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NCT ID: NCT04068181 Completed - Melanoma Clinical Trials

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Start date: January 22, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

NCT ID: NCT04067583 Completed - Clinical trials for Ophthalmology, Macular Degeneration

A Follow-up Physician Survey to Evaluate Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe

Start date: October 8, 2019
Phase:
Study type: Observational

With this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. The questionnaire will gather information related to physician characteristics and experience with Aflibercept, as well as assess physicians' knowledge and understanding of storage and preparation, proper injection technique, and the risks associated with Aflibercept injection into the eye (intravitreal injection). Analysis will be done using descriptive statistics.

NCT ID: NCT04067427 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training

Mental-AF
Start date: August 16, 2019
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.

NCT ID: NCT04066400 Completed - Clinical trials for Diabetes Mellitus, Type 2

Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis

NASH-ATI
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Effects of Wheat-based diet vs. ATI-free diet on NASH

NCT ID: NCT04065893 Completed - Clinical trials for Ventricular Tachycardia

Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

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

Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%. Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.

NCT ID: NCT04065464 Completed - Fertility Monitor Clinical Trials

TRACY - Track My Cycle

TRACY
Start date: July 3, 2019
Phase:
Study type: Observational

The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.

NCT ID: NCT04065295 Completed - Healthy Clinical Trials

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225

Start date: September 9, 2019
Phase: Phase 1
Study type: Interventional

The main objectives of the SRD part of this trial are to investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects following oral administration of single rising doses. The main objective of the BA part of this trial will be to explore the influence of food on the bioavailability of tablet fasted versus tablet fed

NCT ID: NCT04064242 Completed - Clinical trials for Pulmonary Sarcoidosis

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis

Start date: September 23, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this proof of concept study is to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.

NCT ID: NCT04062097 Completed - Clinical trials for Intracranial Hemorrhage

Registration of Idarucizumab for Patients With IntraCranial Hemorrhage

RIC-ICH
Start date: September 19, 2019
Phase:
Study type: Observational

This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".

NCT ID: NCT04061811 Completed - Heart Failure Clinical Trials

Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients

SONGBIRD
Start date: August 1, 2018
Phase:
Study type: Observational

Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis. Background: Dialysis patients are at increased risk of HF. However, diagnostic utility of NT-proBNP as a biomarker is decreased in patients on dialysis. GDF15 and cNEP are biomarkers of distinct mechanisms that may contribute to HF pathophysiology in such cohorts. Methods: We compare circulating concentrations of NT-proBNP, GDF15, and cNEP along with NEP activity in patients on chronic dialysis without and with HF, as diagnosed by clinical parameters and post-dialysis echocardiography. We use correlation, linear and logistic regression as well as receiver operating characteristic (ROC) analyses.