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NCT ID: NCT05747820 Completed - Heart Failure Clinical Trials

Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure

EVOLUTION
Start date: September 28, 2022
Phase:
Study type: Observational

This observational study is conducted to assess the evolution of multiple markers of congestion over 4 weeks after a worsening heart failure (WHF) event treated in an outpatient unit

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05622058 Terminated - Clinical trials for Prevention of Chemotherapy-induced Myelosuppression

A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer

Start date: January 9, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are not dividing may be spared from chemotherapy damage and the patient should have less side effects.

NCT ID: NCT05535946 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT - Maintenance

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

NCT ID: NCT05520957 Completed - Clinical trials for Metabolic Disturbance

Early SARS-CoV-2 Tracheostomy

Start date: January 1, 2020
Phase:
Study type: Observational

Objective of this case series was to evaluate the characteristics of early COVID-19 tracheostomy and its effect on laboratory parameters. A series of 17 patients with COVID-19undergo surgical tracheostomy in our intensive care unit. Demographic parameters, duration indicators, and laboratory parameters before and after tracheostomy were analyzed in patients. Of the 17 patients, 4 were men and 13 women with a mean age of 59 years. The average length of total hospitalization were 12 days, the length of stay in intensive care were 10 days, the length of endotracheal intubation were 9 days, with the seventh day of tracheotomy. Neurological and thyroid diseases and withdrawal had a statistically significant difference (p <0.05), with laboratory parameters without statistically difference. Critically ill COVID-19 patients undergoing early tracheostomy has a lower possibility of weaning from mechanical ventilation, and early tracheostomy itself has no significant effect on renal parameters, lactate and D-Dimer.

NCT ID: NCT05507216 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

Start date: December 21, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

NCT ID: NCT05496816 Completed - Sepsis Clinical Trials

Coagulation Disturbances in COVID-19 Septic Patients

Start date: January 1, 2021
Phase:
Study type: Observational

Objective of this study was to determine the relationship between CAC and septic condition in COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP), fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill patients.

NCT ID: NCT05485259 Completed - Clinical trials for Low-Grade Squamous Intraepithelial Lesions

Effect of Alpha-lipoic Acid on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

Low-grade squamous intraepithelial lesions (LSIL) are premalignant changes on the cervix that can lead to malignant changes, i. e. cervical cancer. Alpha-lipoic acid is a fatty acid that is naturally found in food, and due to its proven antioxidant and anti-inflammatory effects, it is increasingly used as a dietary supplement, most often to alleviate the symptoms of various neuropathic conditions. The purpose of this study was to demonstrate efficiency, safety, and clinical benefit of alpha lipoic acid (ALA) in inducing regression of LSIL. The hypothesis is based on the proven role of oxidative stress and inflammation in formation of LSIL and anti-inflammatory and antioxidative efficiency of ALA. The study was designed as randomized, double-blind, two-arm, placebo-control trial recruiting 100 female patients with diagnosed LSIL. Patients received 600 mg/day of ALA or placebo for 3 months. Progression/regression of LSIL has been defined as primary outcome of the study; inflammation markers and oxidative stress parameters have been defined as secondary outcomes of the study.

NCT ID: NCT05479565 Completed - Clinical trials for Gestational Diabetes

Relationship of Reduced Arterial Stiffness and Hs-CRP With GDM.

Start date: September 1, 2020
Phase:
Study type: Observational

Research hypotheses 1. The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women. 2. The values of highly sensitive CRP in pregnant women with gestational diabetes are higher compared to healthy pregnant women. 3. The arterial stiffness in test subjects with previous gestational diabetes was reduced compared to test subjects with a previously normal OGTT during pregnancy. 4. The values of highly sensitive CRP in subjects with previous gestational diabetes are higher compared to subjects with previously normal OGTT during pregnancy.

NCT ID: NCT05460832 Completed - Clinical trials for Rheumatoid Arthritis

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA

Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage. The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate. Approximately 224 participants with moderate to severe active RA who have not responded to treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world. Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40 mg) or placebo (a "dummy" drug). The maximum duration of study participation for a participant will be 22 weeks, which consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a Follow-up Period of 6 weeks. Participants on the study will be asked to attend the hospital or clinic for regular visits during which they will have planned study assessments to evaluate the effectiveness, tolerability and safety of the study drug.