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NCT ID: NCT06183411 Recruiting - Clinical trials for Developmental Coordination Disorder

Theory of Mind in Children With DCD

TOM_DCD
Start date: November 17, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. In addition, children should be six until twelve years old with a DCD diagnosis confirmed by a multidisciplinary team (including a doctor). During the test moment, ToM will be tested by ToM test-R and the motor skills by MABC-2. Beside, the ToM test-R will be filmed, but the child's face not shown. The parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, CVO, SRS-2, SDQ and ToMBC), this can be completed in advance at home or at the test moment (researchers provide a laptop).

NCT ID: NCT06180642 Recruiting - Breast Neoplasms Clinical Trials

Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment

SOFT-TI
Start date: May 2, 2023
Phase:
Study type: Observational

After 1 year, more than 50% experience upper limb (UL) complaints after treatment for breast cancer. These complaints are disabling and cause limitations in daily life and this leads to a decrease in the patient's quality of life. The cause of these UL complaints is complex and multifactorial. Due to breast cancer treatment, the structural (tissue composition and volume) and mechanical (tissue stiffness) properties of the soft tissue may change. These changes can occur in the muscle, skin and surrounding fascia and especially in the soft tissue around the breast and axilla where that treatment is localised. Ultrasound with specific 'add-on' techniques can objectively assess these features and provide a picture of their role in UL function after breast cancer. The first aim in this study is to investigate the reliability and validity of conventional 2D ultrasound for 1) soft tissue composition and 2) soft tissue thickness at the level of the breast and upper limb. The reliability and validity of shear wave elastography, a specific complement to conventional 2D ultrasound, to assess tissue stiffness will also be examined.

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: NCT06178289 Recruiting - Wound of Skin Clinical Trials

Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skindamage in Nursinghomes

ISR-CASP-MASD
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment in Belgian nursing homes. Methodology: RESEARCH DESIGN: A randomized controlled multicentre clinical trial. DATA COLLECTION: Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced Skin Protectant or local nursing home partial-thickness wound (MASD) treatment protocol, yielding one study group. Due to the obvious differences between the comparative nursing home wound care treatment products and the study device, the study nurses cannot be blinded. A blinded assessor will centrally assess the time to healing and other healing outcomes based on the photographs of the study area. Study area: Defined as all partial-thickness, skin damaged areas on the body - due to exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula effluent or digestive secretions. Study duration: 21 days or until complete healing of the moisture associated skin damage (complete epithelialization). Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the study nurses. Relevant wound and patient information will be recorded (incontinence status, presence of a urinary catheter or faecal management system, number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma, number of applications regarding Cavilon Advanced Skin Protectant or usual nursing home wound treatment protocol). Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. Therefore, daily photographs will be taken with each daily skin assessment after removal of all visual product to ensure blinded skin assessment by the central reviewer. Pain assessment: The Wong-Baker FACES® Pain Rating Scale will be used to assess pain daily. Treatment-related pain (pain experienced during treatment (cleansing and product application)) and wound related pain (pain perception specifically caused by the MASD lesion) will be assessed. Nursing time assessment: Time per cleansing and time per treatment application.

NCT ID: NCT06177457 Recruiting - Clinical trials for Healthy Participants

A Study to Understand the Effect of Multiple Ascending Doses of PF-07293893 in Healthy Adult Participants

Start date: December 20, 2023
Phase: Phase 1
Study type: Interventional

This study has four parts: Part A, Part B, Part C, and Part D. The purpose of Part A of this study is to learn about the: - safety, - tolerability, - how PF-07293893 is processed by the body when multiple doses of PF-07293893 are given to healthy participants. The purpose of Part B of this study is to understand the effect of multiple doses of PF-07393893 on the amount of midazolam when given as a single dose by mouth. The purpose of part C of this study is to understand how PF-07293893 is changed in the body and how much PF-07293893 and it's changed forms are being removed in urine and feces after a single dose given to single participants. The purpose of Part D is to understand the effect of multiple doses of PF-07293893 on the amount of glycogen (storage form of glucose) in the muscle of healthy participants. Part B, C and D will be done if the results of Part A support further study of PF-07293893. The study is seeking participants who: - are females who are not able to give birth to a child. These female participants should be between 18 to 65 years of age. - are males of 18 to 65 years of age. - have a body mass index (BMI) of 20.0 to 35.0 kilograms per squared meter. - have total body weight of more than 45 kilograms (99 pounds). For a given participant in Part A, the total study is going to last up to about 11 weeks. This includes from the time of selection till the last follow-up phone call. The participants will be selected if they are fit for the study 28 days before the first dose of the study medicines. Participants who are selected will be admitted to the study site on Day 1 for around 18 days. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given. For a given participant in Part B, the total study is going to last up to about 11 weeks. This study consists of 4 periods. Participants will be admitted to the study site on Day 1 and discharged on Day 3 in period 4. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine in period 4. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given in period 4. For a given participant in Part C, the total study is going to last up to about 9 weeks. Participants will be admitted to the study site on Day 1. The participants will be discharged on Day 11 after giving the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given. For a given participant in Part D, the total study is going to last up to about 11 weeks. The participants will be selected if they are fit for the study 28 days before the first dose of the study medicines. Participants who are selected will be admitted to the study site on Day -3 for around 17 days. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given.

NCT ID: NCT06177132 Not yet recruiting - Vestibular Disorder Clinical Trials

Vestibular Infant Screening - Rehabilitation

VIS-REHAB
Start date: November 2025
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the short-term effect of a structured, combined postural control and gaze stabilisation protocol (VIS-REHAB protocol) in a group of vestibular-impaired children of different age categories (3-17 years). The main questions it aims to answer are: - What is the short-term effect of the VIS-REHAB protocol? - What are the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol? The participant will undergo both an active rehabilitation program (VIS-REHAB protocol) and a period during which physical therapy is discontinued (CTRL protocol).: - VIS-REHAB protocol: Postural control (static and dynamic postural stability exercises), gaze stability exercises (oculomotor function and VOR-exercises) & general gross motor training with focus on gaze stability and postural control. Researchers will compare the VIS-REHAB protocol with receiving no therapy (CTRL protocol) to evaluate potential enhancements in postural stability, gaze stability, motor performance and quality of life.

NCT ID: NCT06175208 Not yet recruiting - Clinical trials for Fear of Cancer Recurrence

Targeting Fear of Cancer Recurrence in Cancer Survivors: Evaluation of Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies

REMOTE
Start date: May 2, 2024
Phase: N/A
Study type: Interventional

In this trial, the investigators introduce two internet-based psychological methods to meet the currently unmet medical need to cope with Fear of Cancer Recurrence (FCR) beyond the acute phase of cancer treatment: internet-based emotional freedom techniques (iEFT) and internet-based mindfulness intervention (iMMI). The primary aim of this trial is to examine the efficacy of Internet-Based Emotional Freedom Techniques (iEFT) and Internet-Based Mindfulness Meditation Intervention (iMMI) to alleviate Fear of Cancer Recurrence (FCR) in cancer survivors, as determined through the Fear of Cancer Recurrence Inventory (FCRI) in cancer survivors. To translate a statistically significant effect on FCR into a clinically significant change, the investigators would need to detect a between-group difference in mean FCRI at T1 of 10 points using an independent samples t-test (two experimental groups are compared against a single wait-list control). When the application of iEFT and/or iMMI appears effective to reduce FCR, these self-help methods could be implemented in clinical settings. The use of these low cost interventions with a low threshold, by an internet-based approach, will facilitate a potential implementation in clinical practice.

NCT ID: NCT06174987 Recruiting - Metastatic Cancer Clinical Trials

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Start date: January 5, 2024
Phase: Phase 3
Study type: Interventional

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

NCT ID: NCT06174818 Completed - Clinical trials for Trigeminal Neuralgia (TN)

Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study

Progress
Start date: April 17, 2022
Phase:
Study type: Observational

With the Pulsed Radiofrequency treatment (PRF) Of the Gasserian ganglion for tRigeminal nEuralgia: a retroSpective Study (PROGRESS) the objective is to document the outcome of PRF (Pulsed Radiofrequency treatment) for patients with TN (Trigeminal Neuralgia), unresponsive to conservative treatment.

NCT ID: NCT06174805 Not yet recruiting - Clinical trials for Gastric Outlet Obstruction

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

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

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.