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NCT ID: NCT05738278 Recruiting - Clinical trials for Autism Spectrum Disorder

Heart Rate Informed Changes in Care for Non-Communicating Patients

Start date: February 27, 2023
Phase: N/A
Study type: Interventional

The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.

NCT ID: NCT05736094 Completed - Prostate Cancer Clinical Trials

Ultrasound for Detection of Prostate Cancer

SURF
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.

NCT ID: NCT05735834 Recruiting - Clinical trials for Splenic Marginal Zone Lymphoma

Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients

RITZ
Start date: May 21, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare the efficacy and tolerability of the combination of two medicinal products, rituximab, and zanubrutinib, compared to rituximab monotherapy in patients with Splenic Marginal Zone Lymphoma (SMZL), previously untreated and who need systemic treatment. The main questions it aims to answer are: - Is the combination rituximab and zanubrutinib a more effective therapy than rituximab monotherapy? - Is the combination therapy, rituximab and zanubrutinib, well tolerated? Study participants will be put into one of the two treatment groups (rituximab and zanubrutinib or rituximab alone) for a maximum of two years and will undergo regular visits until three years from treatment start.

NCT ID: NCT05734547 Recruiting - Quality of Life Clinical Trials

Stepping Together for Children After Trauma, Norway

NorStep
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to learn about how to effectively help children (aged 7-12) who have developed moderate symptoms of posttraumatic stress after exposure to trauma, and prevent development of more severe problems. The main research questions are: - Will the parent-led, therapist assisted treatment "Stepping Together for Children after Trauma" (ST-CT) be more effective, compared to usual care, in reducing symptoms of posttraumatic stress, depression and sleep disorders, and in improving daily functioning for children and their parents after trauma? - Is ST-CT implemented to the municipal first-line services cost-effective? - Will ST-CT prevent use of health care services and prescribed drugs in the long term? The children and their non-offending caregivers will be randomized to receive treatment with ST-CT or usual care, and symptoms and general functioning will be assessed at five time-points.

NCT ID: NCT05732623 Recruiting - Colorectal Cancer Clinical Trials

Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

DEMETRA
Start date: December 5, 2022
Phase:
Study type: Observational [Patient Registry]

An increase in early-onset colorectal cancers (eoCRC), defined as a CRC before 50 years, is confirmed globally. CRC pathogenesis has been associated with several risk factors (family history, germline pathogenic variants, obesity, alcohol, physical activity, red meat, and a Western diet). Design: an international, multicenter, retrospective case-control study of prospectively enrolled patients; low-risk intervention study as it will perform a fecal occult blood test Endpoint: predictive power of a semi-quantitative food frequency questionnaire (SQFFQ) developed for eoCRC. Cases: Patients with a recent diagnosis of eoCRC (within 2 years from enrollment). Controls: matched by age (matching range ± 5 years) and sex. Healthy volunteers will be mainly enrolled among workers within the participating hospital center. The enrolled healthy volunteers will perform a fecal occult blood test. Variables of interest: age, sex, ethnicity, BMI at the time of eoCRC diagnosis and at 18 years old, country, tobacco smoking at the time of eoCRC diagnosis and at 18 years old, sitting time, TV-viewing time, moderate-to-vigorous physical activity (MVPA), waist circumference (cm), home blood pressure levels (mmHg), fasting blood glucose (mg/dl), regular consumption of aspirin/NSAID, calcium and folate supplements, oral contraceptive agents, post-menopausal hormones and years of consumptions, if the filled questionnaire reflects diet for the last 5-10 years before. Cases only: date of eoCRC diagnosis, symptoms at diagnosis, eoCRC localization, eoCRC stage, histological diagnosis, type of surgery, and date (if performed), chemotherapy and radiotherapy (if performed), vital status and duration of follow-up, family history of CRC and other cancers (uterus, ovary, stomach, small intestine, urinary tract/bladder/kidney, bile ducts, brain, pancreas, skin tumors), type of germline pathogenetic variant (if performed). Before the case-control study, three non-consecutive 24-hour Dietary Recalls (24hDRs) will validate the SQFFQ. The SQFFQ will be administered to the validation study group during three non-consecutive calls, including one non-weekday (30-minute 24-h-recall computer-aided personal interview). Primary Objective To measure the relative risk of specific dietary and lifestyle factors (smoking habit, alcohol intake, physical activity) for early-onset colorectal cancer in countries where eoCRC incidence is increasing versus stable/decreasing

NCT ID: NCT05732402 Recruiting - Lupus Nephritis Clinical Trials

An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases

RUBY-3
Start date: March 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate multiple dose levels of povetacicept (ALPN-303) in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, lupus-related kidney disease (lupus nephritis). or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period.

NCT ID: NCT05732051 Recruiting - Breast Cancer Clinical Trials

Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients

NARNIA
Start date: March 16, 2023
Phase: Phase 2
Study type: Interventional

Breast cancer is the most common form of cancer in women. Modern breast cancer treatments have led to increased survival, but at the same time, increased risk for cardiotoxicity and development of heart failure. In this study, the investigators want to evaluate whether nicotinamide riboside can prevent cancer-related cardiac dysfunction in metastatic breast cancer patients scheduled for anthracycline therapy. Further, the investigators will evaluate change in signs of skeletal muscle injury and functional capacity.

NCT ID: NCT05731453 Active, not recruiting - Breast Cancer Clinical Trials

Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

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

The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.

NCT ID: NCT05731102 Completed - Clinical trials for Substance Use Disorders

Diagnostic Survey of Mental and Substance Use Disorders Among Norwegian College and University Students

Start date: January 24, 2023
Phase:
Study type: Observational

The aims of this observational survey are to 1) collect data on the prevalence of mental and substance use disorders, and 2) investigate risk factors and consequences of mental and substance use disorder

NCT ID: NCT05730608 Recruiting - Clinical trials for Breast Cancer Female

18F-FDG PET/CT Imaging for Breast Cancer

Start date: February 16, 2023
Phase: N/A
Study type: Interventional

Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment. Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC. Objectives Primary: To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment. Secondary: - Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT. - Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome. - Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome. - Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome. - Blood and tumor samples for molecular characterisation: