Lead Investigator: Nima Aghaeepour, Stanford University
Title of Proposal Research: Identifying Subgroups of Patients with Improved Outcomes in Clinical Trials
Vivli Data Request: 9106
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
At present, numerous clinical trials are underway, aiming to find effective treatments for various diseases. While some trials achieve success, many face challenges and fail to deliver the desired outcomes. Our innovative solution seeks to unlock the potential of these trials by investigating whether specific subsets of patients may indeed benefit from the interventions tested.
The journey toward personalized medicine is crucial, as it promises to revolutionize patient care. By studying clinical trial data, we can uncover subsets of patients who respond favorably to particular treatments. This tailored approach ensures that patients receive targeted therapies, boosting treatment efficacy and reducing the risk of adverse effects. Our research aims to transform the landscape of medical science, where novel insights may emerge from understanding the complex interplay between patient characteristics and trial outcomes. By identifying successful subgroups, we can enhance future trial designs, optimize resources, and ultimately elevate patient care.
Our research will employ state-of-the-art machine learning techniques to analyze diverse clinical trial data. By analyzing patient demographics, medical histories, treatment protocols, and trial results, our algorithm will identify patterns that distinguish successful subgroups from the broader patient population. These patterns could encompass genetic markers, age groups, lifestyle choices, or other relevant factors.
By going through vast amounts of data, our algorithm can uncover subtle interactions and associations that might be overlooked through conventional analyses. Through this comprehensive approach, we aim to identify the hidden associations within clinical trials, leading to improved patient outcomes and targeted treatments.
Our approach has the power to redefine patient care, maximizing treatment success and minimizing adverse effects. As we delve into the intricacies of patient data, we hope to lay the groundwork for a future where personalized medicine becomes the gold standard, bringing renewed hope and healing to patients worldwide.
Requested Studies:
A Phase 1, Randomized, Open-Label, Four-Period Crossover, Multiple-Dose Single-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety Following Administration of 60 mg, 90 mg and 120 mg Oral Doses of a Modified Release Formulation of TAK-390 and 30 mg Oral Doses of Lansoprazole in Healthy Subjects
Data Contributor: Takeda
Study ID: T-P104-071
Sponsor ID: T-P104-071
A Phase 1, Single-Center, Randomized, Open-Label, Parallel-Group, Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole MR (30 mg, 60 mg, and 90 mg) in Subjects with Symptomatic, Nonerosive Gastroesophageal Reflux Disease (GERD)
Data Contributor: Takeda
Study ID: T-P105-129
Sponsor ID: T-P105-129
An Open-Label, Randomized, 2-Cohort, 4-Sequence, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin 6.25 mg and 12.5 mg and Metformin 500 mg and 1000 mg When Administered as Individual Tablets and as a Fixed-Dose Combination Tablet
Data Contributor: Takeda
Study ID: SYR-322MET_101
Sponsor ID: SYR-322MET_101
A Phase 1 Two-way Crossover Study to Assess the Effect of Multiple Oral Doses of Febuxostat on the Pharmacokinetics and Pharmacodynamics of Warfarin Following Multiple Oral Doses of Warfarin
Data Contributor: Takeda
Study ID: C03-057
Sponsor ID: C03-057
A Phase 1, Open-Label, Multiple-Dose Study to Assess the Drug-Drug Interaction Between SYR-472 and Caffeine, Tolbutamide, Dextromethorphan, and Midazolam, Administered Concomitantly to Healthy Adult Subjects
Data Contributor: Takeda
Study ID: 01-06-TL-SYR-472-004
Sponsor ID: 01-06-TL-SYR-472-004
A Phase 1, Open-Label, Parallel Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of Dexlansoprazole MR (60 mg) in Subjects With Normal or Moderately Impaired Hepatic Function
Data Contributor: Takeda
Study ID: T-P105-115
Sponsor ID: T-P105-115
An Open-Label, Randomized, 2-Period Crossover Study to Determine the Bioequivalence of SYR-322 and AD-4833 Tablets When Administered as Individual Tablets and as Combination Product and to Determine the Effect of Food on the Pharmacokinetics of Combination Product
Data Contributor: Takeda
Study ID: SYR-322-4833/CPH-001
Sponsor ID: SYR-322-4833/CPH-001
A Phase 1, Open-Label, 2-Period Crossover Design Study to Evaluate the Bioavailability of Over-Coated 100 mg Sitagliptin Tablets Relative to Unaltered 100 mg Sitagliptin Tablets in Healthy Subjects
Data Contributor: Takeda
Study ID: TAK-875_122
Sponsor ID: TAK-875_122
A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients With Chronic Plaque Psoriasis
Data Contributor: AbbVie
Study ID: NCT02016482
Sponsor ID: M13-674
A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID).
Data Contributor: Takeda
Study ID: NCT01452750
Sponsor ID: TAK-438/CCT-301
A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R
Data Contributor: Takeda
Study ID: NCT02079805
Sponsor ID: 279/NRP-001
A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension
Data Contributor: Takeda
Study ID: NCT01496469
Sponsor ID: TMX-67_206
A Randomized Dose-ranging Controlled Trial of DU-176b Versus Warfarin Potassium in Patients With Non-valvular Atrial Fibrillation
Data Contributor: Daiichi Sankyo, Inc.
Study ID: NCT00829933
Sponsor ID: DU176b-C-J225
An Open-label, Randomized, 2-period Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single-dose Administration of TAK-875 25 mg or 50 mg Final Formulation Tablet in Healthy Japanese Male Subjects
Data Contributor: Takeda
Study ID: TAK-875/CPH-040
Sponsor ID: TAK-875/CPH-040
A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Data Contributor: Takeda
Study ID: NCT01642602
Sponsor ID: TAK-390MR_206
A Randomized, 4-Period, 4-Sequence, Double-Blind, Crossover Design Study to Assess the Effect of Single Doses of TAK-438 40 mg, TAK-438 120 mg, Placebo and Positive Control Moxifloxacin (Open-Label) on the QTc Interval in Healthy Adult Subjects
Data Contributor: Takeda
Study ID: TAK-438_113
Sponsor ID: TAK-438_113
Olanzapine Versus Placebo in the Prevention of Relapse in Bipolar Disorder
Data Contributor: Lilly
Study ID: F1D-MC-HGHL
Sponsor ID: F1D-MC-HGHL
Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Data Contributor: AbbVie
Study ID: NCT01760954
Sponsor ID: M12-667
Fluoxetine Versus Placebo in the Treatment of Children and Adolescents with Obsessive-Compulsive Disorder
Data Contributor: Lilly
Study ID: B1Y-MC-HCJW
Sponsor ID: B1Y-MC-HCJW
Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain
Data Contributor: Lilly
Study ID: NCT00408876
Sponsor ID: 10545
First-Line Therapy with Gemcitabine and Paclitaxel in Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
Data Contributor: Lilly
Study ID: B9E-MC-S024
Sponsor ID: B9E-MC-S024
Olanzapine Versus Risperidone in the Treatment of Schizophrenia and Other Psychotic Disorders
Data Contributor: Lilly
Study ID: F1D-MC-HGBG
Sponsor ID: F1D-MC-HGBG
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of IC351 (LY450190) Administered “On Demand” to Patients with Erectile Dysfunction
Data Contributor: Lilly
Study ID: H6D-MC-LVCR
Sponsor ID: H6D-MC-LVCR
A Randomized, Double-Blind, 4-week, Two-Period Crossover Study to Evaluate Patient Preference for IC351 (LY450190) Versus Sildenafil Citrate During the Initial Treatment Period for Erectile Dysfunction
Data Contributor: Lilly
Study ID: H6D-MC-LVCU
Sponsor ID: H6D-MC-LVCU
A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease
Data Contributor: Lilly
Study ID: NCT01621178
Sponsor ID: 13798
Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence
Data Contributor: Lilly
Study ID: NCT00475397
Sponsor ID: 6232
Biomechanical Effects of Duloxetine on Bladder Function and Sphincter Resistance During the Emptying Phase and on Urethral Function During the Filling Phase of the Micturition Cycle in Women With Pure Genuine Stress Incontinence
Data Contributor: Lilly
Study ID: F1J-MC-SBAB
Sponsor ID: F1J-MC-SBAB
Prospective Outcomes of Duloxetine in Usual Naturalistic Care in Women with Stress Urinary Incontinence
Data Contributor: Lilly
Study ID: F1J-MC-SBBA
Sponsor ID: F1J-MC-SBBA
Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes
Data Contributor: Lilly
Study ID: NCT01687998
Sponsor ID: 11949
The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)
Data Contributor: Lilly
Study ID: NCT01088412
Sponsor ID: 2712
The Global Hypopituitary Control and Complications Study
Data Contributor: Lilly
Study ID: NCT01088399
Sponsor ID: 6448
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Data Contributor: AstraZeneca
Study ID: NCT04516746
Sponsor ID: D8110C00001
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation – Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE – AF TIMI – 48)
Data Contributor: Daiichi Sankyo, Inc.
Study ID: NCT00781391
Sponsor ID: DU176b-C-U301
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Data Contributor: Roche
Study ID: NCT01358877
Sponsor ID: BO25126
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
Data Contributor: Lilly
Study ID: NCT00670319
Sponsor ID: 1363
Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)
Data Contributor: Sanofi
Study ID: NCT01887912
Sponsor ID: H-030-014
A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
Data Contributor: Takeda
Study ID: NCT01101035
Sponsor ID: TMX-67_301
A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Data Contributor: Pfizer Inc.
Study ID: NCT01456936
Sponsor ID: A3051123
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Data Contributor: Montreal Heart Institute
Study ID: NCT04322682
Sponsor ID: MHIPS-2020-001
A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Data Contributor: Daiichi Sankyo, Inc.
Study ID: NCT00986154
Sponsor ID: DU176b-D-U305
An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT00949910
Sponsor ID: MO18109
A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Data Contributor: Roche
Study ID: NCT00045032
Sponsor ID: BO16348
An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-α Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
Data Contributor: AbbVie
Study ID: NCT00448383
Sponsor ID: M02-497
Prospective Observational Study of the Risk Factors for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
Data Contributor: Duke University School of Medicine/Duke University Hospital
Study ID: NCT02689531
Sponsor ID: Pro00068313
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
Data Contributor: Takeda
Study ID: NCT00968708
Sponsor ID: SYR-322_402
A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Data Contributor: Sanofi
Study ID: NCT00694382
Sponsor ID: EFC6521
Open Label, Multinational, Multicenter, Real World Treatment Study of Single Agent AZD9291 for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Prior Therapy With an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI)
Data Contributor: AstraZeneca
Study ID: NCT02474355
Sponsor ID: D5160C00022
Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age
Data Contributor: Sanofi
Study ID: NCT01346293
Sponsor ID: M5I02
A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment Due to Alzheimer’s Disease (MCI Due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI Due to AD in Cognitively Normal Subjects
Data Contributor: Takeda
Study ID: NCT01931566
Sponsor ID: AD-4833/TOMM40_301
Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years
Data Contributor: Sanofi
Study ID: NCT01712984
Sponsor ID: QID01
A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies
Data Contributor: AstraZeneca
Study ID: NCT01788163
Sponsor ID: D7913C00074
An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
Data Contributor: Roche
Study ID: NCT01152606
Sponsor ID: BO20652
A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma: The AVANT Study
Data Contributor: Roche
Study ID: NCT00112918
Sponsor ID: BO17920
A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab
Data Contributor: Roche
Study ID: NCT00625898
Sponsor ID: NSABP B-44-I
An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Cancer and Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Excluding Predominant Squamous Cell Histology)
Data Contributor: Roche
Study ID: NCT00388206
Sponsor ID: AVF3991n
A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00306384
Sponsor ID: SYR-322-OLE-012