linjc16/ctgov huggingface dataset:
Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy

Study Overview
=================
Brief Summary
-----------------
The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well as the subject believe that the benefits outweigh the risks to continue the treatment with SUVN-G3031.

Detailed Description
-----------------
The qualified subjects will be given 2mg of SUVN-G3031 expanded access treatment for 30 days. At the end of 30 days if the subject wishes to continue the treatment, he/she will be provided with adequate investigational drug for next 30 days. This cycle will be repeated up to a maximum of 2 times (total duration of expanded access treatment up to 90 days).

Official Title
-----------------
An Intermediate-size, Expanded Access to SUVN-G3031 for the Treatment of Subjects With Narcolepsy Who Have Completed the CTP2S13031H3 Protocol

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

Intervention / Treatment
-----------------
* Drug: Samelisant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have completed the 2-week treatment phase and follow-up period of study CTP2S13031H3 (NCT04072380) as planned and wish to continue unblinded treatment with SUVN-G3031 (2 mg, qd). Subject must sign the ICF to participate in the study. The investigator after review of relevant information and in consultation with the subject believes that continued treatment following study CTP2S13031H3 could be beneficial to the subject. Exclusion Criteria: Any clinically relevant concomitant disease or AEs/SAEs during the Phase 2 study (CTP2S13031H3), which in the opinion of the investigator, makes the subject unsuitable for inclusion in the protocol. Has participated or is participating in any other clinical (investigational) study after completion of CTP2S13031H3 protocol (NCT04072380).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Samelisant|Tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Minoxidil 1% for Eyebrow Enhancement

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.

Official Title
-----------------
Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study

Conditions
-----------------
Eyebrow Hypotrichosis, Thin Eyebrow

Intervention / Treatment
-----------------
* Drug: Minoxidil lotion 1%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female aged 18-60 years hypotrichosis of eyebrows healthy informed consent obtained Exclusion Criteria: underlying diseases alopecia areata or trichotillomania thyroid diseases pregnancy or breast feeding previous eyebrow tattoo, trauma or accident. history of eyebrow or hair medications in 6 months history of minoxidil or its ingredient allergy history of eyebrow surgery.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minoxidil lotion 1%<br>Minoxidil lotion 1% is applied twice daily to one eyebrow. | Drug: Minoxidil lotion 1%<br>* Minoxidil lotion 1% is applied twice daily to one eyebrow.<br>|
| Placebo Comparator: Placebo<br>Placebo is applied twice daily to the other eyebrow. | Drug: Placebo<br> <br> * Other names: Placebo is applied twice daily on the other eyebrow.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of global photographic assessment after 16 weeks from baseline |  | baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of hair diameter after 16 weeks from baseline |  | baseline and 16 weeks |
Phase 3 Study Comparing IOP Lowering in OAG or OH in Japanese Subjects C-01-98

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after twelve months of treatment in Japanese subjects.

Official Title
-----------------
Phase 3 Study to Compare Two Different IOP Lowering Medications for the Treatment of Open Angle Glaucoma or Ocular Hypertension in Japanese Subjects C-01-98.

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

Intervention / Treatment
-----------------
* Drug: IOP Lowering Medications


Participation Criteria
=================
Eligibility Criteria
-----------------
Adults of Japanese Ethnicity

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: IOP Lowering Medications|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
-----------------
Japanese, open-angle, glaucoma, ocular, hypertension, POAG, Iris, Pigmentation
Impact of Right Ventricular Pacing Determined by Electrocardiography

Study Overview
=================
Brief Summary
-----------------
Typically pacemaker electrode has been attached to the right ventricular apex. This method lead to Non-physiological Ventricular contraction. It has been reported to cause by ventricular dysfunction. In conclusion, this study demonstrate that impact of right ventricular pacing determined by electrocardiography was planned.

Detailed Description
-----------------
Patients who has Atrioventricular block scheduled for artificial pacemaker Randomized select 1:1 apex beats and ventricular septal beat.

