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NCT ID: NCT05445141 Recruiting - Emotion Regulation Clinical Trials

Little ACF (Lilla ABC): Evaluation of a Parental Support Program for Parents of Children Aged 1-2 Years

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

Society can promote children's mental health at an early stage by creating good conditions with, for example, general parental support programs that are offered to all parents. One program that has been developed is called All Children in Focus (ACF) [in Swedish: Alla Barn i Centrum (ABC)] which has been evaluated for parents with children aged 3-12 years. The results showed effects on parenting ability, parenting strategies and on children's well-being. Staff in child health care (CHC), a natural arena for parental support programs reaching almost all families, have requested modifications in the program ACF to involve parents with younger children. The parent groups offered within CHC today are not evaluated in younger children and could be thus replaced by researched parental support based on evidence. The investigators therefore want to study the effects of a modified version of ACF for parents of children 1-2 years (Little ACF) to see if Little ACF can strengthen parenting ability and have effects on children's social and emotional development. Parents within CHC are asked to participate and are randomly assigned to Little ACF or the regular CHC program plus a lecture. Little ACF is offered during four group meetings and potential effects are measured with questionnaires. Measurements are made before randomisation, during and after participation in Little ACF. Children's behavior is followed up at 3 years through questionnaires and CHC documentation. The study can provide important knowledge about how Little ACF can promote children's mental health and strengthen parents. The investigators see it as a strength that Little ACF is based on research and on dialogue with parents and professionals. Little ACF, which is aimed at everyone, can form a basis for identifying families and children who need preventive and treatment measures.

NCT ID: NCT05444257 Active, not recruiting - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

NCT ID: NCT05442775 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

COURAGE OLE
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)

NCT ID: NCT05442281 Recruiting - Vegan Diet Clinical Trials

Vegan Diet in Small Children

VHS
Start date: September 1, 2021
Phase:
Study type: Observational

Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports. With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets. In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed. The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.

NCT ID: NCT05441488 Recruiting - Clinical trials for Progressive Multiple Sclerosis

Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis

MAXIMS
Start date: June 28, 2022
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.

NCT ID: NCT05435937 Recruiting - Child Health Clinical Trials

Partnering for Change in Sweden - Intervention to Increase Pupils' Engagement and Participation

Start date: February 10, 2022
Phase: N/A
Study type: Interventional

This project implements an innovative and intersectional collaborative intervention model that addresses challenges that exist for children with special educational needs, who risk school failure, exclusion and poor health. The aim is to evaluate how the intervention model Partnering for Change (P4C) can be used to provide school-based services for creating an inclusive learning environment, and its effects on students 'conditions for learning, such as students' engagement and participation in school activities. The study has a non-randomized controlled intervention study design with pre-, post- and follow-up measurements.

NCT ID: NCT05433779 Terminated - Lung Diseases Clinical Trials

Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2

IMPROVE-2
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit. Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine. The infants will remain in the study as long as the Neosense measuring system is used

NCT ID: NCT05432297 Recruiting - Physical Inactivity Clinical Trials

Preventive Physical Activity Intervention in Head and Neck Cancer

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

The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment

NCT ID: NCT05428735 Recruiting - Clinical trials for Small Future Liver Remnant (FLR)

The DRAGON 2 Trial

DRAGON 2
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).

NCT ID: NCT05427253 Completed - Clinical trials for Pulmonary Hypertension

First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects

Start date: June 15, 2022
Phase: Phase 1
Study type: Interventional

This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in healthy females of non-childbearing potential and healthy males. The trial will be conducted in 2 parts: Part A, single ascending dose (SAD) including a food interaction cohort: safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving single ascending doses of C106. Part B, multiple ascending dose (MAD): safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving twice daily multiple ascending doses of C106 for 8 days.