St. Hyacinthe, Canada
A Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma
Phase
1Span
174 weeksSponsor
Janssen Research & Development, LLCGroningen
Recruiting
Rehablines: a Further Use Databank to (re)Use Routine Clinical Data for Scientific Research in Rehabilitation of People With Physical Disabilities and/or Chronic Diseases
Phase
N/ASpan
1070 weeksSponsor
University Medical Center GroningenGroningen
Recruiting
Groningen
Recruiting
Healthy Volunteers
A Study Protocol for the Implementation and Evaluation of a Self-management Support Program in Burns Aftercare for Burn Survivors in the Netherlands
Phase
N/ASpan
118 weeksSponsor
Martini Hospital GroningenGroningen
Recruiting
Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)
Phase
N/ASpan
569 weeksSponsor
University Medical Center GroningenGroningen
Recruiting
The Dragon PLC Trial (DRAGON-PLC)
Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies only lead to a median survival of 10-14 months. A complete surgical resection increases the median survival to 42 months (range 32-52 months). However, PLC is mainly diagnosed at an advanced stage and >70% of PLC patients are ineligible for an immediate surgical approach. There are different reasons that make a patient ineligible for surgery, one important reason is the risk of liver failure after the surgery due to a small remnant liver. This study aims to improve the oncological, radiological and surgical strategy to allow more patients to undergo liver resection safely, to improve quality of life and to extend overall survival at acceptable costs. Adequate function of the future liver remnant (FLR) is a prerequisite for surgical resectability. This is necessary in order to avoid liver failure after surgery, a major cause of morbidity (38%) and mortality (27%). To mitigate this risk, regenerative strategies based on preoperative calculation of the FLR volume and function are essential. Patients with technically resectable disease but predicted insufficient FLR volume or function are referred to as primarily unresectable or potentially resectable (PU/PR). These patients can undergo strategies that capitalize on the regenerative capacity of the liver which aim to preoperatively increase the FLR volume and function in order to allow surgery. Many of the patients that are primarily unresectable due to an insufficient FLR can become ultimately and safely resectable after the induction of adequate FLR-hypertrophy by the current standard, portal vein embolisation (PVE). However, 25% of patients do not show sufficient FLR growth after PVE and are unable to safely undergo resection. A new approach has been developed to improve this. Combined portal and hepatic vein embolisation (PVE/HVE) has great promise in terms of increasing FLR growth, resection rate (RR), safety and potentially, overall survival. Establishing PVE/HVE as the new standard could result in increased survival and a better quality of life (QoL) for patients.
Phase
N/ASpan
398 weeksSponsor
Maastricht UniversityGroningen
Recruiting
Groningen
Recruiting
Healthy Volunteers
The Impact of a Diagnostic Strategy for Acute Appendicitis in Children with Acute Abdominal Pain in Primary Care
BACKGROUND About 10% of pediatric general practitioner (GP) consultations are for acute abdominal pain of which about 5% have acute appendicitis (AA). Delaying a diagnosis of AA and subsequent appendectomy increases the short and long-term morbidity. AA in an early stage is difficult to distinguish from other (self-limiting) causes of acute abdominal pain (e.g. urinary tract infection, constipation and gastroenteritis), resulting in missing 19% of children with AA at first presentation in primary care and 70% non-AA cases among referrals, which has a negative impact on the child and parents, such as anxiety and psychological distress. As urgent illnesses other than AA are very rare in children with acute abdominal pain, the yield of referrals in terms of detecting other conditions than AA that need urgent specialist care is low. An evidence based diagnostic strategy for AA referral could help the GP in the diagnostic process, thereby reducing non-AA referrals without missing children with AA. OBJECTIVE AND HYPOTHESIS The objective of this study is to evaluate the impact of a diagnostic strategy for AA, consisting of an externally validated cPR based on seven signs and symptoms, selectively followed by a CRP-POCT in the medium-risk group, on referral efficiency in children with acute abdominal pain in primary care, as compared with usual care. The hypothesis is that the diagnostic strategy will decrease the proportion of non-AA referrals, without delaying the diagnosis of AA. STUDY DESIGN A pragmatic cluster RCT will be conducted with 1:1 permuted-block randomization of general practices to the intervention or control group using randomly varying block size. Stratification will be based on the GP practice size (greater or smaller than 5000 patients). Follow-up is 30 days for the primary outcome (efficiency) and 30 days and 3 months for secondary outcomes (7). Alongside the trial, a process evaluation will be performed according to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). STUDY