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NCT ID: NCT05902208 Recruiting - Clinical trials for Periodontitis Chronic Generalized Severe

Contribution of an Antiviral Drug (Valaciclovir) in the Treatment of Generalized Periodontitis (Stage III or IV and Grade A, B or C): Prospective, Randomized and Double Blind Clinical Trial

HERPARO
Start date: February 5, 2024
Phase: Phase 3
Study type: Interventional

Periodontitis is an inflammatory pathology that destroys periodontitis and causes tooth loosening. Its high incidence, combined with very high oral and systemic morbidity, places this pathology at the heart of global public health priorities. The current therapeutic management of periodontitis is not satisfactory because it often leads to a stabilization of the disease, marked by frequent recurrences, especially severe forms. Improving the treatment of patients with periodontitis is therefore an essential priority. If gingival bacterial dysbiosis is a major contributing factor, this model has clinical-biological limitations that suggest that other etiological factors are involved, and worsen the pathology. In particular, the literature provides clear evidence that periodontal lesions are mostly infected with Herpes EBV, CMV and HSV-1 viruses and that periodontal infection with these viruses is very directly correlated with disease progression (severity). In addition, our work provides new cellular and molecular data that demonstrate mechanisms of active EBV infection of cells and periodontal structures, and highlight inflammatory and necrotic effects associated with this infection. Given these observations and the high pathogenicity of herpes viruses, all known to be powerful inflammatory, lytic and immunomodulatory agents, it seems difficult not to evoke a direct etiopathogenic role of these viruses capable of acting synergistically with periodontopathogenic bacteria. In this context, the use of an antiviral appears as a very attractive therapeutic proposal to effectively treat periodontitis in combination with conventional treatments. This original and innovative proposal can also be easily and quickly validated in a randomized therapeutic trial through the availability of antiviral molecules that are non-toxic and very specific to human herpes viruses that are derivatives of aciclovir.

NCT ID: NCT05902169 Recruiting - Glioblastoma Clinical Trials

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

SONOBIRD
Start date: January 29, 2024
Phase: Phase 3
Study type: Interventional

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.

NCT ID: NCT05902130 Completed - Clinical trials for Acute Coronary Syndrome

Symptoms of Acute Coronary Syndrome in Medical Regulation

SCAST+
Start date: January 1, 2023
Phase:
Study type: Observational

The main objective was to analyze the impact of the gender of the attending physician in the differences in the management of ST+ ACS between men and women. This study will be conducted in partnership with the interventional cardiology team of the CHR Metz-Thionville and SAMU (emergency call center) of Moselle, which has a detailed registry of coronary angiographies at the center. A retrospective observational study will be carried out over a "typical" period outside of covid at the CHR Metz Mercy (2021-2022) based on coronary angiographies performed in the context of ST+ ACS at the CHR of patients referred by the center 15. The patient's medical record will be analyzed, going back to his call to the 15 via tape listening. The number of subjects required being calculated at 104 men and 104 women, these patients will be selected from the database of our cardiologist colleagues and we will match one man to one woman by comparing the delays of several items (1st medical contact, time of 1st ECG, medicalization or not, delay of call to the cardiologist, delay of coronary angiography...) according to the sex of the regulator. The consequences of a difference in management will be also evaluated by analyzing in-hospital mortality, mortality at 30 days of management, and functional sequelae at discharge (grades of dyspnea, disturbance of myocardial contractility, LVEF at discharge). This study based on the differences in questioning according to the gender of the regulating physician would allow better identification of the factors that increase the delay in the management of ST+ ACS in women, and to find avenues of correction in order to limit the loss of opportunity for patients. The patients included who are still alive will receive a notification of non-objection by mail.

NCT ID: NCT05902117 Recruiting - Clinical trials for Acute Myocardial Infarction

Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS

CopSCA
Start date: June 28, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old.

NCT ID: NCT05901649 Recruiting - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer

A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide

ArtemisPRO
Start date: July 5, 2023
Phase:
Study type: Observational

The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).

NCT ID: NCT05901194 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma Non-resectable

Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma

Ta-Len-Tra
Start date: June 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Currently in France, hepatocellular carcinoma (HCC) represents over 30% of indications of liver transplantation (LT) (# 500 cases/year). Chemoembolization (TACE) is the most commonly used bridge treatment in those patients (estimate 60%). These patients will present with a complete response in only 60 % of the cases (# 180 patients per year in France) and failure in 40 % of the cases (# 120 patients per year in France). A systemic treatment using lenvatinib might provide a benefit in patients presenting with a non-resectable HCC in waiting list for LT and with a TACE failure (i.e. those with an active disease and a partial response or a stable disease or a progressive disease on imaging data, in particular when AFP remains significantly increased after 2 TACE) by decreasing dropout rate before LT and decreasing recurrence rate post-LT without new safety signal.

