linjc16/ctgov huggingface dataset:
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment. To evaluate the performance and safety of T2769 versus Vismed® Multi.

Official Title
-----------------
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Device: T2769
* Device: Vismed® Multi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent signed and dated (obtained prior to initiating any procedures). Patient aged ≥18 years old. Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit. Surface Disease Index (OSDI) Score ≥ 23. Ocular discomfort evaluated by VAS ≥ 40 mm. Exclusion Criteria: Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study). Severe blepharitis according to the judgment of the investigator Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2769<br> | Device: T2769<br>* T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.<br>|
| Active Comparator: Vismed® Multi<br> | Device: Vismed® Multi<br>* Hyaluronic acid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme. | The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme at D36 in the study eye. | Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36 |
A Study of Emergency Department AI Prediction Impact

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of an AI admission prediction tool on the number of preventable hospital admissions, emergency department (ED) length of stay, when the predictions are displayed only to a dedicated ED triage team. Also, to evaluate user perceptions of the AI tool among the triage team users and medical officer of the day users. Additionally, to evaluate any impact of the AI tool on the number of interventions performed by the triage team, and to evaluate the impact of the tool on time-to-admission after an admission order is placed.

Official Title
-----------------
Evaluation of Emergency Department AI Prediction Algorithm

Conditions
-----------------
Hospital Admission, Length of Stay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the survey component, any HIM clinician that works a shift in the triage area, ED physicians, and the medical officer of the day will be included. For length of stay data, adult patients registered in the Mayo Clinic-Rochester St. Mary's Emergency Department will be included. Exclusion Criteria: For the survey, clinicians not working a triage shift during the study period will be excluded. For the length of stay analysis, only adult ED patients will be included, who do not triaged to the behavioral health/psychiatry pathway, nor patients who are triaged to the Emergency Department observation pathway.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>141 days with AI scores displayed | |
| Group B<br>141 days with AI scores not displayed | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admissions | Number of avoidable admissions prevented as a fraction of all ED patients in a day, specifically, the number of patients who were seen by the SAPPHIRE triage team and discharged home | 282 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AI Prediction Algorithm, Emergency Department
Psychological Status and Self-care in Chronic Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
This is an observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease

Detailed Description
-----------------
400 patients with chronic cardiovascular disease were enrolled in this observational study aiming at exploring the relationship between their psychological status (anxiety, depression, emotional distress and quality of life) and their self-care.

Official Title
-----------------
Psychological Status and Self-care: a Preliminary Study Involving Patients With Chronic Cardiovascular Disease

Conditions
-----------------
Anxiety, Depression, Emotional Stress, Quality of Life, Self-care, Chronic Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: There was no intervention, the study was a cross-sectional observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being aged > 18 years old and > 85 years old Being diagnosed with a chronic cardiovascular disease Being able and willing to sign the Informed Consent Form Exclusion Criteria: Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation Not speaking Italian

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: There was no intervention, the study was a cross-sectional observational study|Questionnaires for measuring self-care, anxiety, depression, emotinal distress and quality of live were administered to patients with chronic cardiovascular disease|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological status and self-care | Investigating the relationship between psychological status and self-care in patients with chronic cardiovascular disease | At the moment of enrollment |
A Study of Changes in Heart Function and Blood Flow in People Receiving Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand changes in heart function (how the heart pumps blood) and blood flow in people who receive general anesthesia during surgery. The researchers are particularly interested in the heart function and blood flow changes in people who experience low blood pressure (hypotension) after receiving anesthesia.

Official Title
-----------------
Changes in Loading Conditions on Induction of General Anesthesia: Mechanisms of Post-Induction Hypotension (PIH)

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ≥ 18 years of age requiring general anesthesia for surgery Intubation required for anesthetic management / surgery Anticipated prep time before incision of 20 minutes Baseline MAP >70mmHg Exclusion Criteria: History of coronary artery disease History of cardiac disease (e.g., HTN, arrythmias, valvular and structural abnormalities) History of peripheral artery occlusive disease Beta-blocker use Anti-hypertensive medication use Patients with epidural, spinal, paravertebral, serratus blocks preoperatively Patients requiring rapid sequence induction (where intubation occurs concurrently with induction) Emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echocardiography<br>Patients participating in this study will undergo routine anesthetic and perioperative care with the addition of an echocardiography and Clearsight BP measurement. | Diagnostic Test: Echocardiography<br>* Echocardiography and Clearsight BP measurements before, immediately after anesthesia induction and after intubation (for 20 min)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with post-induction hypotension (PIH) | summarize the distributions of the echocardiography parameter values (pre-load LVEDd(cm), after-load LVEDs(cm), other measures [e.g., contractility (EF %) and structural abnormalities]) across each timepoint among patients with and without PIH | up to 20-mins after anesthesia induction. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Changes in Heart Function, Changes in Blood Flow, Echocardiography, 23-079
the Bispebjerg Study of Diurnal Variations

Study Overview
=================
Brief Summary
-----------------
To evaluate the influence of time of day on the circulating concentrations of various biochemical markers in healthy men

