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NCT00342134
Our goal is the elucidation of the mechanisms of action of autologous hematopoietic stem cell transplant (HSCT) and immunoablation by high-dose cyclophosphamide in multiple sclerosis (MS). The molecular pathogenesis of multiple sclerosis is poorly understood although T-cell mediated immune destruction of myelin is thought to be an important element. We hypothesize, and the results of previous studies suggest, that radical immuno-ablation characterized by a profound T cell depletion can arrest the progression of disease. Patients with MS with poor prognosis based on the rate of progression and refractoriness to approved treatments (interferon-beta, glatiramer acetate) will be enrolled in clinical trials at the collaborating institution (NWU-Dr. R. Burt; Dr. D Kerr, JHU) and will receive either immune ablation with cyclophosphamide and the antibody Campath-1 followed by reconstitution with autologous peripheral blood stem cells, a procedure similar to autologous bone marrow transplantation, or high-dose cyclophosphamide treatment without stem cell rescue. While the overall treatment-related mortality worldwide is approximately 10%, the collaborating institution and investigators have an outstanding safety record in performing the procedure with no fatal adverse events after having transplanted more than 30 transplants with a previously more aggressive regimen than the one that is in use now. The underlying rationale for this treatment is that immuno-ablation could eliminate myelin-reactive T cells which, in disease-susceptible individuals, may have been activated by previous exposure to environmental agents or other acquired mechanisms of immune dysregulation. In the proposed study we plan to address whether HSCT or immunoablation without stem cell rescue act beneficially in MS via the eradication of myelin-reactive T cells and reconstitution of a functional and non-autoimmune immune repertoire. To achieve this goal, we will compare peripheral blood T cell reactivities to myelin antigens before and after the treatment in 34 patients with MS. In parallel, to identify potential disease-mediating cells that do not recognize these myelin antigens, we will search for clonally expanded cells in the blood of MS patients before treatment employing molecular analysis of T cell receptor repertoire. Expanded T cell clones will be tracked during post-transplant follow-up of patients. If the eradication of certain clonotypes resulting from immuno-ablation correlates with disease remission, we will attempt to isolate these cells in culture from pre-treatment samples and determine their specificity using combinatorial peptide libraries. We would use the same approach in case of reappearance or new clonal expansions concomitant to disease relapses. We will combine these studies with a broader, unbiased approach that employs microarray technology to identify potential changes in gene expression profiles. This approach may also lead to the identification of novel therapeutic targets for pharmacological treatment.
NCT00955370
Background: * Rare and undiagnosed conditions are often chronic and disabling, with symptoms affecting different organ systems at various levels of severity. Perhaps the most challenging feature of an undiagnosed medical condition that has lasted 2 or more years is its characteristic uncertainty. In the absence of a diagnosis, health care professionals can provide only limited treatment and prognostic information. * In the case of a child with an undiagnosed condition, the uncertainty that accompanies what is often a chronic, debilitating medical condition and an undefined prognosis may have physical, psychological, social, and spiritual implications for the entire family. Research suggests that parents of a child with an undiagnosed medical condition may be at significantly increased risk of anxiety, depression, poor health, and overall lower quality of life. * It is not well understood how individuals cope with and adapt to chronic uncertainty, and the factors that influence this process. To design future interventions, descriptive studies are needed to reveal predictors that can be manipulated to improve outcomes. Objectives: * To examine whether perceptions of uncertainty, and perceived personal control, are associated with coping and adaptation. * To examine how the length of time elapsed since child was identified as sick and perceptions of uncertainty affect coping and adaptation. * To assess how perceptions of uncertainty, time elapsed since child became sick, optimism, and perceived personal control affect coping and adaptation. Eligibility: * Parents (older than 18 years of age) of children who have an undiagnosed medical condition. * Participants must have a working e-mail address or fixed postal address. Design: * Parents will be recruited from Web-based support networks for parents of undiagnosed children through Web site postings, electronic mailing lists, and printed newsletter postings. * Participants will be asked to complete a questionnaire about their experiences in living with a child who has an undiagnosed but chronic medical condition. The main outcome variable is adaptation to living with one's child's undiagnosed medical condition. * Participants have the option to complete an online or paper version of the questionnaire. The questionnaire should take between 20 and 30 minutes to complete. * No medical treatments are specifically offered as a part of this study.
NCT00102076
One of the principal safeguards mandated by the Federal Regulations governing clinical research with children is the assent requirement: children who are capable must provide an affirmative agreement to participate unless the research "holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research" (46.408). Despite the importance of the assent requirement, the Federal regulations offer no guidelines on its implementation. In the present study, we propose to survey children and one of their parents in order to obtain information concerning children's role in making decisions concerning their participation in clinical research. Five elements of children's involvement in the decision-making process with respect to their participation in clinical research will be assessed: 1) receipt of information concerning the available options; 2) understanding of this information; 3) assessment of the available options; 4) expression of a preferred option; and 5) coordination with parental decision-making. Three groups will be enrolled: 1. Minor/Parent pairs where the minor is participating in, or is in follow-up for, a drug treatment research study for cancer 2. Minor/Parent pairs where the minor is participating in, or is in follow-up for, a drug treatment research study for asthma, and 3. Minor/Parent pairs where the minor is receiving on-going clinical care for asthma. Children 7-14 years of age will be enrolled. Total enrollment will be 400 subject pairs, approximately 150 in cancer research, 150 in asthma research and 100 involved in clinical care for asthma, with approximate balance between the sites. Two formalized survey instruments - research/clinical minor, research/clinical parent - will be developed in consultation with Research Triangle Institute (RTI).
NCT00341757
Family history of cancer is an important possible indicator of inherited cancer susceptibility, which has helped identify individuals and families at high risk of inherited cancers in research studies and clinical practice. While there are also various potential uses of family history of cancer data in cancer surveillance, the completeness and accuracy of family history of cancer data collected from the general population is unclear. In an effort to evaluate the feasibility of conducting a national surveillance study to determine the prevalence of family history of cancer in the U.S. population, the Risk Factor Monitoring and Methods Branch will undertake a pilot study, entitled the Family Health Study, that examines issues of data quality. In this study, a family history of cancer questionnaire (FHCQ) will be developed for surveillance purposes and administered to a random digit dial (RDD) sample of households in the state of Connecticut. Positive and negative reports of common cancers in the respondent's families will be validated against records of the Connecticut Tumor Registry (CTR) and other data sources. The objectives are to: 1) assess the agreement between respondent reports of specific cancers in first and second degree relatives and medical record-based reports, as measured by percent concordance; 2) quantify the sensitivity, specificity and predictive value of the FHCQ by cancer site; 3) evaluate the possible predictors of reporting accuracy, including cancer site, year of diagnosis, kinship relation of the relative to the respondent and the frequency and quality of their contact, overall family cohesiveness, respondent's own history of cancer, and demographic factors; 4) describe the completeness and reliability of family structure data. Validation of selected relatives' cancer status will be done through data linkage to the Connecticut Tumor Registry, other selected cancer registries, the National Death Index, Medicare claims data bases, state death certificate registries, or by obtaining consent to review available medical records from physicians and health care facilities. Self-reports of respondents' cancer status will also be validated since this may be a predictor of ability to accurately report family history. A pre-established tracing algorithm will be used to triage cancer reports into the medical records systems where true cancer status is most likely to be verified by the highest quality data. Validated cancer outco...
NCT00050180
This study will examine whether a particular type of gene (MDR1) in the body can affect blood levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people with HIV. If blood levels of these drugs are too low or too high, they may not work well or may cause side effects in patients. This study will determine how MDR1 genes might affect absorption of these medicines. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates will be screened with a medical history and blood and urine tests. The blood will be tested for: * Routine laboratory values for assessing general health * HIV * MDR1 gene type * Amount of P-glycoprotein (a protein made by the MDR1 gene) on T cells. Participants will have blood drawn three more times, as follows: * After one dose of the sedative midazolam (Versed(Registered Trademark)): Participants will take an 8-milligram dose of midazolam syrup by mouth. Four hours later, a single blood sample will be drawn through a needle in an arm vein. This part of the study will assess the efficiency of a certain enzyme involved in metabolizing (breaking down) indinavir and saquinavir. * After four doses of indinavir: About a week after taking the midazolam, participants will take 800 mg of indinavir (two capsules) 3 times a day (every 8 hours) for 1 day. The following morning they will come to the clinic, where a catheter (flexible plastic tube) will be placed in an arm vein for repeated blood draws. A blood sample will be drawn, and a fourth and final dose of indinavir will be given. Seven blood samples of about a teaspoon each will then be collected through the catheter over an 8-hour period to measure blood levels of the drug. * After 10 doses of saquinavir: About a week after the last dose of indinavir, participants will start taking 1,200 mg (6 capsules) of saquinavir soft-gelatin capsules 3 times a day for 3 days. On the fourth day, participants will come to the clinic. A catheter will be inserted into an arm vein and about 4 teaspoons of blood will be collected for routine laboratory tests and to measure saquinavir levels. A urine sample will also be collected for routine tests. Participants will then receive the tenth and final dose of saquinavir, and eight blood samples of about a teaspoon each will be collected through the catheter over an 8-hour period.
NCT00001306
No therapy for infertile patients with premature ovarian failure has been proven effective. Some anecdotal reports have suggested that high dose, long term prednisone (steroid) therapy may be useful in treating autoimmune ovarian failure. However, prednisone, when used in high-doses for long periods of time has substantial side effects, including aseptic necrosis of bone where portions of bone die without the presence of infection and are surrounded by healthy tissue. Aseptic necrosis of bone often requires major surgical treatment. Even with this known level of risk, patients with premature ovarian failure are being treated based on this anecdotal evidence. This study will test the hypothesis that a lower risk therapy (alternate-day, lower dose, shorter-term prednisone) will cause a remission of autoimmune ovarian failure. There is no reliable blood test to identify patients who have premature ovarian failure. Therefore, all patients must undergo a laparoscopic ovarian biopsy to confirm the presence of an auto immune reaction in the ovaries (autoimmune oophoritis). Laparoscopy is a surgical procedure that allows doctors to explore the abdomen using a camera-like device called a laparoscope. The procedure has been used clinically by some reproductive endocrinologists to identify patients with premature ovarian failure who have an autoimmune mechanism for the disorder. The treatment will be deemed successful based on the return of ovulation as determined by weekly serum progesterone levels.
NCT00088738
This study is designed to observe the effects of a panic attack in patients with panic disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby, further our understanding of its role in this illness. We will measure levels of Substance P in the brain by obtaining pictures of the brain using PET and MRI....
NCT00014027
This research study is designed to find out if increasing the dietary intake of polyunsaturated fats improves concentration, motor skills and cardiovascular responses under stress. These polyunsaturated fats may also change the chemicals in the brain that control these responses. Specifically, these polyunsaturated fats may raise brain levels of neurotransmitters called dopamine and serotonin. Polyunsaturated fats are important for improving the function of both the brain and the heart. People cannot make these polyunsaturated fats and they can only be obtained from the oils that we eat. For three months subjects will take 8 capsules a day that contain either corn oils flavored with fish oils or fish oil that taste a little like corn oils. Subjects will not be told which oils we expect to work better. An initial evaluation will determine if subjects fit the criteria necessary to enter the study. A battery of tests will be conducted twice, once before starting the capsules and again after three months of taking the capsules. These batteries of tests will include an MRI of the head, paper and pencil tests to evaluate changes in mood, and tests of concentration and motor skills and cardiovascular responses under stress. Two lumbar punctures will be performed to collect cerebrospinal fluid so that changes in neurotransmitters can be evaluated. Subjects will be on a no seafood diet to equalize their dietary intake of polyunsaturated fatty acids. Subjects will be expected to complete all parts of this study.
NCT00310414
This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms. Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test. All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.
NCT00080548
This study will examine and compare how the brain controls the timing of movement in healthy volunteers and in people with schizophrenia. Previous experiments have shown that when people are asked to look at a clock and report the time they first decide to make a movement, they report times later than the first brain waves associated with movement appear. When they are asked to report the time they first initiate the movement, they report times before the muscles actually begin to move. The study may help determine how the sense of willing and initiating an action is altered in schizophrenic patients, and how people may feel more or less "in control" of their movements. Normal volunteers and patients with schizophrenia between 18 and 65 years of age may be eligible for this study. Control subjects must not have any neurological or psychological disorders, and schizophrenia patients must not have any other neurological disorders. All participants will have a medical history, physical examination, and a test to determine their level of attention. Schizophrenia patients will be interviewed about their symptoms and complete psychiatric rating scales. In addition, all participants will undergo the following procedures: Electric shock Participants look at a clock on a computer screen whose hands revolves around the clock fast. While they look at the clock, they are given small, non-painful electric shocks and are asked to say when they receive the shocks, according to the clock. The shocks are repeated 40 times. Arm movement Participants are asked to lift their arm up off a table repeatedly, at random times, while they look at the computer clock. This exercise is repeated a total of 80 times. Of these 80 times, participants are asked 10 times in a row to say the time they first had the desire to move their arm, and then 10 times in a row the time they first felt that they were moving their arm. Electroencephalography (EEG) and Electromyography (EMG) Participants undergo EEG and EMG during the electric shock and arm movement experiments to measure electrical activity of the brain (EEG) and of the muscles (EMG). For EEG, electrodes (small metal discs) are placed on the scalp with a cap, paste, or glue-like substance and the brain waves are recorded. For EMG, electrodes are taped to the skin over the muscle.
NCT00001408
This study will examine the movement of T cells (a type of white blood cell) from the blood to the lungs in patients with asthma after exposure to an allergen, such as cat dander or pollen. Asthma is in large part due to inflammation of the bronchi (the breathing tubes of the lungs), causing heat, swelling and redness. T cells play a major role in the inflammatory reaction. A better understanding of T cell migration to the lungs after allergen exposure may lead to improved therapies for asthma. Patients between 18 and 50 years of age with mild allergic asthma may be eligible for this study. In addition, patients and healthy normal volunteers between 18 and 65 years of age may participate in a sub-study (blood draw) of this protocol. Participants will undergo the following procedures: Visit 1 (screening visit) * Blood tests for blood counts and HIV * Urine pregnancy test for women of childbearing potential. Visit 2 * Physical examination and electrocardiogram (EKG) * Prick skin testing - A drop of allergen extract is put on the skin and the underlying skin is scratched with a needle. A positive test resembles an insect bite and may itch. * Intradermal skin tests - Increasing concentrations of a drop of diluted allergen are injected into the skin and the allergic response is monitored until a 5-mm swelling (1/4 inch) swelling develops. * Methacholine challenge - The subject has repeated pulmonary function (breathing) tests after breathing methacholine, a drug that temporarily (for 5 to 10 minutes) worsens asthma symptoms. * Physician evaluation and repeat pulmonary function test Visit 3 \- Allergen bronchoprovocation - This test will be done in patients whose physical evaluation and breathing test permit them to continue with the study. A heparin lock (needle device that stays in a vein to allow multiple blood draws without repeated sticks) is placed. The subject breathes 5 breaths of allergen through a nebulizer (device that creates a mist), followed by a breathing test. This procedure will be repeated with increasingly higher allergen doses until lung function significantly declines or for a maximum of 6 doses. Subjects are monitored for 8 hours after the last dose. Blood samples of 50 ml each (3.5 tablespoons) are collected at 1, 3, 5 and 8 hours, and a physician evaluation is done at the end of the 8 hours. Additional 50-mm blood samples are collected the following two mornings. Visit 4 * Physician evaluation, blood test for anemia and pulmonary function test * Serial blood draws - 50 ml of blood will be drawn, followed by salt-water nebulization and another 50-ml blood draw after 1 hour. Additional 50-ml blood samples will be drawn 7 hours later and then on the next two mornings. Participants in the sub-study portion of this protocol will undergo the screening blood test, prick skin testing, breathing test after methacholine inhalation and a 100 ml-blood draw. These tests will be done in three sessions.
NCT00260702
This study will evaluate the safety and effectiveness of a laboratory-made antibody called omalizumab in patients with Job's syndrome, or hyper-IgE syndrome (HIES). Patients with HIES have very high levels of IgE antibody, a protein made by white blood cells. IgE plays an important role in starting allergic reactions in the body and may be related to some HIES symptoms, such as skin rashes and asthma. Patients also have frequent lung infections, easily broken bones and other symptoms. Omalizumab, which is approved to treat allergic asthma, is directed against IgE. This study will see if blocking IgE with omalizumab in HIES patients is safe and if it can reduce patients' IgE count. It will also look at how the body handles omalizumab and how it affects patients' symptoms. Patients 6 years of age or older with HIES may be eligible for this study. Each candidate is screened with a medical history, physical examination, skin examination and blood test. Participants receive an injection of omalizumab under the skin once every 2 weeks for 6 doses. At the time of each injection, patients are examined by a doctor, answer questions about their symptoms and have a blood sample drawn. After the sixth dose, patients have a physical examination, blood tests, skin examination and lung function tests. At follow-up visits scheduled 2, 4 and 6 months after the last dose of omalizumab, patients have a physical examination, answer questions about their symptoms, and have a blood sample drawn. Patients who show a significant response to omalizumab stay off the drug for 3 months after the last dose and then discuss with their study doctor and referring doctor about continuing the medicine.
NCT00304941
This study will characterize risk factors associated with breast cancer development in some patients. In particular, it will examine the role of insulin in breast cancer in patients with and without a family history of the disease. Women 30 to 70 years old who have been diagnosed with breast cancer and matched control healthy subjects with and without a family history of breast cancer may be eligible for this study. Participants undergo the following procedures: * Cancer-genetic counseling session, including family history, risk assessment, genetic testing for BRCA1 and BRCA2 (if criteria is met), interpretation of results and management options * Medical history, including questions about symptoms or diseases, reproductive history, use of oral contraceptives, body weight, exercise, lifestyle, and demographic issues * Drawing of family tree * Examination of medical records * Blood drawing for genetic and other tests * CT scan of the abdomen (approximate time \< 1 minute) * Filling out questionnaires
NCT00104026
This study will examine common features of gingival overgrowth (excessive growth of the gums around the teeth) that develops in patients with the hereditary form of the condition and in those who develop the condition as a side effect of medications. A better understanding of gingival overgrowth may help scientists develop medications with fewer oral side effects. Patients of any age with hereditary gingival fibromatosis and their blood relatives, and patients of any age with gingival overgrowth who are taking medications associated with development of the disorder, including phenytoin (diphenylhydantoin or Dilantin), cyclosporine, and calcium-channel blockers, may be eligible for this study. Participants undergo a medical and dental history, including a history of medication use; detailed examination of the teeth, periodontium, head, and neck; photographs of teeth with gingival overgrowth; dental x-rays; and blood tests. DNA is extracted from a blood sample to look for genes related to gingival overgrowth. Patients with gingival overgrowth are offered two options, as follows: * Tissue biopsy: A tissue sample is taken from each affected site, with a maximum of three biopsies. For the procedure, lidocaine is first injected into the gum to numb the tissue. Then, a cookie-cutter instrument is pushed into the numbed skin, and a small piece of tissue is removed. * Gingivectomy: Surgical removal of the overgrown gingival.
NCT01170325
Background: * Electroencephalography (EEG) records electric patterns produced by the brain, and can detect conditions such as epilepsy or other l abnormalities that may affect brain function. In EEG studies, electric patterns that resemble epileptic seizures are known as epileptiform pattern. These patterns are associated with an increased risk of seizures, even in people who have not been diagnosed with epilepsy. Epileptiform patterns also appear on the EEGs of some children who have autism spectrum disorders but do not have epilepsy. It is unclear if these discharges are related in any way to the symptoms of autism (behavior, language or intellectual abilities). * Divalproex sodium (Depakote) is a drug that has been used for many years to treat epilepsy and other brain disorders in children and adults. Researchers are interested determining whether treatment with divalproex sodium can reduce epileptiform patterns in children with autism spectrum disorders, and in doing so study whether this treatment can improve behavior, language or cognition in children with autism spectrum disorders. Objectives: \- To study the effectiveness of using divalproex sodium to reduce epileptiform EEG discharges in children with autism spectrum disorders. Eligibility: \- Children between 3 and 10 years of age who have an autism spectrum disorder and show frequent epileptiform discharges on an overnight EEG. Design: * This study will last for a total of 9 months, with 6 months of treatment with either divalproex sodium or a placebo followed by 3 months of treatment with divalproex sodium only. * Potential participants will be screened with a physical examination and medical history, blood samples, and psychological tests, and will spend the night in the NIH Clinical Center to have an overnight EEG. Children with frequent epileptiform abnormalities on the EEG will continue with the study; all others will be considered ineligible. * Eligible participants will receive either divalproex sodium or a placebo to be taken twice daily for 24 weeks. Neither the investigators nor the participants will know which they are taking. * Participants will have regular visits (every 2-4 weeks) to monitor for adverse effects and to test for possible behavioral improvement, and will also have overnight EEG testing at 12 and 24 weeks. * At the end of the 24-week study period, participants will have the option to have an additional 12 weeks of treatment with divalproex sodium. * A final evaluation (including EEG) will be conducted at the end of the final treatment period.
NCT00084097
This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or environmental allergies, which may play a role in EG. Some patients with EG improve significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is an antibody that plays an important role in initiating allergic reactions. Omalizumab is a monoclonal antibody directed against IgE. The Food and Drug Administration approved omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma. Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants undergo the following procedures: * Leukapheresis. This procedure is done to collect quantities of white blood cells to study the effects of omalizumab on eosinophils and other immune substances. Blood flows from a needle placed in an arm vein through a catheter (plastic tube) into a machine that separates the blood into its components by centrifugation (spinning). Some of the white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm. * Skin testing. Participants are tested for allergies to specific substances. A small amount of various allergens (substances that cause allergies) are placed on the subject's arm. The skin is pricked at the sites of the allergens and the skin reaction after several minutes is observed. * Upper and lower endoscopy. One or both of these procedures is done, depending on the part of the gastrointestinal tract that is involved, to examine the tract. If both procedures are done, they are performed at the same time. For the upper endoscopy, the subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is passed through the rectum into t...
NCT00306501
This study will compare several techniques designed to improve the ability to swallow in stroke patients with chronic dysphagia (difficulty swallowing). Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a stroke resulting in swallowing problems may be eligible for this study. Volunteers are screened with a medical history, physical examination, and urine test for women to rule out pregnancy. Stroke patients are screened additionally with a chest x-ray, physical examination, cognitive screening, swallowing questionnaires, nasoendoscopy (examination of the nasal passages in the back of the throat using a lighted telescopic instrument) and FEESST (passage of a thin, flexible telescope through the nose to the voice box), videofluoroscopy (x-ray of the head and neck during swallowing) and button press training (learning how to press a button on a table in coordination with swallowing). All participants undergo the following procedures: * Transcranial magnetic stimulation (TMS): A metal coil is placed on the head and sends a pulse of energy to the brain through the scalp. The muscle response to the pulse is recorded from the muscles in the throat that are associated with swallowing. * Electromyography: A needle is used to insert tiny wires in specific muscles of the throat to record the muscle response to the TMS pulses. * Magnetic resonance imaging (MRI): During brain MRI scanning, subjects lie quietly and images of the brain are taken. In addition to the above tests, stroke patients undergo the following: * Water test: The subject swallows a small amount of water and the number of times required to clear the throat or cough is counted. This test is repeated five times. * Experimental training. Subjects have a total of 12 60-minute training sessions, one session a day for up to 5 sessions a week. * Button press training: The subject swallows small amounts of water. A device placed on the throat senses when swallowing occurs. The subject learns how to coordinate pressing a button on a table in coordination with swallowing. * Vibrotactile stimulator training: A device that uses a buzzing vibration is placed on the throat at times during the swallowing training. * Transcranial direct current stimulation (tDCS): Wires attached to sponge electrodes are placed on the scalp and over the eye. Small electric currents are delivered to areas of the brain involved with swallowing. This is done at times during the swallowing training. Participants may receive one of several combinations of training approaches; all receive the volitional (button-press) training. Within 5 days of completing training, subjects repeat the tests. TMS, MRI, MEG and x-ray study of swallowing function are also repeated to see if any changes have occurred in the brain or in the ability to swallow after training. Patients are contacted by telephone and in writing 3 and 6 months after training for follow-up on their swallowing status and oral intake.
NCT01693029
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.
NCT00341913
Reduced susceptibility of Staphyloccus aureus to the glycopeptide antibiotic vancomycin is causing increasing concern worldwide in view of the threat of increased morbidity and mortality caused by such resistant organisms. MRL Pharmaceutical Services, a Division of Focus/MRL, has been contracted by NIAID to establish a Network on Antimicrobial Resistance in S. aureus (NARSA) to document cases where staphylococcal isolates with reduced susceptibility to vancomycin (MIC's greater than or equal to 4 micrograms/ml) have arisen and to procure such isolates into a central repository for distribution to registered approved researchers. MRL will be responsible for contacting sites where such isolates have been reported to discuss the test methods used to determine the reduced vancomycin susceptibility status of the isolate. Once the MRL Laboratory has determined that the isolate meets the criteria stated above, the site will be asked to ship the isolate to MRL as a possible candidate for inclusion in the NARSA Repository. The procurement strategy will involve issuing each isolate a temporary strain designation number which will be destroyed once the antibiotic profile of the isolate has been confirmed at MRL, thus preventing any link to the data generated by the site. The isolate and its antimicrobial susceptibility profile to several key drugs will be recorded in the NARSA Repository database. Demographic information related to the isolate and collected from the site includes: The Name of the Donor Site/Institution, City (to be held in a separate secured database, these data points are not available to registered user); State, Country of Donor Site; Isolation Date; Age; Sex; Patient Location; Patient Service; Culture Source; Reporting History. This information will be held in the Registry database. Since patient-specific information will not be collected, a request for a waiver of informed consent has been requested herein. NIAID funded investigators (NARSA Core Investigators) and other approved registered users whose research focuses on S. aureus will have access to the Registry/Repository database and will be able to request isolates for use in their research. Facility specific information will be held in a separate secured database that is not available to registered researchers unless approved through an IRB review.
NCT01231945
Background: \- Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection for cervical cancer screening of underserved women. Two low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3 hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing for HPV. Researchers are interested in evaluating both tests to determine the best strategy for HPV testing of women who live in rural or underserved areas that have a high prevalence of cervical cancer diagnoses. Objectives: * To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting cervical cancer and precancerous lesions. * To evaluate the best low-cost test or combination of tests for women who have been referred for cervical cancer screening or treatment. * To compare the clinical performance of self-collected specimens versus clinician-collected specimens in detecting cervical cancer and precancerous lesions. Eligibility: \- Women between 25 and 65 years of age who live in rural China. Design: * This study involves an initial testing visit and a 1-year followup visit for a high-risk subgroup. * Participants will have the HPV E6 test, careHPV, and a visual inspection test for cervical cancer. For comparison, participants will also have the standard HPV test approved by the U.S. Food and Drug Administration. * Participants who test positive for HPV on any of the above tests will also have colposcopy to collect samples of cervical tissue for further study. * A random sample of women who test negative for HPV will also have colposcopy. Participants may also have biopsies if there is visual evidence of cervical abnormalities. * At the 1-year followup visit, participants in the high-risk subgroup will have the same tests as in the previous visit..
