Clinical Research Directory

Association Between Primary Care Supply and Population Morbidity and Mortality in France at the Territorial Level

The M-OSP study investigates the association between the density of primary care professionals, including general practitioners (GPs), and population-level health outcomes across 2,850 life-health territories in France. Evidence from several OECD countries suggests higher GP density may reduce mortality, particularly cause-specific mortality such as cardiovascular deaths, but uncertainties remain regarding generalizability and other health outcomes. This cross-sectional epidemiological study uses aggregated, territory-level data from 2009-2022, including: mortality rates (age- and sex-standardized), hospitalizations (MCO), emergency department visits, and the distribution of primary care professionals and facilities (GPs, nurses, physiotherapists, dentists, midwives, gynecologists, pediatricians, psychiatrists, and community pharmacies).

Nut Consumption and Prevention of Non-communicable Diseases: A Global Individual Participant Data Meta-analysis

The relationship between nut consumption and the risk of developing non-communicable diseases (NCDs) has been a subject of growing interest. However, the findings from previous studies have been conflicting for some health outcomes, such as type-2 diabetes, and have been underexplored for other outcomes, such as neurodegenerative diseases. One contributing factor to these inconsistencies lies in the different analytical approaches and confounding factors used across studies. Furthermore, the majority of previous studies have primarily focused on populations in Europe or the United States, potentially limiting the generalizability of the findings to other global regions. The NUTPOOL project aims to address these gaps by conducting an extensive individual participant data (IPD) meta-analysis. This study will evaluate the association between total and specific types of nut consumption and the future risk of NCDs.

Minocycline in Stroke Study at Maimonides

The goal of this study is to determine if Minocycline, when added to standard care, can improve survival and functional outcomes in patients with moderate acute stroke (ischemic or hemorrhagic) aged 18 years and older. The main questions it aims to answer are: 1. Does Minocycline improve \*National Institutes of Health Stroke Scale\* (NIHSS) scores at hospital discharge and 90 days post-stroke? 2. Does Minocycline reduce stroke-related disability, all-cause in hospital mortality (mRS -\*Modified Rankin Scale\* = 6) and at 90 days besides reducing brain bleeding complications compared to standard care? Researchers will compare patients receiving oral Minocycline plus standard care to those receiving standard care only to see if Minocycline leads to better neurological outcomes and lower mortality. Participants will: 1. Be randomly assigned by block to receive either: Minocycline 200 mg orally once daily for five days within 24 hours from symptoms onset + Standard Care, or Standard Care only 2. Undergo neurological assessments using NIHSS \*National Institutes of Health Stroke Scale\* and Modified Rankin Scale (mRS) at admission, discharge, 30 days post-stroke, 90 days post-stroke 3. Be monitored for: a) hemorrhagic transformation of ischemic strokes; b) Adverse events and mortality outcomes; c) Safety and efficacy signals through interim analyses NIHSS: \*National Institutes of Health Stroke Scale\*, which is stroke severity scale, mRS: \*Modified Rankin Scale\*, which is stroke disability scale

Home-based Acute Care for Older Persons Initiated by the Emergency Medical and Ambulance Services - a Retrospective Observation of Effects on Healthcare Utilisation and Mortality

This observational study aims to examine outcomes of home-based acute care delivered by a mobile healthcare team in persons aged 75 years and older following an episode of acute illness. The study will assess whether home-based acute care initiated by the emergency medical dispatch centre or ambulance services is non-inferior to emergency department care with regard to care needs and mortality.

Saudi Emergency Laparotomy Audit

The Saudi Emergency Laparotomy Audit (SELA) is a national, multicenter observational clinical audit designed to evaluate outcomes and quality of care for patients undergoing emergency laparotomy in Saudi Arabia. The audit will collect standardized data on patient characteristics, comorbidities, perioperative processes, and postoperative outcomes through a retrospective baseline phase followed by a prospective registry phase. SELA aims to establish national benchmarks, assess applicability of international risk models, support development of a Saudi-specific risk prediction tool, and drive quality improvement through systematic feedback and benchmarking across participating hospitals.

African Studies on Aging and Noncommunicable Diseases Epidemiology

Despite the rising burden of noncommunicable diseases (NCDs), including cardiovascular diseases (CVDs), across Africa, high-quality evidence on the distribution of NCDs and their risk factors remains strikingly scarce. Many global estimates continue to rely on limited empirical data from African countries, and this persistent data gap has led major international research collaborations to underrepresent the continent. This reality highlights an urgent need for granular, context-specific, and methodologically robust data on NCDs and their determinants across Africa. The African Studies on Ageing and Noncommunicable Disease Epidemiology (ASANDE) initiative responds directly to this need by assembling harmonized, individual-level datasets from African populations, complemented by comparable data from other global regions. With recruitment underway, ASANDE seeks to quantify and compare the associations between major NCD risk factors, including cardiometabolic, behavioral, and environmental determinants, and the incidence and mortality of major NCD outcomes (cardiovascular diseases, cancer, chronic respiratory diseases, diabetes, and other NCDs) across world regions, with a particular emphasis on disparities between African populations and the rest of the global population.

GEL-AID: Safe and Effective Hydration for Institutionalized Older Adults

The objective of this clinical trial is to assess whether hydration with gelled water (GEL-AID) can improve fluid intake and reduce cases of dehydration, as well as the incidence of urinary and respiratory infections in institutionalized elderly individuals in nursing homes. The main question this trial aims to answer is: • Do institutionalized elderly individuals hydrated with GEL-AID increase their daily fluid intake and reduce the incidence of dehydration, urinary infections, and respiratory infections? Participants: The control group will follow the center's usual hydration plan. Individuals with swallowing difficulties will receive thickened liquids and/or gelatin, while those without swallowing difficulties will be hydrated with unmodified liquids or gelatin. The intervention group will receive hydration with GEL-AID. For participants with swallowing difficulties, thickened liquids and gelatin will be replaced by GEL-AID, with texture adapted to their needs. Those without swallowing difficulties will receive unmodified liquids and GEL-AID instead of gelatin.

Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome

Postimplantation syndrome (PIS) is a common and clinically important complication following thoracic endovascular aortic repair (TEVAR). PIS is characterized by a strong systemic inflammatory response to the stent-graft implantation and is manifested by flu-like symptoms, which include fever, increased white blood count, increased levels of acute phase proteins, and fatigue, but without a clear inflammatory and infective cause. Besides, it has been demonstrated that PIS is associated with prolonged hospital stay and increased risk for postoperative complications, including acute kidney injury, postoperative delirium, and increased postoperative pain scores. Recently, there has been increasing evidence that PIS is associated with an increased risk of major adverse cardiac events (MACE) and perioperative myocardial injury. Observational studies suggest that preoperative administration of glucocorticoids may decrease the incidence of PIS after TEVAR and EVAR procedures. However, to date, there are no randomised trials that have investigated whether preoperative administration of glucocorticoids can reduce the incidence of PIS and its associated poorer treatment outcomes following TEVAR. This randomized controlled trial was designed to investigate the effect of glucocorticoid administration on reducing the incidence and improving the outcome of patients who develop PIS after TEVAR.

Factor Associated With Mortality in the ICU

ICU mortality indicates the severity of disease, healthcare quality, and the efficacy of interventions. The severity scores are tools to predict the risk of mortality in the ICU, and the APACHE II score is frequently used for this purpose. However, studies validating the score in Colombia are limited. There is uncertainty about the precision and discrimination capacity of the APACHE II score in a population that varies from the original, with varying diseases, and in a different timeline. The investigators determined to evaluate: 1. Evaluate the rate of mortality in the ICU by type of disease and type of admission. 2. The factors associated with mortality. 3. Validate the performance of the APACHE II score as a predictor of mortality.

Mortality and Muscle Mass Loss in Critically Ill Patients.

The aim of the study is to monitor changes in muscle mass in critically ill patients and to verify whether a decrease in muscle mass of ≥10% during the first 7 days of hospitalization is associated with increased 28-day mortality. We will be used ultrasoud for measurement the rectus femoris cross sectional area.

A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma

Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking. The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH. The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years. Ethics approval for inclusion of competent patients has been obtained (N-20240009).

Systematic Assessment of Treatment Effectiveness for Long-Term Management of Stable Atrial Tachycardia in Inpatient and Outpatient Environments

The aim is to analyze long-term outcomes in a multicenter observational registry including patients undergoing atrial tachycardia rhythm control.

Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?

Sepsis is the most common cause of acute kidney injury (AKI) in critically ill patients and is associated with a high mortality rate. Currently there is no available specific treatment to prevent or treat AKI in this setting. Many experimental and clinical data suggest that Nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. The main objective of the study is to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. A 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "Nicotinamide" group.

ICU Background Early Awareness for Critical deterioratiON

The study will compare ICU sub-units, those with additional support of a clinician awareness system, ICU Beacon, and those receiving the standard of care. The win-ratio composite outcome will be assessed by comparing patients by study group and stratified by APACHE score at admission.

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.

Measles Vaccination at Health System Contacts

In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%. In Guinea-Bissau 30% of children do not receive a routine MV scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. The coverage of a second dose of MV, which was added to the Bissau-Guinean vaccination programme in 2022, is even lower. WHO recommends vaccination at health system contacts, including those for curative services. At the paediatric ward of the national hospital in Guinea-Bissau, there are more than 2600 yearly contacts with measles-un or under-vaccinated children aged 9-59 months, but no vaccines are given. In a randomised controlled trial, we will assess the effect of providing MV vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that MV reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.

Limited Versus Extended Trophic Feeding (LET-FEED) Trial

Study Hypothesis/Question In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes. Study Design Type This is a multi-center, open-label, parallel-group, individual randomized controlled trial comparing two different trophic feeding regimens in preterm infants born between 25w0d and 31w6d. These infants will be randomly assigned to either the intervention group, receiving limited trophic feeding (20 to 25 mL/kg/day for one day) or the control group, receiving extended trophic feeding (20 to 25 mL/kg/day for three days) prior to advancing enteral feeds until full feeding volume (140 mL/kg/day) is achieved. Eligibility Criteria Preterm infants with gestational ages between 25 0/7 and 31 6/7 weeks and a birthweight of \<1500 grams who are admitted to six participating neonatal units will be eligible for inclusion. Infants with \<5th percentile for weight at birth, vasopressor use within first 24 hours of life major congenital/genetic anomalies affecting enteral feeding, growth, or mortality, and those with a terminal illness in which decisions to withhold or limit support have been made will be excluded. Infants of parents or legal guardians who are unable to provide consent within 36 hours of birth will also be excluded. Study Intervention/Methods Written parental informed consent will be obtained prenatally or within the first 36 hours of birth. Infants will be randomized to receive limited trophic feeds of 24 to 36 hours or extended trophic feeds for 72 hours prior to the advancement of enteral feeds. Infants will be fed parent's own milk (POM) with donor human milk as the alternative if POM is unavailable. Primary Outcome Late-onset sepsis, defined as positive blood, urine, and/or cerebrospinal fluid (CSF) cultures in the presence of compatible clinical signs of sepsis, occurring after postnatal day 3 and before hospital discharge, and treated with antibiotics for 5 days or more. Secondary Outcome(s) The trial will assess various secondary outcomes including length of hospital stay, all-cause in-hospital mortality, duration of IV fluids and central line utilization, necrotizing enterocolitis (Bell's stage IIa or higher), severe intraventricular hemorrhage (grade III or IV either unilaterally or bilaterally), bronchopulmonary dysplasia (oxygen requirement or positive pressure ventilation at 36 weeks corrected gestational age), or retinopathy of prematurity requiring intervention. Additionally, growth metrics throughout hospitalization will be evaluated using change in weight, length, and head circumference z-scores from birth to 36 weeks' corrected gestational age between infants in the limited and extended trophic feeding groups.

Azithromycin for Child Survival in Niger II

Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.

Prognosis of Veno-Venous Extracorporeal Membrane Oxygenation in Emergency Thoracic Surgery

Veno-vneous extracorporeal membrane oxygenation (VV-ECMO) is an established support strategy for acute respiratory failure, but its role in the perioperative management of emergency thoracic surgery remains poorly defined. This retrospective, multicenter, observational study aims to assess the clinical outcomes and prognostic factors in this high-risk population. Patients undergoing emergency thoracic procedures requiring VV-ECMO will be compared to a control cohort of patients treated with VV-ECMO for medical respiratory failure. Data will be collected from two French academic centers (CHU Amiens-Picardie and CHU Dijon).

Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study

Background: In the intensive care unit (ICU), delirium in patients and long-term mental health challenges in both patients and their family members are highly prevalent. To address these issues, patient- and family-centered care has been recommended to alleviate the burdens associated with critical illness and ICU admission. We have developed the patient- and FAMily-centered care in the adult ICU intervention (FAM-ICU intervention). This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice. In this protocol, we describe a study aiming to evaluate the feasibility and acceptability of the FAM-ICU intervention in the adult ICU setting, including the feasibility of collecting relevant patient- and family-member outcome data. Referenc: Bohart et al. 2024. Acta Anaesthesiol Scand . 2025 Jan;69(1):e14539. doi: 10.1111/aas.14539. Epub 2024 Oct 24. Method: We will conduct a pre-/post two-group study design. We plan to recruit 30 adult ICU patients and their close family members at Herlev University Hospital in Denmark. The pre-group (n = 15) will receive usual care and the post-group (n = 15) will receive the FAM-ICU intervention. The FAM-ICU intervention involves interdisciplinary training of the ICU team and a systematic approach to information sharing and consultations with the patients and their family. Feasibility outcomes will include recruitment and retention rates, intervention fidelity, and the feasibility of participant outcome data collection. Acceptability will be assessed through questionnaires and interviews with clinicians, patients, and family members. Data collection is scheduled to begin in January 2025. Discussion: This study will assess the feasibility and acceptability when implementing the FAM-ICU intervention and the feasibility of conducting a main trial to investigate its effectiveness on delirium in patients and the mental health of patients and family members. The data from the feasibility study will be used to guide sample size calculations, trial design, and final data collection methods for a subsequent stepped-wedge randomized controlled trial.

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery. Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data

Background: The NIH and the American Association of Retired Persons (AARP) conducted a Diet and Health Study. It studied the links between diet, cancer, and cause of death in a group of middle-aged people in the U.S. Researchers want to learn more about how diet and lifestyle can affect cancer and mortality. Objective: To clarify links between diet, lifestyle, cancer, death, and chronic diseases. Eligibility: AARP members ages 50 to 71 who took part in study #OH95CN025 and lived in California, Florida, Pennsylvania, New Jersey, North Carolina, Louisiana, Atlanta, or Detroit in 1995 1996. Design: This study will use existing data and samples. Participants will not be contacted. Participants personal data, like name, date of birth, and address, will be used. This data will be kept private. Their data and samples will get a unique ID. Data from other follow-up studies will be used. Cancer outcome data will be obtained from the 8 sample areas. Many participants have moved to Arizona, Nevada, and Texas. Data will be obtained from those states as well. Cause of death and date of death will be obtained from the National Death Index. Cheek swab samples were gathered from 2004 to 2005. They will be used to study the oral microbiome. The University of Washington (UW) will be added as a study site. UW will study air pollution. The process of linking with the Virtual Pooled Registry Cancer Linkage System will be explored. It uses one system. Right now, 11 state systems are used to get and link data. Paper records will be stored in locked file rooms. Electronic data will be stored on secure servers.

Analysis of the Evolution of Mortality in an Intensive Care Unit

The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment. Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU. Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients. That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit. Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026

Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI

The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury