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NCT ID: NCT04629924 Completed - Pain Clinical Trials

Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection With Conventional Anesthesia

SLEEPER-ONE
Start date: March 24, 2021
Phase: N/A
Study type: Interventional

Anesthesia systems with electronic injection assistance for slow injection pressure-limiting drips (especially for intraosseous anaesthesia) are offered to limit pain. The European Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which avoids the negative aspect of the classic syringe (Kühnisch 2017). A review systematic review of the literature (Smolarek et al 2019) including 20 randomized controlled trials conducted at children and adolescents showed a significant reduction in pain with the systems with electronic assistance compared to conventional anaesthesia performed with a syringe (-0.8: IC95% (-1.3, -0.3)). Only four of them (Tahmassebi et al 2009, Kandiah and Tahmassebi 2012, Patini et al 2018, Smail-Faugeron et al 2019) were at low risk of bias, and only two parallel group trials were of poor quality and included only children in temporary dentition in which anaesthesia, often problematic, was performed only in the maxilla (Allen et al 2002, Klein et al, 2005) without assessing the intensity of the pain felt. (FPS-R). The tested strategy, anesthesia system with electronic injection assistance (SleeperOne® 5 Dental Hi Tec), compared to a conventional metallic anaesthetic syringe currently considered as the standard for performing local anesthesia during oral treatments painful, meets the ISO 13485: 2016 standard. Elements justifying that the particular surveillance modalities added by research do not involve negligible risks and constraints Specific monitoring modalities added by research include : - Explanation of the study to each eligible child and his or her legal guardians - Gathering the informed consent of the child and his or her legal guardians - The determination of comparative anesthesia systems (SleeperOne® 5 versus syringe metal) - Data collection during the two care sessions (maximum 15 days apart) It is a use of a product placed on the market whose conditions of use are in conformity with its destination and its current conditions of use (RIPH Category 2 application decree) There is no additional consultation or visit, nor any additional examination, in relation to the management in accordance with the recommendations of good practice of a child affected by a carious disease corresponding to the children included. On the other hand, the consultation will take a little longer due to the indicators to be collected and the data entry. These particular surveillance modalities added by research have only negligible constraints.

NCT ID: NCT04629443 Completed - Clinical trials for Acute Myeloid Leukaemia

Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

Start date: February 17, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.

NCT ID: NCT04629274 Completed - Clinical trials for Neuromyelitis Optica

In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized NMO

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients. A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease, Neuromyelitis Optica Spectrum Disorders (NMOSD) in this study. The main goal of the study will be to support the selection of Imotopes® (i.e. synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif), and (i) capable of binding with class II HLA antigens of each patient and (ii) causing ex vivo the appearance of epitope -specific cytolytic CD4+ T cells.

NCT ID: NCT04629222 Completed - Clinical trials for Infectious Disease of Lung

Tracheobronchitis in Respiratory Involvement on the Lung SPECT/CT Images of Coronavirus Disease (COVID-19) Patients

Start date: March 11, 2020
Phase:
Study type: Observational

Tracheobronchitis signs may be observed on ventilation lung scintigraphy during coronavirus disease (COVID-19) infection. This case report study aimed to analyze the rates and associated factors of such tracheobronchitis in COVID-19 patients referred to ventilation/perfusion lung scintigraphy with shortness of breath, suspected of pulmonary embolism.

NCT ID: NCT04628234 Completed - Clinical trials for Hematologic Malignancy

Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site (RESPECT)

RESPECT
Start date: July 4, 2020
Phase:
Study type: Observational

This is a non randomized, monocentric, descriptive, transversal and prospective study. The purpose of this study is to assess the compliance with patient expressed choice regarding subsequent care and death -if occured- site (at hospital or at home) after hospitalisation for terminally ill patients with an onco-hematologic solid tumor in palliative care and to identify reasons for potential non-compliance.

NCT ID: NCT04627610 Completed - Rectal Prolapse Clinical Trials

Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele

PEXITY
Start date: March 9, 2022
Phase:
Study type: Observational

Prolapse of the rectum is a pathology that preferentially affects older women with a significant impact on quality of life. A very large number of therapeutic approaches can be proposed (functional treatment, surgical techniques by perineal approach and surgical techniques by anterior approach). D'Hoore and Pennix described Ventral Rectopexy with prosthetic reinforcement which is accepted as a standard of treatment in much of Europe for externalized prolapse but remains maligned in much of the world. Due to the relatively recent appearance of this technique and the great variability in the management methods, the long-term results of Ventral Rectopexy have been little studied. This surgical technique is the preferred approach offered at CHU Grenoble Alpes. Pr Faucheron have internationally recognized experience in surgical grip with a very high patient volume in recent years.

NCT ID: NCT04627025 Completed - Clinical trials for Short Bowel Syndrome

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

STARS
Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

NCT ID: NCT04626466 Completed - Radiotherapy Clinical Trials

Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation

MIFADORESOL
Start date: August 3, 2020
Phase:
Study type: Observational

Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the bone marrow is high. There is a lack of prospective studies and comparative trials to customize the constraints according to the presence or absence of chemotherapy and correlated to the patient's bone marrow potential. This multicentric and prospective study conducted by Strasbourg Europe Cancerology Institute aims to evaluate hematological toxicity (anemia, thrombocytopenia, leukopenia) in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, cervix cancer or vaginal cancer. One hundred patients will be included in the study, including patients treated with exclusive radiotherapy, radiochemotherapy, or radiohormonal therapy. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy. Secondary endpoints are the evaluation of viral, bacterial and fungal infections during and for three months following radiotherapy, as well as the evaluation of the impact of radiation-induced hematological toxicity on the administration of chemotherapy for the concerned patients. The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study.

NCT ID: NCT04626388 Completed - Acetabular Fracture Clinical Trials

Postoperative Score Predictive of the Prognosis of Acetabular Fractures

SCORE_COTYLE
Start date: December 9, 2020
Phase:
Study type: Observational

Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the postoperative reduction. This score is based on the quality of postoperative reduction assessed on pelvic radios. In addition, the thresholds for poor / good results were determined empirically.

NCT ID: NCT04625738 Completed - COVID19 ARDS Clinical Trials

Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respiratory Distress Syndrome

MSC-COVID19
Start date: November 6, 2020
Phase: Phase 2
Study type: Interventional

Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties. The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.