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NCTID string	Standard Section string	SubSections string	Content string
NCT00005780	Alternatives	Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?	It should be emphasized that we do not know at this point whether the EPOCH-R and vaccination we propose to give you is superior, inferior, or equivalent to standard combination chemotherapy for your disease. Alternative procedures that could be used to treat your disease include: - Other combination drug regimens and ...
NCT00005780	Confidentiality	Will Your Medical Information Be Kept Private?\|Certificate Of Confidentiality	We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include: PATIENT IDENTIFICATION CONTINUATION SHEET ...
NCT00005780	Duration of Study Involvement	What Happens After Treatment Is Completed	This depends on how you have responded to the therapy. If all evidence of disease has disappeared, we will schedule periodic visits to the Clinical Center for follow-up examination PATIENT IDENTIFICATION CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Pro...
NCT00005780	Participant's Rights	Research Subject'S Rights What Are The Costs Of Taking Part In This Study?	If you choose to take part in the study, the following will apply, in keeping with the NIH policy: - You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by t...
NCT00005780	Possible Risks, Discomforts, and Inconveniences	Risks Or Discomforts Of Participation\|Psychological Or Social Risks Associated With Loss Of Privacy\|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?	In order to determine whether this study is suitable for you, a number of tests will have to be done. This period of evaluation may take up to two weeks and is usually done on an outpatient basis. Some or all of these tests will be repeated during and after the chemotherapy and vaccine at different times. Depending on ...
NCT00005780	Procedures	Description Of Research Study What Will Happen If You Take Part In This Research Study? Study Design\|Epoch-R Treatment\|Vaccine Treatment\|Research Tests\|What Tests Will Be Done On My Samples?	The study is divided into 3 parts. In the first part, you will undergo a series of tests to determine if you are eligible for the study and to determine the extent (called stage) of your lymphoma. If you are found not to be eligible for the study, you will be referred back to your home physician. If you are eligible, w...
NCT00005780	Purpose of Research	Why Is This Study Being Done?\|Why Are You Being Asked To Take Part In This Study?	Mantle cell is a form of cancer of the white blood cells called lymphocytes. In mantle cell, the abnormal lymphocytes multiply and accumulate in lymph nodes and elsewhere. Standard treatment with chemotherapy can often control the mantle cell for a period but in most patients, INSTITUTE: National Cancer Institute STUDY...
NCT00006436	Alternatives	Alternative Approaches Or Treatments	Alternative treatments for AIDS-lymphoma include: Standard combination chemotherapy regimens. These are sometimes given in lower than standard doses along with antiretroviral therapy. Treatment with single chemotherapy drugs. Therapy with single drugs is better tolerated than combination therapy, and often produce ...
NCT00006436	Confidentiality	Protections Against Misuse Of Genetic Information\|Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?\|Certificate Of Confidentiality\|Privacy Act	This study involves genetic testing on samples. Some genetic information can help predict future health problems of you and your family and this information might be of interest to your employers or insurers. The Genetic Information Nondiscrimination Act (GINA) is a federal law that prohibits plans and health insurers ...
NCT00006436	Duration of Study Involvement	Before You Begin The Study\|During The Study\|How Long Will Your Samples Be Stored?\|When You Are Finished Taking The Drugs (Treatment)	Prior to getting any treatment, there are a number of tests that must be completed. As reviewed in the paragraph above, you will undergo a lumbar puncture to remove a small amount of spinal fluid (about 1-2 teaspoons) that will be tested for the presence of lymphoma cells. A lumbar puncture is done by inserting a small...
NCT00006436	Participant Responsibilities	Reimbursement Will You Receive Reimbursement Or Direct Payment By Nih As Part Of Your Participation?	On this study, the NCI will reimburse the cost for some of your expenses such as those for hotel, travel, meals. Some of these costs may be paid directly by the NIH and some may be reimbursed after you have paid. The amount and form of these payments are determined by the NCI Travel and Lodging Reimbursement Policy. Yo...
