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Набира участници Фаза 1/2

Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca

Solid Tumor, Adult

To determine the recommended phase 2 dose (RP2D) of the combination of neratinib and sodium valproate when given to patients with advanced solid tumors. Then to explore the antitumor effects of the neratinib and sodium valproate combination in advanced solid tumors with attention to RAS-mutated tumors, EGFR-altered GBM, and ocular melanoma, as part of the phase 2 expansion cohort.

Начало: 01.05.2019 Край: 31.01.2031 Възраст: от 18 г.

United States Virginia Commonwealth University NCT03919292

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Sensory-Motor Rehabilitation Post Stroke

Acute Stroke

Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.

Начало: 26.04.2019 Край: 31.12.2027 Възраст: 18–80 г.

United States University of Maryland, Baltimore NCT02369770

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Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction

Sacroiliac Joint Somatic Dysfunction Low Back Pain

There are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. The diagnosis, based mostly on radiological exams, carries a risk of failure to diagnose the sacroiliac joint as the cause of the pain. The study proposes that a quick interrogatory followed by a physical exam with the adequate provocative testing can raise the suspicion of the diagnosis that the pain is originating from the sacroiliac joint. Thereafter, a diagnostic sacroiliac joint block can be performed. The study aims to correlate findings from patient history and physical examination with eventual diagnosis.

Начало: 19.04.2019 Край: 01.12.2026 Възраст: от 18 г.

Spain University of Valencia NCT04381208

Набира участници Фаза 2

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

Milk and/or Peanut Allergy

Background: Atopic dermatitis (AD), also called eczema, makes skin dry, red, and itchy. People with AD are more likely to get a food allergy than people without AD. But some food allergy tests are not always accurate in people with AD. Researchers want to study if people are truly allergic to milk and/or peanuts. Objectives: To improve the ways doctors test for food allergy in people with AD. Eligibility: People ages 3-21 who have had AD; have a high total IgE level (an allergic antibody); might have a milk and/or peanut allergy; and are currently enrolled in another NIH study Design: Participants will be screened under another protocol. Participants will have a physical exam, blood tests, and medical history. Participants will breathe into a plastic device that measures lung strength. Participants may get a small plastic tube inserted in their arm. Participants who have not had an allergic reaction to food in the past 3 years will do 1 or more oral food challenge (OFCs) depending on their allergies. They will eat a little bit of the food they might be allergic to. They will be watched for a reaction. If they have one, they will know for sure they are allergic. They may keep eating bigger portions of the food until they either have a reaction or finish all the food. In some OFCs, participants will get a placebo food. OFCs will last a few hours or 2 days. Participants will repeat all tests at each OFC. Participation can last up to 12 months. ...

Начало: 19.04.2019 Край: 31.12.2027 Възраст: 3–21 г.

United States National Institute of Allergy and Infectious Diseases ( NCT03835767

Набира участници Фаза 1

Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers

Healthy Volunteer

Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious. Objectives: To test the safety and effects of three new HIV vaccines. Eligibility: Healthy adults 18-49 years old (vaccinees) Their household and intimate contacts 18-65 years old Design: Vaccinees will be screened with: Physical exam Medical history Blood and urine tests Questions about HIV risk Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study. Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18-65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam. All applicable participants will have a pregnancy test at every visit. Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get: 1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits The booster vaccine by needle in an arm at 1 visit Nasal swabs taken at some visits Vaccinees will note their temperature and symptoms for at least 1-4 weeks after each vaccine. Vaccinees may choose to have: Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm. Small pieces of the tonsil removed Sponsoring Institute: National Institute of Allergy and Infectious Diseases ...

Начало: 17.04.2019 Край: 30.11.2028 Възраст: 18–65 г.

United States National Institute of Allergy and Infectious Diseases ( NCT03878121

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Children and Adults With Chordoma

Chordoma

Background: Chordoma is a rare type of bone cancer. It occurs in the skull base or spine. Researchers want to study people with chordoma in different ways. They hope this will help them design better future treatments and supportive care studies for this disease. Objective: To learn more about chordoma by looking at its clinical course, how it appears on imagine scans, and how it responds to therapies and treatments. Eligibility: People ages 2 and older with chordoma who are enrolled in NCI protocol 19-C-0016 Design: Participants will be screened with their medical history. Participants will have a visit to examine their disease. This will include: * Physical exam * Neurologic exam * CT scan and MRI: Participants will lie on a table. The table will slide into a machine. The machine will take pictures of the body. Participants will have other tests every 6-12 months: * Smell test * Surveys to assess their emotional, physical, and behavioral well-being and needs * Cognitive function tests Participants or their home doctors will be contacted every 6 12 months. They will be asked to provide information about their disease. This could include test results and imaging evaluations. Some participants may be asked to come to the clinic for more visits. ...

Начало: 16.04.2019 Край: 31.12.2029 Възраст: от 2 г.

United States National Cancer Institute (NCI) NCT03910465

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Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos

Aneuploidy Mosaicism Pregnancy Outcome

To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first five years after birth.

Начало: 11.04.2019 Край: 01.04.2039 Възраст: 18–55 г.

United States Stanford University NCT04109846

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Aspirin 50 mg vs. 100 mg in Elderly Cardiovascular Disease Patients

Atherosclerotic Cardiovascular Disease (ASCVD) Secondary Prevention Cardiovascular Diseases

Elderly patients with cardiovascular disease face a high risk of both thrombotic and bleeding events when receiving antithrombotic therapy. The optimal dose of aspirin for secondary prevention in this population remains uncertain, particularly in Chinese elderly individuals. This multicenter, prospective cohort study aims to evaluate the effectiveness and safety of a lower dose of aspirin (50 mg daily) compared with the standard dose (100 mg daily) for secondary prevention of atherosclerotic cardiovascular disease (ASCVD) in Chinese patients aged 60 years and older. The study is an extension of the existing LAPIS cohort (ChiCTR1900021980), which has enrolled 5,448 participants receiving long-term aspirin for secondary prevention. Participants will be followed for an additional 2 years (total follow-up up to approximately 6 years) through telephone, clinic visits, and electronic medical records. The primary effectiveness outcome is the first occurrence of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, unstable angina, need for revascularization, non-fatal stroke, transient ischemic attack, and cardiovascular death (excluding intracranial bleeding). The primary safety outcome is the first occurrence of bleeding events (classified by BARC criteria). A secondary aim is to develop and validate a risk prediction model (nomogram) for thrombotic and bleeding events specifically for elderly Chinese patients receiving antithrombotic therapy, using LASSO regression and Cox proportional hazards models. The study will provide real-world evidence to guide individualized antithrombotic management in the aging Chinese population.

Начало: 10.04.2019 Край: 31.12.2027 Възраст: от 60 г.

China Peking University First Hospital NCT07542860

Набира участници Фаза 3

An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia

Hyperkalaemia

Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children \

Начало: 02.04.2019 Край: 21.02.2030 Възраст: до 18 г.

Brazil, Canada, China +10 AstraZeneca NCT03813407

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Role of "Asthma School" in Disease Management

Asthma

According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (\~ 10% of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy.The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals

Начало: 01.04.2019 Край: 15.12.2026 Възраст: 18–85 г.

Italy Istituti Clinici Scientifici Maugeri SpA NCT04442646

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Longitudinal Studies of Patient With FPDMM

Inherited Hematological Diseases Rare Diseases FPDMM

Background: Genes tell the body and its cells how to work. Familial platelet disease (FPD) or FPD with associated malignancies (FPDMM) is caused by a variant in the gene RUNX1. People with this disease may have problems with their blood and bleed for a long time when they are injured. Researchers want to learn more about RUNX1 variants and FPD. Objective: To learn more about FPD in people with RUNX1 variants to lead to better diagnosis, monitoring, and treatment. Eligibility: People any age with a suspected or confirmed RUNX1 variant People who have a family member with the variant Design: All participants will be screened with a phone call and a blood, saliva, or cheek cell sample. Participants with a suspected or confirmed variant will have 1 visit. It will last about 2 days. They will then have visits at least once a year. Visits will include: * Medical history and physical exam * Blood tests or saliva sample * Possible skin biopsy: A small piece of the participant s skin will be removed. * Bone marrow aspiration or biopsy: The participant s bone marrow will be removed by needle from a large bone such as the hip bone. * Possible apheresis: Blood will be removed from the body and certain blood cells will be taken out. The rest of the blood is returned to the body. Between visits, participants with a suspected or confirmed variant will keep a diary of disease symptoms and signs. Samples from all participants may be used for genetic testing

Начало: 28.03.2019 Край: 31.12.2028 Възраст: 1–100 г.

United States National Human Genome Research Institute (NHGRI) NCT03854318

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Men at High Genetic Risk for Prostate Cancer

Prostatic Neoplasms

Background: Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer. Objectives: To study men with specific genetic changes and determine who is at higher risk for getting prostate cancer. To study if certain genetic changes and family history can be used to help prevent or treat prostate cancer. Eligibility: Males between ages 30-75 who have one or more specific genetic changes but without prostate cancer. Design: * This study does not perform genetic testing. All participants must have documented genetic changes and able to provide a copy of the report. * Before enrollment, participants will provide a copy of documented genetic changes and go through a telephone interview to determine eligibility for the study. * On enrollment, participants will have medical and family history review, medication review, physical exam, blood collection for clinical and research testing, and MRI (magnetic resonance imaging) of the prostate. * Every year, participants will repeat the physical exam, medical history, family history, medication review, routine blood tests, including PSA and testosterone. * Every 2 years, participants will repeat all the above plus prostate MRI and blood tests for research. * If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be asked to do a biopsy. * If the biopsy results in prostate cancer, participants will be given counseling on next steps, general treatment recommendations, and then followed with a phone call each year. * Participants may ask to speak with a genetic counselor.

Начало: 27.03.2019 Край: 01.01.2039 Възраст: 30–75 г.

United States National Cancer Institute (NCI) NCT03805919

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Study of Endocrine-Related Conditions and Physiology

Endocrine Disease

Background: Endocrine disorders involve changes to glands that produce hormones. Hormones are released by these glands into the blood so they can direct the function of other tissues in the body. Researchers want to study people who may have endocrine disorders. They want to learn more about the conditions that affect endocrine glands. Objective: To study adults with a variety of endocrine disorders for research and physician education. Eligibility: Adults ages 18 and older who have an endocrine or metabolic-related disorder Healthy volunteers 18 and older Design: Participants will be screened with a review of their medical records. Participants will have a physical exam and medical history. The length of the study and the schedule will vary by participant. Tests may include: Blood and urine tests Stool and saliva samples Imaging studies: Participants will lie on a table while a machine takes pictures of the body. They may be injected with a substance to make their organs more visible in the pictures. Tests of endocrine tissue function Consultation with other specialists Sleep study Medical photographs Participants may be treated for their endocrine disorder. This could include: Surgery. If tissue is removed during surgery, it may be studied. Radiation Medicine Participants may have genetic testing. This will be done with a small amount of blood, cells from a cheek swab, or saliva. Sponsoring Institution: National Institute of Digestive, Diabetes and Kidney Disease

Начало: 27.03.2019 Край: 01.01.2036 Възраст: 18–90 г.

United States National Institute of Diabetes and Digestive and Kidney NCT03867448

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Increased Inflammation-resolving Activity by Omega-3 Monoglycerides in Peripheral Blood Mononuclear Cells (PBMC).

Resolution of Inflammation Reduction of Cell Proliferation

The purpose of this biological study is to provide Dr. Samuel Fortin's laboratory with a continuous supply of blood mononuclear cells (PBMCs) so that he can pursue research on the potential beneficial effects of monoglyceride omega-3 fatty acids on the resolution of inflammation.

Начало: 12.03.2019 Край: 01.01.2027 Възраст: от 18 г.

Canada SCF Pharma NCT05161702

Набира участници Фаза 2

A Study Utilizing Escitalopram in Glioma Patients

Glioma of Brain Glioma

Glioma is a cancer of glial cells, a class of tissue supporting neuronal function in the brain. As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also from therapy such as cranial radiation and chemotherapy, which degrades neuronal function. There is evidence that serotonin selective reuptake inhibitors (SSRIs), such as escitalopram, improve cognition or prevent cognitive decline and may also improve outcomes critical to overall survival including functional independence, psychosocial stability, and quality of life. This pilot study will evaluate the effectiveness of the selective serotonin reuptake inhibitor (SSRI) escitalopram for treating cognitive impairment in newly diagnosed grade IV glioma over a 17 week treatment period.

Начало: 06.03.2019 Край: 01.06.2029 Възраст: от 19 г.

United States University of Nebraska NCT03728673

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Long-Term Follow-Up of Survivors of Pediatric Cushing Disease

Cushing Disease

Background: The pituitary gland produces hormones. A tumor in this gland can cause it to produce too much of the hormone cortisol. Too much cortisol in the body causes Cushing disease. This disease causes many problems. Some of these problems might persist after the disease is cured. Objective: To find out the long-term effects of exposure to high levels of cortisol during childhood and adolescence. Eligibility: People ages 10-42years who were diagnosed with Cushing disease before age 21 and are now cured and have normal or low cortisol levels People related to someone with Cushing disease Design: Participants will be screened with a medical history. Participants will complete an online survey. This will include questions about their or their child s physical and mental health. All participants will be seen at 5 -year intervals after cure of Cushing disease (5yr, 10yr, 15yr, 20yr (last visit)) Participants who have a relative with Cushing disease will have a medical history and blood tests or cheek swabs. Participants who have the disease will have: Physical exam Blood tests Cheek swab DXA scan: A machine will x-ray the participant s body to measure bone mineral content. For participants who are still growing, a hand x-ray Participants with the disease may also have: Hormone stimulation test: Participants will get a hormone or another substance that will be measured. Serial hormone sampling: Participants blood will be measured several times through a thin plastic tube in an arm vein. Urine tests: Participants urine may be collected over 24 hours. MRI: Participants may have a dye injected into a vein. They will lie on a table that slides into a machine. The machine will take pictures of the body.

Начало: 04.03.2019 Край: 03.01.2040 Възраст: 2–90 г.

United States Eunice Kennedy Shriver National Institute of Child Heal NCT03831958

Набира участници Фаза 2

Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC

Lung Cancer Stage III

The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.

Начало: 01.03.2019 Край: 31.12.2029 Възраст: 18–75 г.

China Sun Yat-sen University NCT03872661

Набира участници Фаза 3

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Bone Metastases Lymphoma Multiple Myeloma Opioid Use +1

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

Начало: 20.02.2019 Край: 31.03.2027 Възраст: от 18 г.

United States St. Louis University NCT03823534

Набира участници Фаза 2

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

Severe Aplastic Anemia (SAA) Hypo-Plastic Myelodysplastic Syndrome (MDS) Paroxysmal Nocturnal Hemoglobinuria (PNH)

Background: Severe aplastic anemia (SAA), and myelodysplastic syndrome (MDS), and paroxysmal nocturnal hemoglobinuria (PNH) cause serious blood problems. Stem cell transplants using bone marrow or blood plus chemotherapy can help. Researchers want to see if using peripheral blood stem cells (PBSCs) rather than bone marrow cells works too. PBSCs are easier to collect and have more cells that help transplants. Objectives: To see how safely and effectively SAA, MDS and PNH are treated using peripheral blood hematopoietic stem cells from a family member plus chemotherapy. Eligibility: Recipients ages 4-60 with SAA, MDS or PNH and their relative donors ages 4-75 Design: Recipients will have: * Blood, urine, heart, and lung tests * Scans * Bone marrow sample Recipients will need a caregiver for several months. They may make fertility plans and a power of attorney. Donors will have blood and tissue tests, then injections to boost stem cells for 5-7 days. Donors will have blood collected from a tube in an arm or leg vein. A machine will separate stem cells and maybe white blood cells. The rest of the blood will be returned into the other arm or leg. In the hospital for about 1 month, recipients will have: * Central line inserted in the neck or chest * Medicines for side effects * Chemotherapy over 8 days and radiation 1 time * Stem cell transplant over 4 hours Up to 6 months after transplant, recipients will stay near NIH for weekly physical exams and blood tests. At day 180, recipients will go home. They will have tests at their doctor s office and NIH several times over 5 years. ...

Начало: 19.02.2019 Край: 01.06.2028 Възраст: 4–75 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT03520647

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Synergistic Activity of Human Milk Nutrients and Infant Cognition

Breastfeeding, Exclusive

Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal. Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.

Начало: 05.02.2019 Край: 01.03.2027 Възраст: 3–35 г.

United States University of North Carolina, Chapel Hill NCT03838536

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