, leading many participants to report fatigue and difficulty concentrating. To prioritize participant well-being, decision made not to add the NIH computerized cognitive tests. The existing paper-and-pencil battery was well-established, sensitive to cognitive changes, and adequately covered executive function and episodic memory. The NIH computerized cognitive test was never administered, and no data was collected at any time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Schnaider-Beeri, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Mary Sano, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| University of Wisconsin |
De-identified MRI and PET scans and cognitive scores will be made available for investigative collaborations. We expect to share these data with a large number of investigators throughout the world.
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155 participants were enrolled from August 10, 2017, to April 17, 2023. The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers, but the trial was concluded successfully.
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| ID | Title | Description |
|---|---|---|
| FG000 | HBOT Intervention | The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. |
| FG001 | Sham Intervention | The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HBOT Intervention | The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Global Cognition Score | This analysis involves 11 cognitive performance variables, each measuring a specific aspect of cognition. In general, higher scores indicate better performance (Digit Symbol measures processing speed, Semantic Fluency measures verbal fluency, Word Recall Task measures immediate verbal memory, Delayed Word Recall Test measures delayed verbal memory, and Recall Unit measures immediate and delayed story recall), except for two variables (Trail Making Test Part A measures processing speed, Trail Making Test Part B measures cognitive flexibility) that measure time (where higher values indicate worse performance). These variables are standardized using Z-scores, which allow for combining and comparing values across different scales. The standardized values (Z-scores) of all 11 measures are averaged to create the composite score. Full range of composite score is -1 to 1. Higher composite Z-score reflects better cognitive performance and more favorable outcomes. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers. | Posted | Mean | Standard Deviation | Composite z-score | baseline, 12, weeks, 6 months and 12 months |
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HBOT Intervention | The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess in the throat | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Sano | Icahn School of Medicine at Mount Sinai | (212) 659-8838 | mary.sano@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2020 | Apr 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2022 | Apr 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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|
| Sham intervention | Device | Sham was selected as the control condition rather than "usual care" to equate intervention groups with respect to other variables that could influence cognition and functional status, such as a new challenge (completing an activity program), peer socialization, and attention from staff. |
|
| Baseline, 12 weeks, 6 months, 12 months |
| Clinical Dementia Rating-Sum of Boxes (CDR-SB) | Clinical Dementia Rating-Sum of Boxes (CDR-SB), which summarizes impairment in 6 domains (memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care) based on subject and informant interviews. Scores in each of these are combined to obtain a composite score ranging from 0 (no symptoms of dementia) through 3 (severe symptoms of dementia). Total scale from 0-18. Higher scores indicating worse cognitive status. | baseline, 12, weeks, 6 months and 12 months |
| Beck Depression Inventory (BDI) | This is a 21-item, self-report questionnaire that measures attitudes and symptoms of depression during the last week (i.e. mood, feelings of hopelessness, failure, guilt, self-esteem, etc.). Each question has a set of at least four possible responses, ranging in intensity. Total scale 0-63. Higher scores indicate more severe symptoms of depression. | baseline, 12 weeks, 6 months and 12 months |
| Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI) | ADL questionnaire Participant The ADL-PI was developed, comprising 15 ADL (e.g. managing medications, managing finances) and 5 physical function (e.g. shopping and meal preparation) questions. All responses relate to the 3 months prior to the time of rating. Total range 0-30, higher scores indicate greater impairment. | baseline, 12 weeks, 6 months, and 12 months |
| Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI) | ADL Informant This tool is based on caregiver's report to assess participants' abilities to perform basic and instrumental activities of daily living (ADLs) like bathing, walking and self-grooming. All responses should relate to the 4 weeks prior to the time of rating. Full Scale range from 0-53, higher score indicates more impairment for the participant. | Baseline, 12 weeks, 6 months, and 12 months |
| Total Mini-Mental State Examination (MMSE) | Total range 0-30, higher scores indicate better cognitive function. | Baseline, 12 weeks, 6 months, and 12 months |
| Madison |
| Wisconsin |
| 53076 |
| United States |
| Sheba Medical Center | Ramat Gan | Israel |
| Assaf HaRofeh Medical Center | Tzrifin | 70300 | Israel |
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Sham Intervention |
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Total scale from 0-18. Higher score suggests more severe dementia. | Mean | Standard Deviation | units on a scale |
|
| Total Mini-Mental State Examination | Total scale from 0-30, with scores > 25 interpreted as normal cognitive status. | Mean | Standard Deviation | units on a scale |
|
| Total Beck Depression Inventory | Total score from 0-63. Higher score indicates more severe depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | HBOT Intervention | The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. |
| OG001 | Sham Intervention | The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise. |
|
|
| Primary | Cerebral Blood Flow | Cerebral blood flow (CBF) via arterial spin labeling magnetic resonance imaging (ASL-MRI). CBF is defined as the blood volume that flows per unit mass per unit time in brain tissue. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers | Posted | Mean | Standard Deviation | ml blood∕100 g tissue min | baseline, 3 months, and 12 months |
|
|
|
| Primary | Whole Brain SUVr (FDG-PET) | Measures how actively the brain uses glucose, highlighting areas with abnormal activity that may signal diseases like Alzheimer's. Dimmer areas suggest reduced activity seen in disorders like dementia. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers | Posted | Mean | Standard Deviation | Standardized Uptake Value (SUV) | Baseline, 12 weeks, 12 months |
|
|
|
| Secondary | NIH Computerized Cognitive Test | The sum z-scores for 3 computer-based tests (not language dependent), developed through NIH; EXAMINER assessing executive abilities: http://examiner.ucsf.edu). Early in the study, it became clear that participants-older adults with significant frailty, multiple chronic conditions (average >4 per participant), and high medication burden (mean >5 medications)-were finding the assessment protocol burdensome. The protocol already required repeated cognitive testing, MRI, FDG-PET imaging, and other assessments, leading many participants to report fatigue and difficulty concentrating. To prioritize participant well-being, decision made not to add the NIH computerized cognitive tests. The existing paper-and-pencil battery was well-established, sensitive to cognitive changes, and adequately covered executive function and episodic memory. The NIH computerized cognitive test was never administered, and no data was collected at any time. | Data not collected due to decision not to administered instruments. This decision was based on participant frailty and protocol intensity-not technical issues or non-compliance-and was made to ensure feasibility and ethical conduct of the study. The NIH computerized cognitive test was never administered, and no data was collected at any time. | Posted | Baseline, 12 weeks, 6 months, 12 months |
