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NCT ID: NCT06151782 Recruiting - Celiac Disease Clinical Trials

Immunosafe-CeD: Are Partially Hydrolysed Gluten Hamrful to Celiac Disease Patients?

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

The study will compare the immune response in CeD patients to wheat and barley gluten at high doses (1 gram), and also investigate the reponses to low dose barley gluten and also hydrolyzed, malted barley. This will be done by four one-day challenges with intervals around four weeks.

NCT ID: NCT06150716 Recruiting - Clinical trials for Pelizaeus-Merzbacher Disease

Orbit Study: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered ION356 in Participants With Pelizaeus Merzbacher Disease (PMD)

Start date: April 10, 2024
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of ION356.

NCT ID: NCT06150690 Recruiting - Diabetes Mellitus Clinical Trials

Study on Pancreatic Islets in Patients Undergoing (Partial) Pancreatectomy (PRECISE)

PRECISE
Start date: August 21, 2012
Phase:
Study type: Observational

The study investigates the mechanisms underlying the pathogenesis of diabetes by examining structural and functional properties of islets of Langerhans in pancreas specimen from patients undergoing (partial) pancreatectomy.

NCT ID: NCT06149598 Recruiting - Cervical Cancer Clinical Trials

Coughing at Time of Cervical Biopsy

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

To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy.

NCT ID: NCT06149520 Recruiting - Thrombolysis Clinical Trials

A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis

SIRIUS
Start date: January 15, 2024
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT). DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called 'proximal' when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT. BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors. The main purposes of this study are to learn: - How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and - How safe is BAY3018250 as a treatment for participants with proximal DVT? For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time. And researchers will collect the number of bleeding events that require medical attention. The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo. Researchers will closely monitor participants for 90 days after receiving the study treatment. During the study, the doctors and their study team will: - take blood samples - do physical examinations - examine heart health using electrocardiogram (ECG) - check vital signs such as blood pressure, heart rate - undergo ultrasound tests to measure the blood clots - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

NCT ID: NCT06149013 Recruiting - Clinical trials for Mild Cognitive Impairment

Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults With MCI or Mild Dementia

Start date: December 21, 2023
Phase: N/A
Study type: Interventional

This pilot study investigates effects of a digital behavioral activation therapy in treating patients with mild cognitive impairment and mild dementia, applying a randomized controlled parallel group design. The primary goal is to estimate effect sizes for a larger trial. A further aim is to investigate the feasibility of study procedures and to validate new questionnaire scores. Primary outcomes are the change in the patients' quality of life and in their overall activity level.

NCT ID: NCT06147830 Recruiting - Major Bleeding Clinical Trials

A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment

REVERXaL
Start date: December 4, 2023
Phase:
Study type: Observational

REVERXaL study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes of patients with major bleeding in the presence of Factor Xa inhibitor treatment. The generation of insight on treatment approaches and associated outcomes in hospitalized patients with Factor Xa inhibitor-related major bleeds may inform clinical guidelines, health system decision making and streamline treatment pathways in this population.

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: NCT06146010 Recruiting - Clinical trials for Leptomeningeal Disease

Non Interventional German Leptomeningeal Disease Register

Start date: May 13, 2024
Phase:
Study type: Observational [Patient Registry]

The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications.