Multidisciplinary Collaborative Clinical Research, Core Facilities and Other Clinical Services in NIDDK Program Area Diseases

NIDDK 项目领域疾病的多学科协作临床研究、核心设施和其他临床服务

• 批准号: 8940178
• 负责人: James Balow
• 金额: $ 67.1万
• 依托单位: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8940178
• 关键词: Area; Biometry; Biopsy; Blood Glucose; Chronic Granulomatous Disease; Clinical; Clinical Investigator; Clinical Research; Clinical Research Protocols; Clinical Services; Clinical Trials; Collection; Consultations; Core Facility; Cystic Fibrosis; Cystinosis; Databases; Development; Diabetes Mellitus; Diagnosis; Disease; Endocrine; Endocrinology; Endoscopy; Endothelial Cells; Enzymes; Fabry Disease; Functional disorder; Gastroenterology; Gastrointestinal Endoscopy; HIV; Hematology; Hemodialysis; Hemofiltration; Hepatology; Hermanski-Pudlak Syndrome; Human; Immunotherapy; Institutes; Institutional Review Boards; Insulin; Insulin Resistance; Intramural Research Program; Kidney; Laboratory Research; Lead; Liver; Medical; Membranous Glomerulonephritis; Metastatic Melanoma; Mission; Monitor; National Heart, Lung, and Blood Institute; National Human Genome Research Institute; National Institute of Allergy and Infectious Disease; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Neurological Disorders and Stroke; Natural History; Nephrology; Obesity; Pathogenesis; Patient Care; Patients; Pharmacotherapy; Process; Protocols documentation; Recombinants; Renal function; Research; Research Project Grants; Sampling; Services; Sickle Cell Anemia; Stem cell transplant; Testing; Therapeutic procedure; United States National Institutes of Health; Vasculitis; Venous; Wiskott-Aldrich Syndrome; antitumor agent; biobank; capsule; cell injury; chemotherapy; disease natural history; gastrointestinal; graft vs host disease; human subject; indexing; liver biopsy; medical specialties; member; multidisciplinary; novel; novel strategies; programs; protocol development

Credentialed NIDDK clinical staff members have relevant expertise necessary to support patient care needs of human subjects involved in clinical research conducted by all institutes and centers in the intramural research program. Consultative interactions provided by NIDDK clinicians with expertise in the fields of diabetes, endocrinology, metabolism, gastroenterology, hepatology, nephrology and hematology are required for delivery of specialized medical services to patients throughout the Clinical Research Center at NIH. Beyond patient support services, these consultative interactions lead to collaborative clinical investigations to advance the study of natural history of disease, new approaches to diagnosis and treatment, as well as advancing the understanding of disease pathogenesis and pathophysiology. Clinical services include: 1. Blood Glucose Management Service involves comprehensive management of patients with insulin deficient or insulin resistant diabetes mellitus. 2. Consultation services in endocrinology, gastroenterology, hepatology, nephrology, cystic fibrosis and hematology. 3. Gastrointestinal endoscopy, including capsule endoscopy, gut biopsies and therapeutic procedures 4. Liver biopsies and liver fibroscanning 5. Renal biopsies, hemodialysis, continuous veno-venous hemofiltration, specialized research renal function tests 6. Biorepository: collection, barcoding, indexing, storing, and retrieving human samples 7. Biostatistical support for developing, monitoring, analyzing clinical research protocols Examples of completed and ongoing collaborative clinical research projects emerging from consultation services and clinical core services include: 1. Endocrine, gastrointestinal, liver and kidney complications of immunotherapy of metastatic melanoma, stem cell transplantation, chemotherapy and novel biologic anti-tumor agents (NCI, NHLBI, NIAID); 2. Gastrointestinal and renal complications of graft versus host disease (NHLBI, NCI, NIAID); 3. Liver and kidney complications of chronic granulomatous disease (NIAID), Hermansky-Pudlak syndrome (NHGRI) and cystinosis(NHGRI); 4. Natural history and management of kidney and liver complications of sickle cell anemia (NHLBI); 5. Renal complications of HIV disease and HIV drug therapies (NIAID); 6. Kidney manifestations and effects of recombinant enzyme treatment of Fabry disease (NINDS); 7. Membranous nephropathy in patients with non-myeloablative stem cell transplants (NHLBI, NCI); 8. Renal vasculitis in Wiskott-Aldrich syndrome (NHGRI); 9. Glomerular endothelial cell injury and thrombotic microangiopathy in stem cell transplants (NHLBI, NCI, NIAID, NIDDK)

获得认证的 NIDDK 临床工作人员拥有必要的相关专业知识，可以满足所有机构和中心在校内研究项目中进行的临床研究中人类受试者的患者护理需求。 NIDDK 临床医生在糖尿病、内分泌学、新陈代谢、胃肠病学、肝病学、肾病学和血液学领域具有专业知识，需要提供咨询互动，以便为整个 NIH 临床研究中心的患者提供专业医疗服务。 除了患者支持服务之外，这些咨询互动还导致协作临床研究，以推进疾病自然史的研究、诊断和治疗的新方法，以及增进对疾病发病机制和病理生理学的理解。 临床服务包括： 1. 血糖管理服务涉及胰岛素缺乏或胰岛素抵抗糖尿病患者的综合管理。 2、内分泌科、消化科、肝病科、肾病科、囊性纤维化科、血液科的咨询服务。 3. 胃肠内窥镜检查，包括胶囊内窥镜检查、肠道活检和治疗程序 4. 肝活检和肝纤维扫描 5. 肾活检、血液透析、连续静脉-静脉血液滤过、专门研究肾功能检查 6. 生物样本库：采集、条形码、索引、存储和检索人体样本 7. 为开发、监测、分析临床研究方案提供生物统计支持 咨询服务和临床核心服务中已完成和正在进行的合作临床研究项目的例子包括： 1. 转移性黑色素瘤免疫治疗、干细胞移植、化疗及新型生物抗肿瘤药物（NCI、NHLBI、NIAID）的内分泌、胃肠道、肝肾并发症； 2.移植物抗宿主病的胃肠道和肾脏并发症（NHLBI、NCI、NIAID）； 3.慢性肉芽肿病（NIAID）、赫曼斯基-普德拉克综合征（NHGRI）和胱氨酸病（NHGRI）的肝肾并发症； 4. 镰状细胞性贫血（NHLBI）的肾脏和肝脏并发症的自然史和治疗； 5. HIV疾病的肾脏并发症和HIV药物治疗（NIAID）； 6. 重组酶治疗法布里病（NINDS）的肾脏表现及效果； 7.非清髓性干细胞移植患者的膜性肾病（NHLBI、NCI）； 8. Wiskott-Aldrich综合征肾血管炎（NHGRI）； 9.干细胞移植中的肾小球内皮细胞损伤和血栓性微血管病（NHLBI、NCI、NIAID、NIDDK）