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ClinicalTrialSummary

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To evaluate the relative effectiveness of 2 theoretically-informed approaches to preventing the adverse sequelae of maltreatment in infants: Psychoeducational Home Visitation (PHV) and Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers serve as a comparison.~Maltreated infants and their mothers...	The purpose of this study is to compare 2 approaches (interventions) to prevent child-abuse (maltreatment) in infants: Psychoeducational Home Visitation (PHV) vs Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers are studied as a comparison group.~Twelve-month-old infants and their mothers are ...
Participation in daily physical activity programs by young children is currently recommended as a means of promoting bone health. Results from studies of adults indicate that beneficial effects of either physical activity or calcium (Ca) intake may be apparent only when both these factors are present. Our results in in...	Doctors recommend that young children participate in daily physical activity to promote bone health. However, studies in adults show that physical activity and increased calcium intake cause noticeable benefits for bone health only when both factors occur together. The goal of this study is to find out whether calcium ...
Background:~Cancer has an enormous impact on the psychological and social well-being of the family unit. The life-threatening connotations of cancer single out the ill child from his peer/family group as one who is different, and often unable to maintain a normal lifestyle. Physical sequelae of cancer and its treatment...	Background:~Cancer has an enormous impact on the psychological and social well-being of the family unit. The life-threatening connotations of cancer single out the ill child from his peer/family group as one who is different, and often unable to maintain a normal lifestyle. Physical sequelae of cancer and its treatment...
Background:~It may be in the interest of the CCR to continue to follow and treat certain subjects after they have completed their treatment and participation on a research protocol.~Objective:~To provide continuing treatment and medical follow-up for CCR subjects who have completed their treatment and participation on ...	This protocol is to provide continuing medical/surgical/radio-therapeutic care, treatment and follow-up for NCI patients not currently entered on an active research protocol. No investigational treatments will be administered on this protocol.
The present protocol seeks to advance our understanding of sclerosing glomerular and tubulointerstitial kidney diseases, including but not limited to variants of focal segmental glomerulosclerosis (FSGS) and chronic kidney disease of unknown etiology (CKDu). This protocol will encompass studies of the natural history, ...	The present protocol seeks to advance our understanding of sclerosing glomerular and tubulointerstitial kidney diseases, including but not limited to variants of focal segmental glomerulosclerosis (FSGS) and chronic kidney disease of unknown etiology (CKDu). This protocol will encompass studies of the natural history, ...
Measurements of dynamic changes in oxygen uptake (VO2 kinetics) during recovery from exercise may describe regulatory control of oxygen transport and utilization and have greater reliability and less inherent risk than assessment of maximal oxygen uptake (VO2max) in patients for whom exercise is limited by pain, excess...	Measurements of dynamic changes in oxygen uptake (VO2 kinetics) during recovery from exercise may describe regulatory control of oxygen transport and utilization and have greater reliability and less inherent risk than assessment of maximal oxygen uptake (VO2max) in patients for whom exercise is limited by pain, excess...
Acquisition of fresh tumor and normal tissue samples is necessary for the preparation of cDNA libraries, microarray chips, tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of patient samples at the time of tissue sampling for surgery, diagnostic tests, or therapeut...	Acquisition of fresh tumor and normal tissue samples are necessary for the preparation of cDNA libraries, microarray chips, and tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic ...
Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patien...	Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patien...
Genistein is a natural product found in soy beans; its consumption has been associated with a low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase inhibitor, and in preclinical studies it has been shown to increase cell adhesion. Increases in cell adhesion in vivo would phenotypical...	Genistein is a natural product found in soy beans; its consumption has been associated with a low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase inhibitor, and in preclinical studies it has been shown to increase cell adhesion. Increases in cell adhesion in vivo would phenotypical...
This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. The technique measures the difference in MT effect between two symmetrically positioned off-re...	This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. The technique measures the difference in MT effect between two symmetrically positioned off-re...
This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. ...	This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. ...
Background:~-NIH and FDA intramural investigators performing in vitro studies involving human blood components have a need for a steady, reliable, consistent source of these blood components, preferably derived from screened donors documented to be free of potential transfusion-transmissible diseases.~Objectives:~To pr...	This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibi...
Recurrent or Stage IV Lung Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.~OBJECTIVES:~To determine the effica...	Current therapies for Recurrent or Stage IV Lung Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Recurrent or Stage IV Lung Cancer.~PURPOSE: This study is being performed to determine the effects (good and ...
This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and eliminatio...	This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and eliminatio...
Stroke is the third leading cause of disability in the United States. To date, conventional rehabilitation is not able to restore normal, safe, gait for many individuals with stroke. We have identified nine gait component deficits which respond to the FNS-IM intervention. This study will test a refined treatment protoc...	To date, conventional rehabilitation is not able to restore normal, safe, gait for many individuals with stroke. We have identified nine gait component deficits which respond to the FNS-IM intervention. This study will test a refined treatment protocol of 3 months duration to restore volitional gait by restoring those ...
Background:~Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician's task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglyc...	Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician's task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglycemic medicat...
Background:~Prior rehabilitation outcome studies had many weaknesses. They had: a) evaluated rehabilitation effects only in isolated subgroups, b) focused on functional ability rather than on quality of life, c) not used randomized control groups, and d) had inadequate sample sizes. Differences in methodological approa...	Prior rehabilitation outcome studies had many weaknesses. They had: a) evaluated rehabilitation effects only in isolated subgroups, b) focused on functional ability rather than on quality of life, c) not used randomized control groups, and d) had inadequate sample sizes. Differences in methodological approaches have re...
Background:~This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program deliv...	This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program delivered in 8 we...
Background:~The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate...	The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficac...
Background:~Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification ...	Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco u...
Background:~Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-bas...	Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality i...
Background:~Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorl...	Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed ...
Background:~Control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. Practice Guidelines delineating specific ways physicians manage diabetes have been outlined. Missing are guidelines for health care providers to encourage patients to take responsibility for their...	Control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. Practice Guidelines delineating specific ways physicians manage diabetes have been outlined. Missing are guidelines for health care providers to encourage patients to take responsibility for their diabetes. T...
Background:~Falls are the leading cause of nonfatal injuries in the United States and the second leading cause of all unintentional injury deaths. Each year fractures of the hip account for about 200,000 hospitalizations among the elderly and falls are contributing factors in 40 percent of admissions to nursing homes. ...	Falls are the leading cause of nonfatal injuries in the United States and the second leading cause of all unintentional injury deaths. Each year fractures of the hip account for about 200,000 hospitalizations among the elderly and falls are contributing factors in 40 percent of admissions to nursing homes. About 30 per...
Background:~The goal of this research was to determine if providing specialist input to primary care providers (PCPs) by means of informal consultation could improve the process and outcomes of care for diabetes. Several studies support the role for specialists and their specific knowledge and expertise in a variety of...	The goal of this research was to determine if providing specialist input to primary care providers (PCPs) by means of informal consultation could improve the process and outcomes of care for diabetes. Several studies support the role for specialists and their specific knowledge and expertise in a variety of disorders i...
Background:~Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.~Objectives:~ACQUIP was designed to ...	Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.
Background:~A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although vetera...	A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although veterans have been...
Background:~We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health servic...	We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health services implicati...
This research on Functional Incidental Training ( FIT) primarily involves women in community nursing homes.~Objectives:~1. test the effects of FIT on functions such as transfer ability, continence, ambulation/mobility,balance and fall risk, strength, and endurance; 2. determine the characteristics of NHCU residents who...	This research on Functional Incidental Training ( FIT) primarily involves women residing in community nursing homes. It is an individualized rehabilitative protocol intended to improve mobility, endurance, strength and continence in frail, older, functionally impaired and disabled veterans.~Objectives of the project ar...
OBJECTIVES: I. Determine the toxicity and MTD of LErafAON when given by weekly IV infusion for 8 weeks in patients with advanced malignancies.~II. Characterize the plasma pharmacokinetics of LErafAON after IV infusion.~III. Document in vivo inhibition of Raf-1 protein by LErafAON.~IV. Detect anti-tumor effects of intra...	LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein by blocking the gen...
BACKGROUND~This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.~It also provides a mechanism for the correlation and interpre...	Background:~This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our patients, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.~It also provides a mechanism for the correlation and interpretat...
Background:~-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.~Objectives:~-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch...	Background:~-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.~Objectives:~-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch...
Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at...	Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at...
We propose to determine the response of a newly developed laser heated, vycor glass fiberoptic radiation dosimetry system to ionizing radiation in a clinical radiotherapy environment. Present systems measure only total dose or have limitations, such as instability, non-linearity, excessive size or a decoupled measureme...	We propose to determine the response of a newly developed laser heated, vycor glass fiberoptic radiation dosimetry system to ionizing radiation in a clinical radiotherapy environment. Present systems measure only total dose or have limitations, such as instability, non-linearity, excessive size or a decoupled measureme...
Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are to receive immune cells in adoptive transfer, will have less than or equal to 50% of those cells labeled with In-111-oxine and administered along with the remainder of their unlabeled cells. They will then undergo gamma-camera i...	Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are to receive immune cells in adoptive transfer, will have less than or equal to 50% of those cells labeled with In-111-oxine and administered along with the remainder of their unlabeled cells. They will then undergo gamma-camera i...
This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the sur...	This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the sur...
The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a clinical setting will be assessed by comparing results with other fully three-dimensional programs. ROB will investigate PEREGRINE for clinical use at NCI.	The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a clinical setting will be assessed by comparing results with other fully three-dimensional programs. ROB will investigate PEREGRINE for clinical use at NCI in collaboration with Lawrence Livermore National Laboratory (LLNL).
Over 60 million Americans use herbal medicines; of these, one-fourth also take prescription drugs. Physicians are often unaware of herbal use and of possible drug/herb interactions in their patients. Ginseng and ginkgo, enhancers of physical and mental performance, are two of the most widely taken herbals. We propose a...	This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes that process drugs, and 3) enzymes that may help prevent cancer.
This study will attempt to replicate findings suggesting that visual evoked potentials generated in one human brain (Subject A) by photostimulation can generate a correlated EEG signal in the brain of another human subject (subject B) who is located at a distance (14.5 meters) and who is not visually stimulated.~This p...	The purpose of this study is to determine whether visual evoked potentials generated in one human brain by photostimulation can generate a correlated EEG signal in the brain of another human subject who is located at a distance and who is not visually stimulated.
Background:~The NCI Surgery Branch~Multiple risk factors for breast cancer have been identified, including family history, endocrine background, histologic changes in breast tissue, cancer in one breast, radiation exposure, obesity, and others. The histologic phenotypes of breast carcinogenesis include a spectrum of ch...	Background:~Many risk factors for breast cancer have been identified, including family history, endocrine background, changes in breast tissue, cancer in one breast, radiation exposure, obesity and others. There is a spectrum of tissue changes seen in cancerous and pre-cancerous breast tissue.~A cell line is a collecti...