linjc16/ctgov huggingface dataset:
Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

Study Overview
=================
Brief Summary
-----------------
This project investigates the feasibility of assessing the relative blood volume of carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an interventional platform.

Detailed Description
-----------------
This project will enroll patients with non-diffuse liver disease who are candidates for chemo or radioembolization to treat or manage the disease during an image guided intervention. Subjects will undergo a CT perfusion study of the liver prior to the radioembolizaiton mapping procedure or prior to the chemoembolization treatment. During the radioembolization mapping or chemoembolization procedure, 2 DynaCT acquisitions on the interventional C-arm will be acquired (the second during an injection of an iodinated contrast material) and will be processed using Siemens' PBV software to generate blood volume maps. The diagnostic accuracy of the two approaches to assess the vascularity of the tumors will be assessed.

Official Title
-----------------
Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

Conditions
-----------------
Hepatocellular Carcinoma, Metastatic Carcinoma to the Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCC or metastatic liver disease Candidate for radioembolization or chemoembolization Exclusion Criteria: Pregnant Iodine allergy

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 |
| --- | --- | --- |
| Diagnostic accuracy of PBV maps | The accuracy of the DynaCT BV protocol as an indicator of healthy vs. liver tumor compared to the body CT perfusion study will evaluated using a receiver operating characteristic curve. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between blood volume values and patient treatment response | The relationship between the BV values obtained by both methods and treatment response (as measured by RECIST values) will be evaluated by a logistic regression model | 1,4,7,13,19 months | 
| PBV blood volume value accuracy | A Spearman's correlation coefficient will be used to test the rank-based correlation of the BV values in tumor from the DynaCT BV acquisition to the body CT perfusion values. Furthermore, a paired t-test will be used to test for differences in BV using the two approaches. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Perfusion, DynaCT Perfusion, Radioembolization, Chemoembolization
Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using different devices: an esophagus ultrasound device measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and exhaled carbondioxide in the patients' breath measured by the ventilator. The investigators investigate patients after bypass surgery or heart valve replacement, and induce changes in cardiac output with passive leg raise or ventricular pacing.

Detailed Description
-----------------
Measurements with the finger cuff (pulse contour analyses) were aborted due to technical difficulties.

Official Title
-----------------
Non-invasive Volume Evaluation With Exhaled Carbon Dioxide and Pulse Contour Analysis (Nexfin)

Conditions
-----------------
Changes in Cardiac Output

Intervention / Treatment
-----------------
* Other: Ventricular pacing and passive leg raise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons 18 years or older scheduled to undergo arteriocoranary bypass surgery or aortic valve replacement. Exclusion Criteria: Esophageal pathology, EF <40%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comparing cardiac output changes<br>Explore the relationship between changes in cardiac output measured with eosophagal Doppler, the volume-clamp-method and exhaled CO2 during ventricular pacing and passive leg raise. Measurements with the volume-clamp-method were aborted due to technological difficulties. | Other: Ventricular pacing and passive leg raise<br>* Ventricular pacing and passive leg raise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac output |  | 5 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac output, Exhaled CO2, Nexfin, Esophageal Doppler
Gorbly Compression Device for Use in Image-guided Procedures

Study Overview
=================
Brief Summary
-----------------
Prospective cohort study. All patients presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage performed under the care of Dr. Issam Kably will become part of the study population. Based on prior imaging and/or imaging at the time of the procedure, patients will fall into two groups, those for whom no compression is necessary to complete the procedure and those for whom compression may provide benefit. These would be selected based on Dr. Kably's experience as a practicing academic, fellowship-trained, and CAQ'ed interventional radiologist. The latter group would then further subdivide into those who give consent for use of the compression device and those who do not consent. Results of each group would be measured including the following: termination versus successful completion of the procedure; adverse events including bleeding or damage to surrounding structures necessitating further medical or surgical intervention.

Official Title
-----------------
Gorbly Compression Device for Use in Image-guided Procedures

Conditions
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Neoplasm, Sepsis

Intervention / Treatment
-----------------
* Device: Gorbly Compression Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All-comers presenting for percutaneous abdomino-pelvic soft tissue ablation, biopsy, or drainage . Exclusion Criteria: Open surgical or traumatic abdominal wall. Active abdominal wall infection.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Gorbly Compression not needed<br> | |
| Experimental: Gorbly Compression may benefit<br>the use of the Gorbly device with the consent of the patient | Device: Gorbly Compression Device<br>* The compression device provides a way to displace critical structures along the path from skin to target, retract excess body wall tissue, and provide mechanical stabilization in a repeatable and sustainable fashion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of procedures (i.e., ablations, biopsies, or drainages) that are allowed successful completion. |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of complication of bleeding or damage to the surrounding vessels or organs by use of the compression device. |  | intraoperative |
The Hasselt APPendicitis Immunology and Environmental Cohort STudy

Study Overview
=================
Brief Summary
-----------------
The Hasselt Appendicitis Immunology and Environmental Study (HAPPIEST) aims at characterizing factors that influence the development and severity of acute appendicitis. In a cohort of 300 patients and 300 controls, environmental factors as well as genetic make-up of the innate immune system, focusing mainly on pattern recognition, will be analyzed in order to gain insight in their relative importance in the pathology of appendicitis. Furthermore, populations of micro-organisms present in the gut of patients will be characterized, and the interaction between relevant micro-organisms and the innate immune system will be analyzed.

Official Title
-----------------
The Hasselt APPendicitis Immunology and Environmental Cohort STudy

Conditions
-----------------
Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute appendicitis Appendectomy within 7 days after onset of symptoms Signed informed consent Exclusion Criteria: Appendectomy 7 days or more after onset of symptoms Participation in any clinical investigational drug study within 4 weeks of screening Severe, life-threatening disease with a life expectancy of less than 2 months.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Appendicitis patients<br>Patients presenting with acute appendicitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic susceptibility | DNA sample collected at inclusion | Within 2 years after inclusion of the last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunology composite outcome | ex vivo peripheral blood mononuclear cell (PBMC) stimulation experiments | within 4 years | 
| Environmental factors | Questionnaire filled in at inclusion | Within 6 months after inclusion of the last patient |
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: enfuvirtide [Fuzeon]
* Drug: Antiretroviral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; documented chronic HIV infection; currently receiving a stable antiretroviral regimen; CD4 cell count <250 cells/mm3; HIV RNA viral load <400 copies/mL for >12 months. Exclusion Criteria: prior exposure to Fuzeon; prior non-adherence to antiretroviral treatment regimens; active opportunistic infection; currently taking, or anticipated to take during the study, any immunomodulator.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid<br>Drug: Antiretroviral therapy<br>* As prescribed<br>|
| Active Comparator: 2<br> | Drug: Antiretroviral therapy<br>* As prescribed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in CD4 cell count from baseline |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV RNA from baseline |  | Week 24 | 
| Change in HIV RNA and CD4 cell count |  | Weeks 24-48 | 
| Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs. |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Experienced
Pathogenesis and Genetics of Environmental Asthma Ozone Study

Study Overview
=================
Brief Summary
-----------------
The goals of the research are designed to accomplish genetic association studies of candidate genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent exercise in order to search for associations between defined genotypes/haplotypes and 3 specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure; b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20 FEV1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected in the Clearance Halftime of technetium 24 hours after ozone exposure. These studies have been carried forward to take place in 4 phases: i) healthy individuals have been exposed to O3 using our standard exposure protocol; and we will increase the numbers of individuals available for study. ii) perform genetic association studies for the endpoints of spirometry (FEV1, FVC, FEV1/FVC), PC20 FEV1 for methacholine, and epithelial integrity (Clearance Halftime) for 3 candidate O3 response genes taken from literature searches and/or previously characterized to demonstrate associations. These physiologic endpoints have been examined in terms of both a continuum of response, and discrete responder and non-responder endpoints.

Official Title
-----------------
Project 2: Genetic Regulation of Ozone Induced Inflammation in Humans.

Conditions
-----------------
Asthma, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with normal lung function values, and of normal body habitus (i.e., < BMI of 30); Do not have a history of lung disease, and not taking any medications for lung disease or other clinical disorders, and no prior or current smoking history. Exclusion Criteria: Non-willingness to sign a consent form for participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathogenesis and genetics of environmental asthma ozone study | Phenotype physiologic responses to ambient level of ozone exposure. | acute and at 18 to 24 hour followup. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ozone, inflammatory airway disease, polymorphisms
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia

Study Overview
=================
Brief Summary
-----------------
Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.

Detailed Description
-----------------
Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin or placebo, with one week washout period in between. Sleep was objectively monitored by wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, cholesterol (total, HDL and LDL) and some antioxidants were assessed at baseline and end of each period.

Official Title
-----------------
A Randomized Double-Blind, Crossover Study Comparing the Efficacy of Prolonged-Release Melatonin Versus Placebo in a 3 Week Treatment of Diabetic Patients Suffering From Insomnia

Conditions
-----------------
Diabetes Mellitus, Type 2, Insomnia

Intervention / Treatment
-----------------
* Drug: Circadin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with proven presence of the disease who complained of insomnia. Exclusion Criteria: Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo First<br>Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin). | Drug: Circadin<br>* 2 mg prolonged-release melatonin<br>* Other names: Prolonged-release melatonin (2mg);Drug: Placebo<br> <br> |
| Other: Circadin first<br>Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo. | Drug: Circadin<br>* 2 mg prolonged-release melatonin<br>* Other names: Prolonged-release melatonin (2mg);Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency | Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melatonin, insomnia, diabetes, sleep
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Study Overview
=================
Brief Summary
-----------------
Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm surgery and stenting, allowing the surgeon or interventional radiologist to take action quickly, while the colon ischemia is still treatable. This purpose of this study is to establish how T-Stat can best be used to prevent deaths.

Official Title
-----------------
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Conditions
-----------------
Colon Ischemia, Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: Reestablish colon blood flow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aortic Aneurysm, intact or ruptured Repair by catheter based stent or by open surgery during monitoring Patent rectum Absence of rectal bleeding Exclusion Criteria: Lack of informed consent Rectal bleeding Obstructed rectum
Sexes Eligible for Study
-----------------
All

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

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: Reestablish colon blood flow|If ischemia is detected, and the detection in consistent with the physician's clinical view, blood flow to the colon is established using any of the known techniques that would be used had the diagnosis been made in the absence of T-Stat, which include changes in the deployment of stents and/or coils, reanastomosis, reimplantation, or stenting, of obstructed vessels, or other established techniques.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect colon ischemia early |  | Just before, and during, surgery or stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allows change in the untreated course of colon ischemia |  | 28 days or discharge from hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue oximetry, Ischemia, Aortic Aneurysm Repair, Aortic Stent, Vascular Stent, Aortic graft, Vascular graft