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NCT ID: NCT04759664 Recruiting - Clinical trials for EGFRI Induced Acneiform Lesions

LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC

Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

The study evaluates the efficacy and safety of two strengths of LUT014 Gel topically applied once a day for 4 weeks, compared to placebo, in metastatic colorectal cancer (mCRC) patients who developed Grade 2 or non-infected Grade 3 EGFRI induced acneiform lesions

NCT ID: NCT04773210 Recruiting - Clinical trials for Orthodontic Treatment

Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients

OHIPS14ORTHO
Start date: April 12, 2021
Phase:
Study type: Observational [Patient Registry]

To evaluate the association of the level of quality of life related to oral health, between treatment with the minitube system and conventional ligation brackets, in adult patients with moderate malocclusion, during the first six months, of orthodontic treatment.

NCT ID: NCT04773951 Recruiting - Melanoma Clinical Trials

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors

Start date: April 12, 2021
Phase: Phase 1
Study type: Interventional

An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. The study is divided into screening period, treatment period, and follow-up period. 1. Screening period: Subjects will be included in the screening period after signing the informed consent form (ICF). The screening period is up to 28 days, subjects will enter the study treatment period if they meet all the inclusion criteria and none of exclusion criterion. 2. Treatment period: Subjects will be allocated to the designated dose group to receive corresponding treatment in accordance with the progress of study. Subjects in dose escalation phase will receive DLT observation at first, and upon completion of DLT observation, the subjects will continue their administration at the original dose if they are tolerated as judged by investigator, until progression of disease, intolerable toxicity or other reasons specified in the protocol. Subjects in the dose extension phase receive appropriate study treatment until disease progression, intolerance of toxicity, or other causes specified in the protocol occur. Response evaluation criteria in solid tumors (RECIST v1.1) will be used for efficacy evaluation every 9 weeks (±7 days) in the first year and every 12 weeks (±7 days) in the 2nd year and thereafter. 3. Follow-up period: A safety follow-up visit is required 30 days (±7 days) after the last dose of study drug or before the initiation of new antitumor therapy. If the new antitumor therapy has not been initiated, additional safety follow-up should be completed 90 days (±7 days) after the last dose as far as possible.

NCT ID: NCT04781621 Recruiting - Clinical trials for Spinal Cord Injuries

Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy

FIRST
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

The FIRST project compares the dose of robotic gait training (RGT) with usual care gait training for patients with spinal cord injury (SCI) undergoing rehabilitation at Baylor Scott & White Institute for Rehabilitation (BSWIR).

NCT ID: NCT04787783 Recruiting - Mobile Applications Clinical Trials

Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment

Preanestes@s
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal preoperative assessments when the participants are evaluated through a web based application (Preanestes@s) versus the traditional outpatient interview.

NCT ID: NCT04788784 Recruiting - Patient Preference Clinical Trials

Patient-Reported Outcomes HIV BItherapy

PROBI
Start date: April 12, 2021
Phase:
Study type: Observational

HIV Treatment simplification strategies that involve switching cART regimens from four or three antiretrovirals to two in virologically suppressed patients living with HIV are now available in order to reduce long-term toxicity and enhance treatment adherence. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) with noticeable advantages, including a high genetic barrier to drug resistance, once-daily dosing and lower risk of drug-drug interactions because this agent does not inhibit or induce cytochrome P450 isoenzymes or P-glycoprotein transporters. Dolutegravir is generally well tolerated and the INSTI class is considered to be more "metabolically friendly" compared with other drug classes such as protease inhibitors (PIs). Thus, the combination of dolutegravir plus a second active agent is a particularly inviting option for maintenance treatment and research in this area is evolving. However, though safety and efficacy of dolutegravir are well known, there is no study evaluating patient-reported outcomes (PROs), i.e. subjective and self-reported measures of the patient's health perception. In an era of the efficacy of HIV regimens are more and more comparable, the main discriminant criteria to choose the best treatment option are now adherence and self-reported measures of a patient's health - termed "patient-reported outcomes" (PROs). The study, based on a mixed methodology, include a qualitative part and a quantitative part. The qualitative study will explore patients' and health care professionals' perceptions, knowledge, and representations of triple or quadruple and dual therapies and detect the degree of agreement or disagreement between patients' and practitioners' perspectives. The quantitative study's main objective is to measure the Dovato regimen's impact on a patient's perception (Patient-Reported Outcomes - PRO) on acceptability, toxicity, preference, and Health-Related Quality of Life (HRQL). PRO are collected through self-administered questionnaires at D0 (when the patient switch treatment), M1 and M6.

