linjc16/ctgov huggingface dataset:
Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs) after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the prevention of pseudophakic cystic macular lesions

Detailed Description
-----------------
344 Patients undergoing uncomplicated standard phacoemulsification at Kyungpook National University Hospital from 2013 to 2015 were reviewed. CMLs, which is any cystic fluid collections after cataract surgery, were confirmed by preoperative and postoperative optical coherence tomography(OCT) on preoperative, postoperative 1month and 3months examinations. CMLs were classified into two groups: cystic macular edema(CME) and microcystic macular edema(MME).

Official Title
-----------------
Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

Conditions
-----------------
Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

Intervention / Treatment
-----------------
* Drug: topical bromfenac sodium hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015. Exclusion Criteria: patients had complicated cataract surgery (eg, significant corneal edema, posterior capsule rupture, vitreous loss, dropped nuclear material, retained cortical material, or an IOL not placed in the capsular bag)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with topical NSAID<br>197 eyes of - patients were treated with topical bromfenac sodium hydrate (Bronuck®, Taejoon Pharm. LTD.) 2times a day starting 1 day before surgery and continued for 2 weeks after surgery. | Drug: topical bromfenac sodium hydrate<br> <br> |
| Treated without topical NSAID<br>147 eyes did not receive topical NSAID after cataract surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CMLs |  | 12 weeks |
Study in Chronic Kidney Disease (CKD) Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.

Official Title
-----------------
Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lanthanum Carbonate 750 to 2250 mg in Patients With Chronic Kidney Disease Not on Dialysis Who Develop Hyperphosphatemia

Conditions
-----------------
Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged 20 years or above at the time of informed consent Chronic Kidney Disease patients with Epidermal growth factor receptor (eGFR) under 60 ml/min/1.73m2 (stage 3, 4 and 5) who have not been on dialysis Patients who had been in the care of a physician for Chronic Kidney Disease for >2 months and was not expected to begin dialysis for at least 4 months Patients with serum phosphate levels 5.6 mg/dL to 11.0 mg/dL at Week -4 (Visit 1) or Week -2 (Visit 2) Exclusion Criteria: Patients with hypocalcemia or hypercalcemia (corrected serum calcium level of < 7.0 mg/dL or >/- 11.0 mg/dL) at Week -2 (Visit 2). Significant renal impairments Had acute renal failure within 3 months of Run-in period

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)<br>* Daily dose: 750-2250mg 3 times a dayfor 8 weeks.<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* daily dose: 3 tablets TID for 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in serum phosphate concentrations |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of target serum phosphate level (2.7 to 4.6 mg/dL) |  | Week 0, Week 2, Week 4, Week 6, Week 8 | 
| Change in serum Calcium x Phosphor product |  | Week 0, Week 2, Week 4, Week 6, Week 8 | 
| Serum intact PTH level |  | Week 0, Week 2, Week 4, Week 6, Week 8 | 
| Phosphate excretion in urine |  | Week 0, Week 4, Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease not on dialysis, Lanthanum carbonate
The Impact of a Beach Chair Position During Shoulder Arthroscopy on Regional Cerebral Oxygen Saturation : Comparison of Interscalene Block and General Anesthesia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the relationship between the patient positioning in the beach chair position with consequential arterial pressure changes and their influence on regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in one group of patients and interscalene block in the second group of patients.

Detailed Description
-----------------
The participants of the study are patients scheduled for elective shoulder athroscopy. The patients randomise themselves by choosing the type of anesthesia technique (general anesthesia or interscalene block) after detailed description of both techniques. They receive the standard, routine medical care (monitoring and anesthesia techniques) during which the obtained data of arterial pressure, heart rate, peripheral and cerebral oxygen saturation will be statistically analysed and compared.

Conditions
-----------------
Impaired Oxygen Delivery, Cerebral Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criterion for the study was the approval for surgery under general or regional anesthesia with ASA I and ASA II patients classification. - Exclusion Criteria: The patients who have refused to take part in the study, patients assessed as ASA III or higher, who have cerebrovascular or coronary disease, coagulopathy, hypersensitivity to local anesthetics or other contraindications to one or the other type of anesthetic techniques All patients in whom the operation lasted less than 20 minutes or longer than 90 minutes, have been also excluded from the study.

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 |
| --- | --- |
| GA<br>general anesthesia | |
| ISB<br>interscalene block | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in arterial pressure from baseline |  | baseline, during the operation, one hour after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in regional cerebral oxygen saturation from baseline |  | baseline, during the operation, one hour after the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interscalene block, general anesthesia, shoulder arthroscopy, cerebral oxygen saturation, beach chair position
The Care Transitions Intervention

Study Overview
=================
Brief Summary
-----------------
This intervention tests whether encouraging older patients and their caregivers to assert a more active role in their care transitions could improve clinical outcomes. Patients are supported by a nurse transition coach and specific tools, including a Personal Health Record.

Detailed Description
-----------------
See above.

