linjc16/ctgov huggingface dataset:
Nesiritide for Ventilated Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The congestive heart failure is a common disease among patients who receive cardiac surgery and may lead to prolonged ventilation support. Nesiritide was a potential therapy for congestive heart failure. This study aimed to compare the Nesiritide induced hemodynamical status changes among congestive heart failure patients with invasive ventilation support.

Official Title
-----------------
Hemodynamic Effects of Nesiritide on Congestive Heart Failure Patients Receiving Mechanical Ventilation: A Prospective Observational Study

Conditions
-----------------
Venous Return, Congestive Heart Failure, Mechanical Ventilation, Using Nesiritide, Cardiac Function

Intervention / Treatment
-----------------
* Drug: Nesiritide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 years； Congestive Heart Failure; With mechanical ventilation； With hemodynamic monitoring devices; The physicians made the decision of using Nesiritide. Exclusion Criteria: Unstable hemodynamic status； Severe renal dysfunction.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nesiritide|The attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of cardiac output | Changes of cardiac output measured by hemodynamical monitoring tools | Before and 30-min after using a standard dose of Nesiritide | 
| Changes of systemic filling pressure | Changes of the intercept of regression line of paired VR-RAP points at different PEEP levels. | Before and 30-min after using a standard dose of Nesiritide | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of cardiac function curve | Using body position changes (±15°) to simulate the change of preload, and therefore depicte the Starling curve | Before and 30-min after using a standard dose of Nesiritide | 
| Changes of venous return curve | Changes of venous return curve depicted by different PEEP setting | Before and 30-min after using a standard dose of Nesiritide | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, Nesiritide
The Evaluation and Management of Patients With Acute ChesT Pain in China

Study Overview
=================
Brief Summary
-----------------
EMPACT is the first attempt to comprehensively evaluate the current emergency care of acute chest pain from a regional representative sample in China.Findings will allow new opportunities to facilitate the clinical quality improvements and ultimately reduce the mortality and health care burden in patients with acute chest pain. It also will help to establish a regional network and database for further research and performance improvement.

Official Title
-----------------
The Evaluation and Management of Patients With Acute ChesT Pain in China

Conditions
-----------------
Acute Chest Pain, Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Eighteen years and older Presenting to the ED With acute chest pain or suspected ACS Symptoms occurring within 24 hours Informed consent from patient or next of kin Exclusion criteria Chest pain caused by trauma Persisting or recurrent chest pain caused by rheumatic diseases or cancer Transferred from another grade II or grade III hospital Presenting to the ED again within 30 days after initial enrollment

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 |
| --- | --- | --- |
| Major adverse cardiac events (MACE) | The primary outcome was a composite of adjudicated MACEs, including death from all causes, non-fatal acute myocardial infarction (AMI), urgent revascularization, stroke, cardiac arrest, and cardiogenic shock. | 30 days after presenting to the emergency departments(ED) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| revisiting to ED and rehospitalization |  | 30 days after presenting to the EDs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Chest Pain, Acute Coronary Syndrome, Evaluation and Management, Decision Aid, Healthcare Utilization
Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai

Study Overview
=================
Brief Summary
-----------------
Since March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection.

Official Title
-----------------
Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection During the Outbreak of Omicron in Shanghai: a Cohort Study.

Conditions
-----------------
SARS-CoV2 Infection, Neonatal Infection, Outcomes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates born to mothers with SARS-CoV-2 infections. Exclusion Criteria: Parents who rejected to participate in this study.

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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 |
| --- | --- | --- |
| The death of newborns |  | The date of discharge，an average of 4 weeks after the admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The malformation rate of neonates born to mothers with SARS-CoV-2 infections |  | Birth | 
| The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections |  | Birth | 
| The brain injury rate of neonates born to mothers with SARS-CoV-2 infections |  | within 7days after the admission | 
| The development delay rate of neonates born to mothers with SARS-CoV-2 infections |  | within 1 year after the admission | 
| The Chinese standardized Denver Developmental Screening Test (DDST) in neonates born to mothers with SARS-CoV-2 infections |  | Infants ( ≥35 weeks）are at 1 year after birth;Infants（< 35weeks） are at a corrected age of 1 year |
Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.

Detailed Description
-----------------
The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis. In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.

Official Title
-----------------
Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Device: Air- Limb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transtibial amputees due to vascular diseases. Exclusion Criteria: Bilateral amputation. Upper extremity can't bear weight. The sound leg can't bear weight. Amputee that needs Dialysis treatment. Cognitive impairment.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Air- Limb|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis. |  | 1-4 month | 
| The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis. |  | 2-6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of stump healing and functional status of transtibial amputees. |  | 1-6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transtibial amputees due to vascular diseases.
Neurobiology of Opioid Dependence: 1 - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.

Official Title
-----------------
Neurobiology of Opioid Dependence: 1

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamotrigine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral, subjective, measures of naloxone-precipitated opiate withdrawal |  |  | 
| Phsyiological, neuroendocrine measures of naloxone-precipitated opiate withdrawal |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid disorders
Application of Digitized Respiratory Sounds for Confirmation of the Position of the Balloon of Endobronchial Blockers

Study Overview
=================
Brief Summary
-----------------
This observation study is to evaluate the application of the spectral analysis and characteristic parameters of digitized respiratory sounds in the confirmation of the position of the balloon of endobronchial blockers

Detailed Description
-----------------
This is an observational study. We will recruit 30 patients who are scheduled for thoracic surgery under general anesthesia with tracheal intubation and need endobronchial blocker for unilateral lung ventilation during the operation. The standard procedures for confirming the position of the balloon of the endobronchial blocker, including the stethoscopic inspection and the fiberoptic examination, will be performed as routine practice. But in our study, besides the above routine practice, a microphone will be connected to the distal end of the stethoscope (the microphone will not contact directly with the patients) during the checking procedure to record the breathing sound into a digital computer as electronic files. These breathing sound files will be analyzed in a later time with spectral transformation and the characteristics are extracted. These digital signal processing results will be compared with the results of fibroptic exmination and the stethoscopic auscultation in the correct rate of diagnosing the position of the endobronchial balloon. The aim of this study is to examine the usefulness of the spectral parameters of the digitalized breathing sound in confirming the position of the endobronchial blocker balloon.

Official Title
-----------------
The Application of the Spectral Analysis and Characteristic Parameters of Digitized Respiratory Sounds in the Confirmation of the Position of the Balloon of Endobronchial Blockers - an Observational Study

Conditions
-----------------
Respiratory Sounds

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thoracic disease patients who are scheduled for thoracic surgery and lung isolation requiring endobronchial blocker placement during the surgery Adult patients (no younger than 20 years old) Exclusion Criteria: Patients with significant thoracic diseases which result in abnormal respiratory sounds

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Position of the endobronchial blocker | Position of the ballon of the endobronchial blocker (cm) | 1 day |
STHLM3 - Prostate Cancer Diagnostic Trial

Study Overview
=================
Brief Summary
-----------------
STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer

Official Title
-----------------
STHLM3 - Prostate Cancer Diagnostic Trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: STHLM3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50-69 Residential address in Stockholm County Exclusion Criteria: Previous Prostate Cancer Diagnosis Not able to comprehend inform consent material

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STHLM3<br> | Diagnostic Test: STHLM3<br> <br> |
| Active Comparator: PSA<br> | Diagnostic Test: STHLM3<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of biopsies |  | Recorded directly after biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Gleason Score ≥ 7 |  | Recorded directly after biopsy | 
| Number of Gleason Score 6 |  | Recorded directly after biopsy | 
| Number of benign |  | Recorded directly after biopsy |
Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.

Official Title
-----------------
A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: sildenafil (Revatio) 20 mg TID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who completed the A1481244 study and are judged by the Investigator to derive clinical benefit from continuous treatment with Sildenafil 20 mg therapy. Subject who resides in a Brazilian State where Sildenafil is not supplied by State Health Secretary. Exclusion Criteria: Pregnant or lactating women. Current participation in other studies and during study participation.

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 |
| --- |
|Drug: sildenafil (Revatio) 20 mg TID|To provide access to sildenafil for patients completing the A1481244 study, resides in Brazilian States where Revatio™ is not supplied by Health Secretary and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil. It will be supplied until the patient gets access to Sildenafil through Brazilian State Health Secretary from where the patient resides.|

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
-----------------
Open label, sildenafil, PAH, Brazil
Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.

Conditions
-----------------
Prediabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Ume paste and ginger powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting plasma glucose 105-125 mg/dL Exclusion Criteria: Taking anti-diabetic drugs Taking drugs or functional food that may affect blood glucose level Pregnant or nursing a child Participation in any clinical trial within 90 days of the commencement of the trial Renal or hepatic dysfunction Heart disease History of severe disease and/or major surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>3 placebo capsules/day for 12 weeks | Dietary Supplement: Placebo<br> <br> |
| Experimental: Ume paste and ginger powder<br>3 experimental capsules/day for 12 weeks. | Dietary Supplement: Ume paste and ginger powder<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma glucose from baseline |  | Every 6 weeks (Overall 12 weeks) | 
| Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline |  | Weeks 0 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | Weeks 0 and 12 | 
| Change in glycoalbumin from baseline |  | Weeks 0 and 12 | 
| Change in fasting insulin from baseline |  | Weeks 0 and 12 | 
| Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline | HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405 | Weeks 0 and 12 | 
| Change in serum total cholesterol from baseline |  | Every 6 weeks (Overall 12 weeks) | 
| Change in serum LDL cholesterol from baseline |  | Every 6 weeks (Overall 12 weeks) | 
| Change in serum HDL cholesterol from baseline |  | Every 6 weeks (Overall 12 weeks) | 
| Change in serum triglyceride from baseline |  | Every 6 weeks (Overall 12 weeks) |
Diagnosis of Fatty Liver With Outpatient Ultrasound

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether ultrasound performed during outpatient visit is effective in early diagnosis of fatty liver.

Detailed Description
-----------------
All patients presenting to dedicated hepatology clinic with concern for fatty liver will be evaluated by ultrasound. This will be compared with standard imaging performed for this condition. The data will be compared for effectiveness of outpatient evaluation with dedicated imaging currently practiced

Official Title
-----------------
Diagnosis of Fatty Liver With Outpatient Ultrasound

Conditions
-----------------
Liver Steatoses

Intervention / Treatment
-----------------
* Device: outpatient evaluation of fatty liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients presenting to dedicated clinic Exclusion Criteria: presence of ascites, inability to give consent to have study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: outpatient evaluation of fatty liver|outcome of ultrasound evaluation of liver in clinical outpatient settings|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient ultrasound in diagnosis of fatty liver diagnosis | Effectiveness of outpatient evaluation by outpatient bedside ultrasound device in diagnosis of fatty liver compared to standard radiological evaluation. Comparing presence and severity of steatosis reported by standard radiological imaging with bed side imaging tool. | Bedside evaluation performed after consent and compared with radiological imaging perfomed within 3 months of this bedside evaluation |