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NCT ID: NCT04302233 Not yet recruiting - Clinical trials for Health Education, Joint Prosthesis, Breast Implants

A Randomized Study of Superiority of POSToperative Pharmaceutical Support on Patients' Knowledge of Their IMPlant

POSTIMP
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Recently joint and breast prostheses were placed under special post-marketing surveillance in order to prevent new occurrence of serious incidents by agency for medicines and health products safety. Few of french patient are able to identify their prosthesis in the event on health security alert. An usual postoperative pharmaceutical support (UPS) for patients with joint prosthesis has been implemented to prepare them for return home. At the request of surgeons, a new pharmaceutical support (NPS) has been developed to improve the ability of these patients to recall or find information that identify their prosthesis. Objectives : The main objective is to demonstrate that the new pharmaceutical support (NPS) increase the ability to memorize then find correct information of their prosthesis 6 months post-implantation Material and method : This study, approved by an ethic committee, takes place in the orthopedic and plastic surgery departments. The 236 adult patients included are hospitalized following the scheduled placement of either a breast or a hip or knee prosthesis. They are randomized, either in the NPS group or in the UPS comparator group. In both cases, patients benefit from the same written information: a patient-implant file and an information booklet specific to their prosthesis, validated by specialist surgeons, to prepare for their return home. The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization. In NPS group, pharmacist use specific photo and quiz. A telephone follow-up at the 6th month of the patients is carried out by a pharmacist to assess the patient's knowledge, using a standardized questionnaire. Expected results : Based on retrospective data already published, the main hypothesis is that the NPS is associated with an improvement in patient ability to remember the correct model or manufacturer of their prosthesis, compared to the UPS, 6 months after the operation.Secondary hypotheses are that NPS compared to UPS leads to an improvement in patients ability to preserve and find correct items related to theirs prosthesis at 6 months as well as an improvement in their knowledge of medical device vigilance and patient satisfaction declarations and a decrease in anxiety associated with prosthesis.

NCT ID: NCT04301921 Not yet recruiting - Clinical trials for Patients Undergoing Diagnostic Coronary Angiography

Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio

RAPID-1
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion

NCT ID: NCT04300712 Not yet recruiting - Clinical trials for School Difficulties Associated With Mental Health Problems

Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed)

Parpsych-Ed
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Local partnerships between schools (preschool and elementary) and mental health public services are implemented in seven sites in France. They aim to improve recognition of difficulties related to mental health problems and to provide interventions to 3 to 8 years-old pupils in need. Our hypothesis that these local partnerships and interventions enhance the role of school in supporting good mental health and wellbeing of all children and the trajectories of children with mental health service needs. Theses also facilitate community support. One of them, early-interventions involve caregivers. Our objective is to enhance knowledge of the unmet mental healthcare need at school and to explore for whom, in which local context and how partnerships and early intervention work.

NCT ID: NCT04300634 Not yet recruiting - Clinical trials for Healthy Children and Their Parents

Encouraging Physical Activity: Action Or Direction?

Start date: March 16, 2020
Phase:
Study type: Observational

Children's physical activity level is decreasing globally. Habits acquired in childhood and adolescence tend to continue in adulthood. Therefore, to obtain individuals who do physical activity or sports, this habit should be gained in childhood. It is necessary to understand the factors affecting children's lives to increase the physical activity level of the children and make the active lifestyle a habit. These factors can be divided into the environment and family. It is the place where the family socialization process begins first and social norms and cultural values are learned. Parents can be more effective than the environment because they are the main decision-makers on the child. Parents configure the child's time, duties, provide the sports equipment to their child, transfer them for activity. They can support an active lifestyle by taking role models by children. Role modeling is defined as the child's behaviors of observation and social learning and their parents' behavior. In a review, it has been reported that physically active parents encourage their children to have more activities and may have active children. Small-group studies using an objective method are limited in terms of generalizability. While determining the activity level of the child and the family, the fact that the families can respond biased for their children and that the mother or father can take a role model according to the gender of the child reduces the quality of the studies. It remains unclear how and to what extent parents affect children's activity levels. The aim of this study is to compare the physical activity level of children between 9-14 years of age, who have similar physical activity awareness, athletes and physiotherapist parents

