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NCT ID: NCT04441463 Not yet recruiting - Newborn Clinical Trials

Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla)

TryPla
Start date: September 2020
Phase: N/A
Study type: Interventional

Currently the neonatal serum level of severals proteins can be used as an indicator of subsequent risk. For example, we plan to explore the neonatal kinetics of tryptase and other immune proteins as potential markers for the risk of postnatal complications, particularly in premature babies. However, today no study has shown whether the tryptase level in the newborn is a reflection of fetal synthesis alone, or that of the mother by possible transplacental passage. There is also no database that has defined normal values for tryptase in cord blood. Our main objective is to determine the correlation between the level of maternal tryptase and that of the newborn in cord blood immediately after birth in order to estimate the transplacental passage of this molecule.

NCT ID: NCT04436575 Not yet recruiting - Clinical trials for Acute Gastrointestinal Bleeding

Point-of-care Ultrasound Interest in Acute Gastrointestinal Bleeding Emergency Department Patients

Start date: July 1, 2020
Phase:
Study type: Observational

Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department. The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as 10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. Currently, few studies have examined the value of echocardiography in the management of patients presenting for Acute GI Bleeding in the Emergency Department. The main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.

NCT ID: NCT04433325 Not yet recruiting - COVID-19 Clinical Trials

COVID-19 Critically Ill Patients' Evolution After Medical Transport by Train From Paris Intensive Care Units to West of France Intensive Care Units

TOCCIP
Start date: June 2020
Phase:
Study type: Observational

Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients admitted in Intensive Care Units (ICU). It led to a saturation of the French health system, especially in some geographic areas such as East of France or Paris region. Therefore, authorities decided to transfer some critically ill patients from these crowded ICUs to less busy regional ICUs. it was done for the first time by medical train transportation. Knowing that the investigators lack experience regarding this type of medical evacuation, regarding the high number of transferred patients, with such a logistic effort, the investigators decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So far, there are no data in the literature regarding this topic.

NCT ID: NCT04427878 Not yet recruiting - Covid-19 Patients Clinical Trials

Is Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients?

TA/SARS-Cov2
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The hypothesis is that the virus may enter and spread in fat depots.

NCT ID: NCT04424056 Not yet recruiting - Covid19 Clinical Trials

A Trial Using ANAKINRA, TOCILIZUMAB Alone or in Association With RUXOLITINIB in Severe Stage 2b and 3 of COVID19-associated Disease

INFLAMMACOV
Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

COVID19-associated disease may have different clinical aspects classified in 3 stages. Some patients initially presenting with a non-hypoxemic viral pneumonia (stage 2a) may evolve toward a more severe stage 2b or 3 (acute respiratory distress syndrome, ARDS) around the 7th or 10th day of evolution, with a severe biological inflammatory syndrome (CRP>200 mg/l), and some times more severe complications such as acute renal insufficiency, consumptive coagulopathy or shock, requiring increasing oxygen therapy, ICU admission, invasive mechanical ventilation and possibly leading to death. This detrimental evolution is due to a host-derived "cytokine storm" with a great excess of circulating inflammatory cytokines. In animal models of ARDS complicating coronavirus or influenza virus infection, the cytokine storm has been linked to hyperactivation of the NLRP3 inflammasome. NLRP3 constitutes an intracellular protein platform which is responsible for caspase1 activation and processing of interleukin (IL)-1beta and IL-18 . IL-1b is a major proinflammatory cytokine which induces IL-6, whereas IL-18 is an inducer of interferon gamma (IFNg) production by Th-1 lymphocytes. A blood IL-1/IL-6 signature can be defined by increased neutrophilia and CRP concentrations, whereas an IL-18/IFNg signature is characterized by severe hyperferritinemia, consumptive coagulopathy and cytopenia. A majority of patients with COVID-19 infections seems to have an IL-1/IL-6 signature, evolving in the more severe forms toward an IL-18/IFNg signature, mimicking cytokine profiles observed in other inflammatory diseases such as Still's disease or hemophagocytic syndromes. In Still's disease, therapeutic inhibition of IL-1 or IL-6 has proven to be very efficient strategies. During hemophagocytic syndromes, inhibition of IFNg is effective in humans notably through blockade of its receptor signalization, using the JAK kinase inhibitor ruxolitinib. Following this strategy, we propose to use biological drugs currently available for inhibition of IL-1 (anakinra), IL-6 (tocilizumab) or IFNg signaling (ruxolitinib) in the severe forms of COVID19-associated disease. Our hypothesis is that IL-1, IL-6 or JAK kinase inhibition will allow: 1. to prevent stage 2b worsening and the need to be admitted in ICU, by decreasing oxygen-requirement and systemic inflammation 2. to improve stage 3 and extremely severe stage 3, allowing invasive mechanical ventilation weaning, improving multi-system organ dysfunction, leading to a faster ICU exit. We propose an open randomized therapeutic trial (1/1/1) on 216 patients with severe stage 2b and 3 of the disease

NCT ID: NCT04423081 Not yet recruiting - Induction of Labor Clinical Trials

Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) (EXIT)

EXIT
Start date: July 2020
Phase:
Study type: Observational

The objective of the study is to cross-culturally adapt and validate the French version of the EXIT scale: an assessment tool on induction of labor.

NCT ID: NCT04420013 Not yet recruiting - Colorectal Cancer Clinical Trials

Colorectal Cancer Immunomonitoring Combined With Radiofrequency ablatIon

ColIBRI
Start date: September 2020
Phase:
Study type: Observational

The primary objective of the study aims to compare soluble CD154 (CD40L) levels before and after radiofrequency ablation (RFA) in patients with colorectal cancer (CRC) liver metastases. The secondary objectives aims: - to compare soluble CD154 (sCD40-L) levels before and after treatment by RFA or surgery alone in patients with CRC liver metastases; - to study the feasibility and reliability of soluble CD154 (sCD40-L) levels to detect and quantify the induction of immun response in CRC liver metastases patients after RFA; - to study the impact of surgery on plasma soluble CD154 levels; - to study association between CD154 expression level before and after RFA in CRC liver metastases patients and relapses rate at 1 year.

NCT ID: NCT04415190 Not yet recruiting - Cholangiocarcinoma Clinical Trials

the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients

Start date: June 1, 2020
Phase:
Study type: Observational

The prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative care team could increase overall survival. We will also assess whether early management by a palliative care team could impact progression-free survival, the place of death and the date of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an imminent end of life

NCT ID: NCT04413838 Not yet recruiting - Clinical trials for Obesity, COVID-19 Infection

Efficiency and Security of NIVOLUMAB Therapy in Obese Individuals With COVID-19(COrona VIrus Disease) Infection

NIVISCO
Start date: June 15, 2020
Phase: Phase 2
Study type: Interventional

Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

NCT ID: NCT04411264 Not yet recruiting - Chronic Wounds Clinical Trials

Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.

DouReV
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Pain management is a priority axis of health insurance spending objectives and contributes to improving the quality of care.There are several types of pain: acute, chronic and induced. These are often found in the management of chronic wounds. The high prevalence of chronic wounds represents a major public health problem. Chronic wounds require long, painful and regular treatment. When dressing these wounds, pain management is essential. Indeed, it can generate healing delays. Usually, pharmacological methods are used to reduce the pain induced by care. But these methods can lead to undesirable effects. Thus, new non-pharmacological techniques are emerging.The investigators therefore wish to assess the effect of virtual reality on pain induced by care during the repair of dressings in the management of chronic wounds.