Clinical Trials Logo

Filter by:
NCT ID: NCT03111589 Completed - Sickle Cell Disease Clinical Trials

Monocytic Expression of Heme Oxidase-1 (HO-1) in Sickle Cell Patients and Correlation With the Humoral Immune Response to Vaccine and With Allo-immunization.

Start date: October 2016
Phase: N/A
Study type: Interventional

Sickle cell disease (SCD) is an autosomal recessive disorder resulting from a substitution in the β chain of hemoglobin (Hb) which causes hemoglobin S to polymerize when deoxygenated. SCD patients present immune abnormalities that have always been attributed to functional asplenia. It it is now being recognized that patients with SCD have a pro-inflammatory condition with altered immune system activation contributing to the pathology of SCD. Increased levels of neutrophils, monocytes or cytokines have been reported in SCD patients. SCD is associated with many acute and chronic complications requiring immediate support. Actual strongly recommended therapies include chronic blood transfusions (CT) and hydroxyurea (HU). In addition, episodic transfusions are recommended and commonly used to manage many acute SCD complications.There is strong evidence to support the use of HU in adults with 3 or more severe vaso-occlusive crises during any 12-month period, with SCD pain or chronic anemia, or with severe or recurrent episodes of acute chest syndrome. HU use is now also common in children with SCD. Some patients receive chronic monthly RBC transfusion with the objective to reduce the proportion of HbS to < 30 %. Long-term RBC transfusions prevent and treat complications of SCD decreasing the risk of stroke and the incidence of acute chest syndrome (ACS). Therapeutic complications, such as alloimmunization against RBC in 20-50% of patients or hematopoietic stem cell transplantation (HSCT) graft rejection, constitute an immune-based clinical issue in SCD. Poorly understood RBC alloimmunization is responsible for serious hemolytic transfusion reaction associated with severe mortality and morbidity underlying the need for a better understanding of the immunology of SCD to improve SCD transfusion support/outcome. Little evidence exists about HU effects on immune functions in SCD. HU treatment doesn't appear to have deleterious effects on immune function and appears to decrease the abnormally elevated number of total WBC and lymphocytes, while CT does not. Patients with SCD are at higher risk of infections and prophylactic vaccination is strongly recommended. Recent data suggest that vaccinal response to pneumococcal antigens in SCD patients is identical to healthy control while controversy concern the stability of the immune protection after vaccination of SCD patient. Antibody levels declined over the year and the need for more frequent vaccination in SCD patient should be investigated. Currently, there is no evidence whether HU may interfere with pneumococcal immune response. Purohit showed that immune response to inactivated influenza A (H1N1) virus vaccine was altered in patient with SCD receiving CT but little is known on immune response to vaccination in patients with SCD receiving HU. Recent data suggest that not only inflammatory status but also humoral immune response to antigens in SCD patients may differ according to treatment. Yazdanbakhsh reported an imbalance between regulatory T cell (Treg) and effector T cell (Teff) in alloimmunized SCD patients with as consequence an increase in antibody production. In a model proposed by the authors, the balance between Treg and Teff is dictated by the monocyte control of cytokines expression. Altered activity of monocyte heme oxidase-1 (HO-1) would be responsible of a decrease in IL-12 and an increase in IL-10 cytokines secretion impacting the Treg/Teff cells ratio and promoting antibody production by B cells. The objectives of the project are to assess whether different humoral immune responses to vaccines or to erythrocyte alloantigens are related to the type of treatment administered to patients with SCD. We also aim to study if these differences might be related to different expressions of HO-1 by monocytes.

NCT ID: NCT03111511 Completed - Healthy Clinical Trials

A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)

Start date: March 27, 2017
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-56136379 on the single-dose pharmacokinetics (PK) of drospirenone and ethinylestradiol (oral contraceptive [OC]) in healthy female participants and to evaluate the effect of steady-state concentrations of JNJ-56136379 on the single-dose PK of midazolam (sensitive probe substrate for CYP3A4) in healthy female participants.

NCT ID: NCT03110653 Completed - Pain Clinical Trials

Remifentanil and Hyperalgesia: Gradual Withdrawal Versus Immediate Discontinuation

Start date: April 15, 2017
Phase: N/A
Study type: Interventional

Modern anesthesia has made a lot of progress, however, postoperative pain remains one of the major problems associated with patient discomfort, prolonged hospital stay and increased health care costs. Remifentanil is an ultra-short-acting phenylpiperidine opioid analgesic with high lipid solubility and a rapid onset of effect. Recently, opioid use has also been associated with postoperative opioid-induced hyperalgesia or acute opioid tolerance. An immediate discontinuation of remifentanil has been associated to increased postoperative pain levels. We would like to investigate whether a gradual post-operative withdrawal of remifentanil is indeed associated with less immediate pain compared to after an abrupt withdrawal in surgical patients undergoing minor surgery.

NCT ID: NCT03110120 Completed - Analgesia Clinical Trials

Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery

Start date: May 2015
Phase: N/A
Study type: Interventional

The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.

NCT ID: NCT03109496 Completed - Healthy Clinical Trials

The URT and Middle Ear Microbiota in Health and During Chronic OME

Start date: April 26, 2017
Phase:
Study type: Observational

This study analyses which bacteria are present in the middle ear space and adjacent upper respiratory tract niches in healthy people and in patients suffering from chronic otitis media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are more common and more abundant in healthy people and to evaluate their potential to protect against bacteria commonly involved in OME and other upper respiratory tract infections. To this end, samples will be collected from both groups (healthy vs OME) and analysed through sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants will be cultivated to isolate bacteria of interest.

NCT ID: NCT03109483 Completed - Stroke Clinical Trials

Effectiveness of the Geriatric Activation Program Pellenberg (GAPP) on the Geriatric Rehabilitation Ward

Start date: March 17, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for activities of daily living (ADL). Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation; strength, balance, speed, functional training and one day is for testing or group therapy. Participants will be followed for four weeks, with testing on day one, after two weeks and at the last day of the four-week program.

NCT ID: NCT03108092 Completed - Clinical trials for 5 or More Regular Drugs

Health Economic Evaluation Alongside the OPERAM Trial

Start date: December 2016
Phase: N/A
Study type: Interventional

The objective of the health economic evaluation is to perform a state-of-the-art economic analysis of the STRIP intervention, alongside the OPERAM Randomised Controlled Trial (RCT).

NCT ID: NCT03107793 Completed - Crohn Disease Clinical Trials

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

STARDUST
Start date: April 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.

NCT ID: NCT03107351 Completed - Healthy Clinical Trials

Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography

MultiKinVal
Start date: March 27, 2017
Phase: N/A
Study type: Interventional

This study aims to validate the possibility to track cardiac contractility changes with a new technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared echocardiography.

NCT ID: NCT03106987 Completed - Clinical trials for Epithelial Ovarian Cancer

A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

OReO
Start date: June 8, 2017
Phase: Phase 3
Study type: Interventional

The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer)