Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Surgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2).

Training of junior doctors

Lasse Pedersen, m.d.

Lasse L Pedersen, m.d.

Inge Bernstein, PhD, MHM

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) .

Initially a "train the trainers" program will begin with 3 sessions held by Valori et al. at Aalborg University Hospital. 6 Trainers are expected to be trained during the "train the trainers" program. The doctors selected for the "train the trainers" program are doctors specialized in abdominal surgery with an extensive lower GI-endoscopy experience and who is considered to have an excellent teaching ability to educate junior doctor.

The training program for junior doctors consist of the following:

* Initial 1 day endoscopy simulation and theory at Nordsim. Endoscopy simulation scores will be monitored.
* 20 days of fully supervised colonoscopies (max booking of 6 colonoscopies pr day). Trainer is always present in the endoscopy room
* MCSAT (Mayo Clinical Skills Assessment Tool) will be used to grade the trainee multiple times and planned at day 0,5,10,15 and 20. Multiple graders will be used.
* Simulator test will be held at day 0, 10 and 20 colonoscopies to validate progress and compare simulator generated measures with MCSAT. Both the AccuTouch and Symbionix simulator will be used,

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

Computer generated score (Simulator test performed at day 0, 10 and 20)

Computer generated score (Simulator test performed at day 0, 10 and 20)colonoscopies)

Nordsim

Aalborg University Hospital

MD, Ph.D.-student

Substance Related Disorders

Behaviors and Mental Disorders

Symptoms and General Pathology

Tobacco Use Disorder

Carcinogenesis

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Neoplastic Processes

All Drugs and Chemicals

Nicotine

15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.

15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.

30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.

30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.

Switching to Potential Reduced Exposure Products in Adult Smokers

Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History

The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.

To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations

The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations

Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time.

To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial.

Yale University

15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.

ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

3mg Nicotine Concentration

15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.

ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

6mg Nicotine Concentration

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race Customized

Race/Ethnicity, Customized

United States

Region of Enrollment

This is binary count of yes/no responses to whether or not participants smoke their first cigarette within 30 minutes of waking in the morning.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments	NCT02425657	Harm Reduction Perforation Dur... Colorectal Canc...	Training of jun...	18 Years -	Aalborg University Hospital
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments	NCT02425657	Harm Reduction Perforation Dur... Colorectal Canc...	Training of jun...	18 Years -	Aalborg University Hospital
Switching to Potential Reduced Exposure Products in Adult Smokers	NCT04250727	Tobacco Use Dis... Oral Nicotine P... Smoking Behavio... Harm Reduction Toxic Effect of... Carcinogenesis	ZYN	21 Years - 77 Years	Yale University

Spots Global Cancer Trial Database for harm reduction