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NCT ID: NCT05953259 Recruiting - Median Sternotomy Clinical Trials

RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy

FIXTER-2
Start date: September 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk undergoing median sternotomy during cardiothoracic surgery. The main question it aims to answer is: • whether STERN FIX is a safe and efficient device to close the sternum after a sternotomy in patients of risk, achieving higher sternal stability than wires one month after surgery Participants will have their median sternotomy closed using STERN FIX in combination with wires or wires only at the end of their cardiothoracic surgery, according to the allocated treatment.

NCT ID: NCT05952700 Recruiting - Clinical trials for Monitoring of the Bladder Filling

Machine Learning Algorithms for Individual Bladder Filling Level Prediction

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

The aim of this study is to evaluate the bladder filling level of the study participants using the inContAlert sensor. The generated data will be used for the evaluation and optimization of the machine learning algorithms to be able to make precise predictions about the individual bladder fill level. In particular, the hypothesis that the bladder filling level can be estimated by the algorithm will be tested. When testing the hypothesis, it should be determined which deviation (measured by the mean absolute percentage error) of the estimation/prediction differs from the actual value (obtained by measuring the urine output using a measuring cup in combination with kitchen scales).

NCT ID: NCT05952557 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

CAMBRIA-2
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

NCT ID: NCT05951296 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Investigate Leramistat in Patients With IPF

Start date: August 30, 2023
Phase: Phase 2
Study type: Interventional

To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT05949684 Recruiting - Clinical trials for Myelodysplastic Syndromes

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

ELEMENT-MDS
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

NCT ID: NCT05949268 Recruiting - Clinical trials for GastroIntestinal Bleeding

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel

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

Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.

NCT ID: NCT05949125 Recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123

Start date: January 3, 2024
Phase: Phase 1
Study type: Interventional

The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R TM123 functions as a bridging module between Allo RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.

NCT ID: NCT05948943 Recruiting - Clinical trials for Lymphatic Malformations

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

EPIK-L1
Start date: November 24, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study in participants with PIK3CA-mutated lymphatic malformations (LyM) is to assess the change in radiological response and symptom severity upon treatment with alpelisib as compared to placebo.

NCT ID: NCT05948475 Recruiting - Cholangiocarcinoma Clinical Trials

Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

FIRST-308
Start date: December 20, 2023
Phase: Phase 3
Study type: Interventional

This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

NCT ID: NCT05947851 Recruiting - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010)

Start date: August 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).