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NCT ID: NCT05394558 Terminated - Clinical trials for Recurrent High-grade Glioma

AsiDNA Children, Adolescents and Young Adults

AsiDNA
Start date: May 27, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

HGG comprises diffuse midline gliomas (DMG), including diffuse infiltrating brainstem glioma (DIPG), characterised by histone gene mutations, as well as non-DM HGGs mainly in non-midline supratentorial areas, with distinct molecular abnormalities. First-line treatment comprises surgery when doable (non-DM HGGs), and radiotherapy in all cases. Chemotherapy or other drugs in clinical trials may be added during and/or after radiotherapy depending on the HGG subtype. The recurrence rate is nevertheless high in all paediatric and adolescent HGGs. If the time interval between the end of first-line radiotherapy and relapse is long enough, re-irradiation often provides good palliation of symptoms, delays disease progression, improves quality of life and has minimal and manageable toxicity. Nevertheless, strategies to increase efficacy without increasing toxicity in the treatment of recurrent paediatric HGG are much needed. AsiDNA™ is a DNA repair inhibitor that increases the vulnerability of tumour cells to irradiation without increasing toxicity in healthy tissues. Its novel mechanism of action, based on perturbation of the DNA damage recognition steps in DNA repair, makes its activity specific to tumour cells. Intravenous administration of AsiDNA is currently being investigated in adults with advanced solid tumours. The MTD was not reached during the escalating dose study on the safety, pharmacokinetics and pharmacodynamics of AsiDNA administered as a 1-hour infusion, however an optimal dose range (400-600 mg) was identified for further development, based on the favourable safety and PK profiles. Preclinical studies on AsiDNA added to radiotherapy have shown increased survival and no increase in short- or long-term toxicity due to the high doses of irradiation. The study will provide paediatric patients who have recurrent HGG with early access to innovation, even during the early drug development stage in adults.

NCT ID: NCT05384665 Terminated - Clinical trials for Rapid Sequence Induction

Impact of Opioids on Heart Rate During Rapid Sequence Intubation

CANDY-CRASH
Start date: May 16, 2023
Phase: N/A
Study type: Interventional

The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained. Patients will be divided into 3 parallel groups : - Group A (placebo +remifentanil) - Group B (sufentanil + placebo) - Group C (placebo + placebo) Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output. To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR. The MAR injects the drugs according to the standardized study plan (see below): - T1: the patient receives an intravenous bolus (IV) over 5 seconds of molecule n°1 - 3 minute delay - Patient receives Etomidate 0.3 mg/kg IV over 10 seconds - 5 second delay - The patient receives an IV bolus over 30 seconds of molecule n°2 - 5 second delay - The patient receives Succinylcholine or Rocuronium IV over 5 seconds - T2: End of induction, oro-tracheal intubation (= T2) The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13). Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.

NCT ID: NCT05378828 Terminated - Elderly Clinical Trials

Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors for Elderly People in EHPAD

SWADAPT4
Start date: July 21, 2022
Phase: N/A
Study type: Interventional

The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.

NCT ID: NCT05330845 Terminated - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome

Start date: August 5, 2021
Phase: N/A
Study type: Interventional

In the current COVID-19 pandemic, many patients have an acute respiratory distress syndrome (ARDS). Among mechanisms related to COVID-19 acute respiratory distress syndrome, cytokine storm and secretion of IL-6 play a central role. ARDS management involves intubation for protective mechanical ventilation, deep sedation and curarisation. During intensive care unit (ICU) hospitalization, improvement of hematosis induces a switch from a controlled ventilation mode to a withdrawal ventilation mode, such as Spontaneous Ventilation with Pressure Support (SP-PS) or Adaptative Support Ventilation (ASV). This step is essential prior to considering complete weaning from controlled ventilation and sometimes ends with a failure. In this case, deterioration of hematosis and/or ventilatory mechanics is observed. At the same time as withdrawal failure, the investigators observed biological inflammatory rebound in some patients. Therefore, influence of inflammatory biological parameters, including IL-6, on withdrawal failure, needs to be investigated. To this end, the investigators decide to dose different inflammatory markers - such as IL6, C-Reactive Protein (CRP), Procalcitonin (PCT) - in patients with acute respiratory distress syndrome due to COVID-19, during standard of care. Indeed, in patients with acute respiratory distress syndrome not due to COVID-19, the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn. In addition, IL6 rise is associated with poor prognosis for patients with COVID-19 and longer stays in intensive care.

