Mobile
Votre recherche
Source: isrctn
Leiden University Medical Center (Netherlands) MAJ Il y a 4 ans

Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green Background and study aims Ovarian cancer is one of the most common cancers among women. Unfortunately, because early symptoms can be vague and somewhat similar to other conditions, it is often not diagnosed until it has reached an advanced stage and spread (metastasized) to other areas of the body. Surgery is useful in two ways; to remove tumors and to discover how far the cancer has spread (known as tumor staging). It is sometimes difficult to see all the tumors until surgery has begun and finding them all even during surgery can be a challenge, particularly when trying to find smaller ones. However, a new method, near-infrared fluorescent (NIRF) imaging has been developed that can see ovarian tumor tissue during surgery. In early studies it has been shown that ovarian cancer can be identified using NIRF imaging and a special dye called near-infrared fluorescent dye indocyanine green. This is because the dye tends to accumulate in tumors much more readily than they do in normal tissues (called the enhanced permeability and retention - or EPR - effect). We want to see how many tumors are seen using the new technique. Who can participate? Adult women aged at least 18 years either diagnosed with, or suspected to have, ovarian cancer and due for tumor staging or cytoreductive surgery (surgery to remove the tumor(s)) . What does the study involve? Ovarian cancer patients have indocyanine green given to them intravenously during surgery and NIRF performed to make the tumors easier to see. The number of tumors are then counted and a health professional (pathologist) then looks at the tumors that are removed to see how advanced the disease has become. What are the possible benefits and risks of participating? Possible benefits include finding more tumors that would otherwise be the case during surgery. A possible risk is an allergic reaction to indocyanine green. However, this is very rare (< 1 out of 20.000) and can be managed by the anaesthesiologist. Where is the study run from? Leiden University Medical Center (Netherlands) When is the study starting and how long is it expected to run for? October 2012 to October 2015 Who is funding the study? Leiden University Medical Center (Netherlands) Who is the main contact? Dr Alexander Vahrmeijer [email protected] Dr. Katja Gaarenstroom [email protected]

  • Pays Aucun
  • Organes Aucun
  • Spécialités Aucun
Essai clos aux inclusions
Plus d'informations
North Bristol NHS Trust MAJ Il y a 4 ans

INFORM - surgery for hip infection project Background and study aims Hip replacement surgery is common, with over 86,000 cases in England and Wales in 2012. After surgery about 1% patients develop a deep infection in their artificial hip, called a prosthetic joint infection (PJI). If left untreated PJI can result in severe pain, disability and death. When an infection is found, there are two types of surgical treatment: a 1-stage revision involves removing the joint, thoroughly cleaning the infected area and implanting a new joint immediately; a 2-stage revision involves removing the joint, and delaying re-implantation for 3 to 6 months whilst treating with antibiotics. Both treatments are widely used but we don’t know which has the best long-term outcomes for patients. The aim of this project is to determine if there is any difference in patient reported outcomes (pain, stiffness or physical function) after 1-stage or 2-stage revision hip surgery for PJI. Who can participate? Patients that have a prosthetic joint infection that needs surgery. What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 have 1-stage revision surgery. Those in group 2 have 2-stage revision surgery. All participants are then followed up for the next 18 months. They are asked to complete questionnaires every 3 months, to assess their hip pain and function, quality of life and any costs incurred during their treatment. They attend two appointments with a research nurse to complete questionnaires and a walk test. A small number of participants and surgeons are also interviewed about their experiences of treatment and participation in the trial. Participants who decide against the randomised trial are asked to join a monitoring group. This group have treatment-as-usual, and then complete questionnaires at home. The monitoring group provide important information on the wider population of patients with hip PJI, including patient reported outcomes, control of infection and adverse events. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? A total of six orthopaedic centres in England and Wales (UK) When is the study starting and how long is it expected to run for? January 2015 to January 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Mr Simon Strange

  • Pays Aucun
  • Organes Aucun
  • Spécialités Aucun
Essai clos aux inclusions
Plus d'informations
Beijing University of Chinese Medicine (China) MAJ Il y a 4 ans

