linjc16/ctgov huggingface dataset:
Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor

Study Overview
=================
Brief Summary
-----------------
This is a preliminary randomised controlled trial comparing the use of pre-operative 3D models to select an intrasaccular flow disruptor for endovascular aneurysm cure.

Detailed Description
-----------------
Patients will be randomised 3:1 either in the intervention or control group. Intervention consists of using the pre-operative Digital Subtraction Angiography (DSA) to create a 3D plastic model. This model is used to test different sizes of device. At the end of this pre-operative test a single device is recommended for the real procedure. The control group will use the current method for size selection (measurement of mean width and minimum height) on DSA.

Official Title
-----------------
Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Procedure: 3D anatomical model of aneurysm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision Consent form signed The patient benefits from health insurance Exclusion Criteria: Legal incapacity Women at risk of pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With 3D anatomical model<br>Surgery prepared using 3D anatomical model of the aneurysm | Procedure: 3D anatomical model of aneurysm<br>* Surgery prepared with 3D anatomical model of aneurysm<br>|
| No Intervention: Without 3D anatomical model<br>Surgery prepared without 3D anatomical model of the aneurysm (routine care) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with successful procedure | Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor | Day 0 |
SARS-CoV-2 /COVID-19 Admission Screening in a University Hospital Setting

Study Overview
=================
Brief Summary
-----------------
The proportion of asymptomatic carriers of SARS-CoV-2 remains elusive, so the potential benefit of systematic screening during the SARS-CoV-2-pandemic is controversial. We investigate the proportion of asymptomatic inpatients who were identified by systematic screening for SARS-CoV-2 upon hospital admission. Adult patients admitted to the University Hospital Basel from 01.04.-14.06.2020 were routinely tested for SARS-CoV-2 within 72 hours of admission by nasopharyngeal swabs. Each patient screened during the study period was retrospectively classified symptomatic or asymptomatic for COVID-19 based on medical chart review.

Official Title
-----------------
SARS-CoV-2 /COVID-19 Admission Screening in a University Hospital Setting (Covid-Screen Quality Control Study)

Conditions
-----------------
Covid19, SARS-CoV-2

Intervention / Treatment
-----------------
* Diagnostic Test: Testing for SARS-CoV-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient population is defined as all adult patients hospitalized in the University Hospital Basel from April 1st, 2020 to June 14th, 2020. Exclusion Criteria: Outpatients Patients with SARS-CoV-2 screening in the outpatient test center Patients with a SARS-CoV-2 test more than 72 hours before hospital admission Test not performed (for any reason)

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 |
| --- |
|Diagnostic Test: Testing for SARS-CoV-2|All Patients admitted to the hospital were routinely tested for SARS-CoV-2 within 72 hours of admission by nasopharyngeal swabs.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of SARS-CoV-2 -infected patients | We aim to determine the proportion of SARS-CoV-2-infected patients detected by systematic at-admission screening | 01.04.2020-14.06.2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Screening, asymptomatic
Lipid Variability--Influence of Stress

Study Overview
=================
Brief Summary
-----------------
To investigate the variability of lipids and specifically the effects of stress on serum triglyceride levels, total cholesterol, HDL, and LDL in a 2.5 year epidemiological study.

Detailed Description
-----------------
BACKGROUND: While researchers had documented some of the behavioral contributors to fluctuation in individuals' lipid levels (e.g., nutrition patterns, smoking, exercise), little attention had been given to psychosocial stress. Early reports utilizing accountants, race car drivers, and air traffic controllers provided some uncontrolled data associating stress with cholesterol increases. Yet, no empirical research on stress that concomitantly examined other related influences was available. This paucity of data was probably due to lack of objective measures of stress and difficulty in measuring lipid subfractions. DESIGN NARRATIVE: Based on the results of their pilot study, and their research observations, the investigators predicted significant positive associations between stress level and triglycerides. A total of 228 public accountants (148 men and 80 women to provide comparable power between the sexes) were recruited from the greater Birmingham, Alabama area. Participants were evaluated monthly for 18 months, across three stressful and non-stressful work intervals (i.e., tax seasons). The investigators also collected data (during this same time frame) to closely monitor the following variables that affect lipids: dietary intake (including alcohol, caffeine, total calories, total fat, saturated fat, and dietary cholesterol), smoking, and physical activity, and oral contraceptive use, pregnancy status and menstrual stage among the women. Additionally, a substudy presented a unique opportunity for them to investigate the relation between stress and triglyceride-rich lipoproteins in the formation of foam cells. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
First Postoperative Day Review After Uneventful Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized trial was to examine the value of the review on the first postoperative day after uneventful phacoemulsification cataract surgery.

