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NCT ID: NCT06149403 Recruiting - Clinical trials for MPS-IH (Hurler Syndrome)

A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects With MPS-IH Compared With Standard of Care With Allogeneic HSCT

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

A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).

NCT ID: NCT06148701 Completed - Anesthesia Clinical Trials

Preoperative Anesthesia Automatic System:a Retrospective Cohort Study

PACMAN
Start date: October 1, 2021
Phase:
Study type: Observational

To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone

NCT ID: NCT06147635 Recruiting - Acute Pancreatitis Clinical Trials

Prophylactic Tributyrin Supplementation in Acute Pancreatitis

PARROT
Start date: February 12, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate the possible effects of tributyrin supplementation in patients with a first episode of acute pancreatitis. The main question it aims to answer is: • The effect of oral tributyrin supplementation on the plasma endotoxin level Participants will be randomized between two groups: intervention and control group. They will receive: - three times daily 4grams of micro-encapsulated granules of tributyrin, and the control group three times daily 4 grams of micro-encapsulated sunflower oil (i.e. placebo), for a total of 14 days In total 92 adult patients with a first episode of acute pancreatitis will be included.

NCT ID: NCT06147089 Recruiting - Clinical trials for Shift-Work Related Sleep Disturbance

Shift Work Intervention Strategies for Night Shift Workers

GRIP
Start date: February 9, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention study is to test behavioral interventions in night shift workers. The main question it aims to answer is: • Can personalized sleep or nutrition intervention strategies help against the negative health effects of night shift work? Participants will be followed before and after the intervention. Participants will wear smart devices, do a alertness/performance test and complete questionnaires. Blood samples will be collected. Researchers will compare the intervention groups to the control group (which receives no intervention) to see if the sleep and nutrition interventions affected the health of night shift workers.

NCT ID: NCT06146738 Recruiting - Glioblastoma Clinical Trials

The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)

PALSUR
Start date: January 1, 2023
Phase:
Study type: Observational

There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

NCT ID: NCT06146725 Recruiting - Glioblastoma Clinical Trials

The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)

RESBIOP
Start date: January 1, 2023
Phase:
Study type: Observational

There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

NCT ID: NCT06145984 Recruiting - Clinical trials for Depression in Remission

Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression

MINDCOG
Start date: June 19, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.

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: NCT06143982 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.

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.