NCT ID: NCT04299152 Not yet recruiting - Clinical trials for Severe Acute Respiratory Syndrome (SARS) Pneumonia

Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19

Start date: November 10, 2021
Phase: Phase 2
Study type: Interventional

Currently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.

NCT ID: NCT04297033 Not yet recruiting - Clinical trials for Cerebral Arteriovenous Malformation

Lovastatin for Treatment of Brain Arteriovenous Malformations

Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this pilot study is to evaluate the disease-modifying efficacy of lovastatin in patients with brain arteriovenous malformation.

NCT ID: NCT04296747 Not yet recruiting - Clinical trials for Hypopharyngeal Squamous Cell Carcinoma

Toripalimab in Combination With Chemotherapy as Induced Chemotherapy for Localized Hypopharyngeal Cancer

Start date: March 2020
Phase: Phase 2
Study type: Interventional

60% of hypopharyngeal cancers were locally advanced at the time of diagnosis. The standard treatment was surgery and postoperative radiotherapy. Compared with traditional surgery and postoperative radiotherapy, induction chemotherapy combined with radiotherapy has a better laryngeal retention rate without reducing the curative effect, and established an organ function preservation treatment strategy. Induction chemotherapy can reduce tumor burden and reduce distant metastases. At present, induction chemotherapy followed by concurrent chemoradiotherapy has become the standard treatment for the laryngeal preservation in locally advanced hypopharyngeal and laryngeal cancer. This study aimed to investigate the efficacy and safety of a PD-1 inhibitor toripalimab combined with chemotherapy as induction therapy in hypopharyngeal cancer.

NCT ID: NCT04295785 Not yet recruiting - Clinical trials for Immune-Mediated Necrotizing Myopathy

Juvenile Autoimmune Necrotizing Myopathies

MYONECPED
Start date: March 2020
Phase:
Study type: Observational

Autoimmune necrotizing myopathies (AINM) in adult patients are characterized by severity of muscle damage, presence of necrosis with little inflammation on muscle biopsy and anti-HMGCR or anti-SRP auto-antibodies. Data on AINM in children are currently lacking. The purpose of this study is to specify the characteristics at AINM diagnosis, treatments and evolution of juvenile AINM with anti-HMGCR or anti-SRP antibodies.

NCT ID: NCT04291248 Not yet recruiting - Clinical trials for MSI-H or dMMR Advanced Solid Tumors

A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor

Start date: March 2020
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy and safety of Anlotinib combined with AK105 injection or AK105 monotherapy in subjects with MSI-H or dMMR advanced solid tumors. In this study, 138 subjects will be enrolled, and those who met the admission criteria will divide into cohort 1 (anlotinib combined with AK105) and cohort 2 (AK105 ). The first phase of this study is a randomized, open-label, parallel-controlled, multicenter design, in which 30 subjects are randomly enrolled in two cohorts. The second phase is to continue enrollment of cohort 1 or cohort 2 when which cohort has the better clinical benefit than the other one.

NCT ID: NCT04290104 Not yet recruiting - Clinical trials for Cholecystitis; Acute, With Cholelithiasis

Is an Antibiotic Prescription Required After Laparoscopic Cholecystectomy

Start date: October 15, 2020
Phase: Phase 4
Study type: Interventional

The need for antibiotics to reduce surgical site infection after cholecystectomy for acute calculous cholecystitis is still controversial. The researchers aimed to investigate the effect of antibiotics prescribed on surgical site infection when discharged to patients undergoing laparoscopic cholecystectomy for acute calculous cholecystitis.