Clinical Research Directory

MOTORCYCLE THORACIC TRAUMA SEVERITY SCORE: A NEW TRAUMA SEVERITY SCORE

This study aimed to test the hypothesis that a practical, bedside-applicable tool could be developed to help identify patients at high risk of mortality following motorcycle accidents more quickly and facilitate treatment by enabling faster clinical decision-making.

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.

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.

Establishment of Reference Limits for Blood Lactate Levels in Intensive Care Patients With a Particular Focus on Age and Sex

The goal of this observational study is to learn whether there are age- and sex-specific threshold levels of blood lactate that can better predict the risk of death and serious illness in people receiving intensive care, especially those with sepsis (a severe infection that affects the whole body). Lactate is a chemical that the body produces during metabolism. High levels in the blood are often a sign that tissues are not getting enough oxygen, but newer research shows that lactate may also rise due to stress hormones and changes in how cells use energy. Doctors currently define septic shock as sepsis with low blood pressure that does not improve after fluids, combined with a lactate level higher than 2 millimoles per liter (mmol/L). This value was set based on expert agreement but may not be ideal for everyone. Recent studies suggest that even lactate levels below 2 mmol/L can still be linked to a higher chance of dying in the hospital. This study aims to find out if different cutoff levels for men and women, and for different age groups, could improve how doctors identify patients at higher risk, compared with using the same general value for everyone. Main questions: Do older adults and younger adults have different blood lactate thresholds linked to worse outcomes in sepsis? Do men and women show different relationships between lactate levels and risk of death or complications? Can combining lactate levels with other factors (such as blood pressure or medical history) improve predictions of outcome in intensive care? Study design: This is a retrospective observational study based on data from Uppsala University Hospital in Sweden. The study includes all people admitted between 2016 and 2024 who had blood lactate measured during their hospital stay. People without lactate measurements or with unknown identity are excluded. Researchers will analyze the relationship between lactate levels, age, sex, and survival in intensive care. They will use statistical models to find threshold values of lactate linked to higher risk of death or need for advanced care. Machine learning methods, such as clustering algorithms, will be used to identify patient subgroups with similar biological patterns. The researchers will also perform sensitivity analyses to test whether their findings are robust. Why this study matters: If reliable age- and sex-specific lactate thresholds can be identified, doctors may be able to detect patients at risk earlier, even when lactate levels seem normal. This could help guide treatment and monitoring more precisely for each person. The results may contribute to a more personalized definition of septic shock and influence future international guidelines for sepsis management. Background: Traditionally, high lactate levels in sepsis were believed to mean tissues were not getting enough oxygen. However, new evidence shows that lactate can also increase for other reasons, such as overactive stress responses, even when oxygen levels are normal. The liver and kidneys usually remove lactate from the blood, but their function may be reduced during severe infection. Treatments for septic shock currently focus mainly on maintaining blood pressure, but this does not always reflect how well oxygen reaches tissues. Current definitions do not consider differences in how people of various ages or sexes produce or clear lactate. Understanding these differences could improve how doctors interpret blood tests and adjust treatments. Potential benefits: The study will not directly involve new treatments, since it uses existing hospital data. However, its findings may help improve early detection of severe infection, support development of personalized treatment strategies, and reduce death rates among people with sepsis in intensive care. In summary, this study seeks to find better ways to interpret blood lactate levels in intensive care by focusing on age and sex differences. The results may lead to more accurate risk prediction and individualized care for people with sepsis.

Women's Health Initiative Strong and Healthy Study

The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to \~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise \& Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.

EWSs and 28-Day Mortality in Geriatric ED Patients

This prospective observational cohort study evaluated the prognostic performance of commonly used early warning scores for predicting 28-day all-cause mortality among geriatric patients presenting to the emergency department with non-traumatic conditions. Patients aged 65 years and older were consecutively screened during the study period. Demographic characteristics, comorbidities, vital signs, level of consciousness, blood gas parameters, complete blood count parameters, frailty status, and early warning scores were recorded at emergency department presentation or within the first hour of admission. The evaluated scoring systems included National Early Warning Score (NEWS/NEWS2), Modified Early Warning Score (MEWS), quick Sequential Organ Failure Assessment (qSOFA), Rapid Emergency Medicine Score (REMS), Cardiac Arrest Risk Triage (CART), and Hamilton Early Warning Score (HEWS) score. The primary outcome was 28-day all-cause mortality. The study also examined whether age, comorbidity burden, frailty, laboratory markers, and hemodynamic parameters were independently associated with 28-day mortality in this population.

Pre-ICU Hospital Length of Stay and 30-day Mortality in the Very Old: a National Cohort of 315 042 ICU Admissions

How does waiting in hospital before intensive care affect older patients?Patients who become seriously ill are sometimes admitted to a regular hospital ward first, and only transferred to the intensive care unit (ICU) when their condition worsens. The longer this wait, the higher the risk of dying within the following weeks. The number of very old patients (aged 80 and over) considered for ICU care is rising, and decisions about whether and when to admit them are difficult. It is not known whether the wait before ICU matters as much in this age group as in younger patients, or whether it carries different weight when judging how serious their illness is. Over 315,000 adults admitted to Swedish ICUs between 2005 and 2016 were examined, and statistical models were used to estimate how the risk of dying within 30 days depends on age and on the time spent in hospital before reaching the ICU.

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.

The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction. Despite the availability of multiple therapeutic options, COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact. The present real life study is aimed at describing the clinical and functional characteristics, treatment patterns, impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD.

National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns

After 7 then 13 valent pneumococcal conjugate vaccine (PCV) implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.

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.

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.

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.