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.
This is a multicenter, open labeled, phase 2 clinical trial, where patients are stratified to one of two treatment groups based on upfront TP53 mutation status; i.e. TP53 mutated vs. TP53 wt disease, and treated with dose-dense cyclphosphamide. Furthermore, patients included are stratified based on tumor stage; i.e. locally advanced breast cancer (M0 disease) or metastatic breast cancer (M1 disease). All participating cancer centers will prospectively include patients with breast cancer fulfilling the inclusion criteria. If patients do not respond to the experimental treatment as outlined in the protocol, treatment with dose-dense cyclophosphamide will be terminated, and further cancer treatment will continue at the treating oncologist's discretion. The response data for all patients who have received at least one chemotherapy course will be included in the final efficacy analysis. Tumor tissue, blood samples and radiology data will be collected before therapy starts, if therapy needs to be changed, and for patients with locally advanced breast cancer: at surgery. Response data will be evaluated closely during treatment, with clinical assessment of tumor size every two weeks for patients with locally advanced breast cancer and by radiology every eight weeks for patients with metastatic breast cancer. Evaluation of side effects/tolerance will be performed at every clinical visit, i.e. every two weeks for all patients included in the p53 trial.
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patient satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implant designs have been developed to solve the problem. However, most of the designs are based on experimental data and not on in vivo kinematics. In this study, we will analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and compare it with a well documented design and implant (NexGen Cruciate Retaining (CR), Zimmer Biomet). We assume our study will contribute to the development of more satisfying knee implants.
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.
The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
The aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway are to assess the clinical outcomes of patients with an edentate upper jaw having been treated with a removable full prosthesis supported by 3 implants to restore function and aesthetics. Clinical variables beyond implant dimensions and intraoral location, such as recall routines, maintenance needs, patient satisfaction and quality of life, will also be appraised and contrasted with an aim to elucidate their association with clinical outcomes. Specific evaluation will be done with regard to the following outcome criteria: - crestal bone levels and periodontal conditions around implants - incidence rates of biological, technical, traumatic failures / complications related to implants - incidence rates of biological, technical, mechanical, esthetic failures/complications with prosthesis and prosthetic components A secondary objective is to identify the different risk factors for biological failures / complications, including the influence of medical conditions and tobacco use.
The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in HDGECs using the radioligand [18F]MNI-659. The study will be a follow-up, examining HDGECs from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial PET measurement.
The aim for the study is to examined the effect of an individually tailored integrated behavioral medicine in physiotherapy intervention including functional exercise, for older adults, having chronic musculoskeletal pain, living alone and dependent on formal care. The study is a pragmatic randomized controlled trial with one intervention group and one control group. The intervention is a 12-weeks home-based program. The intervention consists of an individually tailored intervention and aims to enhance ability to perform everyday activities by improving physical function and reduce pain-related beliefs and pain-related disability. The comparison group achieves general advice about physical activity. All participants will be tested at baseline, a post-assessment at 12 week and a three month follow-up. Primary outcome is pain interference by the Brief Pain Inventory and physical function by Short Physical Performance Battery. Secondary outcomes measures if the goal setting is reached, self-efficacy in relation to the goal setting, pain catastrophizing, level of physical Activity, falls efficacy and Health related quality of life.
The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome.
Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during sleep due to collapse of the oro-pharynx. The consequences are reduced quality of sleep, increased risk for developing cardiovascular disease and increased risk of accidents caused by daytime sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to 16%. The golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP). This is effective and must be used for life. However, CPAP-treatment might be uncomfortable for the patient, with poor compliance as a result. An alternative is Mandibular Advancing Splints (MAS), which is perceived as less troublesome and may initiate higher compliance. Through mapping of patient characteristics, the researchers investigate which patient-type benefits most from two different treatment-devices. The aim of the study is to assess how the MAS treatment differ from the CPAP treatment in respect to efficacy, compliance and impact on health related quality of life among patient diagnosed with mild/moderate OSA. All OSA patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital, Northern-Norway (UNN) and St.Olavs Hospital were invited to participate in the study. The sample size at completion of the study should be 140 patients. Participants in the trial were randomly allocated to the two treatment groups, and assessed after 4 and 12 months of treatment. Data were collected through anamnesis, clinical examination, clinical photos, radiographs and questionnaires concerning general health related quality of life (SF36), oral health, cognitive aspects (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's Sleepiness scale) and compliance.
The study is a prospective interventional study with three main aims: 1. Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients. 2. Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population. 3. Investigate how the health care providers experience having to adhere to such an algorithm.