Kusajili – Centralise les essais cliniques mondiaux

Customised topographic photorefractive keratectomy (PRK) followed by corneal cross-linking in a single procedure for progressive keratoconus Not provided at time of registration

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The British Thoracic Society trial to assess the safety and efficacy of intra-pleural streptokinase in pleural infection Not provided at time of registration

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Clinical Assessment Study of the HAnd (CASHA) - 6-year follow-up Background and study aims The Clinical Assessment Study of the Hand (CAS-HA) started in 2004 and participants have been followed-up every 18 months over 6 years. The study aims to describe the long-term course of hand pain, hand problems and hand osteoarthritis (pain/stiffness of the joints of the hand) in community-dwelling adults aged 50 years and over. Together with a linked study, this study also aims to look at associations between hand and knee osteoarthritis. Who can participate? Participants were originally recruited in 2004 and 2005 via questionnaire from the practice lists of two participating local General Practices. All those who indicated on the questionnaire that they experienced hand pain or hand problems in the previous 12 months and who provided consent to further contact were invited to attend for a clinical assessment. Participation at follow-up points has been restricted to those in the original cohort who consent to further contact. What does the study involve? The study involves completion of a questionnaire and attendance at a research clinic based within the local hospital for a clinical assessment and x-rays. The questionnaire consists of a Health Questionnaire, which asks about general health and hand problems, and a Regional Pains Survey, which asks about hip, knee and foot pain. The clinical assessment involves an interview, hand examination and assessment, digital imaging of the backs and fronts of both hands, and anthropometric measurement (height and weight). Participants are also assessed using a test of lower limb function. The clinical assessments will be carried out by a team of trained research therapists (occupational therapists and physiotherapists). Plain x-rays are taken of both hands and knees. Participants who do not wish to attend the research assessment clinics will be offered the opportunity to complete postal questionnaires only. Medical records will be reviewed in consenting participants. This is linked to a specific study objective to link osteoarthritis sub-types to GP consultation data in order to explore which hand pain and problems are presented to primary care over the follow-up period of 6 years. What are the possible benefits and risks of participating? As this is an observational study, there are no direct benefits for participants in relation to providing treatment or advice. The x-rays can be reported on by a consultant radiologist should the participant wish this, and the report sent to the GP. The risks from clinical assessment are negligible. Joint pain may be increased during examination, but the participant is fully informed of their rights to request that examinations are not done, and their right to withdraw from the study at any point. The main risk to the participant in this study is from exposure to radiation from the x-rays. The dose has been set by a radiation protection advisor and is relatively low (the equivalent to a few days natural background radiation). The risk from exposure to radiation from x-rays is covered in the Participant Information Sheet, which is sent to the participant prior to attending the research clinic, and is discussed fully during the consent process in the research clinic. Participants are informed that they can still participate in the study without having the x-rays taken. Where is the study run from? The Arthritis Research UK Primary Care Centre at Keele University, Staffordshire, England, UK When is study starting and how long is it expected to run for? October 2011 to August/September 2012 Who is funding the study? The current stage of the study (6-year follow-up) is funded by Arthritis Research UK. Earlier stages of the study were funded by the Medical Research Council (MRC). Who is the main contact? Dr Helen Myers [email protected]

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Remote care of cochlear implant users Background and study aims Hearing loss, or deafness, is a very common condition which develops as people get older. There are two main types of hearing loss: conductive hearing loss, where the problem is in the middle ear (i.e. in the ear drum) and sensorineural hearing loss (SNHL), where the problem lies in the inner ear (cochlea), or the nerve that carries information from the ear to the brain for interpretation. The cochlea is a complex part of the inner each which is responsible for converting sound waves into electrical messages which the brain can interpret. When the cochlea becomes damaged, standard hearing aids (which work by making sounds louder) do not work and so a cochlear implant is often recommended. A cochlear implant (CI) is an electronic medical device which is designed to do the work of the damaged cochlea. It consists of an external sound processor and internal parts which work to convert sounds into electrical signals. Once a patient has had the surgery to install a CI, they commit to regular adjustment and rehabilitation appointments in the first year and then yearly follow-up appointments, in order to ensure that the implant is working properly. These appointments can be very inconvenient for the patient as they often have to travel a long way to specialist implant centres. It is thought that for many patients, these appointments are not necessary and that patients would benefit from having more control over their care plans. A possible solution for this could be using remote care, in which the patient is able to access support and information online and can keep medical staff up to date with their condition from their own homes. The aim of this study is to find out whether a remote care plan would work well for patients with cochlear implants. Who can participate? Adults who have been using a cochlear implant for at least 6 months. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group (remove care group) receive all of their cochlear implant care remotely for six months. This involves tools to test how well the device is working, online support, and help with their speech. Those in the second group (control group) continue to use their current cochlear implant and receive usual care. Patients in both groups attend a clinic after six months, in which they are interviewed in order to find out how well their care plan has been working for them. What are the possible benefits and risks of participating? There are no real benefits of participating, although adults in the remote care group may find the remote care tools useful. There are no risks of participating in the study. Where is the study run from? University of Southampton Auditory Implant Service (UK) When is the study starting and how long is it expected to run for? May 2015 to July 2017 Who is funding the study? The Health Foundation (UK) Who is the main contact? Dr Helen Cullington [email protected]

