linjc16/ctgov huggingface dataset:
A Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhance™ IOL. The study will enroll up to 100 subjects from a single site in China. All subjects will be followed for 12 months postoperatively.

Official Title
-----------------
A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Eyhance™ Intraocular Lens Model ICB00

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

Intervention / Treatment
-----------------
* Device: Model ICB00


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients at least 22 years of age Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Eyhance intraocular lens Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian. Exclusion Criteria: Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit Planned monovision correction (one eye designated for near correction). Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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: TECNIS Eyhance IOL<br>Model ICB00 | Device: Model ICB00<br>* Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean monocular postoperative DCIVA |  | 6 months | 
| percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA |  | 6 months |
Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China

Study Overview
=================
Brief Summary
-----------------
Enhanced recovery after surgery (ERAS) is a new mode to optimize perioperative management, the core of which is to reduce perioperative physiological and psychological trauma and stress damage, and accelerate postoperative rehabilitation. ERAS has been gradually introduced in pediatric surgery in recent years, however, there are limited reports on its overall implementation. We aimed to determine the popularity of ERAS among pediatric populations in mainland China.

Detailed Description
-----------------
The application of ERAS in children with congenital biliary dilatation (CBD) was investigated. A total of 31 province-level administrative regions in mainland China were involved and each of them had at least one participating center. A questionnaire was designed to assess the baseline adherence of 17 recovery elements and chief pediatric surgeons at each center were invited to complete.

Official Title
-----------------
Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China: Based on a Survey of Performing Congenital Biliary Dilatation Operations

Conditions
-----------------
ERAS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chief pediatric surgeons at each center Exclusion Criteria: Incomplete questionnaire
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| This investigation was conducted on chief surgeons at each center.<br>This investigation was conducted on chief surgeons at each center. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Element adherence | Adherence to an element was determined if the frequency of practice reached specific thresholds as defined. | immediately after all the questionnaires are collected | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with baseline ERAS utilization | Factors associated with baseline ERAS utilization | immediately after all the questionnaires are collected |
Impact Of Sacral Neuromodulation On Urine Markers For Interstitial Cystitis (IC)

Study Overview
=================
Brief Summary
-----------------
Urine will be collected and sent to the University of Maryland. Urines will be analyzed for urine markers.

Detailed Description
-----------------
Urine will be collected and flash frozen in liquid nitrogen then placed in a -70 C freezer. All urine will be collected and stored until the final follow-up is complete. The urine samples will then be sent as a single batch to the Department of Infectious Disease, University of Maryland. Urines will be assayed in a blinded fashion and a written report of the levels of each of the 3 urine markers will be sent to Beaumont Hospital. Change in urine marker levels will be analyzed and correlated with change in symptom scores.

Official Title
-----------------
Impact Of Sacral Neuromodulation On Urine Markers For IC

Conditions
-----------------
Interstitial Cystitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be drawn from Dr. Peters patient base that covers Southeast Michigan. Exclusion Criteria: Male

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 |
| --- | --- |
| A<br>One arm study. Urine collection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of this study is measure urine biomarkers levels in patients with interstitial cystitis who have elected to undergo sacral nerve stimulation as a treatment modality for their disease. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial Cystitis, IC, Sacral Nerve Stimulation
Active Powered Prosthesis (APEX) for Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. The objective of this study is to perform focus groups with users and clinicians to evaluate a proof of concept active powered assistance device.

Official Title
-----------------
Active Powered Prosthesis (APEX) for Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal cord injury at levels C3 to C5, and AIS A, B, or C Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder Ability to provide informed consent Age 18 or over Selected for participation based on investigator discretion Exclusion Criteria: Unable to follow instructions Exhibit significant behavioral problems or impaired cognitive ability Inability to provide consent Non-English speaker

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: User Focus Group Participants<br>Target user population will be human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C. | Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury<br>* The Active Powered Prosthesis (APEX) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. Focus group participants will control the APEX device on a test manikin and provide feedback on the device design and function.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Ability to Operate the APEX Device | Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs). | Two hours of in-clinic prototype evaluation |
CArdioSurgEry Atrial Fibrillation Register

Study Overview
=================
Brief Summary
-----------------
CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation.

Detailed Description
-----------------
CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. In particular, the following questions should be answered: Indication: Which are the different indications for cardiac surgical ablation in patients with atrial fibrillation? How often and in which patients the different concepts of surgery and ablation procedures are used? At the same time, how often an intervention at the left atrial appendage is carried out? Safety: How secure is the cardiac surgical ablation of atrial fibrillation (periprocedural, during hospital stay and during the long-term follow up)? Effectiveness: How effectively is the cardiac surgical ablation of atrial fibrillation (procedural success)? How often are AF recurrences in the long-term follow up? What is the concommitant medical treatment after surgical ablation?

Official Title
-----------------
CArdioSurgEry Atrial Fibrillation Register - CASE-AF Register

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrilation Treated by cardiac surgical ablation Exclusion Criteria: Patient denies participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Number of major bleeding events | Documentation of procedural results and clinical short-and long-term results of the documented therapies | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of major adverse cardiac events | Documentation of procedural results and clinical short-and long-term results of the documented therapies | 12 months | 
| Complications during hospital stay | Documentation of hospital mortality, nonfatal major complications | 12 months |
Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm

Study Overview
=================
Brief Summary
-----------------
This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. The investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. The investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.

Official Title
-----------------
Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm Determined by Dynamic Analysis of Exhaled Breath Condensate.

Conditions
-----------------
Asthma, Exercise Induced

Intervention / Treatment
-----------------
* Procedure: Hyperpnea challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician diagnosed asthma Age 12-75 yrs FEV1 > 70% predicted HIB response > 10 % No smoking last 6 mo and < 10 pack yrs No URI last 4 weeks No asthma exacerbation last 4 weks Able to withhold SABA > 8 hrs and LABA > 24 hrs Exclusion Criteria: Other lung disease Cardiac disease or other condition that would preclude safe participation, on theophylline or leukotriene modifiers

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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 |
| --- | --- |
| Asthmatics<br>Asthmatics with exercise induced bronchospasm | Procedure: Hyperpnea challenge<br>* 5 minutes of dry air hyperpnea to induce bronchospasm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of cystLTs and adenosine |  | Before and after hyperpnea challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pH of EBC and change in pulmonary function |  | Before and after hyperpnea challenge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Exercise induced bronchospasm, Hyperpnea induced bronchospasm, leukotrienes, adenosine, exhaled breath condensate
Comparison of Clinical and Radiological Results of Using Only Screws and Plate Use in Latarjet Operation in Shoulder Instability

Study Overview
=================
Brief Summary
-----------------
Randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability

Detailed Description
-----------------
Randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability 2 groups will be determined in the study, while the first group will include the group in which corocoid fixation with cannulated screws was performed, while the second group will include the group that underwent osteosynthesis with plate and screw The results will be evaluated statistically based on clinical scores (constant, vas) and radiological findings (a angle).

Official Title
-----------------
Comparison of Clinical and Radiological Results of Using Only Screws and Plate Use in Latarjet Operation in Shoulder Instability

Conditions
-----------------
Shoulder Dislocation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Recurrent shoulder dislocation; 18-65 age >%10 glenoid loss or Hill Sacs Lesion Exclusion Criteria: - <18 age <%10 glenoid loss shoulder dislocation due to epilepsy Dislocations associated with other upper extremity injuries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Latarjet surgery|Results of using a screw-only plate for fixation of the corocoid bone in recurrent shoulder dislocations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
IGF-1 Therapy in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.

Detailed Description
-----------------
28 week, double blind, cross over study to determine the efficacy of rhIGF-1 on body weight and body composition in patients with cystic fibrosis.

Official Title
-----------------
An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: recombinant human IGF-1
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cystic fibrosis as proven by either sweat chloride or DNA analysis. Age >= 18 yr. Tanner stage: Femake Breasts: 4-5 Male Genitalia: 4-5 Exclusion criteria: Hemoglobin A1C > 8.5 % Diabetic retinopathy Obstructive sleep apnea Respiratory failure requiring mechanical ventilation. Status post pulmonary transplantation. Concurrent or recent (within past 6 months) receipt of human growth hormone. History of adverse side effects to growth hormone other than carbohydrate intolerance. Pregnancy or attempting pregnancy. Women who are breast feeding. Sexually active women who refuse to use or are incapable of responsibly using reliable contraception. Proven non compliance with medical regimens. Inability or refusal to take subcutaneous injections. Known allergy to components in the IGF-I preparation.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IGF-1<br>Recombinant human IGF-1 | Drug: recombinant human IGF-1<br>* rhIGF-1<br>* Other names: mecasermin;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight and body composition |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function |  | 28 weeks | 
| Carbohydrate tolerance |  | 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body weight, Body composition, Pulmonary function, Carbohydrate tolerance
A Study to Evaluate the Efficacy and Safety of AD-208

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of AD-208.

Detailed Description
-----------------
The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Drug: AD-208
* Drug: AD-2081
* Drug: placebo of AD-208
* Drug: placebo of AD-2081


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged 18-50 years, inclusive Patients who meet the appropriate criteria according to the classification of hair loss Signed informed consent Exclusion Criteria: Patients with hair loss disorders other than androgenetic alopecia Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Active Comparator: Active Comparator<br>AD-208 and Placebo of AD-2081 | Drug: AD-208<br>* PO, Once daily(QD), 24weeks<br>Drug: placebo of AD-2081<br>* PO, Once daily(QD), 24weeks<br>|
| Placebo Comparator: Placebo Comparator<br>Placebo of AD-208 and Placebo of AD-2081 | Drug: placebo of AD-208<br>* PO, Once daily(QD), 24weeks<br>Drug: placebo of AD-2081<br>* PO, Once daily(QD), 24weeks<br>|
| Experimental: Experimental Comparator<br>Placebo of AD-208 and AD-2081 | Drug: AD-2081<br>* PO, Once daily(QD), 24weeks<br>Drug: placebo of AD-208<br>* PO, Once daily(QD), 24weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of Change in the total number of hairs | The amount of change in the total number of hairs in the unit area | Baseline, Week 24 |