Goeteborg, Vastra, Sweden

Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder

Primary objective: To determine the clinical efficacy of a therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for body dysmorphic disorder (BDD) in reducing BDD symptom severity in children and adolescents with BDD, compared to a control intervention consisting of a therapist-guided, Internet-delivered relaxation treatment (IRT) for BDD. Secondary objective: To establish the 6-month durability of the treatment effects and to assess the cost-effectiveness of ICBT, compared with IRT, from multiple perspectives and to conduct a health-economic evaluation of ICBT for BDD at the primary endpoint from a health organisation payer, healthcare resource use, and societal perspective. Type of trial: A multisite parallel-group randomised controlled superiority trial. Rationale: BDD is a prevalent and impairing disorder that tends to have a chronic course if left untreated. Adolescent-onset BDD is associated with more severe symptoms, greater lifetime comorbidity, and higher rates of attempted suicide compared to adult-onset BDD. Therefore, early intervention is crucial. BDD can be effectively treated with cognitive-behaviour therapy (CBT), although the current evidence is rather weak and more evidence is needed. Furthermore, CBT for BDD is a highly specialised treatment and many young people do not have access to it. ICBT can be a way to increase the availability of an effective, evidence-based treatment for children and adolescents with BDD. Trial design and methods: Participants will be recruited nationally across Sweden and will be offered 12 modules of therapist-guided ICBT or 12 modules of therapist-guided IRT delivered over 12 weeks. Under certain circumstances, such as illness or holidays, the design allows participants to pause their therapist-support for a maximum of two weeks, which may extend the treatment length to a maximum of 14 weeks. All potential participants will be initially screened via the telephone or at one of the three participating sites. This will be followed by an inclusion/baseline assessment conducted either at one of the three clinics (BUP OCD och relaterade tillstånd, BUP Specialmottagning or BUP Skåne) or, if face-to-face assessments are not feasible, via a secure video application. Participants who are eligible and have consented will be randomised to one of two trial arms. Participants in the comparator group (IRT) will be offered to cross-over to the ICBT intervention after the primary endpoint. The primary outcome variable: The primary outcome variable is BDD symptom severity measured by the Yale-Brown Obsessive Compulsive Scale modified for BDD, Adolescent version (BDD-YBOCS-A) at the primary endpoint (1-month follow-up post-treatment). Based on BDD-YBOCS-A scores, responder and remission rates at all follow-up points will be calculated. Response will be defined as ≥30% reduction from baseline; full or partial remission will be defined as a score ≤16. Planned trial sites: The study will be coordinated from the Department of Clinical Neuroscience at Karolinska Institutet (the Sponsor). There will be 3 collaborating study sites: BUP OCD och relaterade tillstånd (Region Stockholm), BUP Specialmottagning (Västra Götalandsregionen), and BUP Skåne (Region Skåne). Each of the three sites will assess and treat participants from their own region, and occasionally from other regions. Sample: A total of 154 children and adolescents diagnosed with BDD and their primary caregivers. Statistical methodology and analysis: Data will be analysed using a pre-specified intention-to-treat statistical analysis plan.

Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)

The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients with and without Brachyspira infection using advanced imaging. The investigators hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity. Visit 1: inclusion, questionnaires, blood, rectal barostat examination Visit 2: questionnaires, blood, stool, diaries (food and stool), sigmoidoscopy (without laxantives) Allergologist visit (skin prick test and interpretation blood results) Visit 3: stool, confocal laser endomicroscopy (CLE) OR colonoscopic antigen provocation test (COLAP) Visit 4,5 and 6 only if the CLE or COLAP was positive for (at least) 1 food item Visit 4: questionnaires and dietician-led instruction which food item to exclude (positive food item(s) during CLE/COLAP), exclusion for 4 weeks Visit 5: questionnaires, stool diary, instructions re-introduction food item(s) Visit 6: questionnaires QUESTIONNAIRES Baseline questionnaires; demographic, symptoms, symptom/medication/diet history, co-morbid medical conditions IBS symptoms: IBS-Symptom Severity Scale (IBS-SSS) and Gastrointestinal Symptom Rating Scale (GSRS)-IBS Psychological distress: Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire (PHQ)-9 (both visit 1,4,5,6, generalized Anxiety Disorder 7-item scale (GAD-7) Somatization: PHQ-15 for the number and severity of bodily symptoms. Gastrointestinal specific anxiety: Visceral Sensitivity Index (VSI). Sensitivity: Central Sensitization Inventory (CSI). Food avoidance and restriction: (ARFID). Stool habits and GI symptoms: 14-day GI symptom diary based on Bristol Stool Form Scale (BSFS). Quality of life: IBS-Quality of Life (QOL). Food intake: 4-days food diary, MealQ. COLONOSCOPIC ALLERGEN PROVOCATION TEST, COLAP: - A local allergen provocation test, where dietary antigens (soy, wheat, (egg), gluten and milk), with saline and histamine as negative and positive controls, respectively are injected in the rectosigmoid mucosa (similar to skin prick test used for clinical allergy testing). - The intestinal reaction is determined visually ("wheal and flare reaction"), and biopsies are taken to characterize the immune response. - Bowel preparation before the investigation follows the normal clinical routine for colonoscopy, and i.v. sedatives and opioids are given during the investigation according to clinical routines at the endoscopy unit CONFOCAL LASER ENDOMICROSCOPY, CLE, gastroscopy: - A probe-based endoscopic technique to study intestinal food reactions after iv injection of fluorescein. - Disruption of the small intestinal barrier in duodenum upon exposure to food antigens (soy, wheat, egg, gluten, milk, and control) can be determined. VISCERAL SENSITIVITY: •Rectal barostat sensitivity measurement: With the rectal barostat, the investigators can measure the rectal sensitivity. A balloon is inserted and inflated in the rectum in a controlled setting. The patient indicates when defined sensory thresholds are reached (first feeling of the balloon, urge to empty bowel, discomfort or pain). When the patient indicates discomfort or pain, or another reason to stop, the balloon inflation will be stopped. SIGMOIDOSCOPY: •Flexible sigmoidoscopy without bowel preparation, to interfere as little as possible with the normal gut microenvironment; fresh biopsies for specific analyses and biopsies stored for subsequent analyses. BIOLOGICAL SAMPLES: - Blood - and plasma samples: Fasting blood samples are taken for routine blood tests (exclusion of organic diseases) and to determine the metabolic profile and genetic and immunological markers of relevance to intestinal function and nerve function. Serum samples will be analyzed with nuclear magnetic resonance (NMR) for metabolomic profile and microbial composition. - Fecal - and urine sample: The investigators will characterize the composition and function of the metabolome in detail via 16S analysis, metagenomics, transcriptomics, metabolomics, cell culture and cell count. Urine and fecal samples will also be analyzed with nuclear magnetic resonance (NMR) for metabolomic profile and microbial composition. - Biopsies (location based on the performed endoscopic examination): The investigators will conduct a detailed analysis of immune cells, proteins, nerve cells, and intestinal bacteria which will allow detailed mapping of intestinal function with respect to nerve, immune and barrier function.

The Effectiveness of Early Intervention to Correct the Position of PDC:s

Design: A multicentre, parallel 3-group, randomised clinical trial. Setting: Orthodontic Departments in Sweden (5 centres), Germany (5 centres) and the UK (Sheffield). Target Population: Children, aged 10-11 years. Inclusion criteria: One or both upper permanent canine teeth are not palpable or there is a pronounced difference in the eruption between the left and right side. Dental radiographs will be taken to confirm that the permanent tooth is displaced. Canines in sector 5 are going to be excluded from this trial. Exclusion criteria: Buccal displacement of the canine(s), missing permanent lateral incisors; severe upper arch dental crowding (>2mm in each affected quadrant) or associated pathology. Intervention: The trial will examine the effectiveness of early orthodontic intervention, either by removal of the baby canine tooth or opening space for the adult tooth, against no treatment. Primary outcome • The proportion of young people who do not require surgery after 18 months from randomisation. Secondary outcomes - Cost effectiveness of the interventions - Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention. Sample size: A sample size calculation suggests that we will need to recruit 324 children (108 per group), assuming a dropout rate of 15%. Research questions The study aim is to investigate whether early intervention, in children with one or both palatally displaced permanent maxillary canine, prevents the need for later more invasive, prolonged and costly surgical intervention. Secondary research questions will include: - What is the cost of early intervention compared with late intervention (surgery to uncover the tooth)? - Is there a higher or lower incidence of damage to the surrounding teeth following early intervention? - Are there any adverse effects of early intervention? The trial efficacy objective will be to evaluate: • The proportion of participants who have to undergo a surgical operation to uncover or expose the unerupted permanent canine after 18 months from randomisation (primary outcome). Methods Population Children, aged 10-11 years with at least one palatally displaced maxillary permanent canine. Interventions Participants will be randomised, using a centralised web-based system, with allocation stratified according to the position of the unerupted canine. The severity of displacement is important when deciding which treatment might be appropriate. Current practice is to extract the baby tooth in children with moderately displaced permanent teeth, but to retain the baby tooth if the permanent tooth is severely displaced. Canine teeth that are severely displaced towards the midline are thought to be less likely to respond to intervention than those nearer to the ideal position (Bazargani et al. 2014, Naoumova et al., 2015). Young people with moderately displaced permanent canines (Sectors 2, 3 & 4 (Ericson and Kurol, 1988b), Figure below, will be allocated to one of 3 parallel arms: - Control: no treatment; - TrtA: open space between the lateral incisor and primary first molar/permanent premolar, to at least 9 mm, to ensure that there is sufficient space into which the canine can erupt; the space is to open whether with fixed appliance in the upper jaw and push coil or with RME - TrtB: the primary canine(s) removed. The allocation ratio within the stratum will be: Control: 1; TrtA: 1; TrtB:1. Data from previous studies suggest that in about 14% of young people with a palatally displaced canine the tooth is severely displaced towards the midline (Sectors 4, see ref above (Ericson and Kurol, 1988b)). For young people with a moderately displaced permanent canine there is some evidence that extracting the primary tooth might improve the position of the permanent tooth, hence the design of a three-arm trial. This will generate preliminary evidence of the relative efficacy between the two active arms. Patients with both upper canine teeth affected, but with different degrees of displacement, will be randomised according to the position of the most severely displaced tooth. Comparator Those in the comparator group will have no treatment during the observation period of 18 months following diagnosis. Any necessary surgical or orthodontic treatment will be provided after this time if the permanent canine shows no signs of appearing in the mouth. Outcomes The primary outcome will be the proportion of children who do not require surgery after 18 months from randomisation. This will be determined by the clinician treating the participants who will decide if the canine(s) is (are) in such a position that an orthodontic appliance can be placed without the need for surgical intervention. This will also be assessed, by independent judges, from masked clinical photographs taken at T2. Secondary outcomes will include patient reported outcomes: Incidence of Damage: Is there a higher or lower incidence of damage to the surrounding teeth following early intervention? Adverse Effects: Are there any adverse effects associated with early intervention? - Quality of Life: How do children perceive their Oral Health-Related Quality of Life (OHrQoL) before, during and following early intervention, as assessed by the CPQ 11-14 and CHU9D? - Cost-utility analysis: What is the cost of the different early interventions studied in relation to changes in HRQoL measured with CHU9D? All outcomes are going to evaluated according to the intention-to-treat (ITT) analysis. Proposed sample size and analyses The total number of patients required depends on the expected prevalence of the three strata. Assuming an effect size of 0.455 [ Nauomova et al., 2015] and further assuming a 15% drop-out, we will allocate 108 subjects to TrtA, 108 to TrtB and 108 to control (total 324), which gives a 80% power. The primary outcome will be evaluated using a logistic regression with treatment (control vs TrtA or control vs TrtB) and strata as covariates. The same analysis will be used to evaluate the potential damage to surrounding teeth. The economic analysis will be used to assess any differences in the cost effectiveness of early versus late intervention (surgical exposure). Costs of surgical exposures is going to be adapted from Björksved et al. [Björksved et al.; 2021]. Recruitment rate The recruitment rate per centre would be one participant every two months; therefore, to achieve a sample size of 300 participants in at least 15 centres would require 24 months. Procedure Children with uni- or bilateral PDC:s meeting the inclusion criteria and their care givers/parents obtain information about the trial, both verbally and in writing. The children and their parents will be allowed at least one week to decide whether they wish to participate in the trial. After informed consent is obtained, the participants are randomly allocated to 1 of 3 groups. A computer-generated randomization is undertaken to ensure that there are equal numbers allocated to each group. Allocation concealment is held by one individual per centre, not involved with the trial. In the TrtA group, the space creation will be achieved either through bonding fixed appliances in the upper jaw combined with the use of an open-coil or via RME (band on the first upper molars and arms stretching up to the first primary molars/ first premolars). The RME activation protocol is as follows: a single activation (0.25 mm) daily for a period of 14 days, followed by activation every other day until the point at which the palatal cusps of the maxillary first molars contacted the buccal cusps of the mandibular first molars). Within Sweden, TrtB group is set to receive a space-maintaining appliance, a lingual arch, after the extraction of the primary canines. This is in order to preserve the arch perimeters throughout the observation period. Study casts (preferably digital casts) at different timepoints (T0 = baseline, T1= 12 mon follow-up and T2 = 18 mon follow-up, see flowchart) are going to facilitate the monitoring of the space relationships in the dental arch. Standardized panoramic radiographs at T0, T1 and T2 is going to be used to monitor the PDC:s angulation and potential improvement or worsening during the observations period of 18 months. CBCT (cone beam computed tomography) at T0 and T2 are going to determine the presence or absence of root resorptions at baseline and T2 and the exact location of the PDC at baseline and at the end of the trial.

