linjc16/ctgov huggingface dataset:
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.

Official Title
-----------------
ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Enalapril -

Conditions
-----------------
Healthy, Pharmacokinetics of Enalapril

Intervention / Treatment
-----------------
* Drug: ASP1585
* Drug: enalapril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight: =<50.0kg, <80.0kg Body mass index: =<17.6, <26.4 Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data Exclusion Criteria: Attending another clinical trial within 120 days before the study Blood donation within 90 days (400ml) or 30 days (200ml) before the study Receiving any drugs within 7 days before the study History of allergy to drugs Having GI disorders History or complication of liver diseases History or complication of heart disease History or complication of respiratory diseases History or complication of renal diseases History or complication of cerebrovascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-add first group<br>single administration first, then concomitant administration | Drug: ASP1585<br>* oral<br>Drug: enalapril<br>* oral<br>* Other names: Renivace;|
| Experimental: combi-add first group<br>concomitant administration first, then single administration | Drug: ASP1585<br>* oral<br>Drug: enalapril<br>* oral<br>* Other names: Renivace;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of enalapril |  | for 48 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by AE, vital signs 12-lead ECG and lab tests |  | for 7 days after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1585, Drug-drug interaction, enalapril, Healthy volunteer
ROTATEQ Reexamination Study (V260-037)

Study Overview
=================
Brief Summary
-----------------
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.

Official Title
-----------------
Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice

Conditions
-----------------
Gastroenteritis Rotavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants Who Are Vaccinated With Rotateq For The Prevention Of Rotavirus Gastroenteritis Within Local Labeling Will Be Included Exclusion Criteria: Participants who are vaccinated with Rotateq before study start Participant who has a contraindication to Rotateq according to the local label

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 32 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotateq<br>Korean Infants vaccinated with Rotateq in usual practice. The Rotateq vaccination series consists of 3 ready-to-use liquid (oral) doses with the first dose to be administered at age 6-12 weeks and subsequent doses to be administered at 4 to 10-week intervals. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Any Adverse Experience | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. | Up to 42 days after any Rotateq vaccination | 
| Percentage of Participants With Any Adverse Drug Reaction | An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out | Up to 42 days after any Rotateq vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteritis rotavirus
Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood

Study Overview
=================
Brief Summary
-----------------
A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).

Official Title
-----------------
Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood

Conditions
-----------------
Empyema, Pneumonia

Intervention / Treatment
-----------------
* Drug: Urokinase
* Procedure: Video-Assisted Thoracoscopic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain Exclusion Criteria: Existing contraindications or other previous conditions, hypertension, pneumothorax

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urokinase<br>urokinase infusion for 3 days | Drug: Urokinase<br>* Chest tube with intrapleural urokinase infusion for 3 days<br>|
| Active Comparator: Thoracoscopic<br>Video-Assisted Thoracoscopic | Procedure: Video-Assisted Thoracoscopic<br>* Video-Assisted Thoracoscopic decortication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the hospital stay after the treatment |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of the treatment and complications of the disease |  | 3 months | 
| total duration of the hospital stay |  | 3 months | 
| number of days carrying the chest drain |  | 3 months | 
| duration of the fever once the empyema has been drained |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Empyema, Urokinase, Thoracoscopic, Childhood
Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative stress notably with a decrease in certain markers of oxidative stress and on plasma lipid parameters, the investigator proposes to study the effect of 6 months of treatment with XXS in a controlled study against placebo in a population of persons presenting a lipid profile at the upper limit of normal.

Official Title
-----------------
Randomized, Double-blind Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia and on Lipoprotein Kinetics

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Dietary Supplement: XXS
* Dietary Supplement: non-XXS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who have provided written consent Persons aged over 18 years Presenting LDL levels between 1.30 and 1.90 g/l and/or triglyceride levels between 1.5 and 3 g/l Exclusion Criteria: Persons without national health insurance cover Pregnant or breastfeeding women Adults under guardianship Patients with diabetes (Insulin-Dependent Diabetes (IDD) or Non-Insulin-Dependent Diabetes NIDD) Patients with coronary artery disease Patients with atherosclerosis HDL>0.80 g/l receiving treatment with lipid-lowering agents (statins, fibrates, ezetimibe or Ω3) Consuming vitamin supplements (A, C, E…) Consuming oligoelements or minerals (Se, Zn, Ca…) Renal insufficiency (creatinine clearance < 30 ml/min calculated according to the Modification of the Diet in Renal Disease (MDRD))

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XXS<br> | Dietary Supplement: XXS<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: non-XXS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of Malondialdehyde (MDA) |  | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS | 
| Quantification of oxidized Low Density Lipoprotein (LDL) |  | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of overall free-radical defences in the blood by KRL Kyrial Internationaltest |  | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS |
Evaluation of the Mobility of the Digital Flexor Tendons

Study Overview
=================
Brief Summary
-----------------
To study flexor tendon excursion in the hand after surgery by dynamic MRI

Detailed Description
-----------------
The study of the movement of the digital flexor tendon operated on MRI could lead to a better understanding of the biomechanics of this tendon after surgery, to objectively assess the repair of the tendon and the recovery of its mobility. The visualization of the aspect and the movement of this operated tendon would make it possible to adapt the rehabilitation for each patient and to prevent the occurrence of complications which limit functional recovery and source of handicap. The analysis of the imaging in patients evolving would establish useful criteria the surgeon to judge the evolution of the operated tendon. The first step consists in evaluating the feasibility of the acquisition of dynamic sequences in MRI and the possibility of observing the movement of the flexor tendon operated during the mobilization of the finger, and comparing the biomechanical data obtained with those of the nonoperated tendons and experimental models.

Official Title
-----------------
Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.

Conditions
-----------------
Flexor Digitorum Longus on the Right, Flexor Digitorum Longus on the Left, Tendon Rupture, Tendon Injury - Hand

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: flexor tendon injury in zone 2 treatment by surgery insufficient functional outcome after surgery MRI requested by surgeon Exclusion Criteria: pregnancy MRI contraindications previous surgery on the hand rheumatic disorder

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 |
| --- | --- | --- |
| Flexor tendon excursion | Imaging of flexor tendon excursion in the hand after surgery during motion with MRI | 1 year |
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.

Official Title
-----------------
Open, Primary Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Administered to Healthy Chinese Infants at 3, 4 and 5 Months of Age.

Conditions
-----------------
Tetanus, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria

Intervention / Treatment
-----------------
* Biological: diphtheria, tetanus, pertussis & Hib vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject Exclusion Criteria: subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b (Hib) diseases can not participate.

Ages Eligible for Study
-----------------
Minimum Age: 90 Days
Maximum Age: 120 Days

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: diphtheria, tetanus, pertussis & Hib vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events |  |  |
Decision Making in Hypothetical Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case.

Detailed Description
-----------------
Participants will be randomized into 1 of 2 groups and receive a hypothetical scenario of carpal tunnel, with or without cost information, and asked to decide if that hypothetical patient should undergo a carpal tunnel release.

Official Title
-----------------
Patient and Consumer Decision Making in a Hypothetical Case of Carpal Tunnel Syndrome

Conditions
-----------------
Carpal Tunnel Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting to hand clinic OR mturk workers age 18 or older Exclusion Criteria: traumatic mechanism of injury

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention. We will use a random block generator to assign participants to their study arm.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in the control group will be given a hypothetical scenario about carpal tunnel syndrome and asked to make a treatment decision for that hypothetical patient. | |
| Experimental: Intervention<br>Participants in the intervetion group will be given a hypothetical scenario about carpal tunnel syndrome as well as information about the cost of treatment and asked to make a treatment decision for that hypothetical patient. | Other: Cost Information<br>* participants will be given information on the personal and societal costs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision to have Treatment | Participants are asked to answer Should you get surgery right now, with the options of definitely yes, probably, maybe, maybe not, probably not, and definitely not | immediately after completing survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opinion on healthcare costs | a 7 item, likert response questionnaire used to elicit participant opinions on cost in health care. This is a non-validated tool. | immediately after completing survey |
The Impact of Opioids in Fractures - a Case Control Study

Study Overview
=================
Brief Summary
-----------------
In this study, the risk of opioid medications on fractures in older adults is investigated. Patients from the surgical department with fractures and control patients from the internal department of the same hospital are inquired with a standardized questionaire about demographic and clinical risk factors for fractures. Osteoporotic fracture risk is assessed using quantitative ultrasound. An impact of recent opioid medications on fractures is hypothesised.

Official Title
-----------------
Evaluation of Past Medications in Older Patients With Fractures and Patients Hospitalized for a Non-surgical Reason.

Conditions
-----------------
Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for both groups: age > 60 years written informed consent Exclusion Criteria for both groups: malignant Disease within the last 12 month troubles with memory, dementia or Parkinsons disease other fractures within the last 6 month Exclusion Criteria for the fracture group: alcoholised during the fall fracture older than 14 days

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Patients with fracture<br>fracture within the last 14 days no other fractures within the last 6 month patients >60 years | |
| Control Patients<br>patients hospitalized for an internal reason no other fractures within the last 6 month patients >60 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported Opioid medication before hospital admission | Standardized assessment of opioid medications taken before fracture or hospital admission to evaluate the impact of opioids in fractures. Exact doses, substances and intake habits are inquired. | interview: 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density measures using Quantitative ultrasound (SAHARA) | Evaluation of fracture risk due to reduced bone density is performed using quantitative ultrasound. | 10 min |
Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

Study Overview
=================
Brief Summary
-----------------
Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity. The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization). Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures. The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.

Official Title
-----------------
Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

Conditions
-----------------
Occlusion or Malformation of a Cerebral Vessel

Intervention / Treatment
-----------------
* Device: protocol of optimization ALARA
* Device: protocol of optimization Philips


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology Exclusion Criteria: opposition ot the parent(s) to the participation of their child in the trial and/or no social security.

Ages Eligible for Study
-----------------
Maximum Age: 14 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protocol of optimization ALARA<br>protocol of optimization ALARA protocol of optimization of doses | Device: protocol of optimization ALARA<br> <br> |
| Active Comparator: protocol of opimization Philips<br>protocol of optimization Philips usual protocol of optimization of doses | Device: protocol of optimization Philips<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the average dose per child, according to the protocol |  | maximum one day per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of X-rays photographs according to the protocol, quality of photographs according to the protocol, |  | maximum one day per patient |