28 Clinical Trials for Various Conditions
This research project results from the interest in continuing the collaboration with the previous LL-HURS-ONC001 clinical validation study, which gives cause to the present study. LL-HURS-ONC001 was carried out with the participation of HURS' Principal Investigator and the team of experts in prostate cancer, as well as with the participation of the Sponsor's scientific and development team, Life Length SL, led by Dr. Najarro. The main objective of this study is to demonstrate the efficacy of the PROSTAV test in cutting down on unnecessary biopsies in prostate cancer screening/early diagnosis. PROSTAV is a minimally invasive test, easy to implement as biomarker for prostate cancer diagnosis. The efficacy of the PROSTAV test is clinically validated by the results obtained in a previous study, LL-HURS-ONC001. The purpose of this study is to advance in the development of new biomarkers in areas where there is a clinical need and where the telomeric profile influences medical decisions within the patient's clinical context. The association level between each individual's telomere biology and the results of the prostate biopsy will be confirmed. Data will be collected to subsequently delve deeper into and accurately establish the effect of this measure in prostate cancer patient management to substantiate its implementation in standard care.
Prostate Cancer
Background: DNA is a structure in the body. It contains data about how the body develops and works. Telomeres are found on the end of chromosomes in DNA. Some people with short telomeres or other gene changes can develop diseases of the bone marrow, lung, and liver. Researchers want to see if low doses of the hormone drug danazol can help. Objective: To study the safety and effect of low dose danazol. Eligibility: People ages 3 and older with a telomere disease who have either very short telomeres and a specific gene change. They must also show signs of aplastic anemia, lung, or liver disease. Design: Participants will be screened in another protocol. Participants will have: * Medical history * Physical exam * Blood tests * Lung exam. They will breathe into an instrument that records the amount and rate of air breathed in and out over a period of time. 6-minute walking test. * Abdominal ultrasound and liver scan. These tests use sound waves to measure the fibrosis in the liver. Some participants will have: * Pregnancy test * Small sample of the liver removed * Bone marrow biopsy. The bone will be numbed and a small needle will take a sample of the marrow. All participants will have hormone levels checked. All child participants will see a pediatric endocrinologist. Children may need to have a hand x-ray. We will monitor patients for 6 months before starting danazol. Participants will take danazol by mouth twice a day for 1 year. Participants must return to the clinic at 6 months and 12 months while on danazol and 6 months after stopping it. They will have blood and urine tests, a lung exam, abdominal ultrasound, and liver scan.
Telomere Disease
The goal of this clinical trial is to learn if a combination therapy of deoxycytidine (dC) plus deoxythymidine (dT) is safe in patients with telomere biology disorders. The main questions it aims to answer are: * Is the therapy safe with tolerable side effects in patients with telomere biology disorders? * Are peripheral blood counts improved in patients with telomere biology disorders who have cytopenias? Participants will: * Take study drug by mouth three times daily for 24 weeks * Make approximately 2 visits to Boston Children's Hospital during the 24 weeks: once at the beginning of treatment and once at the end of treatment. * Go to a lab for a blood draw an additional 6 times during treatment. * Have 9 phone calls with a research nurse, including one 4 weeks after treatment ends. * Keep a diary to track doses of study drug that were taken or missed.
