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A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety and Pharmacokinetics of CHI-936 in Healthy Participants
CHI-936 is a standardized cannabis extract in an oil preparation that contains an approximate 20:1 ratio of CBD to THC (20 mg/mL CBD and < 1 mg/mL THC). At present, regulatory approvals, physician acceptance, and the utilization of CHI-936 in Phase 2/3 clinical trials for specific indications are hampered by the absence of critical Phase 1 data regarding its safety, tolerability, and pharmacokinetic (PK) profile. Therefore, the aim of this randomized, double-blinded, placebo-controlled, multiple-dose study is to evaluate the safety, tolerability, and PK of CHI-936 in healthy participants.
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Assessment of Inflammatory mediator release, microvascular resistance, and plaque morphology after percutaneous coronary intervention in patients treated with colchicine.
This study first aims to evaluate whether there are differences between patients requiring stenting who have stable blockages in their coronary arteries versus those who present with unstable heart attacks. We hope to examine whether are difference in blood clotting (platelets in particular), release of inflammation markers (neutrophil-derived in particular), resistance to blood flow in the tiny capillaries of the heart muscle (microvascular resistance), and finally in morphology and composition of the culprit blockage or plaque as assessed by a technique named optical coherence tomography (OCT). In the unstable heart attack group in particular, we will also assess whether patients treated pre-procedurally with colchicine will demonstrate changes in these parameters compared to untreated controls. The purpose of the study is to identify whether colchicine could serve as a potential therapeutic option in these high-risk patients and improve outcomes by limiting adverse events such as further heart attack at the time of stenting (peri-procedural myocardial infarction). We hypothesise that levels of inflammation will be higher in unstable heart attack patients compared to patients with stable blockages, and that colchicine will attenuate the release of inflammatory products. We also hypothesise that in the unstable heart attack patients, there will be greater dysfunction in the microvessels of the heart and that this will correlate with inflammatory release and blood platelet adhesiveness, as well as with high-risk features of the culprit blockage/plaque as assessed by OCT.
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Intervention to ascertain the most effective disinfection agent, and time to clean intravenous access port in adult patients
The time required to successfully disinfect needleless connectors varies between 5 and 60 seconds. The primary aim of this research was to establish the most effective disinfection agent (70% isopropyl alcohol or 2% chlorhexidine in 70% isopropyl alcohol) with decontamination (scrubbing) times of 5, 10 and 15 seconds (6 groups). The needleless connector was swabbed prior to decontamination, then following randomised decontamination. It is anticipated that the shorter the time of effective decontamination of the needleless connector the more likely healthcare workers will comply with the decontamination procedure
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Screw versus no screw fixation on cup stability in Total Hip Replacement
Primary fixation of the acetabular cup in total hip arthroplasty is vital for long-term stability. In cementless press-fit cups, this initial stability is achieved by the press-fit fixation. Additional primary fixation may be obtained by the use of extra screws. However, the value of additional screw fixation of press-fit acetabular cup implants on implant survival is questioned. We investigate if screw fixation is necessary when a GB DMD uncemented cup purposefully designed to enhance osseointegration is implanted. The specific objectives of this project are to i) evaluate the migration profile of the GB DMD uncemented acetabular Cup at 3 months, 1 and 2 years ii) compare quality of stability (using radiostereometric analysis) and clinical outcomes with screw verses no screw fixation at 2 years
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A randomised, open-label, two-way crossover study comparing the pharmacokinetics of a solid dosage form and a solution of PN-943 in healthy volunteers
Protagonist Therapeutics, Inc. is developing PN-943 as a potential oral therapy for patients with ulcerative colitis (UC). This study will be conducted in 10 normal healthy volunteers who meet all of the inclusion criteria and none of the exclusion criteria. The study is to assess the multiple dose pharmacokinetics (PK) and pharmacodynamics (PD) of an oral immediate release (IR) tablet of PN-943 compared with an oral solution in healthy volunteers.
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A Phase I clinical trial to evaluate the safety and pharmacokinetics of SHR0302 base ointment at single dose and multiple dose in healthy adult subjects
Atopic Dermatitis (AD) is a common chronic inflammatory skin disease characterized by recurrence, pleomorphic skin lesions, dry skin, and severe pruritus. In most countries worldwide, the prevalence of atopic dermatitis is 10%–20% in children and 2–8% in adults. At present, there is no curable treatment for atopic dermatitis. The goal of treatment is to relieve or eliminate clinical symptoms, recover skin lesions to the greatest extent, eliminate predisposing and/or aggravating factors, reduce and prevent relapses, and improve the quality of patients’ life. Therefore, identification of new effective and safe therapies is an important area of research.
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Evaluating the health beneficial properties of coloured rice consumption in healthy populations
The aim of this study is to evaluate the antioxidant and anti-inflammatory properties in healthy populations post-coloured rice consumption. Participants will have blood samples taken before & at set time points after rice consumption. The blood samples will be analysed for antioxidant and inflammation-related biomarkers. A one week washout period will be implemented for each participant for each variety tested. The intent of this study is to identify if coloured rice consumption has the ability to alleviate risk factors associated with the development of lifestyle diseases such as cardiovascular disease.
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INTIMET: INsulin Resistance in Type 1 Diabetes Managed with METformin
This is a detailed study of liver and muscle insulin resistance in adults with type 1 diabetes. The investigators will study the efficacy of adjunctive metformin in reversing insulin resistance and improve glucometabolic status, endothelial health and other parameters. Predictors of response to metformin will be assessed.
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Addressing eating disorder symptoms through a smartphone app
Novel methods of intervention delivery that factor in scalability, cost-effectiveness, and engagement of hard-to-reach populations are urgently needed to address concerns that fewer than 25% of people with eating disorder symptoms seek or receive treatment. Preliminary evidence indicates that interventions delivered via smartphone apps can effectively address eating disorder symptoms. However, randomized controlled trials of stand alone app-based smartphone interventions have yet to be conducted. The present RCT examines the efficacy of an app-based cognitive-behavioural intervention delivered via a smartphone on eating disorder symptoms. The hypothesis is: Participants allocated to the smartphone intervention will experience significantly greater reductions in eating disorder symptoms, quality of life impairment, and psychological distress at post-test (6 weeks from baseline) relative to participants allocated to the wait-list control.
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Efficacy of a brief internet-based intervention designed to target harmful dieting behaviors
Dietary restraint is one of the most potent risk factors for binge eating. Therefore, this study will examine whether dietary restraint can be addressed through a brief internet-based intervention. It is hypothesized that participants allocated to the online intervention will experience significantly greater reductions in binge eating behaviour and dietary restraint scores at post-test than participants allocated to the control group.