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NCT ID: NCT04656171 Withdrawn - Fanconi Anemia Clinical Trials

Microcephaly, Fanconi Anemia and Praxial Disorders

MicroFancII
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

Fanconi Anemia (FA) is mentioned in children with congenital malformations including kidney, hart and skeletal malformations (absence or abnormal thumb or forearm), and bone marrow failure or myelodysplasia with a progressive onset in childhood or adulthood. No study has focused on microcephaly, a reduction in brain volume, which is present in 20% of children, and its consequences on cognitive and structural level of the brain. Since 2014, Robert-Debré's team has been interested in this functional cognitive and neuroanatomical approach trough a National PHRC. Preliminary results carried out on 12 children show that their intellectual efficiency was in the normal range for age. However, we noticed a significant difference between abilities in comprehension and verbal reasoning corresponding to what is expected for age, and the sensorimotor skills or fine motor praxia significantly reduced. These difficulties, graphically penalizing for these children, are not always explained by a skeletal malformation of the upper limb, suggesting that musculo-tendinous anomalies may be associated. The objectives of our project are: 1) to identify upper limb musculo-tendinous abnormalities and their functional consequences, 2) to determine if these abnormalities could influence the somatosensory representation of the upper limb at the cerebral cortical level. This project should help us to better understand the fine motor disabilities or developmental coordination disorder of these children, which penalize their learning, and provide them with adapted solutions.

NCT ID: NCT04656158 Completed - Low Back Pain Clinical Trials

Therapeutic Effects of Horticulture on Anterior Cingulate Cortex Activation in People With Chronic Low Back Pain

HORTICARE
Start date: May 25, 2021
Phase: N/A
Study type: Interventional

Chronic low back leads to a significant socio-economic burden. It is associated with physical and psychosocial deconditioning. Even a short "nature experience" has positive effects on the affective and cognitive factors involved in chronic pain. In the brain, the anterior cingulate cortex plays an important role in both pain and emotions. Exposure to a natural environment may decrease activation of the anterior cingulate cortex. The main objective of this study is to evaluate the effectiveness of therapeutic horticulture on the decrease of activation of the anterior cingulate cortex in people with chronic low back pain participating in 2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork. The investigators hypothesize that therapeutic horticulture may reduce the activation of the anterior cingulate cortex. The effects of therapeutic horticulture may be mediated through the double exposure to both nature and physical activity.

NCT ID: NCT04655976 Active, not recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy

COSTAR Lung
Start date: December 8, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

NCT ID: NCT04655950 Completed - Spondylodiscitis Clinical Trials

Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.

SPONDIMMO
Start date: February 11, 2016
Phase:
Study type: Observational [Patient Registry]

Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications. The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.

NCT ID: NCT04655911 Terminated - Clinical trials for Mucopolysaccharidosis III-B

A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101

Start date: October 28, 2020
Phase:
Study type: Observational

This is a multicenter, non-interventional, long-term follow-up (LTFU) study in participants who have been treated with ABO-101 in a prior trial. Eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial (up to 5 years post-treatment).

NCT ID: NCT04655885 Recruiting - Clinical trials for Primary or Metastatic Hepatic Adenocarcinoma

Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery

OPTILIVER
Start date: February 3, 2022
Phase: N/A
Study type: Interventional

Major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams. The 1st peroperative phase of "hepatic resection" requires a minimum supply of filling fluids to limit perioperative bleeding (Low Central Venous Pressure). However this strategy exposes the risk of organ hypoperfusion due to low cardiac flow, secondary to hypovolaemia, which may lead to ischemic situations favoring the onset of postoperative complications. On the other hand, the hemodynamic management of the 2nd peroperative phase "post hepatic resection" is marked by the need to correct this hypoperfusion by optimizing cardiac output by suitable vascular filling. The major challenge is thus to restore cardiac output by refilling without excess, by correcting the hypovolemia that arose during the "post resection of the hepatic parenchyma" phase. Our hypothesis is that an individualized protocol for optimizing intraoperative cardiac flow by guided vascular filling during the "post hepatic resection" phase is accompanied by a reduction in postoperative complications in patients operated on for major hepatic surgery.

NCT ID: NCT04655612 Completed - COVID-19 Clinical Trials

Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases

COVID-RIC1
Start date: December 1, 2020
Phase:
Study type: Observational

The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of patients with chronic inflammatory rheumatism with serological testing

NCT ID: NCT04655508 Terminated - Respiratory Disease Clinical Trials

Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation

RESPPEDOBS
Start date: May 21, 2021
Phase: Phase 3
Study type: Interventional

Bronchiolitis Obliterative Syndrome (BOS) is the primary noninfectious pulmonary complication after hematopoietic stem cell transplantation (HSCT) and usually carries a poor prognosis. It occurs in about 10% of children underwent HSCT. The National Institutes of Health (NIH) published guidelines and criteria for the diagnosis of BOS. BOS defined by spirometric criteria according to modified NIH consensus guidelines: FEV1 < 75% predicted and a greater than 10% decline from pretransplant baseline, and FEV1/FVC <0.7 (FCV: Forced Vital Capacity). Nevertheless Cheng and al. indicate that the magnitude of FEV1 decline before diagnosis exceeded the diagnostic requirement of a greater than 10% decline compared with baseline FEV. Moreover, the decline in FEV1 prior to BOS diagnosis appeared to occur within 6 months for those patients. Recent studies suggest that any intervention should be targeted during the FEV1 decline, and before the diagnosis of BOS. For this, inhalated treatment are used: Bergeron et al. reported improvements in symptoms as well in FEV1 one month followed treatment including formoterol and budesonide in a prospective trial including adults (12% increase of FEV1 for 62% adults). Williams and al. in another prospective adult's cohort, showed that the association between fluticasone, montelukast and azythromycin was associated with stable lung function, reduced systemic corticosteroids, and improved quality of life at 3 months for adults with BOS. In our national French prospective cohort which include 300 children with HSCT from 2014 to 2017 (RESPPEDHEM Programme Hospitalier de Recherche Clinique 2012), 35% of children presented a decline of FEV1≥ 10% without BOS criteria (FEV1 < 75% and FEV1/FVC <0.7). Among them, some received combination of corticoids and long acting beta agonists for 6 months. Children with this type of inhalated treatment improved their FEV1 to 88.1% predicted while children without any treatment have a FEV1 at 80.7% predicted. Our hypothesis is that association of Fluticasone Propionate and Salmeterol can be used as a treatment of the decline of FEV1 for children and so prevent BOS.

NCT ID: NCT04655378 Completed - Pediatric ALL Clinical Trials

Validation of the IgA1 Detection Method With Gradient Glycosylation by Mass Spectrometry as a Potential Marker of Renal Involvement in Pediatric Rheumatoid Purpura

FOXIGA-2020
Start date: October 22, 2020
Phase:
Study type: Observational

In this ancillary study on the FoxTreg cohort, the study investigators will select variables to input and thus develop two models (Linear Discriminant Analysis and Decision Tree). The aim of this study is to validate the method in terms of repeatability, reproducibility, control of pre-analytical conditions and sample conservation, to complete the screening of IgA glycosylation in individuals of the FoxTreg cohort and to refine the glycopeptide signature to predict renal involvement.

NCT ID: NCT04655118 Recruiting - Myelofibrosis Clinical Trials

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Start date: October 22, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.