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NCT ID: NCT06368492 Not yet recruiting - Fibromyalgia Clinical Trials

The Impact of Psilocybin on Pain in Fibromyalgia Patients

PsiloFM
Start date: April 2024
Phase: N/A
Study type: Interventional

Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions. Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients. Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.

NCT ID: NCT06367829 Enrolling by invitation - Treatment Outcome Clinical Trials

Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

LARGE
Start date: January 8, 2024
Phase:
Study type: Observational [Patient Registry]

The research questions this study aims to answer are as follows: Primary research question: "Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?" Secondary aims include: - How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques? - Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures? To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis.

NCT ID: NCT06367569 Completed - Retinoblastoma Clinical Trials

Evaluation of MRI of the Pineal Gland in Retinoblastoma

TRbFU
Start date: October 1, 2012
Phase:
Study type: Observational

Rationale: Currently baseline brain MRI (magnetic resonance imaging) with extended follow-up of pineal cysts is systematically performed in all new retinoblastoma (Rb) patients, because children with hereditary retinoblastoma have an increased risk of primitive neuroectodermal tumors (PNET) that are histopathologically identical to the retinal tumors (1). The prevalence of developing a PNET in combination with unilateral or bilateral hereditary Rb is 5-15% (2). Treatment is difficult and the prognosis is poor as only few survivors are reported. Only patients with small asymptomatic PNETs (<15 mm) are potentially curable. Objective: The main objective of this prospective multicenter study is to evaluate the current strategy of baseline MRI screening of the brain in newly diagnosed retinoblastoma patients, with extended follow-up of selected patients with simple and complicated pineal cysts. Study design: The investigators propose a prospective cohort study (part of a larger multicenter study) to investigate the diagnostic accuracy and survival of baseline MRI screening of the pineal gland in new patients with retinoblastoma, with extended follow-up of selected patients with pineal cysts for early detection of pineoblastoma. Study population: Within the European Retinoblastoma Imaging Collaboration (ERIC) about 150 new retinoblastoma patients are diagnosed every year. About 10 percent of all new retinoblastoma patients will be diagnosed at the VUmc. According to our sample size calculations the investigators will need 334 Rb patients. Main study parameters/endpoints: The primary endpoint of the study is pineoblastoma or supra- / parasellar PNET on MRI (index test). Because a gold standard will not be available, tumor cells in cerebrospinal fluid, histopathological confirmation, clinical disease progression during follow-up, and/or follow-up MRI diagnostics will be used as a composite reference standard in case of a positive index test and clinical diagnosis of pineoblastoma or supra- / parasellar PNET within one year of the last MRI will be used as a composite reference standard in case of a negative index test.

NCT ID: NCT06367530 Recruiting - Retinoblastoma Clinical Trials

Trilateral Retinoblastoma: Incidence and Outcomes

GS-TRIO
Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Patients with heritable retinoblastoma are at risk to develop an intracranial brain tumor, which is often fatal. The investigators intend to look at the incidence and survival of trilateral retinoblastoma (which is a brain tumor that can either be located in the pineal gland or elsewhere in the brain) in retinoblastoma patients globally. All retinoblastoma patients from participating centers will be included. The investigators hypothesize that the apparent incidence of trilateral retinoblastoma (especially the usually later diagnosed pineal trilateral retinoblastoma) in low-income countries will be lower because of low chances of surviving the ocular tumors at about 50% and also because of possible under-diagnosis. Therefore, as retinoblastoma care improves in low-income countries the incidence of (pineal) trilateral retinoblastoma might go up. Knowledge about incidence and survival can help improve health practices in parts of the world where this might be needed. Therefore this global study firstly aims 1) to evaluate survival after trilateral retinoblastoma and factors influencing survival and 2) to evaluate incidence of trilateral retinoblastoma by country income level. The study will run from 2024 through 2027.

NCT ID: NCT06366828 Recruiting - Clinical trials for The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection)

Prediction Models for Complications After CRT in Esophageal Cancer

MODELS
Start date: February 1, 2023
Phase:
Study type: Observational

The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer

NCT ID: NCT06365736 Not yet recruiting - Healthy Clinical Trials

The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being

Start date: May 10, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is: Does a 2-week contemplative nature intervention improve spiritual well-being? Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality. Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes. Participants in the active control condition will walk for 30 minutes without further instruction.

NCT ID: NCT06364332 Not yet recruiting - Communication Clinical Trials

#Chatsafe Netherlands: a Social Media Intervention to Improve Dutch Young People's Safe Communication About Suicide Online

CSNL
Start date: April 4, 2024
Phase: N/A
Study type: Interventional

Suicide is the leading cause of death among young people (YP) aged 10 to 25 years in the Netherlands. In addition, YP report high rates of suicidal ideation (16%). While suicidal behavior is a complex phenomenon with many factors and causes, the role of social media is becoming more prominent, especially for YP. Social media has been shown to be a source where YP can find support, but it's also a place where suicidal behavior is glorified or normalized, which can be triggering or harmful to other social media consumers. The #Chatsafe guidelines were developed by Orygen Australia to better equip young people to communicate safely about suicide on social media. These guidelines are supported by a social media campaign to make the content of the guidelines more accessible to them. The #Chatsafe intervention consists of both the guidelines and the social media campaign. A small-scale Australian feasibility study showed promising results in terms of the acceptance and safety of the campaign, and safety regarding communicating about suicide on social media platforms. Currently, in Australia it is tested to what extent these results hold up in a Randomized Controlled Trial (RCT) (Robinson et al., 2023). With funding from the Dutch National Agenda for Suicide Prevention, a contextualized replication study is conducted. The aim of this study is to determine whether the #Chatsafe intervention has an effect on the way in which Dutch YP communicate online about suicide.

NCT ID: NCT06363903 Recruiting - Clinical trials for Pelvic Organ Prolapse

ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation

Start date: May 9, 2022
Phase:
Study type: Observational

In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics.

NCT ID: NCT06362668 Not yet recruiting - Clinical trials for Acute Decompensated Heart Failure

EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)

FASTR-EU
Start date: April 9, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.

NCT ID: NCT06362213 Not yet recruiting - Clinical trials for Dual Sensory Impairment of Vision and Hearing

Gaining Insight Into Dual Sensory Loss

DSL
Start date: April 15, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is: • What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue. Participants will fill out questionnaires and the researchers will measure their vision and hearing functions.