linjc16/ctgov huggingface dataset:
A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in POAG or Ocular Hypertension Patients

Study Overview
=================
Brief Summary
-----------------
TJO-002 or Acitve Control was administered on primary open-angle glaucoma or ocular hypertension patients for 12 weeks. This clinical trial study has hypothesize TJO-002 administration groups are not inferior to Active control administration groups.

Official Title
-----------------
A Multi-center, Randomized,Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in Primary Open Angle Glaucoma or Ocular Hypertension Patients

Conditions
-----------------
Primary Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: TJO-002
* Drug: Latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 19 or over Written informed consent to participate in the trial Exclusion Criteria: Any other Galucoma except POAG(ex, Closed anterior chamber angle, angle-closure glaucoma) Any laser or ocular surgery within 3months prior screening Use of contact lenses Known reactive airways disease Any condition limiting patient's ability to participate in the trial

Ages Eligible for Study
-----------------
Minimum Age: 19 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: TJO-002<br> | Drug: TJO-002<br>* Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye<br>|
| Active Comparator: latanoprost<br> | Drug: Latanoprost<br>* Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in diurnal IOP at Week 12 | After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on reducing diurnal IOP. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in diurnal IOP at Week 8 | After 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on reducing diurnal IOP. | Baseline and Week 8 |
Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique

Study Overview
=================
Brief Summary
-----------------
patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks .

Official Title
-----------------
Evaluation of Minimally Invasive Alveolar Augmentation Procedure of Anterior Maxillary Ridge Using Tunneling Surgical Technique

Conditions
-----------------
Bone Atrophy

Intervention / Treatment
-----------------
* Other: tunneling surgical technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients' age range from 18-60 years. Patients with horizontal bone defect in anterior maxillary area. Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome. Exclusion Criteria: • Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: tunneling surgical technique<br> | Other: tunneling surgical technique<br>* sticky bone prepared by centrifuge patient blood and mixing with xinograft<br>* Other names: mpm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone formation | bone formation assessed by cone beam ct | 14 weeks |
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice

Study Overview
=================
Brief Summary
-----------------
Acute uncomplicated bacterial cystitis is common in general practice. Cystitis is at the second raw of antibiotic treatment indications. It has been now recommended not to perform any urine culture for more than 20 years; hence, the bacterial epidemiology of acute uncomplicated cystitis is surprisingly relatively unknown. The available bacteriological data mainly describe the epidemiology of complicated urinary tract infections or upper urinary tract infections, but the causative bacteria and the resistance rates might differ from those of uncomplicated cystitis. As an example, it is unknown to what extent Staphylococcus saprophyticus is the causative agent of uncomplicated cystitis. Moreover, the urine dipstick test have been evaluated in laboratories. But their interpretation in current practice might not be so easy: in particular, the nitrite detection depends on the bacterial concentration. The nitrite detection, produced in enterobacteriaceae related infections might have therapeutical consequences: trométamol-fosfomycine is almost constantly active on enterobacteriaceae, but ineffective on staphylococci. Knowing the increasing prevalence of fluoroquinolone-resistant enterobacteriaceae, the use of fosfomycin in nitrite positive uncomplicated cystitis might preserve the susceptibility of fluoroquinolones during pyelonephritis. This study will describe: the bacterial epidemiology of acute uncomplicated cystitis in general practice, the correlation in between urine dipstick and urine culture in general practice, the prediction of enterobacterial infection by the nitrite detection, AND the antibiotics prescribed by the practitioners for uncomplicated acute cystitis.

Official Title
-----------------
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test

Conditions
-----------------
Acute Uncomplicated Bacterial Cystitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female >18 years old urinary symptoms Exclusion Criteria: fever lumbar pain co-morbidities

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 |
| --- | --- | --- |
| Bacterial epidemiology of acute uncomplicated cystitis |  | march 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of urine dipstick tests and urine culture results |  | march 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary tract infection, cystitis
Body Image Therapy in Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test a new procedure of body image therapy in anorexia nervosa, using the anamorphic micro software.

Detailed Description
-----------------
Anorexia nervosa is a severe psychiatric disorder, with high level of mortality and hospitalization is often necessary for the treatment of severe and/or chronic cases. Anorexic patients often experience a serious disturbance in body and their own shape perception. Body image work should be enhanced in the treatment of anorexia nervosa. The aim of the study is to test a new body image therapy using the anamorphic Micro software. Ten sessions of assessment of the patient's own shape and of correction of distorted perceptions of body size with Anamorphic Micro software will be compared to ten sessions of body image therapy as usual. French 100 anorexia women hospitalized in a specialized Eating Disorder Unit will participate to the study, randomized in 2 arms : Body image therapy with Anamorphic Micro software Body image therapy as usual

Official Title
-----------------
Body Image Therapy in Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa

Intervention / Treatment
-----------------
* Behavioral: Anamorphic Micro software
* Behavioral: therapy as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman more than 18 years old anorexia nervosa hospitalized in the CMME (CHSA) TCA Unit Body Mass Index ≥ 16 Informed consent Exclusion Criteria: pregnancy severe motor, sensitive or sensorial impairment no affiliation of national health service dependent of a trusteeship or guardianship

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 |
| --- | --- |
| Experimental: Interventional arm<br>Body image therapy with Anamorphic Micro software | Behavioral: Anamorphic Micro software<br>* Body image therapy with Anamorphic Micro software<br>|
| Active Comparator: control arm<br>Body image therapy as usual | Behavioral: therapy as usual<br>* Body image therapy as usual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Shape Questionnaire | Body Shape Questionnaire Score after the 10 sessions of body image therapy | after the 10 sessions of body image therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anorexia nervosa, CMME-TCA Unit, Centre Hospitalier Sainte Anne
Analysis of the Inner Diameter of the Distal Radial Artery and the Influencing Factors in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
Cardiovascular intervention via distal radial artery (DRA) approach has become more and more extensive. However, the DRA is smaller than conventional radial artery (CRA). Assessing the size of the DRA before vascular intervention is extremely important to select suitable patients. There are still few large-sample studies to evaluate the size of DRA and its influencing factors in the Chinese population.

