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NCT ID: NCT02914600 Terminated - Crohn's Disease Clinical Trials

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

DIVERSITYLTE
Start date: March 17, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

NCT ID: NCT02913729 Terminated - Breast Cancer Clinical Trials

Pre- Versus Postoperative Accelerated Partial Breast Irradiation

PAPBI-2
Start date: November 10, 2016
Phase: N/A
Study type: Interventional

Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

NCT ID: NCT02906124 Terminated - Pregnancy Clinical Trials

Study to Evaluate the Safety of Repatha® in Pregnancy

Start date: January 12, 2017
Phase:
Study type: Observational

To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months

NCT ID: NCT02905396 Terminated - Clinical trials for Small Fiber Neuropathy

Spinal Cord Stimulation in Small Fibre Neuropathy

SFN-SCS
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. So far, the results of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents have been developed. This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or at least much improved or very much improved, on the Patient Global Impression of Change (PGIC) for pain and sleep.

NCT ID: NCT02895945 Terminated - Hemophilia A Clinical Trials

BAX 802 in CHA With Inhibitors

CHAWI
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.

NCT ID: NCT02895100 Terminated - Ulcerative Colitis Clinical Trials

Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).

NCT ID: NCT02888756 Terminated - HIV Infections Clinical Trials

iHIVARNA Clinical Trial in HIV Infected Individuals

iHIVARNA-01
Start date: April 4, 2017
Phase: Phase 2
Study type: Interventional

iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients based on in vivo modification of DCs. It consists of HIVACAT-TriMix: mRNA encoding a mixture of APC activation molecules (CD40L, a constitutively active variant of TLR4 and CD70) and the HIV target antigens contained in HIVACAT to be administered through the intranodal route. iHIVARNA-01 aims to achieve the 'functional cure' of HIV infection, i.e. controlling viral replication in the absence of anti-retroviral therapy.

NCT ID: NCT02872298 Terminated - Asthma Clinical Trials

Evaluating the Safety and Feasibility of TLD for the Treatment of Severe Asthma

RELIEF-1
Start date: December 22, 2017
Phase: N/A
Study type: Interventional

Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma.

NCT ID: NCT02856373 Terminated - Clinical trials for Arrhythmias, Cardiac

Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias

Redress VT
Start date: March 3, 2015
Phase: Phase 2
Study type: Interventional

Rationale: Sympathetic activity plays an important role in the pathogenesis of ventricular tachyarrhythmia. Previous studies have shown evidence of significant heritable influences on individual responses to adrenergic stimulation. Catheter-based renal sympathetic denervation (RDN) is a novel treatment option for patients with resistant hypertension, proved to reduce local and whole-body sympathetic activity. The investigators hypothesize that percutaneous transluminal electrical stimulation of the sympathetic nerve bundles in the renal arteries will cause ventricular arrhythmias and renal denervation will suppress these arrhythmias in patients with sympathetic ventricular arrhythmias. Objective: This study will investigate the effects of renal nerve stimulation before and after percutaneous transluminal RDN on cardiac excitable properties including induction of ventricular tachy-arrhythmias before and after RDN in six studies, i.e. patients with catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome and arrhythmogenic right ventricular cardiomyopathy (ARVC), sympathetically driven ventricular arrhythmias, hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM). The aim of the six studies is to assess the anti-arrhythmic effects of RDN in patients with sympathetic ventricular tachy-arrhythmias. Study design: Investigator initiated, multi centre, six pretest-posttest design studies. Study population: Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-85 year. Intervention: RDN will be performed according to routine clinical practice. Prior to the ablation procedure, catheter mapping of the renal arteries will be performed according to routine clinical practice. Clinical and biological responses to transluminal electrical renal nerve stimulation will be assessed before and after RDN. Study endpoints: - Main procedural study endpoint: Induction of ventricular arrhythmias in response to renal nerve stimulation prior to RDN and absence of renal nerves stimulation induced ventricular arrhythmias after RDN. - Main clinical study endpoint: Development of ventricular arrhythmia during exercise stress testing performed 6 months after procedure. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In several studies, it was shown that RDN was safe. The intervention resulted in significantly better control of blood pressure with less medication, and beneficial changes in heart rate variability, autonomic sympathetic balance, renal arteriolar function, and a higher success of atrial fibrillation prevention. In case reports and case series, RDN had a favourable effect in patients with sympathetic drug refractory ventricular tachy-arrhythmias.

NCT ID: NCT02855164 Terminated - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)

FLIGHT-FXR
Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH