linjc16/ctgov huggingface dataset:
Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children

Study Overview
=================
Brief Summary
-----------------
Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic Stable Intramedullary Nailing. The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and Patients'satisfaction (CSS-8). Further on, all complications and problems will be documented.

Official Title
-----------------
Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children and Adolescents: Lessons Learned From the First 20 Patients

Conditions
-----------------
Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only Dislocated Shaft Fractures or Pseudarthrosis after Conservative Treatment of Dislocated CSF in Children and Adolescents Treated with Elastic Stable Intramedullary Nailing Exclusion Criteria: Age > 17 years Pathologic fractures Lateral or Medial Fractures of the Clavicle

Ages Eligible for Study
-----------------
Maximum Age: 17 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
-----------------
ESIN, Clavicular Fracture, Dislocation, Children, Adolescents
Diagnosis of Occult Hip Fractures With Ultrasound

Study Overview
=================
Brief Summary
-----------------
occult hip fractures present to the emergency room with a history of trauma,a painful hip and normal X-ray. these patients usually undergo other imaging modalities such as CT scans, MRI, or bone scans. In this study we check the sensitivity and specificity of a directed ultrasound examination of the hip joint in diagnosing or excluding a hip fracture. We also compare the results of ultrasound examination by the orthopedic surgeon in the emergency room versus the consultant radiologist. The patients undergo bone scans or CT to make the diagnosis.

Conditions
-----------------
Hip Fractures, Occult Fractures

Intervention / Treatment
-----------------
* Procedure: ultrasound examination of the hip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over age of 50 with clinical suspicion of a hip fracture Exclusion Criteria: previous fracture or surgical intervention in the hip pregnancy flexion contracture of hip

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ultrasound examination of the hip|nan|

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
-----------------
hip, fracture, occult
Prevalence of Chronic Kidney Disease in Tunisian Diabetics

Study Overview
=================
Brief Summary
-----------------
In Tunisia, diabetes is a serious public health problem, its prevalence reaches 22.9% of people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic kidney disease is the most common and severe complication of diabetes. It is both a major cause of end-stage renal disease and a risk factor for mortality and cardiovascular morbidity, thus becoming an additional public health concern. Early diagnosis of diabetic kidney disease makes it possible to manage patients more effectively and in a multidisciplinary way, to delay its progression to chronic renal failure.

Detailed Description
-----------------
In Tunisia, little data exist concerning the epidemiology of chronic kidney disease in diabetics. It is then relevant to assess the incidence of chronic kidney disease among the Tunisian diabetic population. The study is an observational, multicentric, cross-sectional, and national project. The study will be carried out for one month at medical departments and ambulatory clinics of general physicians, family medicine specialists, endocrinologists, specialists in nutrition and metabolic diseases, nephrologists, internal medicine physicians, cardiologists, or any healthcare providers in charge of diabetic patients. A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Official Title
-----------------
Prevalence of Chronic Kidney Disease in Tunisian Diabetics

Conditions
-----------------
Chronic Kidney Diseases, Diabetes Mellitus, Diabetes Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Diabetes Type 1 or Type 2 Follow-up at the consultation for at least more than 3 months Informed consent of the patient Exclusion Criteria: Kidney transplant Chronic dialysis

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 |
| --- | --- | --- |
| Prevalence of chronic kidney disease | Frequency of diabetic subjects with chronic kidney disease | At inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Diabetes, Survey
A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.

Official Title
-----------------
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: diquafosol tetrasodium (INS365) ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity of at least +0.7 ETDRS Six month history of dry eye disease Mild severity in two out of five symptoms Unanesthetized Schirmer score of less than or equal to 7mm Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18 Exclusion Criteria: Nasal stimulated Schirmer score of less than 3mm Have ongoing ocular infection Have congenitally absent meibomian or lacrimal glands Have had punctal occlusion within a specified time prior to study Wear contact lens and refuse to remove them Have other excluded eye conditions.

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: diquafosol tetrasodium (INS365) ophthalmic solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer scores |  |  | 
| Corneal staining |  |  | 
| Conjunctival staining |  |  | 
| Tear break-up time |  |  | 
| Change in artificial tear usage |  |  | 
| Patient-reported improvement of foreign body sensation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| Investigator global severity assessment |  |  | 
| Patient-reported dry eye symptoms other than foreign body sensation |  |  | 
| Biomicroscopy |  |  | 
| Ophthalmoscopy |  |  | 
| IOP |  |  |
Prospective Evaluation of Safety and Efficacy of Two Forms of Corneal Stromal Hydration

Study Overview
=================
Brief Summary
-----------------
The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.

