linjc16/ctgov huggingface dataset:
Treatment of Parental Anxiety Virtual Reality (VR)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations

Official Title
-----------------
Treatment of Parental Anxiety With Virtual Reality (VR): A Prospective, Randomized Study

Conditions
-----------------
Anxiety, Parents, Virtual Reality

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality headset with calming scenery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-99 (Patient's parents will be enrolled) Able to consent Exclusion Criteria: People who do not consent Significant Cognitive Impairment History of Severe Motion Sickness Current Nausea Seizures Visual Problems Patients whose children are clinically unstable or require urgent/emergent intervention

Ages Eligible for Study
-----------------
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes | Behavioral: Virtual Reality headset with calming scenery<br>* Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes<br>|
| No Intervention: Control<br>No intervention (i.e. virtual reality headset) will be applied to the participant. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural-Related Anxiety | Validated questionnaires regarding anxiety will be administers pre- and post-intervention (i.e virtual reality) and compared to those in the control arm (i.e no virtual reality) | Duration of intervention, approximately 20-30 minutes |
Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the Colorectal Cancer (CRC).

Study Overview
=================
Brief Summary
-----------------
This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.

Official Title
-----------------
Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Radiation: Hepatic MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years; Histological diagnosis of colorectal cancer; Presence of liver metastases in the staging exams (chest-abdomen CT with contrast medium or PET-CT with 18-FDG); At least one measurable liver lesion according to RECIST 1.1 criteria; Adequate organ and marrow function. Exclusion Criteria: Age < 18 years; Inability to undergo MRI; Major contraindications to liver surgery; No written informed consent.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mCRC patients<br>Patients with mCRC with liver-only metastases | Radiation: Hepatic MRI<br>* The patients will undergo hepatic MRI in pre-established timepoints<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery conversion rates | Negative conversion rate is: patients initially considered operable and subsequently not considered suitable for surgery compared to the total number of patients enrolled. Positive conversion rate is: patients initially deemed ineligible for surgery and subsequently operated, compared to the total number of patients enrolled. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from enrollment to death | 3 years |
Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients

Study Overview
=================
Brief Summary
-----------------
This study explored the incidence of morbidity and mortality associated with AKI in critically ill adult patients infected with COVID-19. There are two groups for comparison. Group1. patients were directly admitted to the intensive care unit (ICU) from the emergency department (ED) Group 2. patients were initially managed on the medical floor and later transferred to the ICU for worsening respiratory status. The investigating team evaluated the correlation of inflammatory markers and common risk factors such as obesity, diabetes, hypertension and ethnicity to the development of AKI in the target population. The primary outcome is mortality participants will received their regular healthcare in a medical setting

Official Title
-----------------
Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive for SARS-CoV-2 on a real-time polymerase chain reaction test (RT-PCR) upon admission to the hospital Exclusion Criteria: chronic kidney disease end stage renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Group1<br>These critically ill patients were directly admitted to the intensive care unit from the emergency department | |
| Group 2<br>These critically ill patients were were initially managed on the medical floor and later transferred to the intensive care unit for worsening respiratory status | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | mortality at hospital discharge | from admission until death from any cause, whichever comes first, assessed up to three months |
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations

Official Title
-----------------
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients

Conditions
-----------------
Arthropathy, Incision, Surgical, Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: Small curved incision with apex lateral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid obese patients with body mass index more than 45 requiring total knee arthroplasty for any cause Exclusion Criteria: candidates not meeting the inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total knee arthroplasty<br> | Procedure: Small curved incision with apex lateral<br>* Small curved incision with apex lateral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcomes | Knee society score | 3 years | 
| length of skin incision | lenght of skin incision in centimeters | 7 years | 
| operative time | Oprative time in minutes | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| revision rate | no. of patients requiring revision | 7 years | 
| wound complications | Any reported wound complications | 7 years | 
| wound infection | No of patients with wound infection | 7 years | 
| Range of motion | Range of knee flexion and extension in degrees | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obese, Total knee arthroplasty
Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the score on urinary function (International Prostate Score Symptom) at 28 days. The main objective is to assess the efficacy of treatment with Ialuril® Prefill on functional recovery at 4 weeks, based on the International Prostate Score Symptom. A paired test will be performed to compare the International Prostate Score Symptom score between 0 and 28 days.

Detailed Description
-----------------
This is an interventional, non-comparative, open-label, monocentric study aimed at evaluating treatment with hyaluronic acid in patients who have undergone surgery (HOLEP procedure) for prostatic adenoma.

Official Title
-----------------
Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)

Conditions
-----------------
Prostatic Adenoma

Intervention / Treatment
-----------------
* Combination Product: Intravesical instillations of Ialuril® Prefill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient eligible for a HOLEP procedure, according to the investigator ; Patient able to understand the information related to the clinical investigation, to read the information leaflet and agrees to sign the consent form. Exclusion Criteria: Known intolerance to one of the treatment components: hyaluronic acid, chondroitin sulphate, calcium chloride; Prostatic volume greater than 140 cm3; Patient under anticoagulant treatment for secondary prevention; Patient under guardianship or curatorship, or under a regime of deprivation of liberty; Participating patient, or in a period of exclusion from another clinical trial; Patient not benefiting from a social security scheme.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient undergoing prostate enucleation by Holmium Laser<br>It is based on a pulsed laser at a wavelength of 2140 nm, which penetrates the tissues over a very short distance. The prostate tissue must therefore be in contact with the laser fiber to be cut or vaporized, and hemostasis will take place nearby. The procedure lasts approximately one hour. | Combination Product: Intravesical instillations of Ialuril® Prefill<br>* 5 injections of Ialuril® Prefill on D0 or D1, D7, D14, D21 and D28 after Holmium laser surgery for prostate adenoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Score Symptom on Day 28 |  | 28 days |
Study of the Incidence of Surgical Site Infections Developed by Patients Hospitalized in the Wards of a Large Teaching Hospital in Rome, Italy

