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NCT ID: NCT05690841 Not yet recruiting - Malaria Clinical Trials

FocaL Mass Drug Administration for Vivax Malaria Elimination

FLAME
Start date: April 1, 2023
Phase: Phase 3
Study type: Interventional

FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.

NCT ID: NCT05687266 Recruiting - NSCLC Clinical Trials

Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin for First-Line Treatment of Patients With Advanced NSCLC Without Actionable Genomic Alterations

AVANZAR
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

NCT ID: NCT05624450 Recruiting - Clinical trials for Acute Respiratory Failure

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

TILIA
Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of tozorakimab as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.

NCT ID: NCT05620407 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (POETYK SLE-2)

POETYK SLE-2
Start date: December 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

NCT ID: NCT05617677 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

POETYK SLE-1
Start date: December 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

NCT ID: NCT05566431 Not yet recruiting - Clinical trials for Severe Traumatic Brain Injury

Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics

BELLA TRIP-P
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.

NCT ID: NCT05564052 Recruiting - Clinical trials for Lymphoma, Mantle-Cell

A Study of Ibrutinib With Rituximab in Relapsed/Refractory Mantle Cell Lymphoma

VEGA
Start date: December 6, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the recommended dosage of ibrutinib when administered in combination with rituximab in participants with relapsed or refractory (r/r) mantle cell lymphoma (MCL) (Phase 2); and to compare the progression-free survival (PFS) of ibrutinib plus rituximab versus physician's choice of lenalidomide plus rituximab or bortezomib plus rituximab (Phase 3).

NCT ID: NCT05551273 Recruiting - HIV Infections Clinical Trials

Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

Start date: December 14, 2022
Phase: Phase 2
Study type: Interventional

The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qHBsAg level >1000 (3 log10) IU/mL at screening. The study will also evaluate if TLR8 stimulation with SLGN will reduce hepatitis B surface antigen (HBsAg) titers in the blood.

NCT ID: NCT05534984 Recruiting - Monkeypox Clinical Trials

Study of Tecovirimat for Human Monkeypox Virus

STOMP
Start date: September 12, 2022
Phase: Phase 3
Study type: Interventional

A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease.

NCT ID: NCT05502601 Not yet recruiting - Periodontitis Clinical Trials

Periodontal Therapy in Patients With Rheumatoid Arthritis

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Aim: A prospective randomized, controlled clinical trial comparing two groups of a cohort of Rheumatoid Arthritis (RA) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (LDA)-remission. Methods: 42 patients with RA and periodontitis from the RA Almenara cohort will be included (ACR 1987 and or ACR/EULAR 2010 criteria with more than 16 years old at diagnosis); those with <6 teeth, current infections, cancer or oral precancerous lesions, diabetics, Sjogren's syndrome, use of antibiotics or drugs associated with dry mouth and dental surgery, will be excluded. Periodontal Disease was defined by the presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss >=5mm, probing depth >=5mm and bleeding on probing according with the 2018 periodontitis diagnostic criteria. Two RA patients groups will be follow up by monthly visits. Patients will be divided into two groups (intervention and no intervention treatment). PD treatment will be performed by a qualified periodontist. No intervention group will receive PD treatment after 6 month visit because ethical principles. Disease activity will be determined according with DAS 28index, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) scores, C-reactive protein (CRP), the erythrocyte sedimentation rate (ESR), and rheumatoid factor levels will be registered before and after PD treatment (baseline, 3 and 6 months visits), and the differences between the groups will be analyzed and compared. Periodontal parameters including probing depth (PD), clinical attachment loss, and sulcus bleeding index (SBI) will be correlated with the factor levels.