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PURPOSE: The aim of this randomized, placebo-controlled, two-stage, phase II/III trial was to determine the efficacy of an oral cannabis extract in adults with refractory nausea and/or vomiting during moderately or highly emetogenic, intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Here, we report results of the prespecified combined analysis including the initial phase II and subsequent phase III components. PATIENTS AND METHODS: Study treatment consisted of oral capsules containing either tetrahydrocannabinol 2.5 mg plus cannabidiol 2.5 mg capsules (THC:CBD) or matching placebo, taken three times a day from days -1 to 5, in addition to guideline-consistent antiemetics. The primary measure of effect was the difference in the proportions of participants with no vomiting or retching and no use of rescue medications (a complete response) during hours 0-120 after the first cycle of chemotherapy on study (cycle A). RESULTS: We recruited 147 evaluable of a planned 250 participants from 2016 to 2022. Background antiemetic prophylaxis included a corticosteroid and 5-hydroxytryptamine antagonist in 97%, a neurokinin-1 antagonist in 80%, and olanzapine in 10%. THC:CBD compared with placebo improved the complete response rate from 8% to 24% (absolute difference 16%, 95% CI, 4 to 28, P = .01), with similar effects for absence of significant nausea, use of rescue medications, daily vomits, and the nausea scale on the Functional Living Index-Emesis quality-of-life questionnaire. More frequent bothersome adverse events of special interest included sedation (18% v 7%), dizziness (10% v 0%), and transient anxiety (4% v 1%). There were no serious adverse events attributed to THC:CBD. CONCLUSION: THC:CBD is an effective adjunct for chemotherapy-induced nausea and vomiting despite standard antiemetic prophylaxis, but was associated with additional adverse events. Drug availability, cultural attitudes, legal status, and preferences may affect implementation. Future analyses will evaluate the cost-effectiveness of THC:CBD.
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INTRODUCTION: Cystic fibrosis transmembrane conductance regulator (CFTR) modulators are increasingly used in children and young people with cystic fibrosis (CF). Data in adults show there may be an impact on glycaemic control in those with CF-related diabetes (CFRD). Paediatric data are rare. Case Series/Presentation: Children aged >12 years with CFRD, who were eligible for elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) were commenced on treatment. Glucose monitoring via the FreeStyle Libre system was commenced prior to, immediately after, and several months after commencing ELX/TEZ/IVA. Glycaemic control, shown by time in range (3-10 mmol/L), percentage of time spent hypoglycaemic (<3 mmol/L), and percentage of time spent hyperglycaemic (>10 mmol/L) on Insulin doses were recorded. Following ELX/TEZ/IVA, four of seven children stopped insulin, two required substantially reduced doses of insulin, one showed no response. Glycaemic control remained similar on lower doses or no insulin. Hypoglycaemia was detected in those not requiring insulin. CONCLUSION: ELX/TEZ/IVA has a positive impact on glycaemic control and insulin requirements in children with CFRD. Close monitoring is required when commencing treatment. Children with CFRD need counselling regarding possible reductions in insulin requirement and re-education regarding symptoms, signs, and management of hypoglycaemia.
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Aminofenoles , Benzodioxoles , Fibrosis Quística , Diabetes Mellitus , Hipoglucemia , Indoles , Pirazoles , Piridinas , Pirrolidinas , Quinolonas , Adulto , Humanos , Niño , Adolescente , Glucosa , Fibrosis Quística/complicaciones , Fibrosis Quística/tratamiento farmacológico , Fibrosis Quística/genética , Automonitorización de la Glucosa Sanguínea , Glucemia , Insulina/uso terapéutico , MutaciónRESUMEN
Sunlight transforms plastic into water-soluble products, the potential toxicity of which remains unresolved, particularly for vertebrate animals. We evaluated acute toxicity and gene expression in developing zebrafish larvae after 5 days of exposure to photoproduced (P) and dark (D) leachates from additive-free polyethylene (PE) film and consumer-grade, additive-containing, conventional, and recycled PE bags. Using a "worst-case" scenario, with plastic concentrations exceeding those found in natural waters, we observed no acute toxicity. However, at the molecular level, RNA sequencing revealed differences in the number of differentially expressed genes (DEGs) for each leachate treatment: thousands of genes (5442 P, 577 D) for the additive-free film, tens of genes for the additive-containing conventional bag (14 P, 7 D), and none for the additive-containing recycled bag. Gene ontology enrichment analyses suggested that the additive-free PE leachates disrupted neuromuscular processes via biophysical signaling; this was most pronounced for the photoproduced leachates. We suggest that the fewer DEGs elicited by the leachates from conventional PE bags (and none from recycled bags) could be due to differences in photoproduced leachate composition caused by titanium dioxide-catalyzed reactions not present in the additive-free PE. This work demonstrates that the potential toxicity of plastic photoproducts can be product formulation-specific.
