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This is an exploratory study designed to evaluate the incidence of, and to quantify sleep disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered breathing will be correlated with: 1. Elevations in pulmonary vasculature resistance at the time of Stage II surgery. 2. Risks of death
This study will determine whether the medication metoclopramide can improve red blood counts in people who have myelodysplastic syndrome (MDS). MDS is thought to affect blood stem cells, which can result in low levels of red blood cells-that is, anemia-as well as low white blood cell and platelet counts. Patients with MDS are at risk for infection, spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow. Although bone marrow can produce some blood cells, this production can be decreased in patients with MDS. The definitive way to treat MDS is stem cell transplantation, but serious complications and a high risk of death make it unsuitable for patients older than age 60 or those who do not have a matched sibling donor. However, scientists have noted improvement in anemia by using metoclopramide, an inexpensive, commonly used medication that does not have many negative side effects. This study will evaluate the safety and effectiveness of that medicine for patients with MDS. Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example, with growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for this study. There will be about 60 participants. Screening tests include a complete physical examination and medical history, during which patients will provide a list of current medications or supplements they are taking. There will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as liver and kidney function. Patients may also undergo a magnetic resonance imaging (MRI) scan of their brain, but the procedure is optional. During the MRI, they will lie on a table that will slide into the enclosed tunnel of the scanner. The MRI takes about 20 to 30 minutes, and patients will be asked to lie as still as possible. There will also be a bone marrow biopsy, if patients have not had one done within 4 weeks of the start of this study. Eligible patients will take a 10 mg dose of metoclopramide by mouth, three times a day, for 20 weeks. They will be given a 4-week supply, which will be renewed monthly at each treatment visit. It is essential that patients be seen at NIH during the first, third, and fifth months of the study. Visits made in the meantime, at the second and fourth months, may be done at the office of their doctors who have referred them for the study, or at NIH. During the treatment visits, patients will be asked to update their medical history, health conditions, and use of medications or herbal supplements. There will also be a collection of about 1 tablespoon of blood for laboratory tests. Patients will be asked to make a similar follow-up visit 1 month after they stop taking metoclopramide, so that the response to treatment can be evaluated. The use of metoclopramide may cause some people to feel dizzy, lightheaded, tired, or less alert than they are normally. For the first 24 to 48 hours, patients should be cautious when driving, using machinery, or performing hazardous activities. This medicine will add to the effects of alcohol and other central nervous system depressants-such as medicines for allergies and colds, tranquilizers, and prescription pain relievers. Patients need to check with the research team before taking any of those types of medicines, as well as herbal supplements, while using metoclopramide. This study may or may not have a direct benefit for participants. For some, the drug may improve red blood cell counts and decrease the need for red cell transfusions. Knowledge gained in the study may help people in the future.
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of alemtuzumab, fludarabine, and melphalan with or without cyclosporine, mycophenolate mofetil, and total-body irradiation before donor peripheral blood stem cell transplant and to see how well they work in treating patients with relapsed or refractory hematologic cancer.
This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection) originating in China. SARS is caused by a new virus that is easily transmitted from person to person. This study will look at the course of the disease; determine how the virus affects the body and how the body fights the infection; and evaluate diagnostic tests to quickly identify the disease. People 18 years of age and older with probable or suspected SARS may be eligible for this study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health care workers involved in the care of patients will also be enrolled. Patients with SARS who require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads easily, hospitalized patients will be in a room by themselves and will not be allowed any visitors. They will not leave their room except for tests, such as x-rays. All participants will have a full medical examination, including a medical history, physical examination, and blood tests. In addition, the participants undergo various tests and procedures as follows: - Probable and suspected SARS patients may be hospitalized or may be seen as outpatients. They are provided the treatment judged best for their disease, usually according to expressed or published recommendations. The best treatment for SARS is not yet known, and there have been no studies evaluating therapies. Outpatients are seen three times a week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have mouth and throat swabs taken three times a week for the first 2 weeks, then once a week for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat swabs are repeated until no virus is detected for 3 weeks in a row. In addition, patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the physician to examine the airways. Cells and secretions from the airways are rinsed from the lung with salt water. A brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways and pieces of tissue are collected for analysis. - Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for 2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks, then once a week for 2 more weeks. Urine and stool samples are collected once a week for 4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose washings and throat swabs continue until no virus is detected for 3 weeks in a row. Blood may also be drawn during the weekly visits. - Recovered SARS patients provide blood, urine, and stool samples and have a mouth and throat swab and nose aspiration to see if the SARS virus is present. For the nasal aspiration, salt water is put in the nose and then suctioned out. Usually, these tests are done only once. If virus is detected, however, the nose washing, throat swabs and blood tests are repeated once a week until no virus is detected for 3 weeks in a row. - Health care workers document their contact with patients, use of isolation procedures and equipment, and any unexpected events that occur during contact. They are evaluated for symptoms of infection and provide a blood sample once a month
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer.
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have primary myelodysplastic syndrome.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.