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NCT ID: NCT04233216 Completed - HIV-1 Infection Clinical Trials

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

NCT ID: NCT04227457 Completed - Lung Cancer Clinical Trials

Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America

LATINO Lung
Start date: July 25, 2018
Phase:
Study type: Observational [Patient Registry]

To describe the overall survival of advanced NSCLC in Latin America.

NCT ID: NCT04209205 Completed - Psoriatic Arthritis Clinical Trials

Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

INVIGORATE 2
Start date: January 29, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.

NCT ID: NCT04198571 Completed - Clinical trials for Community Acquired Pneumonia

Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

Start date: May 17, 2020
Phase:
Study type: Observational

MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

NCT ID: NCT04193202 Completed - Chronic Cough Clinical Trials

Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

Start date: May 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.

NCT ID: NCT04193176 Completed - Chronic Cough Clinical Trials

Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)

Start date: May 10, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of gefapixant, in improving symptoms of cough-induced stress urinary incontinence (SUI) in adult female participants with refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in reducing the frequency of cough-induced SUI episodes over 12 weeks.

NCT ID: NCT04177108 Completed - Clinical trials for Triple-Negative Breast Cancer

A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

NCT ID: NCT04166890 Completed - Drug Effect Clinical Trials

Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia

ECA
Start date: September 4, 2018
Phase: Phase 4
Study type: Interventional

In the complexity of the Dental care the third molar surgery is one of the most common procedures, it is indicated for multiple reasons like infections in root canal, prosthetics or even esthetical purposes. This surgery can be safely performed with the help of local anesthetics, due to their quick action, and reversibility to control pain, reducing possible complications during and after the surgeries. Among the different types of local anesthetics used in dentistry, the articaine bears characteristics that provide some advantages compared to similar anesthetics like Lidocaine, being one of the most used anesthetics worldwide. Different authors have concluded that it is a safe when used in patients at different ages and it is effective as a local anesthetic in the majority of procedures. It is important for dentists to know the differences or similarities of anesthetics in terms of their effects, safety, dosages required in patients undergoing surgical removal of teeth, as well as the mechanism of action and pharmacological properties, in order to take advantage of its benefits and minimize risks. This study aims to test the efficacy and safety of an anesthetic solution, based on the same active molecule, articaine, manufactured by two different commercial houses, one domestic and one international, in order to gather scientific evidence and to show that they are not different. This will provide scientific results to help in the selection of any of these brands to be used with confidence in the dental practice. This will strengthen the collaboration between the academy and the companies, which would allow them to improve the quality of their products. Locally there are no studies available comparing the articaine-type anesthetic with epinephrine at the same concentration, manufactured locally by a national company, to a foreign one, which is an important opportunity to expand the knowledge and create scientific reports, about what a local anesthetic is and what it does. Finally, this study would contribute to the need to guarantee the quality of medicines in Colombia, by means of compliance with the legal provisions contemplated in resolution 1890 of November 2001 and 1400 of August 2001, issued by the Ministry of Health of Colombia : "Requirements to demonstrate the therapeutic effectiveness, through studies of Bioavailability and Bioequivalence of medicines for a special group of them.

NCT ID: NCT04156620 Completed - Clinical trials for Ankylosing Spondylitis

Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA

Start date: December 11, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this global study was to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in participants with active ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA ) at Week 16 despite current or previous non-steroidal anti inflammatory drugs (NSAID), disease-modifying antirheumatic drugs (DMARD) and/or anti Tumor Necrosis Factor (TNF) therapy. In addition, to further support efficacy and safety of an i.v. regimen, data was collected for up to 52 weeks of treatment.

NCT ID: NCT04119843 Completed - Clinical trials for Severe Renal Impairment

Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

SPARKLE
Start date: February 19, 2020
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.