linjc16/ctgov huggingface dataset:
the Effectiveness of Different Risk Scales In Predicting VTE in Respiratory Inpatients

Study Overview
=================
Brief Summary
-----------------
To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk assessment model and the VTE risk assessment in medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant VTE in respiratory inpatients to provide a basis for clinical VTE assessment and treatment.

Detailed Description
-----------------
A case-control study was used to collect patients who developed VTE during hospitalization in the Department of Respiratory Medicine at Peking University Third Hospital Hospital from January 2015 to December 2020 as the case group, and 2-fold patients who did not develop VTE matched to the case group (age, sex, ADL score, diagnosis, and length of hospitalization) as the control group. The general status of the patients was also assessed using the Padua risk model, the Caprini risk model, and the VTE risk assessment scale for medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment, and prevention of pulmonary thromboembolism, and the relevant items involved in the assessment form were obtained by reviewing the cases.

Official Title
-----------------
Comparative Analysis of the Effectiveness of Different Risk Scales in Predicting Combined Venous Thrombophilia in Respiratory Inpatients

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Other: risk evolution scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18y respiratory inpatient Exclusion Criteria: Patients with deep vein thrombosis or pulmonary thromboembolism, sequelae of deep vein thrombosis, and thrombosis in other parts of lower limbs were diagnosed; Patients with severe coagulation dysfunction or other hematological diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| respiratory inpatient<br>respiratory inpatient with VTE | Other: risk evolution scale<br>* Padua score、Caprini score、Prime score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE incidence | VTE incidence in patients with high risk of VTE | during hospitalization， an average of 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VTE
Complication Registry for Tonsil Surgery

Study Overview
=================
Brief Summary
-----------------
Our aim was to establish a feasible method to prospectively register all tonsil surgery-related complications and to find their possible predictive factors. Our long-term objective is to create a surgical complication registration database, which would provide valuable information for quality assurance and give us a benchmarking tool to improve the results of this surgery in our department.

Detailed Description
-----------------
In a six-month period all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment. Demographic and clinical data were recorded prospectively in a database which included 57 variables, such as age, gender, co-morbidities, body mass index, American Society of Anesthesiologists Physical Status Classification, indication for surgery, educational level of surgeon (consultant vs. resident), surgical technique, duration of operation and length of hospital stay. After the operation, all patients were given instructions to contact our emergency department (ED) if experiencing any adverse event. Incidents of postoperative complications were recorded during the post-surgical visits to the ED. Only complications warranting a visit to the outpatient department or hospital admission were registered.

Official Title
-----------------
Developing a Prospective Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort

Conditions
-----------------
Tonsillar Surgery Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no age limits elective tonsillar surgery Exclusion Criteria: procedures carried out due to malignancy as a part of multilevel surgery for obstructive sleep apnea re-tonsillectomies acute operations
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | After the operation, all patients were given instructions to contact our emergency department (ED) if experiencing any adverse event. Incidents of postoperative complications were recorded during the post-surgical visits to the ED. Only complications warranting a visit to the outpatient department or hospital admission were registered. | September 2011 - February 2012 (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay |  | September 2011 - February 2012 (6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
complications, tonsillectomy, tonsillotomy
A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope

Study Overview
=================
Brief Summary
-----------------
The objective of the SECURE Study is to actively gather additional information on the use of the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.

Official Title
-----------------
A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement. Exclusion Criteria: -
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 |
| --- | --- | --- |
| Proportion of Subjects With ECM Related Adverse Events | ECM related adverse events were collected at all study visits. | Participants were followed for an average of 235.0 days. | 
| Number of Participants With Major Pocket Infections | Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis. | Participants were followed for an average of 235.0 days. |
Ovarian Cancer Patient Questionnaire on Genetic Testing

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy.

Detailed Description
-----------------
All eligible patients being seen in the Gynecology Center at the M.D. Anderson Cancer Center and at Gynecologic Oncology of Houston for follow-up or a new diagnosis of ovarian cancer will be asked to participate in this study by completing a questionnaire. This study will end when 400 completed questionnaires have been collected. We estimate that 40-60 ovarian cancer patients are seen in the Gynecology Center at the M.D. Anderson Cancer Center each week and that 20- 40 ovarian cancer patients are seen at Gynecologic Oncology of Houston each week. The completion of 400 questionnaires will provide adequate data to address our question in an expeditious time frame. The initial phase of this study is exploratory and does not involve a comparison group.

Official Title
-----------------
Questionnaire for Ovarian Cancer Patients Regarding Acceptance and Willingness to Undergo Genetic Testing

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have the diagnosis of ovarian cancer. Patients must be at least 18 years of age at the time of enrollment. Patients must be able to read and write in the English language. Exclusion Criteria: Patients that are unable to speak or write in the English language. Currently, the investigators' resources in genetic counseling are limited. In the future, they plan to expand the questionnaire and study to include additional languages. Patients having previously undergone BRCA genetic testing.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ovarian cancer<br> | Behavioral: Questionnaire<br>* A questionnaire will be completed.<br>* Other names: Survey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' Response to Survey Questions (Yes/No) |  | 15-20 minutes to complete survey | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Cancer, Questionnaire, Genetic Testing, Survey
Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient

Study Overview
=================
Brief Summary
-----------------
This is a study of pembrolizumab as consolidation therapy for a patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).

