linjc16/ctgov huggingface dataset:
International Multicenter Mycotic Aneurysm Aorto-iliac Study

Study Overview
=================
Brief Summary
-----------------
The term mycotic aneurysm (MA) is commonly used to describe all infected aneurysms. Although MAs are believed to occur uncommonly, the true incidence is difficult to determine and is probably underestimated since MAs can be asymptomatic and are diagnosed only at autopsy. In an autoptic study, mycotic aortic aneurysms (MAAs) were reported in 3.3% of all detected aneurysms. The incidence of infected aneurysms of the aorta and iliac arteries ranges from 0.6% to 1.3%. A recent literature review of the management of MAAs showed that therapeutic strategies are multiple, including open surgical repair (OSR) in the majority of cases, endovascular aortic repair (EVAR), which increased over the last decade, and medical treatment alone for patients unfit for any aortic repair in a very limited part. Following the unfavorable prognosis towards rupture and since the medical treatment alone in mycotic aneurysms has shown mortality of almost 100%, surgical treatment is generally the preferred option. Surgical treatment includes both open and endovascular surgery. The latter is less invasive than conventional surgery but does not involve resection of the infected tissue and is therefore associated with an increased risk of sepsis and prosthesis infection. The gold standard is still open surgery, including extra-anatomic reconstruction and in situ repair, with different type of vascular graft. This is a multicenter retrospective observational study. It will examine all patients undergoing surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction at the participating centers.

Official Title
-----------------
Long Term Results of Aorto-iliac Mycotic Aneurysms

Conditions
-----------------
Mycotic Aneurysm, Aortic Diseases

Intervention / Treatment
-----------------
* Procedure: Mycotic aortic-iliac aneurysms and in situ reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary mycotic aorto-iliac aneurysm who underwent in situ repair Exclusion Criteria: patient with vascular graft infections; patient with secondary aorto-enteric fistula.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mycotic aortic-iliac aneurysms and in situ reconstruction|Surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early mortality | Mortality after surgery | Mortality within 30 days after surgery |
Impact of Light on Mood

Study Overview
=================
Brief Summary
-----------------
The investigators are examining whether the content of a visual scene impacts the antidepressant effects of light or if this impact is solely mediated by the intensity of the light.

Official Title
-----------------
More Than Meets the Eye? The Impact of Light on Mood Regulation in Humans

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: Light exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-60 Mild depressive symptomatology Exclusion Criteria: No depressive symptomatology Severe depressive symptomatology Active or unstable medical condition Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scene<br>High fidelity scene of nature emitted from a monitor | Other: Light exposure<br>* Participants will be exposed to 15 minutes of each arm. They will be exposed twice and a randomized order (1/2/1/2 or 2/1/2/1)<br>|
| Active Comparator: Scrambled scene<br>The same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor | Other: Light exposure<br>* Participants will be exposed to 15 minutes of each arm. They will be exposed twice and a randomized order (1/2/1/2 or 2/1/2/1)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mood | Change in subjective mood as recored by the Positive and Negative Affect Schedule (PANAS). The PANAS ranges 10-50 on a positive mood scale (higher = more positive) and 10-50 on a negative mood scale (higher = more negative) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fast brain electrical activity | Change in the beta power spectrum (12.5-30 Hz) of the electroencephalogram (brain waves, measured in microvolts) | 15 minutes | 
| Change in systolic blood pressure (SBP) | Change in SBP (mm Hg) as measured by finger plethysmography | 15 minutes | 
| Change in heart rate variability (HRV) | Shift in the ratio of the power of low frequency to high frequency components in heart rate variability | 15 minutes | 
| Change in sympathetic activity | Sympathetic activity will be imputed through the galvanic skin response (GSR). Change in skin conductance (the electrical activity on the skin) will be measured in microsiemens | 15 minutes |
Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth

Study Overview
=================
Brief Summary
-----------------
Sodiumhexametaphosphate will be used as capping material for dental pulp of immature permanent teeth

Official Title
-----------------
Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth ( Randomized Clinical Trial)

Conditions
-----------------
Pulp Disease, Dental

Intervention / Treatment
-----------------
* Other: Pulp capping
* Drug: Sodiumhexametaphosphate
* Other: MTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children cooperative children deep carious lesion traumatic pulp exposure immature permanent teeth Exclusion Criteria: uncooperative children children with systemic disorders non vital immature permanent teeth

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodiumhexametaphosphate<br> | Other: Pulp capping<br>* Pulp capping material for immature permanent teeth in case of carious or traumatic pulp expures<br>Drug: Sodiumhexametaphosphate<br>* Sodiumhexametaphosphate<br>|
| Active Comparator: MTA<br> | Other: Pulp capping<br>* Pulp capping material for immature permanent teeth in case of carious or traumatic pulp expures<br>Other: MTA<br>* MTA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Absence of pain, tenderness, mobility and swelling | One year | 
| Radiographic success | Absence of periapical lesions, internal resorption an external resorption also evidence of continuous root growth | One year |
Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios

Study Overview
=================
Brief Summary
-----------------
In cases diagnosed as idiopathic polyhydramnios and healthy pregnancy between 24-40 weeks (total number of cases (100-120)), prospective fetal echocardiography will be performed to evaluate MPI and EFT.

