linjc16/ctgov huggingface dataset:
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Dexamethasone Drug Delivery System
* Drug: Placebo Drug Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned single cataract extraction with lens implant Best-corrected visual acuity of 20/200 or better in the opposite eye Exclusion Criteria: Glaucoma or history of intraocular hypertension in the study eye History of chronic ocular allergy in the last year requiring treatment Scheduled for cataract surgery in the non-study eye during study participation

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone Drug Delivery System<br>Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. | Drug: Dexamethasone Drug Delivery System<br>* Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.<br>|
| Placebo Comparator: Placebo Drug Delivery System<br>Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. | Drug: Placebo Drug Delivery System<br>* Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Clearance of Anterior Chamber Inflammation | The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst). | Up to Day 71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Levels of Dexamethasone | Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood. | Day 2, Day 7, Day 14 |
Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas

Study Overview
=================
Brief Summary
-----------------
Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer.

Official Title
-----------------
Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas

Conditions
-----------------
Solid Tumor Malignancy, Lymphoid Malignancy (Lymphoma and CLL), Leukemia, Lymphoma

Intervention / Treatment
-----------------
* Drug: SNX-5422 Mesylate Hsp90 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid tumors or lymphoid malignancies refractory to standard therapy measurable disease recovery to Grade < 1 toxicity due to prior adverse event or chemotherapy no chemotherapy within 4 weeks of entering study Age > 18 years Karnofsy >= 60% Life expectancy > 3 months normal or adequate organ and marrow function Exclusion Criteria: receiving other investigational agents brain metastases uncontrolled medical illness HIV+ receiving combination antiretroviral therapy significant GI disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: SNX-5422 Mesylate Hsp90 inhibitor<br>* dose escalated, tablets twice a week; undetermined duration until disease progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD, safety and toxicity |  | continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic profile of SNX-5422 |  | first cycle | 
| tumor response measured by X-rays or scans |  | after every 2 cycles |
Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Detailed Description
-----------------
Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Official Title
-----------------
A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: evogliptin
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with 6.5%≤HbA1c≤11.0% at screening Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening Subjects with 20kg/m2≤BMI≤40kg/m2 at screening Exclusion Criteria: Subjects with fasting plasma glucose≥270mg/dL at screening Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening Subjects with ALT and AST 2.5 times or higher than upper normal range

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: evogliptin<br>evogliptin 5mg qd add-on to metformin | Drug: evogliptin<br>* evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg<br>* Other names: Suganon;|
| Active Comparator: sitagliptin<br>sitagliptin 100mg qd add-on to metformin | Drug: Sitagliptin<br>* sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg<br>* Other names: januvia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | unit: % | Change from baseline at 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose | unit : mg/dL | Change from baseline at 24 week | 
| HOMA-beta | unit: % | Change from baseline at 24 week | 
| HbA1c response rate | unit: % | Change from baseline at 24 weeks |
Comparison for Oral Negative Pressure Therapy and CPAP for OSA Under Sleep Endoscopy Assistance: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This is the study entitled Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial. CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.

Official Title
-----------------
Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch

Conditions
-----------------
OSA, iNAP, DISE

Intervention / Treatment
-----------------
* Device: iNAP
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate OSA Exclusion Criteria: hypopharynx obstruction ASA classification of physical status)>3 allergy toDexmedetomidine COPD stage IV Asthma with exacerbation severe CHF age < 18 year-old claustraphobia any reason : can not tolerate CPAP second or third degree AVB

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iNAP<br> | Device: iNAP<br>* iNAP for the treatment of OSA<br>|
| Active Comparator: CPAP<br> | Device: CPAP<br>* CPAP for the treatment of OSA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Epworth Sleepiness Scale (ESS) | lower ESS means better outcome | Change from Baseline ESS at 1 month | 
| The Epworth Sleepiness Scale (ESS) | lower ESS means better outcome | Change from Baseline ESS at 2 months | 
| apnea-hypopnea index (AHI) | lower AHI means better outcome | Change from Baseline AHI at 2 months |
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair

Study Overview
=================
Brief Summary
-----------------
X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.

Official Title
-----------------
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair

Conditions
-----------------
Abdominal Aortic Aneurysm, Endoleak

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in follow-up after endovascular implantation of abdominal aortic prothesis 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 |
| --- | --- | --- |
| Detection of endoleak with CEUS | Compare CEUS with computed tomography angiography (CTA) sensitivity for detection of endoleak | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Diagnostic Technique, Ultrasound
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.

