linjc16/ctgov huggingface dataset:
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.

Official Title
-----------------
A Randomized, Controlled Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers Using an Open Application Photoallergic Test Design

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: PEP005 (ingenol mebutate) Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are healthy males or females; in the case of females of childbearing potential, are using an acceptable form of birth control and provide a negative urine pregnancy test; read, understand and provide signed informed consent. Exclusion Criteria: are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study; are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study; are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study; have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PEP005 (ingenol mebutate) Gel | Drug: PEP005 (ingenol mebutate) Gel<br>* PEP005 (ingenol mebutate) Gel, 0.01%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peplin, PEP005
Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults

Study Overview
=================
Brief Summary
-----------------
The study is aimed to assess a new system for the automatic detection, quantification and treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The system is comprized of a treadmill and a virtual reality simulation which provides a motor-cognitive challenge to provoke NF. The challenges provided by the system are individualized and using machine learning algorithms will enable the identification and detection of NF under different conditions and allow for the most suitable treatment.

Official Title
-----------------
Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults

Conditions
-----------------
Idiopathic Fallers

Intervention / Treatment
-----------------
* Device: new system to detect Near Falls


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy older adults with a history of falls or complaints of gait instability Able to walk independently for at least 10 minutes Exclusion Criteria: Systemic chronic or acute pathologies: Ischemic heart disease Orthopedic or Rheumatic diseases Severe vision problems Neurological disease: PD, AD, CVA Patients who underwent brain surgery in the last 6 months prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| new system to detect Near Falls<br>the new system comprises of a treadmill and a virtual reality simulation that will be used to induce Near Falls in healthy older adults with a history of falls. | Device: new system to detect Near Falls<br>* We will invite healthy older adults with a history of falls to try the new system and assess whether the new system can induce, detect and quantify Near Fall episodes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usability of the system to detect Near Falls |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Fall severity |  | one year |
A Screening Study To Assess The Cognition Status in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks.

Official Title
-----------------
MULTI-CENTER COGNITION ASSESSMENT IN HEALTHY SUBJECTS TO COLLECT REFERENCE DATA FOR COMPARISON TO PATIENTS WITH DEPRESSION

Conditions
-----------------
Healthy Volunteer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, 18 to 65 years of age, inclusive Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment A body mass index between 18 to 30 kg/m2 inclusive Able to participate and willing to give written informed consent and to comply with the study restrictions At least second generation resident in the country of origin Exclusion Criteria: Current or past history of a psychiatric disorder Family history of psychiatric disorders Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition Change of smoking behavior or smoking cessation therapy within 30 days before screening visit Positive result on hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 and 2 Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 100 or less than 50 mm Hg Resting Pulse Rate greater than 100 or less than 45 beats per minute Clinically significant abnormalities in laboratory test results or in ECG assessment at screening visit Participation in an investigational drug study within 1 month prior to baseline

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive status of volunteers |  | 6 weeks |
REnAL denervatIon by ultraSound Transcatheter Emission

Study Overview
=================
Brief Summary
-----------------
The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.

Official Title
-----------------
REnAL denervatIon by ultraSound Transcatheter Emission

Conditions
-----------------
Resistant Hypertension

Intervention / Treatment
-----------------
* Device: PARADISE percutaneous renal denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resistant hypertension, as defined in the 2007 ESH-ESC guidelines 18 years of age or older Negative pregnancy test for female patients of childbearing potential Willing and able to comply with follow-up requirements Signed informed consent Exclusion Criteria: Secondary hypertension Main renal arteries length < 20 mm Main renal arteries diameter < 4 mm Renal artery stenosis Iliac/femoral artery stenosis precluding insertion of the catheter Allergy to contrast media Currently participating in the study of an investigational drug or device Hemodynamics abnormality Moderate to severe renal insufficiency

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: Percutaneous renal denervation<br> | Device: PARADISE percutaneous renal denervation<br>* Intravascular ultrasound emission<br>* Other names: ReCor Medical PARADISE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of successful interventions | A successful intervention is defined by the ability to successfully: Introduce the PRDS catheter Position the PRDS catheter Deliver ultrasound energy Retrieve the PRDS catheter | Up to 24 hours | 
| Percentage of patients with device- or procedure-related adverse events | Anticipated adverse events include: Puncture site-related events Renal artery stenosis, aneurysm, dissection, or perforation Renal infarction, acute kidney injury, or renal failure Arterial and venous thromboembolic events (including myocardial infarction, stroke, aortic or peripheral artery disease, etc.) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ambulatory blood pressure |  | 12 months | 
| Change from baseline in anti-hypertensive medication intake |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Blood pressure, Renal denervation
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the preventive effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).

