linjc16/ctgov huggingface dataset:
Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987516)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: BAY987516<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987516)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-66_R84-088)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Correlation of Arterial and Venous Lactate and Base Deficit Values

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population.

Conditions
-----------------
Arterial Access, Peripheral Access, Central Venous Catheter

Intervention / Treatment
-----------------
* Device: bedside point-of-care device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included. Exclusion Criteria: Patients who not require arterial access.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arterial blood sample<br>0.5 mL blood sample from arterial line which is clinically indicated | Device: bedside point-of-care device<br>* A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.<br>|
| peripheral venous blood sample<br>0.5 mL blood sample drawn simultaneously with arterial sample from clinically indicated peripheral line | Device: bedside point-of-care device<br>* A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate blood value | blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the lactate value will be assessed by using a bedside point-of-care device, called i-stat. | During surgery- approximately 15-20 minutes after induction in the operating room (OR) | 
| base deficit blood value | blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the base deficit blood value will be assessed by using a bedside point-of-care device, called i-stat. | During surgery- approximately 15-20 minutes after induction in the operating room (OR) | 
| pH blood value | blood will be drawn from peripheral venous line, arterial line, and/or central venous line then pH blood value will be assessed by using a bedside point-of-care device, called i-stat. | During surgery- approximately 15-20 minutes after induction in the operating room (OR) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pH, base deficit, lactate values, venous blood samples, arterial blood samples
Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

Study Overview
=================
Brief Summary
-----------------
Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention that may e instituted during the course of the critical illness.

Detailed Description
-----------------
Fulminant hepatic failure (FHF) is often complicated by cerebral edema, high intracranial pressure (ICP) and brain death. Accordingly the intracranial pressure is often monitored in such patients in order to be able to institute treatment before high ICP evolves. As routinely done in patients with severe head injury a microdialysis monitoring catheter is also placed under this procedure to measure metabolic changes that are responsible for surges of high ICP. The aim in this descriptive protocol is to determine if a rise in glutamate, lactate and pyruvate concentration in the brain cortex are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention during the course of the critical illness.

Official Title
-----------------
Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

Conditions
-----------------
Fulminant Hepatic Failure

Intervention / Treatment
-----------------
* Procedure: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with fulminant hepatic failure Exclusion Criteria: Age below 18 years Pregnancy Not obtained informed consent Suspicion of cancer disease No pupil reaction to light

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| liver<br>patients with acute liver failure | Procedure: no intervention<br>* the value of the clinical use of microdialysis monitoring of the brain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain lactate concentration and intracranial hypertension | to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure | 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ammonia, acute liver failure, brain edema, oxidative metabolism, intracranial pressure
Assessment of Esophageal Motility With Transnasal Endoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry.

Detailed Description
-----------------
Esophageal manometry is a gold standard for diagnosis of esophageal motility disorder. However, esophageal manometry can not detect non-occulsive contraction. Endoscopic evaulation of esophageal motility is difficult becausea swallowing is nearly impossible during endoscopy. Simplified trans nasal endoscopy (E.G. ScanTM, IntroMedic Co.,Ltd.)composed with dysplay system,controller,and disposable probe with compact size. The esophageal motor function will be assessed with both esophageal manometry and simplifed trnasnasal endoscopy in patients with esophageal motility disorder (such as achalasia) and healthy volunteer. The results of simplifed trnasnasal endoscopy is compared with the results of esophageal manometry.

Conditions
-----------------
Esophageal Motility Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Healthy volunteer without organic esophageal or gastric disorder 2) Patients knwon esophageal motility disorder (such as achalasia) Exclusion Criteria: severe organic esophageal disorder including severe reflux esophagitis, stricture, and bleeding. previous opertion of esophagus or stomach GI bleeding, mechanical obstruction medication which can infulence GI motility

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Transnasal endoscopy<br>Healthy volunteers and patients with esophageal motor symptom will be enrolled and esophageal motility assessed by transnasal endoscopy according to clinical and manometric diagnosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of endoscopic diagnosis of esophageal motor function with manometry |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort of simplifed transnasal endoscopy compared with esophageal manomerty estimated by the patietns |  | one day |
Cardiac complicAtions in Patients With SARS Corona vIrus 2 (COVID-19) regisTrY

Study Overview
=================
Brief Summary
-----------------
CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.

Detailed Description
-----------------
The aim of CAPACITY is to collect data regarding the cardiovascular history, diagnostic information and occurrence of cardiovascular complications in COVID-19 patients. By collecting this information in a standardized manner, CAPACITY can aid in providing more insight in (1) the incidence of cardiovascular complications in patients with COVID-19, and (2) the vulnerability and clinical course of COVID-19 in patients with an underlying cardiovascular disease. The CAPACITY extension to the ISARIC-WHO CRF consists of additional data collection instruments for: cardiac history and cardiovascular risk factors prior use of cardiac medication or NSAIDs electrocardiography (ECG) echocardiography cardiac MRI invasive cardiac procedures cardiac complications cardiac biomarkers cardiac outcome during admission

Official Title
-----------------
Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY

Conditions
-----------------
COVID-19; Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Highly suspected/confirmed infection with SARS-CoV-2 Exclusion Criteria: - Patients that opt-out

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 |
| --- | --- | --- |
| The incidence of cardiovascular complications in patients with COVID-19 |  | 30 days |
Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection

Study Overview
=================
Brief Summary
-----------------
Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors

Conditions
-----------------
Diabetic Macular Edema, Vitreomacular Interface, Anti-VEGF Treatment

Intervention / Treatment
-----------------
* Drug: Intravitreal Ranibizumab injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic macular edema treatable with antiangiogenic drugs Exclusion Criteria: age under 18 cardiovascular events during the last year previous vitrectomy previous macular edema treatment during the last 4 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Non-PVD subjects<br>Patients with no PVD on SD-OCT at basal visit | Drug: Intravitreal Ranibizumab injection<br> <br> |
| PVD subjects<br>Patients with PVD on SD-OCT at basal visit | Drug: Intravitreal Ranibizumab injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best-corrected visual acuity |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central macular thickness |  | One year | 
| Number of ranibizumab injections |  | One year |
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.

Official Title
-----------------
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Drug: Cisplatin
* Drug: Doxorubicin
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient who have undergone a definitive surgical resection as their primary surgery are still eligible for participation in this study. No prior chemotherapy or radiation therapy Adequate renal function: creatinine < or = to 1.5 upper limit of normal Adequate liver function as defined by bilirubin < or = to 1.5 X upper limit of normal and AST < or = to 3 X upper limit of normal institutional range Adequate hematopoietic function as defined by platelet count > or = to 100,000/ram3 an absolute neutrophil count > or = to 1,000/mm3. Adequate cardiac function as defined by shortening fraction > or = to 28% by echocardiogram OR ejection fraction > or = to 50% by radionuclide angiogram Performance status < or = to 2 Exclusion Criteria: Prior history of cancer Prior treatment for cancer Prior history of Paget's disease Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic cardiac conduction abnormalities Pregnancy or breast feeding
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> | Drug: Cisplatin<br>* Cisplatin 120 mg/m^2<br>Drug: Doxorubicin<br>* 75mg/m^2<br>Drug: Methotrexate<br>* Methotrexate 12g/m^2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Response | to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST). | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cisplatin, Doxorubicin, Methotrexate, Osteosarcoma, 03-074
Comparing a Horizontal Ultrasound Technique With a Palpation Technique for Localising the Cricothyroid Membrane

Study Overview
=================
Brief Summary
-----------------
The investigators will be comparing a traditional palpation (feeling) technique with an ultrasound technique for finding a specific part of the neck.

Detailed Description
-----------------
This study compares a traditional palpation (feeling) technique with an ultrasound technique for finding a specific part of the neck. Finding this part of the neck is important for anesthesiologists in emergencies and can sometimes be difficult. We would like to determine if using ultrasound is easier and more reliable than examining the neck by hand. Newer methods using ultrasound have not been studied in detail in the pregnant population. This study aims to describe a simple technique for identifying the cricothyroid membrane. The secondary aim is to determine how ultrasound compares to palpation in pregnant women at term.

Official Title
-----------------
A Descriptive Study Comparing a Horizontal Ultrasound Technique With a Palpation Technique for Localising the Cricothyroid Membrane in an Obstetric Population.

Conditions
-----------------
Airway Identification

Intervention / Treatment
-----------------
* Other: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term pregnancy 19yrs and older Exclusion Criteria: preterm pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palpating neck<br>Subjects will have their neck palpated by an anesthesiologist to locate their cricothyroid membrane | Other: ultrasound<br>* subjects' neck will be scanned using ultrasound<br>|
| Experimental: Ultrasound neck<br>Subjects will have their neck scanned with ultrasound by an anesthesiologist to locate their cricothyroid membrane | Other: ultrasound<br>* subjects' neck will be scanned using ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway localization | Subjects necks' will be palpated and then scanned using ultrasound | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cricothyroid membrane, ultrasound
Fatigue and Cognitive Demand With Aging

Study Overview
=================
Brief Summary
-----------------
This study will determine the influence of a cognitive task performed during fatiguing contractions.

Detailed Description
-----------------
Individuals will participate in one familiarization session followed by 3 randomized experimental sessions (crossover design).

Official Title
-----------------
Fatigue and Cognitive Demand With Aging

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Behavioral: cognitive task


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals aged between 18-35 and 65-90 Exclusion Criteria: Metal implants or joint replacement. neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: young men<br>Individuals will participate in 1 familiarization and 3 test sessions | Behavioral: cognitive task<br>* cognitive task<br>|
| Experimental: young women<br>Individuals will participate in 1 familiarization and 3 test sessions | Behavioral: cognitive task<br>* cognitive task<br>|
| Experimental: older men<br>Individuals will participate in 1 familiarization and 3 test sessions | Behavioral: cognitive task<br>* cognitive task<br>|
| Experimental: older women<br>Individuals will participate in 1 familiarization and 3 test sessions | Behavioral: cognitive task<br>* cognitive task<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| force | Change in force of the arm muscles will be evaluated with a custom made device during each test session | Each session will take approximately 2-3 hours (total of 4 test sessions) | 
| anxiety levels | changes in anxiety levels quantified with a questionnaire | Each session will take approximately 2-3 hours (total of 4 test sessions | 
| arterial pressure | changes in arterial pressure will be quantified with a non-invasive device (finometer) | Each session will take approximately 2-3 hours (total of 4 test sessions | 
| fatigue | changes in fatigue will be assessed with questionnaires | Each session will take approximately 2-3 hours (total of 4 test sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sex difference, aging