NCT ID: NCT05901077 Recruiting - Cystinosis Clinical Trials

European Cystinosis Cohort

RaDiCo-ECYSCO
Start date: April 20, 2017
Phase:
Study type: Observational

Cystinosis is a generalized lysosomal storage disease with a reported incidence of about 1:180,000 live births. There are estimated 110-140 cases in France (approximately 500 in Western Europe). The disease is caused by mutations in the CTNS gene coding for cystinosin, a lysosomal carrier protein. The lysosomal cystine accumulation leads to cellular dysfunction in many organs. The first symptoms start at about 6 months of age. In the absence of specific therapy, end stage renal disease occurs between 6 and 12 years of age. Survival beyond this age is associated with the development of extra-renal complications. Renal transplantation and the availability of cystine-depleting medical therapy, cysteamine (EU/1/97/039/001, EU/1/97/039/003), have radically altered the natural history of cystinosis. Cystinosis is a good example of a "paediatric" disease where patients now survive into adolescence and adulthood. These individuals have complex, multisystem problems that require on-going care. Despite some progress in recent years there are still significant limitations in the knowledge of diagnostic and therapeutic procedures. A first European registry was launched in 2011, using the CEMARA application developed by the Banque Nationale de Données Maladies Rares (BNDMR, CNIL authorisation number: 1187326), allowing the collection of data from France, Belgium and Italy. The objective of the current study is to translate this database into a cohort study that will allow and facilitate the collection of a wider range of data including clinical, and personal data such as quality of life data, from an increased number of European countries, improve the monitoring, data-management and analysis of the data, offer the possibility for patients to actively participate to and benefit from the study by developing a module in which patients will enter their own data on quality of life with a direct feed-back on the general results. This project is a unique opportunity for building a consensual European academic cohort not based on company driven, "drug-oriented" objectives. The cohort will collect clinical details to analyse patient outcomes thus providing audit of patient care & clinical effectiveness. It will be possible, through the cohort, to indicate where improvements need to be made and ultimately improve care to the highest standards.

NCT ID: NCT05900869 Completed - Plastic Surgery Clinical Trials

Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia

NYRESED
Start date: May 8, 2023
Phase:
Study type: Observational

Reduction nymphoplasty is the treatment of benign hyperplasia of the labia minora. This surgery is indicated in the event of functional, aesthetic or sexual discomfort. There has been a growing demand for this surgery over the past twenty years. It is necessary to remain vigilant because a request for cosmetic surgery can also be part of an obsession with body dysmorphism, former dysmorphophobia. Investigators wish to study the postoperative results concerning sexuality, self-esteem and obsession with body dysmorphia in a cohort of patients followed prospectively and at more than 3 years postoperatively.

NCT ID: NCT05900596 Completed - Clinical trials for Abnormal Fetal Heart Rate

Fetal Scalp pH During Labour: is it Worth Repeating

Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

In order to reduce the cesarean sections rate, an adjunctive test is recommended in case of non-reassuring fetal heart rate tracing. In France, the reference adjunctive test is fetal scalp blood sampling. However, there is no study about the repetition of fetal blood sampling. Our hypothesis is that the repetition of fetal blood sampling is useful when fetal heart rate stays non-reassuring and may lead to vaginal delivery without impair neonatal prognostic. Therefore, our objective was to compare the patients with three or more fetal blood sampling with the patients with one or two.

NCT ID: NCT05900518 Completed - Clinical trials for Infected Pilonidal Sinus

A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus

LASER SILAT
Start date: June 27, 2018
Phase:
Study type: Observational

Infected pilonidal sinuses are a common pathology, affecting an estimated 0.7% of the population. In France, the most commun technique is extended exeresis with an open wound, followed by directed healing. This technique reduces the risk of recurrence, albeit at the cost of daily nursing care and a long healing period involving prolonged absence from work. Closure or plasty surgical techniques aimed at reducing the duration of nursing care are more restrictive, and seem to have higher recurrence rate. Minimally invasive treatment, such as phenolization and flattening with curettage of the sinus have existed for over 50 years, albeit with disappointing long-term results and morbidity that limits their application. Today, new minimally invasive treatments are being developed, aiming at a less constraining post-operative period. without compromising healing. These include glue, endoscopic treatment (EPSiT : Endoscopic Pilonidal Sinus Treatment or VAASP : Video-Assisted Ablation of Pilonidal Sinus) and laser treatment (SiLaT procedure : Sinus Laser Therapy or PiLaT : Pilonidal disease Laser Treatment). Laser treatment is used since 2014 in the treatment of anal fistulas and more recently in the treatment of infected pilonidal sinus. A laser fiber is introduced, under local or general anaesthesia, into the main cavity and secondary tracts after curettage and opening of the dimples. The energy delivered by the laser is transmitted in the form of heat, in order to seal the cavity during healing of thermal lesions. Initial results report success rates of around 90%, with a healing time of between 1 and 2 months. It also appears to be effective after failure of previous surgery. In cases of incomplete closure or recurrence, a second laser treatment can be performed with high healing rates. The investigators carried out an retrospective study including 29 patients treated with the SILAT technique. The healing rate, defined as the absence of symptoms and recurrence of suppuration, was around 70%. The procedure was painless and no serious complications were observed. The presence of one or more secondary orifices and overweight were associated with a higher risk of failure. In order to confirm these results, to better specify the factors predictive of success, and to evaluate the efficacy of SiLaT in the longer term, the investigators will carry out a single-center study including all adult patients treated with laser between June 2018 and December 2020.