|
|
| Secondary | Clinical Dementia Rating-Sum of Boxes (CDR-SB) | Clinical Dementia Rating-Sum of Boxes (CDR-SB), which summarizes impairment in 6 domains (memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care) based on subject and informant interviews. Scores in each of these are combined to obtain a composite score ranging from 0 (no symptoms of dementia) through 3 (severe symptoms of dementia). Total scale from 0-18. Higher scores indicating worse cognitive status. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers | Posted | Mean | Standard Deviation | score on a scale | baseline, 12, weeks, 6 months and 12 months |
|
|
|
| Secondary | Beck Depression Inventory (BDI) | This is a 21-item, self-report questionnaire that measures attitudes and symptoms of depression during the last week (i.e. mood, feelings of hopelessness, failure, guilt, self-esteem, etc.). Each question has a set of at least four possible responses, ranging in intensity. Total scale 0-63. Higher scores indicate more severe symptoms of depression. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks, 6 months and 12 months |
|
|
|
| Secondary | Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI) | ADL questionnaire Participant The ADL-PI was developed, comprising 15 ADL (e.g. managing medications, managing finances) and 5 physical function (e.g. shopping and meal preparation) questions. All responses relate to the 3 months prior to the time of rating. Total range 0-30, higher scores indicate greater impairment. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks, 6 months, and 12 months |
|
|
|
| Secondary | Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI) | ADL Informant This tool is based on caregiver's report to assess participants' abilities to perform basic and instrumental activities of daily living (ADLs) like bathing, walking and self-grooming. All responses should relate to the 4 weeks prior to the time of rating. Full Scale range from 0-53, higher score indicates more impairment for the participant. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks, 6 months, and 12 months |
|
|
|
| Secondary | Total Mini-Mental State Examination (MMSE) | Total range 0-30, higher scores indicate better cognitive function. | The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks, 6 months, and 12 months |
|
|
|
| 3 |
| 77 |
| 18 |
| 77 |
| 55 |
| 77 |
| EG001 | Sham Intervention | The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise. | 1 | 78 | 6 | 78 | 51 | 78 |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Barotrauma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Bypass surgery | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac Arrythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac catheterization | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Deceased | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intracranial pressure increase | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Metatarsal fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Parathyroidectomy | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Shoulder replacement | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urinary infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Weakness | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acoustic neuromas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (unspecified) | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Arachnoid granulation | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Atrial fibrilation | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Avastin eye injection | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Barotrauma | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Basalioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (unspecified) | Non-systematic Assessment |
|
| BDI=22 | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Blurry vision | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Bone spur | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Bruised ear | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Cardiac catheterization | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
|
| Cataract | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Cavernoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (unspecified) | Non-systematic Assessment |
|
| Chest pain | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Claustrophobia | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Cold | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Colon inflammation | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Colonoscopy | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Covid 19 | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Diabetic foot ulcer | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Diplopia | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Essential tremor | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Exacerbation of post traumatic symptoms (BDI=24) | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Facial paralysis | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Fasciculation | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Fracture of the coccyx | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Gum infection | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Hand tendon injury | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Hip injury | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Hip replacement | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Hypothermia | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Itchy skin | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Knee effusion | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Knee fracture | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Lumbar disc herniation | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Lumbar puncture | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
|
| Metatarsal fracture | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| MRI brain abnormal | Investigations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Myringotomy | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Pains in legs | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Post traumatic pain | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Posture abnormal | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Prostate resection | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
|
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Shoulder fracture | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
|
| Shoulder replacement | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
| Skin cyst | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Stomach ache | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Vision decreased | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Vitreous detachment | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
| Weakness | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
There is an agreement between the sponsor (or its agent) and any non-employee PI(s) that restricts the PI's rights to discuss or publish trial results after the Primary Completion Date.
| 3 months |
|
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| 12 months |
|
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| Visit 2 - 12 weeks |
|
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| Visit 4 - 12 months |
|
|
| 12 weeks |
|
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| 6 months |
|
|
| 12 months |
|
|
| 12 weeks |
|
|
| 6 months |
|
|
| 12 months |
|
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| 12 weeks |
|
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| 6 months |
|
|
| 12 months |
|
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| 12 weeks |
|
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| 6 months |
|
|
| 12 months |
|
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| 12 weeks |
|
|
| 6 months |
|
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| 12 months |
|
|