Promoter: Investigator initiated and funded
Investigator initiated and funded Update l'année dernière

Malnutrition in care homes: a feasibility study Background and study aims Malnutrition increases risk of disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 42% at risk. There is no agreed nutritional treatment for malnutrition. Techniques include food-based intervention and/or the use of prescribed oral nutritional supplements (ONS). It is unclear whether conventional food improves outcomes but there is growing evidence to support use of ONS. However, as conventional food is less expensive, some NHS trusts have developed stricter prescribing guidance to encourage 'food-first'. Care home residents are under-represented in research and evidence to guide best nutritional care is lacking. This is an initial study to compare three approaches within an elderly care home population: food-based intervention, prescribed ONS intervention and standard care for malnutrition. The results will help design a larger study. Who can participate? Care homes that have received dietitian training. What does the study involve? The six care homes that have been identified will be randomly allocated to one of three groups: food-based intervention, ONS intervention or standard care. Residents who are malnourished or at risk of malnutrition will be eligible to participate. The Dietitian researcher will deliver the interventions, aiming to increase participant intake by 600kcal and 20-25g protein daily. Care homes allocated to standard care will continue to provide energy-enriched diets, in line with local guidance. What are the possible benefits and risks of participating? We consider this study to be low risk. The nutritional interventions being evaluated are well stablished and are currently in use to treat malnutrition in the care home population. Given their wide usage, unexpected adverse events are highly unlikely. Expected adverse events include the possibility of diarrhoea, bloating, nausea or satiety (gastrointestinal symptoms) on initiating ONS or a change in diet. Expected adverse events will be minimised as the dietary interventions will be delivered as per usual, standard practice to those that require them, by and under the control of a Registered Nutrition Support Dietitian. If any of the residents within the care homes allocated to the standard care home intervention experience a decline of nutritional status, they will be provided with dietetic intervention (food-based or ONS), after 6 weeks of standard care. This follows local and national best practice guidelines and current, standard care within the local community setting. All of the care home residents that receive the allocated nutritional intervention will be at moderate or high risk of malnutrition. They may benefit from any of the nutritional interventions, if they prove to be effective at improving energy intake and anthropometry parameters. The information we get from this study will be used for a future larger study, which may help us to provide improved nutritional care for future care home residents with malnutrition. The findings will be shared with the local care home community. Where is the study run from? The study is being run from 6 privately run care homes (3 nursing and 3 residential) in Solihull Community (West Midlands). When is the study starting and how long is it expected to run for? December 2013 to September 2014. Who is funding the study? Investigator initiated and funded as part of Heart of England NHS Foundation Trust (UK) Who is the main contact? Miss Ruth Stow ruthstow@nhs.net

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

Platelet rich fibrin effects on third molar surgery Background and study aims Impacted mandibular third molar extraction (also known as wisdom teeth removal) is one of the most common operations in oral and maxillofacial (mouth and teeth) surgery. Wisdom teeth grow at the back of the mouth and are the last teeth that come up through the gums, usually when people are young adults. Due to a lack of space, wisdom teeth can come through the gums on an angle causing them to be impacted. This usually means they need to be removed surgically. The operation consists of a small cut into the gum, extracting (removing) the tooth and then stitching up the area where the tooth was. Usually, the wound heals within a week or two however patients can experience some pain and are at risk of developing dry socket (a dull ache in the gum or jaw and a bad smell or taste coming from the area the tooth was removed). In order to encourage healing, platelet rich fibrin (PRF) has been suggested to be used on the tooth removal area. PRF is collected from the patients’ blood and is then processed to separate out the platelets in order to be placed on the site where the tooth was removed. PRF is thought to help increase healing and reduce the possibility of complications. The aim of this study is to see how well PRF helps reduce edema (swelling) and pain after impacted mandibular third molars surgery. Who can participate? Adults aged 17-27 who require the removal of their impacted mandibular third molar. What does the study involve? Participants give a small sample of blood which is then processed in order to separate out the PRF. Participants then undergo the removal of their wisdom teeth in their lower jaw. Both of the lower wisdom teeth (right and left) are removed according to the standard level of care. However, the right side tooth removal area receives PRF (placed on the area with dental forceps (tool)) and the left side tooth removal area does not receive PRF. Both tooth removal areas are stitched up. Participants receive follow up for seven days after the procedure where they are tested for pain and edema. What are the possible benefits and risks of participating? Participants may benefit from a shorter recovery time. There are no notable risks with participating however participants may feel some discomfort when giving the blood sample. Where is the study run from? Ankara University Dentistry Faculty Oral and Maxillofacial Surgery Department (Turkey) When is the study starting and how long is it expected to run for? June 2011 to October 2013 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Mehmet Fatih Şentürk mehmetsenturk@sdu.edu.tr