Telomere Biology Disorders
The purpose of this descriptive study is to examine telomere length between two groups of people, those with and those without food addiction and identify possible relationships that may play a role in food addiction, it's behaviors and consequences. Research subjects would be adults age 19-70. They would be recruited from the Rural Nebraska Panhandle population. All COVID precautions will be enforced. Human subjects safety plans will be in place for this study.Eligibility: YaleFAS-2 Food Addiction Scale will be used to screen for presence or absence of food addiction. AT a later time, Eligible persons will be given the research consent form to read through and determine if they want to become a participant. If so, they will be consented. The participants will then be assigned an identification number to maintain confidentiality. Intervention: Participants will be given a Oragene saliva DNA collection kit to use and return to investigators. Evaluation:The Oragene saliva DNA collection kit will then be sent in for telomere length testing. Telomere Results will be correlated with food addiction diagnoses and behaviors to identify potential relationships. Follow up: Publication of results
Food Addiction
Background: DC and related TBDs are a group of illnesses caused by variants in genes that regulate telomeres. These illnesses can cause problems with the skin and mucous membranes. They can also cause ophthalmic, dental, immunologic, and other abnormalities. Researchers want to learn more about these illnesses and the people who have them. Objective: To learn about the informational, pragmatic, and psychosocial challenges and unmet needs of individuals and families affected by DC and related TBDs. Eligibility: People aged 18 years and older who have DC or related TBD or who are, or have been, a caregiver to someone with DC or related TBD. Design: This study has 2 parts: a survey and a telephone interview. Participants may choose to take part in one or both parts. Participants may complete an online survey. They will select which group most applies to them: person with DC/TBD; parent/caregiver to a person with DC/TBD; or bereaved parent/caregiver of a person who had DC/TBD. The survey will be based on the group they choose. They will answer 20-30 questions. The survey will take 10-20 minutes to complete. Participants may take part in a phone interview. It will take 50-70 minutes to complete. They will give their name, email address, and phone number to schedule the interview. The interview will be audio recorded and transcribed. Personal identifiers will be removed.
Dyskeratosis Congenita, Telomere Biology Disorders
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) was a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL-CTSC cohort and will examine whether vitamin D or fish oil supplementation has beneficial effects on cellular aging.
Aging
This is a Phase I/II, open label, single center study to assess the safety and tolerability of EXG34217 in bone marrow failure patients with telomere biology disorders.
Telomere Shortening, Bone Marrow Failure
This pilot research trial studies telomere length in predicting toxicity in older patients with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.
Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
Researchers hope to determine if the DNA is shortened in your body and determine if there is an increase in the protein that shortens DNA called telomerase.
Acute Myeloid Leukemia
This study will evaluate and compare the genes of the telomere repair complex in healthy control subjects, patients with blood diseases, and patients with inflammatory bowel disease to identify what, if any, changes are associated specifically with inflammatory bowel disease. Patients between 2 and 80 years of age with ulcerative colitis or regional enteritis may be eligible for this study. Participants are recruited from the practice of Dr. Stuart Danovitch, Washington, D.C. Researchers have established that minor differences in a specific set of genes called the telomere repair complex are related to immune-mediated diseases of the bone marrow. NIH researchers are now interested in whether inflammatory bowel disease and other autoimmune diseases show a similar pattern of genetic differences. Participants provide a cell sample for evaluation of the telomere repair complex. The sample is collected via buccal swab, a gentle scraping of the inside of the cheek, and stored for use in research.
Inflammatory Bowel Disease
This is a long-term rollover follow-up study for Phase I/II study (Protocol EXG-US-01).
Telomere Biology Disorders With Bone Marrow Failure
The GEMLIFE Study is a 12-month clinical trial for menopausal women. The purpose of this study is to promote an improved aging process for women in menopause through lifestyle changes. The changes will include a heart healthy diet, structured walking program, and mindfulness-based stress reduction. During the study, the investigators will monitor components of your genetic make-up that will tell us how you are aging. Investigators will also monitor bloodwork for inflammation that can affect medical conditions. Study participants may qualify if you are within 5 years of your last menstrual period and have well controlled medical conditions. There is no cost to participants to enroll in the study- only potential benefits to the participant's health and aging process.
Menopause Syndrome, Inflammation, Inflammatory Response, Aging, Menopause, Telomere Shortening, Stress Oxidative
Background: Bone marrow failure diseases are rare. Much is known about the diseases at the time of diagnosis, but long-term data about the effects of the diseases and treatments are lacking. Researchers want to better understand long-term outcomes in people with these diseases. Objective: To follow people diagnosed with acquired or inherited bone marrow failure disease and study the long-term effects of the disease and its treatments on organ function. Eligibility: People aged 2 years and older who have been diagnosed with acquired or inherited bone marrow failure or Telomere Biology Disorder. First degree family members may also be able to take part in the study. Design: Participants will be screened with a medical history, physical exam, and blood tests. They may have a bone marrow biopsy and aspiration. For this, a large needle will be inserted in the hip through a small cut. Marrow will be drawn from the bone. A small piece of bone may be removed. Participants may also be screened with some of the following: Cheek swab or hair follicle sample Skin biopsy Urine or saliva sample Evaluation by disease specialists (e.g., lung, liver, heart) Imaging scan of the chest Liver ultrasounds Six-Minute Walk Test Lung function test Participants will be put into groups based on their disease. They will have visits every 1 to 3 years. At visits, they may repeat some screening tests. They may fill out yearly surveys about their medicines, transfusions, pregnancy, bleeding, and so on. They may have other specialized procedures, such as imaging scans and ultrasounds. Participation will last for up to 20 years. ...
Severe Aplastic Anemia, Telomere Biology Disorders, Inherited Bone Marrow Failure Syndromes
The purpose of this study is to explore the differences in quality of life , inflammation, stress, telomere length, and mucosal immune function of Hispanic and non-Hispanic caregivers of persons with Alzheimer's disease and related dementias (ADRD). The caregivers will complete the Stress-Busting Program for Family Caregivers in the language of their choice (English or Spanish).
Stress, Psychological, Telomere Shortening, Stress, Physiological
The investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (Black, Latinx, Pilipinx, and Pacific Islander) as a preventative intervention for health disparities found in these communities. The intervention is comprised of two phases. The first consists of community nature walks in a pristine redwood forest for six months. This is followed by chosen nature activities with family and/or friends for three months. The investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. The use of these measures is in alignment with the National Institute of Minority Health and Health Disparities (NIMHD) Research Framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.
Stress, Psychological, Telomere Shortening, Stress Reaction
Stressful and traumatic experiences in childhood (Adverse Childhood Events, or ACEs) have been associated with poor health outcomes that extend into adulthood. When stress is sustained or severe in the absence of an adequate buffer, the stress response can become dysregulated--a state referred to as toxic stress. Some professional organizations have advocated for ACEs screening to be part of routine medical care. To date, however, no ACEs screening tool has been validated for use with children. Intervening early at critical points in the life course has the potential to allow a child to avoid the negative consequences of these adverse events. The proposed study has three overarching aims: (1) Examine the relationship between ACEs, stress biomarkers, and symptoms in children and caregivers over time; (2) Validate an ACEs screening in a pediatric health care setting; and (3) Test whether providing primary care-based preventive interventions for children with or at risk for toxic stress can lead to detectable changes in biomarkers, behavior, or health outcomes for children and/or caregivers.
Fibrinogen Abnormality, Telomere Length, Mean Leukocyte, Atopic, Acute Infection, Inflammatory Response, Self-regulation
This is a phase II trial of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation in patients with inherited bone marrow failure (BMF) disorders to eliminate the need for routine graft-versus-host disease (GVHD) immune suppression leading to earlier immune recovery and potentially a reduction in the risk of severe infections after transplantation.
Fanconi Anemia, Severe Aplastic Anemia, Myelodysplastic Syndromes, T Cell Receptor Alpha/Beta Depletion, Telomere Biology Disorder, Bone Marrow Failure, Dyskeratosis Congenita
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.
Bladder Cancer, Telomere Shortening, Colorectal Adenoma
This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.
Pregnancy Complications, Mental Health Issue, Depression, Anxiety, Pregnancy, High Risk, Biological Clock Disturbance
The current project will use the Complete Health Improvement Program (CHIP) as an intervention for patients with chronic pain. CHIP is a nationally recognized program that encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that patients who complete CHIP will have increased telomerase activity and longer relative telomere length at follow-up when compared to those who do not enroll in the program. Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres are the caps on these chromosomes that protect them from damage. Telomere shortening occurs normally with aging and once they are too short to replicate cellular death occurs. Telomerase is a ribonucleic protein that counterbalances this shortening by extending the ends of chromosomes. Research has shown that patients with chronic pain may have shorter telomeres relative to others of the same age. This study will investigate this association further.
