linjc16/ctgov huggingface dataset:
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

Study Overview
=================
Brief Summary
-----------------
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

Detailed Description
-----------------
The purpose of this clinical investigation is to evaluate the safety and performance of the Doraya catheter in patients admitted with AHF, presenting persistent volume over load and poor response to diuretic treatment.

Official Title
-----------------
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

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

Intervention / Treatment
-----------------
* Device: Doraya catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHF subjects with poor diuretic response Exclusion Criteria: AHF subjects with sufficient diuretic response

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AHF patients<br>AHF patient treatment with the Doraya catheter | Device: Doraya catheter<br>* Temporary deployment of the Doraya catheter in AHF patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device or procedure related Serious Adverse Event (SAE) rate through 60 days | SAE as defined by ISO 14155 | 60 days |
Balance Performance and Corticomotor Inhibition in PD

Study Overview
=================
Brief Summary
-----------------
Postural instability is one of the motor features of Parkinson's disease (PD). Most patients will develop balance dysfunction, and they may get worse with disease progression. According to previous studies, people with PD had abnormal changes in corticomotor excitability, especially disinhibition in the primary motor cortex (M1). Some evidence had shown that the cortical function in the M1 is crucial for the pathophysiology of the underlying motor symptoms in PD. Furthermore, neurostimulation over the M1 could modulate the corticomotor excitability in individuals with PD, and then improve their motor and also balance performance. However, whether the impaired corticomotor inhibition relates to balance dysfunction in people with PD is still unknown. In this study, the purpose is to investigate the possible relationship between corticomotor inhibition and balance performance in individuals with PD. However, the postural position during TMS measurement may affect the corticomotor excitability. To further establish the above-mentioned relationship, the secondary purpose is to explore and confirm whether the postural position will influence the correlation.

Official Title
-----------------
Relationship Between Balance Performance and Corticomotor Inhibition in Individuals With Parkinsons' Disease

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the Hoehn and Yahr stage between 1 and 3 age 40 to 80 years a stable treatment of anti-PD medications Exclusion Criteria: any contraindications of TMS any injury histories or disorders affecting balance any neurosurgery experience neurologic conditions other than PD the Mini-mental State Examination (MMSE) score < 24

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Intracortical inhibition | Short-interval intracortical inhibition assessed by transcranial magnetic stimulation | 20 minutes | 
| Corticospinal inhibition | Cortical silent period assessed by transcranial magnetic stimulation | 20 minutes | 
| Static balance | Sharpened Romberg test | 3 minutes | 
| Dynamic balance | Functional reach test | 5 minutes | 
| Functional balance | Mini-Balance Evaluation Systems Test | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease; Transcranial magnetic stimulation; Motor cortex; Corticomotor inhibition; Balance performance
Effects of Growth Hormone on Exercise Capacity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure.

Detailed Description
-----------------
clinical studies have focused the effects of GH on left ventricular function and hemodynamics. Little is known about the impact of GH on cardiopulmonary performance and exercise capacity. Such data would be relevant, given the well-recognized importance of cardiopulmonary performance and exercise capacity as markers of disease progression and predictors of mortality in patients with CHF.Consequently we conducted a randomised double blind placebo controlled trial to investigate the effects of a three month course of GH, adjunctive to background therapy, on cardiopulmonary performance and exercise capacity in patients with dilated cardiomyopathy and CHF.The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.

Official Title
-----------------
Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure

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

Intervention / Treatment
-----------------
* Drug: Growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ejection fraction < 40% Left ventricular internal dimension >58 mm II-III NYHA class Stable hemodynamic condition during the previous three months Sinus rhythm Exclusion Criteria: IMA or CABG or PTCA in the previous six months Instable angina Major arrhythmias (Lown class> IV) Diseases limiting exercise capacity Insulin treated diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Growth hormone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography. |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic heart failure, cardiopulmonary exercise, oxygen consumption, growth hormone
Characterization of the Use of Antipsychotics in Posttraumatic Stress Disorder During the Past Decade

Study Overview
=================
Brief Summary
-----------------
The main purpose is to show the percentage of patients taking antipsychotics with PTSD by looking at approximately ten year's worth of data from 1994 through 2004. We will also determine the type and dose of antipsychotics the patients received, and to determine how many of those patients had psychotic versus nonpsychotic symptoms. We will be obtaining this data from the VISN 7 Corporate Data Warehouse. We hypothesize that there has been an overall increase in antipsychotic use in patient's with PTSD over the last 10 years.

Detailed Description
-----------------
This study is a retrospective chart review of patients, at the Tuscaloosa VA Medical Center, who were, treated with antipsychotics as monotherapy or adjunctive therapy. The data will be retrieved from a computerized list of patients treated at the TVAMC for PTSD from 1994-2004 Charts will be reviewed by looking at approximately ten year's worth of data. Charts will then be examined to determine what type of antipsychotics patients were prescribed, the dose and duration of the antipsychotics, and the presence or absence of documented psychotic symptoms.

Official Title
-----------------
Characterization of the Use of Antipsychotics in Posttraumatic Stress Disorder During the Past Decade

Conditions
-----------------
PTSD, Posttraumatic Stress Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of PTSD (309.81) Male or female patients at least 19 years of age Exclusion Criteria: • None

Ages Eligible for Study
-----------------
Minimum Age: 19 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
-----------------
antipsychotics, PTSD, posttraumatic stress disorder
Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γH2AX-analysis and genetic information.

Official Title
-----------------
Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer and Development of a Multi-parametric Decision Support System for Personalised Medicine in Radiation Oncology

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Radiation: Integration of PET/MRI in radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally-advanced HNSCC (Oro- and Hypopharynx) stage III and IV without distant metastases no contraindications for PET/MRI no contraindications for radiochemotherapy informed consent ECOG PS 0/2 Exclusion Criteria: Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC previous PET/CT induction therapy pregnancy or breastfeeding

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: Integration of PET/MRI in radiotherapy<br>Integration of pretherapeutical PET/MRI in adjuvant radiotherapy | Radiation: Integration of PET/MRI in radiotherapy<br>* Integration of pretherapeutical PET/MRI in adjuvant radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locoregional progression free survival | 15% improvement in loco-regional PFS at 2 years through integrtion of pre-operative PET/MR imaging into RT treatment planning | 2 years after primary diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 2 years after primary diagnosis | 
| Overall survival |  | 2 years after primary diagnosis | 
| Development of a multi-parametric decision support system |  | after termination of recruitment and follow up up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Personalized Medicine, Radiation Oncology, Functional Imaging, Biomarker, Decision Support System, Radiomics
Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx

Study Overview
=================
Brief Summary
-----------------
Fluid and volume management are a challenging part of critical care and the difficulties increase in the face of renal failure. Utilizing the Crit-Line to monitor blood volume changes in conjunction with arterial pressure cardiac output monitoring may lead to better understanding of the impact fluid removal during dialysis has on hemodynamics.

Detailed Description
-----------------
Patients in an ICU often require large amounts of IV fluid to maintain adequate cardiac function. In patients with renal failure, the ability to gauge adequacy of circulating blood volume based on urine output is obviously lacking. The FDA approved devices called Flotrac/Vigileo and Crit-Line are used in this setting to determine adequacy of fluid resuscitation. This study proposes to use the data collected in a retrospective manner to determine if correlation of the various measured parameters can serve as a predictor of hemodynamic status.

Official Title
-----------------
Hemodynamic Assessment Comparison Between Arterial Pressure Cardiac Output Monitor and Crit Line Utilized During Renal Replacement Therapy

Conditions
-----------------
Renal Failure, Hemodynamics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indwelling arterial catheter Require dialysis CVP in place Use of Crit-Line and Flotrak device Exclusion Criteria: Aortic Regurgitation Use of an intra-aortic balloon pump Weight less than 90 lbs Cardiac arrhythmias

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?
-----------------
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
-----------------
Hemodynamics
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the intra-saliva penetration of voriconazole in different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in children, ambulatory patients and in patients in whom blood drawing is difficult.

Official Title
-----------------
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.

Conditions
-----------------
Pneumology, Hematology, Internal Medicine, Pediatrics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients from the adult hematology ward treated with voriconazole pediatric patients treated with voriconazole, age 5-18 years patients from the pneumology ward treated with voriconazole Exclusion Criteria: Age under 5 years Women who are pregnant or lactating Mucositis stage 3 or 4 (WHO) Patients which received the following drugs within 14 days before study entry: rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz and barbiturates. Patients which received the following drugs within 24hours before study entry: quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, ritonavir and sulphonylureas.

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| adult hematology patients<br> | |
| pediatric patients age 5-18years<br> | |
| adult pneumology patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voriconazole pharmacokinetics in saliva and plasma in different patient populations |  | One day at steady state of voriconazole plasma levels | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voriconazole, saliva, pharmacokinetics
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

Detailed Description
-----------------
The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.

Official Title
-----------------
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

Conditions
-----------------
Breast Abnormalities

Intervention / Treatment
-----------------
* Device: tomosynthesis and screening mammography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between the ages of 34 and 56. Women presenting for their baseline screening mammography examination Exclusion Criteria: Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE). Women who may be or are pregnant by self report Women older than 55 years of age or younger than 35. Women with known fatty breast tissue Males and children Women who are unable to understand or execute written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

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: tomosynthesis and screening mammography|All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Without Cancer Who Were Recalled | Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared. | upon recruitment/enrollment phase completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
digital breast tomosynthesis, baseline screening mammography, recall rates
Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Study Overview
=================
Brief Summary
-----------------
This study is evaluating the pupil dilation of Horner's Patients who have ever taken an alpha blocker such as Tamsulosin. Patients will undergo eye dilation as would occur at a yearly eye examination, but their pupil dilation measurements will be recorded.

Detailed Description
-----------------
This study will enroll 10 participants who have a unilateral Horner's Syndrome AND have a history of taking an alpha blocker such as Tamsulosin. Participants will be recruited based on those two enrollment criteria, and after consenting they will undergo pupil dilation with 10% phenylephrine. Once fully dilated the pupil size will be measured. Pupil dilation size of the eye affected by the Horner's Syndrome will be compared to the eye not affected by Horner's. Primary study outcome is the comparative dilation size of the Horner's affected eye to the non affected eye in all subjects.

Official Title
-----------------
Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Conditions
-----------------
Horner Syndrome

Intervention / Treatment
-----------------
* Drug: 10% phenylephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Horner's Syndrome History of taking an alpha blocker (tamsulosin/ terazosin/doxazosin/alfuzosin/silodosin) medication Exclusion Criteria: Subjects with untreated hypertension Subjects with thyrotoxicosis Pregnant women Prisoners Inability to consent Subjects with anatomical narrow angles who have never had a dilated exam

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, intervention trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 10% phenylephrine<br>All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured. | Drug: 10% phenylephrine<br>* 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation.<br>* Other names: Phenylephrine 10%, Pupil Dilation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil Size Measurements | pupil dilation measurements will be taken of each eye at the eye examination. | 20-30 minutes after 10% phenylephrine has been placed in each eye. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alpha blockers, Tamsulosin