Detailed Description
-----------------
In recent years, the clinical application of distal radial artery (DRA) approach in cardiovascular intervention has become more and more extensive. However, compared with CRA, the DRA is smaller, resulting in an increased proportion of patients requiring multiple punctures and a lower success rate of implantation. It has been found that the mismatch between artery sheath and vessel size is one of the independent risk factors for postoperative vascular approach complications. Therefore, assessing the size of the DRA before vascular intervention is extremely important to select suitable patients, improve the success rate of puncture, and reduce the complications associated with the approach There are still few large-sample studies to evaluate the size of DRA and its influencing factors in the Chinese population.

Official Title
-----------------
Analysis of the Inner Diameter of the Distal Radial Artery and the Influencing Factors in Chinese Patients

Conditions
-----------------
Distal Radial Artery

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who is prepare for coronary angiography Exclusion Criteria: Lack of upper limbs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasound|Using ultrasound to measure the diameter of distal radial artery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of distal radial artery | Measure the diameter of distal radial artery in anatomic snuffbox by ultrasound | 24 hours before coronary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of conventional radial artery | Measure the diameter of conventional radial artery by ultrasound | 24 hours before coronary intervention | 
| Diameter of ulnar artery | Measure the diameter of ulnar artery by ultrasound | 24 hours before coronary intervention |
Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase.

Official Title
-----------------
A Phase IV, Multicenter, Randomized, Open Label Study To Evaluate The Efficacy And Safety Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes mellitus LDL-C > 130 mg/dL Exclusion Criteria: Insulin therapy Clinically relevant organ disease (creatininemia >2mg/dL, CHF NYHA III and IV)

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atorvastatin|nan|
|Drug: Simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the decrease of LDL-C after 24 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the changes from baseline of targeted blood markers. |  |  | 
| To evaluate safety of Atorvastatin vs Simvastatin |  |  |
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy

Study Overview
=================
Brief Summary
-----------------
Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter monitor.

Official Title
-----------------
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy: The Index of MicrovAscular Resistance (IMR)

Conditions
-----------------
Hypertrophic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 Already have an indication for coronary angiography Previous diagnosis of hypertrophic cardiomyopathy (unless control) Exclusion Criteria: Fractional flow reserve found to be significant (FFR < 0.8) Already have a condition associated with or likely to be associated with an elevated IMR (diabetes, cardiac syndrome X, takotsubo cardiomyopathy, hypertensive cardiomyopathy, severe aortic stenosis, STEMI)

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypertrophic cardiomyopathy<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventricular tachycardia | Measured during 48 h recording after 6 months | 6 months | 
| Chest pain - Canadian Cardiovascular Society (CCS) class |  | Up to 6 months | 
| Shortness of breath - NYHA class |  | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Index of Microvascular Resistance, Microvascular dysfunction
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm

Study Overview
=================
Brief Summary
-----------------
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.

Official Title
-----------------
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial

Conditions
-----------------
Prematurity; Extreme

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D supplementation
* Other: No additional vitamin D supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age of 28 weeks or less Exclusion Criteria: Major congenital anomalies and infants Terminal illness in whom decisions to withhold or limit life support have been made

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 4 Days

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: Vitamin D group<br> | Dietary Supplement: Vitamin D supplementation<br>* Study participants assigned to the intervention group will receive 800 IU/ day of vitamin D plus 200-300 IU/day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.<br>|
| Placebo Comparator: Control group<br> | Other: No additional vitamin D supplementation<br>* Study participants assigned to the control group will receive 200-300 IU/ day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of respiratory morbidity | A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen | 0 - 120 days | 
| Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics | Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX) | 40 - 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonary dysplasia | Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge | 36 weeks PMA or discharge |
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

Study Overview
=================
Brief Summary
-----------------
There is no study hypothesis. The purpose of this study is to compare the accuracy of the: 1) SpHb (Radical 7 Pulse Co-Oximetry with SpHb™) RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery.

Detailed Description
-----------------
The purpose of this study is to compare the accuracy of the: 1) SpHb RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery. The results from the three sensors will be compared to a blood hemoglobin level taken intermittently (as a function of the patient's anesthesia care) and analyzed in the UCSF Clinical Laboratories. This is an observational study.

Official Title
-----------------
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring.

Conditions
-----------------
Blood Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age ASA Classification 1, 2 or 3 Scheduled to undergo spine surgery Exclusion Criteria: Pregnant of nursing In the investigator's judgement would not be suitable for research

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 |
| --- | --- |
| RevF vs RevG vs Pronto-7<br>Comparison of hemoglobin levels derived by continuous hemoglobin sensor RevF versus continuous hemoglobin sensor RevG versus an intermittent hemoglobin level derived from the Pronto-7 hand-held device versus a hemoglobin derived from a blood sample. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample. A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery. | Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample. A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery. | Two or more measurements during surgery |