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NCT ID: NCT05913297 Recruiting - Malformation Brain Clinical Trials

Neuroradiology Assesses Chiari Malformation's Impact on Airways, Cranial Base, and Sleep Disorders in Children.

CHDSB
Start date: June 8, 2023
Phase:
Study type: Observational

The severity of sleep disorders in patients with Chiari malformations can vary. The investigators propose to establish a correlation between the severity of sleep-disordered breathing (SDB) and the quantitative neuroradiological data of the airways, cranial base foramina, and posterior cranial fossae

NCT ID: NCT05912465 Recruiting - Cachexia Clinical Trials

Predicting Lung Cancer-Associated Cachexia With PET Imaging

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

This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.

NCT ID: NCT05912140 Active, not recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Assessment of Trunk Aesthetics: Development of a New Tool

TRACE2
Start date: June 6, 2023
Phase:
Study type: Observational

Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Despite this tool being more sensitive in detecting changes in aesthetics during treatment compared to other existing ones, its reliability is still low, probably due to the small number of elements that make up the rating scale. This study aims to develop a new version of the TRACE tool by adding new items. The development of TRACE2 in a Rasch environment will ensure greater sensitivity and specificity of the scale assessment.

NCT ID: NCT05911633 Recruiting - Clinical trials for Hepatocellular Carcinoma Non-resectable

BioPearlâ„¢ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)

BIOPEARL-ONE
Start date: February 29, 2024
Phase: N/A
Study type: Interventional

The primary objective of the study is to confirm technical success and safety of BioPearlâ„¢ microspheres loaded with Doxorubicin in the treatment of unresectable hepatocellular carcinoma (HCC). The secondary objective of the study is to investigate the efficacy of BioPearlâ„¢ microspheres loaded with Doxorubicin in the treatment of subjects with unresectable HCC.

NCT ID: NCT05911360 Active, not recruiting - HIV Infections Clinical Trials

A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

EYEWITNESS
Start date: July 7, 2023
Phase: Phase 3
Study type: Interventional

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

NCT ID: NCT05910944 Recruiting - Hydrocephalus Clinical Trials

European Study of Prodromal iNPH

STOP iNPH
Start date: November 1, 2023
Phase:
Study type: Observational

To investigate if progression from prodromal into symptomatic NPH can be predicted from advanced neuroimaging, biomarkers in cerebrospinal fluid (CSF) and plasma and investigate the unknown mechanisms causing deterioration by investigating longitudinal changes in the above-mentioned variables. Three different cohorts with both asymptomatic and symptomatic patients as well as healthy controls will be investigated over time, both without intervention and before and after shunt surgery.

NCT ID: NCT05910866 Recruiting - Heart Failure Clinical Trials

LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy

LEAP-CAR
Start date: June 10, 2023
Phase: N/A
Study type: Interventional

LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) >45%. LEAP-CAR is a randomized, prospective, double blind clinical trial.

NCT ID: NCT05909904 Recruiting - Clinical trials for Head and Neck Cancer

Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma

Start date: July 21, 2023
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

NCT ID: NCT05909410 Not yet recruiting - Contraception Clinical Trials

Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome

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

Combined hormonal contraceptives (CHCs), according to the opinion by The Manchester International Consensus Group, should be considered for women wishing contraception because also positively impact endometrial cancer and ovarian cancer risk. The awareness of the effects of hormonal therapies in women at high risk of developing endometrial cancer, colorectal, breast, or ovarian cancer, such as those affected by Lynch syndrome (LS), is currently limited, with few published studies addressing these populations. Making informed decisions about CHC use in this context necessitates careful consideration of individual cancer risk and the potential benefits and risks associated with CHC use. Accurate information regarding the oncological risks associated with CHC use is essential for facilitating shared decision-making between women and their healthcare providers in this patient population. This prospective study aims to evaluate the knowledge, attitudes, and beliefs of women with LS concerning CHCs and their potential effects on specific disease development and cancer risk, comparing them to the general population. By considering psychosocial factors and individual perceptions of cancer risk, this study seeks to contribute to informed decision-making, personalized counseling, and improved strategies for gynecologic cancer risk management in women with LS.

NCT ID: NCT05909397 Active, not recruiting - Breast Cancer Clinical Trials

A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer

VERITAC-3
Start date: August 9, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: - Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. - Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. - Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.