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NCT ID: NCT04595370 Completed - Heart Failure Clinical Trials

Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease

MIRACLE
Start date: January 26, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 60%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between ≥ 20 and ≤ 60 mL/min/1.73 m^2, with at least 20% of participants with eGFR ≥ 20 to <30 mL/min/1.73^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m^2]).

NCT ID: NCT04593992 Completed - Clinical trials for Diabetic Polyneuropathy

HTEMS Treatment of Diabetic Polyneuropathy

HTEMS-RCT
Start date: October 20, 2020
Phase: N/A
Study type: Interventional

So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.

NCT ID: NCT04593251 Completed - Celiac Disease Clinical Trials

Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

Start date: September 28, 2020
Phase: Phase 1
Study type: Interventional

This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.

NCT ID: NCT04592419 Completed - Macular Edema Clinical Trials

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

BEACON
Start date: September 25, 2020
Phase: Phase 3
Study type: Interventional

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

NCT ID: NCT04592042 Completed - Emotional Distress Clinical Trials

Intervention to Improve Coping With Negative Emotions in Patients With Psychosis (Feel-Good-Study)

Start date: January 8, 2021
Phase: Early Phase 1
Study type: Interventional

The aim of the present single-centered pre-post study is to assess the feasibility and to investigate the putative efficacy of an emotion-oriented group intervention for patients with psychosis. Patients with early psychosis in an inpatient unit receive a manualized group intervention focussing on emotional stability and emotion regulation (8 weekly sessions). Assessment will be performed at pre-therapy, post-therapy (after eight sessions and four weeks) and after a follow-up period of 12 weeks (8 weeks post therapy) and includes personal therapy goals and their realization, psychopathology, social functioning and emotion regulation skills as a putative mediator of change.

NCT ID: NCT04590937 Completed - Healthy Clinical Trials

A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body

Start date: October 20, 2020
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to investigate the effect of BI 730357 under steady state conditions on the pharmacokinetics of digoxin, furosemide, metformin and rosuvastatin given as a cocktail (Reference, R: cocktail alone; Test T: cocktail given under steady state conditions of BI 730357).

NCT ID: NCT04590898 Completed - Stroke Clinical Trials

Peri-device Leakage Closure After LAAO

Start date: September 27, 2020
Phase:
Study type: Observational

The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.

NCT ID: NCT04589962 Completed - Clinical trials for Surgical and the Percutaneous Approach to the Upper Extremity Access

SUrgical Versus PERcutaneous AXillary Artery International Registry

Start date: October 9, 2020
Phase:
Study type: Observational

The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.

NCT ID: NCT04587947 Completed - Clinical trials for Heart Failure Patients

Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with implantable cardioverter defibrillators. Patients suffering from heart failure with reduced ejection fraction show impaired heart rate variability, knowing that in these patients such impairment is highly associated with an increased risk of sudden cardiac death. In its pivotal study, sacubitril/valsartan demonstrated a significant advantage over enalapril in terms of cardiovascular mortality and rehospitalization. Against this background, this study was designed to analyze the largely unknown electrophysiological effects of sacubitril/valsartan on the autonomic cardiac nervous system by determining heart rate variability.

NCT ID: NCT04587427 Completed - Clinical trials for Bone Metastatic Castration-resistant Prostate Cancer

A Study to Learn More About How Radium-223 is Being Used With Other Treatments in European Patients Who Have Not Received Radium-223 Before

DIRECT
Start date: May 15, 2021
Phase:
Study type: Observational

In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones. The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed. In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis. The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants' medical records up to December 2020. The researchers will review information from the participants' medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions. They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants' who received radium-223 before the new instructions and those who received it after the new instructions. There are no required visits or tests in this study.