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Harm Reduction clinical trials

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NCT ID: NCT04025671 Completed - Opioid-use Disorder Clinical Trials

A Usability Assessment of Naloxone Administration by Untrained Community Members

Start date: August 23, 2017
Phase: N/A
Study type: Interventional

This will be a randomized, open-label, usability assessment of intramuscular, intranasal, and nasal spray administration of naloxone using two different instruction sets by laypersons. - Design: Single site, open-label, randomized usability assessment of intramuscular, intranasal, and nasal spray administration of simulated naloxone. A convenience sample of participants will consent to volunteer in the study at a public venue. Participants will provide verbal consent and will be randomly assigned a simulated naloxone kit containing either intramuscular, intranasal, or nasal spray administration materials with either standard or study team designed instructions for use. Participants will enter a use scenario station and be asked to assemble and administer the simulated naloxone kit to a mannequin (intranasal and nasal spray) or simulated flesh pad (intramuscular). The participant will be instructed to start and will be timed until the simulated naloxone has been successfully administered or 7 minutes has elapsed. The participant will be observed by one trained investigator who will assess for successful administration of the simulated naloxone and critical errors. The environment will contain distractors.Once the participant has successfully administered simulated naloxone or 7 minutes elapses the timer will be stopped. Successful administration of simulated naloxone will be defined as administration of the agent without any critical errors occurring (defined below). Data collected will include demographics (defined below), successful administration of simulated naloxone, time to successful administration of simulated naloxone, and Likert-item data assessing the ease of use of the device and instructions. - Participants: adults (18 years of age and older) at a public venue will be asked to volunteer. Participants with severe visual or hearing impairment (defined as: legally deaf, legally blind, unable to read print size provided on instructional handout, or unable to hear video audio), that have previous naloxone administration training, that are not English proficient, that are pregnant, or that have previously participated in the trial will be excluded. - Kits: 1. Intranasal: simulated naloxone vial, bristoject, administration instructions (standard or study team designed) 2. Intramuscular: sterile single use needle, sterile single use 3 mL syringe, simulated naloxone vial, administration instructions (standard or study team designed) 3. Nasal spray: simulated naloxone spray, administration instructions (standard or study team designed) - Objectives: 1. Primary: successful administration of simulated naloxone in the time allowed. A successful administration will be defined as administration of the simulated naloxone to the mannequin head of simulated flesh pad within 7 minutes and without any critical errors (defined below). 2. Secondary: time required to successfully administer the simulated naloxone and Likert-item assessment of ease of use of both the device and instructions. - Data and Analysis: 1. The usability trial will be conducted using a convenience sample so no power analysis will be conducted or minimum sample size defined 2. Demographics: age, gender, handedness, level of education, and presence or absence of opioid at risk contacts. 3. Data: successful administration, time to administration, and Likert-item assessment of both the device and instructions. Failure to administer the medication due to a critical use error will be recorded and the specific error reported for all participants. - Critical Errors: 1. Intranasal: failure to remove both yellow caps from bristoject, failure to remove cap from simulated naloxone, failure to attach atomizer, failure to attach simulated naloxone, drug leak prior to administration, administration in only one nostril, and failure to administer within 7 minutes. 2. Intramuscular: failure to attach the needle to the syringe, failure to remove cap from simulated naloxone, failure to draw up >90% (0.9 mL) of the simulated naloxone, failure to puncture simulated flesh pad with needle, failure to push entire volume of fluid in the syringe into the simulated flesh pad, and failure to administer within 7 minutes. 3. Intranasal: failure to place the tip of the device into one nostril, failure to depress the device and release the simulated naloxone, failure to administer within 7 minutes.

NCT ID: NCT03675503 Terminated - Accidental Falls Clinical Trials

Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids

Start date: May 2015
Phase: N/A
Study type: Interventional

This project proposes to evaluate the potential for nurses to assess if a patient who uses an ambulatory aid at home is fit to use one in the hospital, and the effect that providing ambulatory aids to hospitalized patients will have on reducing hospital falls, with a matched pair cluster-randomized controlled trial. Hypothesis 1: Of the patients who use an ambulatory aid at home, patients who receive an ambulatory aid in the hospital will have a lower fall rate as compared to patients who do not receive an ambulatory aid in the hospital. Hypothesis 2: After adequate training, nurses will be able to accurately assess whether or not patients need an ambulatory aid when compared to the gold-standard assessments of physical therapists.

NCT ID: NCT02971488 Completed - HIV Clinical Trials

The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID

Start date: January 15, 2017
Phase:
Study type: Observational [Patient Registry]

Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.

NCT ID: NCT02425657 Recruiting - Colorectal Cancer Clinical Trials

Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments

Start date: September 14, 2016
Phase:
Study type: Observational

Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al. The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .

NCT ID: NCT01838473 Completed - Smoking Cessation Clinical Trials

In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users

SMWS03
Start date: May 2004
Phase: Phase 1
Study type: Interventional

In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

NCT ID: NCT01369693 Completed - Smoking Cessation Clinical Trials

In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus

SMWS03
Start date: May 2004
Phase: Phase 1
Study type: Interventional

In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

NCT ID: NCT01249339 Completed - Smoking Cessation Clinical Trials

In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus

SMWS03
Start date: May 2004
Phase: Phase 1
Study type: Interventional

In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

NCT ID: NCT01130441 Completed - Adolescent Behavior Clinical Trials

Self-harming Behaviors Study of Adolescents in a Juvenile Detention House

Start date: January 2010
Phase: N/A
Study type: Observational

Incarcerated adolescents engage in suicide ideation, self-harming behaviors and have poor coping abilities, suggesting a need for mental health intervention and treatment. Previous research on self-harm among community adolescents revealed that self-harmers were more likely than non-self-harmers to report suicidal ideation, and having made a suicide plan. This study plans to evaluate the suicidal intent of self-harming and non-self harming adolescent admitted at juvenile detention house in Taiwan. Furthermore, this study also plans to identify the prevalence and types of self-harming activities of incarcerated youths. Another purpose is to investigate the coping abilities of incarcerated youth, with evaluation of efficacy of short problem-solving skills therapy intervention by trained psychologists of three sessions for adolescents with poor coping adjustment; referral to adolescent psychiatrist when severe mental disorder or poor coping abilities were found. By analyzing their suicidal ideation, self-harming behaviors, and coping adjustment, the investigators will be able to give timely intervention and identify effective means and methods for better serving this population. This study hopes to help the incarcerated youth to replace their self-destructive behaviors with effective coping adjustment abilities.