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NCT ID: NCT05570409 Recruiting - Clinical trials for Inflammatory Cardiomyopathy

Immunosuppressive Treatment in Chronic Virus-Negative Inflammatory Cardiomyopathy

TRINITY
Start date: March 28, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Evaluating Immunosuppressive treatment (Mycophenolate mofetil and prednisolon compared to placebo) for 6 months in patients with chronic virus- Negative Inflammatory cardiomyopathy - a multicenter, randomized, double-blind, placebo-controlled trial.

NCT ID: NCT05570110 Recruiting - Unipolar Depression Clinical Trials

Enoxolone in Major Depression - Biomarker-outcome Relationship

Start date: September 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Many different forms of depression exist. It is difficult to predict to what treatment a given patient with depression responds. Studies demonstrate that biomarkers can help to distinguish different forms of depression. Simple markers, like aldosterone/cortisol in body fluids, blood pressure and inflammation markers , have been identified as predictors of therapy resistance in depression. Enoxolone is a molecule derived from the licorice plant and has demonstrated an effect on these biomarkers, which may imply an improved response. The current randomized placebo controlled study is assessing whether the presence of markers of therapy resistance can predict a preferential effect of enoxolone vs. placebo on clinical outcome. Secondarily, it is tested whether these markers change differentially in the treatment groups. Finally, the relationship between the change of the markers and clinical change will be assessed.

NCT ID: NCT05569005 Recruiting - COPD Clinical Trials

Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.

Start date: December 16, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the slowing of the disease progression including the improvement of Chronic Obstructive Pulmonary Disease (COPD) symptoms in smoking subjects with mild to moderate COPD and a history of chronic bronchitis symptoms (sputum and cough) who switch to the Tobacco Heating System (THS) as compared to those who continue to smoke cigarettes.

NCT ID: NCT05568459 Recruiting - Hemophilia B Clinical Trials

A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy

Honey-B
Start date: January 17, 2024
Phase:
Study type: Observational

This study is focused on males who have Hemophilia B and who need regular preventive treatment with factor IX protein (FIX) replacement therapy to prevent and also to control their bleeding events. The aim of the study is to gather at least 6 months of information on bleeding events for each individual participant while they continue to use their usual FIX replacement therapy. There is no experimental treatment being tested in this study. The study is informational, and part of a larger program to understand and treat Hemophilia B with a potential experimental new therapy in the future. There is no obligation to agree to taking part in this future study. The study is looking to answer several other research questions to help understand each participant's individual disease characteristics, including: - How often to use FIX replacement therapy, both on a regular basis (prophylaxis) and as needed to treat bleeding events - Measurement of FIX activity (factor IX is a clotting factor) by different laboratories using different types of tests in Hemophilia B participants - Possible complications from the FIX replacement therapy the patient receives (usual standard of care will continue to be used) - How quality of life is affected by Hemophilia B - How joint health is affected by Hemophilia B - How often the participant visits the emergency room, urgent care center, physician's office, hospital, or has a telemedicine visit as a result of bleeding events - Whether the body makes antibodies (a protein produced by the body's immune system) against the FIX replacement therapy you receive, which could make the drug less effective or could lead to side effects

NCT ID: NCT05568225 Recruiting - Clinical trials for Very Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-R

A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)

Start date: November 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of etavopivat (FT-4202) for the treatment of anemia in adult patients with very low risk, low risk, or intermediate risk MDS.

NCT ID: NCT05566795 Recruiting - Low-grade Glioma Clinical Trials

DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Start date: February 27, 2023
Phase: Phase 3
Study type: Interventional

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.

NCT ID: NCT05565794 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements

Start date: November 11, 2022
Phase: Phase 2
Study type: Interventional

The aim of this phase II study is to determine whether pemigatinib is clinically efficious after curative local therapy such as surgery/ SBRT or ablation in iCCA patients harboring FGFR2 fusion/rearrangement and to assess the safety profile to support the continuation of the concept in a large, randomized trial for further development.

NCT ID: NCT05565378 Recruiting - Clinical trials for Lung Cancer, Non-Small Cell

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

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

This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] ≥ 50%), previously untreated, unresectable, locally advanced or metastatic NSCLC. Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

NCT ID: NCT05564754 Recruiting - Hypoxia, Brain Clinical Trials

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

STEPCARE
Start date: August 17, 2023
Phase: N/A
Study type: Interventional

The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.

NCT ID: NCT05564104 Recruiting - Hepatic Impairment Clinical Trials

A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Behaves in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function

Start date: April 5, 2023
Phase: Phase 1
Study type: Interventional

Cagrilintide is under development for weight management. In the development of cagrilintide, it is important to see if liver function influences how the body absorbs, breaks down, and eliminates cagrilintide. This will be tested in this study by comparing the blood levels of cagrilintide in people with reduced liver function to those of people with normal liver function. Cagrilintide is a long-acting study medicine that resembles one of the body's own hormones called amylin that is involved in regulation of food intake and body weight. It is the hope that cagrilintide can help participants with weight management. Both the participant and the study doctor will know what treatment is being provided to the participant. All participants will receive a single dose of 0.9 milligrams (mg)cagrilintide. The study medicine will be given in the form of an injection in a skinfold of the belly (subcutaneous). The study will last up to 10 weeks. If participants are eligible for this study, they will come to the clinic a total of 7 times and stay in the clinic for 7 days (6 nights). Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective contraception and will be counselled on the use of contraception.