linjc16/ctgov huggingface dataset:
The Comparison of Dexmedetomidine and Midazolam for the Sleep in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill patients. And the investigators also compare the incidence of delirium between the two groups.

Detailed Description
-----------------
Sleep is very important for cognitive and immune function. However, patients in intensive care unit (ICU) have a very poor sleep. Almost all ventilated patients in intensive care unit (ICU) take a sedative drug. In Korea, most commonly used sedative drugs are dexmedetomidine and midazolam. The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography. And the investigators also compare the incidence of delirium between the two groups.

Official Title
-----------------
The Comparison of Dexmedetomidine and Midazolam for the Sleep of Mechanical Ventilated Intensive Care Unit Patients

Conditions
-----------------
Poor Quality Sleep, Sleep Deprivation, Sleep Arousal Disorders, Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedation patients with dexmedetomidine or midazolam over 18 years old Exclusion Criteria: Neurologic disease (stroke, seizure, dementia, hypoxic brain damage) Brain infection Alcoholics Major Depression Disorder, Schizophrenia, Anxiety disorder Hearing loss

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 |
| --- | --- |
| Dexmedetomidine group<br>Dexmedetomidine group is the patients who sedated with dexmedetomidine in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of dexmedetomidine will be 0.2-0.7ug/kg/hr. | |
| Midazolam group<br>Midazolam group is the patients who sedated with midazolam in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of midazolam will be 0.05-0.1 mg/kg/hr. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group |  | during ICU stay |
Y-TZP and In-mouth Low Thermal Degradation: A Prospective Clinical Study

Study Overview
=================
Brief Summary
-----------------
The objective of this work is to study in-mouth aging and LTD of monolithic zirconia restorations. Microstructural changes characteristic of LTD processes, wear, and clinical behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D laser surface analysis will be used, directly on the restorations, which will be removed at regular intervals.The working hypothesis is that LTD process is very slow at the scale at the lifespan of dental prostheses.

Official Title
-----------------
Low Thermal Degradation of Monolithic Zirconia Prostheses: an up to 5-year Original Prospective Clinical Study Using ex Vivo Analyses

Conditions
-----------------
Zirconia Monolithic Dental Restorations: In-mouth Behaviour, LTD and Wear

Intervention / Treatment
-----------------
* Device: Lava plus (3M) crowns and bridges


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full zirconia crowns in the posterior region (molar/premolar) On teeth or implants Single unit restorations cemented on natural teeth and implants (including screw-retained restorations if possible, but no internal connections) Multi-unit restorations on implants If nightguard: to be performed on the antagonist Exclusion Criteria: Patients with removable prosthesis as an antagonist
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: Experimental: Zirconia monolithic crowns and bridges<br>Evaluation of Lava Plus zirconia dental crowns and bridges | Device: Lava plus (3M) crowns and bridges<br>* Zirconia monolithic dental crowns and bridges evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-mouth LTD of monolithic zirconia restorations on natural teeth and implants |  | up to 5 years |
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to clarify treatment status and clinical results of acute cerebral ischemia after approval of clot retriever in Japan, and also to obtain a basis for comparative studies.

Official Title
-----------------
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Procedure: endovascular treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted from Oct. 1st 2014 to Sep. 30st 2016. Patients who were 20 years and older admitted within 24 hours after onset. The patients with large vessel occlusion (ICA, MCA, VA, BA, PCA). Patients who did not fulfill the criteria of RESCUE-Japan RCT. Exclusion Criteria: ･Patients who are considered inappropriate to participate in the study are excluded.

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 |
| --- | --- |
| Group with endovascular treatment<br>Group with additional endovascular treatment | Procedure: endovascular treatment<br>* endovascular treatment for acute ischemic stroke patients with large vessel occlusion<br>|
| Group without endovascular treatment<br>Group without additional endovascular treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death within 90 days (+/- 10 day) after the onset |  | 90 days | 
| modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset |  | 90 days | 
| All bleeding within 90 days (+/- 10 days) after onset |  | 90 days | 
| All intracranial hemorrhage within 90 days (+/- 10 days) after onset |  | 90 days | 
| Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset |  | 90 days |
Treatment of Leg Telangiectasias With Nd:YAG 1064nm

Study Overview
=================
Brief Summary
-----------------
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.

Official Title
-----------------
Treatment of Leg Telangiectasias With Nd:YAG 1064nm

Conditions
-----------------
Telangiectasias

Intervention / Treatment
-----------------
* Device: Laser Nd:YAG 1064nm
* Other: Sclerotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with leg telangiectasias Exclusion Criteria: Arterial disease Varices Diabetes

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Nd:YAG 1064nm<br>Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval | Device: Laser Nd:YAG 1064nm<br>* Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval<br>* Other names: Cool Glide;|
| Active Comparator: Sclerotherapy<br>Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval | Other: Sclerotherapy<br>* Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval<br>* Other names: glicose;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment of leg telangiectasias | Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy. | first day | 
| Treatment of telangiectasias | Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of adverse effects | Patients are monitored to adverse effects such as blemishes, scars and ulcers | after 1 month | 
| Pain Scores on the Visual Analog Scale | Patients evaluate pain on the Visual Analog Scale | After 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telangiectasias, leg, sclerotherapy, laser, glycose
Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
The Canadian Atherosclerosis Imaging Network (CAIN) is a pan-canadian imaging network funded through grants from the Canadian Foundation for Innovation (CFI) and the Canadian Institutes of Health Research (CIHR). This unique research network is focused on the pathobiology of atherosclerotic disease as it pertains to the coronary and carotid circulations. The CAIN research program involves the creation of a unique national network focused on in vivo imaging of vessel wall disease, combined with imaging of occult end-organ disease as well as the acquisition of clinical and pathological end points. CAIN enables unprecedented cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease in coronary or carotid vascular beds, and has established an international resource for studying the natural history, progression, regression and novel therapeutic interventions aimed at atherosclerosis. The primary outcome of this study is to accurately characterise carotid plaque morphology in non-surgical patients with mild to severe (30-95%) carotid disease. The investigators will also assess evidence of ischaemic brain disease. Patients will undergo MRI scanning of the brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years or sooner if presenting clinically in order to monitor the natural history of carotid atherosclerosis and its effect on end-organ brain disease. Patients will consent to baseline scanning and follow up at 1 and 2 years, and databasing of clinical and imaging data. After each imaging session images will be processed, stored locally and also sent to a central repository. 500 patients will be recruited over a 2 year period in anticipation of study completion within 4 years.

Official Title
-----------------
Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes

Conditions
-----------------
Atherosclerosis, Carotid Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female patients over the age of 18 years. written informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific procedures. patient with mild to severe carotid artery disease Exclusion Criteria: any condition that would contra-indicate Magnetic Resonance Imaging or administration of contrast agent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Antimicrobials Stewardship by Pharmacist

Study Overview
=================
Brief Summary
-----------------
To study the outcome of antibiotics stewardship

Detailed Description
-----------------
Retrospective cohort study by medical review and evaluation of broad-spectrum antibiotics to determine how appropriately it was bing used.

Official Title
-----------------
Appropriate Use of Controlled Broad-spectrum Antimicrobials by Establish Stewardship and Execute by Antibiotic Pharmacist

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: medical review of controlled broad-spectrum antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria: Inpatient with infectious disease and under broad-spectrum antibiotics exclusion criteria: Poor prognosis was diagnosed or received conservative therapy only.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| inpatient under broad-spectrum antibiotics<br>medical review | Drug: medical review of controlled broad-spectrum antibiotics<br>* medical review of outcome of antibiotics stewardship by pharmacists and infectious disease physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of appropriateness of empirical antibiotics choosing. | For example,the inappropriate of piperacillin-tazobactam as empirical therapy was numbers of participants with no risk factors of deep tissue infection or DM foot /Number of participants treated with piperacillin-tazobactam for soft tissue infection. | up to 8 weeks | 
| The percentage of appropriateness of de-escalation of therapy. | For example,continued piperacillin-tazobactam was seen to be inappropriate when microbiologic results and clinical status permit de-escalation. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events of antibiotics were recorded. |  | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
broad-spectrum antimicrobial, antibiotics pharmacist
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Official Title
-----------------
A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DE-104 ophthalmic solution, low concentration
* Drug: DE-104 ophthalmic solution, medium concentration
* Drug: DE-104 ophthalmic solution, high concentration
* Drug: Placebo
* Drug: 0.005% latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provided signed, written informed consent. Diagnosed with primary open-angle glaucoma or ocular hypertension. 18 years of age and older. If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with 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: 1<br><described in intervention> | Drug: DE-104 ophthalmic solution, low concentration<br>* Topical ocular application<br>|
| Experimental: 2<br><described in intervention> | Drug: DE-104 ophthalmic solution, medium concentration<br>* Topical ocular application<br>|
| Experimental: 3<br><described in intervention> | Drug: DE-104 ophthalmic solution, high concentration<br>* Topical ocular application<br>|
| Placebo Comparator: 4<br><described in intervention> | Drug: Placebo<br>* placebo<br>|
| Active Comparator: 5<br><described intervention> | Drug: 0.005% latanoprost<br>* Topical ocular application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost. |  | 35 days |
Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: tadalafil
* Drug: tadalafil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of erectile dysfunction for at least 3 months. Currently have diabetes mellitus of at least 3 months duration. Agree to not use any other ED treatment during the study. Anticipate the same female sexual partner for the study. Must be willing to make the required number of sexual attempts. Exclusion Criteria: History of other primary sexual disorder Treatment with nitrates or potent CYP3A4 inhibitors Have a penile implant or clinically significant penile deformity History of certain heart problems Have kidney or liver problems

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Active Comparator: 2<br>2.5 mg tadalafil | Drug: tadalafil<br>* 2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks<br>* Other names: IC351;|
| Active Comparator: 3<br>5 mg tadalafil | Drug: tadalafil<br>* 5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks<br>* Other names: IC351;|
| Placebo Comparator: 1<br> | Drug: placebo<br>* Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the GAQ, SEP, IIEF, SEAR, and RSE scores. |  | 12 weeks |
Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy and safety UK-390,957

Official Title
-----------------
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study To Assess The Efficacy and Safety Of Oral UK-390,957 In Men With Premature Ejaculation

Conditions
-----------------
Ejaculation

Intervention / Treatment
-----------------
* Drug: UK-390,957


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature ejaculation as defined by DSM-IV Exclusion Criteria: History of erectile dysfunction

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

Sexes Eligible for Study
-----------------
Male

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: UK-390,957|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy and safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of quality of sexual life |  |  |