linjc16/ctgov huggingface dataset:
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Study Overview
=================
Brief Summary
-----------------
The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.

Official Title
-----------------
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Conditions
-----------------
Macular Hole

Intervention / Treatment
-----------------
* Other: Positioning measuring device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary macular hole Duration less than 24 months Informed consent Exclusion Criteria: Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres) Previous vitreomacular surgery Age under 18 years Unable to sign

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Positioning measuring device<br>The supine time during the first postoperative day is measured | Other: Positioning measuring device<br>* Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular hole closure |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in supine sleeping position |  | 1 day after enrollment |
Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations. If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality. Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.

Official Title
-----------------
Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis

Conditions
-----------------
Patient's With Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Radiation: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult-onset disease. Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis. Exclusion Criteria: Any patient with any collagen disease rather than Rheumatoid arthritis. Patients with joints deformities.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases<br> | Radiation: Ultrasound<br>* Ultrasound examination on the hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of Ultrasound in Rheumatoid Arthritis of the hand | detecting hand ultrasound findings in 30 patients with clinical manifestations suggesting Rheumatoid Arthritis (including synovial thickening, joint effusion, tenosynovitis, bone erosions) particularly in early disease activity, reporting the collected data to assess aspects of strength and weakness of ultrasound use in those patients | 3 months |
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.

Official Title
-----------------
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Device: pessary
* Device: Absorbent pad


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be female 18 years or older; provide written informed consent prior to study participation and been given a signed copy; be in generally good health as determined by the Investigator; have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported); be willing to use the pessary investigational device to control stress urinary incontinence; be willing to comply with study requirements and instructions; Exclusion Criteria: are pregnant, lactating, or planning to become pregnant during the study; within 3 months post partum; intrauterine device (IUD) placement of less than 6 months; has self-reported difficulty emptying her bladder; a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS; experience difficulty inserting or wearing an intra-vaginal device, including a tampon; vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months; has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator and could impact the safety of the subject or the outcome of the study; or for any reason, the Investigator decides that the subject should not participate in the study.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: pad<br>absorbent pad control | Device: Absorbent pad<br> <br> * Other names: placebo comparator;|
| Experimental: pessary<br>disposable, single-use pessary | Device: pessary<br>* disposable, single-use pessary<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent Serious Adverse Event | proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress urinary incontinence, SUI, pessary
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia

Study Overview
=================
Brief Summary
-----------------
The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients

Official Title
-----------------
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia

Conditions
-----------------
Incidence and Severity of Dry Eye After Myopic LASIK

Intervention / Treatment
-----------------
* Procedure: LASIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age ≥ 21 years Normal Pentacam maps Myopia with spherical equation less than 12 D Corneal thickness ≥ 500 Microns Calculated residual stromal bed ≥ 280 microns No signs or symptoms of dry eye. Exclusion Criteria : Keratoconus and forme fruste keratoconus Auto-immune diseases History of dry eye or previous use of tear substitutes Previous ocular surgery Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: LASIK|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dry eye | Schirmer 1 test in millimeters | 6 months | 
| Degree of dryness | Tear break up time in seconds | 6 months |
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)

Study Overview
=================
Brief Summary
-----------------
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise

Official Title
-----------------
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects may be male or female, of an age of 18-55 years inclusive. Subjects must be capable of understanding and providing written informed consent. Subjects must sign a written confidentiality agreement including a photography release form. Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study. Exclusion Criteria: Subjects must not have received or used an Investigational New Drug within the last 30 days. Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor. Subjects must not have a known physical or medical condition that would preclude vigorous exercise Subjects must not have a five-minute resting pulse rate greater than 80 bpm.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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 |
| --- | --- |
| Experimental: Healthy subjects<br>Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams. Subject should sweat profusely. | Drug: BAY987517<br>* Sunscreen formula Y65-158<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent) | The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner | At baseline, and post exercise (30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report of eye stinging assessed by questionnaire | Subjective assessment of eye stinging (where 0=none to 4=severe) | Up to 30 minutes |
Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study.

Study Overview
=================
Brief Summary
-----------------
This study will be a retrospective study in which we will review patients who underwent laparoscopic sleeve gastrectomy at Sohag University Hospital in the period from january 2017 to May 2018.Assessment of outcomes as Effects on weight, Effects on co-morbidities and Post operative complications.

Official Title
-----------------
Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age from 18 to 65 years old body mass index ≥ 35 kg/m2 with comorbidities disease or body mass index ≥ 40 kg/m2, with failure of non operative attempts to lose weight a minimum 2-year follow-up at our outpatient clinic. Exclusion Criteria: secondary causes of obesity (e.g. endocrine diseases) patients unable to participate in medical follow-up; associated comorbidities or diseases impacting on weight loss.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: sleeve gastrectomy|Laparoscopic sleeve gastrectomy gives long-standing improvement or resolution of obesity-related conditions and also survival benefit. It is highly cost-effective. Surgical procedures for the treatment of obesity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on weight reported as percentage of excess weight loss | It is calculated as (initial weight - follow-up weight)/(initial weight - ideal weight corresponding to BMI 25) × 100%. | minimum 2-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
morbid obesity, sleeve gastrectomy, bariatric surgery, weight loss
QEQ Treatment Responsiveness Evaluation Study

Study Overview
=================
Brief Summary
-----------------
The Quality of Erection Questionnaire (QEQ) is a new questionnaire that was developed to assess erectile attributes in men with erectile dysfunction. The study objective is to validate the Quality of Erection Questionnaire (QEQ) through the evaluation of subject responses to the QEQ regarding the quality and hardness of erections at baseline compared to subject responses post 6 and 10 weeks dosing with Viagra (sildenafil citrate).

Official Title
-----------------
An Open-Label, Non-Comparative Study To Evaluate Treatment Responsiveness To The Quality Of Erection Questionnaire (QEQ) In Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: sildenafil citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have documented clinical diagnosis of erectile dysfunction based on a screening SHI-M score of <21 and the subject fulfilling the NIH definition of erectile dysfunction Subjects must be either PDE-5 inhibitor naive; i.e. have never used sildenafil, tadalafil or vardenafil, or have been previously treated with no more than six doses of a PDE-5 inhibitor (sildenafil, tadalafil, vardenafil) and must have taken their last dose no less than 4 weeks prior to the screening visit Exclusion Criteria: Subjects who are currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sildenafil citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 6 of the QEQ total score |  |  | 
| Change from baseline to week 6 in the 5 IIEF domain scores |  |  | 
| Change from baseline in scores of QEQ individual question |  |  |
The Protein (Meat) and Function Study

Study Overview
=================
Brief Summary
-----------------
The aim of the proposed study is to investigate the effects of different amounts of protein intake primarily from meat on muscle function, immune response, mental function, proteomics, biochemical regulators of protein metabolism, energy expenditure, and composition in young healthy males.

Official Title
-----------------
Effect of Normal Versus High Amounts of Protein Intake on Physiological Functions and Proteomics in Healthy Men

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

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, 19-40 y/o Exclusion Criteria: Smokers

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Dietary Supplement: Placebo<br>* Placebo<br>|
| Experimental: 2<br> | Dietary Supplement: Protein<br>* 30 E% from protein<br>|

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
-----------------
Protein Function, normal versus high protein intake
The Specific Elastance in ARDS Patients: a Pediatric Study

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to assess lung specific elastance in a population of pediatric patients with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a pediatric population of ICU patients with healthy lung which are treated with mechanical ventilation for other clinical purposes.

Official Title
-----------------
The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study

Conditions
-----------------
Pediatric ARDS

Intervention / Treatment
-----------------
* Other: Lung specific elastance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS (Berlin Definition Criteria) or mechanical ventilation in healthy lungs Exclusion Criteria: Hemodynamic instability Lung diseases other than ARDS Parental refuse

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- |
| ARDS<br>Patients with ARDS (according to the Berlin Definition criteria) in mechanical ventilation | Other: Lung specific elastance<br>* Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes<br>|
| Healthy control<br>Patients with healthy lung supported with mechanical ventilation for clinical purposes | Other: Lung specific elastance<br>* Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific elastance of the lung |  | 10 minutes from the start of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Lung, Specific Elastance, Pediatric patients
Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.

Official Title
-----------------
Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy

Conditions
-----------------
Emergence Deliruim; Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II. Exclusion Criteria: Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%. | |
| Experimental: Group D<br>Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9% | Drug: dexmedetomidine<br>* dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pediatric anesthesia emergence delirium (PAED) scale |  | during stay in postanesthesia care unit | 
| Heart rate |  | during surgical procedures | 
| systolic blood pressure |  | during surgical procedures | 
| diastolic blood pressure |  | during surgical procedures | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children