Clinical trials: Epigenetics
Infant Development, Stress
Multisensory Early Oral Administration of Human Milk in Preterm Infants
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation.
- Trial name
- M-MILK (NCT06230848)
- Testing
- Multisensory Early Oral Administration of Human Milk (M-MILK)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Loyola University
Breast Neoplasms
Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant
The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human…
- Trial name
- NCT02374099
- Testing
- CC-486, Fulvestrant
- Where
- 35 sites in United States, Belgium and 4 more
- Volunteers
- 97 people
- Sponsor
- Celgene
Lymphoblastic Leukemia, Acute, Childhood, Myelogenous Leukemia, Acute, Childhood
A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML
This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine…
- Trial name
- NCT01861002
- Testing
- Azacytidine, Fludarabine, Cytarabine
- Where
- 23 sites in United States, Australia and 1 more
- Volunteers
- 15 people
- Sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
Carcinoma, Non-Small-Cell Lung
Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer
The purpose of this study is to determine whether the combination therapy of CC-486 (oral azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab alone in patients with previously treated…
- Trial name
- NCT02546986
- Testing
- CC-486, Pembrolizumab
- Where
- 33 sites in United States, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Celgene
Carcinoma, Non-Small-Cell Lung
Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer
This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab…
- Trial name
- abound2L+ (NCT02250326)
- Testing
- nab-paclitaxel IV, CC-486, Duravalumab
- Where
- 34 sites in United States, Canada and 5 more
- Volunteers
- 240 people
- Sponsor
- Celgene
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a)
Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS
The goals of this study are to learn about the effectiveness, the side-effects, if waiting to give the idarubicin and cytarabine may change the side effects or effectiveness, and to identify factors to predict for responses to…
- Conditions
- Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2)
- Trial name
- NCT01607645
- Testing
- decitabine, idarubicin, cytarabine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Fred Hutchinson Cancer Center
Concussion, Brain
Salivary Biomarkers for Concussion Recovery
The overarching purpose of this proposed research is to determine whether BDNF and/or specific miRNAs can serve as biomarkers for recovery from a concussion during prescribed exercise.
- Trial name
- NCT05379920
- Testing
- High Volume Aerobic Exercise, Low Volume Aerobic Exercise
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
Mitochondrial Diseases
Mitochondrial Stress, Brain Imaging, and Epigenetics
The MiSBIE study collects biological, behavioral, psychosocial, neuropsychological, and brain imaging data in participants with either: normal mitochondrial function, individuals with the m.3243A>G mitochondrial DNA (mtDNA)…
- Trial name
- MiSBIE (NCT04831424)
- Testing
- Trier social stress test
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Columbia University
Mild Cognitive Impairment, Metabolic Syndrome
Dietary Ketosis: Fatty Acids Activate AMPK Energy Circuits Modulating Global Methylation
The study explores whether selective memory complaints (SMC), mild cognitive impairment (MCI) and the comorbidity of Metabolic Syndrome symptomatic of peripheral and cerebral hypo-metabolism with corresponding epigenetic shifts…
- Trial name
- NCT03319173
- Testing
- Dietary intervention
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Bristlecone Health, Inc.
Healthy
National Survey to Understand Ethical, Legal and Social Issues in Communicating to the Public About Epigenetics
Few people realize that environmental pollution and some behaviors like physical activity and tobacco smoking can affect their health by "turning on" or "turning off" certain genes through a process called "epigenetic…
- Trial name
- NCT07020234
- Testing
- Epigenetics Video, Nanotechnology Video
- Where
- United States
- Volunteers
- 2,040 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Major Depressive Disorder, Suicidal Ideation
Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation
The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary…
- Trial name
- AFSP (NCT01134731)
- Testing
- paliperidone, lithium
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Alabama at Birmingham
Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma
Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery
This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor, 5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat (SNDX-275), for the adjuvant treatment of patients with…
- Trial name
- NCT01207726
- Testing
- Azacitidine, Entinostat, Laboratory Biomarker Analysis
- Where
- 9 sites in United States
- Volunteers
- 13 people
- Sponsor
- National Cancer Institute (NCI)
Hepatitis C, HIV
Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha…
- Trial name
- LATHCV (NCT01182298)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pediatric Acute Myelogenous Leukemia (AML)
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission…
- Trial name
- NCT01177540
- Testing
- Decitabine
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 25 people
- Sponsor
- Eisai Inc.
Metastatic Castration-Resistant Prostate Cancer
A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
This is an open label, non-randomized, Phase 1b/2a, dose escalation and dose confirmation study of ZEN003694 in combination with enzalutamide in patients with mCRPC.
- Trial name
- NCT02711956
- Testing
- ZEN003694, Enzalutamide
- Where
- 8 sites in United States
- Volunteers
- 75 people
- Sponsor
- Zenith Epigenetics
Metastatic Melanoma
Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat
The purpose of this study is to treat metastatic melanoma with a combination of standard chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug called panobinostat.
- Trial name
- NCT00925132
- Testing
- Temozolomide, Decitabine, Panobinostat
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Iowa
Lung Cancer, Non-small Cell Lung Cancer
Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial
The purpose of this study is to assess whether treatment with the study drug tetrahydrouridine-decitabine (THU-Dec) in combination with nivolumab is more effective than treatment with nivolumab alone in patients with NSCLC.
- Trial name
- PRECISE (NCT02664181)
- Testing
- Nivolumab, oral decitabine, Tetrahydrouridine
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Case Comprehensive Cancer Center
Leukemia, Erythroblastic, Acute, Myelodysplastic Syndromes
Azacytidine Prior to in Vivo T-cell Depleted Allo Stem Cell Transplant for Patients With Myeloid Malignancies in CR
The purpose of this study is to determine whether 5-Azacytidine priming before the conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an effective treatment for high risk myeloid malignancies in…
- Trial name
- NCT02497404
- Testing
- 5-Azacytidine, Fludarabine, Melphalan
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Weill Medical College of Cornell University
Small Cell Carcinoma, Carcinoma, Non-Small-Cell Lung
RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen.
- Conditions
- Small Cell Carcinoma, Carcinoma, Non-Small-Cell Lung, Neuroendocrine Tumors, Ovarian Epithelial Cancer
- Trial name
- NCT02489903
- Testing
- RRx-001, Cisplatin, Etoposide
- Where
- 10 sites in United States
- Volunteers
- 139 people
- Sponsor
- EpicentRx, Inc.
Chronic Pelvic Pain
Effects of Epigenetic Regulation in Chronic Pelvic Pain Syndrome
This study seeks to identify defects in immune activation or regulation that may affect a subset of patients with CP/CPPS. This subset appears to have a reduced ability to mount a regulatory immune response, while simultaneously…
- Trial name
- NCT05185180
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Northwestern University