linjc16/ctgov huggingface dataset:
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers

Official Title
-----------------
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers

Conditions
-----------------
Essential Hypertension, Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: fimasartan
* Drug: fimasartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <Hepatic impairment patient> age: 20 - 64 years sex: male Child-Pugh score A or Child-Pugh score B body weight: greater than 55 kg written informed consent <Healthy volunteer> age: 20 - 64 years sex: male body weight: greater than 55 kg written informed consent Exclusion Criteria: <Hepatic impairment patient> portosystemic shunt surgery Child-Pugh score C creatinine clearance < 80mL/min ascites <Healthy volunteer> AST(SGOT), ALT(SGPT) > 1.5 times of Upper Normal Range Total bilirubin > 1.5 times of Upper Normal Range positive drug or alcohol screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hepatic impairment patients<br>Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C) | Drug: fimasartan<br>* single administration of fimasartan 120mg<br>|
| Active Comparator: Healthy volunteers<br>healthy volunteers group | Drug: fimasartan<br>* single administration of fimasartan 120mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic characteristics of fimasartan | AUC, Cmax, Tmax, T1/2, CL/F of fimasartan | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fimasartan, hepatic impairment
The Effects of Social Media on Food Intake and Behaviour

Study Overview
=================
Brief Summary
-----------------
Participants will be exposed to 3 conditions, in random order: A Facebook page where 70% of posts are related to food. A Facebook page where only 20% of posts are related to food. A control condition (colouring quietly). During each of the above conditions participants will be provided with identical snacks. The snacks will be weighed before and after each condition, to determine whether there is a change in food intake across the 3 conditions.

Official Title
-----------------
The Effects of Social Media on Food Intake and Behaviour

Conditions
-----------------
Sedentary Lifestyle, Hunger, Eating

Intervention / Treatment
-----------------
* Behavioral: Facebook
* Behavioral: Facebook + Food
* Behavioral: Colouring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-25. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facebook<br>Participants will spend 30 minutes interacting with a Facebook page that is made up of 20% food-related posts, and 80% non food-related posts (news, sports, etc). They will be provided with bowls of snacks, which will be weighed before and after their session. | Behavioral: Facebook<br>* Participants will spend 30 minutes on a Facebook page that is primarily non-food related posts.<br>|
| Experimental: Facebook + Food<br>Participants will spend 30 minutes interacting with a Facebook page that is made up of 70% food-related posts, and 30% non food-related posts (news, sports, etc). They will be provided with bowls of snacks, which will be weighed before and after their session. | Behavioral: Facebook + Food<br>* Participants will spend 30 minutes on a Facebook page that is food related posts.<br>|
| Active Comparator: Colouring<br>Participants will spend 30 minutes colouring. They will be provided with bowls of snacks, which will be weighed before and after their session. | Behavioral: Colouring<br>* Participants will spend 30 minutes colouring quietly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad libitum snack food intake | Participants will be provided with snack foods based on a previously completed food preference questionnaire. The food will be weighed before and after each session to determine caloric and macronutrient intake. | 30 minutes |
Clinical and Genetic Examination of Usher Syndrome Patients' Cohort in Europe

Study Overview
=================
Brief Summary
-----------------
This study aims to characterize Usher patients in order to correlate this data with genetic information. Tasks: Standardization and improvement of Usher syndrome diagnosis: refine and elaborate special tests of visual and otological function in association with genotype that enable to determine the most significant markers for Usher disease progression and therapeutic effect. Perform genotype and phenotype correlations in Usher syndrome patients Develop and maintain database for phenotypically and genotypically well-characterized patient cohorts, suitable for future therapeutic trials

Official Title
-----------------
European Research Projects on Rare Diseases Driven by Young Investigators

