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NCT ID: NCT06090864 Recruiting - Hodgkin Lymphoma Clinical Trials

ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells

Start date: April 25, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity. The majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib/II study was conducted based on these observations. The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further. This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma. Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.

NCT ID: NCT06070207 Completed - Pain Clinical Trials

Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Bilateral Inguinal Hernia?

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

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate. One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. These studies are generally planned for unilateral hernias. It is a controversial issue among surgeons that the possibility of mesh migration is higher in bilateral hernias since there is a larger dissection area. This discussion is the starting point of this study. There were no studies in the literature regarding mesh fixation in bilateral inguinal hernias. The aim of this study is to compare bilateral inguinal hernia patients with and without mesh fixation in the eTEP technique in terms of both mesh migration and clinical features.

NCT ID: NCT06070142 Completed - Pain Clinical Trials

Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Inguinal Hernia?

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

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate. One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation. In the eTEP technique, dissection is performed in a larger area than in TEP. For this reason, it can be thought that the possibility of mesh displacement is higher in the eTEP procedure. The purpose of this study is to confirm this idea with a prospective study. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. However, there is no study on mesh detection in the eTEP technique. The aim of the study is to compare patients who underwent without mesh fixation laparoscopic TEP and eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.

NCT ID: NCT05927558 Recruiting - Relapse Clinical Trials

Salvage Treatment With Glofitamab in R/R B-NHL: a GIMEMA-FIL Study

Start date: December 22, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate the anti-lymphoma activity of glofitamab, administered according to the Compassionate Use Program, in relapsed/refractory B-NHL patients. The main question it aims to answer is the rate of patients in complete response.

NCT ID: NCT05926934 Recruiting - Relapse Clinical Trials

The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession

OrthRe10tion
Start date: January 16, 2022
Phase: N/A
Study type: Interventional

There is high possibility of relapse of the lower anterior teeth after orthodontic treatment. Relapse is related with the initial orthodontic anomaly, pathology of surrounding tissues, patient's age and sex and compliance and the retention protocol applied. The options for the later are various. Permanent fixed retainers are considered of the most common ones and vastly vary based of composition. There are fixed retainers distinguished for their composition (SS, β-NiTi, fiber-reinforced composite retainers) or for their shape and dimensions (round or rectangular shape and single-strand or multi-strand respectively), and/or for the teeth they are placed on (canine and canine or canine to canine). Fixed retainers may require patient's cooperation , nevertheless debond failure rate varies between 0.1-53%. The aim of this prospective randomized clinical study is to compare failure incidents and retention effect on lower anterior teeth after orthodontic finish between three different types of fixed retainers. There will be 3 arms studied in this research: a) single strand 0.016x0.022'' β-Ti canine to canine, b) 0.028'' SS canine to canine and c) 0.027'' multi-strand twistflex canine to canine. Variables such as repeatability of failures, and undesired tooth movements will be measured. Measurements will be repeated every 3 months after patient's recruitment in this study, for one year period (12 months in total). Intraoral scans will be collected during baseline (fixed retainer insertion) and after 12 months.

NCT ID: NCT05926167 Not yet recruiting - Multiple Sclerosis Clinical Trials

Observational Trial Evaluating Elevated Factor VIII Related Labs as a Biomarker for Incomplete Relapse Recovery

Start date: September 12, 2023
Phase:
Study type: Observational

Nine Multiple Sclerosis (MS) patients suffering an acute relapse from the outpatient or inpatient settings will be consented to be followed prospectively for three months post relapse, in an effort to identify markers of incomplete relapse recovery. Factor VIII-related labs will be drawn for three months without influencing standard of care treatment decisions. During this time, patients will be followed with clinical and diagnostic assessments in addition to blood tests including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), recovery surveys, and MRIs of the brain, cervical spine, and thoracic spine with and without contrast. Clinical, imaging, and Factor VIII-related lab data individually or in aggregate will be correlated with relapse presence, severity, and extent of recovery following standard treatment interventions.

NCT ID: NCT05915273 Completed - Relapse Clinical Trials

Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study was to compare the differences in relapse and failure rates in patients treated with fixed retainers (FRs) using Computer-Aided Design/Computer-Aided Manufacturing technology, lab-based technique, and chairside method.

NCT ID: NCT05911321 Recruiting - Multiple Myeloma Clinical Trials

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

Start date: December 5, 2023
Phase: Phase 2
Study type: Interventional

This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).

NCT ID: NCT05879601 Recruiting - Relapse Clinical Trials

"Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 24 Hours) Retainer Delivery

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

Orthodontic treatment goals can be expressed as achieving ideal tooth alignment, esthetic, functional occlusion and stability. Various occlusal changes occur after active phase of orthodontic treatment, these unwanted changes are called relapse. Reitan pointed out that major percentage of changes following active phase of treatment is seen within 24 hours. To alleviate the effect of relapse, retention is needed. There is little agreement among clinicians about orthodontic retention protocol due to insufficient evidence in the literature on 1. time of retainer delivery 2. unexpected post- treatment changes. 3.quantification of relapse tendency. The present study will be undertaken to assess the changes and compare if there is any difference in the movement of teeth in post orthodontic treatment cases with immediate and delayed (post 24 hours) retainer delivery. Thus help in deciding when should the retainer delivery is preffered.

NCT ID: NCT05879588 Recruiting - Relapse Clinical Trials

: "Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery

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

Maintaining teeth in their corrected position after orthodontic treatment is one of the most challenging part of orthodontic treatment and hence a period of stabilization termed as retention is provided after orthodontic treatment. Retention is one of the most important phase of orthodontic treatment that attempts to keep teeth in the corrected positions after treatment with orthodontic braces. Following literature search there is no scientific evidence for the timing of retainer delivery.The present study is designed to know if post orthodontic tooth movement vary with different time of retainer delivery and since there is unusual delay after debonding as the retainer is fabricated at the laboratory. Such a study will help us to find out within which time period the retainer should be delivered