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NCT ID: NCT03979274 Completed - Healthy Clinical Trials

A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers

Start date: December 6, 2019
Phase: Phase 1
Study type: Interventional

The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.

NCT ID: NCT03978520 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

SLEek
Start date: July 25, 2019
Phase: Phase 2
Study type: Interventional

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

NCT ID: NCT03976466 Completed - Infection Clinical Trials

Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors.

Stimulan
Start date: May 22, 2019
Phase: Phase 4
Study type: Interventional

To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group. To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.

NCT ID: NCT03974802 Completed - Myopia Clinical Trials

Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

Start date: May 14, 2019
Phase: N/A
Study type: Interventional

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

NCT ID: NCT03974581 Completed - Clinical trials for Myocardial Infarction, Acute

Pharmacoinvasive Strategy vs. Primary PCI in STEMI: A Prospective Registry in a Large Geographical Area

PHASE-MX
Start date: April 30, 2018
Phase:
Study type: Observational [Patient Registry]

For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking, especially in developing countries. The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.

NCT ID: NCT03969901 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)

Start date: October 8, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.

NCT ID: NCT03969212 Completed - Influenza Clinical Trials

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Start date: October 10, 2019
Phase: Phase 3
Study type: Interventional

Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

NCT ID: NCT03966365 Completed - Glaucoma Clinical Trials

Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®

PRO-122/I
Start date: May 2, 2019
Phase: Phase 1
Study type: Interventional

Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension. Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects. Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized. Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.

NCT ID: NCT03965052 Completed - Glaucoma Clinical Trials

Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®

PRO-179/I
Start date: April 24, 2019
Phase: Phase 1
Study type: Interventional

Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects. Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects. Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.

NCT ID: NCT03964987 Completed - Clinical trials for Gestational Diabetes

Pancreatic Duodenal Homeobox Factor-1 (PDX-1) and Neurogenin-3 (NGN-3) in Gestational Diabetes

Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

Introduction: Depletion of the ability of the cells ß to secrete the amount of insulin required by pregnancy, increasing the risk of develop Gestational Diabetes Mellitus (GDM). The aim was to contrast the messenger RNA (mRNA) expression of the pancreatic duodenal homeobox factor-1 (PDX-1) and Neurogenin-3 (Ngn-3) in peripheral blood of pregnant women with GDM versus women with normal pregnancies. Material and methods: This was a prospective, clinical and cross-sectional study, conforming two groups of pregnant women: a) patients with a healthy gestation and b) patients with GDM. Besides anthropometry and routine laboratorial test, real-time polymerase chain reaction (Real-Time PCR), was used to quantify the expression of PDX-1 and NGN-3.