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NCT ID: NCT05107622 Recruiting - Periodontitis Clinical Trials

Administration of L. Paracasei 28.4 as an Adjunct to the Treatment of Periodontitis

Start date: August 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the effects of probiotic administration of L. paracasei 28.4 as an adjunct to the non-surgical periodontal treatment in patients with periodontitis.

NCT ID: NCT05102396 Recruiting - Skin Diseases Clinical Trials

Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect?

TODAY
Start date: September 26, 2022
Phase: Phase 2
Study type: Interventional

The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.

NCT ID: NCT05101187 Recruiting - Clinical trials for Invasive Aspergillosis

Olorofim Aspergillus Infection Study

OASIS
Start date: March 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

NCT ID: NCT05100862 Recruiting - Clinical trials for Marginal Zone Lymphoma

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

MAHOGANY
Start date: March 10, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.

NCT ID: NCT05099172 Recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

Start date: October 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment, BAY2927088, is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC. The main purpose of this study is to learn: Escalation, Backfill, and Expansion Part: - How safe is BAY2927088 for the participants? - What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants? - How does BAY2927088 move into, through, and out of the bodies of the participants? For this, the researchers will measure the followings: - The number of participants with medical problems, also called adverse events and serious adverse events, and their severity - The number of participants who discontinue study treatment due to an adverse event. - The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088 - Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level - The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY 2927088 - The (average) highest level of BAY 2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part - How well does BAY 2927088 work in participants? For this, the researchers will measure the following: • Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor. This study has 4 parts: - The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive. - The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY 2927088 that work well and are safe to be tested in the next part. - The expansion part aims to determine the dose of BAY2927088 to be tested in further studies. - The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well. The participants in this study will take the study treatment BAY2927088 in 3-week periods called "cycles". They will in general take BAY2927088 once or twice daily as a liquid/tablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle. During the study, the study team will: - take blood and urine samples, - check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans, - check the participants' overall health and heart health, - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is considered "serious" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.

NCT ID: NCT05097989 Recruiting - Lupus Nephritis Clinical Trials

Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Start date: January 14, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years. Safety will be monitored throughout the study.

NCT ID: NCT05097287 Recruiting - Asthma Clinical Trials

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

ATLAS
Start date: December 16, 2021
Phase: Phase 4
Study type: Interventional

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

NCT ID: NCT05092165 Recruiting - Acute Kidney Injury Clinical Trials

Methylene Blue for the Prevention of Hypotension During Hemodialysis

BLUE
Start date: October 21, 2021
Phase: Phase 2
Study type: Interventional

Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients. This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.

NCT ID: NCT05092152 Recruiting - Clinical trials for Acute Respiratory Failure

Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients

PROMINA
Start date: October 15, 2021
Phase: Phase 2
Study type: Interventional

Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.

NCT ID: NCT05090891 Recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva (FOP)

To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

Progress
Start date: May 5, 2022
Phase: Phase 2
Study type: Interventional

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).