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STEM PACE - Stem cell Transplantation for Eradication of Minimal PAncreatic cancer persisting after surgical Excision Background and study aims Pancreatic cancer is the third most common cancer related cause of death. Even in the 15% of patients who are eligible for surgical resection, less than 10% of patients surviving after 5 years. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an established treatment capable of curing a variety of hematopoietic malignancies, taking advantage of the graft-versus-tumor effect (GVT). It works best when the underlying neoplasm has been turned into a stage of minimal disease by chemotherapy. There have been attempts of applying allo-HSCT to advanced solid tumors including pancreatic cancer with limited success but studies of allo-HSCT in solid tumors in minimal disease situations have never been performed. The aim of this study is to provide evidence for the clinical value of allo-HSCT in pancreatic cancer put into a minimal disease status by effective surgical resection and standard adjuvant chemotherapy. We want to find out if allo-HSCT can change the unfavourable natural course of this disease and whether allo-HSCT is able to provide long-term disease control to an extent otherwise not possible in pancreatic cancer and improve survival of affected patients. Who can participate? Patients with histologically proven diagnosis of pancreatic ductal adenocarcinoma having undergone radical resection (R1/R0 local resection) within the last 4-6 months at the University Hospital Heidelberg, who are matching the inclusion criteria. What does the study involve? Patients will undergo conditioning for allo-HSCT (fludarabine 30mg/mE2/d d -6 through d -2, cyclophosphamide 60mg/kg/d d-3 and d -2) followed by transplantation of allogeneic unmanipulated peripheral blood stem cells on d 0. Standard GVHD prophylaxis with CSA (target level 150-200; start d -1, taper d +60 onwards in the absence of GVHD) and MMF (2x1g; start d 0, stop d +30 in the absence of acute GVHD) will be instituted. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Clinic of General Surgery, Heidelberg (Germany) When is the study starting and how long is it expected to run for? From May 2012 to June 2016 Who is funding the study? Heidelberg Surgery Foundation, University of Heidelberg (Germany) Who is the main contact? Klinisches Studienzentrum der Chirurgie (KSC) [email protected]

