Clinical Research Directory

Thai Baby Study Phase 1

The goal of this observational study is to examine national trends in mode of delivery and to assess associations between cesarean section and early-life health outcomes using routinely collected health data in Thailand. The study includes mother-infant dyads delivering in public hospitals across Thailand. The main questions it aims to answer are: Is cesarean delivery associated with increased risk of adverse neonatal outcomes compared with vaginal delivery? Is cesarean delivery associated with differences in early-life healthcare utilization and breastfeeding outcomes during the first year of life? Researchers will compare infants born by cesarean section with infants born by vaginal delivery to evaluate differences in neonatal morbidity, healthcare utilization, and breastfeeding patterns. Participants will not receive any intervention. The study involves secondary analysis of de-identified national health administrative and clinical data, including delivery records and linked maternal and infant health outcomes.

Long Term Effects Of a Maternal Cash Transfer Experiment

This is a follow-on study to a cluster randomized trial of maternal conditional incentives conducted in Nigeria. This study found that cash transfers, conditional on women obtaining facility-based prenatal, delivery, and postnatal care, resulted in large, significant effects on maternal and child outcomes (NICHD R01HD083444). This study will answer additional key policy questions. First, are the effects on maternal behavior temporary, or do they result in more sustained behavior change? Second, do measured short run (SR) child health effects persist over the long run? Third, did the program generate spillovers?

Outcomes of Robotic-Assisted Urological Surgery

Retrospective review of the patients who underwent urological robotic surgeries.

Robot-assisted Surgery for Colorectal Cancer Resection: A Population-based Analysis of Prevalence, Trends and Outcomes

The objective of this research project is to conduct a comparative analysis of short- and long-term outcomes between conventional laparoscopic and robot-assisted resection procedures for colorectal cancer. The analysis will utilize population-based DRG data and clinical cancer registry data from Germany. The rationale behind this project is that the number of conversions to open surgery in robotic procedures is approximately half that observed in laparoscopic procedures. Furthermore, it has been demonstrated that conversions are associated with a markedly elevated risk of postoperative complications. The aim of this project is to estimate the number of avoidable adverse outcomes resulting from the use of robot-assisted surgery. Multiple studies have shown, that the conversion rate for robot-assisted surgery (RAS) is consistently lower than that for conventional laparoscopic (LAP) surgery. Additionally, conversions have been reported to be associated with an increased risk of adverse surgical outcomes. However, most studies have not achieved statistical significance, due to limited sample sizes and insufficient statistical power. A comprehensive review of the existing literature reveals three key findings. First, the conversion rate for RAS procedures is approximately half that of LAP procedures. Second, conversions are associated with a significantly higher incidence of adverse short-term outcomes, including increased morbidity and mortality, as well as prolonged hospitalization. Third, although not significant due to low case numbers, there is some evidence suggesting improved long-term survival with RAS. The hypothesis is that the lower conversion rate in RAS for colorectal surgery is associated with fewer adverse outcomes compared to LAP procedures. This study aims to estimate the number of short-term adverse outcomes that could be prevented through avoided conversions when surgeries are performed using RAS rather than LAP. Furthermore, it will estimate the potential life years saved due to improved survival resulting from fewer conversions. To analyze avoidable short-term adverse outcomes, Germany's nationwide diagnosis-related group (DRG) data for the years 2016-2023 will be used. Multiple logistic regression analyses will be conducted, and estimated marginal means will be computed to provide population-based estimates. To estimate potential life years saved, clinical cancer registry data will be analyzed using Cox proportional hazards regression models. Long-term survival curves (three-year overall and disease-free survival) will be computed and compared between RAS and LAP surgeries, with a focus on converted operations. The quality of surgical outcomes (perioperative and short-term postoperative outcomes) for RAS and LAP colorectal surgery will compared using DRG data. This study will analyze the factors that moderate the difference in conversion rates and their relationship to outcome quality. Inclusion criteria will comprise patients who underwent elective resection for a primary malignant colorectal neoplasm. The study further aims to compare long-term overall survival (OS) and disease-free survival (DFS) between RAS and laparoscopic surgery using clinical cancer registry data. This project represents the first comprehensive analysis in Germany of the use of robotic assistance systems in colorectal surgery based on routine data. A key objective is to assess the prevalence of robotic assistance systems in clinical practice and to estimate the number of conversions-and corresponding adverse outcomes-that could be avoided through their use.

Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.

This international, multicenter, observational study aims to describe rehabilitation practices in Intensive Care Units (ICUs) worldwide. The primary objective is to provide an overview of current rehabilitation strategies used in ICUs globally. Secondary objectives include assessing the relationship between rehabilitation and key ICU outcomes such as ICU and hospital mortality, length of stay, duration of invasive ventilation, extubation failures, and long-term outcomes including quality of life and functional performance 28 days post-ICU discharge. The study will also compare rehabilitation practices across different geographic and economic regions to identify potential disparities. The study is structured into three modules, with participation contingent on local resources and feasibility. The BASIC Module (mandatory for all centers) gathers fundamental data on rehabilitation practices and their association with patient outcomes. The EXTENDED Module (optional) collects more detailed information on the type, timing, duration, and safety of rehabilitation interventions, including passive exercises, active mobilization, respiratory therapies, dysphagia training, occupational therapy, and cognitive support. The EXTENDED FOLLOW-UP Module (optional) evaluates the patient's quality of life and functional recovery 28 days after ICU discharge. By examining global rehabilitation practices and their impact on patient outcomes, this study aims to improve rehabilitation strategies in ICUs, contributing to better patient care, recovery, and long-term health outcomes.

Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery

Eligible patients will be admitted from the outpatient clinic to complete the relevant examinations after admission（Preoperative routine examination and chest CT）. The baseline parameters will be registered when admitted to hospital, including case number, diagnosis, sex, age, height, weight, and underlying medical conditions. Patients have at least 12 hours to consider participation in the study and will be given the opportunity to ask questions about the study. Written informed consent will be obtained by the surgical resident or the surgeon after admission to the hospital. Randomization will be done by relevant member . After inclusion, patients will be allocated to one of the two study groups (First-stage Connection or Second-stage Connection) using an online randomization program. The perioperative care will be the same for all included patients.Surgery will be performed by experienced surgeons, with non-expanded ear reconstruction using autologous rib cartilage. The surgery normally comprises two stages. After each surgery, details and duration of the surgery will be documented. For each stage of surgery, patients are scheduled for visits about 3-6 months. In addition, after the total surgery, patients are to fill out 'Glasgow Benefit Inventory' and 'Patient and Observer Scar Assessment Scale'.

Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

The Advancing knowledge in ischemic Stroke PatiEnts on oRal Anticoagulants (ASPERA) study aims to investigate characteristics of ischemic stroke cases occurring in patients on oral anticoagulation for atrial fibrillation (AF) or other cardioembolic arrhythmias and to characterize short and long-term outcomes associated with different secondary prevention strategies to prevent stroke recurrences. The ASPERA study is a multicenter, observational, both retrospective and prospective real-world study involving acute ischemic stroke patients occurring on oral anticoagulation. The study will encompass a retrospective (ASPERA-R) and prospective (ASPERA-P) data collection. Patient will be recruited consecutively at different emergency services and stroke units worldwide. University of L'Aquila (UnivAQ) will be in charge of study coordination, data analysis and management. The duration of ASPERA-R will be of 5-year from the study initiation of the study. Participating centers will be given a 6-month timeframe to enter retrospective data, commencing from the date of study approval. ASPERA-P duration will be of 2 years of enrollment from the study approval and follow-up of 5 years. (study conclusion after 7 years of approval). Inclusion criteria will be: 1.Confirmed diagnosis of ischemic stroke. 2. Availability of at least one neuroimaging exam positive for ischemic lesion(s) consistent with patient symptoms. 3. Ongoing oral anticoagulation at the time of the index ischemic stroke. 4. Prior diagnosis of atrial fibrillation or other cardioembolic arrhythmias. 5. Written informed consent provided by the patient himself or by proxy. Patients with Symptoms not indicative of acute stroke, ongoing intravenous or subcutaneous anticoagulation at the time of stroke will be excluded. ASPERA-R: characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. The primary outcome will be: ASPERA-R : characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. ASPERA-P: risk of ischemic stroke recurrence of ischemic stroke cases occurring on oral anticoagulants across different secondary preventive strategies (i.e., maintaining the same type of oral anticoagulation versus switching to a different secondary prevention strategy) at 90 days, 1 and 5 years after the index stroke. Additionally, the study will aim to investigate the risk of safety events (hemorrhagic transformation, intracranial hemorrhage, other major bleeding events, any bleeding events, death due to any cause), risk of other major ischemic events (transient ischemic attack, myocardial infarction, death due to vascular causes) at each follow-up and to identify demographic, clinical and neuroimaging features of ischemic stroke recurrences.