NCT00006436	Possible Risks, Discomforts, and Inconveniences	Birth Control\|Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study?\|Occasional, Some May Be Serious In 100 People Receiving Doxorubicin, From 4 To 20 May Have:\|Cyclophosphamide: Common, Some May Be Serious\|Prednisone: Common, Some May Be Serious\|Dexamethasone: Common, S...	Because it is possible that drugs in EPOCH-R can affect a developing fetus, and because you can transmit HIV to your sexual partner, you will be asked to practice an effective method of barrier birth control and safe sex while you are participating in this study. Effective forms of birth control include: - abstinence i...
NCT00006436	Procedures	What Will Happen If You Take Part In This Research Study?\|What Tests Will Be Done On My Samples?\|Drugs Used In The Spinal Fluid For Lymphoma:	None of the drugs in this treatment are experimental. The United States Food and Drug Administration has approved all of the drugs for use in lymphoma. However, as explained below, the way the drugs in this research protocol are given in combination together is experimental. In addition to receiving chemotherapy into y...
NCT00006436	Purpose of Research	Why Is This Study Being Done?\|Why Are You Being Asked To Take Part In This Study?\|Description Of Research Study	The major purpose of this research study is to determine if the experimental combination of chemotherapy drugs given to you through your veins can lead to disappearance of lymphoma (by our best ability to test for it) within as few cycles as possible, and to see if the lymphoma will File in Section 4: Protocol Consen...
NCT00006436	Voluntary Participation	It Is Your Choice To Take Part In The Study	You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part i...
NCT00006436	Withdrawal from Study	Stopping Therapy	Your doctor may decide to take you off this study for the following reasons: - if he/she believes that it is in your best interest - if your disease comes back during treatment - if you have side effects from the treatment that are your doctor thinks are too severe - if new information shows that another treatment woul...
NCT00026793	Alternatives	Alternative Approaches Or Treatments	The imaging techniques have no therapeutic role. These techniques are being studied to try and determine if they may be useful in assessing Kaposi's sarcoma lesions using non-invasive methods. Patients can elect to not have any imaging performed without jeopardizing their participation in other protocols in the NIH Cli...
NCT00026793	Confidentiality	Will Your Medical Information Be Kept Private?	We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include: - The National Cancer Institute (NCI) and ...
NCT00026793	Duration of Study Involvement	During The Study	During your participation in this protocol, these experimental imaging techniques will be performed when you begin the study as a baseline evaluation, and then once about every 3 months while you are on the study in order to compare the results of the tests over time. Also, if your Kaposi's sarcoma should improve or wo...
NCT00026793	Participant's Rights	Research Subject'S Rights What Are The Costs Of Taking Part In This Study?	If you choose to take part in the study, the following will apply, in keeping with the NIH policy: - You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by t...
NCT00026793	Possible Risks, Discomforts, and Inconveniences	Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study?\|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?	The risks of participating in this study are minimal. There are no invasive procedures involved other than the drawing of a small amount of blood from your vein through a needle, which will be done by standard procedures. The imaging techniques use a variety of methods as described PATIENT IDENTIFICATION CONTINUATION...
NCT00026793	Procedures	What Will Happen If You Take Part In This Research Study?	On this protocol, you will have conventional photographs made of your lesions, and four additional experimental methods performed. The four methods are called: 1) laser Doppler imaging 2) multi-spectral imaging 3) infrared thermal imaging, and 4) optical coherence tomography. In addition, comparisons will be made wit...
NCT00026793	Purpose of Research	Why Is This Study Being Done?	This is a research study to develop noninvasive methods of determining the density of blood vessels and the amount of blood flow in skin that is affected by Kaposi's sarcoma. The intent is to develop techniques that may in the future help us better assess the clinical state of Kaposi's sarcoma lesions. Why are you bein...
NCT00026793	Voluntary Participation	Optional Studies\|Yes No Initials_________	We would like to keep some of the imaging studies and data that are collected for future research. These imaging studies and data will be identified by a number and not your name. The use of your imaging studies and data will be for research purposes only and will not benefit you. It is also possible that the stored im...
