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NCT ID: NCT05840965 Recruiting - Flatfoot, Flexible Clinical Trials

The Effect of Foot Core Exercises or Foot Orthotics in Symptomatic Flexible Flatfoot

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

The overall goal of this study is to evaluate the effect of a foot strengthening program (focused on the intrinsic foot muscles) on ankle and foot joint kinematics and kinetics (rearfoot, midfoot, and forefoot) in patients with symptomatic flexible flat feet. The investigators will also evaluate the effect on intrinsic muscle morphology, foot strength, pain and other symptoms. The investigators will compare to the standard conservative therapy, which is foot orthotic therapy.

NCT ID: NCT05840211 Recruiting - Clinical trials for Stage IV Breast Cancer

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

ASCENT-07
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

NCT ID: NCT05839626 Recruiting - Clinical trials for Relapsed/Refractory Multiple Myeloma

A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

Start date: May 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA). The study will comprise 3 parts: A dose escalation phase (Part 1) in RRMM participants (Part 1a) that will evaluate several doses administered to determine 2 doses that will be tested in the dose optimization part. A dose escalation will also be done in RRLCA participants (Part 1b) but started sequentially after the end of the dose escalation in RRMM participants. This dose escalation will evaluate the 2 doses planned to be used in dose optimization in RRMM, to ensure those doses are safe also for RRLCA participants. A dose optimization phase (Part 2) that will be evaluating 2 doses determined from Part 1 to determine the preliminary recommended Phase 2 dose (pRP2D) and schedule for SAR445514 in RRMM. A dose expansion phase (Part 3) that will evaluate the preliminary efficacy of pRP2D and schedule for SAR445514 in RRMM (Part 3a) and RRLCA (Part 3b). Approximately 101 participants will be enrolled and treated by study intervention and separated as such: Part 1a: Approximately 18 to 30 participants Part 1b: Approximately 6 to 12 participants Part 2: Approximately 30 participants Part 3a: Approximately 15 participants Part 3b: Approximately 14 participants

NCT ID: NCT05839418 Recruiting - Status Epilepticus Clinical Trials

Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

SENSEII/AROUSE
Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

NCT ID: NCT05838768 Recruiting - Clinical trials for MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

Start date: June 27, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with tislelizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers.

NCT ID: NCT05838339 Completed - Sleep Clinical Trials

Are You Daydreaming?

Health CASCADE
Start date: October 4, 2022
Phase: N/A
Study type: Interventional

Health CASCADE (Marie SkÅ‚odowska-Curie grant agreement n° 956501) aims to address complex public health problems by making co-creation a scientifically sound methodology, aided by evidence-based methods, practices, and technologies. The current study, which focuses on co-creation in the school context is part of this overarching European project. Healthy sleep is important for adolescents' mental and physical health and cognitive functioning. However, sleep difficulties are among the top three health complaints in European adolescents. This indicates a need for successful interventions. Co-creation is a promising approach to design tailored interventions. By actively involving all relevant stakeholders, co-creation has been shown to increase self-efficacy, self-consciousness, empowerment, and feelings of ownership. However, co-created interventions are localized and therefore less generalizable to a broader population. Moreover, the process is very time- and cost- consuming. To make co-creation more feasible, research should focus on the upscaling of existing interventions. The investigators propose that the co-creation process is still absolutely vital for intervention success but that it can be shortened. The investigators aim to scale up an existing intervention to promote healthy sleep. This existing intervention was developed using co-creation together with the target group (adolescents aged 13 to 15) and parents, and implemented with support of teachers and fellow students. To investigate whether the shorter co-creation process is needed in order to scale up the intervention to another setting and context, the investigators will use a three-arm cluster controlled trial. This will include one co-creation intervention school, one standard implementation school (this school receives the existing intervention without a shortened co-creation process), and one control school. The co-creation process will be structured by using the Intervention Mapping Protocol to ensure an evidence-based framework. The effect of the intervention will be evaluated using actigraphy and questionnaires, while the process will be evaluated using questionnaires, interviews, and focus groups.

NCT ID: NCT05834335 Completed - Multiple Sclerosis Clinical Trials

Protection Against Severe Coronavirus Disease 2019 in Patients With Multiple Sclerosis Stratified According to Disease Modifying Treatment

PASCOMS
Start date: March 1, 2020
Phase:
Study type: Observational [Patient Registry]

The investigators will conduct retrospective observational cohort study at the Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek (Belgium), which is a large center specifically focusing on neurological management, multidisciplinary care and/or rehabilitation in patients with MS. Primary endpoint For each DMT category, as defined above, the proportion of patients with a worse COVID-19 outcome (i.e., hospitalization and/or death) will be compared between those 'protected' versus 'unprotected' by vaccination at the time of SARS-CoV-2 infection. Corrections will be applied for any eventual imbalance in demographics, potentially relevant to COVID-19 outcome, between subgroups that are compared to each other, if indicated/feasible.

NCT ID: NCT05832606 Recruiting - Dietary Habits Clinical Trials

Food Intervention to Reduce Immunotherapy toXicity

FORX01
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The FORX (Food intervention to Reduce immunotherapy toXicity) trial will assess whether supplementing dietary fiber intake by providing weekly boxes containing 30 different plants to patients with solid tumors starting immune checkpoint inhibitor therapy affects the incidence of immune related adverse events.

NCT ID: NCT05832528 Recruiting - Clinical trials for Functional Gastrointestinal Disorders

Low FODMAP Diet in FD (PDS)

FFDU
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The goal of this dietary intervention study is to assess the efficacy and mechanisms of a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet in functional dyspepsia patients. The main questions it aims to answer are: - If a low-FODMAP diet can reduce dyspeptic complaints - How a low-FODMAP diet can reduce dyspeptic complaints in functional dyspepsia (FD). Participants will follow a 6-week during low-FODMAP diet followed by powder reintroduction of 6 FODMAPs and 1 control substance.

NCT ID: NCT05831709 Recruiting - Postmenopause Clinical Trials

The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women

OPERATE
Start date: May 12, 2023
Phase: N/A
Study type: Interventional

This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk and insulin sensitivity in postmenopausal women.