Project description:More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids. Opioid-induced constipation (OIC) has consequences that range from daily discomfort with social insecurity and disability to intestinal obstruction. It leads to limitations in self-management, a reduced quality of life and a risk of the need for more care. In the guideline "Diagnosis and treatment of pain in patients with cancer" it is recommended to start preventively with an osmotic laxative such as macrogol/electrolytes or magnesium hydroxide when starting opioids. Macrogol/electrolytes has been proven to be effective for OIC, but is sometimes perceived by patients as unpleasant due to its taste. Magnesium hydroxide, which is less commonly prescribed for OIC, has a neutral taste. Although it is mentioned in the guideline, it is not studied for the treatment of OIC and also not officially registered for this. To support the advice of the guideline and to prove that a choice is possible, it is important to investigate whether there are differences in effectiveness and/or side effects between macrogol/electrolytes and magnesium hydroxide in the prevention of OIC. The aim of this study is to compare macrogol/electrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative (incurable) phase, who start opioids because of pain. The choice of laxative is determined by drawing lots (randomisation). After two weeks, its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids. If the laxative, as assigned by lot, is described as satisfactory by the patient, the patient can continue with the drug that the patient used, after the study through regular prescription. The investigators will ask the patients in the study about their satisfaction with the laxative used, any side effects and the degree of pain. Furthermore, the appeal to care for possible constipation will be examined. Because the best attainable quality of life in the palliative phase is the objective of all care, the investigators will also measure this perceived quality with a questionnaire in this study. The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase.

Project description:While the majority of infants infected with respiratory syncytial virus (RSV) exhibit mild or no symptoms, approximately 3 million children under the age of five are hospitalized every year due to complications from RSV. This research sought to explore the biological processes and related biomarkers responsible for the varied manifestations of RSV disease in young infants. The goal is to pave the way for a more precise categorization of RSV-infected infants based on their medical requirements. Whole blood samples are collected from infant case-control cohort study, the RESCEU case-control cohort is a multinational, multicenter, observational study (clinical trial registration number: NCT03756766). Infants < 12 months old with RSV disease were recruited from the University Medical Center Utrecht (UMCU) in The Netherlands, Hospital Clínico Universitario de Santiago (SERGAS) in Spain, Imperial College (IMPERIAL) National Health Service Trust (NHS) and Oxford University Hospital NHS Trust (OXFORD) in the United Kingdom during the RSV seasons 2017-2018, 2018-2019, and 2019-2020. Healthy controls without underlying comorbidities were recruited outside of the RSV season. Eligibility criteria included hospitalization for less than 48 hours at enrolment or within 96 hours of disease onset, no previous receipt of medications to treat RSV infection, no prior exposure to an investigational RSV vaccine or medication, no previous receipt of immunoglobulins or monoclonal antibodies, and had not used montelukast or oral steroids within seven days before enrolment. Infants with co-morbidities were not evaluated in the manuscript. RSV was detected using RSV point-of-care test (POCT) by either a rapid antigen detection test (Alere I) (Alere Inc, Waltham, Massachusetts) or rapid RSV polymerase chain reaction (PCR) test at the hospital setting, or a RSV PCR test at the laboratory. Convalescence samples were collected 7 ±1 weeks after a positive RSV diagnostic test result. We used microarray to assist us to identify biomarkers for severe RSV disease.

Project description:Interventions: Participants of this study will be receiving prescribed medicinal cannabis product/s via their treating clinician, as per standard of care. Enrolment into the study requires their clinician to consent participants and provide relevant medical history information, prescription information and updates and regular adverse event reporting throughout the study duration (12 months observation per participant). Participants will be asked to complete a total of 14 questionnaires at set time points throughout the study. The study progress questionnaire including additional validated measures of health-related quality of life, medication adherence and patient reported change will be completed at enrolment, and months 1, 3, 6, 9 and 12 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). A short-form questionnaire focused on side effect reporting, current dose and changes to other concomitant medications will be completed at months 2, 4, 5, 7, 8, 10 and 11 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). It is anticipated that each questionnaire will take between 5-30 minutes to complete, requiring a total of 30 minutes maximum participation each month for the 12 months of the study. Clinicians will be asked to complete the baseline enrolment form (10 minutes to complete) for each patient at study enrolment as well as adverse event monitoring questionnaires, each taking 5-10 minutes to complete every 3 months for the period that they have patients enrolled in the study. Primary outcome(s): The type of medicinal cannabis product/s prescribed (including the formulation, prescribed dosage and underlying medical condition) as collected by study-specific questionnaires. [Collected at baseline, and then monthly for a 12 month period post-enrolment. ];Number of adverse and serious adverse events experienced that are related to medicinal cannabis treatment, including but not limited to, dry mouth, somnolence and gastrointestinal upset, as measured by study-specific questionnaires. These will be captured by clinicians at clinical examinations and also reported by patients on a monthly basis using the safety reporting questionnaire. The safety reporting questionnaires being used are study specific. The clinician AE reporting questionnaire is based on the TGA recommended guidelines for AE reporting which conform to WHO grading and causality definitions. [Patient reported data collected at baseline, and then monthly for a 12 month period post-enrolment. Clinician reported data collected at 3, 6, 9 and 12 months post-enrolment. ];Change to patient-reported concomitant medications (including opioid use) over the observational period using study-specific questionnaires. [Completed at baseline, and then monthly for 12 months post-enrolment. ] Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

Project description:The objective of this study is to: 1) Characterize the immune responsiveness to administration of non-live vaccines in three cohorts of healthy adult subjects through the analysis of blood leukocytes transcriptional profiles. 2) Validate whole blood transcriptional profiles generated from standard 3mL blood draws versus 200uL blood draws obtained by finger stick. 3) Discover potential biomarkers for immune-responsiveness to non-live vaccines. A total of 621 blood samples were collected either by venipuncture (387) or finger prick (234) from four groups of healthy adults receiving either, 2009/10 seasonal influenza or 23-valent pneumococcal vaccine or placebo (saline) injections. Subjects were recruited in 3 cohorts with 4-7 individuals per group; cohort 3 was recruited for validation of the systemic day 1 immune signature in response to seasonal influenza and pneumococcal vaccination. From each subject, peripheral blood was drawn into Tempus tubes (Applied Biosystems) or obtained by finger prick into micro capillaries and then transferred into tempus reagent to lyse blood cells and stabilize RNA before storing at -80ºC until mRNA extraction. The training set for transcriptional profiling of blood obtained by venipuncture was performed in cohort 1 which included 6 healthy adult individuals receiving seasonal influenza vaccine, 6 healthy adult individuals receiving pneumococcal vaccine, and 6 healthy adult individuals receiving placebo (saline injections). The test set for transcriptional profiling of blood obtained by venipuncture was performed in cohort 2 which included 6 healthy adult individuals receiving seasonal influenza vaccine, 6 healthy adult individuals receiving pneumococcal vaccine, and 6 healthy adult individuals receiving placebo (saline injections). The validation set for confirming systemic day 1 transcriptome immune signature in response to seasonal influenza and pneumococcal vaccination was performed in cohort 3 which included 6 healthy adult individuals receiving seasonal influenza vaccine and 4 healthy adult individuals receiving pneumococcal vaccine. The training set for transcriptional profiling of blood obtained by finger prick was performed in cohort 2 and the test set in cohort 1.

Dataset Information

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

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