Conditions
-----------------
Phacoemulsification, Complications, BCVA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria: Exclusion criteria were the following: i) intra-operative complications, such as posterior capsule rupture, vitreous loss, lost nucleus, zonule dehiscence and wound leak, ii) inadequate social support for overnight care at home, iii) severely limited visual potential in the fellow eye, iv) uveitis or ocular trauma, v) severe systemic diseases limiting activity, vi) patients with learning disability or dementia.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| first day review<br> | |
| non-first day review<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  |  |
A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.

Official Title
-----------------
A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
-----------------
Moderate to Severe Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: KHK4827-Active
* Drug: KHK4827-Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form Those who have involved BSA (the percentage (%) of body surface area involved with lesion) ≥10%, PASI (Psoriasis Area and Severity Index) ≥12 and sPGA (static Physician's global assessment) ≥ 3 at screening and at baseline. Exclusion Criteria: Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK4827 210 mg SC (Subcutaneous)<br>Single SC administration | Drug: KHK4827-Active<br>* Single SC administration<br>|
| Placebo Comparator: Placebo SC<br>Single SC administration | Drug: KHK4827-Placebo<br>* Single SC administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12 |  | Week 12 | 
| To evaluate static physician's global assessment (sPGA) of clear or almost clear (0 or 1) at Week 12 |  | Week 12 |
The DIEP-Flap as a Model of Ischemia-Reperfusion

Study Overview
=================
Brief Summary
-----------------
It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been directly studied in a human, clinical model of autologous transplant.

Official Title
-----------------
The DIEP-Flap as a Model of Ischemia-Reperfusion

Conditions
-----------------
Ischemia-Reperfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is undergoing a DIEP-breast reconstruction, unilateral as well as bilateral is aged 18 years or older Exclusion Criteria: diabetes mellitus diseases of the kidneys diseases of the liver patients who are taking immunosuppressants

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemia-reperfusion, ischemia, reperfusion, DIEP-flap, flap
Performance and Safety of Routine Cataract Surgery With Visiol

Study Overview
=================
Brief Summary
-----------------
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed

Official Title
-----------------
Performance and Safety of Routine Cataract Surgery With Visiol

Conditions
-----------------
Following Cataract Surgery

Intervention / Treatment
-----------------
* Device: Visiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years and older; Candidate for cataract surgery via phacoemulsification; Ophthalmic surgeon's recommendation to use VISIOL prior to recruitment; Eligible for the use of VISIOL as indicated in the instructions for use; Written informed consent. Exclusion Criteria: Known allergy or hypersensitivity to any of VISIOL components; Known pregnancy or breast feeding; Participation in any other clinical research study within the last 90 days; Patients with legally restricted autonomy, freedom of decision and action (e.g. those with measure of custody or judicial protection); Incapacity to understand the informed consent and/or to comply with the Clinical Investigation Plan (CIP), per investigator's appreciation.

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 |
| --- |
|Device: Visiol|VISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial cells density in percent | The variation of corneal endothelial cells density (cells/mm2) as compared to baseline (pre-surgery) will be calculated (%) | Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90 |
Heart Rate Variability and Stress Management Enhancement

Study Overview
=================
Brief Summary
-----------------
This study will be conducted by using two devices (Apollo and Biostrap) for monitoring of baseline physiologic variables and heart rate variability. The biostrap will be worn by residents and will monitor heart rate, heart rate variability, respiratory rate, sleep patterns, steps, etc. The Apollo is a pulse generator device aimed at modulating heart rate variability for (hopefully) reduction in stress and improving performance in and around the hospital. Resident neurosurgeons will wear the biostrap for a two week cycle and follow that with the addition of the Apollo device for heart rate variability modulation.

Official Title
-----------------
Impact of Heart Rate Variability Modulation on Stress and Performance Among Neurosurgical Residents

Conditions
-----------------
Stress, Heart Rate Variability

Intervention / Treatment
-----------------
* Device: Apollo Wearable Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurosurgical Resident (UPMC) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biostrap/Apollo Device Use<br>Participants wear a Biostrap wearable device which measures steps, heart rate, heart rate variability, sleep metrics, and quantitative data in typical day-to-day activities of residents. Participants then again wear Biostrap except now also with the Apollo device which is worn around the ankle and is suggested to modulate heart rate variability and perceived stress of participants. | Device: Apollo Wearable Device<br>* Participants wear Apollo device which generates vibration frequencies on skin and can be controlled by the user<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to two month heart rate variability | Quantitative (average range, beats per minute) | Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point | 
| Change from baseline to two month Perceived Stress Scale | Questionnaire, 14 point form/scale ranging from 0-50 with higher scores signifiying increased stress | Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point | 
| Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS) | Questionnaire ranging from 0-27 and measuring major depressive symptomatology. Higher scores signify more severe depression. | Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point |
Semaphorins 3A and 4D Levels in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with heart failure. Study protocol: Hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. Control group will include healthy people with no medical records or chronic treatment at the same age range. After signing an informed constent form, full medical history and blood samples will be collected. A second blood sample will be collected 8 weeks later, assuming the patient was discharged and not hospitalized since than. The blood samples will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels in the heart failure group and control group. Statistical analysis will then commence for possible correlatoion with different clinical parameters.

Detailed Description
-----------------
In few previous published studies, Semaphorins 3A levels are overexpressed in patients with heart failure. The aim of our study is the compare semaphorin 3A and 4D in patients with acute decompansated heart failure with healthy donors. Second aim is to compare semaphorin level in the same patients in time of hospitalization and few weeks later when the heart failure presumingly controled. Statistical analysis will then commense for possible correlatoion with different clinical parameters like NYHA (new york heart association) status of the patient, lenghts of hospitalization and BNP (brain natriuretic peptide) levels at time of admition.

Official Title
-----------------
Semaphorins 3A and 4D Levels in Heart Failure Patients: Pathogenesis and Clinical Correlation

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Biospecimen retention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with new onset or previously diagnosed heart failure. Heart failure diagnosis can be based on clinical judgment, echocardiography or elevated BNP levels Exclusion Criteria: Patients with acute myocardial infarction diagnosed clinicly and labratory

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| HF<br>Heart failure patients | Other: Biospecimen retention<br> <br> |
| Controls<br>Healthy donors | Other: Biospecimen retention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semaphrone 3A and 4D levels |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BNP level | Brain natriuretic peptide level in patient plasma | one year |
Examining The Role of Family Support in Bariatric Surgery Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the role of family support on the adhesion to post-op procedures in patients who have undergone bariatric surgery in Singapore.

Official Title
-----------------
To Examine the Role of Family Support for Patients With Obesity Before and After Bariatric Surgery and Whether Family Support Predicts Long-term Weight Loss and Diabetes Outcomes

Conditions
-----------------
Focus of Study is Patient Responses to an Obesity Management Questionnaire Administered by SGH Life Centre

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone bariatric surgery within SGH Life Centre and must have completed the intake questionnaire Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Weight Loss in Kilograms | Immediately post-surgery within first year |
Behavioral Indicators of Pain:Tool Development With Concurrent and Construct Validity

Study Overview
=================
Brief Summary
-----------------
The purpose of the pilot study is to validate an assesment tool to be used in the assessment of pain in the verbal, congitively intact patient. The ultimate goal is to be able to validate this tool in the non-verbal/cognitively impaired patient.

Detailed Description
-----------------
Patinets will be observed for 2 six hour periods. Patients will be videotaped; every 10 minutes: EMG reading will be obtained; hourly - vital signs, pain score and saliva cortisol from spit will be obtained.

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In-patients with Pain diagnosis Exclusion Criteria: Unable to talk and or understand basic instructions Under age 18 or over age 75 Receiving pain medications regularly

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |