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NCT ID: NCT06149182 Active, not recruiting - Clinical trials for Somatic Symptom Disorder

Does the First Interview Matter: A Comparing Life Stress Interview Versus a Standard Psychiatric Intake Interview for Patients With Functional Somatic Disorder

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned. Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT). The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms and high health care consumption. The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created. The research question for this specific study is: Can a therapeutic interview (so-called "EAET life-stress interview") focusing on emotional factors in comparison to a psychiatric interview (so-called "basic assessment") contribute to increased interest in psychological treatment and reduction of physical and psychiatric symptoms in patients with medically unexplained symptoms with relatively high health care consumption? Does the order of interview interventions matter?

NCT ID: NCT06067074 Active, not recruiting - Quality of Life Clinical Trials

Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture

HE-VOCAL
Start date: February 8, 2022
Phase: N/A
Study type: Interventional

A cost-utility analysis based on an earlier published RCT comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture.

NCT ID: NCT06066515 Active, not recruiting - Obesity Clinical Trials

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

SYNCHRONIZE™-1
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have - a body mass index (BMI) of 30 kg/m² or more, or - a BMI of 27 kg/m² or more and at least one health problem related to their weight. People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

NCT ID: NCT06045611 Active, not recruiting - Healthy Clinical Trials

The Effect of Oral Intake of Animal and Plant Proteins on the Metabolism in Healthy Women

PAN-Promet
Start date: October 13, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is to learn about the effects of different proteins (from animals or plants) on the metabolism in healthy, normal weight women between 18-45 year who are not on hormonal birth-control. The main questions the study aims to answer are: 1. How do different proteins affect biological markers of the metabolism and which protein has the strongest effect? 2. How are the different proteins digested and taken up from our body? Participants will drink four different shakes on four different study days in a random order. Three of them contain each a different protein and one does not contain protein. Right before drinking the shake and on 11 timepoints after drinking the shake blood samples will be drawn.

NCT ID: NCT06042790 Active, not recruiting - Quality of Life Clinical Trials

Patients´ Mental and Physical Health After Covid-19 Treated in ICU in Sweden

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

Covid-19 is a disease where both clinical experience and thus knowledge about the long-term effects of the disease are currently sparse. However, current follow-up results indicate a more pronounced cognitive and respiratory impairment than previously seen in a normal ICU population. As we know that the prevalence of impairments in neurocognitive and Health Related Quality of Life (HRQoL) is increased in a majority of ICU patients, it would be of benefit to gain knowledge about the impact on the recovery trajectory for patients treated for Covid-19, and to increase the understanding of which factors that affect the HRQoL and recovery and in what way these differs between patients treated in ICU for Covid-19 and other causes respectively. This can contribute to better structures for follow-up and possibility to individualisation that better address which patients are in risk for decreased HRQoL and where benefit for the patient, health care and social economic can be achieved.

NCT ID: NCT06040996 Active, not recruiting - Parenting Clinical Trials

Evaluation of Improving Parenting Skills Adult ADHD (IPSA): A New Parent Training Program for Parents With ADHD

Start date: January 16, 2019
Phase: N/A
Study type: Interventional

IPSA (Improving Parenting Skills adult ADHD) is a new parent training (PT) program developed and adapted for parents who themselves have Attention-Deficit/Hyperactivity Disorder (ADHD). This study evaluates the efficacy of the IPSA program, that is, whether participation in IPSA is associated with desired treatment outcomes (e.g., improved parental self-efficacy). In addition, it examines the program's feasibility (e.g., what parents think about the program, the extent to which parents complete the program, and program safety). The study is a so called randomized controlled trial (RCT), where participants are randomly assigned to one of two groups: Treatment (IPSA) or Control (continued routine services; offered IPSA approximately six months later). Participants are adults with ADHD (any form) that have at least one child in the ages between 3 and 11 years. Data are primarily collected using questionnaires, completed by parents before and after IPSA, as well as in connection with an IPSA booster session (follow-up).

NCT ID: NCT06016907 Active, not recruiting - Anxiety Disorders Clinical Trials

Stepped vs Stratified Care for Pediatric Anxiety Disorders

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

The purpose of this trial is to evaluate the feasibility, acceptability, and safety of two care pathways (including internet-delivered cognitive behavioral therapy [CBT] and/or in-person CBT) for children and adolescents with anxiety disorders.

NCT ID: NCT05990634 Active, not recruiting - Melanoma (Skin) Clinical Trials

LifeChamps Feasibility Study

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

The purpose of this study is to collect data from various sources (PROM / PREM, sensors, journal data) to train AI based models in the LifeChamps digital platform in a pre-pilot, as well as partly implement a pilot/feasibility study to examine the applicability of the digital technology developed in LifeChamps, as well as the usability for patients (cancer survivors) and health care professionals

NCT ID: NCT05985551 Active, not recruiting - Breast Cancer Clinical Trials

Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment

MagNeo
Start date: January 1, 2020
Phase:
Study type: Observational

The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration. For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST. The main points to investigate are: 1. If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection 2. If the nodal yield and the accuracy of the procedure are affected

NCT ID: NCT05940168 Active, not recruiting - Depression Clinical Trials

Internet-delivered ACT (I-Navigator ACT) for Parents of Children With Disabilities

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

The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. The project consists of three studies: Study 1: An open feasibility trial in which parents participate in an individual, clinician-supported internet-delivered Acceptance and Commitment Therapy treatment. Study 2: A randomized controlled trial in which participants are randomly assigned either: 1. Navigator ACT group treatment, where parents participate in an Acceptance and Commitment Therapy group together with other parents, led by two group leaders, or 2. I-Navigator ACT internet-delivered Acceptance and Commitment Therapy treatment, where the parent participates on their own, coached by a clinician via a message function. Study 3: A qualitative study in which a smaller sample of parents from the open feasibility trial participate in semi-structured interviews. The interviews take place after the parents have completed I-Navigator ACT. All three studies are conducted in a clinical health care context.