Conditions
-----------------
Usher Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Clinical characteristics for USH1, USH2 and USH3 as defined by the Usher syndrome consortium; Informed consent and agreement to participate in the study; Distance best corrected visual acuity ≥ 0.1. Exclusion criteria: Systemic pathologies or severe ocular pathologies, systemic or topical medication usage, and/or other otolaryngology pathologies which could contaminate the results; Unwillingness to provide a blood sample ; Unwilling and/or unable to undergo the study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 70 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 |
| --- | --- |
| no intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype and phenotype correlations in Usher syndrome patients | Protocol outline: patients undergo clinical and molecular studies. These include extensive ophthalmologic (best corrected visual acuity, refraction, tonometry, color vision, visual field testing, pupillography*, full-field electroretinogram, multifocal electroretinogram, autofluorescence imaging, optical coherence tomography, adaptive optics*) examination, audiologic and vestibular evaluation and obtaining blood samples for genetic analysis. *only if available | up to 3 years (2016) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinitis Pigmentosa Syndromic, Congenital Deafness, Usher Syndrome Retinitis Pigmentosa and Deafness, Progressive Hearing Loss, Retinitis Pigmentosa
Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

Study Overview
=================
Brief Summary
-----------------
one year extension study following a previous double-blind study to evaluate safety of the drug

Detailed Description
-----------------
A one year extension study for patients who completed E2020-A001-319. Patients will receive 5my donepezil daily for the first 8 weeks and will be assessed by the incidence of advere events, changes in physical exams, ECG and clinical lab determinations. The results will be assessed 6 timues during the year. After 8 week, the investigator may increase the dose to 10mg/day if the patient if the patients show satisfactory tolerability. Six psychometric scales will also be evaluatd.

Official Title
-----------------
Open-Label, Multicentre, One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease

Conditions
-----------------
Dementia Associated With Cerebrovascular Disease

Intervention / Treatment
-----------------
* Drug: donepezil hcl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have completed previous study E2020-A001-319 Exclusion Criteria: absence of a reliable caregiver clinically significant medical condition recent TIA

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: donepezil hcl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dementia, stroke
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate, in acromegalic patients with disease persistence after surgery who are treated with somatostatin analogues, the histopathological, clinical, morphological and biochemical factors which are predictive of hormonal control.

Official Title
-----------------
Observational Study to Evaluate, in Acromegalic Patients With Disease Persistence After Surgery, Those Histopathologic, Clinical, Morphologic and Biochemical Factors Predictors of Hormonal Control Under Somatostatin Analogue Treatment

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acromegalic patients with persistent disease (growth hormone ≥ 1ng/ml following oral glucose tolerance test and/or insulin like growth factor 1 above the normal range for sex and age) 3 to 6 months after transsphenoidal or transfrontal surgery Exclusion Criteria: Patients not contributing enough material for a tumour histopathological study Patients who have received radiation therapy or will receive it during the observational study period Patients who are being treated, or in whom treatment is anticipated, with either a dopaminergic agonist or a growth hormone receptor antagonist Patients with a history of hypersensitivity to somatostatin analogues

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of ART to Interrupt HIV Transmission Networks

Study Overview
=================
Brief Summary
-----------------
The investigators are conducting a study to learn more about the spread of HIV infection within different geographic regions and populations in San Diego County, with the goal of demonstrating that early use of HIV treatment can reduce the number of new infections in our community. At the study visits, participants will be examined by the study staff and asked to donate some blood. Participants will also be asked several questions about themselves, their background, behaviors, health, and the general geographic area in which they live. By collecting information about antiretroviral treatment choices that are made by study participants, the investigators will be better able to measure how effectively HIV treatment can interrupt (i.e., block) the spread of HIV. All of the information gathered at the study visits will be de-identified and analyzed. Study staff will use the information to better understand in which groups of people, and in what areas of San Diego, HIV is spreading most quickly. This information will be used to determine how well Antiretroviral Therapy (HIV treatment) by certain individuals can control the spread of HIV within the population.

Official Title
-----------------
Efficacy of ART to Interrupt HIV Transmission Networks

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years of age Newly diagnosed HIV infection ART naïve (≤7 days ART, previous use of PEP or PrEP are not exclusions) Subject must be able to provide written consent Subject must agree to study specific specimen collections and visit schedule. Subjects with newly diagnosed HIV infection who were identified on or after May 1, 2014 will be eligible for enrollment as long as they are co-enrolled to either AEH020 (project 08-0278) or AEH030 (project 140093) and DID meet the above study inclusion criteria (items at the time of enrollment to protocols AEH020 or AEH030). Exclusion Criteria: Any factor or factors that in the opinion of the local investigator that could prevent compliance with study requirements. Contraindication to phlebotomy or specimen collection.

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 |
| --- | --- |
| HIV positive<br>Persons newly diagnosed with HIV. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Network-level efficacy of ART as measured by the number of newly infected persons and network cluster growth over time |  | 5 Years |
Evaluation of Platelet Rich Fibrin on Reduction of Periodontal Problems After Surgical Removal of Mandibular Third Molar

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the influence of platelet rich fibrin to reduction of periodontal problems after surgical removal of third molar.

Detailed Description
-----------------
After extraction or surgical removal of third molar, a deep bony pocket created behind the second molar specially in the mandible. For reduction of this problem, investigators, needed to acceleration tissue healing. For this purpose, investigators used platelet rich fibrin (autologous) and followed patient for 3 months.

Official Title
-----------------
Evaluation of Platelet Rich Fibrin Efficacy on Reduction of Periodontal Problems

Conditions
-----------------
Mastication Disorder

Intervention / Treatment
-----------------
* Procedure: autologous platlet rich fibrin
* Procedure: one side in control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have 2 impacted third molars Exclusion Criteria: periodontal disease history of periodontal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prf group.peridontal problem<br>prf insert into surgical site immediate after surgery | Procedure: autologous platlet rich fibrin<br>* one dose immediate after surgery<br>* Other names: prf;|
| Placebo Comparator: control group<br> | Procedure: one side in control group<br>* control group insert any things after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of periodontal pocket depth at mid buccal, disto buccal and distolingual of mandibular second molar |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet rich fibrin, mandibular third molar, periodontal problem
Analysis Before and After COVID 19

Study Overview
=================
Brief Summary
-----------------
In our study, we aimed to compare the average length of stay, death rates and costs of intensive care patients in October-November-December 2019 (before COVID 19) and October-November-December 2020 (during COVID 19).

Official Title
-----------------
Comparative ICU Cost, Hospital Stay and Mortality Analysis Before and After COVID 19

Conditions
-----------------
Cost of ICU

Intervention / Treatment
-----------------
* Other: Cost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years old All patients in intensive care unit in last three months of 2019 All SARS-Cov2 patients in intensive care unit in last three months of 2020 Exclusion Criteria: Under 18 years old

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 |
| --- | --- |
| Before SARS-Cov2<br>Before SARS-Cov2 | Other: Cost<br>* ICU cost<br>|
| After SARS-Cov2<br>After SARS-Cov2 | Other: Cost<br>* ICU cost<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of ICU | Cost of ICU | 1 month |
Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections

Study Overview
=================
Brief Summary
-----------------
The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.

Official Title
-----------------
Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery

Conditions
-----------------
Postoperative Pneumonia

Intervention / Treatment
-----------------
* Device: Endotracheal tube TaperGuard
* Device: Endotracheal tube Hi-Contour Brandt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 ans Elective aortic surgery Admission in ICU after aortic surgery Exclusion Criteria: Tracheostomized patients
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 |
| --- | --- |
| Experimental: endotracheal tube with taper-shaped cuff<br> | Device: Endotracheal tube TaperGuard<br>* Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)<br>|
| Active Comparator: Endotracheal tube with cylindrical-shaped cuff<br> | Device: Endotracheal tube Hi-Contour Brandt<br>* Patients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of first episode of postoperative pneumonia after aortic surgery |  | Within the first 28 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microaspiration |  | Day 1 and day 2 | 
| Length of ICU stay |  | Participants will be followed for the duration of ICU stay, an expected average of 3 weeks | 
| Mortality |  | Day 28 and day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
after aortic surgery