linjc16/ctgov huggingface dataset:
EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)

Study Overview
=================
Brief Summary
-----------------
In this observational study researchers want to gather more information about the characteristics of patients treated with Radium-223 (Xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels (metastatic castration-resistant prostate cancer, mCRPC). In addition researchers want to identify the factors which may contribute to survival over a long period of time in those patients. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

Official Title
-----------------
Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo): Patient Characteristics and Predictors of Long-term Survival

Conditions
-----------------
Metastatic Castration Resistant Prostate Cancer (mCRPC)

Intervention / Treatment
-----------------
* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Adult patients with documented diagnosis of mCRPC (≥18 years at diagnosis), and Received Ra-223 as one of the therapies between Jan 1, 2013 and Jun 31, 2019 after diagnosis of mCRPC Exclusion criteria - Patients involved in clinical trials

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 |
| --- | --- |
| Radium-223 dichloride (Xofigo, BAY88-8223)<br>Patients with mCRPC who received treatment of Ra-223. | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Receiving Ra-223 either alone or in combination with other cancer therapies at any time after diagnosis of mCRPC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival from initiation of Ra-223 |  | Retrospective analysis from Jan 2013 to Dec 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223 | PSA response will be defined ≥ 50% reduction in baseline PSA level after initiation of Ra-223 | Retrospective analysis from Jan 2013 to Dec 2019 |
Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation.

Detailed Description
-----------------
Walking is a repetitive movement that moves your body while keeping your posture stable. The pelvis is located between the hip and lumbar region, where many muscles are attached to regulate the movement of the hip and lumbar spine. Asymmetrical pelvic alignment affects stability of the lower extremities and trunk, making normal walking difficult. The purpose of this study is to investigate the pattern of gait according to pelvic displacement in patients with lumbar disc herniation.

Official Title
-----------------
Correlation Analysis of Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation : Retrospective Study Using Electronic Medical Record Data

Conditions
-----------------
Lumbar Disc Herniation, Gait Analysis, Pelvis Abnormal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI Patient who got gait analysis Exclusion Criteria: Patients without MRI and X-ray Patient diagnosed with ankle disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Correlation between pelvic displacement and gait parameters | <Pelvic displacement> Sacral angle : The angle between the parallel line drawn on the first vertebral body(Sacrum) and the horizontal line Leg Length Discrepancy : Difference between the values of both sides by measuring the height of the upper edge of both femoral heads Pelvic height : Difference between the left and right peaks of both iliac crests Gravity line : Line passing through the gravity point(L3) of the human body <Gait parameters> Step, Stance phase, Swing phase, Single support, Double support, Step time, Stride, Cadence, Load response, Pre swing, Gait cycle, Speed, Acceleration, contact phase, foot flat, propulsive, PCI | A week after data collected | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale | Using NRS-11(0 to 10) which is measured at first visit | A week after data collected | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait, Pelvic height, Leg Length Discrepancy, Sacral angle
Effects of Family Work Shop for Children With Developmental Delays

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the effects of family work shop for children with developmental delays.

Detailed Description
-----------------
Methods： 1. The family work shop has 5 courses, with 6 families in one course. 2. Intervention: 2-3 hours per session, one time per week, for a total of 6 weeks. Effect： Investigate the effects of family work shop for children with developmental delays, including health related quality of life, functional performance. Investigate the effects of family care giver strain on family work shop for parents of children with developmental delays. Investigate the differences of family impact between children with development delays and children with normal development.

Official Title
-----------------
Effects of Family Work Shop for Children With Developmental Delays

Conditions
-----------------
Developmental Delays

Intervention / Treatment
-----------------
* Other: family work shop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of developmental delays and must be able to attend 6 weeks of work shop Exclusion Criteria: Failed to obtain written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>children with developmental delays participated 6 sessions of family work shop The family work shop has 5 courses, with 6 families in one course. Intervention of one course: 2-3 hours per session, one time per week, for a total of 6 weeks. | Other: family work shop<br>* The family work shop has 5 courses, with 6 families in one course. One course of intervention: 2-3 hours per session, one time per week, for a total of 6 sessions in 6 week periods<br>|
| No Intervention: control<br>children with normal development not participate the work shop followed up at before, and 6 weeks later | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in health related quality of life questionnaire | to identify the changes of health related quality of life of children after the workshop | baseline and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
family work shop
Covid-19 Patients With Hypertension and/or Kidney Diseases

Study Overview
=================
Brief Summary
-----------------
correlation between COVID-19 and Hypertension and/or kidney diseases. Assess Assess the effect of COVID-19 on patients with Hypertension and/or kidney diseases. Assess the effect of hypertension and/or kidney diseases on COVID-19 presentation. Assess the outcome of COVID-19 in patients with hypertension and/or kidney diseases

Detailed Description
-----------------
The pandemic situation with the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from China has endangered human lives. Coronavirus disease 2019 (COVID-19) is presented with asymptomatic, mild, or severe pneumonia-like symptoms¹.SARS-CoV-2 has infected humans in all age groups, of all ethnicities, both males and females while spreading through communities at an alarming rate². COVID-19 patients with hypertension, chronic kidney disease, Diabetes, malignancies, HIV, and other comorbidities could develop a life-threatening situation. From the data have reported the characteristics of comorbidities in patients with COVID-19, hypertension was present in nearly 21%, followed by diabetes in nearly 11%, and established cardiovascular disease (CVD) in approximately 7% of patients³. Hypertension posed an increased risk of severe morbidity (approx. 4-fold) and death (approx. 7-fold) from COVID-19 in the presence of multiple comorbidities⁴. The patients with underlying kidney problems are vulnerable to developing COVID-19 infection.The disease also has had consequences on longitudinal management of patients with chronic kidney disease and end stage kidney disease.

Official Title
-----------------
A Study on COVID-19 Patients With Hypertension and/or Kidney Diseases Admitted to Respiratory ICU , Assiut University Hospitals.

Conditions
-----------------
COVID-19, Hypertension, Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above 18 years old. Patients who diagnosed as COVID-19 PCR positive with hypertension and/or kidney diseases. Exclusion Criteria: Young patients below 18 years old. Patients who refused to participate in reseach

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Covid-19 and Hypertension and/or kidney diseases | Effect of COVID-19 on patients with Hypertension and/or kidney diseases and assess the outcome of COVID-19 in patients with hypertension and/or kidney diseases. | Baseline |
Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

Study Overview
=================
Brief Summary
-----------------
Children ages 3-17 who are undergoing port access receive both standard care, topical medicine for numbing (LMX4), and the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The procedures will be performed on 2 separate visits to the clinic. The child's pain with the access procedure is evaluated.

Official Title
-----------------
Randomized Crossover Trial of Sonication Followed by 5 Minute LMX4 Application Compared With 30 Minute LMX4 Application for Topical Anesthesia Prior to Subcutaneous Port Access in Children

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: SonoPrep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 3-17 with subcutaneous port Exclusion Criteria: Emergent need for port access Allergy to lidocaine sodium lauryl sulfate

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SonoPrep|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability |  |  | 
| safety-skin effects |  |  |
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea

Official Title
-----------------
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable angina patient with angiographically confirmed significant residual stenosis Stenosis more than 50% in 2 major coronary arteries at least or Stenosis more than 75% in 1 major coronary artery Exclusion Criteria: No other pulmonary/psychiatry/musculoskeletal disorder limiting CPET Contraindicated to the CPET (e.g. unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, hypoxemia at rest, epilepsy, locomotor disorder, severe hypertension and febrile illness)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine<br>Amlodipine | Drug: Amlodipine<br>* Amlodipine<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 |
| --- | --- | --- |
| Exercise capacity | Difference of the peak oxygen uptake change (VO2 max, mL/kg/min) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sublingual Nitrate | To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months | 1month and 3 months | 
| Biomarkers | To evaluate the change of biomarkers against no CCB group at 9 months | 9 months |
Fecal Calprotectin in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis

Official Title
-----------------
Fecal Calprotectin in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients Exclusion Criteria: Informed consent/assent not obtained

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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 |
| --- | --- | --- |
| collection of 150 stool specimens |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, calprotectin, elastase
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.

Official Title
-----------------
Beta-lactam Monotherapy Versus Beta-lactam - Macrolide Association as Empiric Antibiotherapy Strategies in Non-severe Hospitalized Community-acquired Pneumonia: a Randomized, Non-inferiority, Open Trial.

Conditions
-----------------
Community-acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)
* Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18 years New infiltrate on chest X-ray, unexplained by another disease process Presence of at least two of the following findings suggestive of pneumonia: fever or hypothermia, new or increasing cough, sputum production, pleuritic chest pain, tachypnea, dyspnea or focal signs on chest examination Need for hospitalization as defined by the emergency physician in charge of the patient Exclusion Criteria: Allergy to one of the study drugs Pregnancy Severe immunosuppression Recent (<14 d) hospitalization, or currently hospitalized since > 48 hours Residency in a nursing home Previous use of more than 24 hours of any antibiotic Severe community-acquired pneumonia

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monotherapy<br> | Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)<br>* 1.2 g 4x/d OR 1.5 g 3x/d IV<br>* Other names: Zinacef;|
| Active Comparator: Bi-therapy<br> | Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)<br>* 1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO<br>* Other names: Klacid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Clinical Stability (hours) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | in-hospital, at 30 and at 90 days | 
| length of stay |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community-acquired infections, Pneumonia, Clinical Stability, Antibiotics, Combination therapy, Atypical bacteria
Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

Study Overview
=================
Brief Summary
-----------------
In SICU, Siriraj hospital there were no protocols place for the management of pain. All decisions were made according the attending physicians. There were no information about incidence of inappropriate pain management in SICU due to lack of validated tool for assessment. To date, Thai-version of BPS and CPOT were validated, the incidence of inappropriate pain management in SICU, Siriraj hospital should be assessed.

Official Title
-----------------
Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

Conditions
-----------------
Adult ICU Patients, Pain, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years. Expected duration of mechanical ventilation of more than 24 hours. Exclusion Criteria: Quadriplegia. Receiving neuromuscular blocking medications. Coma or severe brain injury Neurosurgery/ CVT patients/ trauma patients

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 |
| --- | --- | --- |
| overtreatment of pain (Richmond agitation sedation scale) | Richmond agitation sedation scale -3 to -5 undertreatment NRS 4-10 or CPOT 3-8 | day0- 2 after admitted to ICU | 
| inadequate treatment of pain (Numeral rating scale) | Numeral rating scale 4-10 in communicable patient or critical care pain observation tool 3-8 in non-communicable patients | day 0-2 after admitted to ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | 30 days after admitted to ICU | 
| ICU length of stay |  | 30 days after admitted to ICU | 
| Duration of mechanical ventilation |  | 30 days after admitted to ICU | 
| Incidence of acquired complication | Ventilator associated pneumonia GI hemorrhage Venous thromboembolism Central venous catheter colonization | 30 days after admitted to ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incidence, surgical ICU