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NCT ID: NCT05694299 Recruiting - Feeding Disorders Clinical Trials

Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Aim of this study is to compare fixation of nasoenteral feeding tubes using either a nasal patch or a nasal bridle in clinical patients with regard to the occurrence of tube dislocation, complications, and discomfort. 78 (2 * 39) eligible patients will be included in this randomized controlled trial. The study is executed in two general teaching hospitals in the Netherlands (Gelre Hospitals Apeldoorn and Medical Spectrum Twente).

NCT ID: NCT05694247 Not yet recruiting - Corneal Disease Clinical Trials

Pivotal Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

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

A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

NCT ID: NCT05693688 Recruiting - Preterm Birth Clinical Trials

Atosiban Versus Placebo in the Treatment of Late Threatened Pre-term Birth

Start date: December 1, 2017
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.

NCT ID: NCT05693519 Active, not recruiting - Colorectal Cancer Clinical Trials

GastroIntestinal Cancer in Children and Adolescents

Start date: December 22, 2022
Study type: Observational

The goal of this observational population-based cohort study is to investigate the clinical characteristics and outcomes of children and adolescents with primary gastrointestinal malignancies registered in the publicly available Surveillance, Epidemiology, and End Results (SEER) 17 database during 2000-2019.

NCT ID: NCT05693129 Not yet recruiting - APDS Clinical Trials

Pediatric Patients Aged 1 to 6 Years With APDS

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

This is a 2-part, prospective, open-label, single arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of leniolisib in at least 15 pediatric patients (aged 1 to 6 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)

NCT ID: NCT05693077 Not yet recruiting - Clinical trials for Clostridioides Difficile Infection

Clostridioides Difficile Colonisation

Start date: May 2023
Phase: Phase 1
Study type: Interventional

This study will investigate experimental colonisation with non-toxigenic C.difficile (NTCD) in healthy volunteers. Main outcomes will be safety, tolerability, dose needed to obtain colonisation with NTCD and host microbiota factors associated with colonisation.

NCT ID: NCT05690347 Recruiting - Arthropathy of Knee Clinical Trials

Protocol for a Multicenter Study on (Cost)Effectiveness of the Back At Work After Surgery (BAAS): a Clinical Pathway for Knee Arthroplasty

Start date: January 1, 2022
Study type: Observational

Background Optimizing return to work (RTW) after knee arthroplasty (KA) is becoming increasingly important due to a growing incidence of KA and poor RTW outcomes after KA. We developed the Back At work After Surgery (BAAS) clinical pathway for optimized RTW after KA. Since the effectiveness and cost analysis of the BAAS clinical pathway are still unknown, analysis on effectiveness and costs of BAAS is imperative. Method This protocol paper has been written in line with the standards of Standard Protocol Items: Recommendations for Interventional Trails. To assess the effectiveness and cost-effectiveness for RTW, we will perform a multicenter prospective cohort study with patients who decided to receive a total KA (TKA) or an unicompartmental KA (UKA). To evaluate the effectiveness of BAAS regarding RTW, a comparison to usual care will be made using individual patient data on RTW from prospectively performed cohort studies in the Netherlands. Discussion One of the strengths of this study is that the feasibility for the BAAS clinical pathway was tested at first hand. Also, we will use validated questionnaires and functional tests to assess the patient's recovery using robust outcomes. Moreover, the intervention was performed in two hospitals serving the targeted patient group and to reduce selection bias and improve generalizability. The limitations of this study protocol are that the lead author has an active role as a medical case manager (MCM) in one of the hospitals. Additionally, we will use the data from other prospective Dutch cohort studies to compare our findings regarding RTW to usual care. Since we will not perform an RCT, we will use propensity analysis to reduce the bias due to possible differences between these cohorts.

NCT ID: NCT05689918 Active, not recruiting - Clinical trials for Gastro Esophageal Reflux

Gastroesophageal Reflux Disease in the Dutch Population

Start date: December 7, 2022
Study type: Observational [Patient Registry]

Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies. Objective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population. Study design: Cross-sectional population-based survey. Study population: Dutch citizens aged 18-75 years. Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey. Main study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.

NCT ID: NCT05689190 Recruiting - Clinical trials for Lower Extremity Arterial Disease

Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)

Start date: January 16, 2023
Study type: Observational

This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.

NCT ID: NCT05687331 Recruiting - Knee Injuries Clinical Trials

Changes in the Immunomodulatory Properties of Adipose Stromal Cells Due to Hemarthrosis After Knee Injury

Start date: April 5, 2022
Study type: Observational

The goal of this observational study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis in patients older than 18 with a recent knee trauma. The main question[s] it aims to answer are: - What is the natural course of pro-inflammatory factors and hemarthrosis in knee trauma? - What are the effects of inflammation and hemarthrosis on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy? Participants will: - undergo blood withdrawal - undergo knee arthrocentesis for synovial fluid sample collection - physical examination - fill out a questionnaire on knee complaints