Gran Canaria, Spain

Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.

VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial

RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter to Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

Optimized Recovery After Trauma in Geriatric Patient

At present, there is evidence that structured care within healthcare (CGA and ERAS) increases the conditions for good care and better recoveries after acute conditions, planned and unplanned surgery. However, there are gaps in knowledge regarding elderly patients who are cared for within the surgical context. In this project we want to investigate whether a new care concept that combines CGA and ERAS can improve care and recovery for elderly patients who have suffered a physical trauma. We call care concepts for Geriatric Enhanced Recovery After Trauma (gero-ERAT). The project will be implemented as a PhD project for a maximum of 8 years. In the doctoral project, a qualitative interview study is planned during the spring and autumn of 2019. The purpose is to investigate experiences of care and recovery in elderly patients who have been cared for physical trauma. The findings from that study can contribute with new knowledge to the gero-ERAT concept. The overall purpose of the project is to develop, implement and evaluate a structured care with the aim of improving care and recovery in elderly patients affected by physical trauma. Specific purposes 1. Investigate patients experience of the recovery process after trauma 2. Establish, implement and evaluate the gero-ERAT concept (ie the effect of the intervention during the care period) at the trauma care unit at the university hospital. 3. Examine health economics when introducing and using gero-ERAT in the continuum care at the university hospital 4. Investigate in hospital time and recovery based on age and harvest estimation when using gero-ERAT The first study will be a qualitative interview study, 20-25 (depending on when saturation of data occurs) patients will be deeply interviewed at approximately one hour. The interviews will be semi-structured, and the questions are designed so that patients are given the opportunity to tell about their own perception and experience of care and recovery in connection with trauma. Transcribed coded data will be analyzed with the Constructive Grounded Theory methodology of Charmaz. Potential participants will be asked by researchers who are involved in the project upon discharge from the hospital, patients receive both oral and written information. The patients will be interviewed approximately six weeks after discharge from the hospital and the interview session is expected to take between 1-3 hours. The second study which is a Prospective cohort of two groups; conventional care and gero-ERAT will generate three studies. Data will be collected from the patients journal and by surveys that the patient replies to The measurement variables will be collected in connection with the care period when the patient is included in the study (baseline value), as well as at six and 12 months after the patients have been written out from the hospital. The items 1-5 below will be collected via the patients' records and items 6-11 will be filled in by the patients. - Demographic data (age, gender, type of trauma, other morbidity, social status, housing type) - Length of stay - Complications - Re-admissions - Mortality - RAND-SF36 (Short Form Health Survey); is a validated generic questionnaire on health-related quality of life and consists of 36 questions that can be divided into two domains; physical and mental health. - EQ-5D-5L (EuroQol); is a validated generic questionnaire consisting of five questions (health domains) and a VAS scale. In addition to health outcomes, data can be used as a basis for health economic calculations - ADL (Activities in daily life) The staircase describes the degree of dependence / independence with three scale steps for five basic physical activities and a function (food intake, continence, movement, toilet visits, dressing and undressing and bathing). - ESAS (Edmonton Symptom Assessment Scale); are validated symptom estimation scales consisting of ten symptoms (eg, pain, indigestion, nausea). - PREM (Patient Reported Experienced Measures) is a measure for measuring the patient's experience and satisfaction of care. - The PRP Questionnaire (Post Operational Recovery Profile) is a validated form consisting of 19 questions regarding symptoms such as appetite, insomnia and concentration ability that can be answered with four options. Descriptive data will be used to describe the groups. The differences between the groups will be calculated with Fisher's exact test for nominal data, Chi two test (X2) test for ordinal distribution, and normal distributed continuous variables will be calculated with Student t test or if continuous data is not normally distributed with Mann-Whitney U- Test.' 3. The third study will be a health-economic analysis that is based on data from the EQ-5D, which can be used to obtain quality-of-life weights to calculate quality-adjusted life years (QALY). Length of hospital stay, complications and re-admissions will also be collected and reported systematically. While working on this sub study, in addition to statistics, a person within the clinic with expertise in health-economic calculations will also be involved. 4. The fourth study will be Examining length of hospital stay and recovery based on age and frailty estimation when using gero-ERAT. These sub-group analyzes will take place on all collected data described in sub-study II. Before the statistical analyzes begin, consultation with statisticians will take into account the problem of the mass significance's ability to adjust for this.

Spinal Cord Injury in the Pediatric Population - an International Multicenter Study

INTRODUCTION Spinal cord injury (SCI) before the age of 15 is rare affecting less than 1 in every 100 000 children. Over the past decade the management of pediatric spinal cord injury and the long-term outcomes have received increased attention, however, most research has its origin from the US. Thus, there is a need for more knowledge about occurrence and causes, functional recovery, activity, participation and quality of life in children and adolescents in other countries than the US. Moreover, a systematic review 2011 shows that there is limited evidence about the effectiveness of interventions for the management of children with SCI. Knowledge regarding organization of care and rehabilitation is incomplete and differences between countries are substantial. Also, comparisons of data between countries and studies have been problematic due to differences in case definitions and age limits as to what is considered pediatric as opposed to adult SCI. Therefore, there is a need for international collaboration and research within the area of pediatric SCI with uniformity in methodology in the gathering of information and publication of the data to compare results between countries. Due to the low incidence of pediatric SCI and the demand for more knowledge and research, international cooperation is needed for purposes of building a solid and common understanding of the scope of the problem and uniformity in management and methodology. To reach this goal in the SIN context there is a need to benchmark between units, to highlight opportunities to improve systems of care and service delivery and to provide an understanding of the context of the units and the similarities and differences between them as this will be important for interpreting the results from subsequent phases of this project when patient outcomes are reported. Exploration of psycho-social issues from the perspective of the affected young persons and their families will assist targeting issues that are clinically and socially relevant for future service and future research cooperation. In addition, to be able to gather information to compare results between countries it is important to establish use of common outcome measures. AIMS AND OBJECTIVES Long term aim and objective The long-term goal of this research project is to optimize organization, care and rehabilitation in Norway and cooperating rehabilitation units internationally, to increase the awareness of subjective perceptions and psychosocial aspect of young persons with spinal cord injury, and to establish the use of outcome measures in local languages. Participants will be recruited from the rehabilitation hospitals cooperating within the Sunnaas International Network for Rehabilitation; Norway, Sweden, China, Russia, US, Israel, Palestine (SIN-units). Specific aims and objectives - To survey the SIN units in order to describe and compare the organization and delivery of inpatient rehabilitation services and systems of care for pediatric SCI patients - To explore qualitatively psychosocial aspects of living with spinal cord injury in children and adolescents in SIN units using individual, semi-structured interviews MATERIAL AND METHODS Study design This project is a cross sectional international multicenter study. A PhD-student is associated with the study (Oslo Metropolitan University/ Sunnaas Rehabilitation Hospital, start September 2019). The first stage of the project (Phase I) will comprise a descriptive part (Study I, Web survey) and an explorative part (Study II, semi-structured interviews) conducted in clinical settings in Norway, Sweden, China, Russia, US, Israel and Palestine. Recruitment The recruitment will be done within the units cooperating in the Sunnaas International Network for Rehabilitation (SIN). The local principle investigator in each unit will be responsible for collecting data in Study I and recruiting individuals to participate in Study II of the study. Potentially eligible individuals with SCI will be identified from the departmental or institutional database. If no suitable database is present in an investigative site, recruitment through alternative databases will be explored and discussed with project collaborators. Once identified, the study coordinator and local investigator will agree participant identification codes for the selected individuals. The study coordinator will allocate a three letter code (the first two letters will originate from the country of the study site, and the third from the name of the institution). Inclusion criteria´s for the target group - Children and adolescents (< 18 years) - Diagnoses: either a non-traumatic or traumatic SCI after the age of 7 - Has been discharged from initial rehabilitation for 6 months or more General Exclusion Criteria • Diagnosis of severe neurological conditions affecting the cognition of the child or adolescent (e.g. as a result of encephalocele or acquired brain injury) Participants Study I (descriptive study/ web survey). Ten rehabilitation units in Norway, Sweden, China, Russia, US, Israel and Palestine will be participating. The local principle investigator in each unit will be responsible for data collection. Study II (explorative study/semi-structured interviews). Two individuals in each of the ten SIN units, fulfilling the inclusion criteria's, will be recruited. A maximum of 20 young informants 13-17 years will be interviewed and constitute the study group of the International qualitative study. In addition, all norwegian youth with SCI rehabilitated at Sunnaas Rehabilitation Hospital