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Polietileno , Contaminantes Químicos del Agua , Animales , Polietileno/toxicidad , Pez Cebra , Contaminantes Químicos del Agua/toxicidad , Contaminantes Químicos del Agua/análisis , Plásticos/toxicidad , AguaRESUMEN
INTRODUCTION: Various modalities of fixation have been proposed for Lisfranc injuries. Memory staple fixation offers a simple option for transarticular fixation in suitable fracture configuration with no diaphyseal extension. However there is little evidence available in the literature regarding its efficacy and patient reported outcomes. Aim of the study was to present the long term outcomes of Lisfranc injuries treated with memory staple fixation and patient reported outcomes at average follow-up of four years. METHOD: This was a retrospective analysis of all the patients who underwent fixation for Lisfranc injury using shape memory alloy (Nitinol) staples from December 2010 to October 2018. Patient demography, mechanism of injury, classification of Lisfranc injury, duration of followup, complication, revision surgery, implant removal and patient reported outcomes (AOFAS midfoot score) was noted. RESULTS: 31 patients satisfied the inclusion criteria. Mean age was 50 years and 17 patients were females. 54 % patients reported low to moderate energy trauma which included simple fall from standing height or twisting injury. 28 (90.3 %) had B2 type of fracture pattern. 13 had fixation with staples only, 15 with a staple and home run screw. No patient had primary fusion. One patient had superficial infection treated with antibiotics only. Three patients developed symptomatic arthritis, out of which one proceeded to fusion. Six had implant removal for hardware related symptoms. Average AOFAS midfoot score at average four years follow-up was 77.8 which are satisfactory. CONCLUSION: This paper highlights good outcome following memory staple fixation for Lisfranc injuries. We believe staples are more suited for the dorsal buttressing that is typically required and provide stable, reproducible fixation Our findings also suggest less need for implant removal compared to transarticular screw or plate fixation though larger studies would be required to make definitive conclusions.
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Fracturas Óseas , Huesos Metatarsianos , Femenino , Humanos , Persona de Mediana Edad , Masculino , Estudios Retrospectivos , Fijación Interna de Fracturas/métodos , Huesos Metatarsianos/cirugía , Fracturas Óseas/diagnóstico por imagen , Fracturas Óseas/cirugía , Medición de Resultados Informados por el Paciente , Resultado del TratamientoRESUMEN
The nutcracker phenomenon (NCP) refers to the compression of the left renal vein, most commonly between the aorta and the superior mesenteric artery (SMA). Nutcracker syndrome (NCS) should be limited to patients who present with the characteristic clinical signs and symptoms alongside diagnostic imaging of the anatomy associated with the syndrome. We report a case of NCS presenting with painless visible hematuria and left flank pain. Imaging showed a left renal vein stenosis at the origin of the SMA with collateralization. Diagnosis of NCP is made by a variety of imaging techniques; approaches to the treatment of NCS include conservative methods, open surgical, laparoscopic or endovascular techniques. Correlation with symptoms, laboratory results and excluding other causes continues to be important in the workup of NCS. Collaboration with the establishment of an International Consortium database will aid in the understanding of this rare disease.
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Sunlight chemically transforms marine plastics into a suite of products, with formulationâthe specific mixture of polymers and additivesâdriving rates and products. However, the effect of light-driven transformations on subsequent microbial lability is poorly understood. Here, we examined the interplay between photochemical and biological degradation of fabrics made from cellulose diacetate (CDA), a biobased polymer used commonly in consumer products. We also examined the influence of â¼1% titanium dioxide (TiO2), a common pigment and photocatalyst. We sequentially exposed CDA to simulated sunlight and native marine microbes to understand how photodegradation influences metabolic rates and pathways. Nuclear magnetic resonance spectroscopy revealed that sunlight initiated chain scission reactions, reducing CDA's average molecular weight. Natural abundance carbon isotope measurements demonstrated that chain scission ultimately yields CO2, a newly identified abiotic loss term of CDA in the environment. Measurements of fabric mass loss and enzymatic activities in seawater implied that photodegradation enhanced biodegradation by performing steps typically facilitated by cellulase. TiO2 accelerated CDA photodegradation, expediting biodegradation. Collectively, these findings (i) underline the importance of formulation in plastic's environmental fate and (ii) suggest that overlooking synergy between photochemical and biological degradation may lead to overestimates of marine plastic persistence.
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Celulasas , Luz Solar , Dióxido de Carbono , Isótopos de Carbono , Celulosa/análogos & derivados , Océanos y Mares , Plásticos/química , Polímeros , Titanio/químicaRESUMEN
BACKGROUND: Patient-centered care (PCC) is an emerging priority in many healthcare settings but lacks clarity in the emergency department (ED). It is of interest to know what PCC practices are most important to patients to better their experience. The objective of this study was to conduct a mixed-methods systematic review of PCC in the ED. METHODS: We used stakeholder and patient engagement to consult with clinicians, subject-matter experts, patient partners, and community organizations to determine patient needs. We examined all articles in the ED context with PCC as the intervention. Two independent reviewers screened 3136 articles and 13 were included. A meta-ethnographic analysis was conducted to determine common themes of PCC. RESULTS: Themes included emotional support, communication, education, involvement of patient/family in information sharing and decision making, comfort of environment, respect and trust, continuity, and transition of care. Challenges in the ED reflected a lack of PCC. Moreover, implementation of PCC had many benefits including higher patient satisfaction with their care. Though there were commonalities of PCC components, there was no consistently used definition for PCC in the ED. CONCLUSION: The findings of this review support the evidence that PCC is of high value to the ED setting and should be standardized in practice.
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BACKGROUND: This study evaluates the survivorship of the C-Stem total hip replacement, using the "French Paradox" method, at medium-term follow-up. METHODS: 321 cemented total hip replacements in 307 patients were performed, using the canal-filling technique for the femoral stem. Survival analysis was performed for all-cause revision. The secondary outcome was aseptic loosening of the stem. RESULTS: Revision rate for all reasons was 2%. Overall ten-year survival was 95%. There were no revisions for femoral stem aseptic loosening. CONCLUSION: This is a unique study demonstrating successful outcomes of total hip replacement using the "French Paradox" technique with a triple-tapered stem.
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In May 2021, the M/V X-Press Pearl cargo ship caught fire 18 km off the west coast of Sri Lanka and spilled â¼1680 tons of spherical pieces of plastic or "nurdles" (â¼5 mm; white in color). Nurdles are the preproduction plastic used to manufacture a wide range of end products. Exposure to combustion, heat, and chemicals led to agglomeration, fragmentation, charring, and chemical modification of the plastic, creating an unprecedented complex spill of visibly burnt plastic and unburnt nurdles. These pieces span a continuum of colors, shapes, sizes, and densities with high variability that could impact cleanup efforts, alter transport in the ocean, and potentially affect wildlife. Visibly burnt plastic was 3-fold more chemically complex than visibly unburnt nurdles. This added chemical complexity included combustion-derived polycyclic aromatic hydrocarbons. A portion of the burnt material contained petroleum-derived biomarkers, indicating that it encountered some fossil-fuel products during the spill. The findings of this research highlight the added complexity caused by the fire and subsequent burning of plastic for cleanup operations, monitoring, and damage assessment and provides recommendations to further understand and combat the impacts of this and future spills.
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ABSTRACT: Blenderised tube feeding (BTF) has become an increasingly popular method of nutrition support for long-term tube-fed patients mostly children. This study surveyed perceptions and experiences on BTF shared on YouTube. From 71 videos analysed, attitudes towards BTF were mostly positive (91%) and included psychosocial benefits and improvements in gastrointestinal symptoms; no differences between caregivers and healthcare professionals were observed. Very few speakers (8%) felt there was a lack of support regarding use of BTF in schools and from healthcare professionals, because it is not part of the standard clinical management protocols. The most commonly used food items in blends included carrots (n = 16) and chicken (n = 11), and experiences from those who have used BTF included tips on recipes for blends, storing feeds and ensuring nutritional adequacy. Analysis of YouTube content on BTF was considerably positive and suggests that BTF is feasible and safe way to provide nutrition to tube-fed patients.
