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Identifying immune modulating patterns across diseases from open clinical trial data

Identifying immune modulating patterns across diseases from open clinical trial data

Institute for Computational Health Sciences
UCSF School of Medicine

This research will be funded by National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology and Transplantation, contract HSN272201200028C

Potential conflicts of interest will be disclosed when the research is presented and published.

23 July 2015

Cytokines, key regulators of the immune system, play a central role in both health and disease. These small proteins are secreted from a variety of cell types including, but not limited to, immune cell types and are involved in many biological processes. Cytokines have been implicated both as possible diagnostics markers and therapeutics targets. For example, Interleukin 18 (IL-18) has been identified as an early diagnostic marker for acute kidney injury (Parikh, Abraham et al. 2005) while Tumor Necrosis Factor alpha (TNF-a) is a therapeutic target for rheumatoid arthritis (Feldmann 2002). Another important aspect of immunity in health and disease involves different immune cell types such as lymphocytes, leukocytes, macrophages, basophiles and eosinophils in fighting infections, inflammatory responses, allergic reactions etc.

Examining disease-related immune patterns, such as cytokine levels and immune cell counts, can help gain better insight into disease-related immune characteristics and find immune-related similarities and differences between diseases. This research aims to elucidate immune-related patterns in a verity of different disease based on open clinical trial data. Furthermore, these patterns will be used to validate the accuracy of an immune-related dataset that was created by mining the medical literature. Using the placebo, untreated and control arms of several different clinical trials, we aim to identify those disease related immune patterns such as the variability in different cell types that are routinely measured in standard blood tests and mechanistic assays. These immune patterns will then be used to compare between different diseases and to compare it to similar patterns, which were mined from biomedical texts.

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Medicine: SB705498, Condition: Rhinitis, Phase: 2, Clinical Study ID: VR1111924, Sponsor: GSK" },{ "PostingID": 481, "Title": "GSK-49653/331", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Rosiglitazone Maleate in the Treatment of Chronic Plaque Psoriasis

Medicine: rosiglitazone, Condition: Psoriasis, Phase: 3, Clinical Study ID: 49653/331, Sponsor: GSK" },{ "PostingID": 1317, "Title": "ROCHE-BV16052", "Description": "A phase III open-label, randomized, controlled study assessing the efficacy and safety of T-20/Ro 29-9800 (HIV-1 fusion inhibitor) in combination with an optimized background regimen, versus optimized background regimen alone, in triple class (nucleoside reverse transcriptase, non-nucleoside reverse tanscriptase and protease inhibitors) experienced patients or patients naive to one class

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Medicine: peg-interferon alpha-2a, Condition: chronic hepatitis b, Phase: 3, Clinical Study ID: WV16240, Sponsor: Roche" },{ "PostingID": 1336, "Title": "ROCHE-NV15942", "Description": "A phase III, randomized, multicenter, efficacy and safety study examining the effects of the duration of treatment and the daily dose of ribavirin in patients with chronic hepatitis C virus infection treated with the combination of pegylated-interferon alpha-2a and ribavirin

Medicine: peg-interferon alpha-2a, Condition: chronic hepatitis c, Phase: 3, Clinical Study ID: NV15942, Sponsor: Roche" },{ "PostingID": 1350, "Title": "ROCHE-WA17822", "Description": "A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab versus placebo, in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis

Medicine: tocilizumab, Condition: rheumatoid arthritis, Phase: 3, Clinical Study ID: WA17822, Sponsor: Roche" },{ "PostingID": 1359, "Title": "ROCHE-MRA009JP", "Description": "A randomized, double-blind, parallel-group, comparison study of three doses (placebo, MRA 4 mg/kg, or MRA 8 mg/kg) in patients with rheumatoid arthritis

Medicine: tocilizumab, Condition: rheumatoid arthritis, Phase: 2, Clinical Study ID: MRA009JP, Sponsor: Roche" },{ "PostingID": 1369, "Title": "ROCHE-NO25026 (BRIM3)", "Description": "A randomized, open-label, controlled, multicenter, global study on progression-free and overall survival in previously untreated patients with unresectable stage IIIC or stage IV melanoma with V600E BRAF mutation receiving RO5185426 or dacarbazine

Medicine: vemurafenib, Condition: malignant melanoma of skin, Phase: 3, Clinical Study ID: NO25026 (BRIM3), Sponsor: Roche" },{ "PostingID": 1576, "Title": "BI-1218.6", "Description": "Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

Medicine: linagliptin, Condition: Diabetes Mellitus, Type 2, Phase: 2, Clinical Study ID: 1218.6, Sponsor: Boehringer Ingelheim" },{ "PostingID": 1957, "Title": "LILLY-F1D-MC-HGHB", "Description": "A Double-Blind Randomised Comparison of the Efficacy and Safety of Short Acting Intramuscular Olanzapine, Short Acting Intramuscular Haloperidol and Intramuscular Placebo in Patients with Schizophrenia

Medicine: Olanzapine, Condition: Schizophrenia, Phase: 3, Clinical Study ID: F1D-MC-HGHB, Sponsor: Lilly" },{ "PostingID": 2092, "Title": "LILLY-F1D-MC-HGGW", "Description": "Olanzapine Versus Placebo in the Treatment of Bipolar Disorder, Manic or Mixed

Medicine: Olanzapine, Condition: Bipolar Disorder, Phase: 3, Clinical Study ID: F1D-MC-HGGW, Sponsor: Lilly" },{ "PostingID": 2349, "Title": "TAKEDA-C13011", "Description": "A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Medicine: vedolizumab, Condition: Ulcerative Colitis; Crohn's Disease, Phase: 3, Clinical Study ID: C13011, Sponsor: Takeda" },{ "PostingID": 2377, "Title": "UCB-SP650", "Description": "A multi-center, multinational, Phase 3, randomized, double-blind, parallel
group, placebo-controlled trial of the efficacy and safety of rotigotine CDS patch (2 target
doses) in subjects with advanced-stage, idiopathic Parkinson?s disease who are not well
controlled on levodopa

Medicine: Rotigotine, Condition: Parkinson's Disease, Phase: 3, Clinical Study ID: SP650, Sponsor: UCB" },{ "PostingID": 2470, "Title": "LILLY-B1Y-MC-HCEP", "Description": "Fluoxetine vs Placebo in Obsessive Compulsive Disorder

Medicine: Fluoxetine, Condition: Obsessive Compulsive Disorder, Phase: 2, Clinical Study ID: B1Y-MC-HCEP, Sponsor: Lilly" },{ "PostingID": 2620, "Title": "BI-1235.37", "Description": "Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

Medicine: telmisartan + amlodipine, Condition: Hypertension, Phase: 3, Clinical Study ID: 1235.37, Sponsor: Boehringer Ingelheim" }]

Statistical Analysis Plan

The publication citation plan will be added after the research is published.