Official Title
-----------------
Impact of Right Ventricular Pacing Determined by Electrocardiography; Prospective Randomized Trial

Conditions
-----------------
Atrioventricular Block

Intervention / Treatment
-----------------
* Procedure: Septal pacing
* Procedure: Apex pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrioventricular block, pacemaker scheduled Exclusion Criteria: History of myocardial infarction Valvular heart disease (grade ≥ 2 ) History of Left ventricular dysfunction ( ejection fraction <50% or LV dimension >60 mm in the pre-procedure echocardiogram)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Septal pacing group<br>Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis | Procedure: Septal pacing<br>* Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis<br>|
| Active Comparator: Apex pacing group<br>Put RV lead around the apex | Procedure: Apex pacing<br>* Put RV lead around the apex<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| > 10% decrease of ejection fraction |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrioventricular block, cardiomyopathy
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
According to TEG (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.

Official Title
-----------------
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement

Conditions
-----------------
Abnormal Aortic Valve

Intervention / Treatment
-----------------
* Drug: ulinastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40% below of output of left ventricle tricuspid valve failure from moderate to severe urgent surgery required infectious endocarditis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: ulinastatin<br>Administer with 30,000U /ulinastatin | Drug: ulinastatin<br>* Administer 30000U/ulinastatin. Comparison of different dosages of drug.<br>|
| Placebo Comparator: C group<br>administer normal saline | Drug: ulinastatin<br>* Administer 30000U/ulinastatin. Comparison of different dosages of drug.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Observation and Evaluation of Chewing Velocity Changes on Soft Food Chewing Efficiency

Study Overview
=================
Brief Summary
-----------------
Soft food chewing does not require strong bite force. The number of chewing strokes and occlusal surface area of the posterior teeth are more important. Clinically, reduction of occlusal surface to protect the abutments of a fixed or removable partial denture or the implant supported teeth is often necessary. If a certain chewing ability is maintained with reduced occlusal area, changing chewing velocity might help. For this hypothesis, the effect of chewing velocity on soft food chewing ability would be observed first. The purpose of this study is to evaluate the deliberately changed chewing gum chewing velocity on the chewing ability of healthy subjects whose dental occlusal surface area is known. Twenty dental students (10 men and 10 women with an age range of 20-30 years) with healthy masticatory systems and complete dentition will be asked to chew HA containing chewing gum with habitual side teeth at the cycle time of 0.5 sec, 1.0 sec and 1.5 sec for 30, 40, and 50 times. Jaw movement, tooth contact, and muscle activities will be observed during chewing gum chewing. The distribution of HA particles in the gum bolus after each chewing session will be measured and regarded as the chewing efficiency of that subject. Occlusal surface area of the maxillary posterior teeth, chewing rate, chewing time, muscle activity and jaw lateral displacement will be related to the chewing efficiency with multiple regression analysis. The effects of practice due to changing of chewing rate will also be evaluated.

Detailed Description
-----------------
HA containing chewing gum with habitual side teeth at the cycle time The distribution of HA particles in the gum bolus after each chewing session will be measured and regarded as the chewing efficiency of that subject. National Taiwan University Hospital, National Science Council

Conditions
-----------------
Healthy, Mastication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dental students Healthy masticatory system

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chewing efficiency,, Gum chewing, Chewing velocity, Occlusal surface area, EMG, Jaw movement
Performance Evaluation of In-Vitro Diagnostic Device

Study Overview
=================
Brief Summary
-----------------
This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical Chemistry Analyzer. Analyte Principle: Albumin (ALB) - Dye-Binding BCG Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme) Glucose (GLU) - Hexokinase, Colorimetry Total Protein (TP) - Biuret

Official Title
-----------------
Performance Evaluation of In-Vitro Diagnostic Device

Conditions
-----------------
Blood Routine Examination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study. Exclusion Criteria: You may not participate in this study if you do not meet the above inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Quantitative measurement of biochemical indicators in the blood of adult that include of Albumin (ALB), Blood urea nitrogen (BUN), Glucose (GLU), and Total Protein (TP). | Measured results will collected from the at least 120 individuals of adults for each biochemical indicator. | 6 months |
Pseudoexfoliation Syndrome in Myopes

Study Overview
=================
Brief Summary
-----------------
A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic. Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group without pseudoexfoliation syndrome.

