There are about 25435 clinical studies being (or have been) conducted in United Kingdom. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
COPD continues to be a cause of major morbidity for patients. Those patients who also have respiratory failure are at higher risk of exacerbations and death and have worse health related quality of life than similar COPD patients without respiratory failure. Treatment options in this group of patients have been limited and data to support the use of machines to assist breathing (non-invasive ventilators) in stable patients are limited. A major limitation of these devices has been patient acceptance and achieving sufficient control of sleep breathing disturbance. Currently devices are set at a fixed pressure to support the breathing throughout the night. The new software within the trial device will aim to better match the support provided by the machine to that needed by the patient. It is hoped that this may offer enhanced comfort as well as superior control of respiratory failure.
ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib chemotherapy with gemcitabine alone in patients with locally advanced or metastatic pancreatic carcinoma.
The aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function.
Hypothesis: High volume saline injections are an effective pain relieving treatment for people with longstanding pain in the achilles tendon which has not improved with a physiotherapy programme. Objective 1: To establish whether high volume saline injections are an effective treatment in decreasing pain for people with achilles tendinopathy Objective 2: To investigate whether high volume saline injections can improve day to day functioning, quality of life and the ultrasound appearances of the tendon for people with achilles tendinopathy Objective 3: To assess the tolerability of the procedure and levels of patient satisfaction using a simple questionnaire. Objective 4: To follow up the cohort of people who have received the injection for 9 months and ascertain whether any benefits persisted, or if the symptoms recurred. Background: Achilles tendon disorders are a common problem for athletes with a lifetime risk of around 50%. They are also common for less active people with a lifetime risk of around 6%. Tendinopathy is a condition which is characterised by pain, difficulty with weight bearing and swelling of the tendon. Symptoms may occur with exercise at first but can progress to occurring at rest and interfering with day to day activities. When the problematic tendon is examined under the microscope, it usually shows signs of degeneration rather than inflammation - especially when symptoms have been persistent. An ultrasound scan will usually show that the tendon is swollen with an increased water content and a disorganised tendon structure. A special type of ultrasound scan which looks at fluid flows, called a doppler ultrasound, often shows areas of increased blood flow around the tendon. Studies have shown that when these areas of increased blood flow are present, the patient tends to be experiencing more pain and stiffness in the tendon. Under the microscope, these blood vessels are often accompanied by nerve fibres and it has been suggested that these newly growing nerve endings are responsible for the persistent pain that patients experience. There is robust evidence that a particular type of exercise programme (eccentric loading) is an effective treatment for achilles tendinopathy. These exercises involve taking weight on the tendon whilst it is being compressed rather than stretched - heel lowering exercises. Nevertheless after completing a 3 month eccentric loading exercise programme, around 24-45% of patients will still have symptoms. There is no clear consensus amongst doctors as to what is the best second line treatment to try for this group of people. A number of different treatments have been described in research literature to try to treat this group of people with persistent symptoms, although no firm conclusion can be reached. There have been 2 small trials of high volume saline injections which showed some promising potential for the treatment. The aim of this injection is to destroy the blood vessels and nerve endings that grow into the swollen tendon to reduce pain and allow people to move and exercise more normally using the tendon. These studies simply looked at before and after injection results and did not compare the injections to a placebo or other treatment. The aim of this project is to conduct a high quality comparison of this new type of injection against a more common steroid and local anaesthetic injection around the tendon sheath. The design of the trial is a double blind, randomised controlled trial. This means that neither the patient, nor the doctor collecting data on pain scores knows which treatment the participant has been given, allowing a fair comparison of the interventions. The main comparisons between the 2 groups will take place at a 6 week follow up appointment. Once outcome measures have been recorded by the blinded assessor, the participant will then be told which arm of the study they are on. If they previously received the control injection (steroid and local anaesthetic only)and they still have symptoms, they will at this stage be offered the high volume saline injection as well. The investigators will then follow all of the study participants up for 9 months to ascertain whether people show a persistent benefit from the treatment, or whether symptoms subsequently return. The full study protocol is available on request from the Principle Investigator, along with information leaflets, ethical approvals etc.
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy. We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein. Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy alone. Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. We aim to recruit 26 patients into the trial over a two year period. If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe and beneficial in terms of stimulating the immune system, the combination will be tested further in larger clinical trials.
The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid increase in preschool children. Intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model predictive algorithm', which calculates the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control were evaluated in children and adolescents aged 6 to 18 years. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The objective of the current study is to extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D. Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard insulin. On both occasions, participants will receive a self-selected evening meal and closed-loop will run from 17:00 until 08:00am the following day. The study will take place at the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from paediatric diabetes clinics in England.
This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.
INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk. CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference. OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.
Netherton Syndrome is a serious skin disorder caused by damage in a gene called SPINK5. This gene controls the formation of a protein called LEKTI, which important for skin barrier function. LEKTI inhibits certain enzymes (serine proteinases) in the outermost layer of the skin (epidermis). The function of the serine proteinases is to break down the intracellular cement that holds together the horny cells in the epidermis, in order for the skin to be able to shed cells (known as cell desquamation). LEKTI deficiency leads to an uninhibited desquamation of horny cells, and as a result the skin becomes red and scaly. The barrier function of the skin is also affected. The permeability of the skin increases, and its capacity to bind water decreases, which causes dryness. The thinness of the barrier also results in over absorption of chemicals, for example topical medical treatments. Historically one in ten infants dies before their first birthday. Currently there are no proven treatments to cure this condition. The investigators have been developing a gene therapy approach to treat this disorder. The investigators have used a disabled virus (vector) to carry a functional copy of the SPINK5 gene into skin stem cells. Proof-of-principle experiments have shown the investigators can restore almost normal shape and size of the upper layer of the skin in skin grafts grown in the lab. Even if only a small number of cells are genetically modified to carry the corrected SPINK5 gene, there seems to be a correction over a wide area of the graft. In this trial the investigators propose grafting of autologous epidermal sheets generated from genetically modified skin stem cells for the treatment of patients with Netherton Syndrome. The investigators anticipate production and release of LEKTI protein from even a small patch of skin will be beneficial.