linjc16/ctgov huggingface dataset:
Comparison of Standard vs. Accelerated Corneal Crosslinking

Study Overview
=================
Brief Summary
-----------------
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.

Official Title
-----------------
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia

Conditions
-----------------
Keratoconus, Ectasia Corneal

Intervention / Treatment
-----------------
* Combination Product: riboflavin 0.1%
* Combination Product: Riboflavin 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented keratoconus or ectasia after refractive surgery Exclusion Criteria: Insufficient corneal thickness Ocular condition that may predispose the eye to complications History of chemical injury or delayed epithelial healing Condition that would interfere with or prolong epithelial healing Known sensitivity to treatment medications Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 10 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Accelerated<br>Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes | Combination Product: riboflavin 0.1%<br>* Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes<br>|
| Active Comparator: Standard<br>Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes | Combination Product: Riboflavin 0.1%<br>* Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximum keratometry | assessed by corneal tomography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corrected distance visual acuity | assessed with Snellen chart | 6 months | 
| Change in uncorrected distance visual acuity | assessed with Snellen chart | 6 months |
The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Fentanyl 1
* Drug: Fentanyl 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-II obtaining written informed consent from the parents aged 20-65 years who were undergoing radical open gastrectomy Exclusion Criteria: abdominal surgery previously patient who refuse the patient controlled analgesia unstable angina or congestive heart failure uncontrolled hypertension (diastolic bp>110mmHg) coagulopathy hepatic failure renal failure bradycardia on EKG (under 50 bpm) Ventricular conduction abnormality drug hyperactivity neurological or psychiatric illnesses mental retardation patients who can't read the consent form due to illiterate or foreigner 14.infection 15. pregnant 16. obesity (BMI > 30kg/m2)

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional fentanyl-based epidural PCA<br> | Drug: Fentanyl 1<br>* conventional fentanyl-based epidural PCA<br>|
| Experimental: dexmedetomidine to fentanyl-based intravenous PCA<br> | Drug: Dexmedetomidine<br>* Dexmedetomidine mixed fentanyl based intravenous PCA<br>|
| Active Comparator: Conventional fentanyl-based intravenous PCA<br> | Drug: Fentanyl 2<br>* conventional fentanyl based intravenous PCA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs | 48 hours after operation |
Study for Evaluating Different Methods of Measuring Depression Treatment Response

Study Overview
=================
Brief Summary
-----------------
Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in future depression clinical trial. Focus is on increased precision of measurement.

Official Title
-----------------
A Phase 4 Randomized, Double-Blind, Placebo Controlled Methodology Study to Evaluate the Time of Onset of AntiDepressant Response in Subjects With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Procedure: electronic diary
* Drug: Sertraline
* Drug: Placebo
* Procedure: voice acoustics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Major Depressive Disorder with symptoms of depression present at least 1 month Psychotropic medications currently not being taken Exclusion Criteria: Failure to respond in past 5 years to antidepressant therapy of adequate duration and dosing Diagnoses of following conditions or disorders within past 6 months: generalized anxiety, obsessive compulsive, panic, post stress, anorexia, bulimia, alcohol or substance abuse or social anxiety disorder Diagnoses current or past of the following conditions or disorders: schizophrenia, psychotic disorder, delieium, dememtia, amnestic cognitive disorder, bipolar

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: electronic diary|nan|
|Drug: Sertraline|nan|
|Drug: Placebo|nan|
|Procedure: voice acoustics|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is time to treatment response and difference in time to response for the two data collection methods - daily patient electronic assessment versus weekly assessments measured in clinic. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint is the difference in study participation burden between standard and enhanced data collection. |  |  |
Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy

Study Overview
=================
Brief Summary
-----------------
A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.

Official Title
-----------------
Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Belotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 Years and older Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV) ≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated prior platinum based chemotherapy ECOG PS ≤ 2 Life expectancy > 3 months Adequate organ function: hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN renal: serum creatinine ≤ 1.5×ULN Signed a written informed consent Exclusion Criteria: Active infection Symptomatic brain lesion Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases Prior anticancer therapy within 4 weeks before enroll Active pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Belotecan<br>Single arm | Drug: Belotecan<br>* 3.0 mg/m2, Day 1, 8, 15 every 4 weeks<br>* Other names: Camtobell inj.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | every 2 cyc | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 6 months after Last patient out | 
| Progression Free survival |  | 6 months after Last patient out | 
| Adverse event |  | every visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Belotecan, Camtobell inj, NSCLC
Study Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic neuropathy. It is a selective antagonist that binds competitively to the glutamate site of the N-methyl-D-aspartate (NMDA) receptor. This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with placebo in subjects with neuropathic pain associated with diabetic neuropathy.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 3 Fixed Doses of EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

