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Набира участници Фаза 2

Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

Chronic Hepatitis B

The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.

Начало: 01.11.2016 Край: 01.10.2029 Възраст: 2–17 г. Лечение

Belgium, Canada, Hong Kong +8 Gilead Sciences NCT02932150

Набира участници Фаза 3

Duration of Anti-PD-1 Therapy in Metastatic Melanoma

Unresectable/Metastatic Melanoma

The purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.

Начало: 31.10.2016 Край: 31.12.2029 Възраст: от 18 г. Лечение

Australia, Canada Canadian Cancer Trials Group NCT02821013

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Clinical and Molecular Studies in Families With Inherited Eye Disease

Inherited Eye Disease

Background: Genes are the basic units of heredity. When genes are changed, certain cells don t work like they should. Researchers want to try to better understand the genetic conditions that are linked with inherited eye diseases. Objective: To try to identify the genes linked to the development of inherited eye diseases. Eligibility: People ages 4 and older who have or have a family member with an inherited eye disease Design: Participants will be screened with medical history and medical records. Participants will have one visit that will take 3-4 hours. This will include: Medical and family history Eye exam: This includes the pupil being dilated. Electroretinography: A small electrode is taped to the forehead. Participants sit in the dark with their eyes patched for 30 minutes. Then numbing drops and contact lenses are put in the eyes. They will watch flashing lights. Blood tests Saliva sample: They will spit into a container or have the inside of their cheek swabbed. Genetic testing will be done on participants blood or saliva. Participants may meet with the researchers to discuss their genetic tests.

Начало: 04.10.2016 Край: 01.01.2032 Възраст: 4–120 г.

China, India, Italy +5 National Eye Institute (NEI) NCT02771236

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PIERS and BIS, sFIT:PIGF, Adrenomedullin

Eclampsia

Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.

Начало: 01.10.2016 Край: 01.12.2030 Възраст: 18–50 г.

Malaysia Suez Canal University NCT02578810

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ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

Mycosis Fungoides Non-Hodgkin's Lymphoma

The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.

Начало: 01.10.2016 Край: 01.03.2027

Argentina, Australia, Brazil +4 Stanford University NCT02848274

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Primary Tumor Research and Outcomes Network

Spinal Column Tumor

This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.

Начало: 01.10.2016 Край: 01.12.2028

Australia, Canada, China +6 AO Innovation Translation Center NCT02790983

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The Global Angelman Syndrome Registry

Angelman Syndrome

The Global Angelman Syndrome Registry is an online patient organisation driven registry to collect information about the natural history of children and adults with Angelman Syndrome. The registry will facilitate 1) recruitment for clinical trials into therapies and interventions to benefit participants with Angelman Syndrome and their families, and 2) advancement of research and best standards of care for Angelman Syndrome. The registry is currently available in English, Spanish, Traditional Chinese, Italian, Polish, Hindi, and Brazilian Portuguese.

Начало: 28.09.2016 Край: 31.12.2099

Australia Foundation for Angelman Syndrome Therapeutics, Australi NCT05293184

Набира участници Фаза 2

Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia

Severe Aplastic Anemia

Severe aplastic anemia is a rare and serious form of bone marrow failure related to an immune-mediated mechanism that results in severe pancytopenia and high risk for infections and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance of survival; however, a response rate with just immunosuppression for those patients lacking suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1/3 of patients are cured, 1/3 are dependent on long term immunosuppression, and the other 1/3 relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical donor for transplantation has good response rates and significantly lower rates of acute and chronic GVHD.

Начало: 09.09.2016 Край: 31.08.2028 Възраст: 1–75 г.

United States Northside Hospital, Inc. NCT02828592

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REtroperitoneal SArcoma Registry: an International Prospective Initiative

Retroperitoneal Sarcoma

Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority. Primary Objectives of this study are: * to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. * patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM). Secondary Objectives: * to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; * to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; * to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; * to utilize collected pathological material for research collaborations.

Начало: 01.09.2016 Край: 31.12.2030 Възраст: от 18 г.

