linjc16/ctgov huggingface dataset:
Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery

Study Overview
=================
Brief Summary
-----------------
Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.

Official Title
-----------------
Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection

Conditions
-----------------
Glaucoma Patients Scheduled for Trabeculectomy

Intervention / Treatment
-----------------
* Drug: Mitomycin_c
* Drug: Mitomycin_c


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age Range between 18 to 80 years old Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome. Exclusion Criteria: Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mitomycin_c application before sclera flap dissection<br> | Drug: Mitomycin_c<br>* 0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection<br>|
| Active Comparator: Mitomycin_c application after sclera flapdissection<br> | Drug: Mitomycin_c<br>* 0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal endothelial cell density | specular microscopy | six month | 
| corneal endothelial cell polymorphism | specular microscopy | 6 months | 
| corneal endothelial cell polymegathism | specular microscopy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP (intra ocular pressure) | applanation tonometry | six months |
Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions

Study Overview
=================
Brief Summary
-----------------
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.

Official Title
-----------------
Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions: Observational Case Control Study in Upper Egypt

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: glomerular filtration rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All non alcoholic fatty liver disease patients evidenced by abdominal ultrasound. Urine analysis whether normal or renal sedimentation. Exclusion criteria: Alcoholic fatty liver patients. patients known to have diabetes mellitus. patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune. patients known to have kidney disease. Hypertension. Hyperuricemia. Impaired urea and creatinine patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| study group<br>non alcoholic fatty liver disease patients | Diagnostic Test: glomerular filtration rate<br>* collection of blood sample 5 milliliter for calculation of glomerular filtration rate<br>|
| Control group<br>fatty liver patients | Diagnostic Test: glomerular filtration rate<br>* collection of blood sample 5 milliliter for calculation of glomerular filtration rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with abnormal laboratory glomerular filtration rate | decreased glomerular filtration rate <60 mL/minute will be considered abnormal | 1 day |
Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam

Study Overview
=================
Brief Summary
-----------------
This is a cluster randomized controlled trial to determine the feasibility and preliminary effectiveness of culturally adapted psychosocial intervention for Alzheimer's family caregivers in Vietnam. The psychosocial intervention is being compared with an enhance control condition.

Official Title
-----------------
Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam

Conditions
-----------------
Family Caregivers

Intervention / Treatment
-----------------
* Behavioral: REACH-VIETNAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family member providing care to someone in household with Alzheimer's disease or a related dementia Exclusion Criteria: Cognitively impaired

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH-VN<br>In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months | Behavioral: REACH-VIETNAM<br>* Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease<br>|
| No Intervention: Enhanced control<br>Single session with education about nature of dementia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zarit Burden Inventory-4 | Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-4 | Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity). | 3 months | 
| Alzheimer's Disease Knowledge Scale | Scale that assess knowledge of Alzheimer's disease. Range is 0-30. Higher score is better outcome (i.e., more accurate knowledge). | 3 months |
The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. Nateglinide and acarbose are frequently used for this purpose. We hypothesized that the short acting sulfonylurea nateglinide may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. And we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.

Official Title
-----------------
Phase IV Study on Predictive Markers for the Effectiveness of Nateglinide or Acarbose for Controlling Post-Prandial Glucose in Type 2 Diabetics Already on Optimized Insulin Glargine Therapy

Conditions
-----------------
Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: nateglinide
* Drug: acarbose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean Type 2 diabetes mellitus No prior history of diabetic ketoacidosis HbA1c between 7.5-10.0% Exclusion Criteria: Type 1 diabetes mellitus Gestational diabetes mellitus Secondary diabetes mellitus Severe hyperglycemia with symptoms Severe chronic diabetic complications (PDR,s-Cr>1.3mg/dL)

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nateglinide|nan|
|Drug: acarbose|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 point SMBG (self monitoring of blood glucose) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-beta for predicting the effectiveness of each agents |  |  |
Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

Detailed Description
-----------------
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Official Title
-----------------
A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Conditions
-----------------
Dry Eye Syndrome, Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Device: Oculeve Intranasal Neurostimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with dry eye disease Literate, able to speak English or Spanish, and able to complete questionnaires independently Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol Exclusion Criteria: Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device Corneal transplant in either or both eyes Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active - Device<br>The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment. | Device: Oculeve Intranasal Neurostimulator<br>* Neurostimulation device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Meniscus Height Captured by Optical Coherence Tomography | Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography. | Day 1 |
Calprotectin in Chronic Prosthetic Joint Infection

Study Overview
=================
Brief Summary
-----------------
A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.

Official Title
-----------------
Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection

Conditions
-----------------
Prosthetic Joint Infection, Prosthetic Infection, Arthroplasty Complications

Intervention / Treatment
-----------------
* Diagnostic Test: Calprotectin Lateral Flow Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled arthroplasty exchange for any of the following reasons: infection loosening instability malalignment periprosthetic fracture Exclusion Criteria: acute prosthetic joint infection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PJI<br>Patients with septic arthroplasty failure | Diagnostic Test: Calprotectin Lateral Flow Test<br>* Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate<br>|
| Aseptic<br>Patients with aseptic causes of arthroplasty failure | Diagnostic Test: Calprotectin Lateral Flow Test<br>* Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of synovial fluid calprotectin | The level of synovial fluid calprotectin measured in joint fluid aspirate as a diagnostic test for prosthetic joint infection. The accuracy is calculated by comparing its results with the International Consensus Meeting (ICM) on prosthetic joint infection criteria of 2018. | Intraoperatively |
Plethismographic Perfusion Index in Neonates

Study Overview
=================
Brief Summary
-----------------
Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls.

Detailed Description
-----------------
Newborn babies admitted to the NICU and well baby will be connected to a specially designed photoplethismograph (PPG). Right hand (pre ductal), and and one of the legs (postductal) values will be compared, based on the formula Delta amplitude of PPG / baseline absorption (perfusion index (PI)). Normal values will be defined in healthy term and preterm babies, and clinical conditions in which the PI is expected to change (Patent Ductus Artheriosus, Persistent pulmonary hypertension of the newborn)will be compared with these normal values.

Official Title
-----------------
Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography

Conditions
-----------------
Patent Ductus Arteriosus, Persistent Pulmonary Hypertension of the Newborn

Intervention / Treatment
-----------------
* Device: PPG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PDA, PPHN and Normal babies who underwent echocardiography Exclusion Criteria: Other cardiac diseases

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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 |
| --- | --- |
| Term<br>Normal Term Newborn Intervention: PPG | Device: PPG<br>* A PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software<br>|
| Preterm<br>Preterm babies admitted to the NICU not suffering from the conditions to be studied Intervention: PPG | Device: PPG<br>* A PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software<br>|
| PDA<br>Patent Ductus Arteriosus Intervention: PPG | Device: PPG<br>* A PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software<br>|
| PPHN<br>Persistent Pulmonary Hypertension Intervention: PPG | Device: PPG<br>* A PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion Index |  | 5 minutes |
A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

Study Overview
=================
Brief Summary
-----------------
To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.

Detailed Description
-----------------
Pharmacokinetics and Safety

Official Title
-----------------
A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost 0.005%.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks. The pediatric subjects will be grouped by age (0 to <3 years, 3 to <12 years, 12 to 18 years). Exclusion Criteria: Ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit. History of ocular trauma or surgery in either eye within 14-days of the screening visit. Use of continuous wear contact lenses.

Ages Eligible for Study
-----------------
Minimum Age: 0 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: latanoprost<br>* latanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma latanoprost acid concentrations at steady-state. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to systemic exposure of latanoprost |  | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Latanoprost Pediatrics Pharmacokinetics Safety