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NCT ID: NCT05675215 Recruiting - Psychopathology Clinical Trials

External Validation by Machine Learning and Reduction of the Input Dimensions of the D-PSY Scale for Dimensional Psychopathology

D-Psy adultes
Start date: October 11, 2022
Phase:
Study type: Observational

There have been debates about whether psychiatric disorders should be classified according to categories (categorical model) or according to a continuum between normal and pathological functioning (dimensional model). While the former is the main one used to facilitate reliability, it has several limitations. We will use machine learning to develop a predictive model, bridging the gap between the dimensional and categorical approaches. Psychometric measures obtained from a questionnaire will be collected. Then, a supervised descriptor selection approach will be applied to predict categorical outcomes from dimensional inputs. The resulting prediction will be based on nonlinear modeling based on universal approximators. We developed this input questionnaire with four main objectives: 1) to briefly scan most of the categories generally described in the international nosography; 2) to use a continuous scale following a dimensional approach; 3) to use positively oriented sentences to decrease social desirability bias; 4) to be less confronting for the patient. The questionnaire is built on dimensions, whereas psychiatric diagnoses are built on categories. We will model the transition from one to the other. This approach will allow us to verify the hypotheses of diagnostic categories construction in psychopathology, integrated in the RDoC approach; and later on to standardize the psychometric measures used in cognitive-behavioral therapy treatments. 200 adults will undergo a standard clinical interview (SCID-5, First et al., 2017), and the psychological screening self-report questionnaire (D-Psy) and additional questionnaires measuring social desirability dissociation, phobia and autism.

NCT ID: NCT05674994 Recruiting - Clinical trials for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

EXAFIP2
Start date: October 26, 2023
Phase: Phase 3
Study type: Interventional

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.

NCT ID: NCT05674487 Recruiting - Clinical trials for Fetal Growth Restriction

Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)

PROBIN
Start date: April 9, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized trial is to compare two methods of induction in a fetal growth restriction population. The main question it aims to answer is: • Is trans-cervical balloon superior to prostaglandins in reducing the cesarean section rate, without increasing neonatal morbidity? Participants will have an induction of labour by cervical ripening with trans-cervical balloon in the trans-cervical balloon catheter arm and with Prostaglandins in the Misoprostol arm. Researchers will compare two methods of induction: trans-cervical balloon and prostaglandins to see if trans-cervical balloon is associated with a lower risk of cesarean delivery.

NCT ID: NCT05673499 Recruiting - Clinical trials for Congenital Disorders

International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Start date: August 12, 2022
Phase:
Study type: Observational

The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1. The perioperative factors associated with occurrence of cerebral desaturation 2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions. Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.

NCT ID: NCT05673486 Completed - Hip Fractures Clinical Trials

Regional Anesthesia by PENG-Block in Emergency Department

ED-PENGBLOCK
Start date: March 31, 2023
Phase: N/A
Study type: Interventional

The study is a single-centre, open-label randomized comparative trial. Adult patients admitted to the emergency department for a hip fracture will be enrolled. Pericapsular nerve block (PENG-block) is a regional anesthesia technique developed primarily as an analgesic technique in a perioperative setting during hip fractures related surgical procedures. Some authors propose the use of PENG-Block as an alternative to fascia iliaca block and femoral block for the analgesic management of hip fracture in the emergency department, but scientific evidence is weak in this setting. The hypothesis of this study is that the use of PENG Block in the emergency department provides a better pain management for patients suffering from hip fractures with less opioid use.

NCT ID: NCT05673265 Recruiting - Clinical trials for Arthrogryposis Multiplex Congenita (AMC)

Pediatric and Adult Registry for Patients With ARThrogryposis

PARART
Start date: November 1, 2021
Phase:
Study type: Observational

The aim of the study is Epidemiological Evaluation of a single-centre national cohort of patients with Arthrogryposis multiplex congenita (AMC)

NCT ID: NCT05673187 Recruiting - NSCLC Stage IV Clinical Trials

Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

ADEPPT
Start date: June 12, 2023
Phase: Phase 2
Study type: Interventional

ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).

NCT ID: NCT05673057 Recruiting - Leukemia Clinical Trials

Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: December 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

NCT ID: NCT05672550 Recruiting - Clinical trials for Pediatric Kidney Transplant Recipients

Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients (OPTI-TREX)

OPTI-TREX
Start date: June 28, 2023
Phase: Phase 4
Study type: Interventional

Allograft vascular thrombosis is a devastating complication in kidney transplantation in adults and older children. Though uncommon, it is often irreversible and represents the main cause of graft loss within after kidney transplantation in adults and in the first post-operative year in children. Since allograft thrombosis is usually observed in the first 48h post-operatively, the need to promptly achieve appropriate anticoagulation in at-risk patients is of utmost importance. However, no consensus exists regarding the optimal prophylaxis in the peri-transplant period and the following dose-adjustment, and practices are highly heterogeneous among centers. Moreover, the therapeutic target is very narrow and antithrombotic agents may conversely increase the risk of allograft hematoma. Enoxaparin is a low molecular weight heparin commonly used in this context, but off-label in children. Therapeutic ranges are based on anti-Xa levels 4 to 6 hours following injection and extrapolated from adults although evidences suggest that such extrapolation may be inappropriate in many circumstances. The current pediatric practice of dose adjustment to achieve and maintain a target anti-Xa range is empirical and dependent on the physician. The aim of the proposed clinical trial is to assess the efficacy/safety profile of this bayesian-based dose optimization in the clinical setting, as compared to the current practices of empirical adjustment. This should greatly improve the personalized management of renal transplanted children, a subset of patients with singular renal function and little-investigated pharmacokinetics and help standardizing and rationalizing practices.

NCT ID: NCT05672069 Completed - Foot Diseases Clinical Trials

Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices

Start date: December 7, 2022
Phase:
Study type: Observational

This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative. The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status. The target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022. The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.