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NCT ID: NCT05510596 Completed - Lymphoma, B-Cell Clinical Trials

Magnetic Resonance Imaging in Immune Effector Cell-Associated Neurotoxicity Syndrome

MR-ICANS
Start date: September 22, 2022
Phase: N/A
Study type: Interventional

The treatment of large-cell B-cell lymphomas refractory to more than 2 lines of therapy has recently been revolutionized by the use of immunotherapies consisting of autologous genetically modified cells or CAR-T CELLS (chimeric antigen receptor-T cells), which very significantly increase progression-free survival and overall survival. Nevertheless, this therapy is frequently associated with cytokine release syndrome and in approximately 20% to 60% of patients with neurological complications that can sometimes be dramatic and are associated with a significant mortality rate. The mechanisms behind this neurotoxicity are unclear. Despite the frequent occurrence of neurological toxicity characterized in particular by headache, tremor, and encephalopathy that is most often transient, brain imaging by CT or, preferably, MRI are most often normal. The rare abnormalities that have been identified suggest the presence of cytotoxic edema associated with the existence of transient modifications of the blood-brain barrier. To date, the management of neurotoxicity associated with CAR-T CELLS remains empirical. It combines early management of cytokine release syndrome (by administration of anti-IL6) and treatment with corticosteroids, the objective of which would be to control neurotoxicity more specifically. A better understanding of the pathophysiological mechanisms associated with this neurotoxicity appears essential today in order to be able to propose adapted prevention and treatment methods. Main objectives are to compare tissue permeability by quantitative MRI measurement of Ktrans to the theoretical peak of neurotoxicity between patients with CAR-T Cell-induced neurotoxicity and those without neurotoxicity and to Study, by MRI, the evolution of tissue microcirculatory parameters (from D-3 to D7) between groups of patients with or without the occurrence of neurotoxicity associated with CAR-T CELL treatment. For this purpose, 25 subjects will be included (the investigators hypothesize 40% with treatment-induced neurological impairment).

NCT ID: NCT05507255 Completed - Clinical trials for Premenstrual Syndrome

Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.

NCT ID: NCT05504395 Completed - Clinical trials for Prader-Willi Syndrome

A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome

Start date: November 14, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this Phase 1 study is to evaluate the pharmacokinetics (PK) and safety of a single dose of CSTI-500 10 mg in subjects with Prader-Willi syndrome (PWS) between 13 and 50 years of age with a genetically confirmed diagnosis of PWS.

NCT ID: NCT05503303 Completed - Metabolic Syndrome Clinical Trials

T1D, Metabolic Syndrome and Insulin Resistance

Start date: August 1, 2021
Phase:
Study type: Observational

Patients with type 1 diabetes (T1D) and metabolic syndrome (MS) require high doses of insulin to achieve a glycemic control, due to insulin resistance (IR). The investigators identified the presence of metabolic syndrome and insulin resistance in patients with T1D in a population of southeast Mexico. The sampled population was recruited from the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez"; from August 2021 to February 2022, graduated physicians interviewed patients previously diagnosed with T1D. This study included patients older than 18 years and at least six months after being diagnosed with T1D. The interviewers excluded patients who did not attend regular consultations and those who did not agree to participate or to give a blood sample. A diabetologist evaluated and diagnosed all patients based on the World Health Organization (WHO) criteria. Fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols were determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics. The reasearch team determined glycated hemoglobin concentrations by an enzymatic immunoassay method.

NCT ID: NCT05500716 Completed - Clinical trials for Temporomandibular Joint Dysfunction Syndrome

The Effect of Vagus Nerve Stimulation on Temporomandibular Joint Dysfunction

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Temporomandibular joint dysfunction (TMD) is a broad clinical picture involving the TMJ and its disc, masticatory musculature, ligament tissue, and autonomic nervous system (ANS). TMD symptoms include decrease or excessive increase in joint range of motion (ROM), clicking sound or crepitation in the joint, pain around the joint or muscle group, chewing and swallowing problems. Pain caused by MPS, trigger point, fatigue, limitation of ROM, and ANS dysfunction cause TMD. With the inclusion of habits such as clenching and bruxism, pain, spasm and disability develop in the chewing muscles. Exposure to repeated trauma and excessive use of chewing muscles may cause the formation of tight bands and trigger points, which are characterized by MPS. When the relationship between TMD and ANS was examined, it was observed that increased sympathetic activity and decreased parasympathetic activity were effective in the severity of TMD symptoms. Auricular vagus nerve stimulation is a peripheral, non-pharmacological and non-invasive neuromodulation technique that modifies signal processing in the CNS, activates reflex circuits, exploits brain plasticity for different therapeutic purposes, thereby affecting very different areas of the brain. Non-invasive or transcutaneous Vagus Nerve Stimulation delivery systems provide stimulation in the auricular branch of the vagus nerve in the outer ear, thus eliminating the need for surgical implantation. The aim of our study is to reveal the extent to which Auricular Vagus Nerve Stimulation, applied in addition to the conventional rehabilitation program, affects the results of the treatment by stimulating the parasympathetic nervous system in patients with Temporomandibular Joint Dysfunction caused by Myofascial Pain Syndrome.

NCT ID: NCT05499000 Completed - Clinical trials for Premenstrual Syndrome

The Effect of Emotional Freedom Technique on Premenstrual Syndrome

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Objective: This study was conducted to evaluate the Effect of Emotional Freedom Technique on Premenstrual Syndrome. Methodology: The research will be conducted as a randomized controlled trial. The research will be carried out with students studying at the Department of Midwifery, Faculty of Health Sciences, İnönü University, between September and October 2022. The sample size of the study was calculated as 102 people with an effect size of 0.80 and a power of 0.95. Premenstrual syndrome scale will be applied to all students participating in the research first and those who score 110 and above will be listed. Experimental and control groups will be determined by randomization. Personal information form, subjective experience unit scale and premenstrual syndrome scale will be used to collect data. SPSS 22.0 package program will be used in the evaluation of the data. The independent variable of the research is the emotional liberation technique. The dependent variable of the study is the mean scores of the participants from the subjective experience unit scale and premenstrual syndrome scale.

NCT ID: NCT05497089 Completed - Clinical trials for Post-COVID-19 Syndrome

Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome

Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

This study is a Phase 2, 24-week, randomized, prospective, double-blind, multicenter study in patients experiencing neuropsychiatric symptoms and functional impairment in the course of PASC. The purpose of the study is to evaluate the efficacy and safety of Temelimab as a treatment for PASC neuropsychiatric symptoms in patients who had severe acute respiratory syndrome coronavirus - type 2 (SARS-CoV-2) infection but did not undergo intensive care treatment during the acute period. Patients meeting eligibility criteria will be randomized to Temelimab or placebo in a 1:1 ratio via interactive voice/web response system to obtain 182 protocol completers. The randomization will be stratified by age (≤65 years versus >65 years).

NCT ID: NCT05497037 Completed - Clinical trials for Carpal Tunnel Syndrome

Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.

NCT ID: NCT05495269 Completed - Glaucoma Clinical Trials

Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

Start date: November 23, 2022
Phase: Phase 2
Study type: Interventional

Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.

NCT ID: NCT05494008 Completed - Traffic Accident Clinical Trials

Evaluation of Effectiveness and Safety of Korean Herbal Medicine for Post-accident Syndromes After Acute Phase

Start date: July 24, 2021
Phase: N/A
Study type: Interventional

This study is a single blind, randomized controlled trail. condition/disease: Post-accident syndromes after acute phase treatment/intervention: herbal medicine treatment strategy