fulfilling the inclusion criteria and beeing13-17 years of age during the inclusion period, will be recruited and constitute the study group of the Norwegian qualitative study (6-10 persons). Pilot interviews will be conducted prior to data collection. Data collection and analyzing Study I (descriptive study/ web survey) A web-survey based on clinical expertise and literature review have been developed in cooperation between Dr Peter W New, Spinal Rehabilitation Service, Caulfield Hospital, Australia and Norwegian clinicians and researchers with experience in pediatric SCI. The survey is a development and an adapted version of the survey used to conduct an international comparison of the organization of rehabilitation services and systems of care for adult patients with non-traumatic SCI in Italy, Ireland, India, Pakistan, Switzerland, the Netherlands, US, Australia and Canada. The survey will be used to gather descriptive data to review the various forms of care and rehabilitation services available to children and adolescents with SCI in SIN unit catchment areas. In addition, telephone or Skype-interviews will be used to complement data when necessary. The following main issues will be explored (detailed questionnaire is available): I. Hospital setting, interaction with acute hospitals and referral processes II. Rehabilitation beds and patient case-mix III. Spinal rehabilitation and staffing and therapy intensity IV. Availability of secondary staff, ancillary services and support V. Life long follow-up Also, the following background information will be collected: 1. SCI-prevention programmes in the region 2. Brief review of the implementation of child protection in each region The questionnaire will be available both electronically and in a paper version in English and will be completed by the local principal investigator (PI) or by a representative from each of the participating units chosen by the local PI. The local PI will be a bilingual person with good local knowledge. Clarification of responses will occur in cooperation between the local PI and the project manager at Sunnaas. Descriptive analysis will be performed with the median and interquartile range (IQR) reported for numerical data not normally distributed. Study II (explorative study/ interviews) An inductive, exploratory study with a qualitative design will be chosen to obtain a detailed description and understanding of how children aged of 13-17 years, perceive living with SCI in SIN-unit catchment areas. Individual, face-to-face interviews will be conducted based on a thematic, semi-structured interview guide with relevant follow-up questions. The interviews will take place in the informant's home or another place chosen by the informant. Ninety minutes or more will be allowed for each interview. Due to Corona restrictions virual interviews on a safe digital platform like Teams or Norske Helsenett will be allowed. This apply especially for the additional Norwegian interviews as they are planned to take place during the autumn of 2020 and spring of 2021. A semi-structured interview guide has been developed in cooperation between researchers and clinicians with experience in working with children and adolescents. Appropriate open ended questions are listed within each main area of the interview and key-questions are marked to assure that they are asked for. A salutogenic approach with strength based questions built on established principles and guidelines for psychosocial screening in young persons has been used (EuTEACH; HEEADSSS assessment; HEADSSS assessment, Clinical Practice Guidelines). Themes in the semi-structured interview guide (detailed interview guide is available): - The injury/ the accident - Acute care, rehabilitation and follow-up - Daily living with SCI with a pediatric onset - Home, education/employment, eating, activities, drugs, sexuality, suicide/depression/self-image, safety (HEEADSSS) - Resources and networks - Health - Peer learning/ role models - The future/ life goals Pilot interviews will be conducted to test the interview guide before deciding on a final version that will be translated to all relevant languages. To assure that all interviews are conducted in a good manner in different units, an educational curriculum will be developed. Also, the interviewers will be trained in a 2-day seminar. All interviews will be taped with a digital voice recorder and transcribed verbatim in each unit. The transcripts will be translated to Norwegian by bilingual translators with knowledge of neurological rehabilitation and analyzed using inductive qualitative content analysis seeking to identify both manifest categories and underlying, latent meanings. ETHICAL CONSIDERATIONS Ethical approval will be applied for in each country (Norway, Sweden, China, Russia, US, Israel and Palestine). All encoded material will be entered in a database at the Department of Research, Sunnaas Rehabilitation Hospital. Passkey will be stored separately and locked in a fireproof safe. Recorded/taped interviews will be transcribed and encoded and both the audio file (also encoded) and the transcript will be stored in a locked, fireproof safe. Candidate participants will be approached and informed about the study by a letter. The letter will explain (1) the purpose of the study, (2) the procedures and (3) confidentiality. The participant will be informed about their right to withdraw at any time and for any reason without affecting your treatment by any means. The letter will include an 'Informed Consent Form' that he/she and his/her caregivers must sign and date and return to their study site before they can participate.

Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Data for the primary outcome of 112 participants are needed but the aim is to recruit 150, if possible within a reasonable time frame, to take drop-out into account. Participants are randomized (blocked randomization, stratified for ulcer site and study center) to either treatment with a sealed therapeutic shoe or total contact cast. Each participant will be assessed by a cast technician during the treatment period (for ulcer healing and skin complications) and be assessed by a physiotherapist on five occasions: at baseline, approximately 4 weeks into treatment and 1, 6 and 12 months after treatment end. On these occasions the physiotherapist will perform different tests (gait, balance, ankle strength and flexibility, bone mass density in heel bone, etc) and participants will answer questionnaires and have their physical activity measured for 7 days with an activity monitor.

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness > 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.

STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Anterior cruciate ligament reconstruction (ACLR) is complicated by high failure rates in young, active individuals, which is associated with worse outcomes and higher rates of osteoarthritis (OA). ACLR failure reduces quality of life (QOL) and has substantial socioeconomic costs. Therefore, strategies to reduce ACLR failure are imperative. Lateral extra-articular tenodesis (LET) may provide greater stability; however, its effect on the rate of graft failure remains unclear, and surgically-induced lateral compartment OA is a concern given the potential for over-constraint of the joint. Many surgeons believe that autograft choice for ACLR, with or without LET, does not affect graft failure. Specifically, bone patella tendon bone (BPTB) autograft has been perceived to be just as good as a hamstring tendon (HT) graft. However, recent meta-analyses suggest that BPTB grafts provide better stability, albeit with greater donor site morbidity. Increasingly, quadriceps tendon (QT) autograft is being used for ACLR with claims of comparable stability to the BPTB graft without the donor site morbidity. However, the effects of a QT on graft failure are unknown. Despite its importance, there has not been an adequately powered study to evaluate if BPTB or QT is superior to the other in terms of graft failure rates, return to sports, donor site morbidity, lateral compartment OA and healthcare costs. Objectives: Determine if graft type (QT, BPTB, HT) with or without a LET affects: - Rate of ACL clinical failure 2 years after ACLR; - Patient-reported outcomes, muscle function, performance-based measures of function (hop tests, drop vertical jump) and return to sports; - Intervention-related donor site morbidity, complications and adverse outcomes; - Cost-effectiveness of ACLR and LET. Approach: This is a multicenter, international, randomized clinical trial that will randomly assign 1236 ACL deficient patients at high risk of re-injury, to an anatomic anterior cruciate ligament reconstruction (ACLR) using a BPTB or QT autograft with or without a LET in a 1:1:1:1 ratio. Data from this study will be combined with data from a recently completed randomized clinical trial comparing ACLR with a hamstring tendon (HT) graft with or without LET. Randomization will be stratified by surgeon, sex, and meniscal status (normal/repaired v meniscectomy) in permuted block sizes to ensure that any differences in outcome attributable to these factors are equally dispersed between treatment groups. Each site will either use traditional or expertise-based randomization. All randomization will use the web-based application available through the data management center. Methods to Reduce Biases: Selection Bias between STABILITY 2 Intervention Groups: We will partially determine eligibility prior to surgery. Once in surgery, all patients will undergo an examination under anesthesia and diagnostic arthroscopy to confirm final eligibility. The surgeon will document evidence of the participant's ineligibility in the surgical report that is discovered during surgery (e.g. partial ACL rupture where an ACLR is not performed, multiple ligament reconstruction, chondral lesion requiring more than debridement). The operative notes for all participants that were consented will be included in the study database. The study quality control monitors will review the evidence provided by the operating surgeon (arthroscopic pictures/video of ACL integrity and chondral status) and recommend that