Comparison of Two Different External Clearance Markers - Mannitol and Iohexol for Measuring Glomerular Filtration Rate

Written inform consent from the patients or their relatives if they can not communicate. Inclusion criteria: Patients with acute or acute on chronic kidney failure (AKI, CKD), who are treated in the intensive care units because of any kind of organ insufficiency are enrolled. Stabil circulatory parameters needed with or without vasoactive drugs. Continuous intravenous administration of fluids and drugs without significant changes during the study period. Exclusion criteria: Unstable circulation and need for fluid resuscitation. Known extracellular volume expansion as ascites or peripheral edema. Intravenous paracetamol administration between or during the measurement period. Measurement with iohexol as contrast material during the previous days. Missing inform consent. Allergy to contrast material. Sample taking: at time zero and three times after the bolus injection. Timing is scheduled according to the local protocol for iohexol-GFR calculation. Samples are coded and can not identified when results are published. Outcome measures: Is mannitol clearance a reliable method for measuring GFR compared to iohexol-clearance? Comparing the two methods with Bland-Altman plots and statistical calculation for accuracy P30 and P20.

A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices

Background and Rationale This study aims to develop and evaluate a structured multidisciplinary rehabilitation process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet. The project establishes a new collaboration between the Oncology Department and the Department of Orthopedic Technology at Sahlgrenska University Hospital, integrating an orthopedic approach into cancer rehabilitation. Chemotherapy-induced peripheral neuropathy is a common side effect of chemotherapy, affecting 50-90% of patients undergoing cancer treatment. Symptoms such as numbness, tingling, pain, and sensory loss in the feet can lead to chronic discomfort, impaired balance, and reduced quality of life. Despite its prevalence, there are no standardized guidelines for grading or managing chemotherapy-induced peripheral neuropathy within rehabilitation. Additionally, structured follow-up for chemotherapy-induced peripheral neuropathy after chemotherapy is lacking in Sweden, and there are limited effective treatment options available. This research project aims to develop a structured process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet and to evaluate two orthopedic interventions: - Current standard treatment - customized insoles and orthopedic shoes. - A novel intervention - a silicone orthosis, designed as a soft, sock-like device for indoor use. Although silicone orthoses have been introduced in limited clinical settings in Sweden, their effectiveness for chemotherapy-induced peripheral neuropathy remains untested. This study seeks to evaluate whether this new intervention can alleviate symptoms and improve mobility and quality of life for breast cancer patients experiencing chemotherapy-induced peripheral neuropathy . Study Objectives The overall aim is to establish and evaluate a new process for assessing and alleviating symptoms in the feet through orthopedic technology. Specifically, the study will: - Compare the effectiveness of two orthopedic interventions (custom insoles vs. silicone orthosis). - Investigate patient-reported outcomes regarding symptom relief, quality of life, and functional mobility. Study Design and Methodology The study consists of a pilot phase with, followed by a potential randomized controlled trial if preliminary results are promising. This pilot study will include 40 participants, divided equally between the two intervention groups. It is conducted at Sahlgrenska University Hospital, involving a multidisciplinary collaboration between the Oncology Department and the Orthopedic Technology Department . Step 1: Diagnosis and Assessment Patients with chemotherapy-induced peripheral neuropathy in the lower extremities (feet) following breast cancer treatment will be assessed using a standardized grading system based on the Common Terminology Criteria for Adverse Events as well as a symptom questionnaire. Patients will also complete self-reported quality-of-life assessments as well as the EQ-5D scale and undergo 3D foot scanning to measure foot morphology and structural differences compared to the general population. Medical records will be reviewed to collect demographic and clinical variables (age, cancer status, chemotherapy regimen, comorbidities, smoking status, Body Mass Index). Step 2: Orthopedic Interventions Patients will be randomly assigned to one of two intervention groups: Group 1: Receives customized orthopedic insoles and shoes, the current standard treatment for diabetic neuropathy. Group 2: Receives a silicone orthosis, a novel sock-like support designed for indoor use. All participants will receive guidance on footwear selection and be provided with seamless socks to minimize pressure on sensitive areas. All patients will also be examined with - D-Foot: A validated and reliable instrument for structured foot examination, primarily used in diabetic foot assessments. - 3D foot scanning (Volumental scanner): Provides highly accurate foot measurements with a ±1 mm error margin. Step 3: Activity Monitoring To objectively assess mobility and functional changes, patients will wear an activity tracker (Active Pal) attached to their leg using skin-friendly tape for two weeks. The device records data on: - Time spent sitting, standing, walking, or lying down. - Step count and movement patterns. Patients in the silicone orthosis group will also maintain a daily usage diary to document how often they wear the device. Step 4: Follow-Up and Outcome Evaluation Follow-up assessments will occur 3-6 weeks post-intervention, conducted by oncology nurse or doctor via: - Repeat symptom grading (CTCAE). - Self-reported questionnaires on foot health and quality of life. - Semistructured interviews evaluating patients' experiences with their assigned intervention. Interviews will explore: - Perceived symptom relief and comfort. - Impact on daily activities and mobility. - Satisfaction with the provided intervention. - The follow-up can be conducted in person, via phone, or digitally and is estimated to take approximately 45 minutes. Scientific Questions The study aims to answer the following key research questions: - What is the prevalence and severity of chemotherapy-induced peripheral neuropathy in the feet among the patients? - How does chemotherapy-induced peripheral neuropathy affect self-reported quality of life (EQ-5D scores)? - What is the foot status (e.g., structural and functional characteristics) in affected patients? - Are there foot morphology differences between chemotherapy-induced peripheral neuropathy patients and the general female population? - Does the type of orthopedic aid influence activity levels and mobility? - How does chemotherapy-induced peripheral neuropathy impact patients' daily lives? - Are there differences in patient experience and perceived effectiveness between the two orthopedic interventions? Expected Impact If successful, this study will: - Provide new insights into the effectiveness of orthopedic aids for chemotherapy-induced peripheral neuropathy -related foot symptoms. - Establish a structured assessment process for chemotherapy-induced peripheral neuropathy in oncology rehabilitation. - Improve patient quality of life by offering evidence-based interventions for symptom relief. - Lay the groundwork for a larger randomized controlled trial to confirm findings and influence future clinical guidelines. By bridging the gap between oncology and orthopedic technology, this project aims to enhance rehabilitation strategies for cancer survivors dealing with long-term neuropathic complications.

Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin

Swedish CArdioPulmonary bioImage Study 2

The overall aim of SCAPIS is to improve prediction and prevention of cardiovascular and lung disease in the general population by identifying novel risk markers. This is also the purpose of SCAPIS 2, which further aims to gain important insights into risk factors and longitudinal development of heart, vascular and lung diseases such as atherosclerosis and chronic obstructive pulmonary disease. SCAPIS 2 will investigate 15,000 study participants approximately 8-10 years after the baseline examination SCAPIS 1. The five overall objectives of SCAPIS 2 are: 1. To determine characteristics related to the natural progression of atherosclerosis over 8-10 years. 2. To evaluate characteristics related to pathological cardiovascular aging over 8-10 years. 3. To determine characteristics related to the natural progression of lung function over 8-10 years. 4. To determine risk factors associated with the progression of coronary atherosclerosis and the development of impaired lung function or structural changes of the lungs. 5. To compare outcome in individuals who are invited to SCAPIS 2 and those not invited. SCAPIS 2 will recruit approximately 15,000 subjects randomly selected from the baseline examination (SCAPIS 1) study population approximately 8-10 years after their initial participation. During the SCAPIS 1 random samples of men and women aged 50-64 years were drawn from each recruitment area in the Swedish population registry until approximately 30 000 subjects were included. The final number was 30 154 subjects with an even sex and age distribution. The original recruitment process ensured that the study population in SCAPIS 1 was representative for the Swedish population in general. An invitation letter with brief information about SCAPIS 2 will be sent to randomly selected individuals by mail, including phone number and e-mail address to the study center. The invitation letter will refer to a study webpage where the subjects can indicate if they are interested in participating in SCAPIS 2 and read the subject information in advance (voluntary). The invitation also includes contact information to the study center to be used if the subject prefers to not use the web page or has questions. Subjects that have moved since their participation in SCAPIS 1 will be invited to the same study center as their baseline examination. The examinations will be performed during 2-3 days within approximately 2 weeks. Whenever possible, all visits should be performed within a period of 4 weeks. Examinations that are common for all sites include: - Medical history - Anthropometry - Clinical chemistry/hematology: Hb, p-Glucose, HbA1c, s-TG, s- Cholesterol, LDL, HDL, creatinine, detailed leukocyte count) - Biobank sampling (plasma, serum, whole blood, and urine) - Spirometry - CO uptake - Questionnaires - Accelerometry (hip) - Electrocardiogram (ECG) - Heart rate - Blood pressure - Computed tomography (CT) - Body composition - Lung tissue - Coronary artery calcium score (CACS) - Coronary computed tomography angiography (CCTA) All subjects will be fasting overnight (at least 8 hours) before the first visit. If a subject has not been fasting overnight, blood sampling should be rescheduled and performed preferably at an extra visit but no later than Visit 2. For subjects with elevated plasma glucose levels, an overnight fasting glucose measurement will be repeated. Subjects should be instructed to take their regular medication as usual also when fasting. The only medication that should not be taken is medication for diabetes, per oral as well as injections. Subjects with diabetes should be fasting as all other subjects and should bring their medication to take when having breakfast at the clinic. To obtain standardized conditions for the CT examination, subjects are recommended to be fasting for at least 4 hours before intake of a standardized meal. The standardized meal should be consumed 2 hours before the CT scan. All clinical findings and assessment of risk should be taken care of according to current guidelines and SCAPIS manual.

Leadership for Recovery: Evaluation of an Intervention Programme for First-line Healthcare Managers

