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NCT ID: NCT05965414 Recruiting - Alzheimer's Disease Clinical Trials

Safety and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of CS6253 in Healthy Volunteers

Start date: October 23, 2023
Phase: Early Phase 1
Study type: Interventional

- Phase 1A SAD: Five or more cohorts of 8 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo. The first 4 cohorts will be male only. The last cohort will be repeated with the max safe dose of the previous cohorts in healthy elderly subjects (male and female of non childbearing potential, > 50years) - Phase 1B MAD: Two or more cohorts of 8 male and female HVs will receive multiple (4) IV bolus injections of study drug or placebo every 72 hours.

NCT ID: NCT05964738 Recruiting - Heart Failure Clinical Trials

Effect of Diuretics Withdrawal in Chronic Heart Failure With Reduced Ejection Fraction

REDICAE
Start date: December 19, 2022
Phase: Phase 2
Study type: Interventional

REDICAE trial was designed to evaluate the safety and tolerability of diuretics withdrawal in stable, euvolemic chronic outpatients with heart failure with reduced ejection fraction. It is a single-center, randomized, open-label, phase II clinical trial.

NCT ID: NCT05964413 Recruiting - Clinical trials for Pyoderma Gangrenosum

Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum

Start date: August 15, 2023
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum

NCT ID: NCT05964335 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Cough Reduction in IPF With Nalbuphine ER

CORAL
Start date: February 6, 2024
Phase: Phase 2
Study type: Interventional

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of nalbuphine ER (NAL ER). After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms. - Arm 1: Placebo - Arm 2: 27 mg nalbuphine ER - Arm 3: 54 mg nalbuphine ER - Arm 4: 108 mg nalbuphine ER Each arm will be titrated to their fixed dose during the blinded 2-week Titration period followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.

NCT ID: NCT05964153 Recruiting - Glioma Clinical Trials

Analysis of Circulating DNA in Blood Samples of Glioma-affected Patients

Start date: January 31, 2023
Phase: N/A
Study type: Interventional

The present pilot study aims to investigate a new strategy in the liquid biopsy protocol for the diagnosis of gliomas based on the detection of circulating tumor DNA in the blood of patients with brain lesions compatible with this type of tumor. In order to increase the sensitivity of the technique, the investigators will work with raw blood samples through minimally invasive procedures. The subsequent analysis will be done with digital PCR, due to its low detection limit. The mutational results of each patient's samples will be compared with those obtained from the corresponding tissue biopsies. This step will allow the team to determine the robustness and reliability of the liquid biopsy. The grading of the tumor, as well as the confirmation of the diagnosis, will be obtained from the histological data. With the inclusion of more patients in the future, and with the optimization of the mutations investigated, the investigators want to standardize the protocol for the diagnosis of gliomas with liquid biopsy. This technique is less invasive than current surgical procedures used for diagnosis. In addition, using fewer hospital resources should allow a more accurate and rapid diagnosis of the pathology, and therefore, start the more personalized therapeutic stage earlier.

NCT ID: NCT05963997 Recruiting - Breast Cancer Clinical Trials

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

SUMIT-ELA
Start date: October 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

NCT ID: NCT05963984 Recruiting - Breast Cancer Clinical Trials

A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

SUMIT-BC
Start date: December 14, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

NCT ID: NCT05963074 Recruiting - Clinical trials for Small Lymphocytic Lymphoma

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

TAILOR
Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).

NCT ID: NCT05962931 Recruiting - Venous Ulcer Clinical Trials

Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

Start date: July 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.

NCT ID: NCT05962606 Recruiting - Clinical trials for Community-acquired Pneumonia

Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.

Start date: February 2, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the safety and efficacy of AON-D21 versus placebo, both on top of standard of care, in patients with severe community acquired pneumonia admitted to ICU (or similar unit). The main questions to answer are: - The safety and tolerability of AON-D21 vs placebo. - The efficacy of AON-D21vs placebo. - The pharmacokinetics of AON-D21. - The pharmacodynamics of AON D21. - To identify biomarkers for patient stratification and analyses in future trials.