Study Overview
=================
Brief Summary
-----------------
The surgical departments of the hospital were included in the study on a rotational basis over a period of 5 months. All patients undergoing surgery during this period were enrolled in the study. The data collection in each department lasted 6 months (8 in the case of the use of prostheses) of which: 5 months of continuous survey of hospitalized patients 30 days of post-operative surveillance for all operations, 90 days for operations involving the use of prosthetic material Surveillance ends when a surgical site infection occurs, even if the event is prior to 30 or 90 days. For each surgery, information was recorded such as the type of surgery, duration, ASA score, prophylaxis.

Official Title
-----------------
Study of the Incidence of Surgical Site Infections (SSI) in a Large Teaching Hospital in Rome, Italy.

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient undergoing surgery Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgery|any surgery that an inpatient has undergone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site infection |  | 30 days or 90 days (prosthesis) |
Examination of Trends in Colorectal Cancer Patients' Clinical Study Experiences

Study Overview
=================
Brief Summary
-----------------
Clinical study participation percentages haven't always been fully representative of a given demographic. Participation in this observational clinical research is extremely valuable since it allows people with colorectal cancer to contribute their own experiences and unique viewpoints. These vital contributions have the potential to affect the development of novel therapies and support services dramatically. Trial's findings will be critical in furthering the understanding of colorectal cancer, ultimately leading to better patient outcomes.

Official Title
-----------------
A Detailed Exploration of The Perspectives and Experiences of Patients in Colorectal Cancer Clinical Trials

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has a diagnosis of colorectal cancer Patient has self-identified as planning to enroll in a clinical trial for colorectal cancer Patient is at least 18 years of age Exclusion Criteria: Inability to perform regular electronic reporting Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial Pregnant or lactating woman

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 |
| --- | --- | --- |
| Rate of patients who decide to enroll in a colorectal cancer clinical study. |  | 3 months | 
| Number of colorectal cancer patients who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair

Study Overview
=================
Brief Summary
-----------------
The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis. However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years. Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.

Official Title
-----------------
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair

Conditions
-----------------
Degenerative Mitral Valve Disease

Intervention / Treatment
-----------------
* Procedure: Mitral valve repair (PLM)
* Procedure: Mitral valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients failure of previous mitral valve repair which needed a new surgical treatment group Re-PLM: patients reoperated with a new mitral valve repair group Re-SVM: patients reoperated with a mitral valve replacement Exclusion Criteria: urgent/emergent procedures

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 |
| --- | --- |
| Re-PLM<br>Patient in which a new mitral valve repair is performed to treat failed mitral valve repair | Procedure: Mitral valve repair (PLM)<br>* A mitral valve plasty is performed to treat mitral regurgitation<br>|
| Re-SVM<br>Patient in which a mitral valve replacement is performed to treat failed mitral valve repair | Procedure: Mitral valve replacement<br>* A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after reintervention | Time of survival after reintervention for failed mitral valve repair | through study completion, a minimum of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for reintervention | Identification of predictors of reintervention after mitral valve repair | through study completion, a minimum of 2 years |
Women's Knowledge About Endometriosis

Study Overview
=================
Brief Summary
-----------------
In the world, 10% of women of childbearing age have endometriosis with diagnostic mostly between 25 and 30 years old. Endometriosis is the leading cause of infertility in our country. A diagnosis delay of approximately 6.7 years is observed for endometriosis.

Detailed Description
-----------------
The aim of the study will be to describe knowledge of women about endometriosis.

Official Title
-----------------
Women's Knowledge About Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women older than 18 women of childbearing age with or without gynecological history agreed to participate in the study Exclusion Criteria: None

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 |
| --- | --- |
| women of childbearing age group<br>women of childbearing age with or without endometriosis | Other: data collection<br>* data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge score on endometriosis symptoms | 14 questions with yes/no answers, about symptoms of endometriosis (pain, nausea and vomiting, prolonged heavier period flow,…). A correct answer earns 1 point and a wrong answer earns 0 points. The knowledge score will therefore be between 0 and 14, the higher the score the better the knowledge. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women, knowledge, endometriosis
Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether applying high mechanical index (MI) impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent (UEA) microbubble infusion will result in subclinical improvement in left ventricle systolic function.

Detailed Description
-----------------
The purpose of this study is to investigate whether applying high MI impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent(UEA) microbubble infusion will result in subclinical improvement in LV systolic function detected by left ventricular outflow tract velocity time integral (LVOT VTI).

Official Title
-----------------
The Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume in Patients Receiving Intravenous Microbubbles

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Diagnostic Test: high MI impulses
* Diagnostic Test: low MI impulses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 19 years or older Exclusion Criteria: severe aortic valve stenosis pregnant or lactating women atrial fibrillation very poor image quality despite contrast use. unstable cardiac condition such as cardiogenic shock. allergy to UEA presence of right to left or bidirectional shunts. Patients on mechanical circulatory support.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high MI<br>patients receiving high MI impulses | Diagnostic Test: high MI impulses<br>* patients will receive intermittent high MI impulses(>1.0) in addition to low MI imaging. LVOT VTI will be measured at different times per protocol.<br>|
| Active Comparator: low MI<br>patients receiving low MI impulses | Diagnostic Test: low MI impulses<br>* patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI | Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke volume | The volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction | 10 minutes |