Clinical Trials Logo

Filter by:
NCT ID: NCT03664258 Completed - Clinical trials for Non-muscle-invasive Bladder Cancer

A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)

ANTICIPATE X
Start date: June 6, 2018
Phase:
Study type: Observational

Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).

NCT ID: NCT03664011 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How BI 730357 is Processed by the Body

Start date: September 10, 2018
Phase: Phase 1
Study type: Interventional

The main objectives of the study are as follows: - To assess the mass balance recovery of (C-14) BI 730357-radioactivity (also expressed as 14C-BI 730357-EQ) in urine and faeces after a single oral dose of 50 mg BI 730357 base (BS) (C-14) in healthy male subjects - To provide plasma, urine, and faecal samples for metabolite profiling and structural identification

NCT ID: NCT03663335 Completed - Clinical trials for Kidney Transplant Rejection

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

CIRRUS I
Start date: November 28, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients. This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.

NCT ID: NCT03662984 Completed - Clinical trials for Diastolic Dysfunction

Ciprofibrate and Pre-diabetes

FIT
Start date: November 1, 2018
Phase: Phase 3
Study type: Interventional

Free fatty acids (FFA) are the main fuel source in a healthy adult heart, since they are responsible for 70-80% of the myocardial ATP production. Plasma FFA and triglycerides (TG) levels are elevated in obesity and diabetes, evoking substrate competition in the heart: the increased availability of lipids will lead to fat accumulation in the heart, which is associated with cardiac insulin resistance and will therefore restrain insulin-stimulated cardiac glucose oxidation. It is shown that a lower myocardial glucose uptake correlates with decreased diastolic function. The benefits of counterbalancing this lipid overload is proven by previous research in pre-diabetes, which showed the reversibility of impaired myocardial substrate metabolism and improvement of function and structure after modest weight loss induced by lifestyle changes. Ciprofibrates are a ligand of the peroxisome proliferator-activated receptor (PPAR) α and are considered to be a major regulator of the lipid metabolism and promote fat oxidative capacity. They are not only effective in normalizing lipid-lipoprotein levels in patients with the metabolic syndrome, but improve also their insulin sensitivity. We therefore hypothesize that ciprofibrate administration in subjects with impaired glucose metabolism (IGM) influence the myocardial substrate metabolism (via the PPARα pathway) and thereby improve myocardial insulin sensivity.

NCT ID: NCT03662763 Completed - Clinical trials for Attention Deficit Disorder

Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity

SPD503-315
Start date: September 2011
Phase: Phase 3
Study type: Interventional

A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada and the US.

NCT ID: NCT03661528 Completed - Clinical trials for Acute Intracranial Hemorrhage

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

Start date: June 6, 2019
Phase: Phase 4
Study type: Interventional

Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

NCT ID: NCT03661320 Active, not recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Start date: November 6, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

NCT ID: NCT03659916 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

NCT ID: NCT03659448 Recruiting - Clinical trials for Colorectal Neoplasms

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

Start date: June 17, 2019
Phase: Phase 3
Study type: Interventional

The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

NCT ID: NCT03658759 Withdrawn - Clinical trials for Out-Of-Hospital Cardiac Arrest

Rapid Response VA-ECMO in Refractory Out-of-hospital Cardiac Arrest

RESuSCITATe
Start date: July 2, 2018
Phase:
Study type: Observational [Patient Registry]

A selected group of patients with refractory cardiac arrest may benefit from inhospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Many patients will have a coronary event that can be treated by angioplasty. However, up to now absence of ROSC poses a barrier for angioplasty, and most patients are therefore not even transported to a hospital. With the use of extra corporeal membrane oxygenation (ECMO) the circulation can be restored immediately, providing time to diagnose and treat the underlying cause of the cardiac arrest. International cohort studies show that a strategy of pre-hospital triage and transport to a cardiac arrest expertise center for "rapid-response" ECMO and coronary revascularization is feasible and improves survival. A clinical pathway will encompass intense cooperation and optimal logistics between several paramedical and medical disciplines, i.e. from prehospital ambulance service to intensive care. Incorporation of mechanical chest compressions devices (LUCAS™), rapid-response veno-arterial (VA-)ECMO (Cardiohelp, Maquet), and ECMO assisted revascularization in a dedicated clinical pathway will offer a potential lifesaving treatment option that is in accordance with the recommendations in the current Guidelines. The aim of the study is to investigate the feasibility of a new local clinical pathway in our hospital to provide ECPR for refractory OHCA patients.