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NCT ID: NCT06193161 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Prolonged Exposure for Swedish Immigrants

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare therapist-guided internet delivered prolonged exposure (I-PE) in simple english to a waiting list condition for immigrants in Sweden diagnosed with post-traumatic stress disorder (PTSD). The main objectives are to establish feasibility and preliminary efficacy of I-PE for immigrants with PTSD in a single-blind, parallel-group superiority Randomized Controlled Trial (N=100) comparing I-PE with a waiting-list condition, starting with a nested pilot (N=30) to ensure feasible and acceptable recruitment and treatment strategies. Study participants will be randomly assigned to either eight weeks of I-PE or a waiting-list for the same amount of time on a 1:1 ratio without restriction. Feasibility and acceptability data will be reported including recruitment rate, sample demographics, data attrition, treatment adherence and a detailed dropout analysis. A preliminary investigation of the within-group effect size will also be conducted. Recruitment is designed to be broadly inclusive with minimal exclusion criteria.

NCT ID: NCT06187987 Recruiting - Pulmonary Embolism Clinical Trials

Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism - a Retrospective Analysis

Start date: April 1, 2023
Phase:
Study type: Observational

International guidelines recommend intravenous thrombolysis (IVT) for high-risk pulmonary embolism (PE). In high-risk PE where IVT is contraindicated or has failed, surgical embolectomy or catheter-directed intervention (CDI) is recommended. CDI is also recommended as an alternative in patients with intermediate-risk PE with haemodynamic deterioration during anticoagulation treatment. Although there is a lack of randomized studies comparing CDI to anticoagulation or systemic thrombolysis in PE, several studies and recent meta-analyses have shown that CDI is an effective treatment that is associated with fewer complications than IVT, especially bleeding.

NCT ID: NCT06187831 Recruiting - Bleeding Clinical Trials

Bleeding Events Before vs After Lowering Departmental Platelet Transfusion Trigger

OBS-PLATE
Start date: February 26, 2024
Phase:
Study type: Observational [Patient Registry]

Central venous catheters are essential when administering treatment for hematological conditions. Many patients have a decreased platelet count which increases the risk for bleeding complications. Baarle et al. recently published a randomized controlled study where withholding prophylactic platelet transfusions before CVC placement in patients with a platelet count of 10,000 to 50,000 per cubic millimeter did not meet the predefined margin for non-inferiority for postprocedural bleeding events (PMID: 37224197). However, bleedings grade 2 (defined as bleeding that requires external compression) were included despite lacking clinical significance. The aim of the present study is to investigate whether lowering the preprocedural platelet transfusion trigger from 50x10^9/L to 10x10^9/L for insertions of central venous catheters remains safe with regards to postprocedural bleeding events of grade 3-4.

NCT ID: NCT06187350 Recruiting - Neoplasms Clinical Trials

The Use of AI to Safely Reduce the Workload in Breast Cancer Screening With Mammography in Region Östergötland

AIM-RÖ
Start date: August 1, 2023
Phase:
Study type: Observational [Patient Registry]

The overall aim of the project is to investigate how artificial intelligence (AI) can be used to streamline and at the same time increase diagnostic safety in breast cancer screening with mammography. AI has been shown in a number of studies to have great potential for both increasing diagnostic certainty (e.g. reduced occurrence of interval cancers) and at the same time reducing the workload for doctors. However, much research remains to clinically validate these new tools and to increase the understanding of how they affect the work of doctors. The specific goal of the project is to investigate whether the implementation of AI in breast cancer screening in Östergötland, Sweden, can increase the sensitivity (the mammography examination's ability to find breast cancer) and the specificity (that is, the right case is selected for further investigation: a minimum of healthy women are recalled but so many breast cancer cases that are possible are selected for further investigation) and at the same time make screening more efficient through reduced workload. AI will be implemented in the clinical routine and performance metrics such as cancer detection rate etc will be closely monitored. The study do not assign specific interventions to the study participants.

NCT ID: NCT06187337 Recruiting - Clinical trials for Crowding of Anterior Maxillary Teeth

Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition

Start date: December 20, 2021
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare if it is better to treat severe anterior crowding in the early mixed dentition then later in the permanent dentition in children with anterior crowding of the upper teeth. The main questions this trial aims to answer are: - If there is a difference in the degree of anterior crowding between the experimental group and the control group after a five year follow-up period. - If there is a difference between the experimental group and the control group in regard to oral health related quality of life. - If there is spontaneous transversal adaption of the lower dental arch to upper dental arch after maxillary expansion and compare this to the control group. - If early maxillary expansion is more cost-effective than treatment in the permanent dentition. To be eligible for this trial the subject must be children between six and nine years old at the time for inclusion. The children must have crowding of the upper front teeth of six millimeters or more and the lateral incisors should not have erupted or just erupted through the gingiva. Subjects randomized to the experimental group will get an expansion treatment in the upper jaw with rapid maxillary expansion device to gain enough space for the lateral incisors to erupt. All subjects, also the subjects randomized to the control group, are followed until all permanent teeth have erupted. At the end of the follow-up period all subjects fill out a questionnaire to evaluate their oral health related quality of life. Researchers will then compare the subjects in both groups to evaluate if there is a difference in anterior crowding after the follow-up period. Differences in cost-effectiveness, morphological changes and the subjects oral health related quality of life will also be evaluated.

NCT ID: NCT06185244 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Efficacy of Internet-delivered Trauma-focused CBT for Young People With PTSD

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with post-traumatic stress disorder regarding efficacy and cost effectiveness. Young people with post-traumatic stress disorder will be randomly assigned to receive either 12 weeks of therapist-guided internet delivered trauma-focused cognitive behavior therapy (iTF-CBT) or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation and psychoeducation.

NCT ID: NCT06183931 Recruiting - Clinical trials for Transthyretin Amyloid Cardiomyopathy

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

DepleTTR-CM
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the composite endpoint of all-cause mortality (ACM) and total cardiovascular (CV) clinical events.

NCT ID: NCT06181435 Recruiting - Dermatitis Atopic Clinical Trials

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

NCT ID: NCT06177912 Recruiting - Clinical trials for Pneumococcal Infection

A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

STRIDE-13
Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

NCT ID: NCT06173687 Recruiting - Hearing Loss Clinical Trials

Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant

DICE
Start date: January 29, 2024
Phase: N/A
Study type: Interventional

This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the subjects encounter during their daily life outside of the clinic. Improving the monitoring of both aspects may lead to improvements in monitoring and personalising the fitting to optimise hearing outcomes for persons with a cochlear implant.