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Nutrición Enteral , Medios de Comunicación Sociales , Nutrición Enteral/métodos , Humanos , Estado Nutricional , Apoyo Nutricional , Encuestas y CuestionariosRESUMEN
BACKGROUND: A strong primary care system is vital to overall health. Research on the primary care of people with autism spectrum disorder (ASD) has mostly focused on children. A synthesis of the existing literature related to the quality of primary care for the adult population with ASD would elucidate what is known about the topic as well as inform future research and clinical practice. OBJECTIVE: The purpose of our scoping review is to describe what is known about the quality of primary care for adults with ASD and identify knowledge gaps. METHODS: Prior to beginning the literature search, we reviewed literature related to defining both primary care and primary care quality to establish the context and concept of the research question. The search strategy was designed and executed by a research librarian. The MEDLINE, CINAHL, EMBASE, PsycINFO, and ProQuest Dissertations and Theses databases were searched for relevant literature. Grey literature will include relevant reports from government websites and associations with a focus on ASD. Two members of the research team will independently screen the academic and grey literature. Quantitative, qualitative, or mixed methods study designs involving the quality of primary care services or patient-centered care for adults with ASD are eligible for inclusion in our scoping review. Studies that make it past the full-text review will undergo data extraction and quality appraisal by 2 independent reviewers. The data extraction results will be presented in a tabular format to clearly present what is known about the quality of primary care for adults with ASD; this table will be accompanied by a narrative synthesis. Literature selected for extraction will be coded for themes, which will form the basis of a thematic synthesis. The scoping review will follow the guidance proposed by the Joanna Briggs Institute. RESULTS: The search of electronic databases was conducted in October 2020, and it returned 2820 results. This research is still in progress. The results from our scoping review are expected to be available by fall 2021. CONCLUSIONS: The results from our scoping review will be useful for guiding future research on the quality of primary care for adults with ASD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28196.
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Sunlight exposure is a control of long-term plastic fate in the environment that converts plastic into oxygenated products spanning the polymer, dissolved, and gas phases. However, our understanding of how plastic formulation influences the amount and composition of these photoproducts remains incomplete. Here, we characterized the initial formulations and resulting dissolved photoproducts of four single-use consumer polyethylene (PE) bags from major retailers and one pure PE film. Consumer PE bags contained 15-36% inorganic additives, primarily calcium carbonate (13-34%) and titanium dioxide (TiO2; 1-2%). Sunlight exposure consistently increased production of dissolved organic carbon (DOC) relative to leaching in the dark (3- to 80-fold). All consumer PE bags produced more DOC during sunlight exposure than the pure PE (1.2- to 2.0-fold). The DOC leached after sunlight exposure increasingly reflected the 13C and 14C isotopic composition of the plastic. Ultrahigh resolution Fourier transform ion cyclotron resonance mass spectrometry revealed that sunlight exposure substantially increased the number of DOC formulas detected (1.1- to 50-fold). TiO2-containing bags photochemically degraded into the most compositionally similar DOC, with 68-94% of photoproduced formulas in common with at least one other TiO2-containing bag. Conversely, only 28% of photoproduced formulas from the pure PE were detected in photoproduced DOC from the consumer PE. Overall, these findings suggest that plastic formulation, especially TiO2, plays a determining role in the amount and composition of DOC generated by sunlight. Consequently, studies on pure, unweathered polymers may not accurately represent the fates and impacts of the plastics entering the ocean.
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Carbono , Plásticos , Océanos y Mares , Polietileno , Luz SolarRESUMEN
Rural physicians face many challenges with providing rural health care, which often leads to innovative solutions. Despite their creativity with overcoming barriers, there is a lack of support for rural health research - an area of health care where research makes great impacts on small communities. Rural research capacity building (RRCB) is essential to support rural physicians so that they can conduct relevant research, but RRCB programs are sparse. Thus, our team at Memorial University of Newfoundland, Canada, has created an RRCB ecosystem through the 6for6 and Rural360 programs, which outline a pathway for rural physicians to make meaningful contributions to their communities through research. This article describes the RRCB ecosystem and explains how the 6for6 and Rural360 programs address the need for RRCB. Designed to train six rural physicians over six sessions per year, 6for6 fosters learning of research practices through a conceptual framework that envelops complexity science, systems thinking, and anchored instruction. The use of this framework allows the learning to be grounded in issues that are locally relevant for each participant and follows guiding principles that enable many types of learning. Rural360 continues the pathway by providing an in-house funding opportunity with an iterative review process that allows participants to continue developing their research skills and, ultimately, secure funding for their project. This anchored delivery model of RRCB programming is made possible through many support systems including staff, librarians, instructors, the university, and other stakeholders. It has successfully helped form communities of practice, promotes collaboration both between learners and with third parties, encourages self-organization with flexibility for learners outside of the in-house sessions, and ultimately drives social accountability in addressing local healthcare issues.
