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NCT ID: NCT05704829 Not yet recruiting - Clinical trials for HER2-positive Early Breast Cancer

NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

ADAPTHER2-IV
Start date: December 2023
Phase: Phase 2
Study type: Interventional

ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC. ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).

NCT ID: NCT05697640 Not yet recruiting - Post-COVID ME/CFS Clinical Trials

Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome

Start date: February 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the therapeutic value of an approved drug (Vericiguat) in patients with post-COVID-19 syndrome, who suffer from profound tiredness or fatigue, regardless of bed rest.The main questions it aims to answer are: • Does Vericiguat relieve fatigue and/or other symptoms associated with post-COVID-19 syndrome? • What are the side effects of Vericiguat in this patient population; and how common are they? Participants will be asked to participate for approx. 18 weeks. After screening, participants will receive assigned intervention of either 10 weeks of treatment with Vericiguat or matching placebo tablet, followed by 30 day follow-up period. Every participant will undergo trial, cardiovascular safety, and monitoring assessments. The results of this study will provide information on whether Vericiguat can alleviate PCS-related symptoms as well as insights into the pathophysiological processes of PCS, which in turn can help to develop therapies.

NCT ID: NCT05690048 Not yet recruiting - Immunotherapy Clinical Trials

Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)

FLORA
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

The interventional, randomized, placebo-controlled, single blind phase II-trial FLORA will assess safety and immunogenicity of fecal microbiota transfer in combination with standard of care immunotherapy in advanced hepatocellular carcinoma (HCC) in a parallel group design. Subjects will be randomized 2:1 into either the FMT or placebo group.

NCT ID: NCT05681949 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

ADBoard
Start date: November 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to compare the recommendations of the artificial intelligence clinical decision support system 'ADBoard', with the recommendations of physicians by tumor conferences in patients with hepatobiliary tumors. The main questions it aims to answer are: Can ADBoard achieve a high level of similar recommendations as physicians' tumor conferences? Can ADBoard consider a more complete set of patient-related data than in physicians' tumor conferences? Can ADBoard reduce the time between the first time the patient is discussed at the tumor conference and the start of the recommended treatment plan? Participants will have their hepatobiliary tumor treatments determined by either tumor conference with ADBoard, or tumor conference without ADBoard.

NCT ID: NCT05676788 Not yet recruiting - Lung Neoplasm Clinical Trials

HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections

HYPER-Seg
Start date: April 2023
Phase: N/A
Study type: Interventional

The purpose of this study is the identification of the intersegmental plane and navigation during sublobar pulmonary resections in lung cancer using Hyperspectral Imaging, the comparison with ICG fluorescence intersegmental plane identification, and the establishment of automatic intersegmental plane navigation using machine learning strategies for intraoperative navigation.

NCT ID: NCT05670132 Not yet recruiting - Clinical trials for Congenital Heart Disease

Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)

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

Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular/physical variables.

NCT ID: NCT05662904 Not yet recruiting - Clinical trials for Relapsed/Refractory Acute Myeloid Leukemia (AML)

Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients With AML

GALAXY33
Start date: December 2023
Phase: Phase 1
Study type: Interventional

The study "GALAXY33" is an open-label, prospective, nonrandomized, one arm phase I clinical trial in which patients with relapsed AML after allogeneic hematopoietic stem cell transplantation will be transplanted with CD33-deleted CD34+ HSC derived from the initially matched family donor.

NCT ID: NCT05651464 Not yet recruiting - Clinical trials for Catheter-Related Infections

Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation

IPANEMA-ECMO
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective interventional study is to evaluate the impact of antibiotic prophylaxis on bloodstream infections after liberation of extracorporeal membrane oxygenation therapy. The main questions aims to answer are: • does application of vancomycine prior to ECMO liberation have an impact of bloodstream infections? Participants will get 1 dose of vancomycine I.V. (15-20 mg per kgKG) prior to liberation of ECMO. Researchers will compare this interventional group to a group without antibiotic prophylaxis.

NCT ID: NCT05647096 Not yet recruiting - Sepsis Clinical Trials

Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating cfDNA/NETs in Subjects With Sepsis

NUC-CAP
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in sepsis patients.

NCT ID: NCT05628064 Not yet recruiting - Amputation Clinical Trials

1C70 Feasibility Study

Start date: November 21, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to characterize the extend of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.