linjc16/ctgov huggingface dataset:
Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers' performance on a standard over-the-road driving test and a car-following test.

Detailed Description
-----------------
The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows. Rupatadine Hydroxyzine Placebo

Official Title
-----------------
Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Rupatadine
* Drug: Hydroxyzine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy males or females Subjects must be experienced drivers. Vision: normal binocular acuity, corrected, or uncorrected. Exclusion Criteria: 1. Pregnant or nursing females.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rupatadine|nan|
|Drug: Hydroxyzine|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual driving performance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime sleepiness |  |  | 
| Subjective sleepiness |  |  | 
| Alertness |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Driving performance, Antihistamine
A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

Detailed Description
-----------------
An open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.

Official Title
-----------------
A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Drug: Ustekinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Hidradenitis suppurativa Hurley stage II or III No response to conventional local and oral antibiotics, or immunnesuppressive medication, or TNF-alpha inhibitors or surgery The patient has to be able to complete a dutch questionnaire Informed consent must be obtained Exclusion Criteria: Not able to complete a Dutch questionnaire Pregnancy or breast feeding Active hepatitis B or C infection, HIV or tuberculosis Treatment with biologics or other immunosuppressive medicine in the previous 3 months Malignancies in the last 10 years with the exception of basal cell carcinoma Demyelinating disorders Heart failure Known allergy to ustekinumab or to its preservatives Live vaccins in the next 3 months Sever liver or renal failure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ustekinumab<br>Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28 | Drug: Ustekinumab<br>* subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28<br>* Other names: Stelara;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sartorius score | Clinical response is defined as an improvement of the Sartorius score of at least 50% | 76 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hidradenitis suppurativa, Acne ectopica, Inverse acne, Ustekinumab, Stelara
Efficacy and Safety of HE10 for Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.

Detailed Description
-----------------
This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.

Official Title
-----------------
Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: HE 10
* Drug: Restasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal staining score of ≥2(Oxford grade) Schirmer test score (without anesthesia) < 10 mm/5 min in either eye Tear break-up time is 10 seconds or less Screening both eyes, the corrected visual acuity is 0.2 or more Exclusion Criteria: Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status The patients with systemic or ocular disorders affected the test result Being treated with systemic steroid History of eyeball surgical operation within 3 months of screening visit Wearing contact lenses within 2 weeks of screening visit Be a use or used punctual plug within 1 month of screening vist Use of cyclosporine eye drop within 3 weeks Pregnancy or Breastfeeding Intraocular pressure > 25 mmHg Abnormal eyelid function : Disorders of the eyelids or eyelashes

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Experimental: HE10<br>Drug: HE10 1 2 drops b.i.d at 12 hour interval for 12 weeks | Drug: HE 10<br> <br> |
| Active Comparator: Restasis<br>Drug: Restasis(Cyclosporine 0.05%) 1 2 drops b.i.d at 12 hour interval for 12 weeks | Drug: Restasis<br> <br> * Other names: 0.05% cyclosporine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining Test to assess eye dryness | Change from baseline in eye dryness at 12 weeks | 12 weeks |
Bacterial Colonization After Tunneling in Femoral Perineural Catheters

Study Overview
=================
Brief Summary
-----------------
Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis. Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters. Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome). Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling

Official Title
-----------------
Bacterial Colonization After Tunneling in Femoral Perineural Catheters

Conditions
-----------------
Bacterial Colonization

Intervention / Treatment
-----------------
* Procedure: tunnelized perineural catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter Exclusion Criteria: Age under 18 years Local nerve pathology Refusal to regional anaesthesia Major psychological disorder Major cardiac conduction disease Infection at the puncture site

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: femoral tunnelized perineural catheter<br> | Procedure: tunnelized perineural catheter<br>* the catheter will be tunneled 2-3 cm subcutaneously.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of femoral perineural catheter colonization |  | between 24 hours and 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femoral perineural catheter, tunnelization, complication, colonization, infection
Antithrombin III and Post-liver Transplantation Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The reno-protective effect of Antithrombin III (ATIII) has been well-studied in various animal studies; however, little is known about the effect of ATIII on kidney function in patients undergoing liver transplantation (LT). This study aimed to determine the association between preoperative ATIII level and postoperative acute kidney injury (AKI) after LT (post-LT AKI).

Official Title
-----------------
Low Preoperative Antithrombin III Level is Associated With Postoperative Acute Kidney Injury After Liver Transplantation

Conditions
-----------------
Liver Transplantation and Antithrombin

Intervention / Treatment
-----------------
* Drug: Antithrombin III


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018 Exclusion Criteria: patients who underwent re-transplantation patients who were previously diagnosed with end-stage renal disease or Chronic kidney disease patients who were being treated with continuous renal replacement therapy preoperative or postoperative Antithrombin III levels were not available

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| antithrombin III < 50 %<br>preoperative antithrombin III levels <50% | Drug: Antithrombin III<br>* In liver transplant recipients with baseline antithrombin III levels lower than 50%, exogenous Antithrombin III was administrated during the anhepatic phase of the liver transplant surgery.<br>|
| Antithrombin III ≥ 50 %<br>preoperative antithrombin III levels ≥ 50 % | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | serum creatinine >0.3 mg/dL within POD 2 or increase by >1.5 times within POD 7 according to the criteria set by the Kidney Disease: Improving Global Outcomes (KDIGO) classification | postoperative 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic kidney disease | glomerular filtration rate less than 60 mL∙min-1∙1.73m-2 on two consecutive occasions at least 3 months apart | postoperative 3 months | 
| early allograft dysfucion | at least one of the following: total bilirubin ≥10 mg/dL on postoperative day (POD) 7, prothrombin time (INR) ≥1.6 on POD 7, and alanine or aspartate aminotransferases >2000 IU/L within POD 7 | postoperative 7 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute kidney injury, antithrombins, liver transplantation
Comparison of Two Approaches to Weight Loss Follow-Up Study

Study Overview
=================
Brief Summary
-----------------
This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins' diet. We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.

Detailed Description
-----------------
***PLEASE NOTE: Only those who participated in the original study of low carbohydrate and low fat diets are eligable for enrollment in this follow-up study***

Official Title
-----------------
Comparison of Two Approaches to Weight Loss Follow-Up Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Low Carbohydrate Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Body mass index between 30 and 40 Live and work within 1 hour of the study site Stable psychological status Exclusion criteria History of heart disease, heart attack, or stroke Blood pressure >140/90 mmHg Abnormal cholesterol levels Significant psychiatric illness Any medication that affects weight or metabolic rate Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer) Currently using antidepressants, steroids, tobacco, or illegal drugs Pregnant, breastfeeding, or planning pregnancy 10 lb change in weight within 6 months of study entry History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease History of protein wasting diseases or gout Severe arthritis Osteoporosis Certain types of hormone replacement therapy Currently following a vegetarian diet

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Low Carbohydrate Diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Loss
Fetal Orbital Measurements by 3D Ultrasound

Study Overview
=================
Brief Summary
-----------------
The investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other examinations during pregnancy. The investigators will examine 5-10 women in each gestational age in order to create a normal values curve throughout pregnancy.

Conditions
-----------------
Orbital Volume

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: well dated singleton pregnancies Exclusion Criteria: multiple pregnancy pregnancies with known malformations, chromosomal abnormalities or intrauterine infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

Detailed Description
-----------------
Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.

Official Title
-----------------
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

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

Intervention / Treatment
-----------------
* Drug: escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet DSM-IV criteria for Major Depressive Disorder. Patients must have severe depression. MADRS greater than or equal to 30 Exclusion Criteria: Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control. Patients who are considered a suicide risk. Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia. Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder. Patients with history of any psychotic disorder or any psychotic feature.

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 |
| --- |
|Drug: escitalopram|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to premature discontinuation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder
Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia

Study Overview
=================
Brief Summary
-----------------
Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus

Official Title
-----------------
Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia

Conditions
-----------------
Intermittent Exotropia

Intervention / Treatment
-----------------
* Procedure: Non surgical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3 to 12 years (inclusive) IXT for distance or constant IXT for distance and either IXT or exophoria for near IXT size of > 10PD Visual acuity in worse eye of at least 0.3 logMar (Snellen 6/12) Visual acuity of no greater than 2 lines between eyes Parents or guardian willing to accept randomization, and to continue with observation or treatment for at least 6-12 months, unless deterioration of strabismus or fall in best corrected visual acuity of worse than 0.3logMar (Snellen 6/12) in either eye Investigator willing to observe IXT untreated for at least 1 year Exclusion Criteria: Previous non-surgical treatment for IXT, or patch treatment for amblyopia within the last year Prior strabismus, intraocular or refractive surgery or botulinium injection Surgery planned within the next year Prematurity (birth weight < 1500g, gestational age < 34 weeks), systemic illness (eg. cerebral palsy), syndrome (including craniosynostosis) or learning disability Any ocular abnormality (cornea, lens or central retina); nystagmus or conditions that limit eye movements.

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-surgical therapy<br>patching or fusion exercises | Procedure: Non surgical therapy<br>* patching or fusion exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of strabismus |  | 1 year |