NCT ID: NCT05328102 Terminated - Clinical trials for Diffuse Large-cell B-cell Lymphoma

Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)

Start date: April 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in participants with relapsed or refractory DLBCL.

NCT ID: NCT05324852 Terminated - Emergence Delirium Clinical Trials

AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine

AGINASAL
Start date: April 9, 2023
Phase: Phase 3
Study type: Interventional

This study is a non-inferiority phase III randomized trial evaluating the effect of intranasal midazolam versus intramuscular loxapine on the rapid tranquilization of agitated patient in emergency department. Intranasal midazolam is safe and may allow a management of extreme agitation state and prevent adverse effects.

NCT ID: NCT05321524 Terminated - Biliary Atresia Clinical Trials

Obeticholic Acid in Pediatric Subjects With Biliary Atresia

CARE
Start date: July 1, 2015
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in pediatric subjects with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterosomy). The OLE will continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of OCA. In addition, a change in vitamin A and D levels, and where possible the degree of change in liver stiffness, will be assessed during the OLE.

NCT ID: NCT05307471 Terminated - Thoracotomy Clinical Trials

Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism

NITT
Start date: October 28, 2013
Phase:
Study type: Observational

Pulmonary surgery, performed routinely by thoracotomy or thoracoscopy, can cause significant and frequent chronic postoperative pain, most often neuropathic. The role of trauma intraoperative intercostal nerve is evoked to explain the genesis of the neuropathy. Treatments proposed in the indication of neuropathic pain in a broad sense, are exposed to many cases of failures. It is supposed that these failures are due to a mismatch between the selected drug (which is specific to the target) and the real pathology because neuropathy encompasses many different pathophysiological syndromes which are sometimes intricated. The main objective of this project is to study the clinical, psychophysical and electrophysiological (noninvasively) intercostal nerve affected by the surgery at the second postoperative month, by comparing the results with similar observations made shortly before the intervention. This study will be proposed to patients undergoing thoracotomy or thoracoscopy for partial or total lung resection in the service of Thoracic Surgery of Centre Jean Perrin, the objective is to recruit 120 patients (for 100 evaluable patients) over a period of 18 months of inclusion. The other objective of the project is to provide a treatment algorithm for patients in pain, and to compare the efficacy of this treatment with the pre-treatment observations data.

NCT ID: NCT05307276 Terminated - Healthy Volunteers Clinical Trials

Limitation of the Ventilatory Response to Exercise in the Master Athlete

LAHMESS
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

It is generally accepted that the ventilatory system is not a limiting factor in physical exercise in terms of performance or exercise tolerance in healthy subjects. The ventilatory system would be oversized in relation to the stresses it has to cope with, even during maximum intensity exercise. However, some highly trained endurance athletes may be exceptions to this rule. A limitation of the expiratory flow is indeed sometimes found in these athletes, whose maximum values of ventilation can confront the mechanical limits of their ventilatory system. This phenomenon could be accentuated in elderly athletes (known as "master athletes") under the effect of structural and functional pulmonary alterations that accompany aging. Our hypothesis : What is the prevalence of exercise expiratory flow limitation in the master athlete and does it cause a decrease in physical performance via an acceleration of locomotor muscle fatigue?

NCT ID: NCT05305040 Terminated - Clinical trials for Cytomegalovirus Infections

Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Prevent
Start date: March 24, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.