linjc16/ctgov huggingface dataset:
Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multicenter, single-arm observational study to evaluate the efficacy and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform, saccular or dissecting), ruptured or not ruptured.

Official Title
-----------------
Evaluation of the LEO + Stent in the Endovascular Treatment of Wide Neck Intracranial Aneurysms (Fusiform, Saccular or Dissecting), Ruptured or Not Ruptured: Cohort of the Self-expanding Intracranial Stent LEO

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: LEO +


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent Patients (or their parents for minors) must be informed and give written consent Exclusion Criteria: Patients (or parents) who refused to give consent.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LEO +|LEO +: self-expanding intracranial stent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total aneurysmal occlusion rate | Classification of the occlusion observed angiographically as complete occlusion, residual neck or residual aneurysm using the Montreal three-grade scale | 18 months | 
| Morbi-mortality | Number of complications and/or device or procedure related adverse events | 18 months |
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the safety and efficacy of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery.

Official Title
-----------------
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery

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

Intervention / Treatment
-----------------
* Drug: adrenalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female can read and sign informed consent form； Clinical diagnosis of cataract Cataract density grade II-III according to the Emery-Little system classification system Exclusion Criteria: sensitivity to adrenalin； sensitivity to topical mydriatics； any other ocular surgeries； iris abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group,control group<br>Intraocular adrenalin,topical mydriatics, experimental group: Intervention: Procedure:refractive cataract surgery with Intraocular adrenalin, control group:refractive cataract surgery with topical mydriatics | Drug: adrenalin<br>* adrenalin 0.01%<br>* Other names: adrenaline hydrochloride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil size after intracameral adrenaline | We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01% | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial cell count | we would like to evaluate the endothelial cell count 1 month after surgery | 1month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract
Health Effects of Commuter Cycling

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome.

Detailed Description
-----------------
Physical activity plays a crucial role in relation to prevent a clustering of risk factors. In adults a lower all-cause mortality has been found in those cycling to work compared to inactive commuters. It thus seems possible that cycling to school will entail health beneficial effects for children.

Official Title
-----------------
Health Effects of Commuter Cycling

Conditions
-----------------
Prevention

Intervention / Treatment
-----------------
* Behavioral: Cycling to school


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: passive commuted to school last 6 months, own a bike Exclusion Criteria: less than 2 km to school

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: Cycling to school<br> | Behavioral: Cycling to school<br>* Regular cycling to school<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitness | Difference in VO2max determined by use of a metabolic cart | Day 0, Day 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome | Metabolic syndrome as defined by the international diabetes federation based upon: obesity(from age and gender adjusted BMI),TG,HDL,blood pressure,glucose (fasting) | Day 0, Day 120 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
commuter cycling, fitness, metabolic syndrome, children
The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation.

Conditions
-----------------
Urinary Tract Infection, Bacteriuria, Renal Transplantation

Intervention / Treatment
-----------------
* Other: antimicrobial treatment according to in-vitro susceptibility


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are ≥1 month and ≤ 12 months after renal transplantation. Positive urine culture defined as ≥ 105 colony forming units (CFU) per milliliter of a known single pathogen. Exclusion Criteria: Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney Active infections in another site Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl) Elevation of serum creatinine of more than 15% of its baseline level Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization Pregnant or lactating women. Candidates to invasive urologic procedures. Inability to return for regular follow up. Previous enrollment in this study. Patients who incapable of giving informed consent.

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no therapy<br> | |
| Active Comparator: antimicrobial treatment according to in-vitro susceptibility<br> | Other: antimicrobial treatment according to in-vitro susceptibility<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of symptomatic urinary tract infection |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25% reduction in estimated glomerular filtration rate (eGFR) |  | 1 year |
Fracture of Distal Radius and Ulna Healed With Shortening of One Bone. Clinical Significance at Skeletal Maturity

Study Overview
=================
Brief Summary
-----------------
The fractures of distal forearm are the most common trauma in children. Sometimes one of the bones becomes shortened as a result of fracture fragments overlap. When some amount of shortening exists, concern regarding relationship of distal radio-ulnar joint (DRUJ) arises. The common opinion is expressed in one of the textbooks and is represented by one sentence, which usually one bone shortening is well tolerated, probably does not cause a problem, and does not have clinical significance. However, pathology of ulna plus or minus variants is well described and may cause ulno-carpal abutting syndrome or radiocarpal pain. This concern may lead to more aggressive approach in treatment of a fracture, with attempts to make an equal bone length. We did not find in the literature study that investigates this problem. We postulate that obvious shortening of one bone may cause an inequality of DRUJ and can be clinically significant.

Detailed Description
-----------------
We will evaluate the x-ray films of children that at the time of the injury were between the ages 1 day and 12 years. The selection of the x-ray films will be done based on the specific codes of the wrist x-rays (Ulna or Radius). The evaluation will be merely to children that were treated in our hospital from 1996 to 2000.We are aiming to find cases when the fractures were healed with 1cm or more of shortening of one of the forearm's bones (Radius or Ulna). We are going to compare these cases with another 20 patients with the same characteristics as the latter groups on the exception that their fractures were healed without shortening. The two groups will be matched by age, gender and the same diagnosis. These patients will be summoned to the clinic when they are adult in respect to the skeletal maturity. The patients will be evaluated, including clinical examination of the hand wrists (left and right), motion rang, motor muscle function, description of abnormalities if there are and x-ray of both wrists.

Official Title
-----------------
Fracture of Distal Radius and Ulna Healed With Shortening of One Bone. Clinical Significance at Skeletal Maturity

Conditions
-----------------
Forearm Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children that had had Ulna or Radius X-rays Signing Informed consent. Exclusion Criteria: - Unwillingness to sign informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 18 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FRACTURE OF DISTAL RADIUS
Ergocalciferol in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in patients with CKD stage 3 and 4

Official Title
-----------------
The Effect of Ergocalciferol Treatment on 25-Hydroxyvitamin D Levels and Plasma Intact PTH in Patients With Chronic Kidney Disease Stage 3 and 4

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with CKD stage 3 or 4 whose 25-hydroxyvitamin D levels are below 30 ng/ml and plasma intact PTH levels >70 pg/ml. Exclusion Criteria: Patients who are on any form of active vitamin treatment

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?
-----------------
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
-----------------
ergocalciferol, chronic kidney disease, secondary hyperparathyroidism, vitamin D deficiency
Umblical Incision for Neonatal Surgery

Study Overview
=================
Brief Summary
-----------------
Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can solve the problem to some extent by making a smaller scar but takes more time and need special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy and avoid the drawbacks of both.

Detailed Description
-----------------
six cases were subjected to the study 2 cases have duodenal atresia, one case has annular pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of malrotation. all of them had made exploration by the umbilical incision, and no drains had been used.

Official Title
-----------------
Umblical Incision for Neonatal Surgey; is it Suitable

Conditions
-----------------
Neonatal Surgery

Intervention / Treatment
-----------------
* Procedure: umbilical incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonate diagnosed radiologically Exclusion Criteria: unclear diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 20 Hours
Maximum Age: 20 Days

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: umbilical incision<br>neonates undergone surgery by umbilical incision | Procedure: umbilical incision<br>* exploration through umbilical incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | how long the peration does take | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmotic appearance | shape of the wound | 2 weeks |
The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood glucose after a subsequent meal. This phenomenon occurs in normal subjects while it is not clear whether it is also observed in type 2 diabetic patients. This study aims to define whether the second-meal phenomenon occurs in type 2 diabetic patients. We will also seek for the mechanism.

Official Title
-----------------
The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 35-70 HbA1c 6-8% DM duration less than 5 yrs Exclusion Criteria: type 1 DM, secondary DM, gestational DM patients using insulin, TZDs patients using corticosteroid, herb medication or other medications affecting glucose tolerance renal dysfunction (Cr > 1.5mg/dL) hepatic dysfunction (LFT > x 3UNL) anemia (Hg < 10g/dL) ischemic heart disease, congestive heart failure severe diabetic complication (CRF, CVA, PDR, gastroparesis) infectious disease malignancy pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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 |
| --- | --- |
| study A<br>post-breakfast meal tolerance test + post-lunch meal tolerance test | |
| study B<br>fasting + post-lunch meal tolerance test | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of plasma glucose after meal | Compare the post-lunch AUC of glucose between two meal tolerance tests(one after having breakfast, one after not having breakfast) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mechanism of second-meal phenomenon | serum FFA, plasma insulin, C-peptide, incretin concentration will be measured | 3 months |
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

Study Overview
=================
Brief Summary
-----------------
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Detailed Description
-----------------
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.

Official Title
-----------------
A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

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

Intervention / Treatment
-----------------
* Drug: Dextenza
* Drug: Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric cataract diagnosis Subject is >0 - 3 years of age Exclusion Criteria: Any intraocular inflammation in the study eye Ocular hypertension or glaucoma Evidence of acute external ocular infections

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 3 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextenza<br>1 dosing group - Approximately 30 subjects treated with Dextenza | Drug: Dextenza<br>* Dextenza, dexamethasone ophthalmic insert<br>|
| Active Comparator: Prednisolone<br>1 dosing group - Approximately 30 subjects treated with Prednisolone | Drug: Prednisolone<br>* Prednisolone, acetate ophthalmic suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of pain | FLACC score of '0' (Face, Legs, Activity, Cry, Consolability) | 8 days post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dextenza, dexamethasone ophthalmic insert
Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to develop and characterize in situ thermosensitive gels for the vaginal administration of sildenafil as a potential treatment of the endometrial thinning that occurs as a result of the use of clomiphene citrate in induction of ovulation in women with World Health Organization type II EU gonadotrophic anovulation.

Official Title
-----------------
Development and Clinical Evaluation of Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate on the Endometrium of Women Use Clomiphene Citrate for Induction of Ovulation

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

Intervention / Treatment
-----------------
* Drug: preparation F12 sildenafil in situ gel
* Drug: preparation F2 sildenafil in situ gel
* Drug: placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with polycystic ovaries Exclusion Criteria: women with other causes of infertility

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preparation F12 sildenafil in-situ gel group<br>women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + preparation F12 sildenafil gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator (25 mg) per dose | Drug: preparation F12 sildenafil in situ gel<br>* in situ vaginal gel<br>|
| Active Comparator: preparation F2 sildenafil in-situ gel group<br>women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + preparation F2 sildenafil gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator (25 mg) per dose | Drug: preparation F2 sildenafil in situ gel<br>* in situ vaginal gel<br>|
| Placebo Comparator: placebo gel group<br>women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + placebo gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator | Drug: placebo gel<br>* vaginal gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Doppler resistance index after the treatment |  | 10 days |