Conditions
-----------------
Diabetes Mellitus, Diabetic Neuropathy, Painful

Intervention / Treatment
-----------------
* Drug: EAA-090


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women of childbearing potential must have a negative serum pregnancy test result at screening Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy Exclusion Criteria: Pregnancy, lactation, or plans to become pregnant during the study Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EAA-090|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
-----------------
Neuropathic Pain, Diabetic Neuropathy
Kidney Stone Risk Factors in Patients Infected With HIV

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

Detailed Description
-----------------
This study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients. Primary Objective : Finding the cause of renal stone in HIV patients defined as stone composition if stone is available or more probable pathophysiological mechanism Risk profile for stone recurrences estimated on risk indices in HIV1 patients Secondary Objective(s) Identify prevalence of recurrences and describe co-morbidities associated with stone disease Describe urological management for renal stones in HIV patients Describe the causes of drug induced renal stones

Official Title
-----------------
CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV

Conditions
-----------------
Nephrolithiasis, HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female HIV1 infected patients willing to participate in the study Having experienced a renal stone episode within the past six months or living with a renal stone Able to understand the protocol Giving oral consent Exclusion Criteria: CT scan impossible Follow up impossible over 1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Qualitative assessment of the cause of the renal stone | Qualitative assessment of the cause of the renal stone based on different biological and clinical parameters (biochemical analysis of urines, cristalluria, low dose renal CT, patient history, family history…) | at 6 months | 
| Risk profile for recurrence of renal stone | Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease |  | up to 12 months | 
| Urological management for renal stones in HIV patients |  | up to 12 months | 
| Causes of drug induced renal stones |  | up to 12 months | 
| Number of stone recurrences |  | at 6 months | 
| Number of stone recurrences |  | at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CALVIH, Renal stone, HIV1, Renal colic, Atazanavir, Crystalluria, Chronic Kidney Disease, Calcium Oxalate
A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine what effects Esomeprazole (Nexium) has on increasing or decreasing the amount of oral taxane in the blood, and to determine the safety of oral taxane and effect of oral taxane on the cancer.

Official Title
-----------------
Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Oral Taxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cancers excluding cancers within the blood Adequate kidney and liver function > = 4 weeks from last course of chemotherapy Exclusion Criteria: Inability to swallow capsules Other active medical disorder Abnormal heart function or use of drugs that affect the heart

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral Taxane|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of taking Nexium in combination with oral taxane and the effect this combination has on oral taxane's exposure levels in the body. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of a single dose of oral taxane followed by a therapeutic regimen of oral taxane administered twice weekly |  |  |
Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Official Title
-----------------
Evaluation of Ophthalmic Lenses for Myopia Management

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Other: Myopia control lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 5 to 12 years old Myopia (spherical equivalent with cycloplegic) ≤ -0.50D Astigmatism < 1.50D Anisometropia < 1.50D Best-corrected visual acuity ≥ 20/20 Exclusion Criteria: Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses. Participants with ocular pathology such as retinal detachment. Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface. Participants with systemic diseases that may affect vision.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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 |
| --- | --- |
| Experimental: Myopia Control Lens<br> | Other: Myopia control lens<br>* Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Measure of axial length with a biometer | 5 minutes | 
| Refraction | Binocular refraction with autorefractometer under cyclopegia | 5 minutes |
Circulating Epigenetics in Pancreatic Surgery

Study Overview
=================
Brief Summary
-----------------
The overall objective of the study is to assess DNA-methylation changes in circulating blood cells and cell free DNA in plasma from patients undergoing the Whipples procedure for pancreatic caner

Official Title
-----------------
Towards Precision Medicine in Pancreatic Surgery - an Integrative Approach Combining Deep Learning, Genetics and Epigenetics

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pancreatic cancer scheduled for the Whipples procedure Exclusion Criteria: Under 18 years of age Pregnancy Unable to provide informed consent.

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 |
| --- | --- |
| 1<br>Patients undergoing a Whipples procedure for pancreatic cancer | Diagnostic Test: Blood sampling<br>* Blood sampling preoperatively and sequentially up to 30 days post op<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in DNA-methylation patterns from the pre to postoperative setting |  | Up to 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of a postoperative complication |  | 30 days postoperatively | 
| Relapse of pancreatic cancer |  | 2 years from time of operation |