rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals
Status: Not yet recruiting

The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Employed at participating sites (critical-access hospitals in rural Oregon) Patient-care workers (e.g. RNs, CNAs)  Exclusion Criteria:  Non-clinical staff (e.g. clerical, janitorial) Non-unit staff (e.g. physical therapy) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol
Status: Recruiting

The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 40<x<85 included Medial monocompartmental gonarthrosis grade 3-4 sec Kellgren-Lawrence Primary medial gonarthrosis Signing of the Informed Consent and consent to collaborate in all study procedures.  Exclusion Criteria:  Cognitive decline Psychiatric disorders Neuromuscular disorders Age > 85 years or <40 Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence Patella symptoms Secondary medial gonarthrosis Minor age Pregnant women (self-declaration) - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis
Status: Not yet recruiting

The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Both males and females.  Diabetic and non-diabetic patients. Age >18 years old. Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/ m2 but <40 kg/ m2. Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection. Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (>2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, HAIR score of 2 or 3.  Exclusion Criteria:  Patients with a history of hypersensitivity to esomeprazole. Patients with BMI ≥ 40 kg/ m2. Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates. Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine. Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency. Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate. Patients with cancer or with a history of cancer. Patients with cardiovascular diseases. Pregnant and lactating females - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor
Status: Not yet recruiting

The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor

The main questions it aims to answer are:

Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?
How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups
Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day
Group 2 (control) Participant will not need to take a DHA

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Singleton pregnancy Between 24 wk to 34 wk of gestational age Pregnant women diagnosed threatened preterm labor (with no cervical change)  Exclusion Criteria:  Fetal anomalies Multiple pregnancy Premature rupture of membrane Placental disorders: placenta previa, placental abruption Fetal growth restriction Pregnancy complication: gestational diabetes mellitus, Chronic hypertension Allergic reaction to DHA - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy
Status: Not yet recruiting

This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteering to participate in the research, Being over 18 years of age, Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, the threat of premature birth, eclampsia, etc.) Compliance with at least one of the criteria in the "Ministry of Health Pregnancy Risk Assessment Form" in the evaluation of "Current Pregnancy" (Table 1) Being at or above the 32nd week of pregnancy, Having a single living fetus, Having eaten at least two hours before the NST procedure, Not having smoked or consumed alcohol at least two hours before the NST procedure, Knowing how to read and write Turkish.  Exclusion Criteria:  Deceleration or uterine contraction during NST, Presence of cardiovascular disease in the fetus, Presence of fetal distress, Presence of fetal anomaly, According to the physician, urgent intervention is needed, Having a diagnosed psychiatric disease, Having a visual, hearing, speaking, physical or mental disability. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Safety and Efficacy Evaluation of Insight GS Growing System
Status: Not yet recruiting

Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.

The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).

Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.

Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  TCLE signed by parents Ages 3 to 10 years, or Risser 0, or Sanders 1,2,3 and 4 Cobb angle bigger than 30° Thoracic spine height T1-T12 less than 22 centimeters Risk of thoracic insufficiency syndrome (TIS).  Exclusion Criteria:  Need for fixation at occipital or cervical levels Risser sign greater than or equal to 1 Sanders bigger than 4 Previous spine surgery Medullary abnormalities Existence of malignant processes Local or systemic inflammations and infections, acute or chronic Allergy or intolerance to materials Non-reducible scoliosis Morbid obesity Insufficiency or absence of skin coverage - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 10 Years - StdAgeList: Child
Dextrose Prolotherapy on Articular Cartilage
Status: Recruiting

Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.

We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Willing to sign a written consent form Adult men and women with arthritis  Exclusion Criteria:  Pregnant or lactating women Septic arthritis Those who have undergone joint surgery within 30 days - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult
Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors
Status: Recruiting

This multicentric observational study aims to enhance thymic epithelial tumor classification and predict recurrence risks using AI models. By analyzing digital pathology and clinical variables, the project addresses discrepancies in the current WHO classification system.

Main Questions:

Can AI models improve the accuracy of thymic epithelial tumor classification?
Do AI models better predict recurrence risks compared to the WHO classification system?

Participant Tasks:

Digital pathology analysis.
Develop AI models for precise classification and recurrence risk prediction.

Comparison Group:

Researchers will compare AI-enhanced classification with the WHO system to determine if AI models provide more precise subtyping and better predict recurrence risks.

Study Design:

This international project utilizes three databases from Rotterdam, Maastricht, and Lyon, with one database for AI model building and the other two for external validation.

Ultimate Goal:

Develop AI models supporting pathologists in accurately subtyping thymic epithelial tumors, preventing under- or overtreatment with adjuvant radiotherapy for more personalized and effective treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants with specific diagnoses are eligible for inclusion in the study. The eligible diagnoses include various subtypes of thymoma and thymic carcinoma, specifically:  Thymoma A Thymoma AB Thymoma B1 Thymoma B2 Thymoma B3 Thymic Carcinoma  Inclusion is based on a consensus diagnosis with a level of agreement less than 70%. This criterion is applied during the training phase of the model.  Recurrence Criteria:  Participants with a documented recurrence outcome within a 5-year period are considered eligible for this aspect of the study. This criterion is primarily applied during the validation phase. - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Study Population:  This study focuses on individuals diagnosed with thymic epithelial tumors. The study includes patients from three datasets: Erasmus MC (710 patients), Maastro (137 patients), and University Hospital Lyon (181 patients).  Additional Information:  Erasmus MC (710 patients): Includes age, gender, and diagnosis information; each patient may have multiple whole slide images. Maastro (137 patients): Each patient may have multiple whole slide images. University Hospital Lyon (181 patients): Each patient may have multiple whole slide images. - SamplingMethod: Non-Probability Sample
Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization
Status: Recruiting

NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.

Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.

The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.  Exclusion Criteria:  Patients lost for follow-up, patients without preoperative CT. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients treated by TAE with NBCA, based on clinical decisions in emergency and CT scan. - SamplingMethod: Non-Probability Sample
Red Yeast Rice for Primary Prevention of Hypercholesterolemia
Status: Recruiting

This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 35~55 years old, LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl, expected to receive LipoCol Forte Capsule 600mg bid  Exclusion Criteria:  Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month; Female; Have experienced rhabdomyolysis or abnormal liver function ALT >72 U/L due to taking red yeast rice; Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month Liver insufficiency ALT >72 U/L or renal insufficiency eGFR < 30 mL/min/1.73 m2; Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease; Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated; Uncontrolled hypertension (blood pressure ≥160/100 mmHg); Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study; Drug abuse or poor compliance; Use of traditional Chinese medicine in the past month - HealthyVolunteers: No - Gender: Male - MinimumAge: 35 Years - MaximumAge: 55 Years - StdAgeList: Adult - StudyPopulation: The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. - SamplingMethod: Non-Probability Sample
Uganda Sickle Surveillance Study (US-3)
Status: Recruiting

It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings.  Exclusion Criteria:  Repeat samples on the same individuals during the study period will be excluded. - HealthyVolunteers: No - Gender: All - MaximumAge: 12 Months - StdAgeList: Child - StudyPopulation: All Dried Blood Spot (DBS) samples collected from HIV exposed infants from all districts of Uganda from approximately February 2014 to March 2015 will be included in the primary analysis. Up to 1,000,000 additional samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings. - SamplingMethod: Probability Sample
Preventing Failed Extubations
Status: Not yet recruiting

More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Extubated in participating ICU during study period  Exclusion Criteria:  Previously extubated during hospitaliztion Extubation as part of transitioning to comfort measures - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All mechanically ventilated patients in participating intensive care units. - SamplingMethod: Non-Probability Sample
An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
Status: Not yet recruiting

Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients over 18 years Documented or suspected clinically COPD according to the criteria of GOLD Community-acquired pneumonia defined as the presence of a radiological (i.e., chest X-ray or CTscan) infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, chest pain, localized crackles with or without signs of pleural effusion, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³ Admitted to the hospital for less than 48 hours ICU Admission Informed Consent signed by the patient or his representative  Exclusion Criteria:  Patient immunocompromised including congenital immunodeficiency, haematologic malignancy, immunosuppressive drugs (including anticancer chemotherapy and post-transplantation therapies), neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV infection Therapeutic limitation Existence Minor patient or under guardianship or custody Pregnant woman Refusal to participate in the study The inclusion of the subject in another biomedical research protocol in progress or for less than 30 day Patients treated with antibiotics before ICU referral are no excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult