linjc16/ctgov huggingface dataset:
Endothelial Cell Loss After Penetrating Keratoplasty

Study Overview
=================
Brief Summary
-----------------
This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Detailed Description
-----------------
Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Official Title
-----------------
Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: PKP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction Exclusion Criteria: Less than 18 and unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: penetrating keratoplasty<br>A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction | Procedure: PKP<br>* The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery. TICL loading into the STAAR injector cartridge Temporal clear corneal 3 mm incision & 2-side ports then viscoelastic injection into the AC Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris. Pupil constriction with A.Ch. Washing the viscoelastic &Wound hydration. Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refraction | Refractive measured by Diopter | 1 year | 
| Visual acuity | The decimal snellens | 1 year | 
| Intra-ocular pressure | mg | 1 year |
Safety Follow-Up to HP 802-247-09-015

Study Overview
=================
Brief Summary
-----------------
This is a 24-week observational follow safety study for Study 802-247-09-015.

Detailed Description
-----------------
The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.

Official Title
-----------------
A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015

Conditions
-----------------
Venous Leg Ulcer, Venous Stasis Ulcer

Intervention / Treatment
-----------------
* Biological: No HP802 Treatment
* Other: No HP802 Vehicle Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Provide informed consent Willing to comply with protocol instructions, including allowing all study assessments. Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo. Subject has ended their participation in HP 802-247-09-015 by virtue of completing the study, or by dropping out prior to completion. Exclusion Criteria Subjects who refuse to provide written informed consent will be excluded from this trial.

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 |
| --- | --- |
| No HP802 Treatment<br>Treatment received in Study 802-247-09-015 was HP802 | Biological: No HP802 Treatment<br> <br> |
| No HP802 Vehicle Treatment<br>Treatment received in Study 802-247-09-015 was HP802 Vehicle | Other: No HP802 Vehicle Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Closed Target Ulcers at Each Visit | At each visit the status of closed target ulcers was evaluated as remained closed or re-opened. | Over the 24-week study period, at each of the bi-monthly visits | 
| Number of Subjects With Target Wound Closed for the First Time During the Study Period. | At each visit the status of open target ulcers was evaluated as remained open or closed. | Over the 24-week study period, at each of the bi-monthly visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Leg Ulcer, Venous Stasis Ulcer, VLU, VSU, Leg Ulcer, Leg Wound
Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. The investigators' goal is to evaluate whether this method will improve the ability to detect AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories and having patients come back for follow up based on those categories.

Official Title
-----------------
Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Other: No interventions are planned


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-exudative age-related macular degeneration Exclusion Criteria: Exudative age-related macular degeneration

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: No interventions are planned|No interventions are planned|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | Two Years |
The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

Study Overview
=================
Brief Summary
-----------------
Thyroid hormone autoantibodies(THAA) in serum can Interfere radioimmunoassay for the determination of free thyroid hormones. Thyroid function test plays a key role in the diagnosis and treatment of autoimmune thyroid disease (AITD), and abnormal examination results in misdiagnosis and mistreatment. At present, the epidemiological results of THAA in AITD are inconsistent, and the pathogenesis has not been clarified. However, there is no relevant research on THAA in China. This project intends to collect AITD patients and healthy people, detecting THAA, at the same time testing thyroid function and thyroid autoantibodies, definiting positive rate of THAA in AITD patients, observing the effect of common therapeutic drugs for AITD on THAA, investigating the rule of THAA influencing thyroid function test results .This project will provide the basis and method for how to effectively avoid THAA interfering with thyroid function test.

Official Title
-----------------
The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

Conditions
-----------------
Autoimmune Thyroid Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old Exclusion Criteria: Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Hashimoto or Grave's disease patients in treatment<br>Draw 10 ml venous blood | |
| Hashimoto or Grave's disease patients on initial treatment<br>10 ml of venous blood was extracted every month for three months | |
| Pregnant woman with Hashimoto or Grave's disease<br>10 ml venous blood was extracted every month to postpartum for 6 months | |
| Healthy crowd<br>Draw 10 ml venous blood | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of thyroid hormone autoantibodies in AITD | Radioimmuno precipitation test used for thyroid hormone autoantibodies | measured after 1 year of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autoimmune thyroid disease, Thyroid hormone autoantibodies, Hashimoto's thyroiditis, Grave's disease
CPAP Versus NPPV in ACPE

Study Overview
=================
Brief Summary
-----------------
To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.

Detailed Description
-----------------
Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV. Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO. Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask. Inclusion criteria were: severe dyspnoea, respiratory rate > 30, PaO2/FiO2 < 200, muscle fatigue. Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.

Official Title
-----------------
Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.

Conditions
-----------------
Pulmonary Edema

Intervention / Treatment
-----------------
* Device: CPAP and Non Invasive Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rapid onset of the symptoms severe dyspnoea at rest respiratory rate > 30 breath per minute use of accessory respiratory muscles PaO2/FiO2 < 200, radiological findings of ACPE Exclusion Criteria: ST elevation myocardial infarction hemodynamic instability (systolic arterial pressure < 90 mmHg need for immediate endotracheal intubation (respiratory arrest, bradypnea inability to protect the airways, impaired sensorium (agitation or unconsciousness inability to clear secretions, respiratory tract infections chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy pulmonary embolism, pneumonia, recent oesophageal-gastric surgery gastrointestinal bleeding facial deformities haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

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 |
| --- |
|Device: CPAP and Non Invasive Ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of recovery |  |  | 
| hospital length of stay |  |  | 
| mortality and improvement in gas exchange |  |  |
A Medication Adherence Intervention for HIV Infected Veterans

Study Overview
=================
Brief Summary
-----------------
It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Detailed Description
-----------------
Background: It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently. Objectives: Optimizing health for HIV patients requires excellent adherence to antiretroviral medication regimens. However, its unclear how best to incorporate adherence education and support programs into VA HIV outpatient care. We implemented and evaluated a pharmacist program (ACE) and a Pager reminder program to support adherence in veterans with HIV. Methods: We used a quasi-experimental design with pre-post evaluation at four VA Centers. Three treatment conditions (ACE, Pager, Usual Care) were rolled-in sequentially over two study phases, allowing for group comparisons between conditions. ACE is a multi-component manualized 4-session, individual patient education and support program by trained pharmacists. The Pager intervention used alphanumeric pagers to remind patients of dosing times. Electronically-monitored medication adherence (MEMS), self-report questionnaires, and pharmacy refill records were collected. Qualitative site interviews were collected before and after interventions to assist with program evaluation. Multilevel mixed models were used to analyze main study outcomes over time. Secondary analyses compared subgroup who actually received all ACE sessions (�as treated�) to controls. Status: Project has been completed and Final Report submitted to HSR&D CO.

Official Title
-----------------
A Medication Adherence Intervention for HIV Infected Veterans

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be greater than or equal to 18 years old, must be enrolled in HIV Primary care at one of 4 VA study sites and be taking antiretroviral therapy. Exclusion Criteria:

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Outcome of Facial Palsy Following Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Retrospective case series,the aim of this study is to assess the outcome and rate of complications in patients with facial palsy following rehabilitation, a retrospective study.

Detailed Description
-----------------
Data from all patients presenting to the outpatient clinics of the Physical Medicine, Rheumatology and Rehabilitation Department. Faculty of Medicine, Alexandria University in the past 3 years will be collected. The outcome and complications from rehabilitation of facial palsy will be recorded. Primary Outcome: complications of Facial palsy following rehabilitation. Confidentiality of all records will be ensured.

Official Title
-----------------
Outcome and Complications of Peripheral Facial Palsy Following Rehabilitation: A Retrospective Study

Conditions
-----------------
Facial Paralysis

Intervention / Treatment
-----------------
* Combination Product: rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with primary idiopathic peripheral facial palsy Exclusion Criteria: all patients with secondary causes of facial palsy
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with peripheral facial palsy<br>collection of data from records on the outcome of rehabilitation therapy on patients with peripheral facial palsy and types of complications associated with this therapy type | Combination Product: rehabilitation<br>* electro-therapy, heat therapy, massage and exercise therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis or outcome of therapy | have patients recovered fully, partially or did not recover | 3-6 months | 
| complications | types of complications developed during rehabilitation | 3-6 months |
Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify genetic abnormalities and molecular pathways associated with the occurrence of CCAM.

Detailed Description
-----------------
Congenital lung malformations are rare diseases, characterized by the coexistence in the same individual of normal lung and localized lung malformation. Among these malformations, congenital cystic adenomatoid malformations (CCAM) represent the most important group, with an estimated incidence between 1/11 000 and 1/35 000 births. The precise mechanisms leading to these lung malformations remain poorly understood. This project aims to identify key genetic and/or molecular mechanisms associated with the occurrence of CCAM. CCAMs are collected during postnatal surgical resection. Parental agreement is required. A standardised histologic description of malformations is performed for each sample. Normal lung tissue at the periphery of the malformation is considered as control. Malformations will be analyzed in a systematic way by proteome and transcriptome, after laser microdissection. Somatic genetic abnormalities will also systematically be sought.

Official Title
-----------------
Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations

Conditions
-----------------
Congenital Cystic Adenomatoid Malformation (CCAM)

Intervention / Treatment
-----------------
* Genetic: Patient


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children < 8 years Thoracic surgery for congenital lung malformation Parental written consent Exclusion Criteria: Children > 8 years Previous infection of the malformation Parental rebutal

Ages Eligible for Study
-----------------
Maximum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient<br>congenital cystic adenomatoid malformations | Genetic: Patient<br>* Blood and histological samples will be done at day of the inclusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRNA expression | Transcriptomic analysis | at Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein expression | Proteomic expression | at Day 0 | 
| Somatic genetic abnormalities | CGH array | at Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital lung malformation, Congenital Cystic Adenomatoid Malformation, Cystic lung disease
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.

Official Title
-----------------
An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Epoprostenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent prior to initiation of any study-mandated procedure Patients who completed participation in study AC-066A301 Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301 Exclusion Criteria: Patients who prematurely discontinued study drug in study AC-066A301 Patients for whom continued treatment with EFI is no longer considered appropriate
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: Treatment<br>Single arm, open-label | Drug: Epoprostenol<br>* Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent Adverse Events |  | On average 2.72 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure Duration | Duration of exposure to EFI | On average 2.72 years |