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| Name | Class |
|---|---|
| Triangel Scientific | INDUSTRY |
| Center of New Medical Technologies | OTHER |
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The study "Personalized Management of Autoimmune Diseases with AI-Guided (GenAIS TM) Dietary Supplementation" investigated the effectiveness of AI-guided dietary supplement (DS) prescriptions compared to standard physician-guided prescriptions in managing autoimmune diseases. This 6-month randomized controlled trial included 160 participants with conditions like rheumatoid arthritis, lupus, and multiple sclerosis. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in disease activity, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator |
| |
| AI-Guided Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Other | Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles. |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change in disease activity scores for the AI-Guided group compared with the Control group | Systemic Lupus Erythematosus Disease Activity Index, which has a score range from 0 to 105, to measure disease activity in participants with lupus. Disease Activity Score 28 (DAS28), which has a score range from 0 to 10, to measure disease activity in participants with rheumatoid arthritis. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in specific symptoms of autoimmune disease | 6 months | |
| Percent change in high-sensitivity C-reactive protein | 6 months | |
| Percent change in body weight and body mass index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of New Medical Technologies | Novosibirsk | Novosibisk Region | 630090 | Russia |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| AI-Guided Group | Other | Participants receive supplement prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history. |
|
| 6 months |
| Incidence of adverse effects related to dietary supplements. | 6 months |
| Number Participant adherence to the prescribed dietary supplements regimen | 6 months |
| Changes in quality of life score Short Form-36 | Short Form-36 Health Survey, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better health and well-being. | 6 months |
| Changes in quality of life score World Health Organization Quality of Life - BREF | World Health Organization Quality of Life - BREF, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better quality of life. | 6 months |
| D008722 | Methods |