Official Title
-----------------
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months Patients giving informed consent to participate in the survey Exclusion Criteria: Non-ambulatory patients Illiterate patients and patients otherwise unable to complete a written survey
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin-treated patients with diabetes<br> | Other: No treatment given<br>* Patients will be asked to complete a two-part patient self-assessment questionnaire (SAQ) comprising a retrospective cross-sectional evaluation (Part 1), and a prospective observational evaluation (Part 2).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any hypoglycaemic event |  | In the 4 weeks prior to and following the baseline visit (Week 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the reported incidence rates of any hypoglycaemia |  | In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit | 
| Incidence of hypoglycaemic events requiring hospital admission |  | In the 6 months prior to and 4 weeks following the baseline visit | 
| Incidence of all severe hypoglycaemic events |  | In the 6 months prior to and 4 weeks following the baseline visit | 
| Incidence of probable symptomatic hypoglycaemic events |  | In the 4 weeks prior to and following the baseline visit |
Study of ORL-1B in Patients With Biotinidase Deficiency

Study Overview
=================
Brief Summary
-----------------
An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.

Official Title
-----------------
An Open-label, Single-arm, Phase 2 Study of ORL-1B in Patients With Biotinidase Deficiency

Conditions
-----------------
Biotinidase Deficiency

Intervention / Treatment
-----------------
* Drug: ORL-1B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of biotinidase deficiency. Less than 18 years old. Exclusion Criteria: Diagnosis of any other disease that is not a manifestation of biotinidase deficiency.

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- |
| Other: Treatment with ORL-1B.<br>Pediatric patients with biotinidase deficiency. | Drug: ORL-1B<br>* Oral ORL-1B<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in seizure frequency | Statistically significant improvement in seizure frequency after the ORL-1B treatment. | 12 months |
Computer-aided Detection of Colorectal Polyps

Study Overview
=================
Brief Summary
-----------------
In this observational pilot study, we assess the diagnostic performance of an artificial intelligence sytem for automated detection of colorectal polyps.

Detailed Description
-----------------
During standard colonoscopy, a substantial number of colorectal polyps can be missend. As shown in a recent meta-analysis, miss rates for adenomas can reach up to 26%. In this study, it is tested whether an artificial intelligence system that highlights colorectal polyps during screening or surveillance colonoscopy in real time can lead to an increased detection of colorectal polyps during the examination.

Official Title
-----------------
Development and Validation of a New Artificial Intelligence System for Automated Detection of Colorectal Polyps During Colonoscopy

Conditions
-----------------
Adenoma Colon, Polyp of Colon

Intervention / Treatment
-----------------
* Device: Artificial Intelligence System for Detection of colorectal polyps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Screening or surveillance colonoscopy Exclusion Criteria: known or suspected inflammatory bowel disease uncontrolled coagulopathy known polyps or referral for polypectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Artificial Intelligence<br> | Device: Artificial Intelligence System for Detection of colorectal polyps<br>* In this group, an artificial Intelligence System will be used for computer-aided diagnosis of colorectal polyps. Diagnostic Performance of the artificial intelligence System for detection of polyps will be compared against Operator-based detection in the same group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility to use the AI System in vivo during colonoscopy | As a Primary outcome, whether the AI System is capable of detecting colorectal polyps in vivo during colonoscopy | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance of the AI System for detecting colorectal polyps | As a secondary outcome, we assess the diagnostic Performance of the AI System for detecing colorectal Polyp in real time | 4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, endoscopy, adenoma detection, polyp detection, artificial intelligence
Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?

Study Overview
=================
Brief Summary
-----------------
It is unclear the effect of a spouse's presence on the partureint's and the spouse's stress level during the performance of epidural analgesia during labor. Couples will be randomized to two groups: one group where the spouse is present during the performance of epidural analgesia and the second where the spouse is not present. Before and after epidural anlgesia, both the spouse and parturient will be have their blood pressure and pulse checked. In addition, both will have their salivary amylase measured. Salivary amylase is an enzyme whic has been foud to correlate directly with stress levels. To check this enzyme, a sample of saliva is given.

Official Title
-----------------
The Effect of the Presence of a Spouse on the Parturient's and Her Spouse's Stress Level During Epidural Analgesia During Labor as Measured by Salivary Amylase

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Behavioral: stress level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy term parturients Exclusion Criteria: Diabetes Preterm labor Mouth pathologies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spouse present,<br> | Behavioral: stress level<br>* Stress levels<br>|
| Active Comparator: spouse absent<br> | Behavioral: stress level<br>* Stress levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress levels |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic parameters |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parturient, epidural analgesia, labor, spouse, Stress levels, Salivary amylase