Clinical Trials Logo

Filter by:
NCT ID: NCT03911258 Enrolling by invitation - Cystic Fibrosis Clinical Trials

Epidemiology of the Nasal Flora at the Reference Center for Cystic Fibrosis of Queen Fabiola Children's University Hospital.

FLONAMUC
Start date: February 6, 2019
Phase: N/A
Study type: Interventional

Cystic fibrosis (CF) is the most common autosomal recessive inherited genetic disorder in North America, Australia and Europe. CF is due to cystic fibrosis transmembrane conductance regulator gene mutation (CFTR) coding for a chloride channel located at the apical membrane of epithelial cells. The most common mutation is the deletion of the amino acid phenylalanine at the codon 508 (ΔF508) affecting 70% of the patients. The CFTR channel participates in the regulation of the volume and composition of exocrine secretions. At the level of the lungs, this results in a thickening of the mucus with a dysfunction of the mucociliary clearance promoting colonization of pathogenic microorganisms. Patients with cystic fibrosis therefore have a natural susceptibility to develop acute and then chronic respiratory infections, gradually leading to irreversible respiratory tract lesions called bronchiectasis. Different germs such as Haemophilus influenzae and Staphylococcus aureus colonize the airways early in life. The progression of the disease causes furthermore a colonization by opportunistic germs such as Pseudomonas aeruginosa and Burkholderia cepacia, which are associated with higher mortality. Pulmonary exacerbation is a common complication of CF requiring administration of antibiotics. The choice of these antibiotics depends on the germs that the patient carries in his respiratory tract. The type of sampling and the conditions under which they are taken are therefore very important. Sputum and oropharyngeal smear are used in adolescents and children respectively to collect respiratory secretions in clinical routine. The recent literature describes induced sputum, obtained after a physiotherapy session and a hypertonic serum aerosol, as superior to the oropharyngeal smear alone and equivalent to bronchoalveolar lavage for the evaluation of the microbiological profile of patients who cannot expectorate. However, this technique takes time and requires the presence of a physiotherapist. Bronchoalveolar lavage is reserved for complex cases that do not respond to standard treatments. Finally, the nasal flora appears to be involved in the colonization of the lower respiratory tract. Sinuses are described as reservoirs of germs that can induce a recolonization of the lungs despite eradication of the germ (for example after a pulmonary transplantation) . To our knowledge, no study has investigated the involvement of nasal flora in the clinical course of children with CF.

NCT ID: NCT03910920 Enrolling by invitation - Cystic Fibrosis Clinical Trials

Cross Transmissions of Pseudomonas Aeruginosa Between Children From a Same Cystic Fibrosis Center.

PAPED
Start date: February 6, 2019
Phase:
Study type: Observational

Cystic fibrosis is the most common hereditary autosomal recessive disease in the Caucasian population. The diseases is caused by a mutation of the gene coding for the CFTR protein (Cystic fibrosis transmembrane conductance regulator), an ion channel present at the apical pole of the epithelial cells. The channel dysfunction induces a deficit in hydration and a hyperviscosity of different exocrine secretions. Clinically, Cystic fibrosis is a multi-systemic disease. Pulmonary and pancreatic involvement are classically in the foreground. Degradation of respiratory function, associated with acute and chronic infections, represents the major cause of morbidity and mortality. Pseudomonas aeruginosa is a ubiquitous gram-negative bacillus found primarily in stagnant water. Pseudomonas aeruginosa is capable of colonizing the digestive, pulmonary and urinary mucosa and the skin. This bacterium is incriminated in many opportunistic infections including respiratory infections in patients with cystic fibrosis. Pseudomonas aeruginosa infection is the most common parenchymal lung infection in the Cystic fibrosis community. Pseudomonas aeruginosa chronic carriage represents a factor of poor prognosis associated with an increase in morbidity and mortality. Complications related to chronic carriage of Pseudomonas aeruginosa justify the implementation of strategies of eviction, screening and eradication of acute Pseudomonas aeruginosa infection. In addition to Pseudomonas aeruginosa contamination of patients via the environment, hand and airborne infections between patients with Cystic fibrosis have been reported. Measures to eliminate cross-transmissions have therefore been implemented in a majority of hospitals. The aim of the study is firstly to identify the number of Pseudomonas aeruginosa cross-transmissions between patients with Cystic fibrosis followed-up in Cystic fibrosis center of HUDERF. Investigator will use the Pulsed-Field Gel Electrophoresis to assess the possibility of cross-infection. Depending on the results, Investigator will implement new strategies to avoid future cross-contamination in our different places of care (consultation, hospitalization, physiotherapy…).

NCT ID: NCT03891446 Enrolling by invitation - Ocular Hypertension Clinical Trials

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Maia
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

NCT ID: NCT03883243 Enrolling by invitation - Neoplasms Clinical Trials

Monitoring and Telecoaching of Physical Activity in Patients With Stage III and IV Non-small Cell Lung Cancer

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

This study is a prospective non-randomised control study to evaluate the efficacy of a physical activity promotion program on the experience of physical activity in patients with stage III and IV non-small cell lung cancer (NSCLC) with documented disease control (stable disease, partial or complete response defined by RECIST V1.1) at least 6 months after start of first line treatment. The trial will consist of 4 visits. An outpatient clinic visit in which the eligible patients are invited (V1), a screenings visit (V2), a third visit (V3) at which the patients will be divided into the intervention or the control group, according to owning a smartphone and their affinity with it, followed by the start of the intervention consisting of 8 weeks telecoaching by means of an application and step counter and a final visit (V4) 8 weeks after starting up the intervention.

NCT ID: NCT03859895 Enrolling by invitation - Paget Disease Clinical Trials

Zoledronate In the Prevention of Paget's Disease: Long Term Extension

ZiPP-LTE
Start date: April 5, 2019
Phase:
Study type: Observational

Paget's disease of the bone (PDB) is a metabolic bone disorder which in some individuals can cause pain, bone deformity, arthritis and deafness, although in many patients it does not cause symptoms. Paget's disease has a strong genetic component and SQSTM1 is the most important susceptibility gene. People who inherit mutations in SQSTM1 have a high risk of developing PDB later in life. This study is an extension of the ZiPP (Zoledronate in the Prevention of Paget's) study which was is randomised trial currently in progress to determine if the bisphosphonate zoledronic acid (ZA) can prevent or delay the development of PDB-like bone lesions compared with a dummy treatment (placebo) in people who inherit SQSMT1 gene mutations. Although the ZiPP study will provide information on whether early ZA treatment can favourably influence bone lesion development the significance of this to the patient in terms of symptoms is unclear as yet. The aim of the extension study is to keep these individuals under surveillance for any symptoms or signs of PDB over a further 5 year period and to evaluate if there has been any progression of PDB-like lesions by bone scan at the end of this period.

NCT ID: NCT03806881 Enrolling by invitation - Clinical trials for Osteoarthritis of the Shoulder

Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant

Start date: July 1, 2019
Phase:
Study type: Observational

This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system

NCT ID: NCT03745924 Enrolling by invitation - Haemophilia B Clinical Trials

A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN

Start date: April 1, 2019
Phase:
Study type: Observational

This study will collect information on side effects and how well Refixia/REBINYN works during long-term treatment (prophylaxis) in males with haemophilia B. While taking part in this study, participants will receive the same treatment as given to them by their study doctor. All visits at the clinic are done in the same way as the participants are used to. During visits at the clinic, participants might be asked for some relevant tests if considered useful by their study doctor. During the visits, the participants study doctor might ask if the participants had any side effects since their last study visit. The participants will be asked to note down the number of bleeds and the treatment of their bleeds as well as their regular prophylaxis. During the visits to the clinic, the participants will be asked to answer some questionnaires about their quality of life and their ability to be physically active. The participant's participation in the study will last for 4-9 years, depending on when they join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.

NCT ID: NCT03683186 Enrolling by invitation - Hypertension Clinical Trials

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Start date: September 23, 2019
Phase: Phase 3
Study type: Interventional

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

NCT ID: NCT03635359 Enrolling by invitation - Clinical trials for Trisomy 21 and Other Fetal Aneuploidy

Automated Screen for Fetal Aneuploidy

FAST1
Start date: July 15, 2017
Phase:
Study type: Observational

The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.

NCT ID: NCT03568318 Enrolling by invitation - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

AD Up
Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.