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NCT ID: NCT06046092 Recruiting - Influenza A Clinical Trials

H7HLAII DNA Influenza Vaccine

H7N9vax-1
Start date: July 15, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess safety and immunogenicity of H7HLAII, a DNA vaccine encoding influenza hemagglutinin (HA) from influenza A/Shanghai/2/2013 (H7N9) directed to cells expressing human leukocyte antigen class II (HLAII) molecules, for prophylaxis of pandemic H7N9 influenza infection in healthy volunteers.

NCT ID: NCT06045806 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06044623 Recruiting - Quality of Life Clinical Trials

Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients

IMPORTANT
Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach. On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy. This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.

NCT ID: NCT06040437 Recruiting - Bullying of Child Clinical Trials

Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.

Be-Prox
Start date: August 7, 2023
Phase: N/A
Study type: Interventional

With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian children in accordance with the Kindergarten Act §§41-43, the objectives of the current project are: To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and bullying among peers in Norwegian kindergartens. To examine implementation factors that promote and inhibit the effectiveness of Be-Prox Norway in Norwegian kindergartens. To describe the cost-effectiveness of the Be-Prox Norway intervention in Norwegian kindergartens. To generate knowledge on how the Be-Prox Norway intervention can be aligned and implemented in Norwegian kindergartens.

NCT ID: NCT06032715 Recruiting - Clinical trials for Harmful Use of Hypnotic

Brief Intervention for Sleep Medication Misuse Among Elderly

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

Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.

NCT ID: NCT06032091 Recruiting - Dementia Clinical Trials

Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia

DIPHDEM
Start date: May 2, 2023
Phase:
Study type: Observational

Background: Almost 90% of people with dementia develop serious symptoms such as apathy, agitation, pain, and sleep disturbances. Movement and participation in daily activities also decrease dramatically over time. Traditional measures for these symptoms are usually in the form of a questionnaire and are not very accurate. Technology, such as a smartwatch, can be an effective tool for complementing traditional measures. Currently, there are few studies which look at activity and symptom measurements at the end-of-life. This makes results from this study extremely valuable for future care decisions, especially for people which may not be able to communicate their needs during the end-of-life period. Method/Design: DIgital PHenotyping in DEMentia (DIPH.DEM), a 3-year cross-sectional observational study (N=50), will look at activities, apathy, agitation, and sleep disturbances using sensing technologies to monitor participants at the end of life. The objective of the study is to use a smartwatch and wireless radar (bedside) device (Somnofy), in addition to validated assessment tools to describe the activity patterns for patients with dementia at the end of life (baseline and every 6.months). We hypothesize that this will enable better estimation of time of death, facilitating discussion surrounding improvement of end-of-life interventions and directives. Discussion: The use of sensors (smartwatch and wireless beside device) can provide valuable knowledge on living and dying with dementia, improve end-of-life directives, and provide guidance for timely, appropriate interventions, including referral to palliative services. Impact on society: DIPH.DEM has the potential to enable more timely, precise, and quality care for people with dementia living at home, in nursing homes, and hospitals.

NCT ID: NCT06025448 Recruiting - Clinical trials for Arthroplasty Complications

Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?

CARS-2
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).

NCT ID: NCT06025331 Recruiting - Clinical trials for Shoulder Osteoarthritis

Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?

CARS-1
Start date: September 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.

NCT ID: NCT06020716 Recruiting - Clinical trials for Protracted Bacterial Bronchitis

Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study

AMIC
Start date: August 16, 2023
Phase: Phase 4
Study type: Interventional

The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial. OVERALL PRIMARY OBJECTIVES: - To study the clinical efficacy of antibiotics in children with chronic wet cough (CWC). - To study if duration of treatment with antibiotics in children with CWC has impact on efficacy or time to relapse of symptoms. OVERALL SECONDARY OBJECTIVE: -To study respiratory pathogens and the diversity/composition of airway and gut microbiome in children with CWC compared to healthy controls, and changes in pathogens/microbiome after treatment with antibiotics. OVERALL TERTIARY OBJECTIVE: -To study inflammatory markers in children with CWC and the impact of treatment with antibiotics. Furthermore, identify children with CWC who have primary immunodeficiency (PID) based on functional laboratory markers and genetic markers of PID. The study will include two different interventions: INTERVENTION 1: Participants will be randomly assigned to 14 days antibiotics or placebo INTERVENTION 2: Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup

NCT ID: NCT06020391 Recruiting - Drug Usage Clinical Trials

Cooperation for Better Treatment of Polypharmacy in the Community

Start date: September 6, 2023
Phase: N/A
Study type: Interventional

The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal in-patient acute care (MipAC) unit in Oslo, Norway. The intervention involves a clinical drug review conducted by a MipAC physician under the guidance of a geriatrician, followed by a telephone consultation between the MipAC physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.