linjc16/ctgov huggingface dataset:
Cataract Surgery in Indian Patients With or Without LenSx® Laser

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers.

Detailed Description
-----------------
Legitimate patients will receive Standard of Care (SOC) phacoemulsification treatment for cataract and IOL implantation, with or without using LenSx® technology, with followup for 1 month using SOC postsurgical treatment.

Official Title
-----------------
A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: LenSx® laser system
* Procedure: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agree to undergo phacoemulsification cataract surgery in at least 1 eye; Understand and sign an informed consent form; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Refuse to sign the informed consent form or have incomplete medical records; Contraindications for phacoemulsification treatment per Investigator discretion or listed in LenSx® Operator's Manual; Contraindications for anterior capsulotomy, phacofragmentation of the lens using the FLACS; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Cataract surgery<br>Phacoemulsification and artificial IOL implantation with and without LenSx® laser system | Device: LenSx® laser system<br>* Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery<br>Procedure: Phacoemulsification<br>* Removal of the cataractous lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of an anterior capsulotomy |  | Day 0, operative day | 
| Best Corrected Visual Acuity (BCVA) |  | Up to Day 30 postoperative | 
| Uncorrected Visual Acuity (UCVA) |  | Up to Day 30 postoperative | 
| Cumulative dissipated energy (CDE) | Cumulative Dissipated Energy (the amount of ultrasound energy entering the eye during the removal of the cataractous lens) will be reported on the Vision System interface and measured in percent-seconds. | Day 0, operative day | 
| Total phaco + IOL time |  | Day 0, operative day | 
| Aspiration fluid (ml) |  | Day 0, operative day | 
| Success rate of IOL insertion |  | Day 0, operative day | 
| Completion rate of cornea incision |  | Day 0, operative day | 
| Laser procedure time from suction on to off |  | Day 0, operative day |
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.

Official Title
-----------------
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: ProBion Clinica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one malignant tumor in the colon Exclusion Criteria: Study subjects with adenomas, or who received recent antibiotic therapy or consumed probiotics regularly were excluded.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProBion Clinica<br>Probiotic tablets yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin. | Dietary Supplement: ProBion Clinica<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbiota composition after probiotics use | The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples | 8-78 days depending on time elapsed from inclusion to surgical removal of tumor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic changes after probiotics use | DNA methylation levels are analysed at baseline and after probiotics use in tissue samples | 8-78 days depending on time elapsed from inclusion to surgical removal of tumor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Epigenetics, Microbiota
Knowledge, Attitude and Practice of Gastrointestinal Endoscopists Toward PPE in COVID-19 Era

Study Overview
=================
Brief Summary
-----------------
Assessing the knowledge and practice of GIT endoscopists toward the use of PPE.

Detailed Description
-----------------
An online questionnaire assessing the knowledge and practice of GIT endoscopists toward the use of PPE will be used.

Official Title
-----------------
Knowledge, Attitude and Practice of Gastrointestinal Endoscopists Toward PPE in COVID-19 Era

Conditions
-----------------
Knowledge, Attitudes, Practice

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GIT endoscopists Exclusion Criteria: Refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Online questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The knowledge and attitude toward PPE during endoscopy | Online questionnaire | 2 months |
Screw Lengths in Radius Volar Plates

Study Overview
=================
Brief Summary
-----------------
Background Fractures of the distal radius are among the most common. Major complications, including irritation and rupture of the extensor tendons, may occur if epiphyseal screws of inappropriate length are used. Questions/Purposes The main objective of the present study was to determine whether the optimal epiphyseal screw length can be determined by reference to the diaphyseal screw length. Methods Forty CT scans were semi-automatically segmented. A 3D model of the volar plate was affixed to each distal radius with simulation. The maximum lengths of the diaphyseal screws, as well as the four distal epiphyseal screws, were measured. Linear regression analysis was performed.

Official Title
-----------------
Volar Plates for Distal Radius : Can Epiphyseal Screw Length be Predicted

Conditions
-----------------
Fracture Fixation, Internal, Radius; Fracture, Lower or Distal End, Tendon Injury - Upper Limb

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All CT-scans available in our database Exclusion Criteria: Any pathology that could affect the radius morphology Refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- | --- |
| Main objective | The main objective of this study was twofold: 1) to assess the anatomical correlation between diaphysis thickness in the diaphyseal screw region of volar plates and epiphyseal thickness in lateral plane with linear regression analysis for each epiphyseal screw length with regard to the diaphysis screw length, and 2) to evaluate whether the optimal epiphyseal screw lengths can be predicted by reference to the diaphyseal screw length when diaphyseal screws are first positioned. From the CT-scans, Reconstructions in 3D of the radius were realized. Those reconstructions were used in a computer-simulation study. A Volar plate was affixed to the radius using a specific software. Maximum length for each screw located either in epiphysis or diaphysis was measured in mm. This length corresponded with the distance between the entry point of the screw and the opposite point belonging to the wrist along the line perpendicular to the plate. | The measures were performed after the CT-Scans were realized. The CT-Scans were performed from October 2016 to February 2018. The measures on the CT-Scans were realized in june 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone trauma-fracture, Radius, CT-scan, Internal fixation
The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.

Study Overview
=================
Brief Summary
-----------------
A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. For another, we will collect all the perioperative data of the STAAD group and study the role of thyroid function in the prognosis of STAAD.

Official Title
-----------------
The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.

Conditions
-----------------
Stanford Type A Aortic Dissection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with STAAD will underwent aortic surgery who are willing and able to give informed consent for participation in the study. Exclusion Criteria: The main initial exclusion criteria included clinical evidence of sepsis or cachexia or concomitant presence of any predominant severe systemic disease.

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

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 |
| --- | --- |
| STAAD<br> | |
| Normal<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Role of Thyroid Function in the Development of STAAD. | Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis. | 30 days | 
| The Role of Thyroid Function in the Prognosis of STAAD. | Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis. | 30 days |
IBP-9414 for the Prevention of Necrotizing Enterocolitis

Study Overview
=================
Brief Summary
-----------------
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.

Official Title
-----------------
A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.

Conditions
-----------------
Necrotizing Enterocolitis

Intervention / Treatment
-----------------
* Drug: IBP-9414
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age ≤32 weeks Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g. < 48 hours of age. Written informed consent from the patient's legally authorized representative(s). Exclusion Criteria: Participation in an additional interventional clinical trial in which an investigational drug will be administered. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care). Congenital or acquired gastrointestinal pathology. Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.

Ages Eligible for Study
-----------------
Maximum Age: 48 Hours

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IBP-9414<br>IBP-9414 Oral Daily | Drug: IBP-9414<br> <br> |
| Placebo Comparator: Placebo<br>Sterile water | Drug: Placebo<br>* Sterile water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE) |  | 12 months |
A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer

Study Overview
=================
Brief Summary
-----------------
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.

Official Title
-----------------
A Randomized, Open Label, Phase II Study of OSI-7904L Versus 5-FU/LV as First-Line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Adenocarcinoma of the Biliary Tract

Conditions
-----------------
Locally Advanced or Metastatic Adenoca of the Biliary Tract

Intervention / Treatment
-----------------
* Drug: OSI-7904L
* Drug: 5-Fluorouracil/Leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented locally advanced or metastatic adenocarcinoma of the biliary tract; Adequate bone marrow, hepatic and renal function; Bilirubin <= 1.5 times the upper limit of normal; Age 18 years or older; Predicted life expectancy 12 weeks or more; Prior surgery and radiation therapy permitted provided patient has recovered adequately; At least 1 target lesion >= 20 mm (or >= 10 mm on spiral CT-scan); ECOG Performance Status 0-2; No prior chemotherapy for locally advanced or metastatic disease. Adjuvant/neo-adjuvant permitted if therapy was completed at least 12 months prior to study entry; Exclusion Criteria: Concurrent anticancer therapy while on study; History of other malignancy within the past 3 years except basal or squamous cell carcinoma or in situ cervical cancer; Symptomatic brain metastases which are not stable or have required radiation in the past 28 days;

