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NCT ID: NCT05374512 Recruiting - Breast Cancer Clinical Trials

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Start date: May 16, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

NCT ID: NCT05373927 Recruiting - Clinical trials for Peripheral Arterial Disease

Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive MSOT

MSOT_IC
Start date: June 20, 2022
Phase:
Study type: Observational

The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II (intermittent claudication) and a healthy control collective (study group 1). The results will be validated using an independent validation group (study group 2).

NCT ID: NCT05373498 Recruiting - Cardiac Arrest Clinical Trials

Resuscitation Registry in CHD

PRO-CHD
Start date: August 18, 2022
Phase:
Study type: Observational [Patient Registry]

Children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially after cardiothoracic surgery. Due to a lack of data, the exact number of resuscitations in this patient cohort, as well as the morbidity and mortality, is unknown. This study aims to register all cardiovascular arrests in pediatric patients with congenital heart disease and study the mortality and morbidity with a special focus on the neurodevelopmental outcome.

NCT ID: NCT05372952 Recruiting - Clinical trials for Peripheral Arterial Disease

An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach

Start date: July 25, 2022
Phase:
Study type: Observational

This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.

NCT ID: NCT05371613 Recruiting - Clinical trials for Mucopolysaccharidosis II

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

COMPASS
Start date: July 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.

NCT ID: NCT05371093 Recruiting - Clinical trials for Relapsed/Refractory Follicular Lymphoma

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

ZUMA-22
Start date: September 12, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

NCT ID: NCT05370625 Recruiting - Clinical trials for Elevated Blood Pressure

To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

INSIGHT-2
Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The main objective of the study will be to compare the efficacy of a 2.65 g/day dose of TOTUM-854 versus placebo in decreasing SBP in subjects with high-normal blood pressure and Grade I hypertension following 12 weeks of daily intake.

NCT ID: NCT05369975 Recruiting - Clinical trials for Kidney Transplantation in Highly Sensitized Patients

Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts

PAES
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior to desensitized with imlifidase and subsequent kidney transplantation. Two non-comparative reference cohorts are included to assess the impact of differences in post-transplantation management and outcome in less sensitized patients.

NCT ID: NCT05368896 Recruiting - Surgery Clinical Trials

Peri-operative Inflammaging in the Elderly After Surgery

POPIMAGE
Start date: December 1, 2022
Phase:
Study type: Observational

The population older than 80 years will significantly increase in the near future. Older patients' cognitive and physical status is known to deteriorate after surgery, leading to a high 30-day mortality due to post-operative comorbidities. Aging and related diseases share immune-related pathomechanisms. During aging, a chronic, low-grade sterile inflammation, called inflamaging, gradually develops. This likely results from low-grade innate immune activation and a functional, epigenomic and transcriptomic reprogramming of immune cells. Based on the hypothesis that surgical trauma leads to misplaced or altered self-molecules, which exacerbate inflammation and the postoperative risk for morbidity and mortality in elderly patients. There is increasing evidence that the individual's pre-operative immunobiography determines the susceptibility to peri-operative inflammation and post-operative outcome. Current exploratory pilot study will thus perform phenotyping of patients above 80 years undergoing major surgery. Participants will be evaluated for acute and long-term outcomes, including all-cause mortality, physical and cognitive function. To assess the individual's immunobiography, participants will be characterised by inflammation biomarkers combined with immunophenotyping, functional assays, and (epi-) genomic analyses before and after surgery. The cognitive impairment will be evaluated by measuring markers of neurodegeneration and neuropsychiatric testing and relate findings to volumetric imaging using high-resolution MRI to identify brain changes associated with cognitive decline.

NCT ID: NCT05367505 Recruiting - Mobility Limitation Clinical Trials

Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

TIKTIS
Start date: January 9, 2023
Phase: N/A
Study type: Interventional

Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps. The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients. The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.