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NCT ID: NCT04794101 Active, not recruiting - Clinical trials for X-Linked Retinitis Pigmentosa

Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

Start date: December 4, 2020
Phase: Phase 3
Study type: Interventional

A clinical trial of AAV5-hRKp.RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)

NCT ID: NCT04793958 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

NCT ID: NCT04793568 Active, not recruiting - Clinical trials for Critically Ill Patients

Human Recombinant Interferon Gamma-1b for the Prevention of Hospital-acquired Pneumonia in Critically Ill Patients: a Double-blind, International, Phase 2, Randomized, Placebo-controlled Trial - the PREV-HAP Study

PREV-HAP
Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

PREV-HAP study is part of a larger project entitled 'Host-targeted Approaches for the Prevention and the treatment of Hospital-Acquired Pneumonia' (HAP2), funded by the European Union's H2020 research and innovation programme under grant agreement N°847782. HAP2 aims to develop stratified host-directed drugs and biomarkers to enhance the prevention and the treatment of HAP and develop precision medicine in infectious diseases. Its ambition is to revolutionize the management of HAP: capitalising on the novel concept of critical-illness related immunosuppression altering the host-pathogens interactions, the aim is to propose a complete reappraisal of the physiopathology of HAP based on the concept of respiratory dysbiosis. The main hypothesis of the PREV-HAP study is that human recombinant Interferon gamma 1b (rHuIFN-γ, Imukin) treatment can restore immunity in critically ill patients and prevent Hospital-Acquired Pneumonia. The hypothesesis is that the in vivo investigations of the host-pathogens interactions can be used for the stratification of patients into high/low risk and responders/non-responders to host-targeted prevention of hospital-acquired infections. The involvement of a state of critical-illness related immunosuppression in the susceptibility to hospital-acquired pneumonia is widely accepted, and an emerging trend is that the development of drugs for the treatment of this acquired immunosuppression will prevent infection and enhance outcomes of hospitalized patients. It has been demonstrated that the productions of IFN-γ by immune cells are decreased in critically ill patients, and that these defects are associated with the susceptibility to HAP. rHuIFN-γ has neither been tested nor is recommended as adjunctive treatment of patients with HAP. Based on these specific factors identified in the host response, it is proposed in this study to use rHuIFN-γ as novel preventive approach for HAP.

NCT ID: NCT04793100 Active, not recruiting - Clinical trials for Central Retinal Vein Occlusion

Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections

PULSOV
Start date: March 24, 2021
Phase: N/A
Study type: Interventional

Central retinal vein occlusion (CRVO) is the second most common retinal vascular disease after diabetic retinopathy. It induces circulatory slowdown and blood stasis, which can appear as retinal hemorrhages. CRVO has been classically separated into two clinical forms: ischemic CVRO (possibly associated with cotton wool spots) and non-ischemic CRVO, the former being considered the most serious due to neovascular complications. More recently, a new classification has been suggested by Pierru et al. distinguishing two types of CRVO: type A characterized by low acute blood flow and type B with a slower onset. Type A is particularly associated with younger age, the presence of acute paracentral middle maculopathy, concomitant cilioretinal artery occlusion, and/or pulsatile arterial filling. Type B is more likely to occur in elderly patients, usually with high blood pressure, and multiple hemorrhages are frequently found on fundus examination. A retrospective study had shown a slight difference in favor of pulsatile CRVO in terms of the number of intravitreal anti-angiogenic injections required to treat macular edema and visual acuity changes. However, no statistically significant difference was observed. The objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (SPARs) in patients with type A or B CRVO can be considered as a prognostic factor for the evolution of CRVO.

NCT ID: NCT04790994 Active, not recruiting - COVID-19 Clinical Trials

COVID-19 Prevalence in UNIVI Geriatric Institutions: Epidemiological Study of Immunological Status With Rapid Serological Tests

Start date: July 24, 2020
Phase:
Study type: Observational

To date, little information is available on the prevalence of Covid-19 and data are lacking on the proportion of patients, institutional residents and caregivers who have actually been exposed to SARS Cov-2. With the NG Biotech rapid serological test, an individual's immunological status (presence of IgM and IgG antibodies) can be determined in 15 minutes on a finger-prick blood sample. The proposed trial will be a noninterventional study of immunological status among the residents and caregivers of 26 nursing homes and 4 geriatric healthcare institutions belonging to the UNIVI Group who are representative of the institutional geriatric population in France. The NG Biotech rapid test will be carried out concomitantly with polymerase chain reaction (PCR) tests performed within the framework of a national screening campaign. Data on risk factors in staff members and on specific COVID 19 symptoms in residents will also be collected. The study will terminate for residents and caregivers whose tests are both negative (absence of infection and no exposure to the virus). For residents and caregivers who have at least one positive test, follow-up visits will be scheduled in order to study the serology time course and the occurrence of reinfection (follow-up questionnaire).

NCT ID: NCT04786197 Active, not recruiting - Covid19 Clinical Trials

Detection of SARS-CoV-2 (COVID-19) by SERS Spectroscopy Combined With Artificial Intelligence

Kaïssa Covid
Start date: August 10, 2021
Phase:
Study type: Observational

SARS-CoV-2 infection was identified as responsible for several cases of pneumonia and acute respiratory distress syndromes described in Wuhan, Hubei Province, China in December 2019. A global epidemic has spread since and the Director General of the World Health Organization (WHO) declared in March 2020 the state of a global pandemic. As the spread of the virus accelerates, several countries are implementing containment strategies to stem the epidemic. The context of an influx of patients and congestion in healthcare establishments requires rapid and reliable diagnostic solutions for SARS-CoV-2 infection in order to enable patients to be properly referred. These solutions will represent fundamental tools in the management of new epidemic waves, both in terms of health and economics.

NCT ID: NCT04785820 Active, not recruiting - Clinical trials for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

Start date: June 25, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of lomvastomig and tobemstomig, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen. Following approval of the protocol amendment version 3, recruitment into the lomvastomig arm has been stopped. The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for lomvastomig remains unchanged. The study was planned to enroll participants randomized in a 1:1:1 ratio to receive lomvastomig, tobemstomig, or nivolumab. With version 3 of the protocol, recruitment into the lomvastomig arm has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either tobemstomig or nivolumab.

NCT ID: NCT04784715 Active, not recruiting - Clinical trials for Breast Cancer; HER2-positive; Metastatic

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

Start date: April 26, 2021
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.

NCT ID: NCT04782531 Active, not recruiting - MRI Clinical Trials

Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers

RESPIFLUX
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.

NCT ID: NCT04781465 Active, not recruiting - Clinical trials for Chronic Low-back Pain

Feasibility Study on an Immersive Virtual Reality Tool in the Treatment of Chronic Low Back Pain

RIVAGE
Start date: January 7, 2020
Phase: N/A
Study type: Interventional

Chronic low back pain is a major public health problem today, because of its prevalence and its socio-professional impact. Multiple drug or non-drug treatments exist but the pain chronicization mechanism makes the management of chronic low back pain patients difficult. Stress rehabilitation programs in specialized structures have been set up to try to improve the outcome of these patients. Likewise, home exercise is recommended. However, adherence to these exercises is generally poor. Recently, there has been a growing interest in the use of new technologies, based on the use of digital tools, in the management of pain. Thus, in patients with chronic low back pain, the attractiveness of the proposed exercise programs with new technologies, the possibility of progression in the same exercise and the possibility of customizing these exercises have been reported as being able to meet the expectations of patients. for the purpose of rehabilitation. In virtual reality, users interact in an environment simulated by a 3-dimensional computer. This technology uses multisensory resources allowing the user to feel totally immersed in the virtual environment. Virtual reality has shown a benefit in the management of pain in several indications. In low back pain patients, pain avoidance mechanisms are put in place very early due to fear of situations or movements that may reproduce or intensify the pain. Thus, for fear of pain, individuals avoid certain movements, in particular lumbar flexion movements. This avoidance of the lumbar flexion movement actually worsens the pain phenomenon because of the musculoskeletal changes associated with it. Therefore, one of the therapeutic areas for the management of chronic low back pain would be to improve lumbar flexion capacities.