Clinical Studies
Clinical Studies
批准号:
7288639
负责人:
MICHAEL W. KONSTAN
金额:
$21.42万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-05-01 至 2012-03-31
关键词:
Adverse eventAdvisory CommitteesBasic ScienceBiological ProcessBloodBronchial LavagesBronchoalveolar LavageBudgetsCellsChloride IonChloridesClinicalClinical ResearchClinical TrialsCollectionContractsCystic FibrosisDEXADataDatabasesDevelopmentDiffusionDocumentationEpithelialEpithelial CellsExercise stress testExhalationFecesGasesHusbandImaging TechniquesIndustryInfantInvestigationIron binding capacity measurementIrrigationLiquid substanceMeasurementMetabolicNasal Lavage FluidNitric OxideNoseOscillometryOutcome MeasurePatient SelectionPatientsPlasmaPlethysmographyPopulationPopulation ResearchPreparationProceduresProcessProtocols documentationPulmonary function testsPurposeQuality ControlRadiology SpecialtyRecruitment ActivityReportingResearch Ethics CommitteesResearch PersonnelResourcesRetrospective StudiesSamplingScheduleScientistServicesSourceSpecimenSpirometrySputumStandards of Weights and MeasuresSweat testTestingThoracic RadiographyTissue BanksTissuesTranslationsUnited States Food and Drug AdministrationUrineWalkingbench to bedsidedesignperformance testsresearch study
中文摘要
临床研究核心旨在1)协助研究者访问、选择和招募囊性
纤维化和对照患者进行临床试验,并节约中心的患者资源。2)协助
研究者参与临床试验的规划和执行,3)监督和/或执行
测试和程序,包括质量控制。4)监督生物制品的收集和处理
样本,包括BAL液和细胞样本、鼻灌洗液/细胞和鼻上皮细胞,
刮痧、痰(诱导和咳出)、呼出气冷凝液、血液、尿液和粪便。第五章)
维护从当前和以前的患者收集的样本的标本和组织库6)维护
克利夫兰CF中心自成立以来所有患者的数据库(共1558名患者; 360名
活跃患者),用于临床试验和研究的患者选择,回顾性临床研究,
与各国数据库的合作。7)促进基础科学发现的翻译
科学研究者参与临床研究(如适用),包括结局的制定
采取适合具体研究的措施;并请基础科学家调查所确定的问题
在临床实践或临床研究中。该核心使我们的特征良好的患者人群可用
用于临床研究,并促进了从我们的基础科学实验室的想法到床边的翻译。的
核心支持的临床项目还产生假设,这些假设又被送回基础科学实验室,
更详细的调查。这是翻译中心的一个组成部分。
英文摘要
The Clinical Studies Core is designed to 1) Assist investigators in accessing, selecting, and recruiting cystic
fibrosis and control patients for clinical trials, and to husband the patient resources of the Center. 2) Assist
investigators in the planning and execution of clinical trials, 3) Provide oversight and/or performance of
tests and procedures, including quality control. 4) Provide oversight of collection and processing of biologic
specimens, including BAL fluid and cell samples, nasal lavage fluid/cells and nasal epithelial cells from
scrapping, sputum (induced and expectorated), exhaled breath condensate, blood, urine, and stool. 5)
Maintain a specimen and tissue bank of samples collected from current and former patients 6) Maintain the
database for all patients ever seen at the Cleveland CF Center since its inception (1558 total patients; 360
active patients) for purposes of patient selection for clinical trials and studies, retrospective clinical studies,
and cooperation with various national databases. 7) Facilitate the translation of discoveries made by basic
science investigators into clinical investigation where applicable, including the development of outcome
measures appropriate for specific studies; and to engage basic scientists to investigate questions identified
in clinical practice or clinical studies. This Core makes available our well-characterized patient population
for clinical studies, and facilitates the bench to bedside translation of ideas from our basic science labs. The
Core-supported clinical projects also generate hypotheses that are in turn returned to basic science labs for
more detailed investigation. This is an integral component of the Translational Center.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Clinical and Translational Science Collaborative of Cleveland
-
批准号:9978966
-
项目类别:
-
资助金额:$672.2万
-
财政年份:2018
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
Research Career Development in Child Health
-
批准号:7994220
-
项目类别:
-
资助金额:$20.21万
-
财政年份:2008
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
Research Career Development in Child Health
-
批准号:8197139
-
项目类别:
-
资助金额:$21.49万
-
财政年份:2008
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
Clinical and Translational Science Collaborative of Cleveland
-
批准号:9093875
-
项目类别:
-
资助金额:$977.48万
-
财政年份:2007
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
Clinical and Translational Science Collaborative of Cleveland
-
批准号:9093876
-
项目类别:
-
资助金额:$222.31万
-
财政年份:2007
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
PTC124 AS AN ORAL TREATMENT FOR NONSENSE-MUTATION-MEDIATED CYSTIC FIBROSIS
-
批准号:7378077
-
项目类别:
-
资助金额:$4.78万
-
财政年份:2006
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
BIIL284BS IN ADULT AND PEDIATRIC CYSTIC FIBROSIS PATIENTS
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批准号:7202776
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项目类别:
-
资助金额:$1.01万
-
财政年份:2005
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
ORAL THERACLEC-TOTAL IN CF PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY
-
批准号:7202793
-
项目类别:
-
资助金额:$15.45万
-
财政年份:2005
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
TOBRAMYCIN FOR INHALATION (TOBI) IN YOUNG CHILDREN WITH CYSTIC FIBROSIS
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批准号:7202765
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项目类别:
-
资助金额:$0.05万
-
财政年份:2005
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
BIIL284BS in adult and pediatric cystic fibrosis patients
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批准号:6974994
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项目类别:
-
资助金额:$3.01万
-
财政年份:2004
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
Oral TheraCLEC-Total in adult and pediatric subjects with cystic fibrosis
-
批准号:6974986
-
项目类别:
-
资助金额:$6.21万
-
财政年份:2004
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
Fat and protein absorption in cystic fibrosis pts with pancreatic insufficiency
-
批准号:6975001
-
项目类别:
-
资助金额:$7.23万
-
财政年份:2004
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
Neutrophil imaging of the lung for characterizing pulmonary infection in CF pts
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批准号:6974990
-
项目类别:
-
资助金额:$1.21万
-
财政年份:2004
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
PROLASTIN AEROSOL THERAPY IN PATIENTS WITH CYSTIC FIBROSIS
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批准号:6301071
-
项目类别:
-
资助金额:$14.86万
-
财政年份:2000
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
LUNG SPECIFIC BIOEFFICACY OF ORAL DMP 777 IN ADULTS W/ CF
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批准号:6305356
-
项目类别:
-
资助金额:$1.92万
-
财政年份:1999
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
CPX (ORAL, MULTIDOSE) IN ADULTS W/ MILD TO MODERATELY SEVERE CYSTIC F
-
批准号:6305371
-
项目类别:
-
资助金额:$1.92万
-
财政年份:1999
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
PROLASTIN AEROSOL THERAPY IN PATIENTS WITH CYSTIC FIBROSIS
-
批准号:6201835
-
项目类别:
-
资助金额:$14.86万
-
财政年份:1999
-
负责人:MICHAEL W. KONSTAN
-
依托单位:
CPX (ORAL, MULTIDOSE) IN ADULTS W/ MILD TO MODERATELY SEVERE CYSTIC F
-
批准号:6264431
-
项目类别:
-
资助金额:$1.92万
-
财政年份:1998
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负责人:MICHAEL W. KONSTAN
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依托单位:
PROLASTIN AEROSOL THERAPY IN PATIENTS WITH CYSTIC FIBROSIS
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批准号:6105187
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项目类别:
-
资助金额:$0.0万
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财政年份:1998
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负责人:MICHAEL W. KONSTAN
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依托单位:
DMP777 IN ADULT PATIENTS 18 YRS OF AGE AND OLDER WITH CYSTIC FIBROSIS
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批准号:6115324
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项目类别:
-
资助金额:$1.92万
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财政年份:1998
-
负责人:MICHAEL W. KONSTAN
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依托单位:
海外基金