linjc16/ctgov huggingface dataset:
Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia

Study Overview
=================
Brief Summary
-----------------
The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death.

Official Title
-----------------
Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia

Conditions
-----------------
Longitudinal Observational Study With 6 Months Follow-up

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted for unexpected respiratory difficulty Patient admitted to the emergency department One of the following 3 criteria have to be present at admission to the ER: O2 < or = 95% Respiratory rate RR > or = 20 Suffocation sensation Exclusion Criteria: Patients <18 years old and> 85 years' old Pregnancy History of allergic asthma at early age Diagnosis retained of pulmonary embolism Patients with heart failure (HF) with left ventricular ejection fraction LVEF <40% are known beforehand or discovered at admission to ER known Allergy for Polyamide; Polyester; Elastane; Silicone; Silver; Synthetic material Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax Open wound on the skin, at the level of the trunk

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital | Define the proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital for patients admitted to the Emergency Department for acute dyspnea | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion and causes of re-hospitalization and deaths within 6 months of discharge from hospital | Check theses parameters at 6 months, differentiating the cardiac causes from non-cardiac causes and the effect of home follow-up. | 6 months |
Liver Disease in Adults With Alpha-1 AT Deficiency

Study Overview
=================
Brief Summary
-----------------
This cohort study will evaluate the prevalence of the infra clinical liver injuries among a group of adult patients presenting with Alpha-1 AT deficiency followed up in a large university hospital in Lyon, France.

Official Title
-----------------
Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency

Conditions
-----------------
Alpha-1 AT Deficiency

Intervention / Treatment
-----------------
* Other: Transient Elastography and fibrotest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years old Presenting an Alpha-1 AT deficiency (Alpha-1 AT level <0.8g/l at the time of diagnosis) Exclusion Criteria: Patients presenting a liver disease not related to the Alpha-1 AT deficiency

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transient elastography and fibrotest<br> | Other: Transient Elastography and fibrotest<br>* a Transient Elastography and an ultrasound are performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of infra clinical liver injuries | The prevalence of infra clinical liver injuries (lesions or liver abnormalities) in a cohort of adult patients presenting an Alpha-1 AT deficiency. Suspicion of fibrosis was defined as liver stiffness > 7.2kPa measured by transient elastography (TE). | At least one day depending on the schedule of the exams | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphological liver complications description | To describe all the morphological liver complications present at the moment of the investigation. | At least one day depending on the schedule of the exams | 
| measure of biological parameters | - To measure the biological parameters (as AST, ALT, GGT, total bilirubin, lymphocytes, platelets, FibroTest score) and radiological aspects (TE score, liver aspect evaluated by ultrasound) | At least one day depending on the schedule of the exams | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alpha-1 AT deficiency, liver injury, Transient Elastography, FibroTest
Evaluation of Interventions to Prevent Suicide of Medical Students Through the School-Based Social Support System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether school-based social support systems are effective in preventing suicide in medical students.

Official Title
-----------------
Evaluation of Interventions to Prevent Suicide of Medical Students Through the School-Based Social Support System

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: school-based social support system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical university students Grades 1 through 2 Exclusion Criteria: Psychopath
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Training gatekeeper recruited from students and tutors and counselors | Behavioral: school-based social support system<br>* Training gatekeeper recruited from students and tutors and counselors for group 1; training counsellors for group 2; No special intervention for group 3<br>|
| Active Comparator: 2<br> | Behavioral: school-based social support system<br>* Training gatekeeper recruited from students and tutors and counselors for group 1; training counsellors for group 2; No special intervention for group 3<br>|
| No Intervention: 3<br> | Behavioral: school-based social support system<br>* Training gatekeeper recruited from students and tutors and counselors for group 1; training counsellors for group 2; No special intervention for group 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of suicide ideation |  | half of one year and one year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of suicide attempt |  | half of one year and one year after intervention |
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD

Study Overview
=================
Brief Summary
-----------------
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.

Official Title
-----------------
A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)

Conditions
-----------------
Acute Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: pentostatin for injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients 6 months of age with grade 2 GVHD that is steroid-refractory Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC Time post stem cell infusion < 100 days Written informed consent Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2) Exclusion: Post-transplant lymphoproliferative disease Uncontrolled infection Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study ATG within the previous 14 days Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days

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

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

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

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: pentostatin for injection|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
-----------------
acute graft versus host disease, aGVHD, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, cord blood transplant, pentostatin, Nipent, deoxycoformycin
A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.

Official Title
-----------------
A Clinical Trial to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Digoxin + Fimasartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20 - 40 years sex: male body weight: greater than 55 kg written informed consent Exclusion Criteria: known allergy to Fimasartan and digoxin existing cardiac or hematological diseases existing hepatic and renal diseases existing gastrointestinal diseases acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 2 months prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Digoxin + Fimasartan|Digoxin (7 days), Digoxin + Fimasartan (7 days)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, Cmax, Tmax, CL |  | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24 hours at 7 day and 28 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fimasartan, Drug interaction
A Phase II Study in Patients With Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.

Detailed Description
-----------------
The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Official Title
-----------------
A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: SHR0302


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between 18-65 years of age (both inclusive), at the time of informed consent; Must have moderate to severe alopecia areata. Exclusion Criteria: Other types of alopecia or other diseases that can cause hair loss Other scalp diseases that could interfere with assessment of hair loss/regrowth Any previous use of any Janus kinase (JAK) inhibitor

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SHR0302 Dose#1<br> | Drug: SHR0302<br>* Oral tablets taken once daily (QD)<br>|
| Active Comparator: SHR0302 Dose#2<br> | Drug: SHR0302<br>* Oral tablets taken once daily (QD)<br>|
| Active Comparator: SHR0302 Dose#3<br> | Drug: SHR0302<br>* Oral tablets taken once daily (QD)<br>|
| Placebo Comparator: Placebo<br> | Drug: SHR0302<br>* Oral tablets taken once daily (QD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in Severity of Alopecia Tool (SALT) score | Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss | week 24 |
Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, controlled trial study to find whether use of chlorhexidine-alcohol or povidone-iodine for pre-vaginal delivery skin prep is superior to reduce postpartum infection in pregnant women with vaginal delivery. The primary outcome is the episiotomy site infection.

Official Title
-----------------
Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns

Conditions
-----------------
Vaginal Delivery, Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Povidone-Iodine
* Drug: Chlorhexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with singleton pregnancy Women who will undergo vaginal delivery after 37+0/7 weeks of gestation Exclusion Criteria: Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish Women with any infection at perineum (before vaginal delivery)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorhexidine<br>Pre-vaginal delivery skip prep using chlorhexidine-alcohol | Drug: Chlorhexidine<br>* Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.<br>* Other names: Hexitanol 2% Soln., Chlorhexidine Gluconate Solution;|
| Active Comparator: Povidone-iodine<br>Pre-vaginal delivery skip prep using Povidone-iodine | Drug: Povidone-Iodine<br>* Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.<br>* Other names: Povidone-iodine 10%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant with episiotomy site infection | Superficial or deep infection of episiotomy site | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chlorhexidine-alcohol, Povidone-iodine, Perineal infection, Surgical site infection
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the natural course of the androgen profile after bariatric surgery in men with obesity related hypogonadotropic hypogonadism.

Official Title
-----------------
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism

Conditions
-----------------
Morbid Obesity, Hypogonadism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age 20-55 years Planned bariatric procedure Helicobacter pylori negative or adequate HP eradication Exclusion Criteria: Liver and/or kidney dysfunction Psychiatric disease Medication influencing androgen profile and/or bone metabolism Weight > 160 kg

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Eugonadal men with Lapband | |
| 2<br>Hypogonadal men with Lapband | |
| 3<br>Eugonadal men with gastric bypass procedure | |
| 4<br>Hypogonadal men with gastric bypass procedure | |

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
-----------------
hypogonadotropic hypogonadism, bariatric surgery, serum androgen levels, bone density
Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine.

Detailed Description
-----------------
In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine. Patient files will be screened for relevant information. Individual patients can be included multiple times if vancomycin has been administered more than once.

Official Title
-----------------
Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

Conditions
-----------------
Gram-Positive Bacterial Infections

Intervention / Treatment
-----------------
* Other: Plasma exposure vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients hospitalized in the University Hospitals Leuven between January 2012 and April 2014, treated with vancomycin Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plasma exposure vancomycin<br>Pediatric patients treated with vancomycin | Other: Plasma exposure vancomycin<br>* Investigation of plasma exposure of vancomycin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loading dose related plasma exposure vancomycin | Plasma exposure to vancomycin in relation to administered dose | 24 hours after loading dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vancomycin, Pharmacokinetics, Trough level, Pediatric