linjc16/ctgov huggingface dataset:
Study of Escitalopram in Adult Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
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 efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.

Official Title
-----------------
Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder

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

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder. The patient's current depressive episode must be at least 12 weeks in duration. 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 currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder. Patients who are considered a suicide risk. Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.

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
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 |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAMD) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Major Depressive Disorder, Escitalopram
Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effectiveness of a computer-based Cognitive Behavioral Therapy (CCBT) and online stress management program for adolescents, and identify the characteristics of depressed adolescents that participate in the programs.

Official Title
-----------------
Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: CCBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescents that scored above the threshold for mild depression (PHQ, CES-D) Exclusion Criteria: adolescents with severe depression/neuropsychiatric conditions

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 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: computer-based cognitive behavioral therapy<br> | Behavioral: CCBT<br>* computer-based treatment program for depressed adolescents<br>|
| Active Comparator: online stress management program<br> | Behavioral: CCBT<br>* computer-based treatment program for depressed adolescents<br>|
| No Intervention: waitlist<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CES-D |  | 5 week | 
| PHQ |  | 5 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSM-5 Severity measure for Depression, Child-Adolescent version |  | 5 week | 
| Perceived Stress Scale |  | 5 week | 
| Study Stress Scale |  | 5 week | 
| BAI |  | 5 week | 
| EPQ |  | 5 week | 
| Self-esteem Scale |  | 5 week | 
| PedsQL 4.0 |  | 5 week | 
| Homework compliance |  | 5 week |
Contrast Enhanced SWI for Carotid Plaque Imaging

Study Overview
=================
Brief Summary
-----------------
This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study.

Detailed Description
-----------------
Atherosclerosis of craniocervical arteries are one of most important causes of stroke. Carotid artery is the most frequent site of atherosclerosis. Recent research in carotid artery covers not only morphology of lumen but also direct visualization of carotid plaque or vessel wall. Vulnerable carotid plaques share pathologic features of intra-plaque inflammation and hemorrhage. There have been reports about post-contrast SWI in the field of vascular imaging. We hypothesized SWI is so sensitive to gadolinium based contrast agent and hemorrhage that contrast-enhanced SWI can visualize vulnerable carotid plaque. The purpose of this study is to investigate gadolinium-enhanced SWI in detection of vulnerable carotid plaque and compare it with MP-RAGE and DANTE T1-SPACE. This can be used to guide proper treatment for stroke.

Official Title
-----------------
Contrast Enhanced Susceptibility Weighted Imaging (SWI) for Characterization of Carotid Plaque

Conditions
-----------------
Carotid Plaque Imaging

Intervention / Treatment
-----------------
* Other: Methods of carotid wall imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute or recent (within 3months) stroke or TIA 50-99% stenosis of internal carotid artery by NASCET criteria Written informed consent, prior to registration Exclusion Criteria: Hemorrhagic stroke Previous history of carotid endarterectomy (CEA), angioplasty, or stenting Contraindication for MR imaging Hypersensitivity to gadolinium based contrast media Pregnant or lactating women Patients under age of 19-year-old Renal condition : eGFR < 60 Patients unable and/or unwilling to comply with treatment or study instructions.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Patients with acute or recent (within 3months) stroke<br> | Other: Methods of carotid wall imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of findings of vulnerable carotid plaque |  | within 3 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy in delinating geometry of carotid inner lumen and outer wall | Diameter of inner lumen and outer wall; Area of inner lumen and outer wall | within 3 days after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SWI, MP-RAGE, DANTE T1-SPACE
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Study Overview
=================
Brief Summary
-----------------
This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.

Official Title
-----------------
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Conditions
-----------------
Kidney Calculi, Ureteral Calculi, Colic

Intervention / Treatment
-----------------
* Other: Alfuzosin Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age =>18 <8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram Exclusion Criteria: Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets Pregnant/Nursing females Solitary kidney Renal insufficiency (Creatinine>1.8) Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis) Moderate or severe hepatic insufficiency (Childs-Pugh categories B and C) Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since Alfuzosin blood levels are increased Other alpha-blockers Phosphodiesterase type 5 inhibitors for erectile dysfunction Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alfuzosin<br> | Other: Alfuzosin Hydrochloride<br>* One tablet every day for 4 weeks<br>* Other names: Sugar pill;|
| Placebo Comparator: Placebo<br> | Other: Alfuzosin Hydrochloride<br>* One tablet every day for 4 weeks<br>* Other names: Sugar pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous stone passage for distal ureteral calculi |  | increased | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the pain and narcotic use associated with stone passage |  | decrease | 
| Decrease the time to spontaneous passage |  | decrease | 
| Shift the size distribution of stones passed towards larger sizes |  |  |
Complicated Skin and Skin Structure Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.

Official Title
-----------------
A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.

Conditions
-----------------
Skin Infection, Abscess, Cellulitis

Intervention / Treatment
-----------------
* Drug: Meropenem
* Drug: Imipenem-cilastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection Exclusion Criteria: Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication Subjects with underlying infections or conditions which would interfere with evaluation of this study

Ages Eligible for Study
-----------------
Minimum Age: 13 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: 1<br>Meropenem | Drug: Meropenem<br>* Intravenous<br>* Other names: Merrem;|
| Active Comparator: 2<br>Imipenem-cilastatin | Drug: Imipenem-cilastatin<br>* Intravenous<br>* Other names: Primaxin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure is clinical response after all antibacterial treatment is stopped). |  | 7-28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and microbiological response |  | Twice 3-28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin infections, MERREM, PRIMAXIN IV, complex abscess, perirectal abscess, wound infections, infected ischemic/diabetic ulcers, cellulitis, Meropenem, Imipenem-cilastatin
Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition

Study Overview
=================
Brief Summary
-----------------
15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.

Conditions
-----------------
Narcolepsy

Intervention / Treatment
-----------------
* Drug: Orexine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Narcolepsy Age >18 Informed consent GERMAN fluently spoken Exclusion Criteria: Additional severe psychiatric or somatic disorders Pregnancy or nursing Anemia (Hb<10g/dl)

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Orexine A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of orexine A on sleep, neurocognition and immune-system |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narcolepsy, Orexines, sleep, cognition, cytokines
Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.

Official Title
-----------------
Comparisons the Analgesia of Paravertebral Block Combined With Thoracic Wall Block Versus Paravertebral Block Alone for Modified Radical Mastectomy in Breast Cancer

Conditions
-----------------
Mastectomy, Modified Radical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The American Society of Anesthesiologists (ASA) Physical Status classification I to III 20 - 75 years of age female gender Exclusion Criteria: body mass index (BMI) ≥ 35 kg/m2 modified radical mastectomy not performed by the single surgeon (Ben Long Yu) anesthesia not performed by the single anesthesiologist (Nai Liang Li)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PECS 0<br>receiving paravertebral block | |
| PECS 1<br>receiving paravertebral block and blocks targeting pectoral musculature | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative sedation requirement | target controlled infusion (TCI) propofol driven by the Schnider model in effect site control titrated to reach conscious sedation defined as Observer Assessment of Alertness/Sedation score of 2 to 3 | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first request of analgesics |  | postoperative 12 hours | 
| postoperative analgesic requirement |  | postoperation to discharge | 
| side effects |  | postoperation to within 24 hours after discharge |
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: OCV-501


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study. Patients who are capable of giving informed consent Exclusion Criteria: Patients failed to discontinue the Study 311-10-001 even though patients met the discontinuation criteria. Patients who have participated in any other clinical trials , excluding the Study 311-10-001).

Ages Eligible for Study
-----------------
Minimum Age: 60 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: OCV-501<br> | Drug: OCV-501<br>* Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001. After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria | Bone marrow samples were taken by bone marrow aspiration, and the percentage of bone marrow blasts was calculated. The result was assessed according to the International Working Group Response Evaluation Criteria where a case was designated as relapse if any of the following occurred: reappearance of leukemic blasts in the peripheral blood or ≥ 5% blasts in the bone marrow after complete response (morphologic relapse). | Treatment period (from the first IMP administration until the time of discontinuation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myeloid leukemia, WT1
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate

Study Overview
=================
Brief Summary
-----------------
Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.

Official Title
-----------------
Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses

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

Intervention / Treatment
-----------------
* Drug: Atropine (0.01%)
* Drug: Artificial tear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 7 and 10 years Good general health and no family history of ocular diseases No current or history of epilepsy or asthma Myopia : -0.50 to -1.00 D (inclusive, both eyes) Astigmatism : ≤ 0.50 D No hyperopia, amblyopia or strabismus No reported ocular eye diseases or disorders No drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atropine 0.01%<br>Group receiving atropine treatment for 18 months | Drug: Atropine (0.01%)<br>* tropical application<br>|
| Placebo Comparator: Artifical tear<br>Group receiving placebo for 18 months | Drug: Artificial tear<br>* tropical application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive errors | Refractive errors | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Size of the eyeball | up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram