The purpose of this study is to evaluate the ability of an investigational test to predict the risk of preterm or imminent delivery using cervical samples collected with a sterile swab from women less than 36 weeks pregnant and presenting with signs and/or symptoms suggestive of preterm labor and whose fetal membranes are not ruptured. The rapid test is called the Actim PARTUS test. It is an “investigational test”, which means that it is not approved by the U.S. Food and Drug Administration (FDA) and the results from the test cannot be used to assist in making a diagnosis. This study will collect information about the effectiveness of the rapid test to detect in a cervical sample a marker of fetal membrane detachment indicating a high risk of preterm or imminent delivery.
This study will explore women’s views on choosing contraception during the postpartum period in the context of their health care locus of control, trust in their providers and health care system, and reproductive health messages that they received during antenatal and postpartum care. A focus group will be facilitated by a research coordinator during the postpartum period.
This study is for subjects who have cancer of the colon, which has been surgically removed, but has spread to lymph nodes. This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat this type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX”. The Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
In this study, researchers will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. Celecoxib is approved by the FDA to treat arthritis and some other painful conditions. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving subjects celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence.
This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care is 12 treatments with FOLFOX. In this trial, researchers will explore whether 6 treatments are as effective as 12 treatments and whether side effects can be reduced with fewer treatments. It expected that subjects will be enrolled in this trial for up to 3 years.
The purpose of this study is to compare body fat distribution in neonates exposed to antiretroviral (ARV) therapy for the prevention of maternal to child transmission (MTCT) of HIV versus ARV naive neonates born at a similar gestational age to HIV-negative women. As a secondary analysis, we will examine the differences in body fat distribution among ARV-exposed neonates comparing PI-exposed versus non-PI exposed.
The main purpose of this study is to find out what effects, good and/or bad, MEHD7945A has on you and your cancer. In this study there will be two treatment arms. You will be treated with either MEHD7945A or cetuximab, a drug that is commonly used for your type of cancer. You will not be treated with both drugs at the same time.
The purpose of this research study is to obtain several specimens or samples from study participants. The specimens collected are the same samples collected during a standard visit to your doctor. These samples include urine and swabs from your vagina. These samples will be tested for diseases that are passed through sexual contact. These common diseases include gonorrhea, chlamydia, and trichomonas.
The samples will be tested on instruments designed to test for sexually transmitted diseases (STDs). The data generated from testing these samples will be submitted to the Food and Drug Administration (FDA) to support the use of tests developed by the Gen-Probe, Inc. These name of these tests or assays are: 1) APTIMA COMBO 2 Assay and 2) APTIMA Trichomonas vaginalis Assay. These assays will be tested on instrument known as: 1) the PANTHER System and 2) the TIGRIS System.
By testing the samples using the APTIMA assays on these instruments this will help lead to increased detection and treatment of STDs.
This study is for subjects with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after treatment or did not respond to earlier treatment. The purpose of this study is to compare pegylated liposomal doxorubicin (PLD; a standard chemotherapy) to PLD in combination with VTX-2337 (a new type of drug that stimulates the immune system) to see if it helps cancer tumors stop growing or shrink, and if it helps women with these types of cancer live longer. PLD is an FDA-approved treatment for women with ovarian cancer. In prior studies, approximately 15–20% of women who received PLD for relapsed ovarian cancer experienced a temporary shrinkage or disappearance of their tumor. VTX 2337 is an experimental drug (not approved by the Food and Drug Administration, FDA) that stimulates the immune system and may help the body kill cancer cells. The combination of PLD plus VTX-2337 has been evaluated in a previous study of 13 patients. The study is still ongoing, but so far there is evidence that PLD + VTX-2337 may temporarily stop some patients’ tumors from growing (this happened in 6 patients), or it may help cancer tumors temporarily shrink and/or disappear (this happened in 1 patient).
In addition to the treatment part of this study, the researchers plan to test samples of your tumor and some of your blood. You cannot participate in this study if you do not agree to provide these specimens for this research. The purpose of this research is to examine the impact the study drugs have on tumor tissue and specific blood cells and substances.
Lastly, researchers want to know if one's genes (DNA) affect how the body responds to the experimental medication or how one's body breaks it down. Subjects will receive the study drugs as long as there is evidence that their tumor is not growing and they are not experiencing unacceptable side effects.
This is a multicenter, observational study.
This research study will test whether the methods being developed for the detection of fetal aneuploidy from samples of maternal blood can be used in the laboratory and employed in clinical practice
This study is for subjects with ovarian, fallopian tube or peritoneal primary cancer that has come back after original treatment. In this study, subjects will be able to choose whether or not to receive bevacizumab with paclitaxel and carboplatin or gemcitabine and carboplatin treatment. If subjects elect to receive bevacizumab, they will receive it every three weeks beginning with the second cycle of therapy and will continue to receive bevacizumab alone after therapy every three weeks as long as there is no evidence that their tumor is growing or that they are experiencing unacceptable side effects.
The primary purpose of this study is to determine if a second surgery to remove tumor followed by chemotherapy can increase the time that subjects remain disease free. If subjects' doctors feel that they are a good candidate for the second surgery they will be randomized to have surgery or not. A computer program will place subjects in one of the study groups. Neither subjects nor the doctor can choose the group they will be in. If subjects are randomized to receive the surgery it will be performed before chemotherapy is given. Chemotherapy will not be given until subjects recover from the surgery which could take up to six weeks.
Another purpose of this study is to test samples of subjects' blood, some of their tumor if left over from a previous surgery, and some of their tumor and normal tissue if left over from surgery performed as part of this study. The purpose of this research is to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.
Subjects will receive chemotherapy treatment as long as there is evidence that they are benefiting from the therapy and are not experiencing unacceptable side effects up to a total of 8 treatments. If they choose to receive bevacizumab, subjects will receive this therapy in combination with chemotherapy. If subjects appear to be benefiting from treatment and have reached a maximum of 8 cycles of chemotherapy, they will receive bevacizumab as long as there is evidence that they are benefiting from the therapy and are not experiencing unacceptable side effects. Subjects will be followed by the study doctor for the rest of their lives. Subjects can withdraw from the study at any time.