linjc16/ctgov huggingface dataset:
Impedance Measurements in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure impedance during inpatient treatment.

Official Title
-----------------
Impedance Measurements in Heart Failure Patients

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

Intervention / Treatment
-----------------
* Device: Akern BIA101 and Custom Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to hospital for symptoms of congestive heart failure patients older than 18 years patients willing and able to give informed consent Exclusion Criteria: patients who will require adrenergic or positive inotropic medications patients enrolled in a concurrent study that may confound the results of this study patients unable or unwilling to participate in study procedures patients who are pregnant patients who are mentally handicapped or legal incompetent patients who are dependent on investigator or sponsor

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Akern BIA101 and Custom Device|Impedance Measurement every 4 hours|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement |  | every 4 hours up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Respiratory rate determined by impedance measurements |  | every 4 hours up to 48 hours | 
| Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional) |  | every 4 hours up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, HF
Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers. The investigators hypothesize, therefore, that there is a significant difference in the concentrations of inflammatory and infectious markers in the rectal mucosa between patients with septic shock and healthy controls.

Official Title
-----------------
Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Procedure: Rectal biopsy
* Procedure: Measurement of inflammatory markers in the rectal mucosa
* Procedure: Measurement of rectal lactic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Septic shock Exclusion Criteria: Age < 18 years No next of kin Pathology of the descending or sigmoid colon or rectum Pregnancy 1st degree relatives with inflammatory bowel disease Severe coagulopathy

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Rectal biopsy|Rectal biopsy.|
|Procedure: Measurement of inflammatory markers in the rectal mucosa|IL-6, TNF-alfa.|
|Procedure: Measurement of rectal lactic acid|Equilibrium dialysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Quality of Life Among Children and Adolescents With Cancer

Study Overview
=================
Brief Summary
-----------------
This descriptive study aims to allow children and adolescents who have cancer to self-evaluate their quality of life. It is hypothesized that treatment affects quality of life in the areas of physical and social functioning. It is further hypothesized that these effects dissipate within 6 months after treatment is completed.

Detailed Description
-----------------
Study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the Hematology/Oncology Clinic at the CMHC, which will serve as the study site. These individuals will be identified by the health care professionals working in the clinic. Specific study criteria will include only those individuals who (1) can read or write in the English language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the Clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. The weekly list of appointments will be reviewed by the researchers who already work in the Clinic for appropriateness (JH, JB and KS). To prevent participation coercion, solicitation for participation will be provided through the Child Life Specialist (CLS). The CLS is known to each participant and will function as a data collector for this study.

Official Title
-----------------
Quality of Life Among Children and Adolescents With Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the Hematology/Oncology Clinic at the CMHC, which will serve as the study site. These individuals will be identified by the health care professionals working in the clinic. Specific study criteria will include only those individuals who (1) can read or write in the English language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the Clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. - Exclusion Criteria: (1) Those electing not to participate; (2) those with no guardian available to consent or (3) those not yet diagnosed with a cancer condition. -

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, quality of life, adolescents
A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.

Official Title
-----------------
ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: ROX COUPLER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination Exclusion Criteria: Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>ROX Coupler + continuing standard antihypertensive medications | Device: ROX COUPLER<br>* The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).<br>|
| No Intervention: Group B<br>Continuing standard antihypertensive medications | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean office SBP | Change in mean office SBP at six months as compared to Baseline | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean office DBP | Change in mean office DBP at six months as compared to Baseline | Baseline, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Blood Pressure, Hypertension, Resistant Hypertension
Open-Label Trial of the Use of Minocycline in the Treatment of Asthma

Study Overview
=================
Brief Summary
-----------------
The tetracycline minocycline has, in addition to its anti-infective properties, anti-inflammatory properties which may be of use in the treatment of asthma. This study evaluates the benefit of minocycline as add-on therapy for adults with asthma.

Detailed Description
-----------------
Adult asthmatic (ages 18 to 75 years) with a history of moderate to severe persistent asthma are given minocycline capsules as add-on therapy for treatment of asthma. Treatment is for one year. Dosing begins at 150 mg twice daily and can increase every eight weeks by 50mg BID to a maximum of 250 mg twice daily. This is as per patient tolerance as minocycline can cause dizziness and stomach upset, as well as effects of liver enzymes.Patients undergo routine blood toxicity screens every two months, at which time spirometry is performed Exclusion criteria: pregnant women (adequate contraception in mandated) previous history of hypersensitivity to tetracyclines, chronic liver disease Outcome measures: improvement in FEV1 and other spirometric parameters, decrease in oral steroid requirements, change in total serum IgE, improvement in quality of life

