linjc16/ctgov huggingface dataset:
Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal

Study Overview
=================
Brief Summary
-----------------
To evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were also investigated.

Official Title
-----------------
Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal

Conditions
-----------------
Macular Pucker, Macular Cyst

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had macular pucker surgery before cataract surgery. Follow up over 1 year. Exclusion Criteria: Patients had any surgical complications such as posterior capsule rupture, vitreous loss, prolapse through the wound or iris trauma Patients had diabetes mellitus. Patients had uveitis or other inflammatory eye disease. Patients had history of retinal vein occlusion. Patients had retinal detachment; or previous vitrectomy for a disease other than macular pucker.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| Wilcoxon Signed-Rank test | A statistical comparison of average of different time point | 1 day, 1 week, 1 month, 3 months, 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | visual acuity change in logMAR in different time point | 1 day, 1 week, 1 month, 3 months, 6 months and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular edema, pseudophakic cystoid macular edema, macular pucker, internal limiting membrane peeling, pars plana vitrectomy
Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Recent studies have suggested that arginine-vasopressin could be more effective in the treatment of cardiac arrests. The last published study did not outline obvious improvements in the prognosis of all cardiac arrests but pointed out a possible increased survival rate when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare the efficacy of two successive injections of epinephrine (1 mg) with two successive injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be enrolled.

Official Title
-----------------
Comparison of Epinephrine Associated With Vasopressin vs Epinephrine Alone in the Treatment of Out-of-Hospital Cardiac Arrests

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: epinephrine (1 mg/1 mL)
* Drug: arginine-vasopressin (40 UI/2 mL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-of-hospital medical cardiac arrest in adult patients. Exclusion Criteria: Traumatic cardiac arrest Pregnancy Patients younger than 18 years old or older than 85 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Drug: epinephrine (1 mg/1 mL)|nan|
|Drug: arginine-vasopressin (40 UI/2 mL)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at hospital admission |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROSC (Return of spontaneous circulation) Survival at : H24, Day 28, hospital discharge and one year Neurological status at H24 and hospital discharge. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Out-of-hospital cardiac arrest - Vasopressin - Epinephrine
Half-normal Saline in Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.

Official Title
-----------------
Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Half-normal saline
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria male or female between 18 and 75 years of age at the time of enrollment undergoing first-time radiofrequency ablation for atrial fibrillation written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Exclusion criteria robotic-guided atrial fibrillation ablation baseline hyponatremia (serum sodium level < 135 mEq/L) pregnant, breastfeeding, or unwilling to practice birth control during participation in the study presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Half-normal saline<br> | Drug: Half-normal saline<br>* Use of half-normal saline as an irrigant for open-irrigated ablation catheters<br>|
| Active Comparator: Normal saline<br> | Drug: Normal saline<br>* Use of normal saline as an irrigant for open-irrigated ablation catheters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total radiofrequency ablation time, and total procedure time |  | intraprocedural | 
| acute pulmonary veins, and left atrial appendage (if applicable) reconnection |  | intraprocedural | 
| freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs |  | 1 year | 
| long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection |  | in case of a repeat procedure performed during the study follow-up (an average of 1 year) |
Citicoline as Neuroprotector in Preterm

Study Overview
=================
Brief Summary
-----------------
Citicoline as neuroprotector in preterm

Detailed Description
-----------------
Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.

Official Title
-----------------
Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial

Conditions
-----------------
Pre-Term

Intervention / Treatment
-----------------
* Drug: Citicoline
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm on CPAP or ventilator Exclusion Criteria: Multiple congenital anomalies

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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: Citicoline<br>Citicoline as neuroprotector | Drug: Citicoline<br>* Citicoline as neuroprotector<br>|
| Placebo Comparator: Placebo drug<br>Placebo | Drug: Placebo oral tablet<br>* placebo drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children with affection of the brain | Number of children with affection of the brain | 6 months |
Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract

Study Overview
=================
Brief Summary
-----------------
Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the macular development. However, there are different opinions about the effect of amblyopia on the macular thickness . Investigators have performed cataract extraction with IOL implantation on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the macular thickness before and after surgery..Average sectional total thickness was automatically determined by the instrument's software using a modified Early Treatment Diabetic Retinopathy Study (ETDRS) circle grid (fovea, inner ring, and outer ring: 1 mm, 3 mm, and 6 mm. Investigators dynamically observed changes in macular to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

Official Title
-----------------
To Observe and Determine Macular Thickness Changes Before and After Cataract Surgery

Conditions
-----------------
Macular, Congenital Cataract

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital cataract Exclusion Criteria: -incooperative to complete the preoperative and postoperative examinations.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MT<br>Macular thickness | Procedure: cataract surgery<br>* To measure the MT in congenital cataracts before and after the cataract extraction with IOL implantation surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness | macular thickness changes before and after cataract surgery | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular thickness
Treatment of Advanced AIDS Patients With Dextrin Sulfate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.

Detailed Description
-----------------
Patients have intraperitoneal (IP) catheter placement done at study entry. Infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (DS) commences. DS is given three times per week. A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks. Patient evaluations are done regularly during treatment and observation continues for 24 weeks.

Official Title
-----------------
Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Dextrin 2-sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this trial if they: Are HIV-positive. Have been diagnosed with AIDS and are under treatment to prevent opportunistic (AIDS-related) infection. Have had a CD4 cell count greater than 50 microL for at least the past 3 months. Have had a viral load of at least 50,000 copies/ml for at least the past 3 months. Have used up all other treatment options. Are able to understand and give written consent. Exclusion Criteria Patients may not be eligible for this trial if they: Have been in any other study in the 6 weeks before beginning this study. Have an active, opportunistic infection or other infection. Have any other long-term medical condition or nervous disorder that might make it difficult for them to finish 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?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dextrin 2-sulfate|nan|

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
-----------------
Anti-HIV Agents, Viral Load, dextrin 2-sulfate, Infusions, Parenteral
Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

Study Overview
=================
Brief Summary
-----------------
The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St. Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™ will be evaluated in this study. The MRI Activator is a handheld device that allows the user to enable and disable MRI Settings as well as check the status of MRI Settings in the pacemaker. The patient population under study includes patients with a standard bradycardia pacing indication.

Official Title
-----------------
Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

Conditions
-----------------
Bradycardia

Intervention / Treatment
-----------------
* Device: Implantation of an Accent MRI device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved Class I or Class II indication per ESC guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker. Receiving a new Accent MRITM pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices). Ability to provide informed consent for study participation. Is willing and able to comply with the prescribed follow-up tests and schedule of evaluations. Exclusion Criteria: Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment). Have an existing active/inactive implanted medical device (e. g., Neurostimulator, infusion pump, etc.). Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.). Have a lead extender or adaptor. Have a mechanical, prosthetic or bioprosthetic tricuspid heart valve. Have an abdominal diameter (approximately > 60cm) which results in contact with the magnet façade. Are currently participating in a study that includes an active treatment arm. Are pregnant or planning to become pregnant during the duration of the study. Have a life expectancy of less than 6 months due to any condition. Are less than 18 years of age. Are unable to comply with the follow up schedule.

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 |
| --- | --- |
| Accent MRI Group<br> | Device: Implantation of an Accent MRI device<br>* Implantation of an Accent MRI device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

Study Overview
=================
Brief Summary
-----------------
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.

Official Title
-----------------
Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022. Subject has willingness to participate in the study. Subject can give written informed consent to allow for data collection. Exclusion Criteria: The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with AGN1 LOEP<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction | Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction. | Through study completion, an average of 1.1 years | 
| Subject Safety | Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device. | During the procedure | 
| Subject Safety | Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device. | Through study completion, an average of 1.1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, Proximal femur
The Effect of Acupuncture on Blood Pressure and Heart Rate Variability (HRV)

Study Overview
=================
Brief Summary
-----------------
This research is designed to study the effects of needle acupuncture on blood pressure and HRV by stimulating certain acupuncture points and meridians.

Detailed Description
-----------------
Outcome measurements include blood pressure and heart rate variability.

Official Title
-----------------
The Effect of Acupuncture on Blood Pressure and HRV

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: acupuncture
* Device: sham needle treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female suffering from mild hypertension (systolic BP between 130-165 mmHg, diastolic BP between 90-120 mmHg). Exclusion Criteria: Individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders, Currently taking prescription or OTC medications and/or herb/supplements that effect BP or autonomic tone will not be recruited into the study. In addition, individuals who have a pacemaker and/or are pregnant will not be recruited in the study. A health history questionnaire was used to screen subjects.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment group. | Device: acupuncture<br>* to Liv 3 and PE 9.<br>|
| Sham Comparator: 2<br>control group | Device: sham needle treatment<br>* needle not in meridian area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure and HRV |  | five weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, high blood pressure, HRV