Official Title
-----------------
The Care Transitions Intervention

Conditions
-----------------
Continuity of Patient Care

Intervention / Treatment
-----------------
* Behavioral: Care Transitions Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible for this study, patients from the participating delivery system had to: 1) be age 65 years or older, 2) be admitted to one of the participating delivery system's contract hospitals during the study period for a non-psychiatrically-related condition, 3) be community-dwelling (i.e., not from a long-term care facility), 4) reside within a predefined geographic radius of the hospital (thereby making a home visit feasible), 5) have a working telephone, 6) be English-speaking, 7) show no documentation of dementia in the medical record, 8) have no plans to enter hospice, 9) not be participating in another research protocol, and 10) have documented in their medical record at least one of 11 diagnoses, including stroke, congestive heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, diabetes, spinal stenosis, hip fracture, peripheral vascular disease, deep venous thrombosis, or pulmonary embolism. Exclusion Criteria: Those who did not meet the inclusion criteria.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Care Transitions Intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization rate at 30, 90 and 180 days after index hospitalization. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization rate at 30, 90 and 180 days after index hospitalization. Rehospitalization for the same condition as the index hospital stay, at 30, 90 and 180 days. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
care transitions, geriatric, care coordination, self-management, chronic illness, patient-centered care
AI Performance for the Detection of Bone Fractures in Children

Study Overview
=================
Brief Summary
-----------------
The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs. The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting. These patients benefit from a whole body radiography with a double blind reading by a generalist radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results. Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.

Official Title
-----------------
Assessment of AI Performance for the Detection of Bone Fractures in Children Aged Less Than 2 Years Old in Suspected Child Abuse Setting.

Conditions
-----------------
Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: aged less than 2 years old whole body radiography performed for suspected child abuse setting report available with a double blind reading (generalist radiologist and radiologist with expertise in child abuse) Exclusion criteria: Radiograph not interpretable ( poor quality) AI not applicable

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 2 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 |
| --- | --- | --- |
| Percentage of fracture detected by AI on radiographs | Percentage of fracture detected by AI on radiographs | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Radiography, Paediatric imaging, Artificial intelligence, child abuse
Billroth II Versus Roux-en-Y for the Gastrojejunostomy in the Pancreatoduodenectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.

Official Title
-----------------
Billroth II Versus Roux-en-Y for the Gastrojejunostomy Reconstruction in the Pancreatoduodenectomy: a Randomized Controlled Study

Conditions
-----------------
Pancreatoduodenectomy

Intervention / Treatment
-----------------
* Procedure: Roux-en-Y for the gastrojejunostomy reconstruction
* Procedure: Billroth II for the gastrojejunostomy reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive series of patients undergoing pancreaticoduodenectomy (PD). Given informed consent. Exclusion Criteria: Inability to perform pancreatogastrostomy. Resection of other organs, except the superior mesenteric-portal vein. Previous gastric surgery. Preoperative gastric or duodenal obstruction. Previous complex abdominal surgery.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roux-en-Y<br>Roux-en-Y for the gastrojejunostomy reconstruction | Procedure: Roux-en-Y for the gastrojejunostomy reconstruction<br> <br> |
| Active Comparator: Billroth II<br>Billroth II for the gastrojejunostomy reconstruction | Procedure: Billroth II for the gastrojejunostomy reconstruction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delayed gastric emptying (DGE) |  | 30 day after surgery |
Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

Study Overview
=================
Brief Summary
-----------------
A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis. The effectiveness specialized osteoporosis clinics is the subject of numerous publications. It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.

Official Title
-----------------
Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

Conditions
-----------------
Osteoporosis, Osteoporotic Fractures

Intervention / Treatment
-----------------
* Other: Telephone interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015 Acceptation of the telephone interview Exclusion Criteria: Age < 18 years No social security coverage

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

| Intervention/Treatment |
| --- |
|Other: Telephone interview|Structured, directive, telephone interview, in order to collect the outcome measures in addition to the patients electronic health record.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fractures since the enrollment in the clinic | Number of incident fractures suffered by the patient since their enrollment in the osteoporosis clinic. | From the enrollment of patients between january 2012 and december 2015 to the interview date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of bone mineral density since the enrollment in the clinic | Evolution of the bone mineral density since their enrollment in the osteoporosis clinic | From the enrollment of patients between january 2012 and december 2015 to the interview date | 
| Satisfaction with the osteoporosis clinic | Level of satisfaction measured with a four level Lickert scale ( Very satisfied ? Satisfied? Unsatisfied? Dissatisfied?) | From the enrollment of patients between january 2012 and december 2015 to the interview date |
Usefulness of Alpha-GST in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to predict primary dysfunction in liver recipient. The secondary objective was to study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.

Detailed Description
-----------------
Graft primary dysfunction (PDF) after liver transplantation is enhanced by the increasing use of extended-criteria allografts. This complication is burdened with high mortality and morbidity rates among liver transplant recipients. Alpha-GST is a short-life hepatocyte enzyme that may be an interesting biomarker for liver injury. A recently developped ELISA technique may allow fast and easy measurement of alpha-GST plasma concentration (Fastpack IP α-GST Immunoassay, Qualigen Inc., Carlsbad, CA). This study aims to evaluate the ability of plasma alpha-GST measurements in liver donor to predict PDF in liver recipient. Methods: Observational study conducted in one center (Beaujon hospital, APHP, Clichy, France). Measurements of plasma levels of alpha-GST using Fastpack IP α-GST Immunoassay (Qualigen Inc., Carlsbad, CA) at the time of organ removal in liver donor and daily from day 0 to day 7 after liver transplantation in recipients.

Official Title
-----------------
Predictive Ability of Alpha-GST to Detect Graft Primary Dysfunction After Liver Transplantation

Conditions
-----------------
Evidence of Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France ) Exclusion Criteria: age >70 years and <18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Primary dysfunction (PDF) of liver graft | To evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to PDF in liver recipient. | First week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early graft function recovery. | To study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery. | First week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplantation, Primary dysfunction