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NCT ID: NCT06151782 Recruiting - Celiac Disease Clinical Trials

Immunosafe-CeD: Are Partially Hydrolysed Gluten Hamrful to Celiac Disease Patients?

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The study will compare the immune response in CeD patients to wheat and barley gluten at high doses (1 gram), and also investigate the reponses to low dose barley gluten and also hydrolyzed, malted barley. This will be done by four one-day challenges with intervals around four weeks.

NCT ID: NCT06150261 Not yet recruiting - Healthy Aging Clinical Trials

Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing

Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this randomised, double-blind placebo controlled trial is to explore tolerability and the effects of a new omega-3 fatty acid-based supplement on biological and clinical aspects relevant for healthy ageing. Participants will be asked to take a supplement or a placebo for 6 months, and to attend the clinic a total of 3 times and to perform or submit the following: - Physical examination - Muscle function tests - Cognitive testing - Questionnaire completion - Biological samples, including blood, saliva and faeces. Researchers will compare the results from the group taking the supplement to the results of the group taking a placebo to see if the supplement has an effect on biological and clinical aspects associated with healthy ageing.

NCT ID: NCT06144905 Recruiting - Anorexia Nervosa Clinical Trials

Norwegian Microbiota Study in Anorexia Nervosa

Start date: September 24, 2023
Study type: Observational

Anorexia nervosa (AN) is a serious mental disorder occurring mainly in women. AN is characterized by severely restricted food-intake and subsequent low weight. The disease burden for the individual is high with medical complications and psychiatric comorbidities. Despite decades of research, there are large gaps in the understanding of the biological aspects of AN and lack of effective interventions. Current clinical treatment is associated with gastrointestinal problems, high rates of relapse and poor outcome causing long-term sickness absence and disability. During the COVID19 pandemic the prevalence and severity of AN has spiked. Therefore, there is great need of novel strategies for AN treatment, that can be easily implemented in the clinic without adding complexity to the standard care of treatment. During the resent years it has been proposed that mental disorders might be treated via manipulating the composition and function of the microbes that live in the gut (the microbiota) by adding or restricting fermentable nutrients (prebiotics) in the diet. However, in order to use prebiotics to treat the microbiota in AN patients, more knowledge is needed on how the AN microbiota is affected by the current standard care treatment. Whether prebiotics can be useful for normalizing AN microbiota remains to be established. The overall aim of the "Norwegian study of Microbiota in Anorexia Nervosa" (NORMA) is to join forces of researchers, clinical health care services and voluntary sector in a transdiciplinary approach to improve the understanding of the role of the gut microbiota in AN patients. The current project will include a clinical trial in AN patients and experimental studies to screen novel prebiotics for their ability to modify and normalize AN derived microbiota. The long-term goal of the project is to pave the way for a targeted and clinically feasible individualized treatment for better tolerable weight-restoration and improved health in AN patients.

NCT ID: NCT06144502 Enrolling by invitation - Quality of Life Clinical Trials

Promoting Wellbeing: The Five Ways at School Intervention

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to develop a teaching material built on the Five Ways to Wellbeing and investigate its effects on wellbeing and mental health among school pupils aged 10 to 16 in Moss municipality, Norway. The main questions it aims to answer are: 1. How do participating pupils, teachers, and other school personnel experience the teaching material - is it acceptable and experienced as useful? 2. What are the immediate and long-term effects of the teaching material on the pupils' wellbeing and mental health? 3. For whom is the teaching material effective, and what mechanisms may explain potential improvements in wellbeing after exposure to the teaching material? Pupils will be given a teaching program at school, delivered by their teacher. Participating pupils and their teachers will be invited to complete questionnaires. Some teachers, school leaders, school health nurses, and parents will be invited to share their experiences with the teaching material in focus group discussions.

NCT ID: NCT06139770 Active, not recruiting - Anorexia Nervosa Clinical Trials

Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family Based and Metacognitive Approach

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the treatment effects of an integrated treatment called Family-based and Metacognitive therapy for patients with Anorexia Nervosa. In addition, we will evaluate if an active follow-up of the patients will reduce the number of relapses, which is common during the 1 year after discharge. Fifty patients aged 12-18 years old and their parents will be invited to participate in this study and all will receive the same treatment but be randomly allocated to different follow-up conditions. The active follow-up includes 3 sessions of Metacognitive therapy and the passive follow-up includes ordinary follow-up, with no booster sessions. The patients will be assessed at baseline, pre-treatment, post-treatment, and at 6 and 12 months follow-up.

NCT ID: NCT06125808 Recruiting - Psoriasis Clinical Trials

Efficacy and Safety Study of HRO350 in Patients With Mild-to-moderate Psoriasis (the 'HeROPA' Study).

Start date: May 25, 2023
Phase: Phase 2
Study type: Interventional

HRO350 contains an oil-based extract from herring roe (Clupea harengus) in soft capsules and contains phospholipids (complex lipids) which are naturally rich in marine polyunsaturated fatty acids. All the lipids in HRO350 are natural components of the human diet. It is not fully known how HRO350 exerts its effects, however there are indications that it might have a modulatory effect on the inflammatory processes involved in causing psoriasis. The study is a randomised, double-blind, placebo controlled, dose finding, multi-centre, phase 2B study. Approximately 519 patients will be participating in the UK, Norway, Germany, Finland and Poland. Patients will receive either 1050mg or 2100mg HRO0350 daily, or placebo for up to 52 weeks and will be followed up for a further 8 weeks.

NCT ID: NCT06120595 Recruiting - Clinical trials for Cancer Related Fatigue

REBECCA-2 Study: Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data

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

The overall objective of the REBECCA studies at Stavanger University Hospital (SUH) is to improve the QoL of patients affected by cancer-related fatigue during and after end of treatment, by collecting multi-source real world data (RWD) and intervening based on the collected RWD. In the intervention study, REBECCA-2, the investigators will use the collected real world data to provide a personalised follow-up to the breast cancer patients in order to improve their quality of life. The patients in this study are randomised into 2 groups after end of primary treatment: - The control group (n=55): Patients will receive standard follow-up according to national guidelines plus 3 generic lifestyle consultation sessions via telephone. - The experimental REBECCA group (n=55): Patients will, in addition to receiving standard follow-up also receive REBECCA-assisted follow-up. Data will be collected from a REBECCA smartwatch, plug-in and PROMs. If the REBECCA system detects signs of deterioration in patients' QoL during the study period, the intervention will include changes in medication given, dietary advice, referral to a psychologist/psychiatrist and/or personal training with a physiotherapist at 'Pusterommet' (SUH) After 12 months of RWD collection participants will be offered the option to continue in the study for another 6 months. For patients in the experimental Rebecca group this includes the use of the REBECCA system for another 6 months. In the clinical REBECCA-2 study, patients' visits are planned every 6 months and include collection of both PROMs and biological samples.

NCT ID: NCT06119581 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C

Start date: January 3, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

NCT ID: NCT06117098 Recruiting - Prediabetic State Clinical Trials

Mobile App for Risk Reduction of Type 2 Diabetes

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

The aim of this feasibility study is to investigate whether a full scale RCT on the efficacy of a mobile app for risk reduction on type 2 diabetes can be conducted in the way it is planned or whether it needs to be modified. This will be investigated through a feasibility study (small scale RCT) on the efficacy of mobile technology on risk reduction of type 2 diabetes.

NCT ID: NCT06115629 Not yet recruiting - Gastric Cancer Clinical Trials

Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial

Start date: November 2023
Phase: Phase 3
Study type: Interventional

Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most patients with cancer of the oesophagus and stomach are treated with surgery with or without additional chemotherapy or radiotherapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection. Despite these improvements, in around half of patients treated with surgery, the cancer will return, usually within the first three years. At present there is very little evidence as to how patients who have been treated for cancer of the oesophagus or stomach should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery. The SARONG-II study will investigate if regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive imaging surveillance (including regular radiological scans and a camera test (endoscopy)) or clinical follow-up. The study aims to recruit at least 952 participants in Europe over a 32-month period. Patients undergoing surgery for oesophageal or stomach cancer will be invited to participate in the study at around 4 to 8 weeks after their surgery. (i) The imaging surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months after randomisation. They will also receive endoscopy at 12 months after randomisation (ii) The clinical surveillance group will receive a review in clinic or by telephone at 6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year according to local practice The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with oesophagus or stomach cancer. The investigators anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for oesophagus and stomach cancer.