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Introduction: Cannabis products have been used in the management of headaches in adults and may play a role in pediatric chronic pain. Canadian pediatricians report increasing use of cannabis for the management of chronic headaches, despite no well-controlled studies to inform its dosing, safety, and effectiveness. The aim of our clinical trial is to determine the dosing and safety of a Cannabidiol (CBD)-enriched Cannabis Herbal Extract (CHE) for the treatment of chronic headaches in adolescents., Methods and Analysis: Youth, parents, and an expert steering committee co-designed this tolerability study. Twenty adolescents (aged 14 to 17 years), with a chronic migraine diagnosis for more than 6 months that has not responded to other therapies will be enrolled into an open label, dose escalation study across three Canadian sites. Study participants will receive escalating doses of a CBD-enriched CHE (MPL-001 with a THC:CBD of 1:25), starting at 0.2-0.4 mg/kg of CBD per day and escalating monthly up to 0.8-1.0 mg/kg of CBD per day. The primary objective of this study is to determine the safety and tolerability of CBD-enriched CHE in adolescents with chronic migraine. Secondary objectives of this study will inform the development of subsequent randomized controlled trials and include investigating the relationship between the dose escalation and change in the frequency of headache, impact and intensity of pain, changes in sleep, mood, function, and quality of life. Exploratory outcomes include investigating steady-state trough plasma levels of bioactive cannabinoids and investigating how pharmacogenetic profiles affect cannabinoid metabolism among adolescents receiving CBD-enriched CHE., Discussion: This protocol was co-designed with youth and describes a tolerability clinical trial of CBD-enriched CHE in adolescents with chronic headaches that have not responded to conventional therapies. This study is the first clinical trial on cannabis products in adolescents with chronic headaches and will inform the development of future comparative effectiveness clinical trials., Trial Registration: CAN-CHA trial is registered with ClinicalTrials.gov with a number of register NCT05337033., Competing Interests: Lauren E Kelly is the Scientific Director for The Canadian Collaborative for Childhood Cannabinoid Therapeutics (C4T) academic research team. She holds funding from the Canadian Institutes of Health Research, Canadian Cancer Society, Research Manitoba, the Sick Kids Foundation, the Children’s Hospital Research Institute of Manitoba, the University of Manitoba and a Mitacs Accelerate award in partnership with Canopy Growth. Dr. Kelly was a member of the Scientific Advisory Board for Health Products Containing Cannabis at Health Canada and is president elect for the Board of Directors of the Canadian Consortium for the Investigation of Cannabinoids (CCIC). Richard J. Huntsmanis a clinical lead for both the Cannabinoid Research Initiative of Saskatchewan and C4T. He was the co-chair of the Scientific Advisory Committee for Health Products Containing Cannabis at Health Canada. Katelynn E Boerner’s time is supported by a fellowship from the Canadian Child Health Clinician Scientist Program, and she currently holds unrelated funding from the Society of Pediatric Psychology, BC Children’s Hospital Research Institute, Canadian Institutes of Health Research, ZonMw: The Netherlands Organization for Health Research and Development, and the CHILD-BRIGHT Network. Evan C. Lewis has received speaking honoraria from Spectrum Therapeutics, Biome Grow, MedReleaf and Miravo Healthcare. He holds a non-salaried position as the Chief Medical Advisor for the JMCC Group. He was the Vice President of Neurology Services for Numinus, a psychedelic medicine treatment and research company. He is a member of the Expert Committee of the Medical Cannabis Clinicians Society (MCCS) in the United Kingdom and sits on the Advisory Councils for Cannabis Patient Advocacy & Support Services (CPASS) and MedCan. In the last 12 months, Samantha Lee Irwin has received honoraria for authoring a chapter for the Canadian Pharmacy Association (CPhA) and for doing an online lecture for NeuroDiem. She also receives compensation for scientific consulting (Impel NeuroPharma Inc, Biohaven Pharmaceuticals and Lundbeck A/S) and has had research support from the Duke Clinical Research Institute. Manik Chhabra has been granted the 2022 Research Manitoba-George & Fay Yee Centre for Healthcare Innovation in Health Research PhD Studentship Award. There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Chhabra et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Youth have a right to participate in research that will inform the care that they receive. Engagement with children and young people has been shown to improve rates of enrollment and retention in clinical trials as well as reduce research waste. The aim of the study is to gain practical insight on the design of trials specifically on (1) recruitment and retention preferences, (2) potential barriers to research, and (3) study design optimization. Based on this youth engagement, we will co-design two clinical trials in headaches with youth. Two recruitment strategies were used to recruit 16 youth from across Canada (aged 15-18 years) from an existing youth group, the KidsCan Young Persons' Research Advisory Group (YPRAG) and a new youth group in collaboration with Solutions for Kids in Pain (SKIP). Four virtual, semi-structured discussion groups were held between April and December 2020, which included pre-circulated materials and utilized two distinct upcoming planned trials as examples for specific methods feedback. Individual engagement evaluations were completed following the final group session using the Public and Patient Engagement Evaluation Tool. Descriptive results were shared with participants prior to publication to ensure appropriate interpretation. The discussion was centred around three themes: recruitment and retention preferences, potential barriers to participation, and study design optimization. Youth indicated that they would prefer to be contacted for a potential study directly by their physician (not over social media), that they would like to develop rapport with study staff, and that one of the barriers to participation is the time commitment. The youth also provided feedback on the design of the clinical trial including outcome measurement tools, data collection, and engagement methods. Feedback on the virtual format of the engagement events indicated that participants appreciated the ease of the online discussion and that the open-ended discussion allowed for easy exchange of ideas. They felt that despite a gender imbalance (towards females) it was an overall inclusive environment. All participants reported believing that their engagement will make a difference to the work of the research team in designing the clinical trials. Perspectives from a diverse group of youth meaningfully improved the design and conduct of two clinical trials for headaches in children. This study provides a framework for future researchers to engage youth in the co-design of clinical trials using online engagement sessions., (© 2023 The Authors. Paediatric and Neonatal Pain published by John Wiley & Sons Ltd.)

