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13021. Carotid Revascularization Endarterectomy Versus Stenting Trial

will be collected on the appropriate case report forms(CRFs). LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICES(CMS) ADMINISTRATIVE DATA The purpose of linking Medicare-eligible CREST participants with CMS data files is to assess patient outcomes and utilization of health care services. This plan to link in- and out-patient episodes of care using national Medicare data establishes a new resource that will enhance current follow-up strategies, as well as explore alternative strategies (...) and stenting arms of the study will be assessed using carotid duplex ultrasound exams performed annually (standard of care). In addition to restenosis, the "viability" of the procedures will be assessed by the need (or lack of need) for repeat revascularization (either open surgical or endovascular) after the index procedure. The question "has a new carotid intervention been performed since last follow-up" will be asked at every contact with the patient. If answered positively, additional data

2000 Clinical Trials

13022. PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery

( Registry Identifier: PDQ (Physician Data Query) ) NCI-G00-1695 First Posted: January 27, 2003 Last Update Posted: December 22, 2015 Last Verified: December 2015 Keywords provided by Memorial Sloan Kettering Cancer Center: stage II rectal cancer stage III rectal cancer stage IV rectal cancer Additional relevant MeSH terms: Layout table for MeSH terms Colorectal Neoplasms Rectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive (...) Posted : December 22, 2015 Sponsor: Memorial Sloan Kettering Cancer Center Collaborator: National Cancer Institute (NCI) Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center Study Details Study Description Go to Brief Summary: RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment. PURPOSE: This clinical trial

2000 Clinical Trials

13023. Cystagon to Treat Infantile Neuronal Ceroid Lipofuscinosis

. They are admitted to the NIH Clinical Center for a 4- to 5-day period every 6 months for the following tests and evaluations: Review of medical history, including a detailed record of seizures, physical examination, blood tests and clinical photographs. For the initial baseline studies, examinations may also be scheduled with pediatric neurology, ophthalmology and anesthesia services. Magnetic resonance imaging (MRI) of the brain MRI uses a powerful magnet, radio waves, and computers to provide detailed images (...) Development (NICHD) Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ) Study Details Study Description Go to Brief Summary: This study will examine the effectiveness of a drug called Cystagon in treating infantile neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children. At around 11 to 13 months of age, patients develop slowed head

2001 Clinical Trials

13024. Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease

Neurohormonal Core Lab, Jefferson University Principal Investigator: Eric Velazquez, MD Clinical Coordinating Center, Duke University Principal Investigator: Kerry Lee Data Coordinating Center, Duke University Principal Investigator: Daniel Mark Economics and Quality of Life Core Lab, Duke University Principal Investigator: Jae Oh Echocardiographic Core Lab, Mayo Clinic Principal Investigator: Gerald Pohost Magnetic Resonance Imaging Core Lab, University of Southern California Study Chair: Jean Rouleau (...) With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale [ Time Frame: From enrollment to 3-year follow-up ] These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high. H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D

2001 Clinical Trials

13025. Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection

: Centers for Disease Control and Prevention Collaborator: VA Office of Research and Development Information provided by (Responsible Party): Centers for Disease Control and Prevention Study Details Study Description Go to Brief Summary: Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent (...) . The additional data on tolerability in those sub-groups will available for analysis in 2013. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 8053 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention Official Title: TBTC Study 26: Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months Versus Daily Isoniazid for 9 Months for the Treatment

2001 Clinical Trials

13026. Computerized Tomographic Colonography Compared With Standard Diagnostic Procedures in Detecting Colorectal Neoplasia

with computed tomography acquisition parameters that meet the following minimal standards: Slice thickness no greater than 5 mm Reconstruction interval no greater than 3 mm Pitch no greater than 2 Anatomic coverage of the entire colorectum Supine and prone data sets Complete colonoscopy performed within 30 days following CTC by a board certified gastroenterologist or a physician with at least 3 years of colonoscopic experience Pathology reports for all endoscopically or surgically removed colorectal lesions (...) Posted : April 19, 2004 Last Update Posted : February 4, 2013 Sponsor: American College of Radiology Imaging Network Collaborator: National Cancer Institute (NCI) Information provided by (Responsible Party): American College of Radiology Imaging Network Study Details Study Description Go to Brief Summary: RATIONALE: New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colorectal neoplasia. PURPOSE: Diagnostic study

2000 Clinical Trials

13027. CVD Nutrition Modules Tailored to Low Literacy Skills

cardiovascular risk compared to standard care. Subjects with high cholesterol and low literacy skills served by four community health centers were randomly assigned to one of four groups: Innovative Care-Counselor Directed, Innovative Care-Computer Assisted, Standard Care, and Usual Care for dietary treatment of cholesterol, obesity, and hypertension. Standard Care involved the same amount of time and health counselor exposure as Innovative Care, but used currently available materials. Usual Care patients (...) by (Responsible Party): University of North Carolina, Chapel Hill Study Details Study Description Go to Brief Summary: To develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills. Condition or disease Intervention/treatment Phase Cardiovascular Diseases Heart Diseases Behavioral: Computer Program Intervention Group Other: Minimal Intervention Group Behavioral: Health Counselor Intervention Group Not Applicable Detailed Description: BACKGROUND: The study was part

2000 Clinical Trials

13028. Intervention for Hispanic Children With Asthma

. (Am J Respir Crit Care Med; vol. 153). Layout table for additonal information Responsible Party: The University of Texas Health Science Center at San Antonio ClinicalTrials.gov Identifier: Other Study ID Numbers: 4920 HSC19900128H ( Other Identifier: University of Texas Health Science Center San Antonio ) First Posted: May 26, 2000 Last Update Posted: May 10, 2016 Last Verified: May 2016 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Additional relevant MeSH terms (...) and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00005711 Recruitment Status : Completed First Posted : May 26, 2000 Last Update Posted : May 10, 2016 Sponsor: The University of Texas Health Science Center at San Antonio Collaborator: National Heart, Lung, and Blood Institute (NHLBI) Information provided by (Responsible

2000 Clinical Trials

13029. Epidemiology of Coronary Calcification in the Elderly

annual telephone follow-up of the remaining 178 Pittsburgh SHEP participants and 168 controls will be conducted . A final clinic visit will include measures of coronary and aortic calcification using electron beam computed tomography (CT), pulse wave velocity as a measure of aortic stiffening and cognitive function testing. For the Pittsburgh SHEP cohort, the antihypertensive treatment effect has been striking with event rates for the active and placebo groups continuing to diverge beyong the end (...) of SHEP. Successful demonstration of a treatment effect on coronary calcium scores would be the first randomized data showing an antihypertensive effect directly in the coronary arteries. Risk factors for coronary calcification will be evaluated, producing data of a type not yet available in the literature for older adults and not being collected in any other ongoing studies of the elderly. The added measures of vascular stiffness will supplement the extensive data on subclinical atherosclerosis

2000 Clinical Trials

13030. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer

information Principal Investigator: James Abbruzzese M.D. Anderson Cancer Center More Information Go to Layout table for additonal information Responsible Party: National Cancer Institute (NCI) ClinicalTrials.gov Identifier: Other Study ID Numbers: NCI-2012-02330 ID-99-243 CDR0000067823 ( Registry Identifier: PDQ (Physician Data Query) ) First Posted: May 5, 2003 Last Update Posted: January 23, 2013 Last Verified: January 2013 Additional relevant MeSH terms: Layout table for MeSH terms Adenocarcinoma (...) ) [ Time Frame: 6 months ] Estimated using the Kaplan-Meier method. Associated 95% confidence intervals will be computed. Secondary Outcome Measures : Overall tumor response rate (CR + PR) [ Time Frame: Up to 3 years ] Associated 95% confidence intervals. Overall survival [ Time Frame: From date of entry on study to the date of death of the patients; assessed up to 3 years ] Estimated using the Kaplan-Meier method. Toxicity graded using the NCI CTC version 2.0 [ Time Frame: Up to 3 years ] Eligibility

2000 Clinical Trials

13031. Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma

Response [ Time Frame: 5 weeks ] The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as "complete regression of all palpable and radiographic demonstrable disease" by computed tomography (CT) scan or positron emission tomography-CT (PET-CT). Early Treatment-related Toxicity [ Time Frame: Within 30 days of treatment ] Early treatment-related toxicity was assessed (...) and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026208 Locations Layout table for location information United States, California Stanford University School of Medicine Stanford, California, United States, 94305 Kaiser Permanente Medical Center Vallejo, California

2001 Clinical Trials

13032. Natural History of Stroke: Cause and Development

undergoes as part of standard medical care, including findings of medical and neurological examinations and other tests. In addition, studies will be done for research purposes only to gather data about stroke and TIA. These may include the following: Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests. Electrocardiogram (EKG) (heart tracing) electrodes placed on the chest wall detect the heartbeat and heart rhythm. Computed tomography (CT) scan of the head (...) ) Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) Study Details Study Description Go to Brief Summary: The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations. It will 1) establish a registry of patients with cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and transient ischemic

2001 Clinical Trials

13033. Natural History of Patients With Brain and Spinal Cord Tumors

will undergo an initial evaluation at the Clinical Center by a member of the NOB where past medical and oncologic histories will be obtained as well as relevant data such as neuroimaging and pathology review. A total of 3,000 patients will be accrued to this study. Patients may be seen at the NIH Clinical Center at varying intervals depending on the clinical situation but data related to the natural history of their disease course and outcome will be collected at least every six months. Study Design Go (...) Clinical Center (CC) ( National Cancer Institute (NCI) ) Study Details Study Description Go to Brief Summary: This study offers evaluation of patients with brain and spinal cord tumors. Its purpose is threefold: 1) to allow physicians in NIH s Neuro-Oncology Branch to increase their knowledge of the course of central nervous system tumors and identify areas that need further research; 2) to inform participants of new studies at the National Cancer Institute and other centers as they are developed

2001 Clinical Trials

13034. Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer

will be obtained for central review) Clinical stage T2b, T2c, T3a, or T3b disease as defined by the AJCC 4th edition staging manual (see Appendix A) No evidence of metastatic disease (bone, lymph node or visceral) based on bone scan and computed tomography Adequate hematologic function WBC> 4000/mm3 platelet count > 100, 000/mm3 hematocrit of > 30% An ECOG Performance Status of zero or one Age ≥ 18 A life expectancy of 5 years or more(excluding possible prostate related causes) Exclusion Criteria : Prior (...) Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02115 Sponsors and Collaborators Dana-Farber Cancer Institute National Cancer Institute (NCI) Investigators Layout table for investigator information Study Chair: Irving Kaplan, MD Beth Israel Deaconess Medical Center More Information Go to Publications: Layout table for additonal information Responsible Party: Irving Kaplan, Principal Investigator, Dana-Farber Cancer Institute ClinicalTrials.gov Identifier: Other Study ID Numbers

1999 Clinical Trials

13035. Test of A Model of Representational Knowledge Stored in the Human Prefrontal Cortex

. The data we collect in this protocol will be of value in 1) Developing a model of the forms of knowledge representation stored in the human prefrontal cortex; 2) Developing outcome measures for drug and behavioral treatments for disorders of prefrontal cortex functions; and, 3) Developing biologically plausible computer models of the cognitive sub-components stored in the human prefrontal cortex that compose the complex skills referred to above. Study Design Go to Layout table for study information (...) Disorders and Stroke (NINDS) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will examine the underlying mental processes that determine how people understand social behavior, remember information, and think. Language, planning, problem solving, reasoning, social behavior, and memory are the critical parts of cognition that make up daily life. This study will explore the association between performance on various

2001 Clinical Trials

13036. Evaluation and Treatment of Skeletal Diseases

) Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ) Study Details Study Description Go to Brief Summary: This study has four objectives: 1) to provide investigators the opportunity to study bone specimens from patients with various skeletal diseases; 2) to treat patients with skeletal diseases at the NIH; 3) to expose NIH trainees to certain skeletal diseases; and 4) to gain more knowledge about (...) tests, urine tests, and imaging tests, such as X-rays, bone densitometry, bone scan, computed tomography (CT) and magnetic resonance imaging (MRI). Bone specimens from participants will be collected for research use. Specimens will be obtained from bone removed during a patient s planned surgical procedure performed for medical care, or patients may be requested to have a bone biopsy removal of a small piece of bone tissue as part of the patient evaluation procedure. Condition or disease Tumor

2001 Clinical Trials

13037. Eye-Hand Coordination in Children With Spastic Diplegia

Center (CC) Study Details Study Description Go to Brief Summary: This study will examine how the brain controls eye-hand coordination (visuomotor skills) in children with spastic diplegia and will determine whether impairment of this skill is related to the learning difficulties in school that some of these children experience. Spastic diplegia is a form of cerebral palsy that affects the legs more than the hands. The brain injury causing the leg problem in this disease may also cause difficulty (...) with eye-hand coordination. Healthy normal volunteers and children with spastic diplegia between 6 and 12 years of age may be eligible for this study. Candidates will be screened with a review of medical and school records, psychological testing, neurological and physical examinations, and assessment of muscle function in the arms and legs. Participants may undergo one or more of the following procedures: Neuropsychological testing (1 to 2 hours) - involves sitting at a computer and answering questions

2001 Clinical Trials

13038. A Novel Acuity Testing Method

is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00013936 Recruitment Status : Completed First Posted : April 4, 2001 Last Update Posted : March 4, 2008 Sponsor: National Eye Institute (NEI) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: The purpose of this protocol is to develop (...) a valid, reliable, better standardized, and more efficient test of visual acuity (ability to see fine details) for use in clinical trials. Recent improvements in computer video hardware permit calibration, characterization, and accurate rendering of eye-chart-quality letters. The computer can then be used to measure acuity. The modified binary search (MOBS) testing strategy is one method of computer-based testing. This study will compare the accuracy, precision, stability and utility of the MOBS

2001 Clinical Trials

13039. Pyrimethamine and Sulfadoxine for Treatment of Autoimmune Lymphoproliferative Syndrome

or spleen in patients with ALPS. Patients with ALPS between the ages of 4 and 70 years who have had lymph gland enlargement for at least 1 year and are not allergic to sulfa drugs may be eligible for this study. Candidates will be screened with a medical history and physical examination and blood tests. Females of reproductive age will have a urine pregnancy test. Participants will be evaluated at the NIH Clinical Center in Bethesda, MD, with blood tests and a computed tomography (CT) scan of the lymph (...) and Infectious Diseases (NIAID) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will evaluate the safety and effectiveness of an antibiotic called Fansidar on autoimmune lymphoproliferative syndrome (ALPS). Patients with ALPS have enlarged lymph glands, spleen and/or liver, abnormal blood cell counts and overactive immune function. Current treatments are aimed at suppressing the immune system and improving symptoms

2001 Clinical Trials

13040. Language Stimuli Screening in Children

or language disorder; who are performing at or above grade level, and who are native English speakers may be eligible for this study. Participants will be asked to do the following: name pictures or read words that appear on a computer screen listen to stories and answer questions about them match pictures to a spoken word The children's responses will be recorded. Condition or disease Language Disorder Healthy Detailed Description: We propose to study normal children to establish baseline data to use (...) of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00016796 Recruitment Status : Completed First Posted : June 4, 2001 Last Update Posted : March 4, 2008 Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief

2001 Clinical Trials

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