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NCT ID: NCT04451772 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04450745 Completed - type1diabetes Clinical Trials

Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients

Start date: October 30, 2019
Phase: N/A
Study type: Interventional

Physical activity, along with proper nutrition, is the basis for the behavioral treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation. The aim of this study is the assessment of physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric parameters.

NCT ID: NCT04450394 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.

NCT ID: NCT04450329 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Start date: June 23, 2020
Phase: Phase 3
Study type: Interventional

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

NCT ID: NCT04449029 Completed - Hepatitis B Clinical Trials

A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)

B-Clear
Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.

NCT ID: NCT04448665 Completed - Clinical trials for Anti-Infective Agents

Compliance of Initial Empiric Antimicrobial Therapy

Start date: February 1, 2018
Phase:
Study type: Observational

Hospital infections comprise about half of all undesirable complications related to hospital treatment. In case of bacterial infection administration of antimicrobial agent is a therapy of choice. For maximum effectiveness, antimicrobial agents should be administered quickly in optimal doses. Moreover, the therapeutic concentration of properly selected drugs should be achieved as soon as possible. The relation between delays in the administration of antibiotics and increased mortality is well known. That is why proper empiric therapy is so important. Before antimicrobial investigation is completed, which may last up to 72 hours, a wide-spectrum antimicrobial should be administered according to the type of infection, its origin, and the characteristics of the local pathogens. The objective of this study is to compare the initial choice of empiric antimicrobial therapy and the results of both microbiological identification and susceptibility/resistance analysis of isolated pathogens. This project was designed as a prospective cohort study. Analysis was performed in a large multidisciplinary academic hospital and trauma center. All decisions on empiric therapy with antimicrobial used in infections caused by multidrug-resistant pathogens, that are made in different hospital wards except intensive care, are required by hospital procedures to be confirmed by intensivists. In our analysis, the initial choice of empiric therapy in the hospital wards other than the critical care unit was compared with the results of microbiological investigations and susceptibility/resistance analyses of isolated pathogens. Accurate microbial identification was performed with a VITEK® 2 automatic testing system. The microbroth dilution method with VITEK® 2 AST cards was used for the antibiotic susceptibility testing of isolated pathogens. Microbiological analyses were performed between 2018 and 2020 according to the regulations of the European Committee on Antimicrobial Susceptibility (EUCAST, version 9.0, 2019) and the National Reference Centre for Susceptibility Testing (NRCST, Warsaw, Poland).

NCT ID: NCT04444895 Completed - Angioedema Clinical Trials

A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

Start date: February 5, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).

NCT ID: NCT04442919 Completed - Unstable Angina Clinical Trials

Influence of METHoxyflurane on ANtiplatelet Effect of Ticagrelor in Patients With Unstable Angina Pectoris

METHANE
Start date: June 1, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite in patients who received ticagrelor followed with methoxyflurane versus ticagrelor followed with morphine or ticagrelor alone due to unstable angina pectoris

NCT ID: NCT04442269 Completed - Clinical trials for Allergic Bronchopulmonary Aspergillosis

Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)

Start date: September 15, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA). The secondary objectives of the study are: - To evaluate the effects of dupilumab on exacerbations in participants with ABPA - To evaluate the effects of dupilumab on ABPA-related exacerbations - To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent care visits in participants with ABPA - To evaluate the effects of dupilumab on asthma control in participants with ABPA - To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in participants with ABPA - To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and Aspergillus-specific IgE concentrations - To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels - To evaluate safety and tolerability of dupilumab in participants with ABPA - To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with ABPA

NCT ID: NCT04440592 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Start date: February 5, 2021
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52