linjc16/ctgov huggingface dataset:
A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to study the epidemic features and diagnosis of female breast cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival (DFS) and the total survival time(OS) of the breast cancer patients will also be studied.

Detailed Description
-----------------
The study is a multicentric, retrospective clinical study based on the hospital. The target number of cases are X patients who are eligible for breast cancer after radical mastectomy. To collect the clinicopathological data and treatment data of the breast cancer patients and do the follow-up visit of all the patients who are included in the study.

Official Title
-----------------
A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China (Based on Hospital)

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

Intervention / Treatment
-----------------
* Procedure: The radical mastectomy of breast cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients; The hospitalized patients who are confirmed of the primary breast cancer histologically; The date of the inpatients are within the month we chosen; Patients who are within the month we chosen have been received or under receiving the relevant treatment including surgical treatment, chemotherapy and radiotherapy. Exclusion Criteria: Male breast cancer patients; Patients with breast cancer who are not under the chosen time; Non hospitalized patients.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epidemiology breast cancer patients<br>Observe the features of clinical diagnosis and treatment for female breast cancer patients | Procedure: The radical mastectomy of breast cancer<br>* The radical mastectomy of breast cancer could be used for the treatment of breast cancer during the observation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall five-year survival for the female breast cancer patients |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, hospital, epidemiology, diagnosis, treatment
Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).

Official Title
-----------------
Triple Resynchronization in Paced Heart Failure Patients

Conditions
-----------------
Heart Failure, Ventricular Dyssynchrony

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • NYHA class III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month. The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent); Permanent atrial fibrillation (AF); Left ventricular ejection fraction (LVEF) ≤ 35%; Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol; Aortic pre-ejection delay at least equal to 140 ms. Exclusion Criteria: Indication for a cardiac defibrillator; Having presented a myocardial infarct within the previous 3 months; Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures; Presenting chronic pulmonary insufficiency; Patients whose congestive heart failure requires the use of an intravenous inotropic support; Presenting a dysthyreosis; Having a life expectancy of less than one year, for other reasons than the congestive heart failure; Unable to be followed-up in the scope of the study for geographical reasons; Having refused to give their consent; Minors (age < 18 years) and pregnant women.

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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronization Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z-ratio |  |  |
A Study of the Alternative Administration of Ixabepilone and Vinflunine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.

Official Title
-----------------
A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: vinflunine + ixabepilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG status of 0-1 Exclusion Criteria: Inability to tolerate venous access Brain mets Severe nerve damage ANC <2,000/mm3 Platelets <100K Bilirubin >= 1.5 times the IULN ALT/AST >= 2.5 times the IULN Creatinine <50 mL/min Prior treatment with vinflunine and/or ixabepilone Strong use of CYPP450 drugs

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: vinflunine + ixabepilone<br>* solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen. |  | upon occurrence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body. |  | upon occurrence |
VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

Official Title
-----------------
VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: VNRX-5133
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Males or non-pregnant, non-lactating females Body Mass Index (BMI) between 18.5 - 32.0, inclusive. Suitable veins for cannulation Exclusion Criteria: Employee of site or the sponsor Any disease that poses an unacceptable risk to participants Abnormal ECG Abnormal labs Abnormal vital signs Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1 Current smokers or history of smoking within 30 days

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VNRX-5133<br>IV infusion | Drug: VNRX-5133<br> <br> |
| Placebo Comparator: Placebo<br>IV infusion | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis. |  | Part 1: 8 days. Part 2: 17 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers, Pharmacokinetics
Austrian Wearable Cardioverter Defibrillator Registry

Study Overview
=================
Brief Summary
-----------------
Background: The wearable cardioverter defibrillator (WCD) is an established treatment option for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF), either in whom this risk may only be temporarily present, or in patients at high risk for sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator (ICD is currently not possible for other reasons (infection, recent MI <40days, recent PCI/CABG < 3months etc.). Methods: Comprehensive registry including all patients in Austria who received a WCD in 2010-2016.

Detailed Description
-----------------
Observational study to describe WCD indications, event rates, inappropriate shock rates and follow up (including ICD rate, shock rate, morbidity and mortality) in all Austrian WCD patients

Official Title
-----------------
Indications for and Experience With the Wearable Cardioverter Defibrillator (WCD) - Austrian WCD Registry

Conditions
-----------------
Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients, with a prescribed WCD according to guidelines in an austrian center
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Registry|Observational study to describe WCD indications, event rates, inappropriate shock rates and follow up (including ICD rate, shock rate, morbidity and mortality) in all Austrian WCD patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants treated with WCD-treated ventricular arrhythmias | Number of participants treated with WCD-treated ventricular arrhythmias | during WCD wearing period; average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wearable cardioverter defibrillator, LifeVest, sudden death, defibrillator
On-Pump vs. Off-Pump CABG in High-Risk Patients (EuroSCORE 6+)

Study Overview
=================
Brief Summary
-----------------
Previous studies comparing on-pump and off-pump operating strategy did only partially demonstrate benefits of the off-pump myocardial revascularisation.In primary end-points (MI, death, renal failure, and so on) there was no significant difference, but in secondary end-points we observed benefits resulting for patients. We would like to show the benefit of the method without extracorporeal circulation in patients with higher and hight operation risk, coming from EuroSCORE classification system (6 points and more).

Official Title
-----------------
Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass.

Conditions
-----------------
Ischemic Heart Disease, Post-Operative Complications

Intervention / Treatment
-----------------
* Procedure: OPCAB - the off-pump coronary artery bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable form of ischemic heart disease unstable angina pectoris acute myocardial infarction additive EuroSCORE 6 and more informed approval of the patient Exclusion Criteria: significant heart valve disease, requesting surgery aortic aneurysm requesting surgery

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 |
| --- | --- |
| 1<br>Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated with use of the cardio-pulmonary bypass | |
| 2<br>Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass | Procedure: OPCAB - the off-pump coronary artery bypass<br>* surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death, heart stroke, brain stroke, renal failure, early reoperation |  | 30 days | 
| heart stroke, brain stroke, death, renal failure, early reoperation |  | 30 days and 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of in-hospital stay, blood losses, number of blood-transfusion, new appeared atrial fibrillation, 1-year mortality, quality of life-angina classified by CCS in 1-year follow up, length of mechanical ventilation |  | 30 days and 365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Off-pump, OPCAB, EuroSCORE, high-risk patients, Quality of life, Validity of EuroSCORE
Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to prospectively analyse the occurrence of post-interventional internal vena jugularis (VJI) thrombi after minimally invasive cardiac surgery using a VJI cannula to perform cardiopulmonary bypass (CPB). The study follows the question whether the performance of a jugular cannulation for the operation under CPB regularly causes wall thromboses despite continuous anticoagulation and a short length of stay of a few hours. The thromboses to be assessed for the study will be obtained by bedside (Doppler) sonography by experienced intensive care physicians in the cardiac surgery intensive care unit. A prospective analysis of all minimal invasive procedures performed with regard to thrombi in the VJI.

Official Title
-----------------
Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation for Minimally Invasive Cardiac Surgery.

Conditions
-----------------
Post-interventional VJI Thrombi After CPB

Intervention / Treatment
-----------------
* Procedure: minimally invasive cardiac surgery using a VJI cannula.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Minimally invasive cardiac surgery carried out using complete cardiopulmonary bypass. Exclusion Criteria: Postoperative support by veno-venous or veno-arterial extracorporeal membrane oxygenation. Complications of neck cannula placement or removal. Pre-existing occlusion of the vena jugularis interna Pre-existing thrombosis of the vena jugularis interna Pre-existing prothrombotic coagulation disorder Existing catheterisation of the vena jugularis interna within 14 days Pre-existing anatomical anomaly of the vena jugularis interna

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 |
| --- | --- |
| Patients after minimally invasive cardiac surgery using a VJI cannula.<br> | Procedure: minimally invasive cardiac surgery using a VJI cannula.<br>* Observation of postinterventional internal jugular vein thrombus after minimally invasive cardiac surgery using VJI cannulation to achieve complete CPB.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-interventional internal jugular vein thrombi | Incidence of post-interventional internal jugular vein thrombi detectable by bedside (doppler) sonography by experienced intensivists in the cardiosurgical intensive care unit. | Detection of thrombi within 24 hours post-intervention |
Comparing Rates of Glaucoma in Professional Wind Versus Non-Wind Instrument Players

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to compare rates of glaucomatous optic neuropathy in professional wind versus non-wind instrument players in the Philadelphia Orchestra. A secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind instrument players under variable playing conditions.

Detailed Description
-----------------
Participants of this study will be any current or retired member of the Philadelphia Orchestra. Approximately 100 participants will be divided into 2 groups: 1) wind instrument players and 2) non-wind instrument players. A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. A non-wind instrument is defined as any instrument that does not meet the wind instrument criteria. On the day of the eye examinations, the investigator will provide a brief overview to explain the purpose and goals of the study to all potential participants. The examination team will be set up in an adjoining room. Members of the orchestra will be able to visit the examination team at any time during their practice session. A trained technician will perform the following for both eyes for all participants:visual acuity,undilated fundus color photography and intra-ocular pressure measurement. The investigators will record the examination findings using a standard form. Demographic information, including ocular, medical, social, and family history, will be documented for all participants.

Official Title
-----------------
Comparing Rates of Glaucomatous Optic Neuropathy in Professional Wind Versus Non-wind Instrument Players in the Philadelphia Orchestra

Conditions
-----------------
Glaucoma, Intraocular Pressure, Optic Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years. Normal general health. Exclusion Criteria: Incisional eye surgery <1 month prior to visit 1.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wind instrument players<br>A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. | |
| Non-wind instrument players<br>A non-wind instrument is defined as any instrument that does not contain a resonator. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) in wind and non-wind instrument players | Compare IOP in wind and non-wind instrument players | 1 year |
A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The first purpose of this study is to determine how the body absorbs, metabolizes, and eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what effects it has on your cancer.

Official Title
-----------------
Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Oral Taxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-hematological malignancy that has progressed on standard therapy No more that 3 prior chemotherapies given for advanced cancer Adequate renal, hepatic and hematologic function Exclusion Criteria: Uncontrolled or significant pulmonary or cardiovascular disease Active Brain metastases Inability to swallow capsules Serious uncontrolled medical disorder or active infection

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

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

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: Oral Taxane|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the Pharmacokinetics, metabolism, and routes and extent of elimination of a single dose of [14C] BMS-275183 over a 10 day period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly |  |  |