linjc16/ctgov huggingface dataset:
Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.

Official Title
-----------------
Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: nucleoside analog reverse transcriptase inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Naive DLBCL or high grade FL patients Age range 18-75 years old ECOG performance status 0-3 Life expectancy of more than 3 months Adequate organ function HBsAg negative/HBcAb positive at baseline Exclusion Criteria: Infection of HAV,HCV,HIV Pregnant or lactating women Serious uncontrolled diseases

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment. | Drug: nucleoside analog reverse transcriptase inhibitor<br>* tablets 100mg qd<br>* Other names: lamivudine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of HBV reactivation | HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN). | from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the outcome of antiviral therapy in HBV-DNA abnormal patients | Once the level of HBV-DNA exceeds the upper limit of normal, antiviral therapy will be given immediately.Liver function and serum HBsAg and HBcAg of these patients will be monitored until six months after the last dosing of RCHOP. | from the initiation of antiviral thearpy to six months after the last cycle of RCHOP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis B virus reactivation, HBsAg negative, HBcAb positive, lymphoma, rituximab
Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

Study Overview
=================
Brief Summary
-----------------
The primary aim is to describe platelet function in adult patients treated with extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these critically ill patients contributes to an understanding of the mechanisms underlying their coagulopathy. The present study is a substudy to the study entitled; Coagulopathy During Extracorporeal Membrane Oxygenation (pending Clinical Trial ID number).

Detailed Description
-----------------
The knowledge of platelet function during extracorporeal membrane oxygenation (ECMO) remains sparse. In the present study, the aim is to investigate platelet function in adult patients treated with ECMO using flow cytometry. The investigators hypothesize that platelet function increases from day 1 to day 3 in patients treated with ECMO. The secondary aim is to investigate the association between platelet function and the incidence of bleeding episodes and thrombosis during ECMO treatment. The present study is a substudy to the study entitled; Coagulopathy During Extracorporeal Membrane Oxygenation (pending Clinical Trial ID number).

Official Title
-----------------
Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

Conditions
-----------------
Extracorporeal Membrane Oxygenation, Platelet Activation, Platelet Aggregation, Platelet Function Tests, Blood Platelets, Intensive Care Units

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with veno-venous or veno-arterial ECMO Age ≥18 years Exclusion Criteria: ECMO treatment initiated post-operatively

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 |
| --- | --- | --- |
| Changes in platelet function | Platelet function on day 3 compared with day 1 on ECMO. Measured by flow cytometry | Platelet function measured day 1 and day 3 on ECMO | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in platelet aggregation | Comparison of platelet aggregation measured by whole blood impedance aggregometry (Multiplate). | Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends). | 
| Immature platelet count | Estimation of platelet turn-over measured by a blood analyzer (Sysmex) | Measured every morning from day 1 to day 8 on ECMO (except weekends) | 
| Platelet count | Estimation of platelet count measured by a blood analyzer (Sysmex) | Measured every morning from day 1 to day 8 on ECMO (except weekends) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flow Cytometry, eCPR, Extracorporeal Life Support
Local Control After Robot-assisted Supraglottic Laryngectomy

Study Overview
=================
Brief Summary
-----------------
Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.

Official Title
-----------------
Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study

Conditions
-----------------
Supraglottic Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Transoral robotic surgery (TORS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women over 18 years of age Patients with supra-glottic squamous cell carcinoma from T1 to T3, all stages N Patients with a robot assisted supra-glottic laryngectomy with at least 2 years follow-up Exclusion Criteria: Patients for whom follow-up of at least 2 years has not been achieved; Major patients protected by the law (under guardianship or guardianship); Patients who expressed opposition to their participation in the study.

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 |
| --- |
|Procedure: Transoral robotic surgery (TORS)|All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | Proportion of patients without cancer recurrence 2 years after surgery | 2 years after surgery |
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Palliative radiotherapy for head and neck cancer is widely used but the effect and side effects are largely unknown. We will study the effect of short hypofractionated palliative radiotherapy (20 Gy in 4 fractions) on symptom intensity and -frequency as weel as side effects

Official Title
-----------------
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

Conditions
-----------------
Head and Neck Neoplasms, Recurrence, Neoplasms, Second Primary

Intervention / Treatment
-----------------
* Procedure: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incurable primary or second primary head and neck cancer Speaks and reads Danish Capable of filling out questionnaires for at leas two months after radiotherapy Age>=18 years Expected survival> 3months

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Radiotherapy|20 Gy in 4 fx|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and intensity of symptoms before and after radiotherapy (EORTC C30 and H&N35 questionnaires and CTC AE 3.0 toxicity scores) |  | 11 mths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 11 mths | 
| Side effects |  | 2 mths | 
| Other treatments |  | 11 mths | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative radiotherapy, Recurrent, Head and neck Neoplasm, Quality of life
N-acetylcysteine in Bulimia Nervosa

Study Overview
=================
Brief Summary
-----------------
This study tests NAC in the treatment of Bulimia Nervosa.

Conditions
-----------------
NAC

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine NAC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bulimia Nervosa 18-65 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Other: N-acetylcysteine<br>open label treatment. Each subject receives N-acetylcysteine. | Drug: N-acetylcysteine NAC<br>* N-acetylcysteine in the treatment of Bulimia Nervosa<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge-purge episodes | The primary outcome measure will be the weekly frequency of binge-purge episodes. A binge-purge eating episode will be defined using DSM-IV-TR criteria, and accessed via clinical interview and review of subject take-home diaries at each study visit. | per week |
Clot Formation and Clot Stability in Patients With Severe Haemophilia A

Study Overview
=================
Brief Summary
-----------------
In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Detailed Description
-----------------
In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Official Title
-----------------
Clot Formation and Clot Stability in Patients With Severe Haemophilia A - Effect of Recombinant Factor VIII and Tranexamic Acid

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: ReFacto (Recombinant factor VIII) and Tranexamic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe haemophilia A Above 17 years old Thrombocyt count above 100 x 109/l within the past two years Exclusion Criteria: Received recombinant factor VIII with in the past 3 days Inhibitor against recombinant factor VIII HIV-positive Ongoing treatment for hepatitis C Known kidney disease Allergy against Tranexamic acid Not able to give informed consent

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ReFacto (Recombinant factor VIII) and Tranexamic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clot stability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clot formation,thrombine generation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
haemophilia A, thrombelastography, recombinant factor VIII, thrombin generation
Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Human Vascular Endothelial Grown Factor 165 (hVEGF165) administration is promising therapy induces a new vessels, arterioles and capillaries in regions whose revascularization surgery is not possible by direct or by percutaneous angioplasty. This study aims to evaluate the clinical effects and safety of gene therapy with hVEGF165 in patients with advanced coronary artery disease.

Official Title
-----------------
Induced Angiogenesis by Genic Therapy With VEGF165 in Advanced Ischemic Cardiomyopathy - Historical Controlled Trial

Conditions
-----------------
Ischemic Cardiopathy

Intervention / Treatment
-----------------
* Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis coronary artery disease and symptomatic, despite optimal pharmacologic therapy Left ventricular dysfunction - left ventricular ejection fraction between 60% and 25% by echocardiogram Non-conventional revascularization, as seen by cineangiocardiography, attested by interventional cardiologist and cardiac surgeon Age below 75 years Absence of neoplasm Exclusion Criteria: No

Ages Eligible for Study
-----------------
Maximum Age: 75 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 |
| --- | --- |
| Other: 1<br>Controlled | Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165<br>* Patients with previous diagnosis of ischemic cardiopathy were included. The patient must accept and agree to be subject of clinical observation with current optimal treatment for at least 6 months. Following to that, subject undergoes intervention, in addition to consultation and assessments. Surgical technique -Ten injections VEGF165 will be made through a 25F butterfly needle in any ischemic territory where previously identified through scintigraphy. Dosis: 2.000 mg of VEGF165 in 5ml of saline solution. After the procedure, the patients will be kept in a recovery room for about 24hs and in the hospital until full clinical recovery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical finds |  | eighteen months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial revascularization, myocardial ischemia, genetics, medical, Angiogenesis Inducing Agents
The Study of KAP on Drink Driving in Jiangsu Province in China

Study Overview
=================
Brief Summary
-----------------
Conduct a KAP survey before and after intervention and describe the current knowledge, attitudes and behaviors on drink driving in public and analyse the influential factors to provide rational strategies to enhance the awareness on drink driving in public.

Official Title
-----------------
Study of KAP and Influential Factors on Drink Driving in Public in Jiangsu Province in China

Conditions
-----------------
Drink Driving

Intervention / Treatment
-----------------
* Behavioral: health education & law enforcement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-70, resident for more than 6 months. Exclusion Criteria: less than 18 or older than 70, or provisional resident.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Urban area in South Jiangsu Province<br>health education & law enforcement | Behavioral: health education & law enforcement<br> <br> |
| urban area in Middle Jiangsu Province<br>health education & law enforcement | Behavioral: health education & law enforcement<br> <br> |
| urban area in North Jiangsu Province<br>health education & law enforcement | Behavioral: health education & law enforcement<br> <br> |
| rural area in South Jiangsu Province<br>health education & law enforcement | Behavioral: health education & law enforcement<br> <br> |
| rural area in North Jiangsu Province<br>health education & law enforcement | Behavioral: health education & law enforcement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-report drink driving rate in public decreases by 2.5% |  | one and a half year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KAP, drink driving, public, Jiangsu province, China
Heweizhixie capsuleTherapy on Patients With Diarrhea

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.

Detailed Description
-----------------
The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.This is a Phase 4 Open Label trial, enroll 2400 patients with diarrhea Primary Outcome Measure:Percent of subjects with treatment Success Secondary Outcome Measures: Number of unformed stools passed per 24 h period Time (hours) from first intake to the last unformed stools Change from baseline of Leeds dyspepsia questionnaire score Percent of subjects with AE.

Official Title
-----------------
A Post -Marketing Drug Evaluation(Phase IV Clinical Trial) to Study the Safety and Efficacy of Heweizhixie Capsule in Patients With Diarrhea

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Drug: Heweizhixie capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 or more unformed stools in 24 hours Male and female subjects between 18 and 80 years old Signed informed consent Exclusion Criteria: Subjects with serum ALT more than 5ULN or serum Cr more than 442umol/L Subjects are pregnant now, likely to become pregnant Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heweizhixie capsule<br>Heweizhixie capsule, 0.33g/#, 3 #, Tid, Oral | Drug: Heweizhixie capsule<br>* 3 #, Tid, Oral for 3 days<br>* Other names: Changdaoqing capsule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with treatment Success | Percent of subjects with treatment Success | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unformed stools passed per 24 h period | Number of unformed stools passed per 24 h period | per 24 h period | 
| Time (hours) from first intake to the last unformed stools | Time (hours) from first intake to the last unformed stools | 3 days | 
| Change from baseline of leeds dyspepsia questionnaire score | Change from baseline of leeds dyspepsia questionnaire score | 3 days | 
| Percent of subjects with AE | Percent of subjects with AE | 3 days |