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NCT ID: NCT06171243 Recruiting - Neuropathic Pain Clinical Trials

PK of Lidocaine/Tetracaine and PD Derived From a New Topical Formulation for Treatment of Neuropathic Pain.

PK/PDLido
Start date: March 17, 2023
Phase:
Study type: Observational

Post-herpetic neuralgia (PHN) is the most frequent complications related to herpes zoster, and can persist for months or even years, and require extensive treatment. For this purpose, pharmacological therapies based on tricyclic antidepressants (amitriptyline), central nervous system depressants (pregabalin) and also opioids, have been stablished. However, all the drugs mentioned can cause serious systemic adverse effects that worsen the patient's quality of life. To avoid these complications, topical therapies based on Capsaicin or Lidocaine 5% patches have been developed. However, these treatments have shown dissimilar results in controlling PHN, so a mixed formulation of lidocaine/tetracaine could show better results. For these reasons, the main objective of our work is to evaluate the plasma levels of lidocaine derived from the application of a topical formulation of lidocaine derived from the application of a topical formulation of lidocaine 23%/tetracaine 7% in patients with neuropathic pain.

NCT ID: NCT06170788 Recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

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

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

NCT ID: NCT06161116 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

Start date: December 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.

NCT ID: NCT06157138 Recruiting - Lung Ultrasound Clinical Trials

Observation of B-lines in Pulmonary Echography, During Open Abdominal Surgery

LUS-SURG
Start date: December 26, 2023
Phase:
Study type: Observational [Patient Registry]

There is no a reliable marker of intraoperative fluid excess or overload. The use of lung ultrasound in other settings, such as emergency room and critical care patients, helps us to determine if a patient has a condition of augmented intrathoracic fluid, that could be related to several circumstances, such as fluid overload, but also to heart failure, in example. Nevertheless, there is no information regarding the basal incidence of this finding, to ascertain if could be eventually used as a potential marker of fluid overload. This protocol looks for the incidence of the finding of B-Lines, which are related to fluid overload, in patients undergoing open abdominal surgery.

NCT ID: NCT06149026 Recruiting - Cirrhosis, Liver Clinical Trials

Comparison of the Effect of Two Interventions on Liver Frailty Index in Pre-frail and Frail Cirrhotic Patients Enlisted for Liver Transplantation

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

The goal of this prospective, double blind randomized clinical trial is to compare the effectiveness of two interventions in improve frailty (measured by Liver Frailty Index) and quality of life (measured by Chronic Liver Disease Questionnaire - CLDQ) in listed patients with cirrhosis. The main questions it aims to answer are: - if the intervention group (physical and nutritional therapy) could improve LFI over control group (physical and nutritional counseling). - if the intervention group could improve secondary outcomes as CLDQ, hand grip and gait velocity. Participants will be evaluated in a registry of basal variables such as demographic factors, weight, height and brachial circumference, comorbidities, MELD and MELD-Na, Child Pugh classification, general blood exams, etiology of cirrhosis, presence of hepatocellular carcinoma, ascites, or hepatic encephalopathy and their basal LFI, gait velocity, hand grip and CLDQ. The participants will be randomized in an intervention group or in a control group at the same time of their first evaluation and will receive the group instructions depending on what group the participants belong, and will be evaluated at 4 weeks, 8 weeks, and 12 weeks with applying LFI, measuring of gait velocity, hand grip and a nutritional survey with the intake in the last 24 hours. Finally, researchers will compare interventional group with control group if the first group could improve frailty, measured by Liver Frailty Index and the secondary outcomes with the nutritional and physical therapy.

NCT ID: NCT06143046 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

NCT ID: NCT06140836 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).

NCT ID: NCT06136650 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

NCT ID: NCT06136624 Recruiting - Clinical trials for Prostate Cancer Metastatic

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Start date: December 31, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) and to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

NCT ID: NCT06136559 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.