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Creación de Capacidad , Servicios de Salud Rural , Ecosistema , Humanos , Salud Rural , Población RuralRESUMEN
INTRODUCTION: Personal protective equipment (PPE) may protect health-care workers from COVID-19 infection and limit nosocomial spread to vulnerable hip fracture patients. METHODS: We performed a cross-sectional survey amongst orthopaedic trainees to explore PPE practice in 19 hospitals caring for hip fracture patients in the North West of England. RESULTS: During the second wave of the pandemic, 14/19 (74%) hospitals experienced an outbreak of COVID-19 amongst staff or patients on the orthopaedic wards. An FFP3 respirator mask was used by doctors in only 6/19 (32%) hospitals when seeing patients with COVID-19 and a cough and in 5/19 (26%) hospitals when seeing asymptomatic patients with COVID-19. A COVID-19 outbreak was reported in 11/13 (85%) orthopaedic units where staff wore fluid resistant surgical masks compared to 3/6 (50%) units using an FFP3 respirator mask (RR 1.69, 95% CI 0.74-3.89) when caring for symptomatic patients with COVID-19. Similarly, a COVID-19 outbreak was reported in more orthopaedic units caring for asymptomatic patients with COVID-19 where staff wore fluid resistant surgical masks (12/14 (86%)) as compared to an FFP3 respirator mask (2/5 (40%)) (RR 2.14, 95% CI 0.72-6.4). CONCLUSION: Urgent re-evaluation of PPE use is required to reduce nosocomial spread of COVID-19, amongst highly vulnerable patients with hip fracture.
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COVID-19/transmisión , Infección Hospitalaria/transmisión , Fracturas de Cadera/complicaciones , Ortopedia , Estudios Transversales , Inglaterra , Humanos , Máscaras , Equipo de Protección Personal , Ventiladores MecánicosRESUMEN
OBJECTIVES: To determine the safety of urological admissions and procedures during the height of the COVID-19 pandemic using "hot" and "cold" sites. The secondary objective is to determine risk factors of contracting COVID-19 within our cohort. PATIENTS AND METHODS: A retrospective cohort study of all consecutive patients admitted from March 1 to May 31, 2020 at a high-volume tertiary urology department in London, United Kingdom. Elective surgery was carried out at a "cold" site requiring a negative COVID-19 swab 72-hours prior to admission and patients were required to self-isolate for 14-days preoperatively, while all acute admissions were admitted to the "hot" site.Complications related to COVID-19 were presented as percentages. Risk factors for developing COVID-19 infection were determined using multivariate logistic regression analysis. RESULTS: A total of 611 patients, 451 (73.8%) male and 160 (26.2%) female, with a median age of 57 (interquartile range 44-70) were admitted under the urology team; 101 (16.5%) on the "cold" site and 510 (83.5%) on the "hot" site. Procedures were performed in 495 patients of which eight (1.6%) contracted COVID-19 postoperatively with one (0.2%) postoperative mortality due to COVID-19. Overall, COVID-19 was detected in 20 (3.3%) patients with two (0.3%) deaths. Length of stay was associated with contracting COVID-19 in our cohort (OR 1.25, 95% CI 1.13-1.39). CONCLUSIONS: Continuation of urological procedures using "hot" and "cold" sites throughout the COVID-19 pandemic was safe practice, although the risk of COVID-19 remained and is underlined by a postoperative mortality.
