linjc16/ctgov huggingface dataset:
STAR-LIFE: a Post-market Registry on MINIject

Study Overview
=================
Brief Summary
-----------------
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.

Detailed Description
-----------------
The goal of the registry is to collect data of the MINIject in a real-life setting. The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes, and the device safety over a period of 2 years after surgery.

Official Title
-----------------
STAR-LIFE: a Post-market Registry on MINIject

Conditions
-----------------
Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject able to give consent Exclusion Criteria: eyes with angle closure glaucoma eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle patients with known intolerance or hypersensitivity to silicone patients unable to give consent

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 |
| --- | --- | --- |
| QoL | quality of life will be quantified by use of a standardized quality of life questionnaires SHPC-18 | 2 years after surgery | 
| ease of use | the usability of the device will be defined by use of a surgeon questionnaire. | 1 day | 
| Number of participants with treatment-related incidents | collection of incidences (nature (ocular or non-ocular), number and severity) throughout the study | up to 2 years after surgery (study completion) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open Angle Glaucoma, Minimally Invasive Glaucoma Surgery, MINIject
The Effect of Eprosartan on Hormones and Kidney Function in Healthy Humans.

Study Overview
=================
Brief Summary
-----------------
We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in healthy individuals - during baseline conditions and after activation of the sympathetic nervous system.

Official Title
-----------------
The Effect of Eprosartan on Vasoactive Hormones and Renal Tubular Function in Healthy Humans.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Eprosartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders. Age 18 - 65 years. Body mass index less or equal to 30 kg/m2. Women must use oral hormonal anticonception, use intrauterine anticonceptive device, be sterilized/hysterectomized or be postmenopausal. Exclusion Criteria: History or clinical signs of heart, lung, kidney, or endocrine organ disease. Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose. Abnormal screening of the urine regarding: albumin and glucose Malignant disease. Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic. Alcohol abuse. Smoking. Drug use or abuse. Known intolerance or allergy to eprosartan or sodium nitroprusside. Blood donation within 1 month of the start of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Eprosartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  |  | 
| Fractional sodium excretion |  |  | 
| Plasma levels of noradrenaline |  |  |
ActiveCare+SFT Hemodynamic Profile Compare to SCD Express in Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
Purpose: To test the hemodynamic profile generated by the MCS's ActiveCare+SFT device in ventilated patients and compare it to that of the Kendall SCD Express. Design: Comparative, prospective study. Patients are their own controls.

Official Title
-----------------
ActiveCare+SFT Hemodynamic Profile Compare to SCD Express in Ventilated Patients

Conditions
-----------------
DVT Prevention, Ventilated Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ventilated patient (Age >18). The patient or his guardian is able and voluntarily prepared to sign the Informed Consent Form. Exclusion Criteria: Known, preexisting DVT or PE. Patient who is participating in another clinical trial. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DVT prevention, Hemodynamic study, IPC, CECT
Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

Study Overview
=================
Brief Summary
-----------------
To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.

Official Title
-----------------
Effects of Hypertonic Saline and Fluticasone Nasal Sprays on Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Drug: Hypertonic saline
* Drug: Fluticasone Nasal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with chronic sinusitis and/or nasal polyps. Exclusion Criteria: Patients with previous nasal or sinus surgery. Patients with sinonasal Malignancy. Immunocompromised patients. Patients with ciliary motility disorders. Pregnant women

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypertonic saline<br>nasal spray will be used twice daily | Drug: Hypertonic saline<br>* nasal spray<br>|
| Active Comparator: fluticasone<br>nasal spray will be used once daily | Drug: Fluticasone Nasal<br>* nasal spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patient with normal radiological scoring | the score used is Lund Mackay radiological scoring | 1 month |
Validation of the Thai Version CPOT and BPS in Postoperative ICU Patients

Study Overview
=================
Brief Summary
-----------------
The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

Detailed Description
-----------------
The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

Official Title
-----------------
Validation of the Thai Version Critical Care Pain Observation Tool and Behavioral Pain Scale in Postoperative Mechanically Ventilated ICU Patients

Conditions
-----------------
Adult ICU Patients

Intervention / Treatment
-----------------
* Diagnostic Test: Critical care pain observation tool (CPOT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥18 years be able to communicate in Thai intubated during postoperative period. Exclusion Criteria: quadriplegia patients with limb or facial injuries patients receiving neuromuscular blockers patients with limb mobility adversely affected by stroke patients with epidural catheter used for postoperative pain control

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: Critical care pain observation tool (CPOT)|test validity and reliability of Thai-version CPOT and BPS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| construct validity |  | before and after analgesic given during 24 hours postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| content validity, concurrent validity, inter-rater reliability, and practicality |  | 24 hours after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thai version, validated, Critical Care Pain Observation Tool, Behavioral Pain Scale, adult ICU patients
CPR Decision Aid For Patients With Advanced Gynecologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy. We will assess the baseline CPR knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding CPR.