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Plasma renin test guided drug treatment algorithm for correcting different subtypes of hypertension in treated but uncontrolled patients Background and study aims High blood pressure (hypertension), if untreated, increases the risk of serious problems such as heart attacks and strokes. Medication remains the mainstay of treatment, and its benefits are gained mostly from lowering blood pressure; however, the control rates of blood pressure remain unsatisfactory worldwide, which is at least in part due to a lack of methods to select an efficient antihypertensive drug(s) for a individual patient from the numerous drugs available. To this end, an approach for selecting anti-hypertensive drugs called the renin test guided therapeutic (RTGT) algorithm has been demonstrated to work better than standard care in patients with treated but uncontrolled hypertension. The aim of this study is to examine whether the blood pressure lowering ability of this approach varies according to the different types of hypertension, namely isolated diastolic hypertension (IDH), systolic diastolic hypertension (SDH) and isolated systolic hypertension (ISH). Who can participate? Patients aged 18 or over with hypertension who are not currently taking anti-hypertensive medication What does the study involve? In the first visit, the patient’s blood pressure is recorded and they are classified into one of the three hypertension types. They are then prescribed with one of two antihypertensive drugs depending on their blood pressure. At the second visit scheduled 2 weeks later, patients whose blood pressure reached the target level are excluded from the study to ensure that the patients being further tested are those with treated but uncontrolled hypertension with their original hypertension types. A blood sample is taken for the plasma renin activity (PRA) test. The patients are then randomly allocated to be treated with antihypertensive drugs according to the RTGT algorithm or senior general cardiologist’s care (SGCC), where the drugs are chosen based on the physician’s personal judgment unaware of the patient’s PRA values. The changes in blood pressure levels and antihypertensive drugs between the second and the last visit are compared between the RTGT and SGCC groups and between the three types of hypertension. What are the possible benefits and risks of participating? Patients in the RTGT group may benefit from lower blood pressure and/or may need fewer anti-hypertensive drugs to control their blood pressure compared with the SGCC group receiving drug treatment as usual. The only anticipated risk for the participants is the possibility that their blood pressure remains high or rises during the study leading to heart complications, but the chances are minor because the antihypertensive drug(s) are continuously given during the study. Where is the study run from? Second Hospital of Hebei Medical University (China) When is the study starting and how long is it expected to run for? November 2009 to June 2012 Who is funding the study? Hebei Science and Technology Agency (China) Who is the main contact? 1. Prof. Zejun Tian 2. Prof. Yuming Hao [email protected]

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Community pharmacists optimising treatment for patients with psoriasis Background and study aims Psoriasis is a long-term inflammatory skin condition that affects up to 2% of the people in the UK. There is no cure for psoriasis and the condition tends to come and go but once it has developed it is normally life-long. The majority of people with psoriasis need to use creams or ointments on a daily basis. This requires a high level of commitment yet research shows that many people don’t get enough advice from anyone on how to use them. As a result, psoriasis is often poorly managed by patients. In this study we want to see if advice given by community pharmacists can lead to better management of psoriasis and ultimately improvements in the severity of the condition. Who can participate? The study is open to anyone over the age of 18 who is prescribed creams or ointments to manage their psoriasis. What does the study involve? Patients who visit participating community pharmacies to collect their prescriptions for topical psoriasis treatments will be invited by the pharmacist or a member of staff to join the study. The study involves two consultations with the pharmacist. At the first appointment the pharmacist will use a specially designed guide to ask the person several questions to assess their understanding of psoriasis and if they know how to use their treatments. The pharmacist will also ask the person to complete two further questionnaires; one of these looks at the impact of psoriasis on their quality of life and the second asks them to rate the severity of their psoriasis. Both of these questionnaires have been used previously in research studies and are very quick and easy to complete. During the initial appointment the pharmacist will provide advice to help the person use their treatments properly. A second appointment will then be arranged for about 4 weeks later to go through the same initial questions to see if the person now has a better understanding of what to do with their treatments. The two questionnaires will also be repeated to see if the person’s quality of life is improved and if they think their psoriasis is less severe. What are the possible benefits and risks to participants? The benefits for the patients are that they should have a better understanding of their condition and how to manage it. It is also likely that improvements in both quality of life and disease severity will occur once the person knows more about how to use treatments properly. There are unlikely to be any risks associated with the study. Where is the study run from? The study will be run from participating pharmacies and is being co-ordinated by Robert Gordon University, Aberdeen. When is the study starting and how long it is expected to run for? We hope to start the study in September 2014 and it will continue until we have recruited and completed two interviews with 30 patients. Who is funding the study? The Psoriasis and Psoriatic Arthritis Alliance (UK). Who is the main contact? Dr Rod Tucker [email protected]

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Sleep disordered breathing and the impact of nocturnal non-invasive ventilatory support on quality of life in motor neurone disease Not provided at time of registration

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Efficacy, safety and population pharmacokinetics of artesunate-mefloquine combination for the treatment of uncomplicated falciparum malaria in African children versus artemether-lumefantrine Background and study aims We are conducting a study on a new malaria combination drug called artesunate-mefloquine. This drug will be used by sick children who are able to take the drug orally. Available information about this drug, which comes mostly from the use of this drug in East Asia and Southern American countries, indicates that the artesunate-mefloquine combination is better and safe for children. However, we need to understand more about the safety of this combination drug in the African continent, where this information is rare. It is for this reason that this study is conducted. Who can participate? Children aged between 6 and 59 months, either sex, with uncomplicated falciparum malaria. What does the study involve? Patients will be divided into two groups to ensure that each participant has an equal chance of being in either group (like a lottery). Half of the children will be given the trial drug artesunate-mefloquine (ASMQ) and the other half will be given a combination drug with a known efficacy (i.e. artemether-lumefantrine, AL) in order to be able to compare the results of the current malaria drug and the new drug. At the first visit your child will be seen by a doctor and a small amount of blood (less than a teaspoon) will be drawn from her/his hand to verify if the child has malaria parasites and to check the health status. This initial investigation will help us to know if your will be able to participate or not. Following this stage, your child will receive treatment based on the assigned group as described above. Blood from a finger prick to follow the malaria parasites will be taken every eight hours until the malaria parasites are not seen. Your child will be admitted in the ward not less than 3 days until she/he receive the last dose of malaria drug. A blood sample will be taken once again from the finger at days 1, 2, 3, 7, 14, 21, 28, 35, 42,49, 56 and 63 when the child will be brought for follow up. The doctor will see and examine your child during all these 12 visits. An extra blood sample will be taken during the investigation of your child on days 7, 28 and 63 and any other sample will be taken only if it is needed for the child’s treatment. Also, on day 0 (i.e. before the first dose) and day 7, a sample will be taken from every child to test the amount of drug in the child’s body, as well as the last day if the child has recurrence of parasitemia. A total of 100 children (50 in each group, ASMQ and AL) will be selected out of the 940 for follow up of drug levels in the child’s body. For the 50 children in ASMQ group, four additional samples will be taken on day 0 (after the first dose), day 2 (after the third dose), day 3, and either on day 28, 35, 42, 49, 56 or 63. For the 50 patients in the AL group, two additional samples will be taken on day 3 and either on day 28, 35, 42, 49, 56 or 63. You may stay with your child during the treatment, follow-up and in all stages. The child will be in the study for a total of nine weeks. In case of recurrent parasitaemia during the efficacy follow-up period (63 days), your child will be treated with the investigational product of the other arm. For example, if your child has received Coartem he would receive ASMQ, and vice versa, and follow-up of 63 days will recommence after the day of failure in order to supervise the progression. Three visits will be performed during this follow-up: at 7, 28 and 63 days. The following assessments will be done during these three visits and any other day if you return spontaneously: blood from a finger prick to follow the malaria parasites and recording of eventual adverse effects and concomitant medications. What are the possible benefits and risks of participating? If you agree for your child to participate in this study, you may have the following benefits: the child will be watched closely for a period of more than six weeks and in case of any sickness during that period, she/he will be given treatment without any cost. Also, participating in this study could help to understand if the combination drug artesunate-mefloquine is better and safe for African children and this will facilitate availability of this drug in African countries where children are dying of malaria.Incentives will not be provided to persuade people to participate in this study; however, to value your time and recognize your participation in this study; we will pay the treatment costs for your child in this hospital during the study period. Moreover, you will be paid for travel costs during the follow-up days. During the time you are admitted in the ward, you will be provided with food from the hospital cafeteria and at discharge you will be given an insecticide-treated bed net. When participating in this study, there is a possibility of discomfort to your child during examination and frequent blood sampling. Also in participating in this investigation there is a possibility of increased nausea and vomiting. We will try to reduce the possibility of discomfort, and in case of any problem your child will be provided with appropriate medical care without any cost. The sponsor will have an insurance policy which will be in place prior to the start of the trial. Where is the study run from? 1. Centre National de recherche et de Formation sur le paludisme (CNRFP), Burkina Faso. 2. NIMR, Dar Es Salaam, Tanzania. 3. NIMR Korogwe, Korogwe, Tanzania. 4. Ifakara Health Institute, Bagamoyo, Tanzania. 5. KEMRI, Nairobi, Kenya. When is the study starting and how long is it expected to run for? October 2010 to October 2013 Who is funding the study? Drugs for Neglected Diseases initiative (DNDi) (Switzerland) Who is the main contact? Dr Sodiomon Bienvenu Sirima Centre National de recherche et de Formation sur le paludisme (CNRFP), Burkina Faso

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Comparative evaluation of immunogenicity of monovalent type 1 oral poliovirus vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in Egypt Not provided at time of registration

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