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NCT ID: NCT06209541 Recruiting - Anxiety Symptoms Clinical Trials

Internet-based Cognitive Behavioral Therapy: A Factorial Randomized Controlled Trial About Treatment Content and Support

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the differences in treatment outcomes between individually tailored and transdiagnostic internet-based cognitive behavioral therapy (ICBT), as well as the differences between weekly support by a specific therapist and weekly support by a team. The target group is adults (18 years or older) who experience mild to moderate depression symptoms, anxiety, stress or other psychological symptoms. The ICBT, in both types of treatment contents, consists of modules that the participants will work with for eight weeks in total. Participants will be recruited in Sweden with nationwide recruitment.

NCT ID: NCT06208150 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

MonumenTAL-6
Start date: January 22, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

NCT ID: NCT06207942 Recruiting - Clinical trials for Cognitive Impairment

Stepcare Extended Follow-up Substudy

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

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

NCT ID: NCT06206603 Recruiting - Colorectal Cancer Clinical Trials

Epigenetic Regulation of Colorectal Polyps and Cancer

Start date: January 3, 2024
Phase:
Study type: Observational

The goal of this study is to learn about the epigenetic and genetic regulation (microRNA/mRNA) of colorectal polyps and their evolvement as polyps and to colorectal cancer. Furthermore, the study aims at investigating whether certain epigenetic features, linked to polyps and/or cancer are traceable in blood samples. The main questions the study aims to answer are: 1. Are there specific microRNA/mRNA that are expressed in different types of polyps and cancers and their respective stages? 2. Is microRNA/mRNA expression in polyps and cancer traceable in blood from the same patient? 3. Is the intestinal microbiata correlated with colorectal polyps and cancer and their microRNA/mRNA expression? Type of study: clinical trial Participant population Participants consist of patients undergoing a scheduled colonoscopy where a polyp or cancer is discovered. Healthy controls, with normal colonoscopy findings will be enrolled. Biopsies will be obtained from polyps/cancers and from normal surrounding intestinal mucosa. Biopsies will be obtained from defined intestinal locations from healthy controls. Blood samples will be collected from all participants. Researchers will compare microRNA/mRNA and microbiota in patients with polyps/cancers and their respective stages as well as healthy controls. Comparisons include biopsies and blood samples.

NCT ID: NCT06205706 Recruiting - Clinical trials for Hepatocellular Carcinoma

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors

Start date: December 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this first in human clinical trial is to test BI-1910 administered as single agent and in combination with pembrolizumab in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy. The main questions it aims to answer are: - how safe and tolerable is BI-1910 - what is maximum tolerated or administrated dose - to determine recommended dose for further clinical trials Participants will receive infusions of BI-1910 alone or combination with pembrolizumab every 3 weeks.

NCT ID: NCT06199076 Recruiting - Clinical trials for Alcohol Use Disorder

Experimental Study on Alcohol Use and Behavior in Young Adults

OXYCAC
Start date: October 17, 2023
Phase: Phase 2
Study type: Interventional

The goal of this double blind randomized placebo-controlled clinical trial is to compare intranasal oxytocin and placebo in young adult individuals with alcohol use disorder as compared to healthy controls. The main questions it aims to answer are: - The effect of oxytocin versus placebo on prosocial behavior in individuals with high- versus low alcohol use - The effect of oxytocin versus placebo on impulsivity, emotion recognition, social learning, and alcohol craving in individuals with high- versus low alcohol use Participants in both groups will on two separate visits perform the following validated behavioral task measures: - Dictator game tasks assessing prosocial behavior - Delay discounting task assessing impulsivity - Emotion recognition task assessing emotion recognition - Alcohol cue craving task assessing alcohol craving - Observational fear learning task assessing social learning Researchers will compare groups of high and low alcohol use to see if there is a difference in effect of oxytocin versus placebo between groups.

NCT ID: NCT06195930 Recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction

Start date: April 18, 2024
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction. Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is too weak to pump enough blood to the rest of the body. This results in a reduced supply of the oxygen that the body requires to function properly. The common symptoms of HFrEF include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays or even death. Vericiguat is an approved drug for use in people with chronic HFrEF. It works by activating a protein called soluble guanylate cyclase, which helps dilating the blood vessels and in turn improves heart function. Currently, treatment with vericiguat starts at a daily dose of 2.5 milligrams (mg), which increases to 5 mg after 2 weeks. The dose is then increased to the target dose of 10 mg after another 2 weeks. In this study, researchers are trying to learn how well participants can tolerate and how safe it is to start vericiguat at a dose of 5 mg. Starting directly at the 5 mg dose is expected to help reach the target dose of 10 mg faster. Participants will take vericiguat 5 mg as a tablet by mouth once daily along with their regular heart medications. At the start of the study, study doctors will check participants' medical history and perform full health check-ups to confirm if they can take part in the study. Throughout the study, study doctors will monitor participants' previous and current medications, their heart health, and their overall well-being. This will help researchers assess how safe the study drug is and if they experience adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment. Access to study treatment after the end of this study is not planned. Everyone, including study doctors and participants, will know what drug the participants receive during the study. Participants may be in the study for about 4 weeks. Participants may not benefit from the treatment as the study is designed to assess safety and tolerability: the duration of the study is very short and participants will be taking a low dose of vericiguat without moving to the target dose of 10 mg during the study. However, the findings of this study may enable people with chronic HFrEF to safely skip one initial dosing step and reach the target dose of vericiguat faster. Participants may experience medical problems such as low blood pressure, upset stomach, nausea, dizziness, and headache. Researchers will monitor and manage all these, and other, medical problems participants may have during the study.

NCT ID: NCT06195865 Recruiting - Breast Cancer Clinical Trials

Autologous vs. Implant-based Breast Reconstruction

GoBreast II
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.

NCT ID: NCT06193772 Recruiting - Clinical trials for Depression in Adolescence

Increasing Treatment Response Rates in Depressed Adolescents Via Feedback-Informed IPDT

ERiCA3
Start date: January 26, 2024
Phase: N/A
Study type: Interventional

The overarching research project aims to evaluate of an internet-delivered affect-focused psychodynamic treatment (IPDT) for adolescents aged 15-19 with depression. The previous study was a non-inferiority randomized controlled trial (RCT) comparing IPDT with internet-delivered cognitive behavior therapy (ICBT). The results showed that IPDT and ICBT had similar effects. Adolescents in both treatments showed large improvements in both depression and other outcome measures. Online psychological treatment is also known as guided self-help, where the participant reads texts and performs exercises on their own, with the support of an online therapist. The planned study is an RCT to investigate the effect of therapist feedback and customized treatment for adolescents at risk of not being helped by IPDT. The study builds on analyses of predicted treatment trajectories in the project's previous study. Based on these analyses, algorithms have been developed that identify which young people who, after three weeks of treatment, are at risk of not getting a good outcome from the treatment. In the present study, 240 young people aged 15-19 with major depression will begin IPDT. After three weeks of treatment, the course of the treatment is analyzed using the algorithm and the young people who are at risk of not having a good outcome are identified. These adolescents are randomized to either continue unchanged treatment or to receive detailed therapist feedback on the adolescent's treatment prognosis and instructions to adapt the treatment in consultation with the individual adolescent. The IPDT treatment consists of eight modules and treatment duration is ten weeks. The study evaluates the effect of the treatment on depression and other variables such as anxiety symptoms, emotion regulation and self-image. The project's previous studies have shown that IPDT is an effective treatment that can be offered to adolescents with depression. The planned study can show whether the outcome of IPDT can be further improved by paying attention to adolescents with poorer treatment progress and adapting the treatment more to their needs.

NCT ID: NCT06193499 Recruiting - Clinical trials for Osteoarthritis Thumb

A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.

Start date: January 17, 2024
Phase: N/A
Study type: Interventional

This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.