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NCT ID: NCT04553575 Completed - Clinical trials for Coronavirus Infections

CoViD-19 Patient in Reims University Hospital in March to April 2020

COVID-Reims
Start date: September 25, 2020
Phase:
Study type: Observational [Patient Registry]

Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up. Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research) Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients. Material and methods: Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022 Expected results: Better knowledge of the cares of patients with CoViD-19

NCT ID: NCT04553237 Completed - Stroke Clinical Trials

Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy

PCAT
Start date: September 11, 2020
Phase:
Study type: Observational

Stroke is a significant cause of death and disability in France and internationally. The incidence of stroke increases with age, equal for both sexes. Of all strokes, 50% of cases occur in patients over 75 years of age. This advanced age leads to a high risk of mortality, long hospitalization, causing neurological sequelae in most cases. Neurological handicap in the elderly is due to a high rate of comorbidity, reduced neuronal plasticity, nutritional status, and the short time to convert the penumbra area to ischemia. Currently the standard treatment for the acute phase of HF is thrombolysis or thrombectomy. The principle of thrombolysis is based on the use of a thrombolytic drug (Actylise®). It is a tissue plasminogen activator (t-PA) that will cause lysis and dissolution of clots blocking the artery. Thrombolysis is recommended until 4:30 a.m. after the onset of symptoms in the absence of contraindication. Mechanical thrombectomy consists of removing the blood clot by introducing a probe into the artery having a proximal carotid or sylvic occlusion in its M1 portion or in the vertebro-basilar territory of an indeterminate schedule of less than 24 hours or determined from 6 hours to 24 hours having a radio-clinical mismatch, according to the DAWN study. The results of this study were analyzed according to age, NIHSS score and lesion volume on perfusion scanner or MRI (RAPID software). The interim analysis at 31 months on 206 randomized patients (107 thrombectomies versus 99 medical treatments alone) showed a clear superiority of the thrombectomy, leading to the premature end of the study, over the handicap at 3 months with more than 35 % of independent patients. In most of the randomized studies, patients over 90 years of age have been excluded or are under-represented. This lack of data therefore does not make it possible to determine the effectiveness of thrombolysis or thrombectomy treatments in these patients. A recent meta-analysis has shown that the functional recovery in these patients treated by thrombectomy is superior to those of the same age without thrombectomies. According to American studies, the advanced age of a patient is not a contraindication to this treatment. Patients affected by a cerebral infarction represent 40 to 50% of hospitalizations in the neurology department of the Groupe Hospitalier Paris Saint-Joseph. In the intensive care of the neuro-vascular unit, the patient is received as quickly as possible to decide whether he can benefit from an extreme emergency treatment (intravenous thrombolysis or thrombectomy). The present study should show that the clinical course after treatment in patients over 90 years of age is substantially comparable to younger patients, and that age is not a contraindication to treatment in the acute phase of stroke in the elderly.

NCT ID: NCT04553224 Completed - Atopic Dermatitis Clinical Trials

Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis

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

Atopic dermatitis represents a real challenge in public health as it affects a large percentage of children and adults. Affected individuals must cope with a significant psychosocial burden, in addition to dealing with the medical aspects of the disease. The purpose of this exploratory study is to collect clinical severity AD data, using PO-SCORAD (self-assessment by the subjects), SCORAD evolution, instrumental measurements and treatment follow up of subjects. The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician. Development of a method of early detection of flares will open new treatment pathways for AD management.

NCT ID: NCT04553172 Completed - Bleeding Diathesis Clinical Trials

Vascular Abnormalities and Bleeding Diathesis

Start date: March 1, 2016
Phase:
Study type: Observational

Inherited bleeding disorders (IBD) consist of a heterogeneous group of diseases including coagulation and/or platelets defects and more rarely vascular dysfunctions. A family of four patients suffering from unexplained excessive bleeding has been followed clinically in France for many years. Recently, whole exome sequencing (WES) of DNA allowed the identification of a heterozygous genetic variant which segregated to family members with bleeding diathesis. The aim of the study was to better characterize the phenotype by studying VWF and platelets in affected family members ultimately contributing to the pathogenesis of a bleeding diathesis.

NCT ID: NCT04553094 Completed - Marfan Syndrome Clinical Trials

Effects of Personalized Training at Home Combining Endurance and Resistance in Patients Suffering From Marfan Syndrome

MARF'HOME
Start date: January 4, 2021
Phase: N/A
Study type: Interventional

Marfan syndrome (MS) is an autosomal dominant genetic disorder caused by a mutation in the fibrillin-1 gene (FBN1) encoding the protein fibrillin-1. Fibrillin is the main component of microfibrils, elements found in all of the body's tissues, and this pathology is characterized by the multitude of its clinical manifestations. These patients may develop aneurysms in the aortic root and one of the main factors of morbidity in patients with MS is aortic dissection. Prevention mainly involves preventive aortic surgery. However, the repercussions are global and can affect the functioning of other tissues such as skeletal muscle tissue, bone tissue, lung tissue and the eyes. The association of skeletal (scoliosis, hyperlaxity), muscular and ocular disorders is clearly associated with an impairment in the quality of life. These disorders are associated with pain and disability which affect professional activity, leisure and family life. Physical activity could represent a relevant alternative for these patients. A recent animal study suggests that moderate training is beneficial.

NCT ID: NCT04552964 Completed - Glaucoma Clinical Trials

Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma

CONDORE
Start date: September 25, 2020
Phase: N/A
Study type: Interventional

Glaucoma is one of the most common chronic pathologies and affects several millions patients. Among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness. One between principal reasons for poor glaucoma medication adherence is forgetfulness. To improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.

NCT ID: NCT04552899 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

STARSCAPE
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT04552873 Recruiting - Clinical trials for Subarachnoid Hemorrhage

Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

NAT-URE
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

Hyponatremia is defined as a plasma sodium concentration below 135 mmol / L. This is a common occurrence (20-50%) during subarachnoid hemorrhage (SAH). Its appearance is often associated with vasospasm. It is associated with an increase in morbidity and mortality linked to induced neurological disorders. Hyponatremia is caused by two etiologies: the syndrome of inappropriate secretion of anti-diuretic hormone (SIADH), and the cerebral salt wasting syndrome, CSWS. Theoretically, these two entities are differentiated by the patient's volemia; in practice, this parameter is difficult to measure. In addition, the correction of hyponatremia is diametrically opposed according to its mechanism: water restriction in the case of SIADH, sodium intake in the event of CSWS. Urea is offered as a second-line treatment in the event of treatment failure to correct hyponatremia. However, the efficacy of this treatment is based on small, observational, retrospective studies. Moreover, the mechanism of action of urea remains poorly understood: it could be a hyperosmolar effect or passive renal reabsorption of sodium.

NCT ID: NCT04552249 Completed - Clinical trials for Age-related Skin Changes

Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities

Start date: September 22, 2020
Phase:
Study type: Observational

To evaluate the reliability of different non-invasive skin probe measurements.

NCT ID: NCT04551495 Active, not recruiting - Clinical trials for HER2-negative Breast Cancer

Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)

ROSALINE
Start date: January 14, 2021
Phase: Phase 2
Study type: Interventional

Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsies and surgical specimens, as well as liquid biopsies.