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OSI-7904L|nan|
|Drug: 5-Fluorouracil/Leucovorin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Enhanced Recovery After Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Introduction: Multimodal rehabilitation (MMR), combines various elements in the management of the surgical patient which lead to a decrease in surgical stress and a more comfortable and faster postoperative recovery. Objective: To assess the introduction of MMR in a specialized Colorectal Unit and compare the results with the traditional model assessing its´ efficacy as to recovery, and reduction of hospital stay and costs.

Detailed Description
-----------------
Materials y Methods: A prospective randomized trial was conducted which analyzed 119 patients who underwent elective colorectal surgery between 2009 and 2010. 58 patients were assigned to the traditional group and 61 patients to the MMR group. MMR included preoperative education, early feeding and mobilisation.

Official Title
-----------------
Impact of the Introduction of a Multimodal Rehabilitation Programme for Colorectal Patients. A Prospective Randomized Trial.

Conditions
-----------------
Fast Track, Enhanced Recovery

Intervention / Treatment
-----------------
* Other: Multimodal rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent elective colorectal surgery between 2009 and 2010. Signed informed consent Live in Valencia metropolitan area Exclusion Criteria: Emergency surgery No colonic resection Unable to continue follow-up Dependent on others for daily activities

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional<br>Involves traditional management of patients with preoperative mechanical bowel preparation, no preoperative education, nasogastric tube, delayed feeding and mobilisation, use of drains | Other: Multimodal rehabilitation<br> <br> |
| Active Comparator: Multimodal rehabilitation<br>Involves preoperative patient education, no preoperative mechanical bowel preparation, no nasogastric tube, early oral feeding and mobilisation, physiotherapy | Other: Multimodal rehabilitation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative stay |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal surgery, multimodal rehabilitation, fast track, early feeding
Relationship Between Gestational Diabetes Mellitus and Inflammatory Adipocytokins in Obese Mothers and Their Newborn at Delivery

Study Overview
=================
Brief Summary
-----------------
ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)

Detailed Description
-----------------
ADIPOGEST is a cross sectional study in which mothers are divided into 2 groups : exposed and unexposed to GDM, matched on pregestational BMI, date of delivery and child gender. Mothers are recruited in the maternity ward of the University Hospital in South of Reunion Island. It is planned a conveniance sample of 20 mother-child pairs per group.

Official Title
-----------------
Relation Entre diabète Gestationnel et Adipocytokines Inflammatoires Chez Des mères obèses et Leur Nouveau-né à l'Accouchement

Conditions
-----------------
Diabetes, Gestational

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Obese women (BMI : 30 kg/m² or more) Aged over 18 years With single pregnancy With alive newborn at 37 weeks of amenorrhea or more With informed consent Exclusion Criteria: Smoker Treatments by corticoïds or thyroid hormons Overt diabetes Complicated pregnancy Premature delivery threat

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 |
| --- | --- |
| GDM<br>Mother-child pairs from mothers with GDM diagnosis (ADA, 2012) | |
| No GDM<br>Mother-child pairs from mothers without GDM diagnosis (ADA, 2012) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of leptin in mother and her child |  | 2 years | 
| Blood levels of adiponectin in mother and her child |  | 2 years | 
| Blood levels of IL-6 in mother and her child |  | 2 years | 
| Blood levels of TNF-alpha in mother and her child |  | 2 years | 
| Blood levels of C- Reactive Protein in mother and her child |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood level of C-peptide in mother |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational Diabetes Mellitus, Obesity, Adipocytokin