linjc16/ctgov huggingface dataset:
An Open Label Study of a Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Non-Small Cell Lung Cancer.

Official Title
-----------------
An Open Label, Multi-center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Lung Neoplasm

Intervention / Treatment
-----------------
* Biological: EP2101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Non-Small Cell Lung Cancer, stage IIb or IIIa At least four weeks following prior standard treatment, with no evidence of disease Must use adequate birth control Exclusion Criteria: Prior cancer vaccine therapy or concurrent participation in any other investigational study A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine Women who are pregnant, intend to become pregnant, or who are breast feeding

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 |
| --- |
|Biological: EP2101|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
-----------------
vaccine, lung, cancer, Carcinoma, Large Cell, Non-Small-Cell Lung Carcinoma
Diagnosis of Transient Tachypnea of Newborn

Study Overview
=================
Brief Summary
-----------------
Transient tachypnea of the newborn (TTN) is the most common cause of respiratory distress in fullterm newborn. TTN is a diagnosis of exclusion, It is primarily diagnosed based on medical history and typical clinical presentation. Lung ultrasonography is an accurate, non invasive and reliable tool for diagnosing TTN. Cardiometry is presently the only tool to evaluate thoracic fluid content continuously and noninvasively at the bedside.

Official Title
-----------------
Thoracic Fluid Content Using Electrical Cardiometry Versus Lung Ultrasound in the Diagnosis of Transient Tachypnea of Newborn

Conditions
-----------------
Transient Tachypnea of the Newborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fifty newborns with gestational age ≥ 34 weeks (calculated from the first day of last menstrual period and using New Ballard score) diagnosed with TTN Exclusion Criteria: Gestational age less than 34 weeks. Major congenital abnormalities. Congenital heart diseases. Neonatal sepsis. Neonatal pneumonia. Other causes of respiratory distress (RD)

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 3 Days

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 |
| --- | --- | --- |
| change of thoracic fluid content | measured by electrical cardiometry ( ICON®; Osypka Medical, Berlin, Germany) | at enrollment and after 72 hours of birth | 
| change of ultrasound data: double-lung point, interstitial lung syndrome, and fuzziness of the pleural lines (A-lines) and pleural effusion. | using Siemens Acuson X300 ultrasound machine ( Siemens Health Care GmbH, Erlangen, Germany ) | at enrollment and after 72 hours of birth |
Gene Polymorphisms and Gene Products as Biological Markers of Aging and Correlation With Clinical Geriatric Assessment, Tolerance of Chemotherapy and Outcome in Elderly Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The goal is to study the biology of aging in breast cancer patients, and to study the impact of chemotherapy on aging related blood biomarkers.

Official Title
-----------------
Gene Polymorphisms and Gene Products as Biological Markers of Aging and Correlation With Clinical Geriatric Assessment, Tolerance of Chemotherapy and Outcome in Elderly Breast Cancer Patients.

Conditions
-----------------
Breast Cancer, Elderly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 70 years or older Female Early breast cancer Candidate for systemic adjuvant therapy

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>chemotherapy: elderly patients receiving 4x adjuvant taxotere cyclophosphamide adjuvant for breast cancer | |
| 2<br>adjuvant hormone therapy: 40 patients receiving adjuvant aromatase inhibitor without chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, elderly, biomarker
A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects with advanced solid tumors and to determine a phase 2 dose.

Official Title
-----------------
A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: HGS1029


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed advanced solid malignancy Life expectancy of at least 3 months Age 18 years or older Acceptable liver function Acceptable renal function Acceptable hematologic status Exclusion Criteria: Received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment. Received non-investigational agent within 3 weeks before enrollment. Progressive CNS involvement including the need of corticosteroids Pregnant or breast-feeding women Active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of Cycle 1 Day 1 Known HIV infection

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>HGS1029 | Drug: HGS1029<br>* Escalating doses by IV (in the vein), on days 1, 8 and 15 of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity<br>* Other names: AEG40826•2HCl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity |  | throughout the study |
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage

Detailed Description
-----------------
During pressure injuries formation early sub dermal bio signal appear. By applying infrared spectroscopy at a suspicions injury site on the human body and obtaining a reflected infrared light infrared allows to determine early formation of a pressure injury/

Official Title
-----------------
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device

Conditions
-----------------
Pressure Ulcer Not Visible

Intervention / Treatment
-----------------
* Device: Infrared spectroscopy (ODP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stage 1 pressure injury Patients with high risk of developing pressure injury Exclusion Criteria: Patients with stage 2 pressure injury or higher

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspected pressure injury<br>Patients evaluated with high-risk for pressure injury | Device: Infrared spectroscopy (ODP)<br>* Infrared spectroscopy device will be used to detect non-visible pressure injuries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early detection of pressure induced tissue damage | Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury | Ten minutes | 
| Pressure injury probability | Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days | Ten minutes |
Single Dose Pharmacokinetics of Egalet® Oxycodone

