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NCT ID: NCT06181201 Active, not recruiting - Cancer of Rectum Clinical Trials

Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer

Neo-Flo-Rect
Start date: January 19, 2024
Phase:
Study type: Observational

This is an observational, single-centre study (RIPH3) for patients with rectal cancer soon to be treated with chemotherapy (+/- neo-adjuvant radio-chemotherapy) looking at the relationship between the composition of the gut microbiota before treatment and the tumour response after chemotherapy +/- radio-chemotherapy

NCT ID: NCT06180785 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia (HIT)

Performance Evaluation of the Biological Diagnosis of HIT

HIT
Start date: June 27, 2022
Phase:
Study type: Observational

Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.

NCT ID: NCT06180382 Not yet recruiting - Crohn's Disease Clinical Trials

Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.

VEDIAN
Start date: June 2024
Phase: Phase 4
Study type: Interventional

A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class. Moreover, according to STRIDE 2 recommendations and CALM study, optimize patients based solely on lack of biological remission (CRP, calprotectin) can be discuss. If CALM study has showed that the intervention arm based on regular monitoring fecal calprotectin, CRP and/or CDAI to optimize patients under adalimumab was significantly associated to an increase rate of mucosal healing that the standard of care strategy based on only clinical activity, TDM was not available to guide drug optimization strategy.

NCT ID: NCT06180291 Not yet recruiting - Cerebral Palsy Clinical Trials

EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

PRECOP
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Cerebral Palsy (CP) is the most common motor disability in children. It is due to damage that occurs during brain development in the fetus or infant. Early treatment (before 2 years) will allow the child to promote brain plasticity to compensate for the effects of the lesion and reduce the severity of CP. The goals of early intervention are to increase motor, cognitive and communication skills, prevent complications and provide parental support. Most authors agree to recognize the benefit of early care by emphasizing home intervention programs with active parental participation. To date, no recommendations exist in France for the management of cerebral palsy in children under the age of two. It is therefore necessary to conduct scientific studies in this population. Based on published international studies, the PRECOP program (PREcoce intervention in parent-professional COoperation in Cerebral Palsy) consists of individualized care adapted to the specific needs of each child, from the arrival of the infant at home, by a multidisciplinary team during the child's first two years.

NCT ID: NCT06179823 Completed - Clinical trials for Thromboembolic Disease

Safety of Direct Oral Anticoagulant During Pregnancy

SACOD
Start date: January 1, 2019
Phase:
Study type: Observational

Pregnancy is a major risk factor of thromboembolic disease (2 to 10 increased risk of thromboembolic event for pregnant women). This risk is related to the physiological changes inducing venous stasis and hypercoagulability. Thromboembolic disease is the first preventable cause of death during pregnancy (in France 1.1 maternal death per 100 000 living births. The recommended treatment for pregnant women is low molecular weight heparin requiring subcutaneous injections daily. Vitamin K antagonists are contraindicated due to a teratogenic risk. Direct oral anticoagulants (DOAC) are easier to use. Currently available preclinical and incidental exposure data on DOAC in pregnant women are very limited and insufficient to conclude on their safety. Therefore, its use during pregnancy is currently contraindicated for the grounds of precaution. The use of reimbursement data from the Système National des données de santé (National Health Data System) would provide more information on accidental exposure to DOACs during pregnancy, thanks to its completeness. The primary objective of SACOD is to compare the prevalence of adverse perinatal outcomes in pregnant women treated with a direct oral anticoagulant versus pregnant women treated with heparin and Vitamin K antagonist. The secondary objectives of the SACOD study are to i) determine the frequency of patients exposed to a direct oral anticoagulant during pregnancy according to pregnancy, ii) measure the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with a direct oral anticoagulant therapy, iii) compare the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with direct oral anticoagulants compared with pregnant women treated with heparin and a vitamin K antagonist, iv) compare the prevalence of adverse perinatal outcomes in pregnant women with Antiphospholipid syndrome treated with a direct oral anticoagulant versus pregnant women treated with heparin and anti-vitamin K, v) measure the incidence of thrombo-embolic episodes during pregnancy under anticoagulant treatment.

NCT ID: NCT06179251 Recruiting - Otosclerosis Clinical Trials

KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING

Luxation
Start date: December 13, 2021
Phase:
Study type: Observational

Titanium pistons cause MRI artifacts that prevent interpretation of the vestibule. This disadvantage is not present on CT but the vestibule is not visible. Hence the interest in creating a model with 6 reference cuts in order to position the utricle and the saccule in the vestibule in CT. Furthermore, the scanner has fewer contraindications, greater availability and a shorter examination time than MRI.

NCT ID: NCT06179199 Not yet recruiting - Clinical trials for Transcranial Direct Current Stimulation (tDCS)

Evaluation of the Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) for Sedated Patients in Intensive Care Unit.

REASTIM
Start date: April 2024
Phase: N/A
Study type: Interventional

Pain management for sedated ICU patients is complex, partly because of the difficulty of assessing pain in non-communicative patients, and partly because of the side effects associated with excessive use of morphine. In this context, the use of another non-pharmacological approach, transcranial direct current stimulation (tDCS), could be of interest. With tDCS, neuronal activity is modulated by inducing a weak electric current through the cerebral cortex between two electrodes applied to the surface of the scalp. Although the mechanisms of action of tDCS are not yet fully understood, the medium-term effects are thought to be linked to the activation of N-methyl-D-aspartate receptors, glutamate-activated receptors involved in cellular memory. The use of tDCS as an analgesic therapy for chronic pain has produced encouraging results in patients suffering from fibromyalgia, migraine and central pain following spinal cord injury, Its use in sedated intensive care patients is unknown. To assess the possible analgesic effect of tDCS in these patients, we will use quantitative pupillometry, a technique already used in routine intensive care, to quantify nociception during a standardized nociceptive simulation.

NCT ID: NCT06179160 Recruiting - Solid Tumors Clinical Trials

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Start date: January 4, 2024
Phase: Phase 1
Study type: Interventional

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

NCT ID: NCT06178614 Recruiting - Clinical trials for Advanced Solid Tumors

A Study of JNJ-87890387 for Advanced Solid Tumors

Start date: December 14, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).

NCT ID: NCT06178497 Recruiting - Clinical trials for ACL - Anterior Cruciate Ligament Deficiency

5 Years' Follow-up Assessment of Surgical Repair for ACL Proximal Rupture

RUPTUPROX
Start date: December 1, 2023
Phase:
Study type: Observational

Isolated ruptures of ACL (anterior cruciate ligament) are ligament injuries that can be proximal, central or distal. Treatment of patients with proximal lesions should be graded. Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and progression risk to a functionally unstable knee less marked. In athletes, the risk of a new sprain must be explained and the patient will choose functional treatment or surgical treatment. Surgical treatment generally involves ligamentoplasty at the expense of a knee tendon to replace the ruptured ACL. In the context of proximal ACL rupture, the patient can be offered surgical repair of the ACL. There are numerous studies on ACL ligamentoplasties results but literature is poor on modern ACL repair outcomes. In this context, this study aims to describe the relapse rate at 5 years of patients operated for a proximal ACL tear.