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NCT ID: NCT05664698 Recruiting - ADHD Clinical Trials

Emotion Regulation Training for Adolescents With ADHD

Start date: January 24, 2023
Phase: N/A
Study type: Interventional

The goal of this single-case study is to pilot and evaluate a new psychological intervention (SKILLS-ER) targeting emotion regulation in adolescents with ADHD. Participants (n=9; 13-18 years of age) and their parents will partake in the intervention consisting of a total of eight sessions.

NCT ID: NCT05663047 Recruiting - Pedophilia Clinical Trials

Prevent It 2.0/GPP -iCBT to Reduce the Risk of Committing Child Sexual Abuse

Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Child sexual abuse is a large-scale global problem, and with the internet and communication technologies enabling new ways to sexually abuse children, the problem is drastically increasing. Prevent It is a free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention for individuals concerned about their sexual urges or behaviors involving children. The treatment program is based on many years of clinical experience from working with this patient group, results from several previous research projects. Using the scientifically rigorous design of a randomized controlled trial with waitlist control, we want to evaluate Prevent It 2.0 - an updated cognitive behavioral therapy treatment for individuals who are concerned about their sexual urges regarding children. The study design is an academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control. Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior. Recruitment will be carried out through multiple channels, and takes place on both "Darknet" and "Clearnet". All contact with participants, the treatment, evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi, designed specifically for clinical trials of Internet-mediated CBT. The treatment contains nine modules over thirteen weeks and the content of the therapy is classic CBT.

NCT ID: NCT05662241 Recruiting - Clinical trials for IgG4 Related Disease

A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

INDIGO
Start date: September 30, 2022
Phase: Phase 3
Study type: Interventional

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

NCT ID: NCT05660109 Recruiting - Celiac Disease Clinical Trials

A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

Start date: December 12, 2022
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the safety and the pharmacodynamic (PD) effects of TPM502 in adults with celiac disease. The main questions it aims to answer are: - if TPM502 is safe and well tolerated - if TPM502 can induce modifications in parameters indicating that it may induce tolerance to gluten Participants will: - undergo 1-day gluten challenge during screening and after administration of TPM502 or placebo. - receive 2 infusions of TPM502 or placebo, 2 weeks apart

NCT ID: NCT05657899 Recruiting - Olecranon Fracture Clinical Trials

The With Or Without Olecranon K-wires Trial

WOW-OK
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Fractures of the elbow tip (olecranon) that leave the elbow joint stable but where the fracture ends are separated (Mayo type 2a and 2b) can be treated with pins and a metal wire (tension band wiring, TBW) or metal wiring alone (cerclage fixation, CF ). Previous studies have reported high re-operation and complication rates following TBW. The current study's hypothesis, based on two retrospective studies, is that CF of these fractures yield lower re-operation rates compared with TBW. The investigators also hypothesize that the overall complication rate will be lower following CF. The aim is to investigate this hypothesis in a randomized controlled trial. Patients that are 18 years or older with Mayo type 2a and 2b olecranon fractures at Skåne University hospital will be invited to the study. Participation is voluntary. Patients who accept participation will be randomly assigned to surgery by either TBW or cerclage fixation. Two hundred participants will be followed by physiotherapists for 36 months post-surgery assessing re-operations, complications, patient reported outcome, and elbow function.

NCT ID: NCT05657730 Recruiting - Healthy Diet Clinical Trials

Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults

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

The goal of this intervention study is to analyse the microbiota composition after the water kefir consumption. The main questions are to evaluate the potential probiotic drink can have beneficial effect on the gut microbiota. Participants will consume the water kefir for two weeks and microbiota will be analysed. Researchers will compare the microbiota composition before and after consumption.

NCT ID: NCT05656001 Recruiting - Emotion Regulation Clinical Trials

Neuro- and Biofeedback in Nonsuicidal Self-injury

Start date: September 10, 2021
Phase: N/A
Study type: Interventional

Nonsuicidal self-injury (NSSI) is defined as the direct, deliberate destruction of one's own body tissue without suicidal intent, typically including behaviors such as cutting, burning, or hitting oneself. The risk of engaging in NSSI is particularly high during adolescence. NSSI is associated with impairments in emotion regulation and NSSI behavior serves as an attempt to regulate emotion. We propose to examine whether training adolescents with NSSI to self-regulate using emotion regulation skills to down-regulate hemodynamic activity of the salience network, involved in emotional processing. Moreover, we propose to examine whether limbic-prefrontal cortex connectivity can be increased following neurofeedback, thereby helping adolescents find an optimal way to emotionally regulate with the help of neurofeedback, instead of engaging in NSSI to regulate emotions. We also aim to examine effects of real-time biofeedback by investigating if adolescents can regulate their psychophysiological activity during emotional reactivity with biofeedback. Sixty participants with NSSI will be recruited and offered either real-time functional magnetic resonance imaging (rt-fMRI-NF) (n = 30) or real-time biofeedback (n = 30) training. Participants each each condition will then be randomized to either an active or a control condition (n = 15/group). Participants will take part in three runs of feedback training. Changes in emotional reactivity as measured with facial electromyography (EMG) before and after feedback training will be the proximal outcome measure together with changes of the blood oxygenation level dependent (BOLD) response during real-time fMRI-neurofeedback for the neurofeedback training. Proximal outcome measures for the biofeedback will include psychophysiological measures of emotional reactivity (facialEMG). More distal outcome measures for both neuro- and biofeedback will be measures of NSSI: frequency, methods and severity as well as self-report measures of difficulties with regulating emotions, emotional reactivity and psychiatric symptoms.

NCT ID: NCT05655962 Recruiting - Public Health Clinical Trials

A Structured Framework for Assessment of Rehabilitation and Sicklisting in Primary Care - a Multicenter Study

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

In a controlled pragmatic multicenter primary care study, centers working according to a newly constructed structured framework for assessment of rehabilitation and sicklisting (STARS) will be investigated. Nine intervention centers working according to STARS will be compared to matched control centers not working according to STARS. The design of this study includes qualitative as well as quantitative measures, with the aim to evaluate the effects of STARS at patient, staff, and organization levels.

NCT ID: NCT05654623 Recruiting - Clinical trials for Advanced Breast Cancer

A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

VERITAC-2
Start date: March 3, 2023
Phase: Phase 3
Study type: Interventional

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

NCT ID: NCT05649982 Recruiting - Drinking Excessive Clinical Trials

Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the effects on alcohol consumption, and the consumption of time spent by a qualified clinician, by adding different forms of guidance to a digital intervention based on an alcohol diary and techniques from cognitive behavioral therapy and relapse prevention. The participants will be adults with problematic alcohol use. The trial will be a 2*2 factorial experiment where written guidance and/or an extra mid-treatment telephone interview will be added to the basic digital intervention, by randomization. The randomized factorial experiment will create four equally large groups (1:1:1:1) who will receive different combinations of added guidance. Main outcome will be effects on alcohol consumption. Effects on alcohol consumption will also be combined with clinician time spent on guidance to assess the resource-effectiveness of added forms of guidance.