linjc16/ctgov huggingface dataset:
The Role of Capsular Tension Ring (CTR) in Anterior Capsular Contraction

Study Overview
=================
Brief Summary
-----------------
This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients with Retinitis Pigmentosa

Detailed Description
-----------------
Cataract is a common complication in retinitis Pigmentosa (RP) patient especially posterior sub capsular cataract. Continuous curvilinear capsulorhexis is the preferred method of capsulotomy in cataract surgery. Anterior capsular contraction (ACO) is a unique complication following cataract surgery. The rate of which is higher in RP patients due to the weak zonules and the increased rate of inflammation. CTR has been proven to reduce the rate of contraction. Study population includes 40 eyes having RP with cataract. 20 eyes will receive CTR and the other 20 would not receive CTR. The percentage of anterior capsular contraction would be evaluated using EPCO software.

Official Title
-----------------
Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients

Conditions
-----------------
Retinitis Pigmentosa, Cataract

Intervention / Treatment
-----------------
* Procedure: IOL surgery
* Procedure: IOL surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 35 to 65 years Typical retinitis pigmentosa Reside within a radius of 100kms from Madurai Patients willing to come for follow up Patients with nuclear sclerosis grade 2 or 3 or cortical cataract or pscc Exclusion Criteria: Diabetic patients Traumatic cataract Uveitis Glaucoma Pseudoexfoliation Myotonic dystrophy Corneal pathology Pupil size <6mm Intra op complications like zonular dialysis,pc rupture Rhexis not covering iol optic

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>IOL surgery with Capsular Tension Ring | Procedure: IOL surgery<br>* IOL surgery using capsular tension ring (AURORING)<br>* Other names: AURORING;|
| Placebo Comparator: Arm 2<br>IOL surgery without Capsular Tension Ring | Procedure: IOL surgery<br>* IOL surgery without CTR<br>* Other names: Phacoemulsification;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of anterior capsular contraction |  | 1 day, 30 days,90 days,180 days,270days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 1 day, 30 days,90 days,180 days,270days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinitis Pigmentosa, Cataract
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment

Study Overview
=================
Brief Summary
-----------------
The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after unilateral or bilateral cochlear implantation.

Official Title
-----------------
Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment

Conditions
-----------------
Long Term Neurobehavioral Effects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital Patients who have not participated in other clinical trials ASA class I-II selective operation without any acute infectious diseases or systematic diseases Infant's family members agree to participated in the trials and sign the informed consent Exclusion Criteria: Reject to sign the informed consent and participate in the trials Patients with severe liver and kidney damage or other heart, lung and nervous system diseases The Gesell developmental scale is less than 86 in motor behavior and physical energy With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice Infant who is allergic to egg and milk Family history of malignant hyperthermia Allergy to anesthetic drugs

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 2 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Short time anesthesia group<br>Unilateral cochlear implantation,which time of anesthesia is less than 3 hours | |
| Long time anesthesia group<br>Bilateral cochlear implantation, which time of anesthesia is more than 3 hours | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Baseline Gesell Developmental Scale after 6 month | Neurobehavior effects | change in 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Baseline Gesell Developmental Scale after 12 month | Neurobehavior effects | change in 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, anesthesia, neurobehavioral development
Human Irisin Concentration in Sarcopenia

Study Overview
=================
Brief Summary
-----------------
Irisin has been identified as a novel myokine that drives brown-fat-like conversion of white adipose tissue. In this cross-sectional study, the researches investigated whether serum irisin levels are decreased in patients with sarcopenia compared with control subjects with normal muscle mass, and assessed the association between serum irisin levels and various metabolic parameters.

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20<age<80 apparently healthy subjects Exclusion Criteria: a history of cardiovascular disease diabetes stage 2 hypertension malignancy severe renal or hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of irisin in the subjects with sarcopenia |  | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of serum irisin levels with lipid profiles |  | 12 week | 
| The relationship of serum irisin levels with skeletal muscle mass index |  | 12 wks |
Multisite Pacing With a Quadripolar Lead

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.

Official Title
-----------------
Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Quadripolar LV lead (pacing configurations)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a scheduled CRT implantation at the participating clinical study site Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations Exclusion Criteria: Have persistent or permanent atrial fibrillation Have an intrinsic heart rate of <50 beats per minute Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures Have had a recent CVA or TIA within 3 months prior to enrollment Have had intravenous inotropic support in the last 30 days Have ischemic etiology and are unable to tolerate stress echocardiography

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Quadripolar LV lead (pacing configurations)|Quadripolar LV lead will be used to deliver a combination of pacing configurations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dP/dt max |  | acute: during implant procedure; 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodynamic response, Cardiac resynchronization therapy
Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients

Study Overview
=================
Brief Summary
-----------------
A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.

Detailed Description
-----------------
The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.

Official Title
-----------------
This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities

Conditions
-----------------
Maxillary Deficiency

Intervention / Treatment
-----------------
* Device: Fixed Tongue Appliance
* Device: Fixed Face Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Growing patients Class III with maxillary deficiency Exclusion Criteria: Previous orthodontic treatment Uncooperative patients

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 11 Years

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

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

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: Group A<br> | Device: Fixed Tongue Appliance<br>* A functional appliance used for maxillary protraction. It has two bands on first molars, expansion screw and long palatal plate in the canine area which cages the tongue and transfers the force of the tongue during physiological activity to the upper arch.<br>* Other names: tongue plate;|
| Experimental: Group B<br> | Device: Fixed Face Mask<br>* An extra-oral appliance used for treatment of maxillary deficiency in growing patients. It takes anchorage from the chin and forehead, has a fixed intra-oral appliance with an expansion screw and hooks for elastics that exert a force of 300 gr. It should be used 14 hours a day.<br>* Other names: face mask;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cephalometric angles and clinical features |  | At least 6 months |
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.

Official Title
-----------------
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer.

Conditions
-----------------
Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: CP-547,632


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc). Bidimensionally measurable disease >2cm x 1 cm by conventional CT Scan or >1 cm x 1cm by spiral CT Scan. Exclusion Criteria: No tumors in close proximity to major veins or arteries. No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease. No evidence or history brain metastases.

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: CP-547,632|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Given the outcome of the primary objective, analysis of secondary objectives were not formalized. |  |  |
The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.

Study Overview
=================
Brief Summary
-----------------
Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

Official Title
-----------------
The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.

Conditions
-----------------
Breast Cancer, Surgery

Intervention / Treatment
-----------------
* Other: e-consult application (tool)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 18 years old Patient referred for first consultation for surgery Patient referred for a breast tumorectomy and axillary sentinel node No patient opposition to participating in this study Exclusion Criteria: Non-surgical management Management by any surgery other than breast tumorectomy and axillary sentinel node Any associated medical, social or psychopathological condition that could compromise the patient's ability to participate in the study Patient deprived of liberty or under guardianship Person subject to legal protection or unable to express their consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group without the e-consult tool<br>standard consultation | |
| Group with the e-consult tool<br>The e-consult tool is a digital application developed and designed by the Center François Baclesse, This tool is a consultation support to explain the surgical management of the patient. | Other: e-consult application (tool)<br>* A numeric application used as a support in consultation to explain the surgical management of the patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation. | The average obtained in the CARE questionnaire by patients (score [10-50]) | before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
empathy
Bariatric Dose-ranging Study With Dexmedetomidine

Study Overview
=================
Brief Summary
-----------------
After obtaining informed consent,80 morbidly obese ASA II-III patients undergoing laparoscopic bariatric surgery procedures would be randomly assigned to one of four study groups at UTSWMC at Dallas.Hemodynamic paarameters, recovery times, postoperative pain scores, the need for rescue analgesics and side effects will be recorded.The purpose of this study is to determine the optimal linfusion rate of dexmedetomidine for maintaining cardiovscular stability during general anesthesia.

Official Title
-----------------
A Randomized, Double-blind, Controlled Study of Dexmedetomidine (Precedex) Infusion for Improving Control of Acute Autonomic Response During Laparoscopic Bariatric Surgery

Conditions
-----------------
Abdominal Surgery Patients

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects may be included in the study only if they meet all of the following criteria: Age 18 to 70 years Undergo laparoscopic bariatric surgery requiring general anesthesia Be capable of giving informed consent ASA physical status I-III ( Appendix 1) Exclusion Criteria: Subjects will be excluded from the study for any of the following reasons: With history of hypertension and allergy to dexmedetomidine Patients who have greater than first degree heart block. Performing major intracavitary surgery procedures Patients who are pregnant or breast-feeding History of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexmedetomidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit

Study Overview
=================
Brief Summary
-----------------
Hypokalemia is very common in heart failure patients. Deleterious effects have been report on the cardiovascular system. Most of the clinical data concerning this ionic trouble are based on post-hoc study and some findings seemed disjointed.

Detailed Description
-----------------
This study tried to describe hypokalemia impact during hospital stay in hospitalized patients with heart failure and particularly on mortality and re-hospitalization.

Official Title
-----------------
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit: Morbidity-mortality Impact

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patient in the Therapeutic Cardiac Failure Unit in the CHR Metz-Thionville Patient with congestive heart failure Exclusion Criteria: None
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 |
| --- | --- | --- |
| Composite of death and re-hospitalization | The number of death for any reason and re-hospitalization for congestive heart failure | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Percentage of death for any reason | Month 3 | 
| Re-hospitalization | Percentage of re-hospitalization for congestive heart failure | Month 3 | 
| Length of stay | Days spent at the hospital | Month 3 | 
| Incidence of hypokalemia | Percentage of incidence during the stay of hypokalemia | Month 3 | 
| Prevalence of hypokalemia | Percentage of initial prevalence during the stay of hypokalemia | Month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypokalemia, cardiac failure