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NCT ID: NCT05192837 Recruiting - Cancer Clinical Trials

Preoperative Smoking Cessation in Patients Undergoing Surgery

PORTICO
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption. Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups. Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.

NCT ID: NCT05197491 Recruiting - Anxiety Clinical Trials

Women's Menstruation During the Covid-19 Pandemic

Start date: April 1, 2022
Phase:
Study type: Observational

The COVID-19 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to their family. All these factors have likely resulted in significant levels of stress, anxiety, and affection of the general health

NCT ID: NCT05199324 Recruiting - Clinical trials for Gram-negative Bacteraemia

Early Oral Step-down Antibiotic Therapy for Uncomplicated Gram-negative Bacteraemia

Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

Current management of uncomplicated Gram-negative bacteraemia entails prolong intravenous (IV) antibiotic therapy with limited evidence to guide oral conversion. This trial aim to evaluate the clinical efficacy and economic impact of early step-down to oral antibiotics (within 72 hours from index blood culture collection) versus continuing standard of care IV therapy (for at least another 24 hours post-randomisation) for clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia.

NCT ID: NCT05203120 Recruiting - Clinical trials for Hepatocellular Carcinoma

A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

350 new cases of hepatocellular carcinoma (HCC) are diagnosed in Denmark each year, but the overall prognosis is poor with a 1-year survival rate of less than 40% and a 5-year survival rate of 10% for the entire patient group. This national phase II non-randomized single-arm study of proton therapy in HCC is conducted with the aim to offer a safe and efficient radiation treatment to fragile patients with reduced dose to the normal liver compared to conventional photon-based radiotherapy.

NCT ID: NCT05203640 Recruiting - Type 1 Diabetes Clinical Trials

Effects of Resistance Exercise on Blood Glucose in Post-menopausal Women With Type 1 Diabetes

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Regular physical activity has substantial health benefits in people with type 1 diabetes. The fear of hypoglycemia, both during and after exercise, is a major barrier to exercise in this population. A major obstacle to providing specific physical activity and exercise advice is that there are still significant gaps in the fundamental understanding of the impact of physical activity and exercise on blood glucose levels in type 1 diabetes. Women with type 1 diabetes have a substantial increase in cardiovascular risk once they have passed menopause. They may lose both bone quality and muscle mass at a faster rate with aging than those without diabetes. Overall, these changes greatly increase the risk of both cardiovascular and frailty related complications. Despite the many potential benefits of resistance exercise for post-menopausal women with type 1 diabetes, there are currently no published studies examining the effects of resistance exercise in this population. Before being able to design a clinical trial of resistance exercise, an examination of the acute effects of resistance exercise on blood glucose levels in post-menopausal women with type 1 diabetes is required. The present study will compare the glycemic effects of a low resistance, high repetition (3 sets of 15 to 20 repetitions) weight lifting program to the effects of a moderate resistance, moderate repetition (3 sets of 8 to 10 repetitions). The investigators hypothesize that the high repetition program will be associated with a bigger decline in blood glucose during exercise, but that the moderate resistance program will be associated with a higher risk of post-exercise hypoglycemia.

NCT ID: NCT05205382 Recruiting - Clinical trials for Electronic Cigarette Use

Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The rapid increase of electronic nicotine delivery systems (ENDS) use by young people in the US and their potential to harm health, cause addiction, and serve as a risk for cigarette smoking or dual-use is alarming. The epidemic of ENDS use among young people in the US has been associated with the rise in popularity of ENDS products that are very efficient in delivering high doses of nicotine to users. Therefore, the investigators propose to study the effects of nicotine reduction (NR) on young ENDS users as a potential regulatory strategy to reduce the addictiveness and use of ENDS. The proposed studies are directly responsive to research priories identified by the FDA and specified in this RFA under Addiction; studying the "Impact of changes in tobacco product characteristics (e.g. nicotine formulation) on dependence". This project aims to provide an overview of this project's rationale significance divided into 1) scientific rationale and regulatory implications; 2) the need to respond to the rising trend of ENDS use among young people in the US; 3) the importance of reducing the addictiveness of ENDS; 4) the strength of our clinical and analytical lab approach for regulatory purposes; and 5) the strengths and weaknesses in the rigor of prior research about NR for ENDS.

NCT ID: NCT05206877 Recruiting - Glaucoma Clinical Trials

Topical Insulin for Glaucoma

TING1
Start date: April 1, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this Phase 1 trial is to determine the safety over 1-2 months of topic sterile human recombinant insulin on subjects with optic neuropathies (glaucoma, ischecmic optic neuropathy, and optic disc drusen).

NCT ID: NCT05207033 Recruiting - Tobacco Use Clinical Trials

Responses to Regulated E-Cigarette Advertisements

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest.

NCT ID: NCT05210790 Recruiting - Polycythemia Vera Clinical Trials

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

VERIFY
Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

NCT ID: NCT05216042 Recruiting - Obesity Clinical Trials

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health. Obese and Black individuals have ~30% lower levels of NP and are at a greater risk of developing cardiovascular (CV) events as compared to lean and White counterparts. Some people have common genetic variations that cause them to have ~20% lower NP levels. Similar to other low NP populations, these individuals with low NP genotype (i.e., carrying a common genetic variation called rs5068) are at a greater risk of developing cardiometabolic diseases. By understanding the NP response following the exercise challenge and the glucose challenge in individuals with genetically lower NP levels will help us understand how to improve cardiometabolic health in them.