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NCT ID: NCT06149286 Recruiting - Clinical trials for Marginal Zone Lymphoma (MZL)

A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma

OLYMPIA-5
Start date: December 28, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how the combination of odronextamab and lenalidomide works compared to the combination of rituximab and lenalidomide, (the current standard-of-care treatment for FL and/or MZL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug in combination with lenalidomide - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on your quality-of-life and ability to complete routine daily activities

NCT ID: NCT06146244 Completed - Clinical trials for Implant Site Reaction

Comparison of ISQ in Implants Placed in Antral Area on Native Bone vs Regenerated Bone

Start date: March 1, 2018
Phase:
Study type: Observational

Compare ISQ values of implants placed in antral area in native bone vs regenerated bone with a follow-up at 3 months to compare values changes.

NCT ID: NCT06146231 Recruiting - Breast Cancer Clinical Trials

Motiva Flora® Aesthetic Breast Recon® Clinical Study

Start date: August 18, 2023
Phase: N/A
Study type: Interventional

The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.

NCT ID: NCT06145646 Recruiting - Healthy Subjects Clinical Trials

Intramuscular Temperature on the Echo-textural Characteristics

Start date: November 30, 2023
Phase: N/A
Study type: Interventional

Echointensity and echotexture have been used as a physiological marker for changes in skeletal muscle quality and structure caused by physical training, low activity, ageing and some neuromuscular disorders. However, there are some influencing factors on muscle echo-intensity and echotexture, such as temperature, which may not be taken into account when performing an ultrasound assessment and may alter the results. This study aims to investigate the effects of muscle temperature on echointensity and other 2nd order echotextures variables such as homogeneity, contrast, correlation and entropy of muscle tissue, in order to gain a better understanding of this correlation and minimise its influence, which would allow greater precision in the use of muscle ultrasound as a diagnostic tool. The methodology of this study includes firstly the acquisition of ultrasound images of the vastus lateralis muscle. This acquisition will be performed during the continuous recording of muscle temperature, carried out during a passive cooling process after 20 min of heating using microwave equipment. In addition, to standardise the results, a correction factor will be calculated to compensate for the influence of subcutaneous adipose tissue thickness on echogenicity and echotexture.

NCT ID: NCT06145620 Not yet recruiting - Clinical trials for Lumbar Radiculopathy

Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery

Start date: January 2024
Phase: N/A
Study type: Interventional

The purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery.

NCT ID: NCT06145529 Not yet recruiting - Muscular Fitness Clinical Trials

Resistance Training Based on Gamification in Children Aged 10-12 Years Old During Physical Education

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

For this investigation a total of ≃300 children (grades 5 and 6; 10-12 years of age) from 6 randomly selected schools in Valencia (Spain) will be enrolled during 8 weeks in one of the experimental groups (EG): EG1 (15' of RT Functional HIIT circuit program), EG2 (the same EG1 program but with a gamification approach) or CG (control group). Outcomes will include age and sex, maturity, PA profile, MF (assessed using an ad hoc battery), anthropometry and body composition (weight, height, sitting height, waist circumference and BMI) as well as the enjoyment and motivation during physical education. An interactive app in a digital device will be used for the gamification story, the point's registration with the personal children's avatar and content learning by flipped classroom. The hypothesis of the RETRAGAM study posits that children who participate in the gamified RT intervention will experience greater improvements in MF, body composition, motivation, and enjoyment compared to those who carry out the same intervention without gamification, as well as the control group (CG). Thus, the primary aim of the RETRAGAM study is to examine the effectiveness of a school-based RT intervention on MF, body composition, motivation, and enjoyment in children aged 10 to 12 years. Additionally, the study will compare the effects on the main outcomes among several intervention groups (i.e., RT, RT with gamification approach and the CG).

NCT ID: NCT06144840 Recruiting - Clinical trials for Erythropoietic Protoporphyria (EPP)

INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP

INSPIRE
Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

NCT ID: NCT06144567 Not yet recruiting - Psoriatic Arthritis Clinical Trials

Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis

Start date: December 2023
Phase:
Study type: Observational

Primary objective To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 24. Secondary objective: 1. To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 12. 2. To evaluate the clinical response of enthesitis to upadacitinib by LEI, at week 12 and week 24. 3. To evaluate the clinical response of disease activity by DAPSA, at week 12 and week 24. Study Design: single-arm, observational longitudinal, prospective study Population: The study population will consist of adult patients (aged ≥ 18 years old and ≤ 65 years old) with PsA according to CASPAR classification criteria, who have been prescribed upadacitinib over the course of routine practice, in accordance with the applicable approved label and local regulatory and reimbursement policies ("In patients with psoriatic arthritis, upadacitinib would be a therapeutic alternative after failure, inadequate response or intolerance to csDMARDs and anti-TNF") and have at least one ultrasound-determined peripheral enthesitis.

NCT ID: NCT06143891 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

ROCKnrol-1
Start date: January 23, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.

NCT ID: NCT06143878 Recruiting - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Start date: January 17, 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.