Detailed Description
-----------------
A retrospective study of 5753 eyes of cataract surgery patients was conducted at investigators Clinic in a period of 2.5 years. Pseudoexfoliation syndrome was found in 255 eyes. There were only 26 cataract myopic eyes with pseudoexfoliation syndrome. Refractive eye state was defined by preoperatively calculated emmetropization intraocular lens (IOL) value done by optical low coherence reflectometry biometer LENSTAR LS 900®. Ocular optical components of the cataract myopic eyes with pseudoexfoliation syndrome measured by this biometer were put in comparison with matched cataract myopic eyes group without pseudoexfoliation syndrome that have emmetropization IOL value within the same range as the cataract myopic eyes with pseudoexfoliation syndrome.

Official Title
-----------------
Pseudoexfoliation Syndrome in Myopes Defined With Optical Low Coherence Reflectometry

Conditions
-----------------
Pseudoexfoliation Syndrome in Cataract Myopic Eyes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cataract surgery patients ≥ 40 years old Exclusion Criteria: cataract surgery patients < 40 years old

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| eyes with pseudoexfoliation syndrome<br>cataract myopic eyes with pseudoexfoliation syndrome | |
| eyes without pseudoexfoliation syndrome<br>cataract myopic eyes without pseudoexfoliation syndrome | |

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
-----------------
myopia, pseudoexfoliation syndrome, optical low coherence reflectometry, ocular optical components, cataract
Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation. After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.

Official Title
-----------------
Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation

Conditions
-----------------
Pain, Anesthesia

Intervention / Treatment
-----------------
* Drug: ketamine
* Procedure: Tetanic stimulations of incremental intensities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted to pediatric burns care unit Burnt skin area 5-40% Scheduled for a dressing change under ketamine sedation Exclusion Criteria: Neurologic or ophthalmic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine sedation<br>Procedure scheduled under ketamine sedation. Baseline pupillary diameter measurement in alert subjects. Injection of a bolus of 1 mg/kg of ketamine. Every minute, tetanic stimulations of incremental intensities (10-20-30-40-60 milliamps), during 5 seconds. Pupillary diameter measurement before and after each stimulation. End of study period, beginning of procedure. | Drug: ketamine<br>* bolus 1 mg/kg<br>Procedure: Tetanic stimulations of incremental intensities<br>* 10-20-30-40-60 milliamps on the patient's left forearm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry | Non-invasive measurement of pupillary diameter using an infrared camera, for each of the 6 stimulations per patient | 30 seconds after each stimulation (6 stimulations per patient) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variation |  | 30 seconds after each stimulation |
Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis

Study Overview
=================
Brief Summary
-----------------
The values of laboratory examinations which are useful for the diagnoses of appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). However up to date there is no laboratory marker for the pre-operative diagnosis of appendiceal perforation in acute appendicitis. Recently hyperbilirubinaemia has been associated with appendiceal perforation. Aim of this retrospective study is therefore to investigate if hyperbilirubinaemia has a diagnostic value for the pre-operative diagnosis of appendiceal perforation in patients with appendicitis.

Detailed Description
-----------------
We identified 538 patients with histologically proved acute appendicitis who underwent laparoscopic or conventional appendicectomy between January, 2004 and December, 2007 in a surgical department of an academic teaching hospital. A retrospective multiple chart review of the medical records including laboratory values (bilirubin, CRP, white blood count) and histological results was conducted.

Official Title
-----------------
A Retrospective Study Investigating the Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis

Conditions
-----------------
Perforated Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Appendicitis and a preoperative laboratory workup with Leukocytes, C-reactive Protein, Bilirubin and liver transaminases GOT and GPT Exclusion Criteria: Alcoholism A history of viral hepatitis Gilbert's disease Dubin Johnson syndrome BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary Hemolytic or liver diseases associated with hyperbilirubinaemia.
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 |
| --- | --- | --- |