linjc16/ctgov huggingface dataset:
Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate two surgical interventions in patients with AMD.

Detailed Description
-----------------
The Submacular surgical trials have shown that submacular membrane extraction alone did not improve or preserve visual acuity in patients with AMD. Transplantation of autologous RPE and translocation of autologous RPE and choroid represent two promising therapeutic interventions in patients with AMD. This prospective, randomized clinical trial compares the two surgical treatments and additionally compares the clinical results (visual acuity, FLA) with OCT- and UHR-OCT data.

Official Title
-----------------
Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: Transplantation of autologous RPE
* Procedure: Translocation of autologous RPE and Choroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AMD and submacular cnv non responders to laser treatment or pdt treatment: rpe transplantation or rpe + choroid translocation age over 50 years Exclusion Criteria: other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases. optic atrophy unstable glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Procedure: Transplantation of autologous RPE|RPE cell suspension|
|Procedure: Translocation of autologous RPE and Choroid|RPE patch|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity: distance and near |  | preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months | 
| FLA |  | (preoperatively, 3 months, +/- 12 months after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT |  | (preoperatively, 3 months, 12 months after surgery) | 
| UHR OCT |  | (after surgery, including silicone oil removal) | 
| autofluorescence |  | (preoperatively, 3 months, +/- 12 months after surgery) | 
| perimetry |  | (if feasible) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
submacular membrane, transplantation of RPE, translocation of RPE and Choroid
Postural Orientation In The Use Of School Backpacks

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of postural orientation in the use of school backpacks among elementary school students.

Official Title
-----------------
Effects Of Postural Orientation In The Use Of School Backpacks In Elementary School Students

Conditions
-----------------
Backpain, Prevention, Physical Therapy

Intervention / Treatment
-----------------
* Other: Postural Orientation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from seven to ten years of age. Studing in private elementary school.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Postural Orientation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Availability of Poor Quality Embryos

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos

Detailed Description
-----------------
Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are further cultured to different developmental stage and then cryopreserved. The viability of these embryos are tested in frozen-thawed transfer.

Official Title
-----------------
Availability of Poor Quality Embryos in Frozen-thawed Embryo Transfer Cycles

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unfertile women Exclusion Criteria: women older than 40 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| day-3 poor quality embryos<br> | |
| developmental stage<br>day3 poor quality embryos day4 morular day-5/6 blastocyst | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
day-3 poor quality embryo, vitrification, clinical outcome
Symphony IL-6 Reference Range Study

Study Overview
=================
Brief Summary
-----------------
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device. The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.

Official Title
-----------------
Symphony IL-6 Reference Range Study

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is willing and able to provide informed consent > 18 years of age Whole blood specimen collected in EDTA anticoagulant tubes Minimum volume of 100µL for Symphony IL-6 testing Specimen is available for testing within 12 hours from collection C-Reactive Protein (CRP) < 10 mg/L Exclusion Criteria: Subjects presenting with a fever Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection Subjects otherwise self-reported as unhealthy Hemolyzed specimens

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 Reference Range Study | Establishment of the interleukin-6 concentration in whole blood samples from healthy individuals. | Specimen is tested within 12 hours from collection |
Serum Tryptase Levels During Cardiac Surgery, Diagnosis and Treatment Decisions for Allergic Reactions

Study Overview
=================
Brief Summary
-----------------
The investigators aim to assess tryptase test efficacy for measuring the allergic response to protamine during cardiac bypass surgery. Additionally, the investigators aim to establish a differential diagnosis on the basis of potential allergens or clinical causes.

Detailed Description
-----------------
Venous blood samples from cardiac surgery cases will be obtained for tryptase measurement upon admission to the operating room (OR) and immediately prior to and 30 min after protamine infusion initiation. A rapid effect-response-based clinical assessment will be made using clinical and laboratory monitoring data for diagnosis and treatment decisions during protamine infusion, which may complicate the recovery from surgery.

Official Title
-----------------
Investigation of Anaphylactic Reaction in Cases Undergoing Cardiac By-Pass Surgery

Conditions
-----------------
Protamine Allergy, Protamine Adverse Reaction

Intervention / Treatment
-----------------
* Drug: protamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac by-pass cases Exclusion Criteria: Insulin dependent diabetes Atopy Drug allergy history

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

| Intervention/Treatment |
| --- |
|Drug: protamine|Protamine infusion exposures|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients number with high tryptase level (> 25 µg/L ). | Tryptase will be measured using the ImmunoCAP Tryptase kit (Phadia, Uppsala, Sweden), and the cutoff level for elevated tryptase is >11.5 µg/L. A 25 µg/L cutoff value has been found to be highly suggestive of an İmmunoglobulin E (IgE) -mediated reaction. | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients number with allergic reaction involving of 1 or more organ/systems (skin, respiratory, or cardiovascular system) following the study drug infusion. In this study, mainly the cardiovascular and skin symptoms will be focused on. | These outcomes will be determined following the Council for International Organizations of Medical Sciences (CIOMS 1999 and ) definitions for anaphylactic reactions. Additionally, (World Health Organization - Uppsala Monitoring Centre) WHO-UMC system will be used for assesment of causality categories for adverse drug reactions. | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anaphylaxis, cardiac by-pass, protamine, tryptase, hypotension
Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.

Official Title
-----------------
A Multi-center, Randomized, Subject-evaluator Blind, Active Controlled Design Clinical Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Conditions
-----------------
Penile Enhancement

Intervention / Treatment
-----------------
* Device: Potenfill
* Device: Powerfill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects aged above 19 and below 65. (20≤male≥65) be rating himself, when screening, as Small or Very Small on Self-Questioned Questionnaire ( SQQ) including the question:  How do you rate your penile size? // Very small, Small, Normal, Big, Very Big? Subjects will sign an informed consent form Exclusion Criteria: Prior treatment for penile enhancement (e.g. fat, dermal graft). Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention Allergic to hyalluronic acid. Inflammatory or/and infectious disease on penis that can affect on this study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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: Potenfill<br> | Device: Potenfill<br>* Maximum: 22ml<br>|
| Active Comparator: Powerfill<br> | Device: Powerfill<br>* Maximum: 22ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Penile Circumference difference at 24 weeks from baseline | Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement | 24 weeks |
Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.

Official Title
-----------------
Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

Conditions
-----------------
Radiologically Isolated Syndrome (RIS), Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Neurological consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his informed consent and signed the consent form. The patient must be affiliated or beneficiary of a health insurance plan. The patient is at least 18 years old (≥) and under 50 years old (≤). Patients with radiologically isolated syndrome according to the criteria of Okuda et al. (2009) Diagnosis of a radiologically isolated syndrome confirmed by the national expert center of Nice for less than 3 years. Exclusion Criteria: The subject participates in another study. The subject is in an exclusion period determined by a previous study. The subject is under guardianship, curatorship or safeguard of justice. The patient is pregnant or breastfeeding The subject refuses to sign the consent. It is not possible to give the subject informed information. Patient presenting a pathological neurological examination. Patient with visual acuity less than 5/10 or with ocular instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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 |
| --- | --- |
| Experimental: Neurological consultation group<br> | Other: Neurological consultation<br>* study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the occurrence of oculomotor disorders | using a video-oculographic recording system | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder | number | Day 0 | 
| To identify a correlation between oculomotor disorders and MRI abnormalities. |  | Day 0 | 
| To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test) |  | Day 0 |
Study of Energy Expenditure in Infants With Ventricular Septal Defects

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.

Detailed Description
-----------------
PROTOCOL OUTLINE: Height, weight, and vital signs (including oxygen saturation by pulse oximetry) are measured on Day 1. Resting energy expenditure, oxygen consumption (VO2), carbon dioxide production (VCO2), and resting respiratory exchange quotient (RQ) are measured using open circuit respiratory calorimetry on Day 1. Patients undergo assessment of total daily energy expenditure using the doubly labeled water method comprised of oral deuterium and oral oxygen O 18 with the next scheduled feeding on Day 1. Urine samples are collected prior to isotope administration, then serially for approximately 12 hours after isotope administration on Day 1, and then daily on Days 2-7. These samples are analyzed by mass spectrometry. On Day 1, patients also undergo echocardiogram to confirm size of defect and measure the degree of pulmonary/systemic blood flow ratio and pulmonary artery pressures.

Official Title
-----------------
Study of Energy Expenditure in Infants With Ventricular Septal Defects

Conditions
-----------------
Heart Septal Defects, Ventricular

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Infants with moderate to large ventricular septal defect (VSD) by most recent echocardiogram who meet the following conditions: no other concurrent heart or lung disease; no chromosomal defects or congenital anomalies OR Healthy control infants without VSD who meet the following conditions: clinically well; no heart disease; no chromosomal defects or congenital anomalies --Prior/Concurrent Therapy-- Surgery: VSD infants -- No prior cardiac surgery or palliative procedures; VSD and control infants -- Greater than 6 weeks since other prior surgery Other: VSD and control infants: Greater than 6 weeks since prior hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 4 Months

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular and respiratory diseases, heart defects, rare disease
EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.

Detailed Description
-----------------
This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.

Official Title
-----------------
This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation

Conditions
-----------------
Uncontrolled Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is planned to undergo a renal denervation procedure for the treatment of hypertension Subject is ≥18 years of age at time of consent Subject must be able and willing to provide written informed consent Subject must be able and willing to comply with the required follow-up schedule Subject has office Systolic Blood Pressure (SBP) ≥ 140 mmHg Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs Exclusion Criteria: Subject has known significant renovascular abnormalities such as renal artery stenosis > 30% Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts Subject has a history of hemodynamically significant valvular heart disease Subject has blood clotting abnormalities Subject life expectancy is < 12 months, as determined by the Study Investigator Subject is participating in another clinical study which has the potential

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 |
| --- | --- | --- |
| Mean Reduction in Office Systolic Blood Pressure at 6 Months | Positive number indicates a reduction (improvement) in blood pressure | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uncontrolled hypertension, Renal Denervation