There are about 8552 clinical studies being (or have been) conducted in Sweden. 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.
The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.
The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.
The study will be an open controlled pilot study of 6 patients with early-onset severe preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients will be followed up within the study until three days after delivery. Laboratory analyses and uterine and umbiliacal blood flow will be determined.
The purpose of this study is to determine whether a food supplement consisting of vitamins, minerals and fish oil taken during and after pregnancy can decrease the need for additional iron supplementation due to anemia during pregnancy, and optimize levels of nutritional markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal blood and breast milk, compared to placebo.
The purpose of this prospective randomized controlled study is to determine whether acute and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after surgical management as compared to conservative management.
The purpose of the trial is to investigate the safety and effectiveness of renal denervation for the treatment of chronic heart failure (CHF).
Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (HSCT), and is classified as acute (aGVHD) or chronic (cGVHD). aGVHD onsets within the first 100 days after transplant or with clinical features including erythema, liver dysfunction and oral mucositis, whilst cGVHD or persistent GVHD occurs in approximately 30-60% of transplant patients who survive their first year . Long-term five-year prognosis for cGVHD patients is poor with a 70% mortality rate. cGVHD manifests as an autoimmune-like disease affecting multiple sites, including skin, mouth, eyes, gastrointestinal tract, liver, and joints. The oral cavity is the second most common site to be affected with symptoms in 45-83% of cases. In the mouth a diverse spectrum of clinical features can be found for example mucosal lesions can affect almost any site, salivary gland dysfunction and restricted mouth opening. Short-term patients can experience mucosal sensitivity, malnutrition, problems speaking, increased caries risk, xerostomia, oral pain and a diminished quality-of-life. Long-term complications include secondary malignancies and perhaps early death. Clinical management seeks to alleviate the symptoms and improve quality-of-life but 50% of patients fail front-line systemic steroid therapy. Oral cGVHD can be treated with topical high potency corticosteroids and oral rinses, however these treatments are not always effective and carry a risk of systemic absorption. Mesenchymal stem/stromal cells (MSCs) resident in adult and fetal tissues, such as the bone marrow have the capacity to form bone, cartilage, stroma, muscle and fat, are known to exhibit immunosuppressive and immunoregulatory properties both in vivo and in vitro. MSC infusions have been used to treat disorders such as osteogenic imperfecta, cardiovascular disease and to heal large bony defects. Indeed, the immunosuppressive capacity of MSCs have led to infusions being used as a second-line treatment for GVHD patients, and our group has shown within a Phase II clinical trial, 55% aGVHD patients who failed front-line steroid treatment responded to MSC infusion these studies are going with cGVHD patients. The goal of this project is to perform a pilot study to determine whether MSC injections directly into mucosal lesions in patients with oral cGVHD are able to alleviate the symptoms and facilitate the reparative process.
Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney failure,heart disease and premature death. Unfortunately, the best medical therapies available for DKD today are ultimately unable to prevent its progression, especially in obese patients.Surgical rerouting of food within the gut with a gastric bypass operation (RYGB), improves diabetes and some of its complications. The investigators propose to investigate whether RYGB in combination with best medical therapy in patients with DKD and obesity prevent further deterioration of kidney function over a 3 years follow up period. Study design: This is an international collaboration with leading centres in Sweden and Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer to be randomly assigned to receive best medical therapy with RYGB or best medical therapy without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney function. Yearly measurements of kidney function will then be done over a period of 3 years as a primary outcome to determine whether differences in DKD can be detectable. The study will also examine and compare a) safety of the interventions, b) the health economic impact on direct healthcare costs and Quality of Life in patients as well as c) the value of a new marker of DKD in determining which patients are most likely to benefit from surgery. Overall the study will strengthen the evidence base guiding clinical decisions about the usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD in patients with obesity and diabetes.
Background Paleolithic diet is a modern dietary regimen based on food eaten during the Paleolithic (2.5 million-10.000 years before present); lean meats, fish, shellfish, fruits, vegetables, root vegetables, eggs and nuts. Food that was not eaten during the Paleolithic is avoided; cereals, dairy products, salt, refined sugar and fat. The rationale for Paleolithic diet is based on the lack of type 2 diabetes and associated diseases among hunter-gatherer populations. Our group have previously studied effects of Paleolithic diet in an observational study in humans, an intervention study in animals and two intervention studies in patients with type 2 diabetes or lowered glucose tolerance and ischaemic heart disease. Our intervention studies showed significant improvement of glucose tolerance, HbA1c, blood lipids, blood pressure, weight, waist circumference and satiety on Paleolithic diet compared with a Mediterranean-type diet and diabetes diet. Studies by other research groups on healthy individuals found that Paleolithic diet lowered weight, waist circumference, blood pressure, PAI-1, blood lipids and ectopic lipid deposition, and also improved glucose tolerance and insulin sensitivity. Purpose and aims Our goal is to study effects of Paleolithic diet compared to recommended diet on risk factors, morbidity and mortality from type 2 diabetes and associated diseases in a sufficiently large and well executed study to be included in basis for future dietary recommendations. Project descriptions SwePaD is a study with an initial 18 month long randomized cross-over dietary intervention on 150 patients with type 2 diabetes where the whole study population upon finishing the initial dietary intervention is studied as a cohort for another 5 years. The initial 18 month long dietary intervention compares 6 months on Paleolithic diet with 6 months on recommended diabetes diet separated by 6 months wash-out period. After the initial 18 month long dietary intervention the study participants are recommended to follow recommended diabetes diet with implementation of optional elements from a Paleolithic diet for the remaining 5 years of the study. The intervention, in the form of diet information, will be given orally and written by the study participant's own diabetes nurse or doctor, based on similarly designed written information on the two diets. The same intervention was successfully used in our pilot study. The study participants will otherwise receive usual treatment. Power calculations show that 126 participants are needed to obtain significant results with 80% power at the 95% significance level for the primary outcome HbA1c. The pilot study with the same intervention but slightly healthier participants than the average patient in Diabetesregistret showed significant results on HbA1C with only 13 participants. Secondary outcomes are fasting glucose levels, weight, waist circumference, blood pressure, blood lipids, urinary albumin, diabetes retinopathy, smoking, physical activity, monofilaments (detection of peripheral neuropathy) and health related quality of life assessed by the health survey questionnaire SF-36. Primary and secondary outcomes as well as medication will be registered before and after each intervention diet. Data on primary and secondary outcomes, morbidity and mortality from type 2 diabetes and associated diseases will be retrieved for up to five years after participants' completion of the dietary intervention from the Diabetes register, Cause of Death Register (Dödsorsaksregistret) and the Hospital Discharge Register (Patientregistret) and compared to expected outcome from a statistical model based on the Diabetes register (A new model for 5-year risk of cardiovascular disease Cederholm et al 2011) and/or a matched control group from the Diabetes register. Participants will be recruited nationwide through information to health care personnel in primary health care and hospital diabetes clinics and to patient organisations. Participants' registration, intervention and data gathering will be administered by the participants' own diabetes nurse or doctor via REDCap, a web based tool for secure electronic data capture hosted on secure servers with daily back-up by the Library and IKT department of the medical faculty at Lund University. Dietary evaluation will be made using four day weighed food records on paperforms before and after each intervention diet and 6 months after the last intervention.
The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection