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NCT07359976
The present cross-over study investigated whether cannabidiol (CBD) or its metabolites and delta-9-tetrahydrocannabinol (THC) can be detected in the systemic circulation following a single topical application of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium chain triglycerides (capric, caprylic triglycerides or medium chain triglycerides (MCT)) derived from coconut oil. Since consumers can consider hemp/CBD oil as a nutritional product or dietary supplement, it can be ingested by consumers. Therefore, we analyzed the concentrations of CBD, THC, and their metabolites in systemic circulation after oral NHEC administration. Additionally, we tested whether a single topical or oral use of the NHEC would lead to detectable levels of THC in the urine samples using Easy@Home THC detection strips. This study has no intent to treat or prevent any diseases or conditions. In this study, volunteer participants were assigned to one of two study groups: Cohort A (oral administration) or Cohort B (topical administration). After completing the study in the first assigned Cohort, participants had a 15-day washout period before beginning the study in the next Cohort.
NCT07285447
Various methods confirm stone clearance during surgical exploration of bile duct, but choledochoscopy is considered the most effective. However, choledochoscopes are expensive and often unavailable in low-resource settings. The Ambu aScope, a disposable flexible video-bronchoscope used in anesthesia, has been successfully tried as a cheaper alternative for CBD (Common Bile Duct) exploration in other countries. In Nepal, where affordability is a concern, reuse of properly disinfected Ambu aScopes may be justifiable if proven safe. Existing studies are limited and small in scale; this study is the first from Nepal to evaluate the reuse of Ambu aScope for choledochoscopy. This retrospective observational study will include all patients with CBD stones who underwent CBD exploration for stone using Ambu aScope in Department of Surgery of BPKIHS, Dharan between January 2022 and December 2024. Case record files of all patients who underwent CBD exploration using aScope as a Choledochoscope over last 3 years period will be obtained from medical record section and computer database of our department. All relevant information including patient demographics, indication for a CBD exploration, operative approach and procedure performed, intraoperative achievement of acceptable view of extrahepatic biliary tree using an aScope, intraoperative stone clearance on direct visualization of biliary tree and confirmation on postoperative T-tube cholangiogram or imaging on 10-14th postoperative day and intra/post-operative complications associated with the use of the aScope will be entered in a preformed proforma. In case of some missing information in medical case report sheet or computer database of our department, patient will be called directly on the contact number provided in admission sheet and through the telephonic conversation, the concerned queries will be cleared. Data will be entered in Microsoft Excel and analyzed by SPSS version 29.0.1.0. Qualitative data were described using numbers and percentages. Quantitative data will be described using range (minimum and maximum), mean, standard deviation, and median.
NCT01668186
The Peroxisome Biogenesis Disorders (PBD) are a group of inherited disorders due to defects in peroxisome assembly causing complex developmental and metabolic sequelae. In spite of advancements in peroxisome biology, the pathophysiology remains unknown, the spectrum of phenotypes poorly characterized and the natural history not yet systematically reported. Our aims are to further define this population clinically, biochemically and genetically. The investigators will prospectively follow patients from Canada, the US and internationally, and collect data from medical evaluations, blood, urine and imaging studies that would be performed on a clinical care basis. For patients who are unable to attend our clinic, we will collect all medical records and images since birth as well as subsequent records/images for the next 5 years or until the end of the study. Clinical data from medical records will be banked in our Peroxisomal Disorder Research Databank and Biobank. The investigators will use this information to identify standards of care and improve management.
NCT04680130
The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.
NCT07069478
The aim of this study is to determine the effects of regular cannabidiol (CBD) use on the psychobiological mechanisms of the stress response. This will be achieved by comparing acute stress responses of adults who either use or do not use CBD regularly. Correlates of CBD use, including tobacco use, will be collected.
NCT04611347
Rationale: CBD is commonly being used as an over-the-counter treatment for arthritis-related pain, however no clinical trial has been performed to establish efficacy. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for thumb basal joint arthritis. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
NCT06514911
The aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus T-tube drainage in laparoscopic common bile duct exploration for management of CBD stones and provide evidence-based guidance to the selection of the most appropriate operative technique.
NCT04527003
The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) in patients with endometriosis. It is believed that CBD will improve both pain and quality of life. The study will last a total of 12 weeks and involve several onsite visits in addition to daily pain assessments.
NCT06578455
Cannabidiol (CBD), derived from the Cannabis sativa plant, is being investigated for its potential health benefit without the psychoactive properties and adverse reactions that arise from the use of delta-9-tetrahydrocannabinol (Δ9-THC). Few studies have characterized the pharmacokinetic (PK) effects and safety of oral CBD administration. Epidiolex (Epidyolex), an oil form of CBD, is the only marketed monotherapy approved by the United States Food and Drug Administration (FDA) and Health Canada. Delivery of a CBD in a powder/capsule form may provide a more efficient method for consumers. The goal of this study is to characterize the PK profile of the test product, CBD-NE (a capsule formulation) compared to Epidyolex under both fasted and fed conditions. Each participant will receive a dose of each product under both fed and fasted conditions in a crossover design.
NCT06315647
This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation.
NCT04976738
This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.
NCT04423341
The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
NCT02365922
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials. The consortium, referred to as Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner with six patient advocacy groups to manage the consortium. Participants will be evaluated at 14 clinical sites throughout North America and a genetics core will genotype all individuals for FTLD associated genes.
NCT04775030
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients
NCT04589455
Rationale: Cannabidiol (CBD) is a non-hallucinogenic plant compound of Cannabis sativa L. and has gained attention for its potential health purposes, favorable safety profile and low abuse potential. Mainly sold as food supplements, CBD-containing preparations of different composition, concentration and quality are widely available in the Netherlands via druggist stores or via Internet. However, CBD- containing preparations do not yet have a novel food status and most EU countries are currently applying a tolerance policy for CBD present in- or derived from hemp products low in THC. Likewise, there are no approved health claims for CBD, which leads to a situation that products sold by official drugstores do not contain any indication for use. Last but not least, products are not subject to any official quality control which creates a situation that consumers are unaware of the CBD content and potential contamination of the product they purchase. Getting novel food status would an important step in better regulation. Such a procedure requires a well-documented safety assessment. As part of this assessment the pharmacokinetics of CBD need to be assessed. The aim of the present study is therefore to investigate the pharmacokinetics of CBD after single oral administration of a full-spectrum hemp extract. As fatty food is reported to increase CBD oral bioavailability, we will also study the effect of a high-fat meal. Objective: To determine the pharmacokinetics of CBD following oral administration of a novel oil-based hemp extract containing 70 mg CBD and to study the effects of a high-fat meal on the oral bioavailability of CBD. Study design: Single dose randomized crossover intervention study Study population: healthy human volunteers, men and women from 18 to 60 years old with a BMI from 18 to 25 kg/m2. Intervention (if applicable): In a random order, research subjects receive a single dose of hemp extract containing 70 mg CBD in soft gel capsules, both in a fasting state and with a high-fat meal. Main study parameters/endpoints: The plasma-time curve of CBD (quantitively) and 2 of its metabolites (semi-quantitatively) after intake of the Becanex natural hemp extract. These data will be evaluated studied applying descriptive pharmacokinetic analysis (maximum peak height (Cmax), time-to-peak (Tmax), Half-life (T1/2) and area-under-the-curve (AUC)). Relative bioavailability in the fed versus fasted state will be determined by dividing individual AUC values.
NCT03744546
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-8E12 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.