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This Guidance addresses the essential elements of informed consent to novel, provisionally registered COVID-19 vaccines which conform to the current definition of an investigational vaccine namely, lacking requirements for approval for full registration. 1 First, it addresses the ethical obtaining of informed consent in a setting of short and long term knowns and unknowns, by structuring the personal nature of informed consent into its twelve component parts. Second, as a guidance for family physicians, it explores reasonable medical concerns arising for individuals from both knowns and unknowns about COVID-19 disease and vaccines.Where there are waves of pandemic pressure impelling political, economic, social and public health forces to promote vaccination to health care providers and their patients, the necessary constituents of valid informed consent can be sublimated and possibly forfeited. This context of informed consent for COVID-19 vaccines is not unique to Australia. The analysis and presentation of international data by Australian Government agencies is a process occurring in all countries. Therefore, the Australian experience of consenting for vaccination is relevant to informed consent across the globe.The purpose of this Guidance is to assist personalised risk-benefit assessment for the informed consent of the vaccinee. Its aim is not to give a therapeutic guide nor to draw conclusions which can only rightly be drawn pertaining to each individual recipient in discussion with a health care provider. This is especially true in the setting of incomplete research where the many unknowns may be more significant for some than others. Since data is changing over time, national tables have not been used for specifics which the vaccine provider should access at the time of consultation.While we recommend the Guidance be read in conjunction with Government issued information, this Guidance will address specific fields relevant to informed consent which may not be addressed in those communications, but which a consenting individual as a person with their own values and experiences may wish to know. Aim: To address the requirements of ethical informed consent of the individual adult in the context of reasonable concerns pertaining to the unknowns and incomplete research attending novel, provisionally registered COVID-19 vaccines. Methodology: To elucidate what might be reasonable concerns for individuals considering vaccination, Public Assessment Reports of regulatory authorities (Food and Drug Administration and Therapeutic Goods Administration) and published trials of currently available vaccines were reviewed. International Covid-19 vaccine safety discussions were observed for peer-reviewed and, if necessary, pre-print references base. These references were studied for potential relevance to vaccine recipients. Vaccine Development Guidelines were also reviewed for pre-clinical requirements and compared with pre-clinical data presented at licensing. Missing information was requested from the Therapeutic Goods Administration (TGA).Pertinent unknowns were thereby identified as issues potentially relevant to fully informed consent, and compared with the content of standard Government-issued vaccine consent advice forms. Disparities were selected as relevant unknowns or reflecting incomplete research.Pertinent issues were incorporated into a twelve point structure for reasonable consideration to guide ethical inform consent. Paediatric COVID disease and vaccination are mentioned briefly due to paediatric vaccination being unapproved in Australia at the time of writing in under 12-year-olds, and exclusion of minors from phase III safety and efficacy trials. Conclusion: The provision of ethically obtained, fully informed consent is very pertinent to an investigational vaccine notwithstanding the pandemic context. To ascertain informed consent to the best of our ability, the gap between officially delivered information and reasonable concerns generated by knowns and relevant unknowns, can be addressed in a structured manner by physicians. Consent should not be coerced but be free of inducements and reprisals, respecting declarations of human rights, particularly given the investigational nature of COVID-19 vaccines. Each recipient requires adequate information to make their own judgment. The process of validly informed consent will therefore include discussion of concerns and of relevant information we do and do not yet have. Ethical informed consent should address those concerns as best is possible.
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COVID-19 , Vacunas , Adulto , Humanos , Niño , Vacunas contra la COVID-19 , COVID-19/prevención & control , Australia , Consentimiento Informado , VacunaciónRESUMEN
With cannabis medicines now obtaining legal status in many international jurisdictions (generally on the authorisation of a medical professional), a rapid increase in consumer demand for access to cannabis as a therapeutic option in the treatment and management of a range of indications is being noted. Despite this accessibility, knowledge on optimal use is lacking. Further drug development and clinical trials at regulatory standards are necessary both if a better understanding of the efficacy of cannabis medicines, optimal product formulation and indication-specific dosing is needed and to ensure the broader quality and safety of cannabis medicines in the clinical setting.To enable this, clinical, academic and public calls for the undertaking of rigorous clinical trials to establish an evidence base for the therapeutic use of cannabis medicines have been made internationally. While this commitment to undertake human studies with cannabis medicines is welcomed, it has highlighted unique challenges, notably in the review stages of ethics and governance. This often results in lengthy delays to approval by Human Research Ethics Committees (herein 'HREC', Australia's nomenclature for Institutional Review Boards) and trial commencement. A principal concern in these cases is that in contrast to clinical trials using other more conventional pharmaceutical products, trials of cannabis medicines in humans often involve the use of an investigational product prior to some (or any) of the preclinical and pharmaceutical safety issues being established. This paucity of data around product safety, potential drug interactions, continuity of supply, shelf life and product storage results in apprehension by HRECs and governance bodies to endorse trials using cannabis medicines.This manuscript draws from the experiences of Australian researchers and staff involved in clinical trials of cannabis medicines to describe some of the common difficulties that may be faced in the HREC approval process. It also presents practical advice aimed to assist researchers, HRECs and governance officers navigate this complex terrain. While the authors' experiences are situated within the Australian setting, many of the barriers described are applicable within the international context and thus, the solutions that have been proposed are typically adaptive for use within other jurisdictions.