Togo's phosphate processing plant at Kpeme discharges waste, containing Cd, Pb, and fluoride, into the sea and on the soil. Heavy metals toxicity on kidneys and the liver has been studied. However, fluoride toxicity on these organs remains to be investigated. The present study deals with the variation in renal and hepatic functioning parameters due to fluoride, Cd and Pb. Totally, 350 volunteers were recruited from five different localities around this phosphate processing plant for sample collection. Cd and Pb contents in blood samples were determined by spectrophotometry and fluoride by the titanium chloride method. Biochemical parameters were measured using Biolab kits. The pollutant contents were elevated in polluted areas where ASAT, ALAT, creatinine, and urea increased, and total protein decreased. Correlation and multivariate tests showed that fluoride is related to the various pathologies mentioned. PCA revealed that phosphate processing in Togo is a source of renal and hepatic toxicity., (Copyright © 2021 Elsevier GmbH. All rights reserved.)

The biomedical analysis laboratory is a structure intended to carry out biological, immuno-serological, biochemical, hematological or other examinations of substances of human origin to provide information useful for the diagnosis, management, prevention or treatment of diseases. These laboratories produce solid and liquid biomedical waste (BMW) that constitutes a serious health problem for humans and their environment. Temain goal of this study is to assess the management of solid BMW produced by biomedical laboratories in Togo. It is a descriptive, exploratory and transverse study that took place from March 5 to July 5, 2018. Through a systematic random sampling 82 public and private biomedical analysis, laboratories were selected and submitted to a questionnaire. Direct observation and an interview were made with the managers of these laboratories to assess the state of BMW management. The assessment of BMW management of the prospected centers showed that among the 67.1% of public centers and 32.9% of private centers present in the study sample, only 26.3% present all laboratory units and together in 87.8% of cases. Males predominate in these facilities (85.3%) with an average age of 37.07 ± 7.34 years and work experience of 10.24 ± 5.81 years. While in 67.0% of the cases, the location of waste storage is available, only 18.3% of these locations meet international requirements. Incinerators were available in 72.0%. Plastic pedal/balance garbage cans were the most commonly used tools for collection in 32.9% of the facilities. Black bags are used 82.9% for collection. Waste generation is significant with 13.4% of the laboratories producing more than 8 kg/d. Gloves were available and taps in sufficient number in the laboratories. The most common health problems reported were respiratory disorders (32.9%) followed by gastrointestinal disorders (17.1%). BMW is in most cases (18.3%) disposed of in public dumps, while 72% of producers have received training on BMW management. The problem of BMW management remains a concern in health facilities in Togo. Safe disposal of BMW is therefore necessary., Competing Interests: The authors declare no conflict of interest., (© 2021 The Author(s).)

Ethnopharmacological Relevance: Combretum micranthum G. Don (CM) is extensively used in traditional medicine throughout West Africa and commonly known as "long-life herbal tea" or "plant to heal". Further, traditional healers frequently use the title plant to mitigate of renal disorders., Aim of the Study: To explore the nephroprotective property of standardised hydroalcoholic extract of Combretum micranthum in nicotinamide-streptozotocin induced diabetic nephropathy in rats. In addition, in-silico computational experiments were performed with bioactive compounds of the title plant against PPARα and PPARγ., Material and Methods: Male rats were made diabetic by a single intraperitoneal (ip) injection of STZ (50 mg/kg), 15 min after ip administration of NA (100 mg/kg) dissolved in normal saline. The diabetic rats received CM extract (200 and 400 mg/kg p.o.) daily, for eight weeks. Body weights and blood glucose (non-fasting and fasting) of rats were measured weekly. Daily food and water consumption were also measured. After 8 weeks of treatment, urine biochemical parameters such as N-Acetyl-β-D-Glucosaminidase (NAG), urea (UR), uric acid (UA), creatinine (CRE), and serum markers of diabetes, kidney damage and liver damage such as insulin, lipid parameters), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyl transferase (γGT), albumin (Alb), magnesium (Mg 2+ ), calcium (Ca 2+ ), phosphorus (P), were estimated. Blood glycosylated hemoglobin (HbA1 C ) were also estimated. kidney and liver were used for biochemical estimation of oxidative stress markers such as lipid peroxidation, superoxide dismutase (SOD) activity and glutathione peroxidase (GPx) activity. The kidney and pancreas were used for histopathological study. Further, HPLC chemoprofiling of CM extract and in-silico molecular simulation experiments were performed., Results: At the end of eight weeks, renal damage induced by the consequence of prolong diabetic condition was confirmed by altered levels of serum and urine kidney and liver function markers, oxidative stress markers and histopathological variations in kidney. Treatment with CM extract ameliorated the diabetes mellitus-induced renal biochemical parameters and histopathological changes. Further, HPLC-UV & MS experiments revealed that CM extract contains several bioactive compounds including hyperozide (62.35 μg/mg of extract) and quercitrin (19.07 μg/mg of extract). In-silico experiment exhibited cianidanol (-17.133), epicatechin (-15.107) exhibited higher docking score against PPARα and luteoforol (-11.038), epigallocatechin (-10.736) against PPARγ. Based on docking and drug likeness score, four bioactive compounds were selected for molecular dynamic experiments. Cianidanol and epigallocatechin out of the 30 compounds are concluded as a potential candidate for the treatment of DN through activating PPARα and PPARγ target protein., Conclusions: Taken together, the present study provided the scientific footage for the traditional use of Combretum micranthum., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Combretum micranthum (CM) (Combretaceae) is widely used in traditional medicine throughout West Africa for the treatment of diabetes, hypertension, inflammation, malaria and liver ailments. In our recent research we demonstrated that CM has nephroprotective potentials in diabetes mellitus, hypertension and renal disorders. However, to the best of our knowledge, no systematic study concerning its toxicity profile has been reported., Aim of the Study: The study carried out to evaluates the potential toxicity of the hydroalcoholic extract from leaves of the CM, through the method of acute and sub-chronic oral administration in rats., Materials and Methods: During the acute toxicity study, male and female rats were orally administrated with CM extract at single doses of 5000 mg/kg (n = 5/group/sex). Abnormal behaviour, toxic symptoms, weight, and death were observed for 14 consecutive days to assess the acute toxicity. For sub-chronic toxicity study, the extract was administered orally at doses of 500 and 1000 mg/kg (n = 5/group/sex) daily to Wistar rats for 28 days. The general behaviour and body weight of the rats was observed daily. A biochemical, haematological, macroscopical and histopathological examinations of several organs were conducted at the end of the treatment period. The CM extract was subjected to Fourier transform infrared spectrophotometric examination in order to detect the presence or absence of cyanide toxic compounds., Results: The absence of absorbance peaks between the 2220-2260 cm -1 region of FT-IR spectrum of CM, indicating the absence of cyanide groups. This suggested that the CM extract may not contain toxic substances. During the acute toxicity test, no mortality or adverse effects were noted at the dose of 5000 mg/kg. In the subchronic study, the CM extract induced no mortality or treatment-related adverse effects with regard to body weight, general behaviour, relative organ weights, hematological, and biochemical parameters. Histopathological examination of vital organs showed normal architecture suggesting no morphological alterations., Conclusion: The present study revealed that oral administration of CM extract for 28 days, at dosage up to 1000 mg/kg did not induce toxicological damage in rats. From acute toxicity study, the median lethal dose (LD 50 ) of the extract was estimated to be more than 5000 mg/kg., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2020 The Authors.)

In Togo, the phosphate ore mill discharges waste containing xenobiotics like cadmium, lead and fluoride. If the role of heavy metals in the appearance of pathologies is known, the role of fluoride remains to be studied alongside xenobiotics. This study tested the hypothesis that the toxicity of fluoride contributes, along with heavy metals, to physiological dysfunction. In this process, we have studied the variation in the parameters of cardiovascular functioning, depending on the level of human contamination by fluoride and xenobiotics. The concentration of Cd and Pb in blood samples were determined by AAS and fluoride by titanium-chloride method. Lipid peroxidation, the total antioxidant potential of collected blood samples and the parameters of cardiovascular dysfunction were also measured. Cd, Pb and F contents and lipid peroxidation were found to be significantly elevated in polluted areas than control zone as well as total cholesterol, LDL and triglyceride. HDL and antioxidant potential of blood decreased in the polluted areas. Correlation tests showed that fluoride levels are related to variations in the bio-indicators of high blood pressure and oxidative stress (R varied from 0.354 to 0.907). Togo phosphate treatment leads to human contamination with fluoride, along with Cd and Pb, increasing the risk of cardiovascular dysfunction and oxidative stress., (Copyright © 2019 Elsevier GmbH. All rights reserved.)