The clinical study of pasting "Wei Tan Wai Fu Fang" on acupuncture point to treat patients suffering postoperative gastroparesis of digestive cancer Background and study aims We are carrying out a study to find out the effect of "Wei Tan Wai Fu Fang" on the symptoms of postoperative gastroparesis (abnormal functioning of the stomach after surgery) in digestive cancer. We want to see whether it is effective to paste "Wei Tan Wai Fu Fang" on acupuncture point when treating postoperative gastroparesis of digestive cancer. Who can participate? The study aims to recruit adult men and women suffering from postoperative gastroparesis of digestive cancer whose local identification of abdomen is cold pattern ,which means this kind of patient prefers heat to cold ,likes hot food and hates cold ones. What does the study involve? Over a period of one and a half years participants will be invited to have Wei Tan Wai Fu Fang or placebo (dummy) on two acupuncture points every morning . This can be had along with the routine treatment . At the end of the study , we will find out the effects of having Wei Tan Wai Fu Fang on acupuncture points when treating postoperative gastroparesis of digestive cancer. What are the possible benefits and risks of participating? The results of the study are likely to find out a new way to treat the symptoms of postoperative gastroparesis of digestive cancer. The main risk of this study is unknown allergy because Wei Tan Wai Fu Fang includes many Chinese medicinal herbs which are potential allergens. If this occurs, the volunteer can quit the study . Where is the study run from? The study is run from the following hospitals in China: 1. Dongfang Hospital affiliated to Beijing University of Chinese Medicine 2. Chinese PLA General Hospital 3. Peking University People's Hospital 4. Cancer Institute and Hospital Chinese Academy of Medical Sciences (CAMS) When is study starting and how long is it expected to run for? The recruitment started in mid-2013. Participants will be enrolled in the study for a year and a half. Who is funding the study? Beijing Municipal Science and Technology Commission, China. Who is the main contact? Dr Kaiwen Hu [email protected]

  • Pays Aucun
  • Organes Aucun
  • Spécialités Aucun
Essai clos aux inclusions
Plus d'informations
Servier Deutschland GmbH (Germany) MAJ Il y a 4 ans

Triveram in patients with hypertension and concomitant primary hypercholesterolemia or mixed hyperlipidemia Background and study aims Cardiovascular (heart) diseases present are the most frequent reason for premature death, accounting for almost 4 million deaths in Europe per year. High blood pressure (hypertension) and high levels of blood lipids (fats) are two of the most commonly co-occurring cardiovascular risk factors. More than 64% of patients with high blood pressure also have high blood fat levels, and conversely, almost 47% of patients with high blood fat also have high blood pressure. These two factors together cause an accelerated damage to blood vessels. Treatment with a combination of the blood pressure lowering drugs perindopril and amlodipine with a lipid-lowering agent atorvastatin has been found to better protect against cardiovascular events such as heart attacks compared to a similar combination of betablocker, diuretic and atorvastatin. Triveram® is a combination of the above mentioned agents, atorvastatin, perindopril and amlodipine, in a single tablet. It is used to treat high blood pressure and/or stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) in adults who also suffer from elevated cholesterol levels (primary hypercholesterolemia) or elevated cholesterol and fat (triglyceride) levels at the same time (combined or mixed hyperlipidemia). Triveram® is intended for patients already on treatment with atorvastatin, perindopril and amlodipine as single tablets. The aim of this study is to gather information on the use of Triveram® in adult outpatients suffering the above mentioned diseases in daily practice, with a focus on changes in blood pressure, lipid parameters and other treatments, as well as treatment adherence, pill burden and treatment satisfaction. Who can participate? Adult outpatients with arterial hypertension and elevated cholesterol levels or elevated cholesterol and fat levels at the same time. What does the study involve? All patients involved in the study are treated with Triveram® under the circumstance that the decision about the treatment was made before the start of the study. The patients are asked to come to two follow-up visits after 1 and 4 months. During these visits a routine practice investigation is carried out and a form will be filled out by the treating physician regarding blood pressure, blood lipids (fats), and other diseases and medications. The patients are asked to fill out the patient questionnaire about treatment adherence, pill burden and treatment satisfaction at the first and the last visit. What are the possible benefits and risks of participating? There are no particular benefits or risks of participating in this study. The treatment given to the patient is the standard medical routine treatment and is completely independent of the study. Patients are free to withdraw from the study at any time without giving a particular reason. Where is the study run from? It is planned that the study will be carried out by about 700 general practitioners and cardiologists across Germany. There is no lead center. When is the study starting and how long is it expected to run for? April 2016 to May 2017 Who is funding the study? Servier Deutschland GmbH (Germany) Who is the main contact? Dr Peter Martinka

  • Pays Aucun
  • Organes Aucun
  • Spécialités Aucun
Essai clos aux inclusions
Plus d'informations