linjc16/ctgov huggingface dataset:
The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass

Study Overview
=================
Brief Summary
-----------------
Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.

Conditions
-----------------
Coronary Artery Disease, Off-pump Coronary Artery Bypass, Aspirin

Intervention / Treatment
-----------------
* Drug: aspirin
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective, off-pump coronary artery bypass with at least two grafts patient able to give informed consent Exclusion Criteria: on-pump CABG combined with the valve surgery Preoperative use of clopidogrel and warfarin allergy to aspirin History of severe liver disease History of bleeding diathesis,significant GI bleed Patient has known renal failure or contraindication for Cardiac CT Angio Redo CABG

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative aspirin use<br> | Drug: aspirin<br>* aspirin 100mg daily until the surgery day<br>|
| No Intervention: preoperative aspirin nonuse<br> | Drug: aspirin<br>* aspirin is stopped 5-7 days before operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft patency examined by CT scan | we would like to compare the graft patency within the one week after the surgery between the preoperative aspirin use and preoperative nonuse.We just want to know wether preoperative aspirin use could improve the graft patency in off-pump coronary artery bypass. | one week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding, transfusion, re-exploration |  | perioperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, off-pump coronary artery bypass, aspirin
Caffeine's Effect on Attention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether caffeine improves attention.

Detailed Description
-----------------
Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo

Official Title
-----------------
The Effect of Caffeine on Attention

Conditions
-----------------
Attention

Intervention / Treatment
-----------------
* Other: Food
* Other: Food


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy male and female Aged 40-60 years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Mannitol administered at visit 1 and at visit 2 | Other: Food<br>* Active group<br>* Other names: Caffeine;Other: Food<br>* Control group<br>* Other names: Placebo;|
| Active Comparator: caffeine<br>caffeine administered at visit 1 and at visit 2 | Other: Food<br>* Active group<br>* Other names: Caffeine;Other: Food<br>* Control group<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention test: milliseconds and index of stimulus sensitivity |  | duration 10 days from screening to last visit (V2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Nervous System :response time. |  | duration: 10 days from screening to last visit (V2) | 
| Mood measures: Visual Analog scale. |  | duration 10 days from screening to last visit V2 |
TAILORx Tissue Bank

Study Overview
=================
Brief Summary
-----------------
This is an exploratory, translational, non-interventional and multi-centre biobank. The aim of the development of such a biobank is to identify potential biomarkers that are indicative of disease relapse.

Detailed Description
-----------------
The primary objective is to develop a biobank, tissue microarrays (TMAs) and full face sections, which will be used to identify candidate/ novel biomarkers prognostic for disease relapse and predictive for endocrine and/or chemotherapy resistance. The secondary objectives are: To validate emerging signatures/biomarkers identified. To develop new assays for the breast cancer clinic.

Official Title
-----------------
Breast Cancer Bank of Tissue From Trial Assigning Individualized Options for Treatment (TAILORx Tissue Bank)

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that were registered with the ICORG 06-31 TAILORx trial and participated in trial arms Patients with adequate tumor tissue available

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| TAILORx ICORG 06-31<br>Patients must have participated in TAILORx ICORG 06-31, participated in trial arms, and have adequate tumour tissue available | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease relapse, endocrine and/or chemotherapy resistance prognosis | A biobank, TMAs and full face sections, will allow for the identification of candidate/novel biomarkers prognostic for disease relapse and predictive for endocrine and/or chemotherapy resistance | For duration of follow up, expected 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signature/biomarkers | Validation of emerging signature/biomarkers | For the duration of follow up, expected 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Must have registered with the ICORG 06-31 TAILORx trial
Response of Immune System to Flu Vaccination in PHTS

Study Overview
=================
Brief Summary
-----------------
this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.

Official Title
-----------------
Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome

Conditions
-----------------
PTEN Hamartoma Tumor Syndrome

Intervention / Treatment
-----------------
* Biological: Influvac Tetra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be diagnosed with PHTS based on genetic testing Must be a Radboudumc patient Must be 18 years or older Must be mentally competent Must have provided written informed consent to participate in the study Must be able to adhere to visit schedule and available to complete the study Exclusion Criteria: • Known history of significant medical disorder, which in the investigator's judgment might confound the results of the study or pose additional risk to the subject by participation in the study Known hypersensitivity to previous influenza vaccinations (Anaphylaxis) Must not be allergic to chicken eggwhite Pregnancy at start of study Immunocompromised patients and those receiving concomitant immunosuppressive therapy or other immune modulating drugs including chronic steroid treatment. Bleeding disorders including haemophilia and thrombocytopenia or treatment with anticoagulants(Due to risk of intramuscular hematoma after injection) Must not have received vaccination with attenuated pathogens in the 4 weeks leading up to study. (Measles, mumps, rubella, yellow fever, rotavirus, BCG, typhoid)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vaccination<br>Arm contains all subjects; vaccination with Influvac Tetra will be administered at start of study, response will be measured in 7 and 21 days. | Biological: Influvac Tetra<br>* Tetravalent seasonal flu vaccination 2018/2019<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination inhibition assay titre |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proliferation assay |  | 21 days | 
| interleukin profile |  | 21 days, 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PHTS, PTEN, Vaccination
French Observatory Syndromes Tako-Tsubo

Study Overview
=================
Brief Summary
-----------------
Tako Tsubo syndrome (TTS) is characterized by the occurrence in the context of mental or physical stress, a clinical and ECG of acute myocardial infarction without significant coronary artery stenosis, accompanied by a disorder Acute, reversible left ventricular who takes on a characteristic apical ballonnisation evoking the image of a Japanese octopus trap called Tako (octopus) tsubo (jar). Pathophysiology of unknown changes immediate life-threatening prognosis is often good in the longer term.

Official Title
-----------------
French Observatory Syndromes Tako-Tsubo

Conditions
-----------------
Myocardial Necrosis, Tako Tsubo Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 allowed for an array of myocardial necrosis on clinical and electro cardiographic having a left ventricular ballooning echo cardiography, MRI or ventriculographic with normal coronary angiogram. Exclusion Criteria: Absence of left ventricular ballooning and / or presence of coronary lesions on angiography Refusal by the patient to participate in the observatory

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TT Syndrome<br>Will be included over a period of one year, prospectively, all patients newly diagnosed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological events | Study of psychological events that triggered the event by using the stress scale of the Canadian Association for Mental Health | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left ventricular ballooning
Evaluation of the Effectiveness of Vibroacoustic Therapy in the Complex Treatment of Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure

Detailed Description
-----------------
Assessing the dynamics of changes in physical, instrumental and laboratory parameters in patients with acute respiratory failure taken in the study according to the inclusion criteria and comparing the results with the control group, studying the effectiveness of vibroacoustic lung therapy.

Official Title
-----------------
Assessing the Ventilatory Parameters in Patients With Acute Respiratory Failure After Vibroacoustic Pulmonary Therapy.

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: Vibrolung


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults P/F less 300 torr ARDS by Berlin convention Exclusion Criteria: children acute stroke acute coronary syndrome DVT implanted pacemaker rib fracture infection on chest

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: Parallel Assignment
Interventional Model Description: monitoring of treatment of patients with respiratory failure, the list of therapeutic measures which includes vibroacoustic therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SaO2 (oxygen status)<br>Measurment 4 times per day, ABA (acid-bases analyses) | Device: Vibrolung<br>* Device for vibroacoustic respiratory therapy<br>|
| Active Comparator: PaO2/FiO2 (respiratory index)<br>Measurment 4 times per day, ABA (acid-bases analyses) | Device: Vibrolung<br>* Device for vibroacoustic respiratory therapy<br>|
| Active Comparator: AB (actual bicarbonat level)<br>Measurment 4 times per day, ABA (acid-bases analyses) | Device: Vibrolung<br>* Device for vibroacoustic respiratory therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of time spent on ventilation | Changing of the time spent by patients on mechanical ventilation | 1-2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vibroacoustic therapy, acute respiratory failure, pneumonia
Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.

Official Title
-----------------
A Randomized, Multi-center, Evaluator and Subject Blind, Active-controlled, Parallel, Medical Device Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Compared to Hyalobarrier Applied to Postoperative Intrauterine

Conditions
-----------------
Postoperative Adhesion of Uterus

Intervention / Treatment
-----------------
* Device: ABT13107
* Device: Hyalobarrier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients aged from 19 to 70 Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc. Exclusion Criteria: Those who will apply other intrauterine device rather than investigational device during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT13107<br> | Device: ABT13107<br>* Dose: 3mL, maximum 10mL<br>|
| Active Comparator: Hyalobarrier<br> | Device: Hyalobarrier<br>* Dose: 10mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intrauterine adhesion | Incidence rate of intrauterine adhesion after surgery | 4 weeks |
Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects.

Official Title
-----------------
An Open-Label, Randomized, Single-Dose, Parallel-Group Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Moxidectin Administered Orally to Healthy Subjects

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: moxidectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men or women of non childbearing potential aged 18 to 50 years inclusive at screening. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. Exclusion criteria Any clinical important deviation from normal limits in physical examination findings, vital sign measurements, electrocardiograms or clinical laboratory test results. Presence or history of any disorder that may prevent the successful completion of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: moxidectin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiograms |  | 4 months |
Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks

Study Overview
=================
Brief Summary
-----------------
Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..

Official Title
-----------------
Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: Type II endoleak treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated for type II endoleaks by endovascular therapy Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Patients treated for type II endoleaks<br>Patients treated for type II endoleaks between the 01 January 2008 and the 31 March 2018 in the Cardiovascular and Thoracic Surgery Unit of Dijon Burgundy University Hospital | Procedure: Type II endoleak treatment<br>* Type II endoleak endovascular treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of type II endoleaks treated with endovascular intervention |  | 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of type II endoleaks treatment |  | 12 years |
Treatment of Late-life Anxiety in Primary Care Settings

Study Overview
=================
Brief Summary
-----------------
The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.

Official Title
-----------------
Treatment of Late-life Anxiety in Primary Care Settings

Conditions
-----------------
Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder Not Otherwise Specified

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioral therapy
* Behavioral: Enhanced usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 60 years a DSM-IV diagnosis of GAD able to read English. Exclusion Criteria: current psychotherapy a DSM-IV diagnosis of alcohol or substance abuse a diagnosis of dementia or global cognitive impairment operationalized as a score of < 24 of the Mini-Mental Status Examination psychotic symptoms active suicidal ideation

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive-behavioral therapy<br>cognitive-behavioral therapy | Behavioral: Cognitive behavioral therapy<br>* Participants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety.<br>|
| Placebo Comparator: Enhanced usual care<br>enhanced usual care | Behavioral: Enhanced usual care<br>* Participants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSWQ-A |  | 4 months | 
| HAM-A |  | 4 months |