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NCT ID: NCT05005897 Recruiting - Clinical trials for Vitamin B 12 Deficiency

Early Infant Micronutrition and Development

RART
Start date: December 8, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway. Vitamin B12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation infants on neurodevelopment. We also aim to measure the impact of B12 supplementation on several other outcomes. Study design: Individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year). Pregnant women will be informed about the study during their first antenatal visit at the clinic and that we will re-approach them on their 6-week visit to their public health nurse. Infants who are deficient will be treated with peroral or intramuscular injections with 400 µg cyano-cobalamin. Infants in the control group will not be offered any intervention their blood sample will be stored for one year and then analyzed for the same nutrients as the intervention group. Outcomes: Primary: (i) neurodevelopment in children measured at 12 months of age (ii) growth in children measured by attained weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children later in life

NCT ID: NCT05004675 Active, not recruiting - Clinical trials for Hypercholesterolemia

Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients

LIBerate-VI
Start date: June 20, 2022
Phase: Phase 3
Study type: Interventional

Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy

NCT ID: NCT05003180 Recruiting - Clinical trials for Thoracolumbar Burst Fracture

StUdy oN Burst Fractures (SunBurst)

SunBurst
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Thoracolumbar (TL) burst fractures are seen in all ages and usually associated with high-energy trauma. Treatment include both surgical and non-surgical options. In cases without neurological deficit or definite rupture of the posterior ligament complex (PLC) both surgical treatment and non-surgical treatment are considered standard of care. This study aims to compare outcome between surgical and non-surgical in patients with a single level TL burst fracture (AO A3/4) in a randomized controlled trial (RCT).

NCT ID: NCT05002569 Active, not recruiting - Melanoma Clinical Trials

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

RELATIVITY-098
Start date: October 19, 2021
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT04998955 Completed - Clinical trials for Inflammatory Rheumatism

MST in Patients With Inflammatory Rheumatic Disease

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the feasibility of 10 weeks of maximal strength training (MST) in patients with inflammatory rheumatic disease. As well as the effects of MST on maximal strength, rate of force developement and quality of life in this patient population.

NCT ID: NCT04998344 Active, not recruiting - Clinical trials for Influenza Viral Infections

An Effectiveness Trial to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh

FluEffect
Start date: April 7, 2021
Phase: Phase 4
Study type: Interventional

Annually influenza is a leading cause of severe disease and mortality particularly in young children <5 years old and pregnant women in the low and middle-income countries (LMICs) and both groups are prioritised for vaccination by the World Health Organisation (WHO). In Bangladesh, influenza is responsible for 10% of all childhood pneumonias and 9% of all death. Maternal influenza is associated with an increased risk of hospitalisation and foetal malformation. Influenza is a vaccine preventable disease, however, in most LMICs influenza vaccination is not part of the vaccination programme. This study will evaluate the effectiveness of inactivated influenza vaccine against influenza illness among pregnant women and children in Bangladesh. Influenza vaccine has not yet been studied as combined immunization strategy in a cluster randomized trial. This study is a community-based randomised trial in both pregnant women and young children to assess the impact of inactivated influenza vaccine in preventing influenza in the community as well as population level impact by both direct and indirect effect of vaccination.

NCT ID: NCT04997980 Completed - Clinical trials for Out-Of-Hospital Cardiac Arrest

AMSA and Amiodarone Study in Cardiac Arrest

MOSAIC
Start date: January 1, 2015
Phase:
Study type: Observational

Investigators' aim is to assess whether the administration of amiodarone during resuscitation could cause a reduction of the values of the amplitude spectral area (AMSA). Amiodarone is recommended for the treatment of cardiac arrest due to ventricular tachycardia/ventricular fibrillation (VT/VF) ( with a low level of recommendation cause of conflicting results. AMSA is a parameter expressing the amplitude of VF and it has been shown to predict defibrillation success and the return of spontaneous circulation (ROSC). No data are available so far about the impact of amiodarone administration on AMSA values.

NCT ID: NCT04996875 Recruiting - Clinical trials for Aggressive Systemic Mastocytosis (ASM)

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

Start date: November 9, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

NCT ID: NCT04994327 Completed - PreDiabetes Clinical Trials

Bread Replacement - Facing the Challenge to Improve Its Quality for Better Metabolic Health

Start date: May 7, 2021
Phase: N/A
Study type: Interventional

This is a multicenter study testing the effect of bread containing beta-glucan on glycemic control in participants with intermediate hyperglycemia. The main hypothesis of the study is that bread enriched with beta-glucan will have a positive effect on blood glucose control (HbA1c) in persons with intermediate hyperglycemia. Bread (intervention and control) will be produced by Nofima (Ås, Norway) using food-grade beta-glucan from oat and barley and shipped to the study centers (Bergen (N), Gothenburg (S), Paderborn, and Leipzig (D)) and there distributed for free to the participants of the study. The study will last for 16 weeks with measurements at baseline, after 8 weeks and after 16 weeks. Blood and urine samples will be taken, anthropometry and body composition measured, and questionnaires on health status and socio-economic status, physical activity, nicotine use, alcohol habits, chronotype, quality of life, and consumer acceptance of the study bread will be filled in.

NCT ID: NCT04993131 Recruiting - Bile Duct Cancer Clinical Trials

Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma

TESLA II
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.