linjc16/ctgov huggingface dataset:
Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Study Overview
=================
Brief Summary
-----------------
Upper gastrointestinal hemorrhage (UGIH) is common urgency condition.The estimate mortality rate about 7 percent from peptic ulcers disease(PUD). A proton pump inhibitors (PPIs) intravenous infusion are standard treatment for high risk ulcer bleeding. Vonoprazan,subclass of potassium-competitive acid blockers (P-CABs), have beneficial effects including rapid, long-lasting and strong acid suppression.The investigators design a randomized-controlled trial comparison between 72 hours of intravenous PPIs infusion and oral vonoprazan in high risk ulcer UGIH after achieve endoscopic hemostasis. Outcome measurement are re-bleeding rate in 30 days as primary and re-bleeding rate in 3 days, 30 days mortality, rate of angioembolisation, unit of blood transfusion, hospital cost and length of stay as secondary outcome.

Official Title
-----------------
Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Conditions
-----------------
Peptic Ulcer With Haemorrhage

Intervention / Treatment
-----------------
* Drug: Vonoprazan
* Drug: PPIs IV infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk peptic ulcers bleeding (Forrest class Ia,Ib,IIa,IIb) Exclusion Criteria: Patients were not achieve endoscopic hemostasis End stage cancer disease Severe critical illness and ICU setting Uncorrectable coagulopathy Pregnancy or breast feeding Allergy to PPIs or Vonoprazan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vonoprazan<br>Vonoprazan 20 mg oral every 12 hours (total 72 hours) then vonoprazan 20 mg oral once daily for 28 days | Drug: Vonoprazan<br>* Vonoprazan 20 mg oral every 12 hours (total 72 hours)<br>|
| Active Comparator: PPIs<br>PPIs IV infusion for 72 hours then oral PPIs twice per day for 28 days | Drug: PPIs IV infusion<br>* Pantoprazole 80 mg IV loading then 8 mg/hr<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate |  | 3 days | 
| Mortality rate |  | 30 days | 
| Number of blood transfusion unit |  | 30 days | 
| Rate of immobilisation or surgery |  | 30 days | 
| Length of stay |  | Until discharge, assessed up to 30 days |
Prospective Evaluation of FibroScan in Patients Treated With Methotrexate

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.

Detailed Description
-----------------
Methotrexate (MTX) is an effective treatment for induction of remission and maintenance in patients with Crohn's disease, rheumatoid arthritis, or psoriasis which may induce liver fibrosis with high cumulative doses. Transient elastography (FibroScan) is a new non-invasive rapid, reproducible and bed-side method, allowing assessment of liver fibrosis by measurement of liver stiffness. A preliminary study (Laharie et al, Alimentary Pharmaceutical Therapeutics 2006) had shown that significant liver fibrosis was rare in Crohn's disease patients treated with a high dose of methotrexate. FibroScan was a reliable non-invasive method to detect liver fibrosis which could be recommended in these patients. Therefore, liver biopsy could be performed only with patients with high FibroScan values and/or with chronic liver enzymes abnormalities. However, further longitudinal and prospective studies are mandatory to confirm these preliminary data, in patients with crohn's disease but also with rheumatoid arthritis and psoriasis.

Official Title
-----------------
Evaluation of Liver Fibrosis Using FibroScan and Non-invasive Biochemical Markers in Patients Treated With Methotrexate

Conditions
-----------------
Liver Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, ≥18 years of age. Patient treated with Methotrexate. Written informed consent Exclusion Criteria: Patients refusing to participate to the study and to provide written informed consent Pregnant women

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver fibrosis, cirrhosis, FibroScan, transient elastography, elastometry, methotrexate, non invasive blood markers, FibroTest, treatment
Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)

Study Overview
=================
Brief Summary
-----------------
Progressive Supranuclear Palsy (PSP) is a relentlessly progressive neurodegenerative disorder, clinically characterized by parkinsonism with prominent axial involvement and postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and selective brainstem structures result in dysfunction of the five frontosubcortical circuits and brainstem functions. There is no effective treatment for PSP. One of the key feature in the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of GSK3b and could exert a neuroprotective effect through this inhibition. The investigators thus decided to conduct this controlled study to assess the putative neuroprotective effects in patients with PSP.

Official Title
-----------------
Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy

Conditions
-----------------
Progressive Supranuclear Palsy

Intervention / Treatment
-----------------
* Drug: valproic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with possible or probable PSP from 45 to 75 year of age

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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: valproic acid<br>Depakine | Drug: valproic acid<br>* Depakine<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSPRS score (specific score for PSP) |  | This score will be measured every three months during the two-year follow up of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological evaluation |  | inclusion, one year and two years follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Progressive supranuclear palsy (PSP)
SEPSIS 3 Critera for Risk Stratification in Emergency Patients

Study Overview
=================
Brief Summary
-----------------
Investigators aim to evaluate the SEPSIS 3 criterion for sepsis and septic shock in a prospective manner. Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection

Official Title
-----------------
Validation of the SEPSIS-3 Criterion for Sepsis and Septic Shock in the Emergency Department

Conditions
-----------------
Sepsis, Emergency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult that present to the emergency department Diagnosis of infection by the treating emergency physician Exclusion Criteria: Refuse to participate pregnancy prisoner Low acuity infection (localised, not requiring general treatment, without any abnormal vital parameters)

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 |
| --- | --- | --- |
| In hospital mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| admission in ICU |  | 30 days | 
| length of ICU stay more than 72 hours |  | 30 days | 
| Length of hospital stay |  | 30 days |
An Optional Investigation of Biomarkers of Efficacy

Study Overview
=================
Brief Summary
-----------------
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients. ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy. Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002 study participants

Official Title
-----------------
An Optional Investigation of Biomarkers of Efficacy in TH002 Clinical Study Subjects.

Conditions
-----------------
Rhinoconjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously randomised into study TH002, completed the study and received either placebo or the 12 nmol dose in TH002. Exclusion Criteria: Subjects who have received allergen or peptide immunotherapy during the last 12 months (other than TM-HDM)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| To identify cellular, proteomic or genetic biomarkers of efficacy to ToleroMune House Dust Mite (TM-HDM) treatment in TH002 study participants. |  | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
House Dust Mite, Rhinoconjunctivitis, ToleroMune
Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography

Study Overview
=================
Brief Summary
-----------------
The objective of this study is analyze the influence of TV entertainment in children less than 3 years of age during echocardiography in order to achieve a complete and accurate test. This is an experimental study in children with suspected congenital or acquired cardiac disease. An examination room was prepared with a TV on the ceiling that was positioned in a way that would provide unobstructed viewing for children during the echocardiography procedure.

Official Title
-----------------
Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography.A Prospective Randomized Study

Conditions
-----------------
Echocardiography, Pediatrics

Intervention / Treatment
-----------------
* Procedure: echocardiography
* Behavioral: Watching Animated cartoons


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients who were referred to pediatric cardiology consultation. Patients younger than 3.5 years. Signed informed consent by parents. Exclusion Criteria: No signed informed consent by parents.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 43 Months

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group with television<br>Animated cartoons with sound were reproduced during the echocardiography | Procedure: echocardiography<br>* TV was connected to display the cartoon video during the echocardiography: the episode number 125 of 'Dora the Explorer': 'Baby Winky Goes Home!' was reproduced during the echocardiography.<br>Behavioral: Watching Animated cartoons<br> <br> |
| No Intervention: control group with usual care<br>Echocardiography was performed by using the distractions available at the time of test. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography time | Time used to perform the Echocardiography | procedure | 
| Quality of technique | The quality of echocardiography (1 poor, 2 medium, 3 high) | procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents opinion | Parents completed a questionnaire about the use of TV during the test | procedure | 
| Parents stress | The parent's opinion about the sensation of stress by using a scale from 0 (no stress) to 10 (so much stress | procedure | 
| Blood pressure | blood pressure of child | procedure |
Comparison Between Ultrasonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment

Study Overview
=================
Brief Summary
-----------------
To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in nulliparas at term.

Conditions
-----------------
Failed Induction of Labor

Intervention / Treatment
-----------------
* Other: Assessment of cervical status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous patients singleton pregnancy live fetus with vertex presentation intact amniotic membranes > 37 weeks gestation absence of labor no previous uterine surgical procedures Exclusion Criteria: major congenital anomaly
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bishop score<br> | Other: Assessment of cervical status<br>* Assessment of cervical status based on Bishop score versus sonographically measured cervical length<br>|
| Active Comparator: transvaginal ultrasound<br> | Other: Assessment of cervical status<br>* Assessment of cervical status based on Bishop score versus sonographically measured cervical length<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful labor induction | Induction success was defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥ 4 cm within 11 hours of initiating oxytocin (i.e., within 22 hours of the administration of a dinoprostone vaginal insert) on the first day of induction. | Eleven hours of initiating oxytocin on the fist day of induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the need for oxytocin induction | the interval from start of oxytocin to the active phase of labor the interval from start of oxytocin to delivery vaginal delivery within 24 hours of starting induction the incidence of cesarean delivery | After removing prostaglandin, the following day when an intravenous oxytocin infusion was started | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bishop score, Cervical length, Cervical ripening, Labor induction
The Prevalence of Erectile Dysfunction (ED) and ED Related Quality of Life of Diabetic Men

Study Overview
=================
Brief Summary
-----------------
Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan University Hospital are invited to attend a face to face screening and interview. After obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and complications of diabetes are recorded.The results will be used to investigate the prevalence of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of life change.

Detailed Description
-----------------
Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan University Hospital are invited to attend a face to face screening and interview. After obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and complications of diabetes are recorded.The results will be used to investigate the prevalence of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of life change.

Official Title
-----------------
Investigating the Prevalence of Erectile Dysfunction and Erectile Dysfunction Related Quality of Life of Diabetic Men in Taiwan

Conditions
-----------------
Diabetes, Erectile Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic male age above 20 Exclusion Criteria: men using any form of erectile dysfunction treatment-

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, erectile dysfunction, erectile dysfunction related quality of life
12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018

Official Title
-----------------
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: CP-526,555 (varenicline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have smoked on average of at least ten cigarettes per day during the past year Subjects must have no period of abstinence greater than three months in the past year Exclusion Criteria: Subjects with any history of clinically significant cardiovascular disease Uncontrolled hypertension

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-526,555 (varenicline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence rate from target quit date to end of treatment (Week 12) |  |  | 
| Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12 |  |  | 
| Number of cigarettes smoked per day |  |  | 
| Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale |  |  | 
| Rewarding effects of smoking assessed by Smoking Effects Inventory |  |  | 
| Weight change from baselin |  |  |