linjc16/ctgov huggingface dataset:
Special Drug Use Investigation for ROTARIX®

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.

Detailed Description
-----------------
This is non-interventional study conducted in one group received Oral Rotarix®.

Official Title
-----------------
Special Drug Use Investigation for ROTARIX

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Biological: Oral Rotarix®
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation. Exclusion Criteria: All infants included in the drug use investigation of Oral Rotarix will be excluded.
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 |
| --- | --- |
| Rota Group<br>Subjects will receive Rotarix® as per routine practice | Biological: Oral Rotarix®<br>* 2 doses administered orally.<br>Other: Data collection<br>* Additional information on intussusception will be collected through interview and by phone-contact.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the incidence of IS |  | During the 31-day (Day 0 -Day 30) observation period after each vaccination | 
| Determination of the incidence of IS |  | On the 1 year birthday of the subject | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intussusceptions, Special Drug Use Investigation, Rotavirus
Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1 study).

Official Title
-----------------
A Randomized, Double-blind, 2-way Crossover, Placebo-controlled Study to Investigate the Influence of a Single-dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation in Selected Centers of the PATENT-1 Trial

Conditions
-----------------
QTc Evaluation, Electrocardiography

Intervention / Treatment
-----------------
* Drug: Avelox (Moxifloxacin, BAY12-8039)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age 18-75 years - Normal ECG Exclusion Criteria: Abnormal ECG - Intolerance to fluorochinolones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Avelox (Moxifloxacin, BAY12-8039)<br>* Single dose of 400 mg<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Single dose of matching tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval at 3 hours |  | Day 1 of treatment period 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables | Adverse events, clinical laboratory, vital signs, ECG findings | Up to last visit of follow up | 
| Pharmacokinetic parameters | Cmax, Cmax,norm, tmax | On different time points | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moxifloxacin
GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers.

Detailed Description
-----------------
Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.

Official Title
-----------------
GBR 12909 Study in Cocaine Experienced African American Volunteers

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: GBR 12909


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be within 20% of ideal body weight and must weigh at least 45 kg. Must understand the study procedures and provide written informed consent. Must meet DSM-4 criteria for abuse or dependence on cocaine. Must be non-treatment seeking at the time of the study. Exclusion Criteria: Please contact the study site for more information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GBR 12909|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic assessment |  |  |
Therapeutic Patient Education and Cancer Pain

Study Overview
=================
Brief Summary
-----------------
Describe the expectations of therapeutic education for patients in management of cancer pain.

Official Title
-----------------
THERAPEUTIC PATIENT EDUCATION AND CANCER PAIN

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with cancer diagnosed for at least one month Patient with pain from the tumor or its treatment Patients with a life expectancy ≥ 6 months Health condition compatible with the requirements of the program (WHO performance scale < or= 2) Age over 18 years Patient able to understand, speak and read French Absence of cognitive impairment Exclusion Criteria: Primary cancer of the central nervous system or brain metastases Disorders of the documented higher functions Evolutionary psychiatric pathology Drug User Abusive alcohol consumption than the WHO recommendations (or 3 glasses of wine per day) Refusal to participate

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

| Intervention/Treatment |
| --- |
|Other: Questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| describe the expectations of therapeutic education for patients in management of cancer pain |  | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the expectations of close person in therapeutic education on management of cancer pain |  | at inclusion | 
| Estimate the intensity of the pain |  | at inclusion | 
| Estimate the echo of the pain on the daily activity of the patient |  | at inclusion |
Influence of Knee Alignment and Pelvis Rotation on Accuracy of Radiograph Measurements Before Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the accuracy of long leg standing X-rays with respect to coronal alignment of the knee.

Detailed Description
-----------------
Long leg standing x-ray is a routine examination to measure the femoral valgus angle before a total knee arthroplasty. Newer studies have shown that coronal leg alignment influences the rotation of the distal femoral part. This rotation might influence the measurements obtained with a long leg standing x-ray. The primary purpose of this study is to determine whether there is a significant difference between 2D measurements taken on the x-ray and 3D measurements obtained with a CT scan.

Official Title
-----------------
The Influence of Lower Extremity and Pelvic Alignment on Accuracy of Hip-Knee-Ankle Radiograph Measurements Before Total Knee Arthroplasty

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Radiation: CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Knee osteoarthritis scheduled for knee arthroplasty Exclusion Criteria: previous leg deformities or surgery that changes alignment

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Group<br>All patients scheduled for a total knee arthroplasty without any previous lower limb deformities or previous hip/knee surgery will be enrolled. A long leg standing x-ray and a CT scan of the lower limb will be obtained for every patient. | Radiation: CT scan<br>* CT of the lower limb<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The angle difference between an x-ray and a CT scan | The femoral valgus angle, femoral mechanical angle, tibial mechanical angle and hip knee ankle angle are measured separately on the x-ray and on the CT scan. The difference in individual angle is the calculated. | Before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee aligment, total knee arthroplasty, coronal alignment of the lower limb, x-ray accuracy
Effects of Global Postural re-Education Program

Study Overview
=================
Brief Summary
-----------------
The postural alterations present in the seniors people act as predisponent form of incapacities that provoke alterations in the quality of life. The objective of this study is to evaluate the biomechanical characteristics of the balance of elderly people, before and after treatment with Global Postural Re-education. This research is characterized by experimental method of investigation.Thirty elderly people (30 women) will be randomized to two different groups from Group of Studies of Third Age - GETI, at University of the State of Santa Catarina: fifteen elderly women will be submitted to the Global Postural Re-education (GPR) program and to the GETI program of activities fifteen elderly women will be submitted only to the GETI program of activities. At baseline the subjects will be screened for balance measurements with the chattecx balance system and Berg Scale. These measurements will be repeat immediately after the intervention. The subjects randomised to the GPR program will participate in posture retraining techniques of approximately forty minutes, one time a week for ten weeks. The independent t test for pairs of random samples will be used, with level of significance of p≤0,05.

Official Title
-----------------
Effects of Global Postural re-Education Program on the Biomechanical Characteristics of the Elderly Balance.

Conditions
-----------------
Healthy, Elderly

Intervention / Treatment
-----------------
* Other: GPR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Senior that accomplish physical activity in the GETI (group of studies of the third age - Santa Catarina State University) Exclusion Criteria: Visually impaired person Vestibular disorder Neurologic disorders Use of prostheses and ortheses Cancer

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GPR<br>Global postural re-education intervention | Other: GPR<br>* The subjects randomised to the GPR program will participate in posture retraining techniques of approximately forty minutes, one time a week for ten weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| center of pressure (cop) |  | pre-treatment, five weeks and pos-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Global postural re-education, Balance, Physical therapy, older people
Retrospective Safety Study to Compare Mortality in Intensive Care Unite (ICU) Patients Undergoing Echocardiography With or Without DEFINITY®

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis to observe changes in short term mortality

Official Title
-----------------
A Retrospective Observational Database Study To Compare In-Hospital All-Cause Mortality in Critically Ill Patients Undergoing Echocardiography With or Without DEFINITY®

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females At least 18 years of age

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 |
| --- | --- |
| Non-contrast echocardiography<br>Non-contrast echocardiography | |
| Contrast Echocardiography<br>Contrast Echocardiography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term mortality |  | 48 hours post echo produre | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD
The Clinical and Pharmacoeconomic Impact of Rapid Diagnostic Test (Multiplex PCR FilmArray) on Antimicrobial Decision Making Compared to Conventional Decision Making Among Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
We will show in this study the impact of use the rapid diagnostic method (multiplex PCR filmArray) on clinical and pharmacoeconomic aspects among Critically Ill Patients.

Detailed Description
-----------------
Prospective and retrospective study on 100 patients complaining from sepsis in intensive care unit in International Medical center. Two phase study 50 patients before and 50 patients after use rapid diagnostic test (multiplex PCR filmArray)

Official Title
-----------------
The Clinical and Pharmacoeconomic Impact of Rapid Diagnostic Test (Multiplex PCR FilmArray) on Antimicrobial Decision Making Compared to Conventional Decision Making Among Critically Ill Patients

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Diagnostic Test: rapid diagnostic test (multiplex PCR filmArray)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 85 years Critically ill patients admitted to ICU, diagnosed as sepsis. Exclusion Criteria: Surviving time less than 48 hours.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 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 |
| --- | --- |
| A<br>50 patients before use rapid diagnostic test (multiplex PCR filmArray) | |
| B<br>50 patients after use rapid diagnostic test (multiplex PCR filmArray) | Diagnostic Test: rapid diagnostic test (multiplex PCR filmArray)<br>* novel diagnostic platform, the FilmArray®, which combines automated sample preparation, nucleic acid extraction and PCR-based detection of 31 separate targets from a single unprocessed sample in one hour. It combines nesting and multiplexing of the PCR (referred to here as nested multiplex or nmPCR) together with DNA melting curve analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical | Clinical resolution of sepsis ( by percentage) | through study completion, an average of 1 year | 
| Pharmacoeconomic | 1-Reduction of cost and reduction of respective antimicrobial cases (by percentage ) | through study completion, an average of 1 year | 
| clinical | survival (by percentage ) | through study completion, an average of 1 year | 
| clinical | length of stay in ICU (by days) | through study completion, an average of 1 year | 
| clinical | change strategy of antibiotic in first week (by percentage) | through study completion, an average of 1 year | 
| pharmacoeconomic | DOT of antimicrobial (by days ) | through study completion, an average of 1 year |
The Characteristics of Falls and Its Potential Predictors

Study Overview
=================
Brief Summary
-----------------
A prospective study to examine the fall characteristics among elderly faller in Hong Kong and the potential predictors of falls incidence.

Detailed Description
-----------------
This will be a prospective study. One thousand and five hundred older fallers would be recruited. Baseline assessments would be conducted to examine potential fall risk factors and the fall history. The subjects would be followed up for 1 year for fall incidence. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.

Official Title
-----------------
The Characteristics of Falls in Community-dwelling Older Adults in Hong Kong and Its Potential Predictors

Conditions
-----------------
Fall Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 60 or older able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3 able to walk for ≥ 10 meters history of falls in the past 12 months living in the community able to understand Chinese Exclusion Criteria: blindness

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Number of falls | Prospective fall data will be collected through telephone follow-up for 1 year. The number of fall during the follow-up period and the circumstances while the falls occur would be recorded. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fall, elderly
Eosinophilic Gastrointestinal Disorders Patient Registry

Study Overview
=================
Brief Summary
-----------------
The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that does not involve medical interventions, but serves as a record of demographics, characteristics of disease and treatment, utilization patterns, quality improvement measures and clinical outcomes. The database is proposed so that epidemiologic research can be performed and current and accurate data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life.

Official Title
-----------------
Eosinophilic Gastrointestinal Disorders Patient Registry

Conditions
-----------------
Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Enteritis, Eosinophilic Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female participants of any race or ethnicity age 0 to 21 years diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis Exclusion Criteria: hypereosinophilic syndrome non-eosinophilic gastrointestinal or allergic disorder

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| eosinophilic gastrointestinal disorders<br>Individuals with a diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define characteristics of an eosinophilic gastrointestinal disorder population in a rural southern state | To develop a database of patients with eosinophilic gastrointestinal disorders so that epidemiologic research can be performed and current data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life. | After 12 months of data collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis