
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections...
Urinary Tract InfectionsAcute PyelonephritisThis study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory...
Respiratory Tract InfectionsThis is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Two newly developed and two existing Echinacea formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal 3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days or until symptom resolution. Nasopharynx samples will be collected for analysis of common viral respiratory agents throughout treatment. Safety and efficacy variables will be assessed.

Protecting Brains and Saving Futures - the PBSF Protocol
Brain InjuriesCongenital Heart Disease15 moreBackground: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care. Such initiative involves the use of standardized protocols, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG (aEEG) and Near Infrared Spectroscopy (NIRS), neuroimaging and training. Brazil is a very large country with disparities in health care assessment; some neonatal intensive care units (NICUs) are not well structured and trained to provide adequate neurocritical care. However, the development and implementation of these neurocritical care units requires high expertise and significant investment of time, manpower and equipment. In order to reduce the existing gap, a unique advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) protocol was developed and implemented in some Brazilian NICUs. Methods: A prospective observational cohort study will be conducted in 20 Brazilian NICUs that have adopted the PBSF protocol. All infants receiving the protocol during January 2021 to December 2023 will be eligible. Ethical approval will be obtained from the participating institutions. The primary objective is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period. The use of the PBSF protocol will be measured by quantification of neuromonitoring, neuroimaging exams and sub-specialties consultation. Clinical outcomes of interest after the protocol implementation are length of hospital stay, detection of EEG seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, and referral of patients to high-risk infant follow-up. These data will be also compared between infants with primarily neurologic and primarily clinical diagnosis. Discussion: The implementation of the PBSF protocol may provide adequate remote neurocritical care in high-risk infants with optimization of clinical management and improved outcomes. Data from this large, prospective, multicenter study are essential to determine whether neonatal neurocritical units can improve outcomes. Finally, it may offer the necessary framework for larger scale implementation and help in the development of studies of remote neuromonitoring.

A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts
Condylomata AcuminataPapillomavirus Infections9 moreThis is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A & B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.

A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine...
HIV InfectionsSevere ImmunosuppressionPhase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment.

Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections...
Acute Respiratory Viral InfectionsPurpose of the study: • To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute respiratory viral infections.

Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection
Viral Respiratory InfectionTo evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI).

The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection
Coronavirus InfectionsThe study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .

A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection...
HIV-1-infectionEHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.

Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
Clostridium Difficile InfectionClostridium Difficile Infection RecurrenceThe purpose of this study is to gain further knowledge regarding the effectiveness of vancomycin prophylaxis in preventing Clostridium difficile infections in order to guide physicians' practices.