Official Title
-----------------
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women (RUTI) in Post-menopausal Women With Signs of Urogenital Ageing (UGA)

Conditions
-----------------
Menopause, Urinary Infections

Intervention / Treatment
-----------------
* Drug: estradiol, 25 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal woman with Urogenital ageing (UGA) Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months Exclusion Criteria: Known or suspected allergy to trial product or related products Present UTI History of RUTI during fertile period of life
Sexes Eligible for Study
-----------------
Female

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: estradiol, 25 mcg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first symptom of urinary tract infection (UTI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of urinary tract infection (UTI) |  | During the 12 months of treatment |
Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum

Study Overview
=================
Brief Summary
-----------------
This study is intended to be an evaluation of the properties of human sputum collected from patients with COPD. It is hypothesized that cationic airway lining modulators will have beneficial effects on the rheological properties of sputum derived from patients with COPD. Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be collected and tested in laboratory tests.

Official Title
-----------------
Determination of the in Vitro Effects of CALM on COPD Sputum

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and spirometric diagnosis of COPD Smoking history of at least 10 pack yrs Sputum production of greater than 2 tablespoons per day by patient report. Exclusion Criteria: a primary diagnosis of asthma or bronchiectasis a COPD exacerbation within 4 weeks Inability to comply with study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 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
-----------------
Sputum, chronic obstructive pulmonary disease
Muscle Mass and Nutritional Risk in Older Adults

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the COAST (comprehensive older adult screening tool) to muscle mass as determined by BIA (bioelectric impedance analysis) and thus, determine if the COAST is a valid predictor of muscle loss in older adults. This study follows a comparison of COAST to MNA and will further test the validity of the COAST nutrition screening tool.

Detailed Description
-----------------
The association between muscle mass, as determined by BIA (bioelectric impedance analysis), and the recently developed COAST (Comprehensive Older Adult Screening Tool) has not been studied. Therefore, the main objective of this study is to test the correlations between muscle mass, measured by BIA, and COAST. The population to be studied will be older adults (n=150). Participants will be included if they are 60 years or older, willing to have weight, height, handgrip and body composition measured, willing to provided demographic information and answer questions related to their nutritional and health status. Individuals will be excluded if they have had recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device. Participants will be recruited from community groups in Florida. Participants muscle mass will be measured using BIA. Also, their handgrip strength will be tested using a dynamometer. Weight and height will be measured and demographic information will be collected. In addition, the participants will be given COAST (5 questions related to their nutritional and health status). The associations among BIA, handgrip strength and the COAST will be analyzed.

Official Title
-----------------
The Association Between Muscle Mass and Nutritional Risk by COAST in Older Adults

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 -100 years of age willing to weight, height, handgrip and body composition measured, willing to provide demographic information and answer questions related to their nutritional and health status Exclusion Criteria: recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COAST (Comprehensive Older Adult Screening Tool) score | Ability of the COAST score to predict depleted muscle mass. A five question survey, scored from 0 to 8 points; 8 being the maximum score. | baseline only |
Regulation of Sterol Homeostasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how people with high triglycerides metabolize and absorb bile acids, compounds made in the body from cholesterol. This project has two objectives: A) To define the mechanism of impaired bile acid absorption in hypertriglyceridemia (specifically we will determine if the active or passive component of absorption is abnormal) and B) to determine the contribution of an alternative pathway of bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase is present in endothelial cells as well as liver, this pathway may play a role in removal of cholesterol from incipient atherosclerotic plaque.

Official Title
-----------------
Regulation of Sterol Homeostasis

Conditions
-----------------
Hypertriglyceridemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Hypertriglyceridemia and normal controls with normal lipids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
-----------------
triglyceride, bile acids, cholelithias
Salt Sensitivity, Cardiovascular and Metabolic Disease

Study Overview
=================
Brief Summary
-----------------
To identify the role of salt-sensitivity of blood pressure in the pathogenesis of hypertension.

Detailed Description
-----------------
DESIGN NARRATIVE: Approximately 498 of 750 normal and hypertensive subjects who were carefully characterized in terms of blood pressure response to salt loading and depletion in the late 1970s were re-examined to identify physiological factors contributing to salt-sensitivity of blood pressure. This helped to confirm preliminary observations suggesting that salt sensitivity in normotensive subjects predicted the subsequent development of hypertension with aging. In addition, longitudinal observations in hypertensive patients and in normotensives helped to determine whether salt-sensitivity or salt-resistance of blood pressure were associated with differences in the risk for development of specific forms of cardiovascular disease (stroke, angina, myocardial infarction, congestive heart failure), renal and metabolic (diabetes mellitus) disorders.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Angina Pectoris, Cerebrovascular Accident, Myocardial Infarction, Diabetes Mellitus, Heart Failure, Congestive, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for subject with non small cell lung cancer.

Official Title
-----------------
A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small-Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: Cetuximab + Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with advanced or metastatic non small cell lung cancer. Subjects should have had at least one prior chemotherapy with a platinum based therapy. Exclusion Criteria: Subjects are excluded from this study if they do not have non small cell lung cancer that is advanced or metastatic or have not had at least one prior platinum based chemotherapy.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Cetuximab + Gefitinib<br>* IV solution + tablet, IV + oral, ERB (100 mg/m2, 200 mg/m2 + 250 mg/m2 IV) +GEF 250 mg tablet, ERB weekly/ GEF once daily, Until disease progression.<br>* Other names: Erbitux;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe and effective dose of combination of Erbitux and Iressa therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response will be measured by radiographic measurement of disease every 4 weeks. |  |  |