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NCT ID: NCT03669588 Completed - Clinical trials for Generalized Myasthenia Gravis

An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

ADAPT
Start date: August 22, 2018
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

NCT ID: NCT03668314 Completed - Healthy Clinical Trials

Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects

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

A three (3) part study to evaluate the safety, tolerability and PK of RDN-929

NCT ID: NCT03668119 Completed - Pan Tumor Clinical Trials

A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

CheckMate 848
Start date: October 31, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

NCT ID: NCT03666013 Completed - Muscle Weakness Clinical Trials

Mitochondria and Muscle Health in Elderly

ELMIH
Start date: June 27, 2017
Phase:
Study type: Observational

The aim of this study is to characterize the relation between skeletal muscle mitochondrial metabolism and muscle health in elderly, physically compromised humans. To study this relation, a cross-sectional study will be performed in well-defined, distinct subject groups. Thus, to obtain insight in the relation between mitochondrial health and muscle function, not only subjects that differ in mitochondrial function (based on physical activity) will be compared but also subjects with high- versus low muscle function will be selected.

NCT ID: NCT03665168 Completed - Palliative Medicine Clinical Trials

A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs

MuSt-PC
Start date: September 1, 2018
Phase:
Study type: Observational

A nationwide, cross-sectional study, to determine the prevalence of symptoms of patients in the palliative phase in various care settings will be performed within a set period of two weeks in September 2018 and two weeks in November 2018. The participating settings will be selected by a total of seven coordinators, one for each consortium of palliative care in the Netherlands. To identify common combinations of symptoms and for multidimensional screening the Utrecht Symptom Diary-4 Dimensional (USD-4D) and Utrecht Symptom Diary (USD), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used. The current protocol focuses on the cross-sectional study.

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.