Chronic Pain
Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically causing failure of the blood system. Lung disease, liver disease and cancer are other frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood system but can make the lung and liver disease and risk of cancer worse, because of DNA damaging agents such as alkylators and radiation that are typically used in the procedure. Based on the biology of DC, we hypothesize that it may be possible to avoid these DNA damaging agents in patients with DC, and still have a successful BMT. In this protocol we will test whether a regimen that avoids DNA alkylators and radiation can permit successful BMT without compromising survival in patients with DC.
Dyskeratosis Congenita, Hoyeraal Hreidarsson Syndrome, Revesz Syndrome, Aplastic Anemia
Background: - Some people have bone marrow and lung disorders that are caused by genetic problems. These problems often involve damage to the ends of the chromosomes that pass down genes. One of these disorders is aplastic anemia. This is a disorder in which the bone marrow does not make enough blood cells. Currently, doctors use a male hormone-based drug called Danazol to improve bone marrow function and treat aplastic anemia. More information is needed on whether Danazol can help repair the damaged chromosomes that cause aplastic anemia and similar disorders that cause low blood cell counts or lung problems. Objectives: - To study the safety and effectiveness of Danazol for bone marrow and lung disorders caused by damaged genes. Eligibility: - Individuals at least 2 years of age who have low blood cell counts or lung fibrosis caused by damaged genes. Design: * Participants will be screened with a physical exam and medical history. Then they will have blood and urine tests, imaging studies, and a lung function test. They will also take a 6-minute walking test and have a bone marrow biopsy. * Participants will receive Danazol to take twice a day for the duration of the study. * Participants will have regular study visits at 6, 12, and 24 months, with blood tests, imaging studies, a lung function test, and a 6-minute walking test. A bone marrow sample will be collected at the 12-month visit. * Participants will remain on the study for up to 2 years. Researchers will follow up with them for 2 years after the end of the study.
Aplastic Anemia
The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.
Obesity, Morbid
A method of detecting amyloid in the retina has been developed. A specially designed retinal camera will directly visualze and record retinal amyloid and via image processing will generate a number: the retinal amyloid index (RAI). The amount of retinal amyloid correlates with cerebral amyloid and has a predictive value in Alzheimer's disease. Telomere attrition accounts for cellular aging and is felt to have a pivotal role in Alzheimer's disease. The investigators plan to screen individuals to select those having retinal amyloid then evaluate an oral telomerase activator to determine if its use can alter the RAI over time compared to placebo.
Alzheimer Disease
The purpose of this study is to determine whether an aerobic training intervention will alter markers of immune cell aging, improve exercise capacity and blood pressure and decrease psychological distress over 24 weeks in 32 caregivers compared to 32 age-matched wait list control caregivers.
Aging, Stress, Disease Risk
The purpose of this research study is to examine whether a stress reduction intervention can improve health, mood and biological markers of cellular stress and aging in a group of chronically-stressed maternal caregivers and healthy maternal controls.
Stress, Aging, Well-being
The purpose of this research study is to examine whether a short term meditation intervention can improve health, mood, and biological markers of cellular stress and aging in novice and experienced meditators compared to controls.
Stress, Ageing, Wellbeing
The aim of this study is to develop a blood test to determine which patients are at risk for pre-cancerous colon polyps (ACPs: Advanced Colon Polyps). The telomere length of peripheral blood lymphocytes (PBLs) can be measured from a blood sample. Mechanistic pathways and the investigator's preliminary data support PBL telomere length as a biomarker for ACPs. The long-term goal of this project is to decrease deaths from colon cancer by using a blood test to target colonoscopy for those patients who are at high risk for pre-cancerous polyps.
Colonic Polyp