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NCT ID: NCT05653635 Not yet recruiting - Glioblastoma Clinical Trials

Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study

ReciDOPA
Start date: September 1, 2023
Phase: Phase 2
Study type: Interventional

ReciDOPA is a phase II, single-stage randomized, multicenter, prospective trial assessing the efficacy of an irradiation protocol based on Intensity-modulated radiation therapy with simultaneous-integrated boost guided by FDOPA-PET in patient with recurrent glioblastoma.

NCT ID: NCT05653609 Completed - Neoplasms Clinical Trials

Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Tool

POSITEA-VA
Start date: November 15, 2022
Phase:
Study type: Observational

Cureety is a digital telemonitoring platform specifically designed to monitor cancer patients through self-reporting of adverse events, accompany patients and their medical teams and complement existing healthcare practices. The platform aims to detect signs and symptoms of health deterioration and disease progression, allowing the medical team to intervene earlier than usual compared to conventional care. The patients are asked to respond to an electronic patient-reported outcome (ePRO) questionnaire. The digital tool is configured for each patient that generates specific questions that allow grading of adverse events relevant to their specific treatment and disease profile. At the core of the platform is the medical device "Cureety TechCare", an algorithm that outputs a "clinical classification" based on the adverse events reported by the patients. There are four levels that correspond to the patients' health states, either "critical" ("red"), "to be monitored" ("orange"), "compromised" ("yellow"), or "correct" ("green"). In the case of a red or orange classification, the patients are asked to contact their medical team. In addition, the medical team can monitor the patient classifications from a distance including receiving notifications when patients are classified red and orange. The present study was designed to retrospectively evaluate the performance of the "Cureety TechCare" medical device in real-life using data collected in the Cureety database.

NCT ID: NCT05653531 Withdrawn - Lung Cancer Clinical Trials

Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

HEPATICI
Start date: October 25, 2022
Phase: N/A
Study type: Interventional

Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.

NCT ID: NCT05653349 Recruiting - Clinical trials for Primary Immune Thrombocytopenia (ITP)

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

VAYHIT1
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

NCT ID: NCT05653219 Recruiting - Clinical trials for Primary Immune Thrombocytopenia

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

VAYHIT2
Start date: January 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

NCT ID: NCT05653115 Recruiting - Clinical trials for Bariatric Surgery Candidate

Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

BARIAPORTAL
Start date: January 12, 2022
Phase:
Study type: Observational

The worldwide obesity epidemic has led to an increase in the proportion of patients with chronic liver disease due to non-alcoholic fatty liver disease (NAFLD) and in the prevalence of obesity in patients with cirrhosis of all etiologies. The reported prevalence of obesity in patients with cirrhosis is of 30% which appears similar to that of the general population. Bariatric surgery is currently considered as the most effective and durable means for the management of morbid obesity as it is associated with the remission and/or improvement of many obesity associated comorbidities as well as improved quality and expectancy of life. However, the surgical risk is increased compared to individuals without cirrhosis, and determining the risk/benefit ratio of bariatric surgery in the setting of cirrhosis is a complex task further hampered by the lack of randomized controlled trials. The Nationwide Inpatient Sample study reported a slightly increased rate of mortality of bariatric surgery in the setting of compensated cirrhosis compared to individuals without cirrhosis (0.9% vs 0.3%). Interestingly, this risk was as high as 16.3% in individuals with decompensated cirrhosis (16.3%). However, this study has been published more than 10 years ago and the mortality of bariatric surgery has decreased significantly and is around 0.1%. Furthermore, the introduction of transient elastography in clinical practice has allowed the early identification of patients with chronic liver disease (CLD) at risk of developing clinically significant portal hypertension (CSPH). A few series including a limited number of patients have been published indicating that CSPH should not be considered as a formal contraindication for bariatric surgery. This study is meant to assess the outcomes of bariatric surgery in patients with morbid obesity and compensated advanced chronic liver disease (cACLD) (currently synonymous of the term "compensated cirrhosis'') associated with clinically significant portal hypertension (CSPH) in a large multicentric, multinational series.

NCT ID: NCT05653089 Recruiting - Clinical trials for Neurological Disease

Positioning in Wheelchair Bound Patients

AAPO'G
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The choice of the most suitable chair as well as the improvement of the patient's positioning on this wheelchair is important to limit the discomfort, to prevent the risks of bedsores, the pains related to prolonged sitting and finally to support the interaction of the patient with its environment. The goal of this prospective, longitudinale, monocentric study is to evaluate the impact of standardized positioning in wheelchair-bound patients at risk of slipping. The main questions on the positioning actions are: - their actions impact of positioning actions on shear forces - their impact on sliding in the chair - their impact on the feeling of discomfort in the chair - their impact on the caregivers' feelings about the patient's difficulties (eating, transfers, sliding) Participation in this study will involve an increase in the number of transfers required for shear sheet placement and removal, as well as the time required for ischial measurement and the time to complete the (Tool for Assessing Wheelchair disComfort) TAWC questionnaire.

NCT ID: NCT05652582 Completed - COVID-19 Clinical Trials

Seroprevalence of Covid-19 in the Staff of the University Hospitals of Strasbourg

SeroPrevHUS
Start date: June 24, 2021
Phase:
Study type: Observational

The Grand Est region is one of the most affected regions in France during the first wave of the COVID-19 epidemic. A significant increase in the number of patients hospitalized for SARS-CoV 2 infection at the University Hospitals of Strasbourg (HUS) led to a sudden saturation of their capacities. Hospital workers appear to be a population at particular risk for this new infectious agent. The percentage of hospital workers who have been in contact with the virus or have contracted COVID-19 is unknown. The objective of this work is to determine the prevalence of SARS-CoV-2 positive serologies among hospital staff screened from June 22, 2020 to November 1, 2020 following a screening campaign offering serological testing to all volunteer HUS professionals.

NCT ID: NCT05652335 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Start date: November 22, 2022
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

NCT ID: NCT05652296 Recruiting - Clinical trials for Cerebrospinal; Disorder

External Ventricular Drainage Post-Market Clinical Follow-up Registry

Start date: March 3, 2023
Phase:
Study type: Observational

This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.