POPULATION Inclusion criteria are: children, 4 to 18 years, presenting with acute abdominal pain (onset ≤ 7 days) in primary care. Exclusion criteria are: a history of appendectomy, pregnancy, traumatic cause of abdominal pain. INTERVENTION The intervention in this study is a diagnostic strategy for AA referral using an externally validated cPR selectively followed by a CRP POCT in the medium risk group. By using the diagnostic strategy, GPs will evaluate a set of signs and symptoms on a structural basis and get guidance for indication and interpretation of CRP POCT, for which current practice is very heterogeneous. The cPR includes seven signs and symptoms of AA: sex (2 points), duration of symptoms (< 24 hrs= 1 point, 24-48 hrs= 2 points), nausea or vomiting (2 points), elevated temperature (≥ 37.3 °C) (1 point), tenderness of the right lower quadrant (5 points), peritoneal irritation (4 points), and abnormal bowel sounds (1 point). For children in the low-risk group (score 0-7; mean probability AA 0.5%) safety netting advice should be provided. In the high-risk group (score ≥14; mean probability AA 41.0%), the GP should refer the patient to the emergency department. In the medium-risk group (score 8-13; mean probability AA 7.5%), GPs should perform CRP POCT according to Dutch laboratory quality standards. CRP values <10mg/l (mean probability AA 1.3%) imply safety netting advice and for CRP >50 mg/l a referral is needed (mean probability AA 41.8%). In case of a CRP value between 10 and 50 mg/l (mean probability AA 16.8%), the GP will discuss the following two management options with the patient: 1) a reconsultation later the same day or the next day; or 2) immediate referral. The cPR will be made available electronically for GPs, by a link integrated in the GP registry. USUAL CARE Care provided as usual is according to the recommendations of the Dutch College of GPs guideline 'abdominal pain in children', which states that AA could be suspected when a child presents with pain and tenderness in the right lower quadrant and fever. Children with peritonitis signs and abnormal bowel sounds need to be referred. In case of doubt, GPs should perform safety netting and/or plan reassessment. CRP testing is not recommended, because lack of evidence for added diagnostic value in primary care. The GPs in the control group receive a leaflet with a summary of the NHG guideline 'abdominal pain in children'. SAMPLE SIZE CALCULATION Results from previous studies show that the cut-off for the high-risk group based on the cPR had a specificity of 97% and that CRP value of ≥50 mg/l in children in the medium risk group had a specificity of 94%. As the weighted mean of these is a specificity (efficiency) of at least 95%, an improvement of efficiency from 88% (current care) to 95% is expected. In order to detect this difference, with 80% power, using a two-sided 5% significance level, and expecting 10% loss to follow-up, a randomized controlled trial would need to include 566 children (283 per group). The researchers assume to recruit on average 4 children per practice in 2 years and that 10 practices will not recruit any children. Therefore, 150 practices will be recruited which each recruit children for 2 years. STATISTICAL ANALYSIS The primary outcome will be evaluated on an intention-to-treat basis. Children will be analyzed in the intervention or control group based on the GP practice in which they are registered, irrespective of the actual care received. In addition, a per protocol analysis will be done. In the intervention group according to the per protocol analysis, only children who received the intended diagnostic strategy and CRP-POCT testing in the prescribed way will be included. In the control group, we will only include children who did not undergo CRP POCT testing. Separately in both randomized groups, characteristics of children will be compared in the intention-to-treat and per-protocol analysis. A multilevel logistic regression model will be used to analyze the primary outcome, accounting for clustering of observations within GP practices and adjusting for the stratification variable (practice size) and, if necessary, for baseline differences. Exploratory analyses will assess subgroups by age and sex. For secondary outcomes, multilevel logistic (dichotomous variables) or linear regression (continuous variables) will be used, as appropriate. In addition, adverse health outcomes (e.g. complications in AA cases and non-AA cases, missed other emergency diseases) will be described without statistical evaluation. COST-EFFECTIVENESS ANALYSIS Cost-effectiveness will be calculated from societal and healthcare perspective with a time horizon of 30 days. Secondary analyses will address a 3-month time horizon. Efficiency will be the primary effect parameter. Cost-utility will be calculated based on the EQ-5D-(Y)-3L. Bootstrap re-sampling will be performed on the costs, and on costs and effect pairs (cost-effectiveness and cost-utility analyses) in order to calculate confidence intervals. Furthermore, both cost-effectiveness and cost-utility planes will be plotted, along with acceptability curves.
Phase
N/ASpan
208 weeksSponsor
University Medical Center GroningenGroningen
Recruiting
QUALAS Validation in Dutch
Introduction and rationale Patients with spina bifida often face challenges in different areas. It is common to have a dedicated team of medical specialists for yearly follow-up. This team includes paediatricians, neurosurgeons, orthopaedics, urologists and rehabilitation specialists. Patients with spina bifida may experience symptoms in each of these areas which will have an impact of these patient's quality of life. From the urologist perspective urinary incontinence and faecal incontinence have a high impact on quality of life. Questionnaires to evaluate quality of life in patients with spina bifida do not incorporate these specific symptoms. The QUAlity of Life Assessment in Spina bifida in Children (QUALAS-C), QUAlity of Life Assessment in Spina bifida in Teenagers (QUALAS-T) and The QUAlity of Life Assessment in Spina bifida in Adults (QUALAS-A) have been developed to take these symptoms into account when assessing quality of life. These questionnaires are validated in the United States. For children aged 8-12 years the QUALAS-C version is available. For children between 13-17 years of age the QUALAS-T version is available. For adults the QUALAS-A version is available. Currently, no versions of the QUALAS-C, QUALAS-T, QUALAS-A questionnaires are available in Dutch. With the QUALAS-C, QUALAS-T and QUALAS-A the investigators will be able to assess spina bifida related quality of life and monitor the development over time. This will enable clinicians to offer improved standardized care. Objective(s) The aim of this study is to validate the QUALAS questionnaire for children, teenagers and adults in Dutch. Methods This is a multicenter prospective cohort validation study of the QUALAS questionnaire. This is a spina bifida related quality of life questionnaire. The investigators will validate the QUALAS using the validated KIDSCREEN-27 for children 8-17 years of age and the World Health Organization Quality of Life instrument (WHOQOL-BREF) and (International Consultation on Incontinence Questionnaire) ICIQ for adults questionnaires to determine spina bifida related quality of life in a standardized manner. All patients are subject to treatment at the department of Paediatric Urology in Erasmus MC-Sophia or University Medical Center Groningen. Participation in this study will not interfere with their treatment. For this study two different phases are distinguished: - Phase 1: The QUALAS will be translated following a standardized translation process. This includes three forward translations by Dutch native speakers, one backward translation by a English native speaker and face-to-face testing in the target population. - Phase 2: Children of 8 years and older and adults are asked to fill out the questionnaires, QUALAS and KIDSCREEN for children 8-17 years of age and the WHOQOL-BREF and ICIQ for adults, and repeat filling out the QUALAS questionnaire one week later. The team asks all parents to fill out the questionnaire in order to secure a constant answer during the study. Children of 8 years and older and adults in the control group are asked to fill out the QUALAS and KIDSCREEN-27 for children 8-17 years of age and the WHOQOL-BREF and ICIQ for adults. Internal consistency, criterion validity, construct validity an reproducibility will be determined.
Phase
N/ASpan
16 weeksSponsor
Erasmus Medical CenterGroningen
Recruiting
Healthy Volunteers
First-Line Intervention for PTSD - Intensive Treatment
Phase
N/ASpan
189 weeksSponsor
ARQ National Psychotrauma CentreGroningen
Recruiting