Official Title
-----------------
The Effect of a CPR Decision Aid on CPR Knowledge and Code-Status Preferences in Patients With Advanced Gynecologic Malignancies

Conditions
-----------------
Advance Care Planning

Intervention / Treatment
-----------------
* Behavioral: video
* Behavioral: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with stage III or greater cervical, ovarian, or uterine malignancies receiving chemotherapy at UAB gynecologic oncology infusion center Exclusion Criteria: early stage gynecologic cancer receiving chemotherapy at a different location Non-English speaking deafness blindness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>video decision aid | Behavioral: video<br>* informational video<br>|
| Active Comparator: Usual care<br> | Behavioral: usual care<br>* usual physician counseling on end of life care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPR knowledge | Patient CPR knowledge assessment score (0-4) | one month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPR preference | Patient CPR preference (Yes, No, Unsure) | baseline | 
| CPR preference | Patient CPR preference (Yes, No, Unsure) | one month after intervention | 
| CPR knowledge | Patient CPR knowledge assessment score (0-4) | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, cardiopulmonary resuscitation, end of life care, endometrial cancer, cervical cancer
A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.

Study Overview
=================
Brief Summary
-----------------
This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid. Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: A4I Antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-59 years of age; relapsing multiple sclerosis patients with types 1-4 (established through McDonald criteria); >=1 MS attack or a Gd-enhancing MRI lesion between 1 month and 1 year before enrollment; EDSS score of <=6.5; inadequate response to approved treatment(Canada only). Exclusion Criteria: MS attack within 1 month before enrollment; systemic corticosteroids within 1 month before enrollment; MS treatments (non-symptomatic) within specified periods before enrollment; an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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

| Intervention/Treatment |
| --- |
|Drug: A4I Antagonist|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No. of new active MRI lesions; no. of patients with >=1 objective/subjective MS attack; total no. of MS attacks; no. of patients requiring systemic corticosteroids; change from baseline to wk 12 in EDSS |  |  |
Study Evaluating Novel Biomarkers of AKI (Acute Kidney Injury) in Post-operative Patients

Study Overview
=================
Brief Summary
-----------------
To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra abdominal surgery.

Detailed Description
-----------------
A prospective pilot single center study to investigate the potential of [TIMP-2].[IGFBP-7] to predict AKI (Acute Kidney Injury) in patients undergoing major abdominal surgery. The investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on PACU (post anesthesia care unit).The primary endpoint of this study is the development of AKI stage 2 or 3 within the first 72 postoperative hours.

Official Title
-----------------
A PILOT Study Evaluating Novel Biomarkers of AKI in Post-operative Patients Undergoing Major Intra-Abdominal Surgery

Conditions
-----------------
Acute Kidney Injury, Arterial Hypertension, Obesity, Cardio Vascular Disease, Diabetes Mellitus, Chronic Liver Disease, Hypercholesterolemia

Intervention / Treatment
-----------------
* Device: Nephro Check Test
* Other: serum creatinine measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years High risk patients: General Surgery AKI Risk Index Class III, IV or V Major abdominal surgery Exclusion Criteria: Ongoing acute kidney injury Stage 2/3 History of kidney transplant

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nephro Check Test<br>We take urine samples and analyse the level of [TIMP-2]●[IGFBP-7] using the NephroCheck Test to diagnose AKI | Device: Nephro Check Test<br>* Urine sample<br>Other: serum creatinine measurement<br>* Blood sample<br>|
| Active Comparator: serum creatinine measurement<br>This is the Golden standard to diagnose AKI | Device: Nephro Check Test<br>* Urine sample<br>Other: serum creatinine measurement<br>* Blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle KDIGO guidelines |  | 72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who need renal replacement therapy | the need renal replacement therapy wil be evaluated by the nephrologist (acid base disturbances, hypervolemia,...) | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarker, Intra Abdominal Surgery, AKI
Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the safety, efficacy, characteristics of patients, characteristics of physicians and quality of life in patients who are prescribed OZURDEX® as treatment for non-infectious uveitis of the posterior segment of the eye in France.

Official Title
-----------------
Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Conditions
-----------------
Non-infectious Uveitis

Intervention / Treatment
-----------------
* Drug: dexamethasone intravitreal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patient with non-infectious uveitis affecting the posterior segment of the eye. Exclusion Criteria: -Patient not residing in metropolitan France.

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 |
| --- | --- |
| OZURDEX®<br>Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of non-infectious uveitis affecting the posterior segment of the eye. | Drug: dexamethasone intravitreal implant<br>* Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.<br>* Other names: OZURDEX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters |  | 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline |  | Baseline, Months 6 and 18 | 
| Change from Baseline in BCVA |  | Baseline, Months 2, 6 and 18 | 
| Change from Baseline in Vitreous Haze Score Using a 5-Point Scale |  | Baseline and Months 2, 6 and 18 | 
| Change from Baseline in Macular Thickness |  | Baseline, Months 2, 6 and 18 | 
| Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities) |  | 18 Months | 
| Change from Baseline in the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ25) Score Using a 25 Item Questionnaire |  | Baseline, Months 2 and 18 | 
| Number of Repeat Treatments with OZURDEX® and Other Drugs |  | 18 Months | 
| Time Between Repeat Treatments with OZURDEX® and Other Drugs |  | 18 Months | 
| Percentage of Participants with Adverse Events (AEs) |  | 18 Months |