NCT ID: NCT04791748 Recruiting - Vestibular Diseases Clinical Trials

Virtual Reality in Children With and Without Vestibular Deficits

ReViCHILD
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

Vestibular information is important in establishing a child's static and dynamic postural control. Any vestibular deficit can have major consequences on development, spatial cognition and quality of life. In order to interact with the world around us, we must simultaneously integrate different sources of sensory informations (vision, hearing, perception of the body...). The brain integrates these different sensory components to form a unified and coherent perception: this is multisensory integration. Multisensory integration has been studied using virtual reality in adults, in the "spatial orientation" team of the Center for Integrative Neurosciences and Cognition. These experiments were carried out on healthy subjects and in weightless situations (international space station or parabolic flight). However, no protocol has been developed in children or in subjects with vestibular deficit. Virtual reality is interesting for developing such a protocol because it creates multisensory stimulation capable of promoting visual and proprioceptive compensation of the vestibular deficit. It induces an immersion of the patient in a virtual spatial and temporal environment difficult to carry out with traditional vestibular rehabilitation techniques. Its main advantage is that it is a fun and safe interactive diagnostic and therapeutic tool, which is particularly suitable for children. Being able to modulate certain sensory information using virtual reality, in children without vestibular function deficit and in children with vestibular function deficit, will make it possible to better understand the role of the vestibule in the construction of the self in relation to space and environment. In addition to the scientific aspect, the diagnostic and therapeutic benefits are potentially numerous. The objective of the study is to determine a reliable, well-tolerated and age-appropriate virtual reality protocol in children without vestibular deficit and in children with chronic vestibular deficit, making it possible to study the hand-eye coordination.

NCT ID: NCT04798001 Recruiting - Covid19 Clinical Trials

Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults

Start date: April 12, 2021
Phase: Phase 1
Study type: Interventional

This study evaluates an investigational vaccine that is designed to protect humans against infection with SARS-CoV-2, the novel coronavirus causing COVID-19 disease. The investigational vaccine, MV-014-212, is a live attenuated vaccine against respiratory syncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212 is administered as drops or a spray in the nose. Specifically, this study analyzes the safety of, and the immune response to, the vaccine when administered to healthy adults between the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have not received a prior vaccine against COVID-19.

NCT ID: NCT04798105 Recruiting - Clinical trials for Learning; Lack of (Specific)

Predictors of Probabilistic Selection Task Performance

Start date: April 12, 2021
Phase: N/A
Study type: Interventional

The project aims to investigate whether tDCS has an effect on reward and punishment learning sensitivity. Further, whether tDCS will modulate extraversion and impulsivity personality traits, and eye-blink-rate's effect on learning. For instance, trait extroversion in past research is linked to the dopamine neurotransmitter system, where it is thought that extreme low and high levels are detrimental to cognitive performance. Since tDCS has been shown to increase dopamine levels, it is thought that people who are already high in dopamine may experience less benefit (or even impairment) on cognitive performance following tDCS.

NCT ID: NCT04799912 Recruiting - Cesarean Section Clinical Trials

Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE)

FRENCH-ARRIVE
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

The recent ARRIVE trial conducted in United States of America in 2014-2017 demonstrates that elective induction of labor at 39 weeks for nulliparous women did result in a significantly lower frequency of cesarean delivery with no significant differences of adverse perinatal outcomes. But the expected benefits of elective labor induction at 39 weeks have to be confirmed in other settings outside US before considering routine induction of labor for all low-risk nulliparous women at 39 weeks of gestation worldwide.