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NCT ID: NCT05040971 Recruiting - Obesity Clinical Trials

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

STEP 10
Start date: September 6, 2021
Phase: Phase 3
Study type: Interventional

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT05038280 Recruiting - Burnout Clinical Trials

Let´s Talk About Children Intervention in School Context

Start date: September 2021
Phase: N/A
Study type: Interventional

The aim of this study is to examine the fidelity, the perceived benefits, and the effectiveness of the Let's Talk about Children (LTC) -intervention in a school context. The Let's Talk about Children method is a standardised, family-focused intervention aimed to build a shared understanding between parents, children, and teachers to find ways of working together to support the child's everyday life, well-being, learning, and development, both at home and at school. The Let's Talk about Children intervention is used in several different schools in Finland. The study examines the effects of the Let's Talk about Children method on the teacher-student relationship, the trust between teachers and parents and the students', teachers' and parents' well-being. Participants (N=1316 school-children, N=188 school-teachers and N=1316 parents) are recruited and divided into intervention and control groups. The intervention group consists of teachers who use the Let's Talk about Children method in their work and those students and parents who participate in the Let's Talk about Children discussions. The control group includes teachers who do not use the method in their work and students and parents who do not participate in the discussions. The fidelity and perceived benefits of the method are examined in the intervention group. Otherwise, there is two data collection points. The data is collected in intervention and control groups before the intervention and 6 months after the intervention.

NCT ID: NCT05035095 Recruiting - Obesity Clinical Trials

Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)

OASIS 1
Start date: September 13, 2021
Phase: Phase 3
Study type: Interventional

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: - healthy food choices - how to be more physically active - what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

NCT ID: NCT05034367 Recruiting - Cough Clinical Trials

Reference Ranges for the Cough Responsiveness to Inhaled Mannitol

Start date: September 2021
Phase: N/A
Study type: Interventional

Cough is the most common reason why people seek medical attention in developed countries. The main mechanisms for prolonged cough are hypersensitivity of the cough reflex arc, sputum production, and constriction of the airway smooth muscles. Recognition of the mechanism in each cough patient is essential for the efficient management of prolonged cough. At present, there are no feasible tests for everyday clinical work to recognize cough reflex arc hypersensitivity. Mannitol test was originally developed for asthma diagnostics. We have recently shown that it can also be used to investigate hypersensitive cough reflex arc. The purpose of the present study is to create reference ranges for normal cough responsiveness to inhaled mannitol. Without them, the test cannot be utilized in everyday clinical work. For that purpose we will perform mannitol test in 140 subjects, who are at least 18 years old and without any chronic respiratory symptoms or disorders. The subjects will be recruited in three centers: University of Eastern Finland and two Australian hospitals: John Hunter Hospital and Royal Prince Alfred Hospital.The material will be collected 1.9.2021-31.12.2022. We apply funding for both personnel and material expences, to carry out this study.

NCT ID: NCT05030584 Recruiting - Clinical trials for Vasomotor Symptoms Associated With Menopause

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause

OASIS-3
Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat women who have hot flashes after they have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants will take the study treatments for 52 weeks. During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks. During the study, the participants will: - record information about their hot flashes in an electronic diary - answer questions about their symptoms The doctors will: - check the participants' health - take blood samples - ask the participants questions about what medicines they are taking and if they are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05025319 Active, not recruiting - X-Rays Clinical Trials

Optimization of Bedside Chest X-rays Taken in the Intensive Care Unit by Using Current Software-based Techniques

Start date: August 1, 2020
Phase:
Study type: Observational

This study investigates how to utilize an algorithm-based virtual grid in lung imaging in intensive care unit patients. The aim is to compare the radiation dose caused by imaging with a virtual grid and a traditional grid and relate this to the achieved image quality. The study aims to determine how the radiation dose can be lowered and still obtain the same diagnostic image quality as using a traditional scatter-limiting lattice.

NCT ID: NCT05014048 Recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men

Start date: January 4, 2018
Phase: N/A
Study type: Interventional

Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men

NCT ID: NCT05008601 Recruiting - Clinical trials for Arrhythmias, Cardiac

Aino ECG Ambulatory Study

Start date: April 1, 2021
Phase:
Study type: Observational

The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydänkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Data collection takes place outside the hospital in normal daily conditions. The monitoring is started during the outpatient visit at Heart hospital polyclinic or when leaving home from cardiac ward and it continues for 2 days. Reference information about the occurrence of arrhythmia episodes and the reference ECG data are obtained from simultaneously worn Holter device. During the two days the study device and the reference device are worn continuously. Wearing the devices does not affect the daily routines of the participant except there is no possibility to take a shower. The arrhythmia episodes are labelled in post-hoc signal analysis and annotations visually confirmed by a cardiologist. The participants are instructed to take ECG recordings with the wrist device every time the device gives a notification and also whenever the participant feels arrhythmia symptoms. There will be at least four intermittent ECG records taken on each day.

NCT ID: NCT05005117 Recruiting - Colorectal Cancer Clinical Trials

Laparoscopic Approach for Emergency Colon Resection

Start date: September 17, 2021
Phase: N/A
Study type: Interventional

This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.

NCT ID: NCT05002569 Not yet recruiting - Melanoma Clinical Trials

A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

RELATIVITY-098
Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.