Official Title
-----------------
the Bispebjerg Study of Diurnal Variations

Conditions
-----------------
Diurnal

Intervention / Treatment
-----------------
* Other: Diurnal variation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically healthy Normal sleep-wake pattern Exclusion Criteria: acute or chronic medical diseases had worked nightshifts the last 14 days before the study transatlantic traveling the last 14 days before the study had been smoking the last 14 days before the study had an irregular sleep-wake pattern, didn't sleep 7-8 hours pr night were extreme morning- or evening types, had plasma hemoglobin < 8.0 mmol/L ody mass index (BMI) <18.5 kg/m2 or >24.9 kg/m2.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diurnal variations<br>Venous blood samples were obtained under standardized conditions from 24 healthy young men every third hour through 24 hours | Other: Diurnal variation<br>* Venous blood samples were obtained under standardized circumstances from 24 healthy young men every third hour through 24 hours, nine time points in total.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematology parameters | Composite measurement of hematological measurements | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Levels of Glucagon |  | 24 hours | 
| Plasma levels of GLP-1 |  | 24 hours | 
| Plasma levels of GIP |  | 24 hours | 
| Plasma levels of c-peptide |  | 24 hours | 
| Plasma levels of glucose |  | 24 hours |
Efficacy of Osimertinib in Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Official Title
-----------------
Efficacy of Osimertinib in Patients With Lung Cancer Positive for Uncommon EGFR Exon 19 Deletion Mutations

Conditions
-----------------
Advanced Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be ≥18 years. Provision of fully informed consent prior to any study specific procedures. Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology. According to the RECIST 1.1 standard, the patient must have at least one measurable lesion. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | From registration onto that step until death, or censored at the date of last contact. | 3 years | 
| Overall survival | From registration onto that step until death, or censored at the date of last contact. | 3 years |
To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.

Official Title
-----------------
Phase Ib/II Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Drug: STSA-1002 Injection Placebo
* Drug: STSA-1002 Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old≤Age≤85 years old; In 14 days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients); The nearest PaO2/FiO2≤200mmHg; Low peripheral blood lymphocyte count; Patients (including patients' partners) did not plan to have children during the trial period and for 4 months after the end of the last dose and agreed to use appropriate and effective contraceptive methods; Exclusion Criteria: Use ECMO before first administration; The time between first administration and invasive mechanical ventilation was more than 48h; Survival is expected to be no more than 24 hours or a cardiac arrest has occurred 4 weeks before screening; Vital organs failure, including the liver, kidneys and heart; Immunosuppressed state; Serious underlying disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Patients in this group will receive basal treatment and placebo. | Drug: STSA-1002 Injection Placebo<br>* Intravenous infusion<br>|
| Experimental: Low dose group<br>Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002. | Drug: STSA-1002 Injection Placebo<br>* Intravenous infusion<br>Drug: STSA-1002 Injection<br>* Intravenous infusion<br>|
| Experimental: High dose group<br>Patients in this group will receive basal treatment and High-dose STSA-1002. | Drug: STSA-1002 Injection<br>* Intravenous infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission time |  | Baseline to Day30 |
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.

Study Overview
=================
Brief Summary
-----------------
In the course of this clinical trial, it was shown that the use of Granudacyn/VERIFORTE med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the wound. No risks have been reported. The benefits of using Granudacyn/VERIFORTE med wound irrigation solution therefore outweigh the potential risks.

Detailed Description
-----------------
Aim of this clinical trial was to collect clinical data on the performance and safety of the use of Granudacyn/VERIFORTE med as a wound irrigation solution, for cleansing and irrigation of acute, chronic or contaminated wounds. The evaluation of the safety of the use of Granudacyn/VERIFORTE med wound irrigation solution within the scope of use was based on the frequency of adverse events (AEs) and, in particular, treatment-emergent adverse events (ADEs). Study Design: Open-label, retrospective, monocentric, PMCF, non-interventional, observational study. One treatment group (single arm): All subjects participating in the study will be treated with Granudacyn/VERIFORTE med wound irrigation solution. The study will be conducted in Austria. The participating trial centre is in Lower Austria: WPM Ges.m.b.H

Official Title
-----------------
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Device: Granudacyn/Veriforte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of a documented case report within the indication, which enables a retrospective evaluation of the target variables. Subjects are ≥ 18 years of age. Gender: All. Exclusion Criteria: Vulnerable persons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Granudacyn/Veriforte|Wound irrigation solution for all kinds of wounds (Acute, chronic or contaminated wounds).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety: • AES: 0,00%, 95% CI: (0,00% - 4,16%) • ADEs: 0,00%, 95% CI: (0,00% - 4,16%) | Evaluation of the safety of the use of Granudacyn/VERIFORTE med wound irrigation solution within the scope of use, based on the frequency of adverse events (AEs) and, in particular, treatment-emergent adverse events (ADEs). | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute wounds, chronic wounds, burns
Breastmilk as a Source of Lactocytes

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the suitability of lactocytes derived from human breast milk for gene expression analysis, and to explore whether there are any correlations between gene expression and the micronutrient composition of breast milk.

Detailed Description
-----------------
Participants will be included in the study if they are willing to express milk and if their child is between 2 weeks and 6 months old. Participants' feeding practices (exclusive breastfeeding/non-exclusive breastfeeding) and micronutrient supplementation will be recorded. On the day of donation, child's age, the health status of both the mother and child (sick/not sick), the time of sample collection, and the number of feeding sessions that have taken place since midnight will be recorded.

Official Title
-----------------
Assessing Gene Expression in Lactocytes Using Human Breast Milk as a Non-Invasive Source: A Pilot Study

Conditions
-----------------
Breastmilk Collection, Micronutrients

Intervention / Treatment
-----------------
* Other: Collection of breastmilk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to express breastmilk Breastfed infant aged between 2 weeks and 6 months Exclusion Criteria: Not willing to express breastmilk Infant older or younger than specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lactating individuals<br>Lactating adults (age >= 18) with children aged 2 weeks to 6 month | Other: Collection of breastmilk<br>* Collection of breastmilk and other information about the participant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Expression | Gene expression of cellular markers from various cell populations in breast milk, as well as expression of proteins involved in micronutrient transport will be investigated. Additionally, these gene expression patterns will be investigated over time. | 6 month after completion | 
| Micronutrient Content | Micronutrient content of breastmilk will be analyzed and whether changes occur over time | 6 month after completion |