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NCT ID: NCT04153760 Completed - Clinical trials for Venous Thromboembolism

Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

PARTUM
Start date: October 7, 2020
Phase: Early Phase 1
Study type: Interventional

The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.

NCT ID: NCT04153721 Completed - Colorectal Cancer Clinical Trials

Impact Study of a Digital Solution for Patient Engagement

Get Ready
Start date: March 11, 2020
Phase: N/A
Study type: Interventional

The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative). Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital. The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices. The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device. This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.

NCT ID: NCT04153344 Completed - Clinical trials for Neurofibromatosis Type 1

Function of the Pigment Epithelium in Patients With Type 1 Neurofibromatosis

NEF-1
Start date: May 11, 2020
Phase:
Study type: Observational

The objective of this study is to study the function of the pigment epithelium in patients with neurofibromatosis type 1 using electro-oculogram to confirm abnormally high values reported in previous studies, but also to correlate this hyperactivity of the pigment epithelium with the presence and size of choroidal hyperreflective areas observed in infra-red imaging of the fundus. The hypothesis of the study is that the function of the pigment epithelium measured by the electro-oculogram correlates with the surface of choroidal hyperreflective areas. Finally, the potential consequences of a supra-normal function of the pigment epithelium on the global retinal function are not known. A full-field electroretinogram will evaluate the global neurosensory retinal function.

NCT ID: NCT04153331 Completed - Emergencies Clinical Trials

Burden of Influenza at Emergency Department Level : BIED

BIED
Start date: January 13, 2020
Phase: N/A
Study type: Interventional

Seasonal influenza surveillance in France relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. However, the data collected do not fully measure the impact of epidemics on the hospital system. Increasing the investigator's knowledge of the impact of influenza on the hospital system, particularly on emergencies, which are the most affected service, is essential to better adapt the resources put in place to care for patients. The study will allow a better understanding of the influenza burden, by systematically documenting the severe events (i.e. requiring consultations to the Emergency Rooms) that are triggered by influenza but not necessarily reported/recorded as influenza.

NCT ID: NCT04152941 Completed - Clinical trials for Relapsed Ovarian Cancers Patients

Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients

RETROLA
Start date: October 11, 2018
Phase:
Study type: Observational

This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.

NCT ID: NCT04152421 Completed - Depression Clinical Trials

Acceptability and Clinical, Cognitive and Brain Efficacy of the Pilot of a Computerized Psychotherapy Program Based on Behavioural and Cognitive Techniques in the Depressed Patient

STOP DEPRESS
Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Depression is a common disease with a high rate of recurrence. It is a major public health problem with significant health costs. World Health Organization estimates that 34 million people worldwide are affected by depression but not treated. Common barriers to accessing care in depression would be: the high cost of therapy, long waiting times, low presence of therapists in some communities, travel difficulties, fear of being "stigmatized", not to mention the presence of negative biases towards psychotherapy. Behavioural and Cognitive Therapies are standardized psychotherapies using operationalized methodologies and offering a pedagogical approach to learning specific change techniques and skills. They are the treatment of choice for many of the mental disorders, including depression, which has been proven effective through numerous scientific studies. They are now recognized by the French Authority for Health as the most scientifically validated psychotherapies and are recommended in particular for the treatment of depression. In a context of constant development of information technology and the Internet, computer programs and websites concerning health, and in particular mental health, have emerged. Among the mental health programs, Computer Based Cognitive Behavior Therapy programs in English-speaking countries now offer patients remote Internet-based behavioural and cognitive therapies. These programs, which are not available in France, have been the subject of numerous meta-analyses demonstrating their therapeutic effectiveness. Some of these Computer Based Cognitive Behavior Therapy programs such as Beating The Blues® are recommended by health organizations such as the National Institute of Health and Clinical Excellence in the treatment of depression. This advent of computerized therapies is part of a movement to raise awareness of the epidemiological extent of mood disorders and the inadequacy of management methods. These "therapist-free" programs are, via an interactive and multimedia interface, an alternative means of care, making it possible to overcome the usual obstacles to accessing care. In our opinion, they represent an important area of research in an increasingly computerized health system. We propose to study the acceptability and effectiveness of the pilot of a Computer Based Cognitive Behavior Therapy targeting depression developed at the University of Nice Sophia Antipolis; in three dimensions: 1. Clinical: via scales for measuring depressive symptomatology and depression characteristics; 2. Cognitive: via specific scales of cognitive-behavioural dimensions and validated in depression. 3. Neurophysiological: via electroencephalographic markers linked to cognitive processes; The research framework would be that of a prospective trial. This work bridges the gap between neurosciences, neuropsychology and the psychiatric clinic, while at the same time being part of a commitment to research in the field of "e-health".

NCT ID: NCT04151797 Completed - Clinical trials for Medication Therapy Management

Impact of a Mobile Geriatric Team With a Pharmacist on the Optimisation of Prescriptions in Elderly Inpatients

PHARMOG
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

In patients aged 75 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy coupled with a lack of proactive elderly care can sometimes lead to hospitalisation. Due to comorbidities and complex problems, management of geriatric patients usually requires a multidisciplinary approach. In Toulouse University Hospital, elderly inpatients can benefit from a geriatric assessment by a Geriatric Mobile Team. Whether this team improve the prescriptions through the advice of a clinical pharmacist has not been demonstrated yet.

NCT ID: NCT04150393 Completed - Chemotherapy Effect Clinical Trials

Safety and Tolerability Evaluation of MaaT033

CIMON
Start date: October 20, 2020
Phase: Phase 1
Study type: Interventional

Richness and diversity of gut microbiota are increasingly found to be associated with cancer outcomes. Moreover, an adequately responsive immune system seems to rely on the existence of a functioning gut ecosystem that includes the microbiota and its natural environment. Cancer by itself, but also cancer treatments - in particular chemotherapy - induce gut dysbiosis, impair the constant reparation mechanisms of the gut epithelium, disrupt immune homeostasis, and stunt immune responsiveness. The objective of MaaT033 is to (1) prevent the decay of the gut ecosystem (dysbiosis) to preserve immune homeostasis, (2) restore and optimize the gut ecosystem to full functionality including its role in repairing the gut epithelium and healthy gut barrier, and (3) maintain a restored gut ecosystem and fully functional immune homeostasis. Restoring the full gut ecosystem and its associated microbiota could become an important therapeutic option to improve clinical outcomes and control adverse events of conventional approaches, including immunotherapy in cancer patients. As a first step, MaaT033 capsules containing lyophilized, pooled, full-ecosystem microbiota in its natural environment are to be tested for their safety and tolerability in hematological malignant patients, who are exposed to intensive rounds of chemotherapy and antibiotics.

NCT ID: NCT04150328 Completed - Clinical trials for Diffuse Large B Cell Lymphoma

Lenalidomide Monotherapy in R/R DLBCL

RE-MIND
Start date: April 12, 2019
Phase:
Study type: Observational

This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

NCT ID: NCT04149535 Completed - Stroke Clinical Trials

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement

PROTECTED TAVR
Start date: February 7, 2020
Phase: N/A
Study type: Interventional

To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).