Browsing Institutt for klinisk og molekylær medisin by Journals "Trials"
Now showing items 1-14 of 14
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Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial
(Journal article; Peer reviewed, 2021)Background: Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of ... -
Detailed statistical analysis plan for the Danish Palliative care trial (DanPaCT)
(Journal article; Peer reviewed, 2014)Background Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial ... -
Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial
(Journal article; Peer reviewed, 2014)Background Cerebral palsy (CP) is the most common motor disability in childhood (2 to 3 per 1000 live births), and is frequently accompanied by cognitive impairments and behavioural problems. Children with CP are at ... -
Early skin-to-skin contact or incubatorfor very preterm infants: study protocol for a randomized controlled trial
(Journal article; Peer reviewed, 2016)Background Skin-to-skin care immediately following delivery is a common practice for term infants and has been shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since ... -
Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: Study protocol of a cluster randomized controlled trial
(Journal article; Peer reviewed, 2015)Background Fecal incontinence has a high prevalence in the older population, which cannot be explained by comorbidity or the anatomical or psychological changes of aging alone. Fecal incontinence leads to a high economic ... -
Exercise prior to assisted fertilization in overweight and obese women (FertilEx): study protocol for a randomized controlled trial
(Journal article; Peer reviewed, 2016)Background Overweight and obese women show reduced conception rates compared to women of normal weight. Insulin resistance and increased amount of visceral fat may be important mechanisms for reduced fertility in these ... -
Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial
(Journal article; Peer reviewed, 2011)Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child. Observational studies regarding ... -
Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial
(Peer reviewed; Journal article, 2023)Background Sexual assault and rape are the traumatic life events with the highest probability for posttraumatic stress disorder (PTSD), which can have devastating consequences for those afflicted by the condition. Studies ... -
Neural correlates of working memory training in HIV patients: Study protocol for a randomized controlled trial
(Peer reviewed; Journal article, 2016)Background Potent combined antiretroviral therapy decreased the incidence and severity of HIV-associated neurocognitive disorders (HAND); however, no specific effective pharmacotherapy exists for HAND. Patients with HIV ... -
Specifying the target difference in the primary outcome for a randomised controlled trial: Guidance for researchers
(Journal article; Peer reviewed, 2015)Background Central to the design of a randomised controlled trial is the calculation of the number of participants needed. This is typically achieved by specifying a target difference and calculating the corresponding ... -
SPIOMET4HEALTH—efficacy, tolerability and safety of lifestyle intervention plus a fixed dose combination of spironolactone, pioglitazone and metformin (SPIOMET) for adolescent girls and young women with polycystic ovary syndrome: study protocol for a multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial
(Peer reviewed; Journal article, 2023)Background: Polycystic ovary syndrome (PCOS) is the most prevalent, chronic endocrine‑metabolic disorder of adolescents and young women (AYAs), affecting 5–10% of AYAs worldwide. There is no approved pharmacological therapy ... -
The Memory Aid study: Protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI)
(Journal article; Peer reviewed, 2014)Background Mild cognitive impairment (MCI) is a condition characterized by memory problems that are more severe than the normal cognitive changes due to aging, but less severe than dementia. Reduced working memory (WM) ... -
The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial
(Journal article; Peer reviewed, 2017)Background Intramuscular injections of botulinum toxin A (BoNT-A) have been a cornerstone in the treatment of spasticity for the last 20 years. In Norway, the treatment is now offered to two out of three children with ... -
Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial
(Journal article; Peer reviewed, 2018)Background Despite the high prevalence of insomnia in patients with advanced cancer, there are no randomized controlled trials on pharmacological interventions for insomnia in this group of patients. A variety of ...