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NCT ID: NCT03995537 Completed - Clinical trials for Liver Transplantation

Monocytic Expression of HLA-DR After Liver Transplantation

EdMonHG
Start date: February 26, 2020
Phase:
Study type: Observational

A defect of the immune response has been described in patients with severe liver disease. This immune-paresis is partly driven by a compensatory anti-inflammatory response following a systemic inflammatory response syndrome and affects the innate immune response. The innate immune defect has been described in patients with advanced cirrhosis and more significantly in patients with acute liver failure or acute on chronic liver failure (ACLF). The monocytes/macrophages pro-inflammatory response and finally the antimicrobial response are thus strongly impaired, leading to higher sepsis risk. The monocytes/macrophages phenotype associated with these functional alterations has been widely described, with a weaker expression of Human Leukocyte Antigen - DR isotype (HLA-DR) on the monocytes surface, correlated with poor outcomes. The low monocytic expression of HLA-DR, its functional and clinical impact has been widely described in the context of septic shock with similar pathophysiological mechanisms. Liver transplantation (LT) is often the only therapeutic option for patients with advanced liver failure. Post-transplant survival of the most severe patients is similar to the survival in the whole population of LT patients, but the complication rate remains higher, with a major risk of infection. Currently used immunosuppression protocols do not take into account the quality of pre-transplant immune response. Some treatments, such as corticosteroids, which are widely used for the induction of post-transplant immunosuppression, may affect the innate immune response. However, it has been shown that low expression of post-transplant monocyte HLA-DR was associated with a greater risk of septic complication. The general objective of this study is to focus on the evolution of a robust marker of immune dysfunction, HLA-DR monocyte expression, before and following LT, and to analyse its post LT expression depending on the level of pre-transplant expression as well as its association with post-transplant complications. This study will bring new insights for the design of a prospective study on the relevance of adapting post-transplant immunosuppression protocols to HLA-DR expression on monocytes surface, which is a robust marker of the innate immune response. Evaluation of innate immune dysfunction pre-LT by quantification of monocytic HLA-DR expression and monitoring of its post-LT kinetics may be relevant for assessing post-transplant immune status and adapting immunosuppressive therapy. A descriptive, observational study associating clinical and biological data is needed to confirm the relevance of HLA-DR expression quantification on the surface of monocytes in a population of selected patients, before and after LT. These data will allow setting up a prospective interventional study reporting the possible benefit of post-transplant immunosuppressive treatment modulation, according to the HLA-DR monocyte dosage and its kinetics evolution. The main objective of this study is to describe the association between evolution of monocytic HLA-DR expression on monocytes/macrophages surface during the first month after LT and the occurrence of one of the 2 following clinical events reflecting a post LT immune dysfunction (acute cell rejection and sepsis).

NCT ID: NCT03995524 Completed - Clinical trials for Spasticity as Sequela of Stroke

Spasticity and Treatment Satisfaction Among Stroke Survivors

REBOT
Start date: July 20, 2019
Phase:
Study type: Observational

To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.

NCT ID: NCT03995459 Completed - Clinical trials for Malignant Liver Tumor

Deportalization, Venous Deprivation, Venous Congestion

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

Patients with multiple primary or secondary liver tumors have a low survival rate unless they can benefit from curative extended hepatic resections with R0 or R1 marge resection. Post-operative acute liver failure may occur after such surgery when the remnant liver is insufficient, leading to high morbimortality. The future remnant liver (FRL) preoperative evaluation is then the key consideration before performing extended liver resection. The FRL volume measurement on computed tomography (CT) imaging is the most widespread method of FRL evaluation. Threshold values of acceptable FRL volume depend on the underlying liver function, it ranges from 20-30% in healthy liver to 40% in cirrhotic liver. However, it recently appeared that the FRL function would be more valuable in predicting post-operative liver failure. 99mTc-mebrofenin hepatobiliary scintigraphy (HBS) combined with SPECT/CT enables reliable FRL function measurement with a threshold value calculated at 2.69%/min/m2, to predict post-hepatectomy liver failure. When the FRL evaluation does not reach the acceptable threshold values to avoid liver failure, portal vein embolization (PVE), consisting of portal branches occlusion of the future removed liver, can be performed. It is now the standard of care to induce FRL regeneration before surgery. Right PVE induces right hemiliver (S5-8) deportalization (portal input deprivation with hepatic venous drainage preservation) leading to left hemiliver (S2-4) regeneration. To optimize PVE results, recent effective techniques have been developed such as the simultaneous embolization of the right portal branch and the right hepatic vein (HV), and the right accessory HV if so, which is called liver venous deprivation technique. Additional simultaneous embolization of the middle HV defined the extended liver venous deprivation (ELVD) technique. ELVD induces right liver (S5-8) venous deprivation (deprivation of both portal input and venous drainage) and leads to rapid increase in FRL function. After ELVD, segment IV (S4) portal input from left portal branch is preserved while its venous drainage through the middle HV is disrupted, resulting in venous congestion. The aim of this study is to analyze the volumetric and functional evolutions after embolization procedures in deportalized liver (S5-8 after PVE), vein-deprived liver (S5-8 after ELVD) and congestive liver (S4 after ELVD).

NCT ID: NCT03994302 Completed - Adverse Drug Event Clinical Trials

Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

APSTOX
Start date: June 1, 2019
Phase:
Study type: Observational [Patient Registry]

Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

NCT ID: NCT03994237 Completed - Alzheimer Disease Clinical Trials

Accompanying ALZHEIMER CAREGIVER

ACCAIDANT
Start date: December 12, 2018
Phase:
Study type: Observational

Initiatives have been taken hotline in France and abroad for other conditions, they provide support to patients and their caregivers.

NCT ID: NCT03993899 Completed - Clinical trials for Sensorineural Hearing Loss, Bilateral

Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Main objective: Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces. Secondary objectives - Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test). - Analyze the link between the results of musical perception tests and the subjective preference of musical listening. - Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements. - Analyze the link between the results of musical perception tests and the results of the perception of speech elements. - Analyze the qualitative multidimensional perception with HDCIS and FS4

NCT ID: NCT03993015 Completed - Clinical trials for Pregnant Women Less Than 14 Weeks of Gestation

Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

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

In a recently published study, a poor knowledge of guidelines in the field of early pregnancy was observed in France, Belgium and Switzerland. To improve the respect of the most recent criteria of diagnoses, a computerized tool was developped.

NCT ID: NCT03992846 Completed - Endometriosis Clinical Trials

Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

NCT ID: NCT03992703 Completed - Clinical trials for Bacterial Infections

Clinical Impact of Rapid AST Directly From Blood Cultures

MHR-BC
Start date: April 1, 2019
Phase:
Study type: Observational

Bacteremia is defined as pathogenic bacteria presence in blood as evidenced by positive blood cultures. These bacteremia have significant consequences in terms of morbidity and mortality (ref. 1,2,3). They can lead to a state of septic shock that is life-threatening for the patient and must be treated as a matter of urgency. Any delay in treatment is detrimental to the patient. Management is based on prescription of probabilistic antibiotic therapy as soon as bacteremia is suspected. At the Groupe Hospitalier Paris Saint Joseph (GHPSJ), as soon as a blood culture is known to be positive, the Mobile Clinical Microbiology Unit (UMMC) is notified in real time. The UMMC infectiologist, in consultation with the microbiologist, evaluates microbiological data and compares them with clinical data in order to prescribe probabilistic antibiotic therapy in the patient's bed. The possible adaptation of antibiotic treatment then depends on the results of antibiotic susceptibility test. Early adaptation of antibiotic treatment to antibiotic susceptibility data, to reassess ineffective treatment or to reduce antibiotic therapy spectrum, significantly improves patient prognosis: it is therefore important that the laboratory makes antibiotic susceptibility test results available to the clinician as early as possible.

NCT ID: NCT03992651 Completed - Clinical trials for Blood Gas Monitoring, Transcutaneous

Optical Transcutaneous Sensors of Capnia and Oxygenation

CTCO
Start date: June 12, 2019
Phase: N/A
Study type: Interventional

This study aims at validating new optical transcutaneous sensors to evaluate tissue capnia (CO2 partial pressure) and oxygenation (blood oxygen saturation) by comparing them to standard laboratory measurements (end tidal CO2 measurements and oxygen saturation by near-infrared spectroscopy).