Official Title
-----------------
A Prospective Evaluation of the Safety and Efficacy of Two Forms of Corneal Stromal Hydration

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: wound hydration method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visually significant cataract requiring surgery Exclusion Criteria: Evidence of Fuch's dystrophy, anterior basement membrane dystrophy, or corneal thinning or scarring Any intraoperative complications Cataract incision length < 1 mm Pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Anterior stromal hydration (Wong method) | Procedure: wound hydration method<br>* Anterior vs lateral wound hydration<br>|
| Active Comparator: 2<br>Traditional lateral wound hydration | Procedure: wound hydration method<br>* Anterior vs lateral wound hydration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eyes with wound leakage at the end of surgery |  | Intraoperative |
Evaluation of the Repeated Usage of Systane Ultra Eyedrop

Study Overview
=================
Brief Summary
-----------------
Comparison of two contact lens solutions.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane Ultra
* Other: Optive lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or more. Non contact lens wearer. Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire: Score ≥13 for OSDI Questionnaire total score; AND Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire Best visual acuity of 6/9 or better in each eye. Willingness to adhere to the instructions set in the clinical protocol. Signature of the subject informed consent form. Exclusion Criteria: Use of systemic medication which might produce dry eye side effects. Systemic disease which might produce dry eye side effects. Active ocular infection. Use of ocular medication. Significant ocular anomaly. Previous ocular surgery Previous use of Restasis Any medical condition that might be prejudicial to the study. The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment. The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus). The subject, based on their knowledge, must NOT have diabetes.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Ultra<br>Systane Ultra Lubricant Eye Drops | Other: Systane Ultra<br>* Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks<br>|
| Active Comparator: Optive<br>Optive Lubricant Eye Drops | Other: Optive lubricant Eye Drops<br>* Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in objective vision |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of tear film evaporation |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, Visual Performance
Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.

Detailed Description
-----------------
We have previously developed and tested in a treatment population a promising MET program for alcohol and drug use. We will broaden the MET intervention to also target tobacco use and convert the new materials into a self-administered format.

Official Title
-----------------
Dental and Medical Office Internet/Intranet Motivational Enhancement Therapy to Reduce Teen Tobacco, Alcohol, and Drug Use

Conditions
-----------------
Use; Tobacco, Harmful, Alcohol Abuse, Drug Abuse

Intervention / Treatment
-----------------
* Behavioral: iMET
* Behavioral: iMET/TE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-21 years old Coming for routine care Exclusion Criteria: Medically or emotionally unstable day of visit Already receiving behavioral health services Cannot read/understand English Will not be available for post-tests

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 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 |
| --- | --- |
| No Intervention: Treatment as usual<br>Participants will receive treatment as usual from their provider. | |
| Experimental: iMET<br>Participants will receive the iMET intervention. | Behavioral: iMET<br>* Participants will receive the iMET intervention<br>|
| Experimental: iMET/TE<br>Participants will receive the iMET intervention and Technological Extenders (TEs). | Behavioral: iMET/TE<br>* Participants will receive the iMET intervention and also receive TEs (Technological Extenders)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of tobacco, alcohol, marijuana, and other drug use |  | 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of initiation and cessation of tobacco, alcohol, marijuana and other drug use |  | 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol abuse, marijuana abuse, drug abuse, tobacco use, tobacco dependence
Validation ( Endometriosis Health Profile) EHP-30 (Turkish Version) for Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
Endometriosis can affect quality of life, including physical, psychological and social aspects. It is important to include quality of life measures in evaluating disease severity and response to any given treatment. The 30-item Endometriosis Health Profile (EHP-30) from in-depth interviews with patients with endometriosis is currently the most reliable questionnaire for the measurement of health-related quality of life in women with endometriosis. It includes specific questions addressing the problems faced by patients with endometriosis. The aim of the present study is to validate the Turkish version of EPH 30, a self reported questionnaiere already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.

Official Title
-----------------
Validation ( Endometriosis Health Profile) EHP-30 (Turkish Version) for Patients With Endometriosis

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

Intervention / Treatment
-----------------
* Other: The Endometriosis Health Profile EPH-30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous surgical and histological diagnosis of endometriosis Exclusion Criteria: Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological) Psychiatric diseases Refusal or inability to sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The Endometriosis Health Profile EPH-30|Self-reported questionnaires|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Endometriosis health profile-30 (EHP-30) Turkish version | internal consistency and construct validity | baseline |
CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation

Study Overview
=================
Brief Summary
-----------------
CTEPH-SOLUTION aims to create a risk score for the early detection of Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH) among patients with previous pulmonary embolism. The risk score, created on retrospective data, will be validated on newly diagnosed pulmonary embolism patients.

Detailed Description
-----------------
CTEPH-SOLUTION is a multicenter observational cross-sectional and prospective study in patients with a prior and new diagnosis of pulmonary embolism. Patients with prior pulmonary embolism will be screened at baseline with doppler echocardiography: an estimated sPAP ≥ 40 mmHg will be the indication for pulmonary hypertension detection. After 24 months from baseline, patients will be followed-up for CTEPH detection. CTEPH diagnosis will be carried out according to the current ESC/ERS guidelines. Incident (pulmonary embolism episode at least three months before the baseline) and prevalent (pulmonary embolism episode) patients will be enrolled.

Official Title
-----------------
Evidence-based Detection of CTEPH in Patients With Prior Pulmonary Embolism: Risk Score Evaluation and Validation.

Conditions
-----------------
Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 at baseline evaluation Diagnosis of prior (> 30 days from pulmonary embolism onset) or new-onset pulmonary embolism, according to the ESC guidelines on the diagnosis and management of acute pulmonary embolism Exclusion Criteria: patients without pulmonary embolism diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| CTEPH-SOLUTION score | The CTEPH-SOLUTION score will be created on retrospective parameters (i.e., demographic data, diagnostic and clinical information, risk factors, laboratories parameters) collected on pulmonary embolism patients. The minimum and maximum values will be defined after the multivariate statistical analysis, and the risk factors analyzed a posteriori. Higher scores mean a worse outcome. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of the subject with a diagnosis of CTEPH on the total number of subjects enrolled. |  | 24 months |