Australia, Canada, France +8 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano NCT03838718

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Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy

Healthy Volunteer

Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy Background: New therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Researchers want to use the healthy cells of volunteers to perform research studies. To do this, they are collecting lymphocytes through leukapheresis. Objectives: To collect healthy cells from volunteers for research studies for new cancer therapies. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a standard donor questionnaire. It asks about their health and past medical problems. It also asks about risky behaviors that could increase their exposure to viruses or bacteria that could be transmitted through a transfusion. Participants will give a blood sample to make sure they are able to donate. They will have a physical exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might give a urine sample. Participants will undergo apheresis. For this, a needle is placed in a vein in each of their arms. Their blood is taken from one arm. A machine separates the white cells from the red cells and plasma by a spinning process. The white cells are removed and directed into a plastic bag. The red cells and plasma are returned through the needle in the other arm. The entire procedure takes 4 6 hours. Participants may donate every 21 days in this protocol if they choose to.

Начало: 08.08.2016 Край: 01.02.2035 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT02821806

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Natural History, Pathogenesis, and Outcome of Ocular Disorders

Eye Disease

Background: The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people with eye diseases. Objective: To examine and treat people with eye diseases and learn more about eye diseases and how they are inherited. Eligibility: People with eye diseases who can give consent or have a guardian who can consent for them. Asymptomatic first-degree relatives willing to provide a blood sample may also be enrolled for the purpose of genetic testing. Design: Participants will be screened with an eye exam. Participants will have 1-12 visits per year depending on their eye disease for up to 5 years. Visits last about 4 hours and could include: Medical and family history Physical exam Eye exam and photography. Oculography: They put on contact lenses or goggles. They watch spots on a computer screen for 20-30 minutes. Electrooculography: Small metal disks are placed on the skin next to both eyes. They look left and right in the dark and light for about 30 minutes. Electroretinography: They sit in the dark with their eyes patched. A small metal disk is taped to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They watch flashing lights. Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is injected through the tube and travels up the blood vessels in the eyes. Pictures are taken of the eyes. Immunosuppressive treatment Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small biopsy sample from the surface of the eye. Blood tests Skin, tear, urine, saliva, stool, or hair sample Exam under anesthesia for some children At each visit participants could get medications, eye drops, eye injections, laser treatments, or surgery.

Начало: 03.08.2016 Край: 01.07.2026 Възраст: 1–100 г.

United States National Eye Institute (NEI) NCT02821767

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Thoracic Tumours Register

Thoracic Tumors

Observational, multicenter study in patients with lung cancer and other thoracic tumors. The GECP, in its commitment to improve the treatment and prognosis of patients with lung cancer and other thoracic tumors, has marked the individualization of treatment according to the expression of markers predictive of response to chemotherapeutic agents and molecular inhibitors of cell proliferation as one of its primary objectives. This could significantly improve the prognosis of patients with lung cancer, and will lead to a radical change in routine clinical practice. The aim of the register is to explore all data available of all patients treated because of thoracic tumours.

Начало: 21.07.2016 Край: 30.12.2031

Spain Spanish Lung Cancer Group NCT02941458

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Evaluation of Children With Endocrine and Metabolic-Related Conditions

Adrenal Insufficiency Growth Disorder Endocrine Diseases Metabolic Disease +1

Background: Endocrine glands give off hormones. Researchers want to learn more about the disorders that affect these glands in children. These disorders might be caused by changes in genes. Genes contain DNA, which is the blueprint of how a cell works. Researchers want to identify the genes involved in endocrine and metabolic disorders. This might help develop new ways to diagnose and treat the disorders. Objective: To study the inheritance of endocrine or metabolism disorders. Eligibility: Children ages 3month-18 with known or suspected endocrine or metabolism disorders. Family members ages 3months-100. They may participate in the DNA part of the study. Design: Participants will be screened with a review of their medical records. Their parents or guardians will allow the records to be released. Participants will have a clinic visit. This may include a physical exam and medical history. Parents or guardians will give their consent for the study. Participants may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include: Blood, urine, and saliva tests Growth hormone test Pituitary and adrenal function tests Picture of chromosomes Imaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey. Genetic tests Sleep study Medical photographs If surgery is done, a tissue sample will be taken. Participants may have follow-up visits for diagnosis and treatment. Participating relatives will have one visit. This will include medical history and blood and saliva tests. The blood and saliva will be used for DNA testing.

Начало: 12.07.2016 Край: 31.12.2030 Възраст: 3–100 г.

United States Eunice Kennedy Shriver National Institute of Child Heal NCT02769975

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Natural History of Spinocerebellar Ataxia Type 7 (SCA7)

Spinocerebellar Ataxia

Background: Spinocerebellar ataxia type 7 (SCA7) is a disease in which people have problems with coordination, balance, speech and vision. It is caused by a change in the ATXN7 gene. A mutation in this ATXN7 gene causes changes in eye cells, which can lead to vision loss. There is no cure for SCA7 but researchers are looking for possible treatments. Researchers need more information about SCA7. They want to collect vision and neurology related data from people with SCA7. They want to learn how and what changes in the eye and brain when the ATXN7 gene isn t working properly. Objective: To learn more about SCA7 and its progression. Eligibility: People ages 12 and older with SCA7. Design: Participants will be screened with medical history and genetic testing from a previous National Eye Institute study or their personal physician. Participants will have at least 7 visits over 5 years. They will have 2 visits during the first week of the study. Then they will be asked to come back every year for the next 5 years. Each visit will last several days and will include: * Medical and eye history * Several eye tests: some will include dilating the pupil with eye drops and taking photos or scans of the eyes. * Electroretinography (ERG): Participants will sit in the dark with their eyes patched for 30 minutes. After this, the patches will be removed and contact lenses put into the eyes. They will watch flashing lights and information will be recorded. * Neurological exams: Sensation, strength, coordination, reflexes, attention, memory, language, and other cognitive functions will be tested. * Brain MRI: They will lie in a machine that takes pictures of the brain. * Blood and urine tests * Optional skin biopsy: About 3 millimeters of skin will be removed for more research testing; this is half the size of a pencil eraser.

Начало: 11.07.2016 Край: 31.12.2028 Възраст: 12–100 г.

United States National Eye Institute (NEI) NCT02741440

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Evaluation of Adults With Endocrine and Metabolic-Related Conditions

Endocrine Diseases

Background: There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases. Objectives: To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions. Eligibility: Adults age 18 years and older with a known or suspected endocrine disorder. Relatives ages 18 years and older. Doctors will review all requests and available medical records to determine final eligibility for the protocol. Design: Participants will have a medical history and physical exam. Most participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include: * Blood, urine, and saliva tests * Imaging tests. These may include X-ray, ultrasound, or scans. * Sleep study * Medical photographs * Visits with other specialists at NIH Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies. Participants may be asked to participate in genetic testing. They will give a blood or saliva sample for this.

Начало: 09.07.2016 Край: 31.12.2029 Възраст: 18–100 г.

United States National Institute of Diabetes and Digestive and Kidney NCT02830308

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Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease

Aortic Aneurysm Aortic Dissection Aortic Diseases

The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD.

Начало: 15.06.2016 Край: 01.01.2037

Australia, Belgium, Canada +3 The University of Texas Health Science Center, Houston NCT04005976

Набира участници Фаза 4

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

End-Stage Kidney Disease

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

Начало: 01.06.2016 Край: 01.12.2026 Възраст: от 18 г. Здравни услуги

Australia, Canada, Germany +3 University of Sydney NCT02823821

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Williams Syndrome (WS) and Supravalvar Aortic Stenosis (SVAS) DNA and Tissue Bank

Williams Syndrome Supravalvular Aortic Stenosis Cardiovascular Disease

Williams syndrome is a rare genetic disorder occurring in 1:8000-12,000 individuals. It is caused by the deletion of 25-27 coding genes, including elastin (ELN) on the 7th human chromosome. Haploinsufficiency for these genes leads to the features of the condition, including: * Distinctive facial features; * Characteristic vascular problems including hypertension, focal vascular stenosis, (when present in the aorta this is referred to as SVAS), vascular stiffness and differences in heart rate variability; * Endocrine abnormalities including hypercalcemia, hypothyroidism, and early puberty; * Metabolic concerns with colic and failure to gain weight in infancy and obesity and early glucose intolerance in adulthood; * Characteristic neurocognitive profile comprised of cognitive impairment, high sociality with concurrent social awkwardness, difficulty with visual-spatial tasks, relative strengths in speech, and lack of social fear; * Anxiety and chronic pain in adulthood Most individuals with WS carry the same basic deletion on Chromosome 7q11.23. However, each feature may present as mild or more severe in any given individual. Variation in the presence and severity of these vascular phenotypes remains unexplained. The supravalvar aortic stenosis (SVAS) phenotype is caused by haploinsufficiency for elastin. This can come about due to the WS deletion (as above) or due to heterozygous variation in elastin (ELN) gene itself in this region. When this protein is reduced, connective tissues lose its strength, flexibility, and overall support. When this happens in the aorta, it may cause vascular narrowing that presents as shortness of breath, chest pain, and even heart failure if left untreated. Narrowing also occurs in other vessels especially the pulmonary and renal arteries. Changes in non-vascular elastic tissues such as the skin and lungs also occur. As in WBS, phenotypic variation also occurs in people with ELN gene changes--This variability remains unexplained despite all the on-going research. Most individuals with features of SVAS have either WS or an elastin variant. There are, however, a smaller number of individuals with the phenotypic features of the condition whose genetic underpinnings are yet to be defined (they are referred to as SVAS-like). Additionally, there are 26 other coding genes within the WS critical region that contribute to various other features of the condition Objective: 1. To collect historical information and to bank DNA, cells, and tissue from individuals with genetic alterations in the WS/ELN gene region, those with an SVAS -like phenotype and unaffected family members/controls to facilitate future research into the many phenotypes seen in these individuals. 2. Currently, we plan to use the collected samples to identify genetic and environmental factors that contribute to the variability in different phenotypes (vascular and non-vascular) in individuals with WS, SVAS and SVAS-like conditions, individuals with variation in WS genes other than elastin and unaffected family members and controls. For the non-vascular features of WS and SVAS-like conditions for which a specific gene has not been implicated in the disease, we would also like to identify causative genes as well as modifiers. Likewise, by evaluating people with variation in other WS region genes, we can determine what contribution those genes make to the studied phenotypes. Controls will be both used to assess the frequency of genetic features in people without the phenotype in question and to evaluate heritability, penetrance, and expressivity of relevant variants. Eligibility: People ages 0-85 with either WS, SVAS, and/or an SVAS-like condition, unaffected family members or adult unrelated controls. Design: This study is not a treatment protocol. This study will consist of: Collection of personal history (questionnaires) and medical record data (relevant physician notes, lab and diagnostic tests and studies) to study the natural history of these conditions, allow stratification of disease severity, and identification of environmental risk factors; Collection of blood, saliva, urine and surgical tissue waste to allow DNA and RNA preparation as well as study of tissues both in situ and through the generation of IPSCs; Expression studies on available tissues (lymphocytes, IPSCs, vascular, skin, other collected tissues) to look for differential regulation of target genes; Direct imaging of tissues (lymphocytes, IPSCs, vascular, skin, other collected tissues); Storage of collected data and specimens for future research; A questionnaire may be sent to participants or parent/guardian or LAR to respond on behalf of participant.

Начало: 11.05.2016 Край: 25.09.2040 Възраст: 1–85 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT02706639

Набира участници Фаза 1

Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer

Metastatic Colorectal Adenocarcinoma Metastatic Pancreatic Ductal Adenocarcinoma Stage IV Colorectal Cancer AJCC v7 Stage IV Pancreatic Cancer AJCC v6 and v7 +2

This phase I trial studies the side effects and best way to give personalized peptide vaccine in patients with pancreatic or colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Personalized peptide vaccine is a vaccine developed from patient's own tumor cells and blood in order to use as a biological therapy. Biological therapies, such as personalized peptide vaccine may attack tumor cells and stop them from growing or kill them.

Начало: 11.05.2016 Край: 31.05.2027 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT02600949

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Quality of Pediatric Resuscitation in a Multicenter Collaborative

Cardiac Arrest Cardiopulmonary Arrest

This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests. The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes.

Начало: 02.05.2016 Край: 01.01.2030 Възраст: до 18 г.

Australia, Brazil, Canada +12 Children's Hospital of Philadelphia NCT02708134

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