Official Title
-----------------
Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Minocycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (ages 18 to 75 yrs) Mild to severe asthma History of or current oral steroid use to control asthma atopy Exclusion Criteria: Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minocycline<br>addition of minocycline to standard asthma care as add-on therapy: 150 mg bid to 250 mg bid for up to one year | Drug: Minocycline<br>* addition of 150 mg to 250 mg po bid to standard asthma care regiment<br>* Other names: Minocin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in FEV1 on spirometry |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in total serum IgE |  | one year | 
| decrease in oral steroid requirements |  | one year | 
| improvement in quality of life scores |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, minocycline, oral steroids, IgE
Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

Detailed Description
-----------------
Background: Transabdominal ultrasound cannot be used to quantitate fibrosis in patients with cirrhosis due to variability in the abdominal wall thickness and composition. This variability can be eliminated by using endoscopic ultrasound. Aim: To determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

Official Title
-----------------
Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound.

Conditions
-----------------
Alcoholism, Cirrhosis, Hepatitis c

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatic cirrhosis and hepatitis C and undergoing endoscopy Alcoholic liver and undergoing endoscopy Normal liver undergoing endoscopy Exclusion Criteria: pregnancy Children

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Patients with Hepatitis C Cirrhosis<br>Patients with Hepatitis C Cirrhosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luminosity on ultrasound |  | Once at the time of the endoscopic ultrasound | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcoholic cirrhosis, hepatitis c cirrhosis, cirrhosis
International Retrospective Study of Pipeline Embolization Device

Study Overview
=================
Brief Summary
-----------------
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed to observe and capture information from numerous hospitals. Data collection will be initiated starting March 2012 and continue until approximately April 2017.

Official Title
-----------------
International Retrospective Study of Pipeline Embolization Device

Conditions
-----------------
Brain Aneurysms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
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 |
| --- | --- | --- |
| Relative incidence of neurologic clinical events that occurred after treatment with PED | Incidence of neurologic events from the time of Approval of the Pipeline Embolization Device in the country of use until IRB approval at facility. | From Approval of PED in country of use until IRB approval at facility allowing for approximately 8-12 months of data for each subject. Outcomes are expected to be reported on 6 mo, 12mo, 2 yr, & 5yr data. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain aneurysm PED Pipeline
Study of ONO-2506 in Patients With Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.

Official Title
-----------------
Controlled Study of ONO-2506 in Patients With Acute Ischemic Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Drug: ONO-2506
* Drug: ONO-2506
* Drug: ONO-2506


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have a clinical diagnosis of acute ischemic stroke Subjects within 72 hours after onset of the stroke Other inclusion criteria may apply. Exclusion Criteria: Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction) Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant. Other exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: ONO-2506<br>* Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days<br>|
| Experimental: E1<br> | Drug: ONO-2506<br>* Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days<br>|
| Experimental: E2<br> | Drug: ONO-2506<br>* Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale at 90 days |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale at 30 days |  | 30 days | 
| National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-2506, stroke, Acute ischemic stroke
Pregnancy at a Time That Is Happy and Healthy for You

Study Overview
=================
Brief Summary
-----------------
In an effort reduce maternal and infant mortality and health disparities overall, PATH4YOU (Pregnancy At a Time that's Healthy and Happy for You) will be implemented starting in Marion County, and will ultimately be a statewide comprehensive contraceptive access program that ensures that patient-centered counseling and same-day access to no (or low) cost contraception are delivered to women across the state. The goal of this project is to partner with community stakeholders to tailor and implement a patient-centered, comprehensive contraceptive access intervention, the PATH4YOU Bundle. The health center level intervention will consist of three key principles: Pregnancy Intention Screening: Provide training for health care providers and assist in health center implementation of a patient-centered pregnancy intention screening strategy within clinical settings Contraception and Reproductive Health Counseling: Implement the use of a pre-visit patient-centered decision-aid for all patients presenting to a health center for reproductive health care. Same-Day Access to Contraception: Provide training for health care providers and logistical assistance to health centers to implement care consistent with providing patients with their chosen method of contraception the day of patient contact.

Official Title
-----------------
Pregnancy at a Time That Is Happy and Healthy for You

Conditions
-----------------
Contraception Behavior

Intervention / Treatment
-----------------
* Behavioral: PATH4YOU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women live in Indiana Exclusion Criteria: history of hysterectomy or sterilization or post-menopausal
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: PATH4YOU|PATH4YOU offers patient-center, comprehensive, contraceptive counseling; pregnancy planning; and same to next day access to birth control. This clinical care program will reduce obstacles to contraception in Indiana and enables access to healthy pregnancy planning conversations.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Measuring patient satisfaction with PATH4YOU as a program | 2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of infant mortality rate | Review the infant mortality rate in counties throughout Indiana | 2025 | 
| Reduction of maternal mortality rate | Review the maternal mortality rate in counties throughout Indiana | 2025 |