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® oxycodone formulations and compare to a marketed oxycodone product.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oxycodone hydrochloride
* Drug: Oxycodone hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: ≥18 years and ≤55 years Non-smoker BMI ≥18.0 and ≤30.0 Main exclusion criteria: Any clinically significant abnormality or abnormal laboratory test results found during medical screening History of allergic reactions to opioids or other related drugs History of significant alcohol abuse or drug abuse Use of any drugs known to inhibit hepatic drug metabolism Pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egalet® oxycodone Treatment A<br>Single Dose Administration | Drug: Oxycodone hydrochloride<br>* Extended release tablet<br>|
| Experimental: Egalet® oxycodone Treatment B<br>Single Dose Administration | Drug: Oxycodone hydrochloride<br>* Extended release tablet<br>|
| Experimental: Egalet® oxycodone Treatment C<br>Single Dose Administration | Drug: Oxycodone hydrochloride<br>* Extended release tablet<br>|
| Active Comparator: Active comparator<br>Single Dose Administration | Drug: Oxycodone hydrochloride<br>* Extended release tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24. |  | Single-dose evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring. |  | Single-dose evaluation |
Modeling Impaired Judgement in Cocaine Abusers - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is for the modeling of impaired judgement in cocaine abusers.

Detailed Description
-----------------
The objective of this study is to investigate recognition memory and appreciation of changing contingencies in relation to a response judgement.

Official Title
-----------------
Modeling Impaired Judgement in Cocaine Abusers

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Amantadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (3 groups)Normal, healthy controls. Recent cocaine experience. Over 6 months since the last cocaine experience. Exclusion Criteria: Psychosis or mood disorder. History of seizure, head trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Amantadine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Reslizumab in Chronic Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.

Official Title
-----------------
Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial

Conditions
-----------------
Sinusitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Willingness and ability to comply with the requirements of the study Female or male patients ages 18-75 at the time of screening A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery Elevated blood eosinophils Significant findings on computed tomography (CT) scan Exclusion Criteria: Unable to sign informed consent form A woman that is pregnant or nursing a child Known hypersensitivity to Reslizumab Active cigarette smoking in the year prior to screening Known underlying immunodeficiency History of alcohol or drug abuse in the year prior to screening Other criteria may apply. Please contact the investigator for more information

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reslizumab<br>Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg. | Drug: Reslizumab<br>* Reslizumab 3mg/kg intravenous (IV)<br>|
| Placebo Comparator: Placebo<br>Matching placebo. | Drug: Placebo<br>* Matching Placebo intravenous (IV)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in computed tomography (CT) score |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire |  | 24 weeks | 
| Smell test |  | 24 weeks | 
| Endoscopy score |  | 24 weeks | 
| Adverse events by body system |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sinusitis, rhinitis, rhinosinusitis, chronic
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home. Study hypothesis: The tampon self-test correspond to the routine cervical smear.

Official Title
-----------------
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

Conditions
-----------------
Uterine Cervical Dysplasia, Uterine Cervical Neoplasms

Intervention / Treatment
-----------------
* Procedure: Regular Tampax used in 3 hours


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with cervical dysplasia been referred to conisation or Women invited to cervical screening program Exclusion Criteria: Women not performing the tampon self-test before conisation or Women not performing the tampon self-test af least 1 month after receiving the tampon

Ages Eligible for Study
-----------------
Minimum Age: 23 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Regular Tampax used in 3 hours|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the tampon self-test |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The womens socio-demographic relations according to accept the tampon self-test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self test, PAP smear, tampon test, cervical dysplasia
Laparoscopic Measuring Device Study

Study Overview
=================
Brief Summary
-----------------
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.

Detailed Description
-----------------
In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued a recommendation stating that: Surgeons should measure and document the size of the hernia defect they are repairing. The total area encompassing all the defects should be measured, and surgeons should be familiar with internal and external measurement techniques for all hernia locations, as well as how to avoid common measurement errors. An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh. According to the SAGES recommendation: Overestimating the defect size will result in the choice of a larger prosthetic size, which may be more difficult to handle and may have more laxity, allowing it to bulge into the defect more than if it was placed taut. The difficulty in prosthetic handling may also lead to errors in fixation, and the prosthetic can more easily sway between fixation points, due to the larger dimensions. While a smaller mesh size can also be problematic: Underestimating the defect size may lead to choosing a prosthetic that is too small, thus increasing the risk of hernia recurrence. In order to aid surgeons in more accurately measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring device. This study aims to obtain feedback from surgeons on the usefulness and design of the device.

Official Title
-----------------
Laparoscopic Measuring Device Usability Study

Conditions
-----------------
Physician Feedback

Intervention / Treatment
-----------------
* Device: LMD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with hernia defect that requires laparoscopic measurement Exclusion Criteria: Minors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| LMD<br>Physician uses LMD during procedure. | Device: LMD<br>* Physician uses LMD to measure defect during procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Feedback | Physician forms opinion on usefulness and design of LMD | 6 months |