Background Healthcare staff are often subjected to high workload and insufficient opportunities for recovery. Recovery (including sleep) is an important factor for good health and performance , not least during periods of high stress and strain. Previous research has shown that leadership and organisational factors play a major role in employee health and performance. However, managers in healthcare often report a demanding work situation themselves, which might affect their own health and become an obstacle for the leadership. Thus, healthcare managers have a key role in promoting their employees' recovery, but to be able to manage that important task, they may also need support for managing their own recovery. Furthermore, there is a lack of research on how healthcare managers can work with supporting employees' recovery. In a previous research project, the investigators developed and evaluated a group-administered proactive recovery programme for new nurses, focusing on enhancing beneficial strategies for recovery. The programme showed promising effects in terms of reduced burnout and fatigue symptoms. However, the intervention was directed only towards the employees, on the individual level. A focus on interactions with organisational factors and leadership is likely needed to support long-term recovery among healthcare staff. Aims To evaluate an intervention programme, "Leadership for recovery", for first-line healthcare managers in Swedish hospital settings, focusing on both 1) strategies for promoting own recovery and 2) strengthening a "leadership for recovery" (a leadership that promotes employee recovery). The main question the study aims to answer are: - Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' own recovery and leadership for recovery improve their employees' recovery? The hypotheses are: The leadership for recovery program will: - improve the employees' recovery (including sleep) - improve the employees' health, including somatic symptoms and burnout symptoms - improve the employees' cognition - reduce the employees' work interference with personal life - reduce the employees' intention to leave work Research design The study is a cluster randomised controlled trial. Participating managers will be randomised to either intervention group or control group. Employees of managers in both the intervention and control group will be invited to participate in the study. Thus, the employees are beforehand (before recruitment) already assigned (cluster randomised) to intervention or control group based on which group their manager belongs to. Recruitment Managers are recruited from Swedish hospitals through contacts with Human Resources Departments and second-line managers. All employees of participating managers will be invited via e-mail for participation in the study. Procedure The intervention programme for managers includes both educative and reflective parts with a focus on promoting strategies for recovery. It is based on previous interview studies with nurses and first-line healthcare managers (unpublished results), previous interventions for a health promoting leadership, our previously evaluated recovery programme for nurses, and organisational behavioural management techniques. The first parts of the programme focus mostly on managers' own recovery, and the latter parts focus on ways to promote employees' recovery. The programme consists of 6 group sessions distributed over approximately 6 months. Employees in both intervention and control group will fill out surveys at baseline (before intervention group managers' start the leadership intervention) post-intervention (about 1 month after intervention group managers' fifth session) and at follow-up (12 months after baseline). A subsample (voluntary) will also fill out diaries and wear actigraphy wristbands (objective sleep measure) at baseline and follow-up. Employees in the intervention and control group will be compared in terms of effects of the programme. Primary outcomes will be measures of recovery (including sleep). Secondary outcomes include measures of general health; somatic symptoms; burnout symptoms; cognition and work performance; work interference with personal life and intention to leave work. Both primary and secondary outcomes will be measured in both surveys and diaries. Sleep will also be measured through actigraphy wristbands. Data from surveys and diaries/actigraphy will be analysed and reported separately. Randomisation and masking The randomisation will be performed by a person not working in the project that is blinded to the participants. Block randomisation will be used. The randomisation will be made separately for different hospital sites (i.e. managers from the same hospital site will be randomised together, so that the ratio will be 1:1 for intervention/control group in each hospital site if possible). The randomisation may occur continuously as participants sign up for the study. If two or more managers work at the same unit/ward (shared leadership) they will be assigned to the same group. It is not possible for participants or group leaders to be blinded to group allocation. Sample size The aim is to recruit approximately 80 first-line healthcare managers to be randomized to intervention or control group. Employees of participating managers will be invited to participate in the study. Based on the assumption that every manager has ≈ 40 employees, in total ≈ 3200 employees will be invited to participate. The investigators expect approximately 30% to sign up for the study, i.e. 960 participants. Drop out from the program Managers who drop out of the leadership program will be asked if they are willing to continue filling out questionnaires. Data analysis plan To be published. The analyses will follow the intention to treat principle. Per-protocol analysis will also be conducted.

Smart MDI Study (CIP343)

This is a post-market, prospective, open-label, multi-center, randomized controlled trial in adult and pediatric subjects with type 1 diabetes. The study consists of a run-in phase of 3 weeks and a study phase of 6 months. The purpose of the run-in phase is to collect baseline HbA1c and CGM data while subjects are on their current therapy. During the 6-month study phase, subjects will be randomized to continue with their current therapy or to start using the Smart MDI system. Approximately 140 subjects with type 1 diabetes aged 2 years and older will be enrolled in the study at up to 20 investigational centers in Europe to achieve approximately 112 subjects randomized and completing the 6-month study phase.

Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time. This is a prospective cohort study where all research persons have SLN biopsy using both SPIO and the dual technique. Then the investigators will compare SLN detection rates between Magtrace 0.1 ml and the dual routine technique with radioactive tracer (Technetium99m, Tc99) +/- blue dye.