either the participant remain in the study or be withdrawn since they were never eligible. At the traditional randomization sites, full randomization occurs during surgery following arthroscopic evaluation of eligibility, which already serves to reduce the risk of selection bias. The action of requiring evidence of ineligibility at time of surgery therefore, reduces the risk of sampling bias (applicability) in traditional randomization sites. At the expertise-based randomization sites, where randomization to graft type occurs prior to surgery, this action will prevent unsubstantiated post-randomization withdrawals prior to randomization to LET or no LET, which reduces sampling bias (applicability) and selection bias by avoiding unequal exclusions between the LET/no LET assignment since randomization to LET/no LET occurs after the arthroscopic examination. In summary, having to provide evidence of eligibility at surgery will serve as a deterrent for surgeons declaring eligible consenting patients ineligible during surgery, which serves to reduce the likelihood of sampling and selection bias. Selection Bias between STABILITY 1 (NCT02018354) and STABILITY 2 Comparisons: STABILITY 1 followed the exact same protocols as are proposed for STABILITY 2 and the two studies will be performed immediately in series; thus, changes in ancillary care and surgeon expertise are unlikely. Consequently, analyses that combine data from STABILITY 1 and STABILITY 2 are unlikely to suffer significant between-study selection biases that are usually a concern for non-randomized comparisons. Further, to evaluate selection bias between the STABILITY 1 and STABILITY 2 samples, the baseline characteristics of the samples will be evaluated to identify any systematic differences between the samples. Performance Bias, Fidelity & Adherence: Surgeons have agreed upon standardization of aspects of the surgical interventions that could potentially influence outcomes. All other aspects of the surgical interventions are meant to be pragmatic and may vary by surgeon. Aspects allowed to vary are not expected to influence outcome. Further, randomization is stratified by surgeon so that nuance differences by surgeon are balanced between groups. In terms of fidelity, all participating surgeons have the necessary expertise to conduct both surgical procedures (BPTB, QT) if they have elected to participate in traditional randomization. Surgeons who have a preference for or greater skill performing one graft type over the other, will participate in expertise-based randomization and have identified another surgeon with similar expertise/preference performing the opposite graft type. In terms of performing a LET, all surgeons who have not completed at least 10 LETs will participate in a cadaver training lab and be required to complete at least 10 LET procedures prior to randomizing their first patient. The investigators have agreed upon a protocol for ACL rehabilitation following ACLR. All patients will receive a copy of the protocol with a standardized referral from their surgeon for their physical therapist. Deviations from the protocol are not expected to be different from usual practice and as such patient adherence with rehabilitation protocols is expected to vary. Given the large sample size, we expect that adherence to rehabilitation will be balanced between groups and we will adjust the analyses for length of time in rehabilitation. This study will track the number of rehabilitation sessions attended, milestones and timing of rehabilitation-specific activities to collect some adherence and fidelity data. Detection Bias: An independent surgeon, primary care sports medicine physician, physical therapist or athletic trainer who is unaware of group allocation will conduct all assessments of graft stability (primary outcome). Although incisions are unique for each procedure, patients will wear a tubigrip sleeve over both knees to conceal the incisions and reduce bias in assessments that require side-to-side comparisons, including the primary outcome. Data assessors for other outcomes will also be kept unaware of group allocation using this method. Intention-to-Treat Principle: Patients will be analyzed within the group to which they were randomized regardless of graft type received or adherence to protocols. Attrition Bias: From STABILITY 1, we have complete data on 95% of the 618 patients who are at least 2 years postoperative demonstrating that we are capable of successful recruitment and retention in a study of this magnitude. We will use the same measures to maximize completeness of follow-up Statistical Methods: Sample Size: We estimate that the absolute risk of graft failure (as defined above) in the ACLR will range from 25-35%. STABILITY 1 supports this estimate. We consider a relative reduction in graft failure rate of at least 40% to merit a change in practice (i.e. of sufficient magnitude to warrant the additional costs of adding a LET). With 255 patients per group and a type I error rate of 1% we would have 80% power to detect a relative risk reduction in rate of failure of 40% or greater in those with LET assuming the graft failure rate in ACLR is 33%. We have used a small type I error rate of 1% to reduce the risk of multiple comparisons error. To reduce the risk of losing precision from withdrawal and lost-to-follow-ups, we will over recruit by 15%, for a total of 309 per group or 1853 participants in total (combined STABILITY 1 and STABILITY 2 data). While not all sites have the infrastructure to conduct the isokinetic quadriceps and hamstring tests (13 sites) and in vivo kinematics during the DVJ (one site), these outcomes are reported using a continuous metric and therefore do not require as large a sample size as the proportional primary outcome. Statistical Analyses: The data collected through this study will be pooled with the data from STABILITY 1 for analysis (n=1800). To determine whether graft type (QT, BPTB, HT) with or without a LET offers a greater reduction in rate of failure following ACLR (primary research question), we will use a random-effects logistic regression with failure following ACLR at each visit (yes/no) as the outcome where fixed effects include intervention group, meniscal repair status, sex and time (as a categorical variable) and random effects include patient and surgeon. We will conduct a similar analysis for secondary outcomes like return-to-activity and donor site adverse events, as both are binary outcomes. For each continuous secondary outcome including patient-reported outcomes (PRO) scores, measures of impaired range of motion (ROM) and muscle strength, performance-based measures of physical function, and lateral compartment joint space narrowing, we will conduct a linear mixed-effects model where the fixed effects include ACLR group, meniscal repair status, sex and time (as a categorical variable) and random effects including patient and surgeon. For missing data, we will evaluate whether data are missing completely at random by comparing the available data (especially at baseline) for those with and without missing data at follow-up. We will use multiple imputation techniques to handle missing data. Sex-based analysis: To compare failure between HT+LET and other graft options (BPTB or QT) for males and females separately, we will conduct a random-effects logistic regression with the same fixed and random effects as in the primary analysis. Health services analyses: We will assign the average procedure cost for an ACLR surgery at each participating institution with the additional cost of the lateral extra-articular tenodesis for those patients randomized to the LET group. Patients who undergo a revision ACLR will complete a healthcare resource diary to capture additional direct and indirect costs. We will conduct a cost-effectiveness analysis from a healthcare payer and societal perspective using quality-adjusted life years (QALY) as our effectiveness outcome at two years postoperative. We will estimate the incremental net benefit (INB) of ACLR + LET using a random effects multilevel model. To characterize the statistical uncertainty around our estimate of INB, we will use an extension of the standard net benefit regression framework using the hierarchical data to generate location-specific net benefit curves, and cost-effectiveness acceptability curves.

Detection of Cerebral Ischemia With Artificial Intelligence.

The neurobiomarkers that will be analyzed for detection of cerebral ischemia is Glial Fibrillary Acidic Protein, Neurofilament light chains, S-100B, Neuron specific endolas, Total-tau. Cardiac biomarkers are troponin-t and NT-pro brain natriuretic peptide. Blood sampling will occur before anesthesia induction and 2 and 24 hours after surgery or plausible ischemia for patients undergoing surgery for carotid endarterectomy. For patients undergoing acute thrombectomy blood sampling will be performed as soon as possible after the patient has arrived to the hospital as well as 2 hours and 24 hours later. For patients undergoing mixed abdominal surgery, sampling will be done before anesthesia induction and 2 hours and 24 hours after surgery.