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NCT ID: NCT03626688 Recruiting - Hypertension Clinical Trials

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Start date: August 30, 2018
Phase: Phase 3
Study type: Interventional

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

NCT ID: NCT03623529 Recruiting - Septic Shock Clinical Trials

A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock

Start date: August 2018
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.

NCT ID: NCT03623295 Recruiting - Hemophilia Clinical Trials

The Dynamic Interplay Between Bleeding Phenotype and Baseline Factor Level in Moderate and Mild Hemophilia A and B

DYNAMO
Start date: January 1, 2018
Phase:
Study type: Observational

There are large inter-individual differences in the bleeding pattern of patients with moderate or mild hemophilia. The major determinant of bleeding phenotype is the level of coagulant factor VIII or IX. In hemophilia A, studies addressing the association between factor VIII level and the clinical bleeding pattern yield conflicting results. In hemophilia B such studies have not yet been performed. The primary aim of this project is to analyze the association between factor VIII and factor IX levels and the bleeding phenotype. The secondary aim is to analyze potential differences in phenotype between hemophilia A and B. The project is a multicentre observational cohort study. We will include 500 patients with moderate or mild hemophilia A (FVIII 0.02-0.35 IU/mL) and 500 patients with moderate or mild hemophilia B (FIX 0.02-0.35 IU/mL) who are 12 to 55 years old. The main cohort study consists of clinical data collection, one blood sample and an online questionnaire for patients. Data will be collected on the nature and duration of all bleeding episodes, disease and treatment characteristics, physical activity level and musculoskeletal status. One blood withdrawal will be performed for centralized laboratory assays for FVIII or FIX levels (both one-stage and chromogenic assays) and genetic analysis for the most prevalent prothrombotic mutations. The online questionnaire for patients focuses on bleeds experienced in the past. A subset of 200 patients aged 24 years or older (100 with moderate or mild hemophilia A and 100 with moderate or mild hemophilia B) will be investigated in more detail by longitudinal data collection including analysis of physical joint status, MRI imaging of joints and biomarkers for joint damage. This longitudinal observation will consist of two time points that lie two years apart, allowing us to identify any changes that occur over the observed time period with respect to joint status.

NCT ID: NCT03621618 Recruiting - Sepsis Clinical Trials

Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.

Start date: March 31, 2019
Phase: N/A
Study type: Interventional

The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. A secondary aim is the assessment of the influences of vasopressors and inotropic drugs on Eadyn, as a parameter of ventriculo-arterial coupling.

NCT ID: NCT03621566 Recruiting - Central Sleep Apnea Clinical Trials

Belgian Central Sleep Apnea REgistry

B-CARE
Start date: June 25, 2018
Phase:
Study type: Observational [Patient Registry]

This study evaluates different factors that determine the treatment choice and treatment compliance in patients with central sleep apnea. All patients will receive routine care (registry).

NCT ID: NCT03614767 Recruiting - Overactive Bladder Clinical Trials

Sacral Neuromodulation & Urodynamics

Start date: August 1, 2017
Phase:
Study type: Observational

In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR). Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy

NCT ID: NCT03614754 Recruiting - Clinical trials for Overactive Bladder, Non Obstructive Urinary Retention

Sacral Neuromodulation and Pudendal Somatic Afferents

Start date: August 1, 2017
Phase:
Study type: Observational

Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is. This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.

NCT ID: NCT03614000 Recruiting - Clinical trials for Autism Spectrum Disorder

Early Screening of Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.

Start date: January 12, 2018
Phase: N/A
Study type: Interventional

A significant group of children with functional constipation (FC) continues to have symptoms despite recommended standard therapy. Underlying psychiatric problems could explain therapy resistance. However, a work-up for psychiatric problems is only recommended after unsuccessful 6 months standard therapy. Earlier detection and check-up could lead to faster start-up of a more adequate therapy. Therefore, we investigate the prevalence of emotional, behavioural and social problems in the FC-population at the first contact with a paediatric gastroenterologist in a tertiary care hospital.

NCT ID: NCT03612089 Recruiting - Low Back Pain Clinical Trials

From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain

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

To delineate the underlying mechanisms that contribute to chronic low back pain, by extending our knowledge on structural characteristics of the lumbar multifidus muscle using ultrasound muscle imaging, and by examining the association of structural features with functional performance, more precisely proprioceptive control.

NCT ID: NCT03608046 Recruiting - Clinical trials for Colorectal Neoplasms, Malignant

Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer

AVETUXIRI
Start date: October 3, 2018
Phase: Phase 2
Study type: Interventional

Cancer immunotherapy with immunostimulatory antibodies targeting the CTLA-4 or PD-1/PD-L1 pathways has demonstrated its efficacy in variable proportions of cancer. For metastatic colorectal cancer (mCRC) it appeared that only the small subgroup of patients with MSI-H tumors (microsatellite instability-high phenotype) had a clinically meaningful response to the anti-PD-1- L1 antibodies. In the majority group of non-MSI-H CRC (90-95% of patients), current research expect that additional means would be able to render the tumor "immunogenic" (like MSI-H CRC) and increase the intratumoral immune infiltrate which is the prerequisite to observe a benefit from PD1-PD-L1 inhibitors. Combinations of immune checkpoint inhibitors and procedures that increase intratumoral immune responses, such as targeted therapy, are actively explored.