There are about 5161 clinical studies being (or have been) conducted in Norway. 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.
Aims The primary aim is to examine the relation between maternal nutrition, placental transport of nutritional substances, and fetal blood flow distribution in normal pregnancies and in pregnancies complicated by altered fetal growth. Specific aims: 1. Examine the relation between fetal glucose, amino acid and lipid consumption, and ultrasound Doppler measures of fetal cerebral vascular resistance. 2. Examine the influence of extended fasting for two hours compared to a standard meal in a group with appropriate fetal group on fetal liver blood flow and fetal cerebral vascular resistance. The examinations will be performed at approximately 36 weeks gestation. 3. Examine the influence of a standard maternal meal on fetal liver blood flow and fetal cerebral vascular resistance in pregnancies complicated by fetal growth restriction (FGR). Study 1: Investigator will use the 130 fetal-maternal pairs from the "placental 4 vessel sampling method" (see below) which includes measures on fetal blood flow distribution. Some calculations will be performed on the restricted cohort of 70 pregnancies who also includes maternal blood flow measures. Study 2: A limitation of investigators previous studies on the influence of glucose intake or a regular maternal meal on fetal blood flow distribution in healthy pregnancies with appropriate fetal growth is the lack of a control group without food intake (extended fasting for two hours). To serve as participants own control the included participants will meet for examinations at two different days (one with food intake and one with extended fasting) within a few days interval. Participants will be examined in the morning and two hours after food intake or after two hours extended fasting. The study will include 25 pregnancies with gestational age about 36 weeks Study 3: Investigator will include approximately 55 women (see power calculation below) with pregnancies complicated by FGR defined as estimated birth weight (EFW) below the 3rd percentile and/or EFW below the 10th percentile and sign of fetal Doppler blood flow redistribution representing possible fetal compromise . Investigator hypothesize that there will be no reduction in fetal cerebral vascular resistance (measured as change in MCA-PI from before to after food intake). Fetal liver blood flow will also be measured. Methods The "Placental 4 vessel sampling method" This method has recently been developed by investigators research group and described in recent publications. In brief, blood samples are obtained from incoming (arterial) and outgoing (venous) vessels both at the maternal and fetal side of the placenta simultaneously during cesarean section. Samples have been taken from women with normal pregnancies but with a range of BMI and metabolic profiles: the physiological range group (undergoing cesarean delivery on own request). Investigators have a complete dataset including blood sampling and fetal blood flow measurements in the UV, DV and MCA-PI in 130 women. Further, investigators have maternal blood flow measures in 70 of these pregnancies. Doppler blood flow measurements Doppler blood flow measurements will be performed in the morning immediately before (fasting state) and after a standard breakfast meal (SBM) (approximately120 min). Internal vessel diameter (D) and time-averaged maximum velocity (TAMX) will be measured in the straight portion of the intra-abdominal UV and at the inlet of DV, respectively. In the MCA Doppler velocity waveforms are sampled from the proximal part emerging from the circle of Willis . MCA in the hemisphere near the transducer will be used unless there are better insonation properties in the opposite hemisphere. Umbilical artery Doppler traces will be sampled in a free-floating loop. The Doppler tracings will be used to measure fetal heart rate (FHR). All measurements will be performed during periods of fetal quiescence.
This study examines feasibility of R&D activities in the planned randomized controlled trial where effectiveness of somatocognitive therapy intervention will be compared to treatment as usual in provoked vestibulodynia.
Kidney transplant recipients of living- and deceased donor grafts and treated with both mycophenolate mofetil (MMF) and tacrolimus (Tac) will be included. A 12-hour pharmacokinetic (PK) investigation of both mycophenolate (MPA) and Tac will be performed in pharmacokinetic steady state conditions between 3 to 8 weeks and one year after transplantation. Feces samples will be collected before (if possible), 1 week after transplantation and at the day of the 12-hour PK investigations. Data on dietary intake and physical activity will be obtained in association with the feces sampling in all patients. Patients will be invited to a follow-up visit one year after transplantation where the 12-hour PK investigation, feces sampling, dietary and activity data collection is repeated. Standard follow-up data after renal transplantations, such as acute rejection episodes, infections, renal function, post transplant diabetes mellitus (PTDM), protocol biopsies, adherence to immunosuppressive drugs, graft loss and death will be collected for all patients up to 5 years after transplantation according to standard schedule at the transplant center. A subgroup of kidney transplant recipients scheduled for living donor transplantation will be included before transplantation for pre-transplant investigations in addition to the investigations after transplantation. These patients will be randomized to either receive one week of treatment with MMF or Tac before transplantation. Feces samples and a 12-hour PK investigation will be performed after one week of treatment (before transplantation).
The aim of this study is to translate into Norwegian and cross-culturally adapt the Foot Functional Index- revised, short form (FFI-RS) according to international guidelines. Furthermore, the reliability and the validity, responsiveness as well as floor and ceiling effect of the Norwegian version of the FFI-RS will be determined.
Iron deficiency is a prevalent nutritional deficiency and a common cause of anemia. Although iron deficiency is traditionally linked to anemia, iron deficiency is prevalent even in the absence of anaemia and in itself limits function and survival. Iron deficiency is a common feature of various chronic diseases, and up to 50% of patients with heart failure have iron deficiency. Iron deficiency is more prevalent the more advanced the disease is and occurs more frequently in women. Iron deficiency comprises absolute iron deficiency (usually defined as ferritin < 100 ng/ml) as well as functional iron deficiency, in which iron supply is inadequate to meet the demand for the production of red blood cells and other cellular functions despite normal or abundant body iron stores. Iron deficiency is associated with poor exercise capacity, lethargy and reduced quality of life. Results from our studies have shown that iron deficiency is prevalent in patients with aortic stenosis. Some of the symptoms associated with aortic stenosis, such as fatigue, reduced exercise capacity, dyspnoea and cognitive dysfunction, have traditionally been thought to be caused by the haemodynamic derangements precipitated by the valvular stenosis. However, similar symptoms can be brought about by iron deficiency, and the investigators hypothesize that intravenous iron supplement will improve exercise capacity, muscle strength, cognition, health-related quality of life and myocardial function in patients with severe aortic stenosis and iron deficiency. This is a phase 2, double blind, randomised, placebo-controlled trial. Participants will be randomised in a 1:1 fashion to receive a single intravenous dose of iron isomaltoside (50 patients) or matching placebo (50 patients). The study is designed to show superiority with regard to the primary endpoint in patients assigned to active treatment versus patients allocated to the placebo arm. The main goal is to evaluate the effect of a single dose of intravenous iron isomaltoside on exercise capacity after transcatheter aortic valve implantation in patients with severe aortic stenosis and iron deficiency. For this study, the investigators have defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %.
Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.
This study evaluates the safety associated with the addition of sulfasalazine to stereotactic radiosurgery for recurrent glioblastoma. Sulfasalazine is a potential tumor selective radiosensitizer.
This is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the Emergency department, as well as identidying novel sepsis endotypes. Around 1500 patients will be enrolled.
Neck pain is one of the most prevalent musculoskeletal disorder in Norway among older adolescents and young adults. Despite this, little research exist on risk factors for neck pain in the transitional life phase from adolescence to young adulthood. In this prospective cohort study, already collected data from The Nord-Trøndelag Health study, Young HUNT 3 and HUNT 4 will be used to investigate possible risk factors and risk profiles developed in adolescence.
Some persons with intellectual disability or comprehensive cerebral palsy cannot communicate unequivocally how they are, how they react to situations and people, whether they are in pain or experience discomfort, anger or fear. Their modes of communication (sounds, grimacing etc) may be unintelligible or ambiguous to their caregivers. With the use of heart and/or respiration monitors the investigators aim to give these persons a means to communicate their immediate reactions or responses. The respiration monitor is meant to register sleep at night, so that the participants can communicate whether they have slept well or not the previous night.