linjc16/ctgov huggingface dataset:
Ex Vivo Human Thrombosis Chamber Study

Study Overview
=================
Brief Summary
-----------------
Purpose of study is to evaluate a thrombosis chamber model

Official Title
-----------------
Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Clopidogrel
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects BMI 18-30 kg/m² Male ages 18-45 Exclusion Criteria: Significant acute or chronic illness History of abnormal bleeding or coagulation disorder, intracranial hemorrhage, or a family history of abnormal bleeding or coagulation disorder in a first degree relative under 50 years of age Easy bruising Smoking within 3 months prior to Day 1

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel + Aspirin<br> | Drug: Clopidogrel<br>* Tablets, Oral, 75 mg, Once daily, 8 days<br>* Other names: Plavix;Drug: Aspirin<br>* Tablets, Oral, 325 mg, Once daily, 8 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation |  | Period 2, Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess variability of thrombosis chamber measurements |  | Period 1 and Period 2 | 
| Assess relationship between platelet aggregation and thrombus formation |  | Period 1 and Period 2 | 
| Safety and tolerability of multiple doses clopidogrel and aspirin |  | From Day 1 through Study Discharge |
Metabolic FingerPrinting

Study Overview
=================
Brief Summary
-----------------
The MetaPrint study aims to characterize the metabolic fingerprint of genetic diseases in order to enhance knowledge on the physiological disease status and establish so new tools for diagnosing, monitoring and personalizing treatment of genetic diseases.

Official Title
-----------------
Metabolic FingerPrinting

Conditions
-----------------
Genetic Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent is obtained from the participant or from the parent/ legal guardian The participant is 2 months or older The participant is diagnosed with a genetic disease The participant is a first degree relative of a subject diagnosed with a genetic disease Exclusion Criteria: Informed consent is not obtained from the participant or from the parent/ legal guardian The participant is younger than 2 months The participant is not diagnosed with a genetic disease The participant is not a first degree relative of a subject diagnosed with a genetic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with a genetic disease<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of newly identified, disease-specific Metabolic Fingerprints | Plasma-derived metabolite profiles that are specific for a particular genetic disease in comparison to healthy controls and other genetic diseases | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Fingerprint
Effects of Coordinated Care for Disabled Medicaid Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve the quality of care for individuals with multiple chronic conditions, health care systems have begun turning to coordinated care. Although coordinated care can refer to many different things, it usually includes activities such as assessing patients' needs, referring them to the right doctors, helping them make and keep appointments, and helping them comply with medical or dietary recommendations. To understand the effects of coordinated care for high-needs Medicaid recipients, MDRC is conducting a randomized trial of a pilot coordinated care program run by Kaiser Permanente for blind and disabled Medicaid recipients in the Denver area.

Official Title
-----------------
Effects of Coordinated Care for Disabled Medicaid Recipients

Conditions
-----------------
Chronic Conditions Faced by Medicaid Recipients With Disabilities

Intervention / Treatment
-----------------
* Behavioral: Coordinated care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disabled, in fee-for-service Medicaid Exclusion Criteria: Under age 18, over age 64

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coordinated care<br>Individuals will be passively enrolled in Medicaid managed care. Those who do not opt out of managed care will be provided with care coordination. | Behavioral: Coordinated care<br> <br> |
| No Intervention: Usual care<br>The usual care group will remain in fee-for-service Medicaid and receive services normally available through that system. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care use through Medicaid |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary and preventive care |  | Six months, two years | 
| Emergency department use |  | Six months, two years | 
| Hospital admissions |  | Six months, two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All conditions faced by disabled Medicaid recipients
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.

Official Title
-----------------
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer, or Pancreatic Cancer

Conditions
-----------------
Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Drug: CI-1040


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer. No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer. Original or recent tumor tissue must be available. Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks. Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor). Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug. Exclusion Criteria: Unstable medical condition prior chemotherapy within 4 week of screening series infection other tumor types ECOG performance status of 3 or 4.

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 |
| --- |
|Drug: CI-1040|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall objective response and clinical benefit response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to objective response, duration of response, time to progression and survival |  |  |
Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM)

Study Overview
=================
Brief Summary
-----------------
In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive value for detecting heart failure. We also investigate if left ventricular filling pattern measured by echocardiography and/or brain natriuretic peptide (BNP) level can be used to improve the positive predictive value of the Optivol alert

Detailed Description
-----------------
Patients who have a Medtronic (R) ICD equipped with the Optivol (TM) impedance monitoring will be included in your study after informed consent. The OptiVol (TM) feature will be activated and at baseline data is collected (blood sample including BNP, electrocardiography, echocardiography, chest X-ray and ICD check-up). During follow-up patients will be re-assessed in case of an OptiVol alert or in case of heart failure.

Official Title
-----------------
Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM) in Medtronic(R) ICD's for Early Detection of Decompensated Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic heart failure of any cause implanted Medtronic ICD with OptiVol impedance monitoring Exclusion Criteria: inability to receive informed consent

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 |
| --- | --- | --- |
| clinical efficacy and value of ambulatory intrathoracic impedance measurement of the Optivol alert as an indicator of decompensated heart failure reflected by sensitivity and positive predictive value |  | end of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of left ventricular filling pattern and brain natriuretic level on the positive predictive value of the Optivol alert |  | end of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrathoracic impedance, cardiac resynchronization therapy, heart failure
Influence of Tonic and Burst Transcranial Magnetic Stimulation (TMS) Characteristics on Acute Inhibition of Subjective Tinnitus

Study Overview
=================
Brief Summary
-----------------
Transcranial magnetic stimulation (TMS) is already broadly used in different areas of neuroscience research. Last year, special attention was drawn to TMS in tinnitus. The aim of the researchers' study is to investigate the stimulation characteristics of TMS in tinnitus patients, in particularly the effect of tonic and burst stimulation of the superior temporal lobe.

Official Title
-----------------
Influence of Tonic and Burst TMS Characteristics on Acute Inhibition of Subjective Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Procedure: TMS transcranial magnetic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presented to our Multidisciplinary Tinnitus Clinic with tinnitus as a main complaint. Exclusion Criteria: Patients with known history of epilepsy, pacemakers, cochlear implants, neurostimulators or intracerebral pathology were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- |
| Tinnitus<br>Tinnitus patients | Procedure: TMS transcranial magnetic stimulation<br>* 200 pulses of tonic TMS (see Graph 1) were administered with an intensity at 50% of the maximal TMS device output (50%DO). The frequency of the tonic pulses was randomly chosen between 1Hz, 5Hz, 10Hz or 20Hz. Burst stimulation was delivered at a burst frequency of 5, 10 or 20Hz. Each burst consisted of 3, 5 or 10 pulses. The individual pulse rate within a burst was 50 or 100Hz.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS visual analogue scale |  | immediately before and immediately after single session TMS |
Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

Study Overview
=================
Brief Summary
-----------------
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

Official Title
-----------------
Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft

Conditions
-----------------
Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Juxtarenal Aneurysms

Intervention / Treatment
-----------------
* Device: Zenith(R) Fenestrated AAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm Exclusion Criteria: Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal Renal artery stenosis greater than 50 percent

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Zenith(R) Fenestrated AAA Endovascular Graft | Device: Zenith(R) Fenestrated AAA Endovascular Graft<br>* The Zenith(R) Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Success | Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis. | 6 months |
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.

Official Title
-----------------
A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML)

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Gemtuzumab Ozogamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study Phase II will only allow enrollment of younger de novo AML Exclusion Criteria: AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration De novo patients with M3 AML AML secondary to exposure to chemotherapy or radiation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemtuzumab Ozogamicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute, Myeloid, Leukemia
Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. Aim of the study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (Glitazon or Metformin) in obese patients with stable CAD and impaired glucose tolerance.

Conditions
-----------------
Stable Coronary Artery Disease, Obesity, Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Other: training
* Other: training + metformin
* Other: training + glitazon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: either impaired glucose tolerance (2-h plasma glucose concentration >7.8 and <11.1 mmol/L during an oral glucose tolerance test) or impaired fasting glucose (fasting glucose concentration >6.0 and <7.0 mmol/L) coronary artery disease determined by coronary angiography BMI > 25 male patients aged 35-75 years Exclusion Criteria: diabetes mellitus type 1 diabetes mellitus type 2 in combination with glycosylates hemoglobin >6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration > 11.0 mmol/L unstable angina pectoris indication for coronary artery bypass graft operation myocardial infarction within the last 3 months reduced left-ventricular systolic function < 40 %

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>regular physical exercise training | Other: training<br>* regular physical exercise training for 6 months<br>|
| Other: 2<br>regular physical exercise training + metformin | Other: training + metformin<br>* regular physical exercise training in combination with metformin for 6 months<br>|
| Other: 3<br>regular physical exercise training + glitazon | Other: training + glitazon<br>* regular physical exercise training in combination with a glitazon for 6 months<br>|
| No Intervention: 4<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in endothelial function in patients with stable coronary artery disease |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in metabolic parameters |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adiposity