linjc16/ctgov huggingface dataset:
Atrial Fibrillation at the Viennese University Emergency Department

Study Overview
=================
Brief Summary
-----------------
The results of this study could imply that a atrial fibrillation registry, as a tool for structured diagnosis and therapy in patients with atrial fibrillation, may improve patient care for this rapidly growing population.

Detailed Description
-----------------
Atrial fibrillation is the most common cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality, with stroke being an especially important and potentially devastating complication. The number of patients with atrial fibrillation is likely to increase 2.5-fold during the next 50 years, reflecting the growing proportion of elderly individuals. Emergency departments play a central role in diagnosis and treatment (rhythm and rate control, initiation of anticoagulatory therapy for stroke prevention) of atrial fibrillation. Additionally, embolic (e.g. stroke, mesenteric ischemia) complications of atrial fibrillation and bleeding complications (e.g. gastrointestinal and intracranial) of anticoagulatory therapy are likewise treated at emergency departments. Therefor the investigators hypothesis implies that the atrial fibrillation registry could serve as a tool for structured diagnosis and therapy in patients with atrial fibrillation and therefore may improve patient care. Additionally, diagnostic and therapeutic shortcomings by analyzing registry data may be detected.

Official Title
-----------------
Atrial Fibrillation Registry at the Emergency Department of the Medical University of Vienna: A Tool for Structured Diagnosis and Treatment

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with atrial fibrillation treated at the Emergency Department of the Medical University of Vienna Signed consent Exclusion Criteria: Inclusion criteria not met

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 |
| --- | --- | --- |
| Number of participants with major adverse cardiac events | frequency distribution | Follow up (10 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successfully conducted cardioversions | frequency distribution | Follow up (10 years) |
Rijavithi Viral and Mycobacterium PCR Arrays in CNS Infection Study

Study Overview
=================
Brief Summary
-----------------
This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both AIDS and non AIDS patients. Patients with clinical viral encephalitis and all meningoencephalitis including all patients with HIV/AIDS CSF and non AIDS will be banked and test for RNA and DNA viral sequence by Real time PCR arrays and IS6110 gene of Mycobacterium tuberculosis. Clinical data and final diagnosis will be used to analyze the result of this PCR arrays technique compared to clinical gold standard criteria.

Official Title
-----------------
Cerebrospinal Fluid Polymerase Chain Reaction Arrays for Central Nervous System Neurotropic Viral Infection and Mycobacterium Infection Study

Conditions
-----------------
CNS Viral Infection

Intervention / Treatment
-----------------
* Other: LUMBAR PUNCTURE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AGE MORE THAN 15 YRS ABLE TO INFORM CONSENT BY THEMSELF OR THEIR PARENT SUSPECTED CNS VIRAL INFECTION Exclusion Criteria: UNABLE/CONTRAINDICATED FOR LUMBAR PUNCTURE OR CSF COLLECTION WITHDRAW CONSENT SUSPECTED SEVERE OR VILURENT VIRAL INFECTION SUCH AS H5N1/SARS INFECTION

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| 1<br>AIDS PATIENTS | Other: LUMBAR PUNCTURE<br>* LUMBAR PUNCTURE FFOR CSF COLLECTION<br>|
| 2<br>NON-AIDS PATIENTS | Other: LUMBAR PUNCTURE<br>* LUMBAR PUNCTURE FFOR CSF COLLECTION<br>|

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
-----------------
CNS viral infection, PCR, HYBRIDIZATION
Comparison of Upper Extremity and Lower Extremity Function and Quick DASH

Study Overview
=================
Brief Summary
-----------------
Patient reported outcome measure (PROM) are a method by which to assess outcomes from a patient perspective. The QuickDASH is a commonly used PROM. QDASH was validated against grip strength and ability work, however not against its ability to actually measure what it sets forth to measure (ie: patient's ability to use a hammer, carry a shopping bag, wash a wall, etc). The purpose of this study is to correlate the self-reported QDASH with patients' ability to perform the functions on the QDASH and compare to a control group who completes the task on a lower extremity PROM, KOOS JR.

Official Title
-----------------
Comparison of Upper Extremity and Lower Extremity Function and Quick DAS

Conditions
-----------------
Hand Injuries

Intervention / Treatment
-----------------
* Other: QDASH
* Other: KOOSJR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new patient stanford hand surgery clinic patient Exclusion Criteria: -

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QDASH<br>Completing the tasks on the QuickDASH | Other: QDASH<br>* completing the tasks on the QDASH: open jar, wash wall, carry shopping bag, wash back, cut food, hammer wood<br>|
| Active Comparator: KOOSJR<br>Completing the tasks on the KOOSJR | Other: KOOSJR<br>* completing tasks on the KOOSJR: pivot, straighten, go up/down stairs, stand upright, rise from sitting, bend over<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QDASH score | the quickdash is a validated outcome measure for hand function, scored 0-100 with higher scores indicating worse disability which is bad. | Immediately after completing the taks |
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)

Study Overview
=================
Brief Summary
-----------------
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.

Official Title
-----------------
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Device: Device: Silicon ring (Arabin Pessary)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimal age of 18 years Episode of threatened preterm labour Exclusion Criteria: Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) Spontaneous rupture of membranes at the time of randomization Cervical cerclage in situ Active vaginal bleeding Placenta previa Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Expectant Management<br> | |
| Experimental: Placement of cervical pessary since 23 weeks until 37 weeks<br> | Device: Device: Silicon ring (Arabin Pessary)<br>* Placement of a silicon pessary in the vagina, around the cervix.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous delivery before 34 completed weeks |  | Each 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight |  | Each 6 months | 
| Fetal-Neonatal Death |  | Each 6 months | 
| Neonatal morbidity |  | Each 6 months | 
| Maternal adverse effects |  | Each 6 months | 
| Preterm birth before 37 weeks or 28 weeks |  | Each 6 months | 
| Rupture of membranes before 34 weeks |  | Each 6 months | 
| Hospitalisation for threatened preterm labour |  | Each 6 months |
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
* Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 58 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) | Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)<br> <br> |
| Active Comparator: 2<br>Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) | Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiemetic
Laryngeal Disorders After Childhood Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).

Official Title
-----------------
Prevalence of Laryngeal Disorders After Childhood Cardiac Surgery and Evaluation of Their Long-term Recovery

Conditions
-----------------
Laryngeal Injury, Swallowing Disorder, Voice Disorders in Children, Surgery--Complications

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No opposition from children and parents Patient or parents able to understand the ins and outs of the study Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 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 |
| --- | --- |
| No laryngeal mobility disorder post cardiac surgery<br>No Follow up, no questionnaires and no nasofibroscopic control. | |
| Laryngeal mobility disorder post cardiac surgery<br>During a follow-up consultation, questionnaires will be offered to assess the child's quality of life. | Other: Questionnaires<br>* To explore the quality of life, two questionnaires will be submitted to the parents and the child. The first one is the pediatric version of the VHI (Voice Handicap Index), which explore, using 23 items, the functional, physical and emotional aspects of the dysphonia. The second one is the PEDI-EAT-10 (Pediatric Voice Handicap Index - Eating Assessment Tool), which explore, through 10 items (ranging from 0 to 4), the risk of aspiration and assess the impact of possible dysphagia on quality of life.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of a laryngeal mobility disorder after childhood cardiac surgery | The prevalence will be evaluated on the respiratory, food or phonatory difficulties reported after surgery as well as on the result of early postoperative nasofibroscopy. | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laryngeal dysfunction, Cardiac surgery
Frailty Index and Mortality After a Burn Surgery

Study Overview
=================
Brief Summary
-----------------
Frailty is a condition of a reduced physiological reserve and is associated with postoperative morbidity and mortality. We evaluated the impact of preoperative frailty index (CFI) on 90-day mortality after a burn surgery.

Official Title
-----------------
Preoperative Frailty Index and 90-day Mortality After a Burn Surgery

Conditions
-----------------
Burns, Frailty

Intervention / Treatment
-----------------
* Other: Burn surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with burn injuries were admitted to the burn ICU. Exclusion Criteria: Patients with incomplete medical records were excluded.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with burn injury<br> | Other: Burn surgery<br>* Patients underwent burn surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality after burn surgery | Postoperative 90 days |
Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China

Study Overview
=================
Brief Summary
-----------------
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and coronary heart disease in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

Detailed Description
-----------------
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study. A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014. Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals Data will be collected in three aspects by three different forms as following: Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system Form

Official Title
-----------------
A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China

Conditions
-----------------
Ischemic Stroke, Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients using Dengzhanxixin injection from 2012 to 2014 Exclusion Criteria: none
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 participants with adverse events; incidence of Dengzhanxixin's ADRs and identify factors that contributed to the occurrence of the adverse reaction. | All patients will be measured and assessed at the time Dengzhanxixin is administered to them until they discharge. Patients using Dengzhanxixin will be registered on a registration form including disease background, Dengzhanxixin's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Dengzhanxixin. | The registry procedure will last 3 years only for patients using Dengzhanxixin |
Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea

Study Overview
=================
Brief Summary
-----------------
This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous glabellar lines.

Conditions
-----------------
Lateral Canthal Lines, Crow's Feet Lines

Intervention / Treatment
-----------------
* Biological: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject and Investigator decision to treat crow's feet lines with Botox® Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Botulinum Toxin Type A<br>Subjects who receive botulinum toxin Type A injected into crow's feet line areas per clinical practice. | Biological: Botulinum Toxin Type A<br>* Botulinum toxin Type A injected into crow's feet line areas per clinical practice.<br>* Other names: onabotulinumtoxinA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale |  | Baseline, Up to 3 months | 
| Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale |  | Baseline, Up to 3 months |
Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion

Study Overview
=================
Brief Summary
-----------------
1. To establish a follow-up database for uterine adhesions and a library of biological specimens for Intrauterine Adhesion. 2. using epidemiological surveys and biological analyses to screen risk factors for the development and prognosis of Intrauterine Adhesion. 3. Predictive models based on clinical and biochemical indicators, specimen testing and hysteroscopic images are also combined with statistical analysis and machine learning algorithms to enable patients' risk stratification and prognostic assessment.

Official Title
-----------------
Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion

Conditions
-----------------
Database for Intrauterine Adhesion, Risk Factors for Intrauterine Adhesion, Risk Stratification and Prognostic Assessment, Intrauterine Adhesion

Intervention / Treatment
-----------------
* Diagnostic Test: Hysteroscopy
* Diagnostic Test: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously diagnostic hysteroscopy confirmed adhesions combined with infertility or recurrent pregnancy loss (early pregnancy loss >2) Desiring to conceive Ages between 20-45 years; Patients without gynecological endocrine disorders (e.g. PCOS) and AMH>1ng/ml; Signing informed consent. Exclusion Criteria: Hysteroscopy contraindications; Hormone therapy contraindications; Pregnancy contraindications; History of malignant pelvic tumor and radiotherapy; Severe hepatic or renal dysfunction; Complicated with hematological disorders (eg.platelet dysfunction, severe anemia, blood-borne infections); Male factor infertility(eg.seminal abnormalities).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Hysteroscopy|Hysteroscopy for CSGE, AFS, and endometrial receptivity assessment|
|Diagnostic Test: Ultrasonography|Ultrasonography for Uterus size and endometrial thickness|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pregnancy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of IUA | Recurrence rate of Intrauterine Adhesion | 3 month | 
| Menstrual blood volume |  | 3 month | 
| CSGE | CSGE (Chinese Society of Gynaecological Endoscopy score), scale 0-28, higher scores mean a worse outcome | 3 month | 
| AFS | AFS(American Fertility Association score), scale 1-12, higher scores mean a worse outcome | 3 month |