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

General versus specific spinal manipulation for back pain Background and study aims Pain in the lower back is very common and can get better over time. However, if it becomes worse it can require treatment. Spinal manipulation is often used to treat the low back pain. Spinal manipulation is therapeutic technique applied by a doctor, physiotherapist or other manual therapist to help patients with spinal pain. Spinal manipulation involves the rapid movement (thrust) of the spine to stimulate the nerves and joints in a certain way that reduces pain. This often makes a popping noise come from the joints. The application of spinal manipulation has traditionally involved targeting the technique to a particular level of the spine where the problem is occurs. This involves a time-consuming assessment process to figure out where this is, which has been deemed necessary as the effect of spinal manipulation was thought to be related to specific joint changes, found both before and after manipulation. Recent research has questioned both the accuracy of spinal manipulation and the necessity for specific targeting of the spine. This study evaluates the effects of a targeted manipulative thrust technique versus a thrust of equal magnitude (strength), applied to the spinal region, to assess any difference in muscular responses and pain. Who can participate? Adults aged 18 to 60 with lower back pain. What does the study involve? Participants are randomly allocated to one of two groups. All participants attend three one hour treatment sessions within seven to nine days apart. Those in the first group receive a targeted thrust at a certain part of the spine (as determined by their physiotherapist). Those in the second group receive a thrust in a more general area of the lower spine. The thrusts in both groups are done with the same amount of strength and force. Participants are measured for their pain levels and muscle responses at each of the sessions. What are the possible benefits and risks of participating? Participants may benefit from long-term reduction in back pain. There is a small risk of short-term (less than 24 hours) of soreness after a treatment session. Where is the study run from? Wellcome Clinical Research Facility (UK) When is the study starting and how long is it expected to run for? April 2005 to June 2007 Who is funding the study? Investigator initiated and funded (UK) Who is the main contact? Dr Chris McCarthy cmccarthy@mmu.ac.uk

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

Mechanistic and efficacy studies on a tomato extract with antiplatelet properties Background and study aims Several studies have shown that populations who consume a Mediterranean diet enjoy a degree of protection from heart disease. A link to tomato consumption has been suggested, which could be in part due to the anti-blood-clotting (antiplatelet) properties of tomatoes. Based on extensive research carried out by Provexis Natural Products Limited using the branded tomato extract Fruitflow, a heart healthy fruit juice drink was tested in the UK throughout 2006 under the brand name Sirco. Other commonly consumed foods can also have antiplatelet effects, such as fish oils, garlic and cocoa, but when consumed in normal dietary amounts the antiplatelet effects are often small. For example, you would need to consume 3g of fish oil per day for at least several weeks to have an antiplatelet effect. We are interested in combining mild dietary antiplatelets and Fruitflow to increase their antiplatelet effects. However, most dietary antiplatelets are impractical choices for a study as we are not sure how they work or what dose is required, or the quantities which must be consumed are too high. In addition, we would like to focus our study on acute antiplatelet effects, i.e. effects immediately after consumption of a single dose, and we would like to select an antiplatelet which works in a different way to Fruitflow. The range of dietary antiplatelets with such effects is very limited. Therefore to allow us to begin our research into the interactions of Fruitflow with other antiplatelets, we have selected the commonly used over-the-counter drug aspirin at a low dose as our second antiplatelet. Low-dose aspirin is a common part of daily life for many individuals, and its mechanism of action and dosage requirements are all well established and different to that of Fruitflow. Its use is also not associated with side effects in healthy volunteers over a short time. We wish to investigate the effects of repeated intake of Fruitflow along with a daily dose of aspirin. This will ensure that the effects of aspirin and Fruitflow are likely to overlap over the course of the study day. These data will enable us to judge whether the tomato extract has any additional effects on the clotting system of healthy volunteers when taken with a daily dose of aspirin. Who can participate? Healthy subjects aged 45 - 75 What does the study involve? Participants are randomly allocated to take one of two treatments: either aspirin (plus three placebo [dummy] capsules) taken once per day for seven consecutive days, or an apparently identical placebo capsule set. On day 1, participants provide a blood sample before consuming the first capsule, and the effect of this capsule is assessed after 3 and 5 hours. Participants then depart, taking with them a supply of capsules to be taken once per day for the following seven days. On the morning of day 8, participants return to the study unit and a blood sample is taken to measure the effect of the capsules they had taken for the intervening seven days. The participants then consume 3g of Fruitflow, along with their other capsules. Again, blood samples are taken after 3 and 5 hours, after which the participants are free to leave. All participants undertake this process twice, switching between the aspirin and placebo capsules with a break of 14 days (minimum) in between. What are the possible benefits and risks of participating? Participants are healthy volunteers and as such do not benefit directly from involvement in the study. Participants are informed of the reason for the study, and became involved to help with development of a new functional food which might possibly benefit them in the future. Participants are recompensed for lost time and transport costs. Risks associated with the study are related to blood sampling. Participants with particularly thin/thread veins or whose veins are not clearly palpable are excluded from the study. Attempts at blood sampling are limited to four, in order to prevent activation of the clotting system. All blood samples are taken by an experienced nurse phlebotomist, and a closed syringe system is used for the blood collections, minimising risk of blood contact. Where is the study run from? University of Aberdeen (UK) When is the study starting and how long is it expected to run for? May 2007 to March 2010 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Niamh O'Kennedy

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

Retrospective study on the evaluation of chronic and long-term pain therapeutics to manage post-traumatic cervical dystonia Background and study aims Neck pain is a very common condition, which can be cause great discomfort and restriction of movement. Whiplash injury is a common type of neck injury caused by sudden movement of the head forwards, backwards or sideways. It occurs when the soft tissues in the neck become stretched and damaged, often due to wearing a seatbelt in a roach traffic accident. Pain from whiplash often lasts for months and for some can severely limit their activities. Treatment often involves taking painkillers in combination with physiotherapy. Studies have shown that botox injections can help to relief long-term pain. It works by blocking nerve pathways that are causing pain and allowing nerve pathways to form without pain. The aim of this study is to review the medical records of people who have had botox treatment for neck pain as part of their usual care to look at its effectiveness. Who can participate? Adult patients who have long-term neck pain after whiplash from a road traffic accident. What does the study involve? Patients who have neck pain after a road traffic accident for whom taking pain killers have not worked for six weeks receive a botox injection into their neck muscles as part of their normal care. These patients then return to follow up appointments where their pain levels and ability to move their necks is assessed using a questionnaire and a physical examination after six weeks and 90 days. This study involves this information being collected from medical records in order to see how effective the treatment has been. What are the possible benefits and risks of participating? There are no direct benefits or risks involved with participating in this study. Where is the study run from? Advanced Pain Specialists, PLLC. (USA) When is the study starting and how long is it expected to run for? October 2015 to March 2017 Who is funding the study? Investigator initiated and funded (USA) Who is the main contact? Dr Ricardo Borrego

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

Comparison of two different matrix band systems in restoring two surface cavities in posterior teeth done by senior undergraduate students at Qassim University, Saudi Arabia Background and study aims Cavity restoration refers to the dental treatment used to treat a hole in the tooth (for example, caries or injury). Matrix band systems are made up of a piece of metal or other material and are used to support and give form to the cavity restoration being used (for example, a dental filling) both when its being applied and then when its hardening in the tooth. Matrices are used to try and ensure the end result is similar in shape to that of the original tooth. The aim of this study was to compare two different types of matrix band system (circumferential matrix system and sectional matrix system) to see which is the best at duplicating the natural structure of the tooth. Who can participate? Adults (aged over 18) that need cavity restoration treatment. What does the study involve? Participants are randomly allocated to one of two groups. Those in group 1 have cavity restoration treatment using the circumference matrix band system. This is the oldest established matrix band system used in dentistry and it still widely used. Participants in group 2 have cavity restoration treatment using the much newer sectional matrix system. Both systems were assessed in terms of their ability to duplicate the natural shape and structure of the teeth immediately after treatment. What are the possible benefits and risks of participating? Benefits include the participants having dental treatment and having their cavities restored using one of the two were receiving restorations using one of the above mentioned matrix band system technique. There were no risks involved in this study. Where is the study run from? College of Dentistry, Qassim University (Saudi Arabia) When is the study starting and how long is it expected to run for? December 2014 to June 2016 Who is funding the study? Investigator initiated and funded Who is the main contact? 1. Dr Durre Sadaf (public) 2. Dr Muhammad Zubair Ahmad (scientific) dr.zubair.ahmad@qudent.org

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

Effect of a dual intervention in elderly heart failure patients with cognitive impairment and their caregivers after hospital discharge: a randomized controlled trial Background and study aims Heart failure (HF) is a common disease that gets worse over time, is responsible for many hospital admissions and deaths, results in a poor quality of life for the patient and places an economic burden on the health care system. HF happens when the heart becomes unable to pump enough blood around the body at the right pressure. Symptoms include difficulty with breathing and leg swelling. When the part of the heart that pumps blood around the body (the left ventricle) becomes too weak to work properly, the heart failure is being caused by left ventricular systolic dysfunction (LVSD). When the left ventricle becomes stiff, making it difficult for the heart chamber to fill with blood, this is heart failure with preserved ejection fraction (HFPEF). HFPEF may account for up to two-thirds of cases in patients over 70. HF is the final common stage for several diseases more common in aging patients, like hypertension (high blood pressure), valvular heart disease (heart disease involving one or more valves of the heart) or coronary heart disease, but it can also be the result of physical changes due to age itself. HF is most common in older people and is the leading cause of hospitalization and the third cause of cardiovascular death in this age group. Although advanced pharmacological intervention (drug treatments) has improved the prognosis for people with HF, hospital readmission and mortality rates (number of deaths), particularly for hospitalized elderly patients, remain high. There is good evidence that patients with HF and at high risk of being admitted to hospital can benefit from disease management programs (DMP), resulting in fewer admissions to hospital, lower mortality rates, improvements in quality of life and lower medical costs. In these DMPs a case manager provides patients and their caregivers with enough information and support to develop and follow a plan to control HF. However, most studies investigating HF have not included elderly patients with cognitive impairment (for example, trying to remember or learn new things, concentrating or making decisions), despite the fact that this would affect how successful a DMP would be, especially with regard to HF knowledge, self-care, and treatment adherence (sticking with the treatment). This is important because cognitive impairment (CI) is common in elderly adults with HF (more than 25%) and is associated with poor health outcomes, so it is important to determine which interventions (treatments) are beneficial in individuals with both conditions. This study aimed to test the effectiveness of a DMP in elderly HF patients with CI after being discharged from hospital, involving both patients and caregivers, and its follow-up by a multidisciplinary team. Who can participate? Adults over 65, with CI, discharged from hospital after a stay of at least 48 hours for HF, that have a responsible caregiver. What does the study involve? The participants are randomly allocated to one of two groups. Both groups will receive medical treatment in accordance with current clinical practice. Those in group 1 (control group) receive the usual care given after being discharged from hospital. Those in group 2 (intervention group) are placed on the DMP after discharge from hospital. The DMP includes, for example, education on the management of HF for both caregivers and patients, monitoring treatments and how the patients is progressing and it also looks at how much of a burden the DMP is placing on the participants caregiver and social network. All participants on the DMP are closely followed-up at a geriatric day-hospital by a multidisciplinary team consisted of a geriatrician (case manager), a nurse and a social worker. The participants are monitored by telephone and also face-to-face visits at the clinic. What are the possible benefits and risks of participating? All participants, including controls, are given medical treatment. The principal goals of HF therapy will be to relieve symptoms, maintain or improve the ability of the participants to do everyday activities and quality of life, preserve their independence, and extend survival. There are no known risks to participants. Where is the study run from? Hospital of Caceres (Complejo Hospitalario de Cáceres) When is study starting and how long is it expected to run for? March 2016 to March 2019 Who is funding the study? Hospital of Caceres (Complejo Hospitalario de Cáceres) Who is the main contact? Dr José Luis González Guerrero joselglezg@gmail.com

  • Country None
  • organs None
  • Specialty None
Opened trial
Investigator initiated and funded Update l'année dernière

Mechanical debulking to eliminate thrombolysis and/or open surgery from initial therapy of acute and subacute ischaemia of lower limbs Background and study aims Peripheral arterial disease (PAD) is a common condition in which the blood flow to the legs is restricted. This happens because of the buildup of a fatty substance (plaque) on the walls of arteries. Over time this can cause the main arteries in the legs to become narrowed (stenosed) or blocked (occluded). As the arteries become narrower, patients begin the feel pain even when at rest and are at severe risk of developing ulcers or gangrene (acute lower limb ischaemia), which in severe cases can lead to amputation. Many patients are treated with blood thinning medication or surgery to restore blood flow to the leg (revascularisation), however these treatments are not always successful. Today, the most popular and frequently used treatments are surgery and/or thrombolysis. Thrombolysis is a treatment which involves breaking down blood clots which may be blocking the arteries using a type of medication called thrombolytics. They are administered through catheter (tube) inserted into the major artery in the groin. Both therapies are associated with high death rate and serious complications. Catheter therapy itself is less invasive than surgical treatment and therefore, different catheters have been developed that can break up the clot mechanically (mechanical debulking). However, mechanical removal has not replaced the traditional treatment so far, mainly due to limited experience with the new techniques as well as low efficacy of those approaches alone which often requires a combination with thrombolysis. The aim of this study is to find out whether mechanical debulking can be successfully and safely used without having to use thrombolysis and/or open surgery. Who can participate? Adults with symptomatic acute lower limb ischaemia. What does the study involve? All participants undergo treatment using the mechanical debulking method. This involves a catheter (thin, flexible tube) being inserted into the main artery in the affected leg via the groin and used to mechanically break down the blood clot. Participants are monitored closely for any complications until they are discharged from hospital. In addition, they undergo blood vessel scans to see if the arteries have become successfully unblocked at discharge and after 30 days and 12 months. In addition, the number of patients who require further treatment, such as amputation or thrombolysis, are recorded for one year. What are the possible benefits and risks of participating? Participants may benefit from a better chance of survival and lower complication rate. In addition, patients who are unable to have traditional treatment for medical reasons benefit from being able to receive treatment. There is a small risk of a blockage to blood flow or blood vessel perforation (piercing). Where is the study run from? University Hospital and 3rd Medical Faculty of Charles University (Czech Republic) When is the study starting and how long is it expected to run for? January 2009 to December 2016 Who is funding the study? Investigator initiated and funded (Czech Republic) Who is the main contact? Professor Miroslav Bulvas miroslav.bulvas@fnkv.cz

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

Occlusion of the portal liver vein to permit liver surgeries for liver cancer Background and study aims Hepatocellular carcinoma (HCC) is the most common type of liver cancer. This type of cancer starts in the liver (primary liver cancer). When other cancers spread to the liver it is known as secondary liver cancer. When possible, surgery is the main treatment because it still is the best options for treating primary and secondary liver cancer. As the liver is able to re-grow itself, surgeons are able to remove affected sections of the liver completely (liver resection). However, a certain amount of the liver must remain in order for the liver to re-grow. Patients who require a large section of their liver to be removed can undergo a portal vein embolization (PVE) which tries to get the liver to grow prior to a liver resection. A needle is placed through the skin into the liver and the blood vessel that has the largest amount of the tumour is embolized (cut off) by injecting an embolizing material (that is similar to glue). This tricks the liver into regrowing on the side without the tumour. After a few weeks, enough of the liver should have grown in order to have the surgery to remove the cancerous area. There are different types of materials that can be injected into the blood vessel to embolize it such as n-butyl-cyanoacrylate (NBCA) which is a liquid embolic material that usually is used as a tissue adhesive (glue). The aim of this study is to evaluate the efficacy of portal vein embolization (PVE) using n-butyl-cyanoacrylate (NBCA) through an ipsilateral approach as well as evaluate the accomplishment of liver surgery, patient out-come after hepatectomy and safety of the proposed PVE technique. Who can participate? Patients aged 5-75 who require a liver resection. What does the study involve? This study reviews the surgical outcomes of participants who have undergone a PVE and liver resection. After these procedures, participants are followed up with visits to the study centre every two weeks during the first month after the procedure and then every three months for the next five years. The follow up consists of scans of the liver and reviewing medical charts in order to assess how well the PVE worked in regrowing the liver and the overall health outcomes of the liver resection surgery. What are the possible benefits and risks of participating? There are no notable benefits or risks involved with participating. Where is the study run from? INCA - Brazilian National Cancer Institute (Brazil) When is the study starting and how long is it expected to run for? January 2011 to December 2016 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Jose Hugo Luz

  • Country None
  • organs None
  • Specialty None
Closed trial
Investigator initiated and funded Update l'année dernière

Efficacy of Dexmedetomine versus Ketofol for sedation of postoperative mechanically ventilated patients with obstructive sleep apnea Background and study aims Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (wind pipe) collapse repeatedly during sleep, stopping the flow of air into the lungs. This prevents the sufferer from being able to breathe properly while they are asleep, causing excessive sleepiness throughout their waking hours. Patients with OSA are at risk of developing lung complications following surgery, meaning that use of pain killers and sedatives during care after surgery needs to be restricted. Dexmedetomidine is an anxiety reducing, sedative, and pain medication, which may be useful in the post-operative period for patients with OSA who are having surgery. Ketofol is a medication made from a mixture of ketamine (a medication mainly used for starting and maintaining anesthesia) and propofol (a sedative), which has been shown to be effective at reducing the dose of sedatives needed by patients and so reducing the risk of lung complications. The aim of this study is to look at the effectiveness of dexmedetomine versus ketofol for sedation of patients with OSA after surgery that need help breathing. Who can participate? Adults aged between 18 and 50 years who have obstructive sleep apnea and require mechanical ventilation. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive dexmedetomine through a drip and those in the second group receive ketofol through a drip to provide sedation. Both groups receive sedation for a total of 12 hours after surgery while they undergo mechanical ventilation (use of a breathing machine). The length of time they need to stay on the breathing machine and the length of their hospital stay is recorded. In addition, their vital signs are monitored throughout. What are the possible benefits and risks of participating? There are no notable benefits or risks involved with participating. Where is the study run from? Benisuef University Hospital (Egypt) When is the study starting and how long is it expected to run for? May 2016 to April 2017 Who is funding the study? Investigator initiated and funded (Egypt) Who is the main contact? Dr Hatem Elmoutaz form@med.bsu.edu.eg

  • Country None
  • organs None
  • Specialty None
Closed trial