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NCT ID: NCT06079892 Recruiting - Hemorrhoid Prolapse Clinical Trials

Hemorrhoid Radiofrequency

RFH
Start date: March 1, 2017
Phase:
Study type: Observational

Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution. The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively. The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").

NCT ID: NCT06079619 Completed - Pigmented Lesions Clinical Trials

Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20

Start date: March 1, 2022
Phase:
Study type: Observational

Pigmented lesions of the genital mucosa are common, affecting between 10% and 20% of the population. The clinical appearance is sometimes confusing. They are often extensive, irregular, and inhomogeneous in color, which can make them look suspicious. Moreover, dermatoscopic imaging is often complex to interpret, as shown by the many different patterns reported in the literature. Thus, preliminary work in confocal microscopy has shown that it is possible to simplify diagnosis by using microscopic, in vivo, non-invasive imaging. However, CIM cameras are rare, very expensive and difficult to access. Conversely, digital dermatoscopes with 400x magnification are much less expensive and can also allow, in a certain number of cases, an examination at the cellular level of tumors, with, in our opinion, the advantage of being easy to learn. In the context of the pooling of resources within medical centers in particular, their dissemination should accelerate. Furthermore, x400 dermatoscopy can provide similar information to IVCM for the most frequent black genital tumors.

NCT ID: NCT06079567 Recruiting - Clinical trials for Facioscapulohumeral Muscular Dystrophy Type 2

An 18-month Prospective Natural History Study to Gain Insight Into FSHD2 Pathophysiology and Disease Progression

INSIGHT FSHD2
Start date: October 3, 2023
Phase: N/A
Study type: Interventional

Facioscapulohumeral muscular dystrophy (FSHD) is one of the most common inherited myopathies in adults. It is associated with genetic and epigenetic deregulation of the D4Z4 locus on the sub-telomeric region of chromosome 4q35, resulting in abnormal expression of DUX4p. Type 1 FSHD (FSHD1) is the most common form of the disease and accounts for 95% of cases, while Type 2 FSHD (FSHD2) accounts for only 5% of all FSHD cases. FSHD1 and FSHD2 are closely related in terms of genetic and epigenetic foundations, pathophysiology and clinical manifestations. Although initially described as distinct entities based on their genetics, recent information suggests that both forms of myopathy may represent the opposite ends of a spectrum of molecular diseases in which alteration of the genetic and epigenetic factors that govern DUX4 suppression in skeletal muscle have a different impact in both forms of the disease. FSHD1 and FSHD2 are both associated with re-expression of DUX4 leading to muscle atrophy, but the genetics underlying this re-expression are different, depending on whether it is type 1 or type 2. For FSHD1, it is associated with a critical contraction of the D4Z4 region and the 4qA permissive allele, leading to the expression of DUX4. In contrast, FSHD2 is caused by the inheritance of two independent genetic variations. A heterozygous mutation, mainly located on the SMCHD1 (Structural Maintenance of Chromosome flexible Hinge Domain containing 1) gene, results in a loss of function of chromatin D4Z4 repressor. This mutation, combined with the 4qA allele bearing the DU4 polyadenylation site, makes this allele permissive for the expression of the DUX4 topical gene. Therefore, because the two forms of FSHD are genetically distinct and very few patients have FSHD2, our knowledge of the impact of chromatin D4Z4 repressors, such as SMCHD1, or the progression and severity of the disease remains very limited. It is important to note that a lack of reliable biomarkers specific to the severity and progression of the disease may prevent the development of therapies to treat patients with FSHD2. This study will allow us to better understand the natural progression of FSHD2 over time, to assess the responsiveness of clinical outcome measures (COMs) and to identify and validate inflammatory serum biomarkers predicting the severity and progression of the disease.

NCT ID: NCT06079372 Recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

CHESTNUT
Start date: April 2, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.

NCT ID: NCT06079359 Recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

MULBERRY
Start date: May 14, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.

NCT ID: NCT06079294 Recruiting - Clinical trials for Autoimmune Encephalitis

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

ENCEPHATAIP
Start date: May 31, 2024
Phase: N/A
Study type: Interventional

Prospective cohort study evaluating FDG PET in 56 patients with confirmed autoimmune encephalitis - based on 2016 Graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before immunomodulating treatment, or within 10 days of treatment initiation.

NCT ID: NCT06079281 Recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

HICKORY
Start date: January 3, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

NCT ID: NCT06079268 Completed - Healthy Volunteer Clinical Trials

Diagnostic Performance of Gastric Ultrasound in Children

QUALIGASTR
Start date: December 20, 2023
Phase: N/A
Study type: Interventional

Pulmonary aspiration of gastric contents is a complication responsible for the third highest cause of anaesthesia-related mortality in France, and for 50% of airway management-related mortality in the UK. The occurrence of pulmonary aspiration of gastric contents is often the result of a poor assessment of the risk of a "full" stomach, and could therefore often be avoided if the preoperative gastric contents were known to the anaesthetist. It is therefore useful to be able to discriminate easily between patients at risk of aspiration and those at low risk before general anaesthesia, and this can be done by ultrasound examination of the gastric contents in the gastric antrum, non-invasively (abdominal ultrasound) using a 2-5 MHz abdominal ultrasound probe or a high-frequency linear probe in small children (under 10 kg). European recommendations on preoperative fasting in paediatrics recommend that the examination should be interpreted in a qualitative manner only, without measuring the antral surface. However, the diagnostic performance of this qualitative approach alone has never been evaluated. The aim of this study was to determine the diagnostic performance of the qualitative assessment of gastric contents by ultrasound in children, and to compare it with that of the clinical algorithm, for the detection of a volume of fluid greater than 1.25 ml/kg. Children will present themselves in the morning after fasting. Upon arrival, if their weight is not known, the children will be weighed. Subsequently, they will be positioned on an examination table in a supine inclined position at 45° (head of the bed elevated). An initial gastric ultrasound will be performed by a physician (investigator 1) who will not conduct the study ultrasounds. This initial ultrasound aims to confirm the absence of gastric content in the supine and right lateral decubitus positions, thereby establishing gastric emptiness. Investigator 1 will then proceed with the random selection of the clear liquid volume to be ingested for the study. The child will then be asked to drink this determined volume of clear liquid (water or apple juice according to their preference), as per the randomization results, under the supervision of the first investigator who performed the initial ultrasound. Subsequently, investigator 2 will perform a gastric ultrasound blindly with respect to the ingested liquid volume, three minutes after the consumption of the clear liquid. The examination will last a maximum of 3 minutes. Non-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance. The diameters (longitudinal D1 and anteroposterior D2) of the antrum will also be measured in the supine (semi-seated and lying) and right lateral positions in the sagittal plane passing through the abdominal aorta and the left lobe of the liver, for the calculation of the antral section area, given by the formula: Antral area = π x D1 x D2 / 4.

NCT ID: NCT06079229 Completed - Pancreatic Cancer Clinical Trials

Quality of Life in Elderly Patients After Pancreatic Cancer Surgery

ADL_DPC_PA
Start date: November 6, 2023
Phase:
Study type: Observational

Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men. Surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. The main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied. The aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. These patients underwent surgery at Édouard Herriot Hospital (Hospices Civils de Lyon) since July 2021, and the assessment will be conducted through telephone questionnaires. It is hypothesised that these patients will be able to maintain their independence in terms of daily activities.

NCT ID: NCT06079190 Recruiting - Alzheimer's Disease Clinical Trials

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

PROGRESS-AD
Start date: October 20, 2023
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.