NCT00026793	Withdrawal from Study	Stopping Participation	Your doctor may decide to stop your participation in this study - if he/she believes that it is in your best interest - if you do not follow the study requirements In this case, you will be informed of the reason that your participation is being stopped. You can stop taking part in the study at any time. However, if ...
NCT00038727	Alternatives	Alternative Treatments For Impaired Glucose Tolerance	The DPP showed that metformin or the DPP intensive lifestyle program is effective in preventing or delaying the development of diabetes. At the end of DPP all participants were offered the DPP lifestyle training in group sessions. During DPPOS, continued lifestyle lessons were offered to all participants on a quarterly...
NCT00038727	Confidentiality	Confidentiality	To help us further protect your privacy, the investigators have obtained a Confidentiality Certificate from the Department of Health and Human Services (DHHS). With this Certificate, the investigators cannot be forced (for example by court subpoena) to disclose research information that may identify you in any Federa...
NCT00038727	Duration of Study Involvement	Mid-Year Visit:\|Annual Visit:\|Interim Visit (Approximately 30 Minutes To 2.5 Hours):\|Retinal Photographs And Ocular Tomography (1-2 Hours):	- At mid-year visits, no measurements will be taken. Mid-year visits will be completed by phone, or occasionally in clinic. You will be asked to answer questions about your health. For those taking study metformin, pills will be provided in person or mailed if the mid-year visit is completed by phone. For annual visit...
NCT00038727	Participant's Rights	Participant'S Statement:	The study described above has been explained to me. I understand that I am consenting to participate in the DPPOS. If I have any questions, I know that I can contact one of the investigators listed on the first page. In addition, I agree to the following: I give permission for my blood and urine to be stored in a cen...
NCT00038727	Possible Risks, Discomforts, and Inconveniences	Risks, Stress, And Discomfort	Oral Glucose Tolerance and Blood Tests: The risks of drawing blood include temporary discomfort from the needle stick, possible bruising or redness of the skin, lightheadedness, and on rare occasion, infection. It is possible that some may get nausea or an upset stomach with the glucose (sugar) drink that is given duri...
NCT00038727	Procedures	Procedures	If you choose to take part in Phase 3 of the DPPOS you will continue in your original randomly assigned intervention group. Although many of the features of DPPOS Phase 3 are the same as for DPPOS, there are some differences: - Participants in all treatment groups will be invited to take part in an annual Healthy Lifes...
NCT00038727	Purpose of Research	Investigator'S Statement: Purpose And Background	This research study is called the Diabetes Prevention Program Outcomes Study and is an extension of the Diabetes Prevention Program (DPP), of which you were a participant. The purpose of Phase 3 of the DPPOS is to look at the effects of the study interventions on the development of type 2 diabetes as well as diabetes r...
NCT00051311	Possible Risks, Discomforts, and Inconveniences	Risks Or Discomforts Of Participation\|Potential Benefits Of Participation	Filgrastim (G-CSF) may cause bone and muscle pain, headache, fever and chills, tiredness, and difficulty sleeping. There can be some pain, bruising and swelling at the injection site. Some people who receive filgrastim shots and apheresis have a temporary decrease in blood platelets (cells that help your blood to clot)...
NCT00051311	Procedures	Your Evaluation For Stem Cell Donation\|The Donation	On your first visit to the NIH Clinical Center, you will have a complete medical history and physical examination in the NCI Medical Oncology Clinical Research Unit clinic. You will meet with members of the transplant team, who will review your medical history and explain the procedure for stem cell donation. About 5 t...
NCT00051311	Purpose of Research	Description Of Research Study	We are conducting a study of allogeneic stem cell transplantation for cancers (and certain pre-cancerous conditions) of the blood and immune system. In the past, stem cell transplantation was more commonly called "bone marrow transplantation." When "stem cells" for the blood and immune system are taken from one person ...
NCT00051311	Voluntary Participation	Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study\|Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study\|Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study\|Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study	STUDY NUMBER: 03-C-0077 CONTINUATION: page 2 of 6 pages Allogeneic stem cell transplantation (SCT) has been used successfully to treat, and sometimes cure, many kinds of cancer or pre-cancerous conditions that originate in the blood or immune system cells. Chemotherapy drugs and/or radiation are used to eliminate most ...
NCT00069238	Alternatives	Alternative Approaches Or Treatments	It should be emphasized that we do not know at this point whether the combination of drugs we propose to give you/your child is superior, inferior, or equivalent to standard combination chemotherapy for your/your child's disease. Alternative procedures that could be used to treat your/your child's disease include: 1....
NCT00069238	Confidentiality	Will Your Medical Information Be Kept Private?\|Certificate Of Confidentiality	We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include: x The National Cancer Institute (NCI) and ...
NCT00069238	Duration of Study Involvement	What Happens After Treatment Is Completed:	This depends on how you/your child have responded to the therapy. If all evidence of disease has disappeared, we will schedule periodic visits to the Clinical Center for follow-up examination and tests. If the disease gets worse while receiving therapy, does not disappear entirely or if it should recur after having dis...
NCT00069238	Participant's Rights	Research Subject'S Rights What Are The Costs Of Taking Part In This Study?	x You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not av...
NCT00069238	Possible Risks, Discomforts, and Inconveniences	Risks Or Discomforts Of Participation\|Side Effects That Have Been Observed With The Drugs In This Program When They Are Used Individually Include The Following:\|Acute Infusion Reactions\|Immune Suppression\|Bone Marrow Toxicities\|Miscellaneous Toxicities\|Potential Benefits Of Participation	In order to determine whether this study is suitable for you/your child, a number of tests will have to be done. This period of evaluation may take up to two weeks and is usually done on an outpatient basis. Depending on the tests you/your child have already had before coming here, these may include blood and urine tes...
NCT00069238	Procedures	Treatment Consists Of The Following Drugs:	1. Doxorubicin, etoposide, and vincristine - These three drugs are given by continuous IV infusion over four days, beginning on day 1 and ending on day 5 of each cycle. We deliver these drugs with the aid of one lightweight, portable infusion pump, each about the size of a portable tape recorder; this permits treatment...
NCT00069238	Purpose of Research	Description Of Research Study\|Objectives And Design Of This Study:\|Treatment Of Disease In The Nervous System:	Lymphoma and its treatment: You/your child have a disease called T-cell or NK cell nonHodgkin's lymphoma which your/your child's doctors think would be better treated with chemotherapy than surgery or radiation. For your/your child's particular kind of non-Hodgkin's lymphoma, previous studies have shown that combinatio...
NCT00104858	Alternatives	➢ Are There Benefits To Taking Part In This Study?	The primary possible benefit is that it may provide an effective and potentially curative treatment for the patient's disease without the risks of treatment with high doses of radiation and chemotherapy. We cannot and do not guarantee the patient will benefit by taking part in this study. The treatment patients receive...
NCT00104858	Confidentiality	➢ How Will Information About Me Be Kept Private? We Will Try To Keep Your Personal Information As Private As We Can. There Is No Guarantee Of	absolute privacy. Your personal information may be disclosed if required by law. Organizations that are listed below may inspect or copy your research records for quality assurance and data analysis. Your research records will identify you by name and will include things such as your medical history, results of your bl...
NCT00104858	Duration of Study Involvement	➢ How Long Will I Be In The Study?\|➢ What Is Long-Term Follow-Up?	Your treatment will last approximately 3 and 1/2 months, but could be longer. You will be asked to return for follow up at 6 months and every year thereafter. We would like to keep track of your medical condition for the rest of your life to look at the long-term effects of the study. However, you may be taken off the ...
NCT00104858	Participant's Rights	➢ What Are My Rights As A Study Participant?	Even after you agree to take part in this study, you may withdraw at any time. Before withdrawing, you should notify one of the people involved with this research. This will allow that person or someone else supervising the research to inform you of the medical risks associated with withdrawing. The medical risks may b...

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