There are about 8563 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.
Rectal cancer is a common diagnosis. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery. For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio-frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens. These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery. In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative. MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed information about the position of the metastasis and the relation to large vessels. The aim of this study is to examine the possible differences in percentage of patients requiring further radiology examinations after basic set-up comparing the routine of initial MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of the pelvic organs). Further included is an analysis of the rate of liver metastasis using the two different routines, and finally outcome over 12 months in terms of liver treatment for metastasis.
This is an open-label, single centre, Phase I study to determine the brain exposure of [11C]osimertinib in patients with EGFRm NSCLC with brain metastases.
The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).
In a randomized multicenter trial the investigators want to compare the ability of two hCG-based models in correctly classifying EPs as high risk among PULs and correctly classifying IUPs and failed PULs as low risk after two hCG measurements. After the classification of PULs into high or low risk of EP, the clinical management will be the same within each risk group (high and low) regardless of randomization group (which model classified the patients). The clinical management will be according to the management protocol published in a NICE guideline.
The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to medical abortion provided traditionally following face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate whether counselling through telemedicine is non-inferior to face-to face counselling a RCT will be conducted including women who chose medical abortion up to 63 days of gestation with home administration of misoprostol and self assessment of the outcome. The results of this study could be of major importance to increase access to safe and acceptable abortion services.
One initiative to address communication problems between migrant women not fluent in Swedish and caregivers throughout childbirth is to provide language assistance, cultural interpretation and labour support to the woman through Community Based Doulas (CBDs). CBDs are bilingual women from migrant communities trained by midwives to provide cultural, language and labour support to migrant women throughout their labour and birth. The study will evaluate the effectiveness of community-based doula support for improving the intrapartum care experiences and postnatal wellbeing of Somali-, Tigrinya -, Arabic- and Russian-speaking migrant women giving birth in Stockholm, Sweden. The randomisation ratio will be 1:1; CBD support in addition to standard intrapartum care or standard intrapartum care. Women allocated to receive CBD support in addition to standard intrapartum care (intervention group), will be contacted by a Somali, Arabic-, Russian- or Tigrinya-speaking CBD as appropriate, and arrangements will be made for the doula and the women to meet twice prior to the birth to get to know each other and discuss the woman's wishes regarding support in labour and what the CBD can offer. Each woman will then contact her CBD when she goes into labour and the CBD will attend hospital with her and stay with her throughout labour and birth, in addition to any other support people she may have, such as her partner. Women allocated to the comparison arm of the trial will receive standard intrapartum care as provided at their chosen hospital of birth. The hypothesis is that women randomised to receive CBD support in labour will rate their care for labour and birth more highly and have better emotional wellbeing (lower mean scores on the Edinburgh Postnatal Depression Scale) two months after birth than women allocated to standard care.
The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).
The ENSURE study will comprise two phases. Phase 1: European multicenter survey of surveillance protocols after esophageal cancer surgery ENSURE questionnaire will be circulated to representatives from participating European countries. Phase 2: European multicenter retrospective observational study of the impact of postoperative surveillance protocols on oncologic outcome and HR-QL Phase 2 will constitute a retrospective observational study of patients undergoing treatment with curative intent for esophageal cancer at participating Centers from June 2009 to June 2015.
Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the estimated 47 million people with dementia worldwide. The amyloid cascade hypothesis of AD proposes that amyloid-β (Aβ) peptide accumulation in the brain, caused by an imbalance between Aβ production and clearance, is the initiating factor of a cascade ultimately leading to dementia. Aβ peptides are generated from sequential cleavage of the amyloid precursor protein (APP), including Aβ40 and Aβ42. Aβ40 is the predominant variant (90%) among the secreted Aβ forms and although Aβ42 is more hydrophobic and prone to aggregate, and Aβ42 oligomers are regarded to be the most neurotoxic species, Aβ40 can also produce highly toxic diffusible aggregates, which can be prevented in vitro by specific anti-Aβ40 antibodies. Several studies have proposed that a high concentration of Aβ40 in the brain distinguishes patients with AD from those who have senile plaques but are cognitively normal, pointing to the importance of Aβ40 in the onset of dementia. In keeping with this, previous studies have demonstrated that specific anti-Aβ40 antibodies label NFTs in the entorhinal cortex and the hippocampus of AD brains, and that these do not co-localize with tau NFTs, suggesting the presence of degenerating neuronal populations filled with C-terminal fragments of Aβx-40. In addition, Aβ40 is the main component of amyloid deposition around cerebral arteries causing cerebral amyloid angiopathy (CAA), which has a prevalence of about 80-90% in patients with AD (for more information see Lacosta et al. Alzheimer's Research & Therapy (2018) 10:12 DOI 10.1186/s13195-018-0340-8). Considering those previous results suggesting that strategies targeting Aβ40 could represent novel disease-modifying therapies, we have developed ABvac40, the first active vaccine targeting the C-terminal end of the Aβ40 peptide. The purpose of this Phase II study is to confirm in patients with a-MCI or vm-AD the level of safety and tolerability obtained in the ABvac40 Phase I clinical trial in patients with mm-AD. In addition, the study is aimed to better characterize the immune response elicited by ABvac40 and to explore its effects on AD biomarkers.
The long-term purpose of an on-going participatory action research program "The KLUB-study" in Sweden, that involves scientists and representatives from all levels of athletics, is to develop a sustainable framework for safe athletics (track and field) training for child athletes born 2002-2006. The first part of the research program, a 1-year longitudinal study analysing training and injury data, was completed in November 2017. The present study sets out to evaluate a website that aims to support coaches and caregivers in their role as adult key stakeholders to foster young athletes to become adult athletes who possess the tools to maintain a healthy sporting lifestyle.