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.
Being diagnosed and treated for cancer is usually associated with severe physical symptoms, impaired functional status, complex emotional, psychosocial and existential issues and substantial worries. Failure to help patients with their problems and worries can unnecessarily delay patients' recovery and rehabilitation, lead to chronic functional impairments, anxiety and depression and prolong patients' needs for health care and social services. The objectives of this interdisciplinary, international research project that includes collaboration with HELFO (The Norwegian Health Economy Administration), are to test and compare, in a randomized, controlled trial (RCT), the effects of (1) a practice-integrated online patient-provider communication (OPPC) service including access to asking questions to HELFO, (2) a multi-component Interactive Health Communication Application (IHCA) called WebChoice, and (3) usual care on: patient outcomes, health care and social services use and costs. Breast cancer patients undergoing treatment at three different hospitals in Norway will be randomized into two experimental and one control groups and will be followed with 5 repeated measures over one year. The proposed study will contribute to innovative methods and technologies that can radically improve patient-provider communication, care quality, and continuity of care. The two interventions tested in this study, the OPPC service with and without additional features of WebChoice, represent new forms of interactions and information sharing between patients and clinicians where patients can get seamless access to communication and information services from where and whenever they need it. This could significantly contribute to reducing unnecessary suffering, less fragmented health care, better efficiency, patient safety, patient satisfaction and have an impact on patients' health services utilization. The investigators' work addresses, therefore, important health policy goals with the potential for considerable societal gains.
The Norwegian Social and Welfare Act of 1992, opened for compulsory commitment of patients with serious alcohol and drug problems to inpatient care. Clinical research of compulsory committed dual diagnosed patients is to date unavailable and is demanded by the health authorities of Norway. Because there has been limited examination/screening and no post-treatment research efforts on this group of patients, the investigators have limited knowledge of the treatment as well as the patient group. Do compulsory treated patients differ from those voluntarily admitted? Does this type of treatment influence the patients' motivation to change their behaviour, and does the treatment effort lead to positive outcome effects in the long run? The primary aim is to acquire new and in depth descriptive knowledge about the compulsory treated group of patients according to: Drug dependence, psychiatric and somatic co-morbidity and socio-demographic characteristics, and investigate whether the treatment yields the intended outcomes in terms of improved substance abuse measures. A second aim is to compare the group with a corresponding group of voluntarily admitted patients within the same wards. A follow-up interview focusing on motivational issues within 6 months post treatment to evaluate the long-term results of the treatment is planned. A quasi-experimental, prospective case-control study will be conducted. Compulsory committed patients in five counties during a two year period, will be compared to a group of voluntarily admitted patients. The groups will be compared regarding 1) description and screening 2) motivation to change and 3) outcome results after 6 months. Both official authorities as well as clinical practitioners would benefit from valid Norwegian results and knowledge within this field to form further policies and evidence based best practice for this vulnerable group of patients.
Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas. The efficacy of pelvic floor muscle exercise (PFME) in treating urinary incontinence is well documented, however, to date there is little evidence to support the efficacy of PFME in treating symptomatic anal incontinence. This project consists of three separate studies. The prevalence survey/ study (1), investigates the prevalence of symptomatic anal incontinence among primiparas at Ostfold Hospital Trust Fredrikstad, Norway and St Olav's Hospital, Trondheim University Hospital, Norway, and the results in this study will form the basis of the two identical randomized controlled trials (RCT) investigating the treatment efficacy of PFME two groups of postpartum women. Women reporting symptomatic anal incontinence at six months postpartum (2) and women who have sustained a traumatic 3rd or 4th degree tear of the sphincter ani muscles during delivery (3), respectively, are randomized to an intervention group receiving PFME treatment for six months, or a control group. All RCT participants will undergo examination of PFM strength and activity, as well as anal ultrasound prior to randomization and after the intervention period.
Extract from the mushroom Agaricus blazei Murill har been shown to have strong immunomodulating properties both in cell cultures, animal models and in humans. Furthermore antitumor properties have been shown in animal models, among them in mice with multiple myeloma. The investigators now want to investigate the effect of Agaricus as supplementary treatment in addition to chemotherapy in patients with multiple myeloma.
This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily (BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 142 evaluable subjects. This is a double-blind, randomized, placebo-controlled, parallel group study. Subjects will undertake a screening period which may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over 28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg BID.
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.
The purpose of the validation study is to develop a valid test battery for assessing driving ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented and well-characterized effects on driving behaviour and accident risk, and will be used to assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios have been refined and their ability to predict driving accident risk have been validated, we plan to use the simulator to assess driving ability under the influence of different drugs suspected to produce driving impairment.
Patient participation is a central concept in Norwegian health policy. It is mandatory in hospitals and emphasised as one of the most prioritised areas by the Government. Studies from Norway have repeatedly found that patients who seek help in community mental health centres ("DPS") are dissatisfied with the information they receive and about their possibility for real influence in their treatment. One way to improve individual patient participation might be to give patients information before they start their treatment. This can be done as group based patient education to reduce the resources needed. Furthermore, as there are waiting lists for treatment, such introduction seminars could be held while patients are waiting to use this time in a meaningful way. The present study therefore aims at testing the effect of an introduction seminar for patients on waiting list in a community mental health centre.
Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal. Consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups: 1. Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening 2. Control Group - standard treatment The primarily endpoints in this study are nausea, retching and vomiting. The effect of acupuncture/acupressure will be studied with regard to any association with possible factors of predisposition to PONV, as well as with other factors registered during the study. Adverse effects from the acupuncture site and wristband will be registered.
The hypotheses of the study are that children / youth with CP will by possibly use of technical aids be able to perform high intensity endurance training by walking / running on a treadmill, and that this training will improve their health by increased aerobic capacity and quality of life.