Detailed Description
-----------------
: gestational week, maternal age, amniotic fluid index measurement, modified myocardial performance in fetal echo and epicardial thickness of all cases will be evaluated. week of pregnancy, body mass index, fetal biometry, umbilical artery doppler, middle cerebral artery doppler measurements will be taken. Birth weight and fetal intensive care hospitalizations at the birth week of all cases will be recorded. All data will be evaluated with the appropriate statistical method.

Official Title
-----------------
Comparison of the Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios and in Healthy Normal Pregnancies

Conditions
-----------------
Fetal Diagnose, Fetal Cardiac Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: prenatal diagnose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 24-40 weeks gestational age, polyhydramnios and healthy pregnancy - Exclusion Criteria: multıpl pregnancy, fetal anomaly, growth restriction, maternal chronic disease -

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: myocardial performance and epicard thickness in case with polyhidramnios<br>we will do a fetal echo, and fetal screening with ultrasonography | Diagnostic Test: prenatal diagnose<br>* we will do a fetal echo in pregnant women with polyhidramnios<br>|
| Active Comparator: pregnant women with polyhidramios<br> | Diagnostic Test: prenatal diagnose<br>* we will do a fetal echo in pregnant women with polyhidramnios<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal and fetal outcome | Do epicardial thickness and myocardial performance index determine fetal outcome in cases with polyhdramnios? | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polyhidramnios, epicard, myocardial performance index
Delirium Related to Proton Pump Inhibitors Use

Study Overview
=================
Brief Summary
-----------------
Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium. Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.

Official Title
-----------------
Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database

Conditions
-----------------
Proton Pump Inhibitor Adverse Reaction, Delirium, Hyponatremia

Intervention / Treatment
-----------------
* Drug: PPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PPI use Delirium mentioned in the safety report

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPI users<br> | Drug: PPI<br>* Use of PPI defined as PPI mentioned in the safety report<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium occuring when using PPI |  | 09/02/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between PPI use and occurrence of delirium | Association assessed by performing a disproportionality analysis with adjustment on confounders | 09/02/2022 | 
| Association between PPI use and occurrence of delirium and hyponatremia | Association assessed by performing a disproportionality analysis with adjustment on confounders | 09/02/2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proton Pump Inhibitor, Delirium, Drug safety, Hyponatremia
Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascular Anomalies in Adult Patients With Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and MRI are interrupted at the diaphragmatic level.

Official Title
-----------------
Role of Cardiac Magnetic Resonance Angiography (1.5-T Ingenia, Philips) in the Diagnosis of Cardiac and Thoraco-abdominal Vascular Tree Anomalies in Adult Patients With Turner Syndrome

Conditions
-----------------
Anomaly Heart, Turner Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of Turner Syndrome patients underwewnt angioRMN 1.5 T age > 18 years

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: imaging|cardiac angioRMN|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of the main cardiovascular anomalies at the thoracic and abdominal level |  | 5 years |
Endogenous Lithium Clearance in Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. We hypothesized that endogenous lithium reabsorption is impaired in the early stages of critical illness. We would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10 healthy controls. Blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during one day. Renal clearance of creatinine (CCr) and lithium will be calculated.

Official Title
-----------------
Endogenous Lithium Clearance in Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury Due to Sepsis, Proximal Tubule Function, Lithium Clearance

Intervention / Treatment
-----------------
* Diagnostic Test: Lithium clearance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients diagnosed with AKI, without AKI and healthy controls Exclusion Criteria: -

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 1<br>ICU patients with AKI | Diagnostic Test: Lithium clearance<br>* Blood and urine samples<br>|
| Group 2<br>ICU patients with normal renal function | Diagnostic Test: Lithium clearance<br>* Blood and urine samples<br>|
| Group 3<br>Healthy controls | Diagnostic Test: Lithium clearance<br>* Blood and urine samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lithium clearance |  | 2 days |
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.

Official Title
-----------------
CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Conditions
-----------------
Obstructive Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: Mavacamten


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants 19 years of age or older Participants who receive mavacamten according to the approved product label Participants who sign the informed consent form Exclusion Criteria: Participants who are prescribed mavacamten for therapeutic indications not approved in Korea Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving mavacamten for oHCM<br> | Drug: Mavacamten<br>* According to approved product label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 12 months |
Calcium Levels in Major Trauma

Study Overview
=================
Brief Summary
-----------------
To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions .

Detailed Description
-----------------
Primary objective: to evaluate the level of ionized calcium in multiple trauma patients with massive hemorrhage Secondary objective: to build a relation between the level of ionized calcium and the degree of hemorrhagic shock

Official Title
-----------------
Ionized Calcium Level Abnormalities In Major Trauma Patients Pre And Post Receiving Blood Transfusion And Its Relation To Mortality Rate

Conditions
-----------------
Major Trauma

Intervention / Treatment
-----------------
* Diagnostic Test: ionized calcium levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old - < 70 years Major trauma patients. Admission and Ionized calcium measurement before blood transfusions Exclusion Criteria: patients below 18 years or > 70 years of age. Pregnant women Arrested patients Patients managed outside the hospital and had received blood transfusions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ionized calcium levels|measuring calcium level in trauma patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow up ionized calcium level |  | 24 hrs |
Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell 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
-----------------
Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers

Conditions
-----------------
Extensive-stage 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. Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors). 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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first) | 2 years | 
| OS | Defined as the time from the start of treatment to the death of the subject due to any cause. | 2 years |