Detailed Description
-----------------
It is an open-label single patient Clinical Trial to be conducted at Princess Margaret Cancer Centre for a patient with Small Cell Carcinoma of Ovary - Hypercalcemic Type (SCCOHT) who has rare and aggressive malignancy with no current consensus on treatment approach and surveillance.

Official Title
-----------------
Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)

Conditions
-----------------
Small Cell Carcinoma, Hypercalcaemic Type, Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Pembrolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT) Exclusion Criteria: N/A

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
Intervention Model: Single Group Assignment
Interventional Model Description: It is an open-label single patient Clinical Trial to be conducted at Princess Margaret Cancer Centre for a patient with Small Cell Carcinoma of Ovary - Hypercalcemic Type (SCCOHT) who has rare and aggressive malignancy with no current consensus on treatment approach and surveillance.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pembrolizumab<br>Pembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles. | Drug: Pembrolizumab<br>* Pembrolizumab is an antineoplastic agent, monoclonal antibody against PD-L1.<br>* Other names: KEYTRUDA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Determined by CT scans | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall performance status | Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans. | 2 years | 
| Objective evidence of response to treatment | Recorded with CA-125 every 6 weeks and CT scans after every 2 cycles of treatment | 2 years | 
| Exploratory Endpoint | Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease | 2 Years |
Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether fish oils may be of benefit to patients with certain heart rhythm disturbances called atrial fibrillation and atrial flutter. Atrial fibrillation and atrial flutter are two heart conditions that can be successfully treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in the case of atrial fibrillation). Ablation involves the application of high frequency energy waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a normal rhythm with the use of an electric current. Fish oil supplements may be of benefit to patients with heart problems. Recent evidence suggests that fish oils may benefit those with rhythm disturbances.

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

Intervention / Treatment
-----------------
* Drug: Fish oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic atrial flutter requiring radiofrequency ablation. Chronic atrial fibrillation requiring internal cardioversion. Exclusion Criteria: Sinus rhythm. Pregnancy. Patients > 80 years and < 18 years of age

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No fish oil | |
| Experimental: Fish oil<br>Patients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio | Drug: Fish oil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm. |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial mechanical stunning and, atrial electrical remodeling
The Role of Angiotensinogen Gene Polymorphism in the Pathogenesis of Non-familial Sick Sinus Syndrome

Study Overview
=================
Brief Summary
-----------------
Evidence has been documented for the close relationship between the arrhythmia pathogenesis and the gene expression in renin-angiotensin system. However, it remains unclear for involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers thus investigated the possible relationship between non-familial sick sinus syndrome and the polymorphism and haplotype of the AGT promoter.

Conditions
-----------------
Sick Sinus Syndrome

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sick sinus syndrome Exclusion Criteria: 1.Severe systemic disease. 2.Acute coronary syndrome. 3.bradycardia with reversible cause.
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 |
| --- | --- |
| sick sinus syndrome<br> | Other: observation<br>* genotyping<br>|
| control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults

Study Overview
=================
Brief Summary
-----------------
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks

Official Title
-----------------
Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Peginterferon alfa-2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of HBsAg positive for more than 6 months HBeAg-positive or HBeAg-negative within 8 weeks Serum AST or ALT ≥ 80 IU/L HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10^5 copies/mL (or 20,000 IU/mL) HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10^4 copies/mL(or 2,000 IU/mL) Exclusion Criteria: History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment Prior treatment of interferon Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus) Other chronic liver disease or decompensated liver disease platelet<90,000/mm3 or absolute neutrophil count < 1,500 mm3 Pregnant or lactating woman History of Organ transplantation Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginterferon alfa-2a<br> | Drug: Peginterferon alfa-2a<br>* Patients will receive Peginterferon alfa-2a according to the standard medical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B |  | 12 week from baseline | 
| The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB |  | 12 week from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of HBV DNA at Week 12 from baseline |  | 12 week from baseline | 
| The change of HBsAg at Week 4, 8, 12 from baseline |  | 4, 8, 12 week from baseline | 
| The change of ALT at week 4, 8, 12 from baseline |  | 4, 8, 12 week from baseline | 
| The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12 |  | 12 week from baseline |
Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this follow-up study is to look carefully at the long-term course of multiple sclerosis (MS) and possibly the long-term effects of Betaseron in the patients who were previously enrolled in the original North American study that led to the marketing approval of Betaseron.

Detailed Description
-----------------
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Official Title
-----------------
A Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in North America have to have been previously enrolled in the original Betaseron trial from 1988-1993 Be able to understand the consent form (or have a guardian who can) Exclusion Criteria: North American patients cannot be included if they have not participated in the original Betaseron trial from 1988-1993

Ages Eligible for Study
-----------------
Minimum Age: 33 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 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Betaseron was not administered as part of this study, only the treatment and disease status was assessed. As part of the MRI analysis Gadolinium was administered in patients who underwent this procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of long term course of disease |  | 16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison to natural history cohort |  | 16 years |