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NCT ID: NCT06259266 Withdrawn - Clinical trials for Chronic Renal Failure

Catheter Dysfunction Rate in Patients Undergoing Kidney Replacement Therapy. Evaluation of the Safety and Efficacy of Anti-reflux Valves Without Heparin Lock Solution

DUKE
Start date: December 2013
Phase: N/A
Study type: Interventional

Catheter dysfunction and infections are the most common complications observed among patients with dialysis catheters for long-term dialysis ( CDLD ) . They are causing a worsening of the morbidity and mortality of patients , loss of quality of renal replacement therapy , a reduction in the duration of catheterization , as well as increased spending related to health care. The use of anti- reflux ( Tego ® , ICU Medical , USA, distributed by the Laboratory Hemotech , FRANCE ) valves reduces the rate of dysfunction and infections CDLD( catheters for long-term dialysis ). Unpublished preliminary data suggest that these valves allow parallel use of interdialytic saline locks without increasing the risk of dysfunction. This strategy would therefore achieve significant savings usual interdialytic CDLD( catheters for long-term dialysis )locks ( including heparin) whose use is not devoid of potentially serious adverse events and whose health care costs have increased dramatically in recent years . Moreover, this would also produce savings in fibrinolytic treatment. A randomized controlled trial is needed to assess the effectiveness of TEGO ® valves in combination with saline locks on the risk of dysfunction CDLD(catheters for long-term dialysis ) .

NCT ID: NCT06232707 Withdrawn - Multiple Myeloma Clinical Trials

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

ALUMMINATE
Start date: May 3, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT06205290 Withdrawn - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.

NCT ID: NCT05964348 Withdrawn - Aneurysm Aortic Clinical Trials

REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair)

AI-EVAR-FOLLOW
Start date: April 5, 2023
Phase:
Study type: Observational

The objective of this registry is to find and validate a correlation between morphological indicators such as volume sac evolution, graft migration or length between anatomical landmarks with aneurysm rupture risk or complications such as endoleaks requiring re-intervention… Secondary objectives are the validation of the reproducibility and accuracy of a dedicated fully automated software enabling Abdominal Aortic Aneurysm (AAA) segmentation to measure AAA diameter, volume evolution and growth over time, proximal and distal sealing zones analyze as well as device migration and integrity after EVAR on computed tomography angiography (CTA). This validation is in comparison with semi-automated analyse controlled by physician.

NCT ID: NCT05814523 Withdrawn - Clinical trials for Refractory Status Epilepticus

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

Start date: March 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.

NCT ID: NCT05743270 Withdrawn - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN

Start date: January 30, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, 2-cohort (Locoregionally Advanced Cohort or Recurrent/Metastatic Cohort) study evaluating RP3 in combination with concurrent chemoradiation therapy (CCRT) followed by nivolumab (for the LA Cohort) or combined with chemotherapy and nivolumab (for the R/M Cohort) in patients with advanced, inoperable squamous cell carcinomas of the head and neck (SCCHN), including of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.

NCT ID: NCT05724524 Withdrawn - HIV Clinical Trials

Exploratory Study on the Role of the Digestive Microbiota in Adults Living With HIV-1

MICRACTIVIH
Start date: May 2022
Phase:
Study type: Observational

Chronic immune activation present in aviremic people living with HIV under treatment promotes the onset of insulin resistance and metabolic syndrome, paving the way for the comorbidities that are currently the main causes of morbidity. This activation continues despite effective antiretroviral therapy. In the ACTIVIH study (NCT02334943) the analysis of 68 AI markers allowed classification of 120 aviremic PLHIV under treatment for at least 2 years according to 5 different immune activation profiles. Among these 5 profiles, Profile 2 was characterized by high blood pressure figures, high waist sizes, low HDL-cholesterol levels, high triglyceridemia, and especially hyperinsulinemia. Several studies have shown that the digestive microbiota of this population is less rich and less diverse than that of healthy subjects. However, the digestive microbiota and in particular bacterial proteins and metabolites seem to play a key role in immune activation in people living with HIV. Finally, the digestive microbiota has already been shown to have an impact on insulin sensitivity. The study investigators hypothesize that a particular digestive microbiota could promote the appearance of Profile 2. This microbiota could be the cause of digestive dysbiosis leading to intestinal inflammation, digestive permeability and bacterial translocation.

NCT ID: NCT05685095 Withdrawn - Parkinson Disease Clinical Trials

Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson

ACTI-PARK
Start date: February 2023
Phase: N/A
Study type: Interventional

The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD). Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point. The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function. Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.

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: NCT05597592 Withdrawn - Clinical trials for Neuromuscular Diseases

Experimentation of a Personalized Physical Self-education Program at Home: Feasibility Study (PROSOL TELEKINECT)

TELEKINECT
Start date: February 2023
Phase: N/A
Study type: Interventional

ALCOTRA (Alpes Latines COoperation TRAnsfrontalière) is one of the European cross-border cooperation programmes covering France and Italy and financed by the ERDF (European Regional Development Fund). It includes the thematic plan (PITEM), called "PROSOL" (PROximity and SOLidarity), set up in the PIEDMONT region (Italy). The PITEM PROSOL strategy aims to develop new social and health services for vulnerable populations in the rural areas and cross-border Franco-Italian mountains of the South regions (Provence Alpes Cote d'Azur, Liguria, Piedmont and Aosta valley). As part of the PITEM PROSOL project, a PROSOL telemedicine platform has been developped for the management of isolated patients from the territory of the Latin Alpes and suffering from neurological diseases (neurodevelopmental disorders, neuromuscular diseases and neurodegenerative diseases). These patients are divided into 3 experimental groups: WOMEN (project 5106), SENIORS (project 4128) and YOUTH (project 5162). A PROSOL e-learning platform (https://www.prosol-elearning.com/) has also been developped for these patients, their caregivers and community physicians to improve knowledge and management of these diseases. Experimentation of these platforms by several participants (and their caregivers) has highlighted the need, often discontent, of a personalized management of physiotherapy for patients with neuromuscular diseases (MNM) and neurodegenerative diseases (Alzheimer's disease). As physical activity has a beneficial and protective effect of these diseases, and inactivity is one of the important risk factors in worsening symptoms contributing to the loss of patients' motor and cognitive functional abilities, a program of self-physical rehabilitation has been designed by neurologists and physiotherapists of expert centers for a personalized and adapted treatment for each patient. The PROSOL TELEKINECT project offers a physical rehabilitation program to be carried out autonomously at home, with coaching by physiotherapists via the telemedicine platform, as well as close monitoring of exercise response regarding the level of pain and fatigue of patients, thus ensuring their maximum safety. The objective of the PROSOL TELEKINECT project is to evaluate the value of an appropriate physical rehabilitation programme for each type of patient. The feasibility and beneficial effects of this program will be assessed using conventional assessments of motor function and patient quality of life, but also using a connected watch coupled with artificial intelligence algorithms to collect and analyze physiological data remotely in real time in the patients' natural environment. The results of this pilot study will be used to lay the foundation for a larger clinical study to test a new digital strategy for self-treatment rehabilitation, aimed at reducing unequal access to care for patients with neuromuscular and neurodegenerative diseases, and residents of transboundary territories, thus offering the establishment of a preventive and supportive approach to these diseases.