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NCT ID: NCT06356129 Recruiting - Clinical trials for Large B-cell Lymphoma

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

GOLSEEK-1
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

NCT ID: NCT06350123 Recruiting - Clinical trials for Chronic Kidney Disease

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease

MIRO-CKD
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.

NCT ID: NCT06344858 Recruiting - Analgesia Clinical Trials

Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI

Keta-ANI
Start date: April 30, 2024
Phase:
Study type: Observational [Patient Registry]

Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose.

NCT ID: NCT06313320 Recruiting - Nociceptive Pain Clinical Trials

Intraoperative Electroencephalographic Biomarkers of Postoperative Pain

Start date: May 1, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this study is to explore whether specific intraoperative EEG signals (brain waves or neuronal electrical activity) are associated with the severity of acute postoperative pain.

NCT ID: NCT06307652 Recruiting - Clinical trials for Heart Failure and Impaired Kidney Function

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

BalanceD-HF
Start date: April 12, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

NCT ID: NCT06307431 Recruiting - Clinical trials for Renal Cell Carcinoma

A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)

Start date: April 10, 2024
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

NCT ID: NCT06305767 Recruiting - Bladder Cancer Clinical Trials

A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

Start date: March 28, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.

NCT ID: NCT06295809 Recruiting - Clinical trials for Carcinoma, Squamous Cell

A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)

Start date: April 18, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.

NCT ID: NCT06291376 Recruiting - Clinical trials for Immunoglobulin A Nephropathy

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

ICAN
Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.

NCT ID: NCT06283966 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

THARROS
Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.