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NCT ID: NCT05799053 Recruiting - Clinical trials for Irritable Bowel Syndrome

Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study

MINT
Start date: May 12, 2022
Phase: Phase 3
Study type: Interventional

Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in adults. Few studies of low quality are performed in an paediatric setting. Therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in paediatric IBS or Functional Abdominal Pain - Not otherwise specified (FAP-NOS) patients.

NCT ID: NCT05798949 Recruiting - Clinical trials for Small Fiber Neuropathy

Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy

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

Small fiber neuropathy (SFN) is a condition that is dominated by invalidating neuropathic pain. Pharmacological neuropathic pain treatment is often disappointing, since pain reduction is mostly slight and side effects can be debilitating. Although neuropathic pain is caused by a lesion of the somatosensory system, also psychological factors, such as fear and catastrophizing, appear to play a role in the origin and maintenance of disability in chronic pain. Rehabilitation based on pain education and cognitive behavioral treatment including elements of acceptance and commitment therapy, exposure in vivo or graded activity can be performed to influence these factors. To date no specific rehabilitation programs are available for patients diagnosed with SFN.

NCT ID: NCT05798273 Completed - Clinical trials for Malignant Brain Tumors

(68^Ga)-GaPSMA-11 PET/MR-imaging of Malignant Intra-axial Brain Tumors

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

PSMA is a transmembrane protein specifically expressed in the vascular endothelium of malignant brain tumors, most notably glioblastoma and not in healthy brain parenchyma. It has been shown to be involved in (neo)angiogenesis and endothelial cell invasion. By means of 68Ga-labeled PSMA ligands, investigators are able to non-invasively visualize/quantify PSMA expression in glioblastoma (neo)vasculature in vivo by means of PET. The primary aim of this study is to confirm PSMA as suitable diagnostic and potential theranostic target in patients with intra-axial brain tumors by means of [68Ga]Ga-PSMA-HBEC-CC ([68Ga]Ga-PSMA-11) PET. The secondary aim is to assess whether uptake is increased with intra-arterial injection in those tumors that show uptake after intravenous injection of [68Ga]Ga-PSMA-11.

NCT ID: NCT05798065 Not yet recruiting - Readmission Clinical Trials

Inpatient Endoscopy Procedure Planning Delays and Impact on Length of Stay and 30-day Readmission

Impatience
Start date: April 1, 2023
Phase:
Study type: Observational

Single center retrospective cohort study of all inpatient endoscopy procedures to asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission

NCT ID: NCT05797740 Recruiting - Multiple Sclerosis Clinical Trials

Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

Start date: August 3, 2023
Phase:
Study type: Observational

This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.

NCT ID: NCT05797116 Completed - Preoperative Care Clinical Trials

Practice Variation in Preoperative MDT Meetings

Start date: January 31, 2023
Phase:
Study type: Observational

The goal of this observational survey study is to evaluate the current practice variations of preoperative multidisciplinary team meetings (MDT meetings) for high risk noncardiac surgical patients. The main questions it aims to answer are: - What is the current variation in Dutch hospitals in the practice of preoperative MDT meetings for high risk noncardiac surgical patients? - Which facilitators and barriers influence the implementation process of preoperative MDT meetings? Participants are anesthesiologists in Dutch hospitals who will be asked to fill in a one-time survey. One anesthesiologist per anesthesiology department will be asked to fill in the survey. The survey will take approximately 5 to 10 minutes to complete.

NCT ID: NCT05795881 Recruiting - Critical Illness Clinical Trials

Effect of Continuous Versus Cyclic Daytime Enteral Nutrition on Circadian Rhythms in Critical Illness

CIRCLES
Start date: June 14, 2023
Phase: N/A
Study type: Interventional

Disruption of circadian rhythms is frequently observed in patients in the intensive care unit (ICU) and is associated with worse clinical outcomes. The ICU environment presents weak and conflicting timing cues to the circadian clock, including continuous enteral nutrition. The goal of this clinical trial is to evaluate the effect of timing of enteral nutrition on the circadian rhythm in critically ill patients. Patients admitted to the intensive care unit will be allocated to receive either continuous or cyclic daytime (8am to 8 pm) enteral feeding. Differences in circadian rhythms will be assessed by 24h patterns in core body temperature, heart rate variability, melatonin and peripheral clock gene expression. Secondary outcomes include depth of sleep, glucose variability and incidence of feeding intolerance. This study is expected to contribute to the optimalisation of circadian rhythms in the ICU.

NCT ID: NCT05794906 Recruiting - Clinical trials for Biochemically Recurrent Prostate Cancer

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

ARASTEP
Start date: April 3, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

NCT ID: NCT05794529 Recruiting - Lung Cancer Clinical Trials

Lung Tumor Protein Synthesis Rates in Lung Cancer Patients

LungMaas
Start date: March 2023
Phase:
Study type: Observational

The current study will recruit lung cancer patients to measure tissue protein synthesis rates of non-small cell lung carcinomas and healthy lung tissue. The protein synthesis rates of healthy lung tissue will be compared to lung tumor tissue to establish the remodeling characteristics of healthy versus cancerous lung tissues. We will also examine whether tissue protein synthesis rates of non-small cell lung carcinomas are associated with various tumor- (i.e., size, subclassification) and patient-derived (i.e., inflammation, lung function, smoking status, and smoking history) parameters.

NCT ID: NCT05794139 Recruiting - Clinical trials for Spinal Muscular Atrophy

Safety and Efficacy of NMD670 in Ambulatory Adult Patients With Type 3 Spinal Muscular Atrophy

SYNAPSE-SMA
Start date: September 21, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular atrophy type 3