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NCT ID: NCT06335069 Not yet recruiting - Breast Cancer Clinical Trials

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

Start date: March 2024
Phase: Phase 2
Study type: Interventional

The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.

NCT ID: NCT06334575 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels

3TR-ICS-COPD
Start date: July 2024
Phase: Phase 4
Study type: Interventional

The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or > 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome

NCT ID: NCT06333899 Not yet recruiting - Glioblastoma Clinical Trials

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

Start date: September 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.

NCT ID: NCT06332560 Not yet recruiting - Endometriosis Clinical Trials

Pain in Endometriosis And the Relation to Lifestyle

PEARL
Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet intervention on health related quality of life and pain symptoms in women with endometriosis. And whether the addition of CBT enhancing this effect. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome. Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy. Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet.

NCT ID: NCT06327217 Not yet recruiting - Clinical trials for Femoro Acetabular Impingement

Long Term Results After Hip Arthroscopy

Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown.

NCT ID: NCT06324188 Not yet recruiting - Atrial Fibrillation Clinical Trials

Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Start date: June 2024
Phase: N/A
Study type: Interventional

EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial). The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

NCT ID: NCT06308510 Not yet recruiting - Gastric Cancer Clinical Trials

Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer

Start date: July 2024
Phase:
Study type: Observational

Aneuploidy may be used as a more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques. Our aim is to establish whether aneuploidy as detected in cfDNA (as a measure for ctDNA) in PLF of patients with GC may hold value as an additional staging and tumor evaluation method in GC patients.

NCT ID: NCT06307366 Not yet recruiting - Mental Illness Clinical Trials

Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research

PANDAcc
Start date: March 2024
Phase:
Study type: Observational

Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research.

NCT ID: NCT06307067 Not yet recruiting - Clinical trials for Urinary Tract Infections

Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia

URINDO
Start date: March 4, 2024
Phase:
Study type: Observational [Patient Registry]

In the present study, we aim to analyze the impact of the introduction of a urinary dipstick test for patients presenting with uncomplicated UTI-associated symptoms on antibiotic prescription in primary health care in Indonesia. In addition, the knowledge of HCW regarding antibiotics and prudent use of antibiotics in the community setting will be investigated. Specific aims of the study: 1. To analyze the quality of antibiotic prescriptions for uncomplicated UTI in the primary health care settings in Indonesia, before introduction of urinary dipstick testing compared to after introduction of urinary dipstick testing. 2. To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia.

NCT ID: NCT06306339 Not yet recruiting - Clinical trials for Moderate to Severe Rheumatoid Arthritis

A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug)

Start date: March 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA).