linjc16/ctgov huggingface dataset:
Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

Study Overview
=================
Brief Summary
-----------------
Collect DNA from well-characterized healthy volunteers.

Detailed Description
-----------------
DNA and plasma will be used to identify and determine allele frequencies of genetic variants in membrane transporters and other genes relevant to human disease or drug response, including drug metabolizing enzymes, collagen, race/ethnicity, neurovascular disease, asthma/allergy/lung disease, and cardiovascular disease. This phase of the study will serve as the hypothesis-generating phase for future studies by identifying genetic variants and determining allele frequencies among an ethnically diverse cohort of healthy volunteers. Future investigations (separate IRB applications) will attempt to correlate genotypes to phenotypes among this cohort of volunteers. The allele identification and frequency data from this group of healthy volunteers will also be used to design association studies in relevant disease populations. Determine if identified sequence variants are associated with gain or loss of in vitro biologic function using lymphocytes obtained from patients.

Official Title
-----------------
Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

Conditions
-----------------
Focus Groups

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult subjects of both genders and specified ethnic groups Subjects must be between 18-40 years of age Exclusion Criteria: Smokers Drink > 2 alcoholic beverages/day Take any chronic medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| African American<br>Must self identify as African American with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications. | |
| Cuacasian<br>Must self identify as Caucasian with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications. | |
| Hispanic<br>Must self identify as Hispanic with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications. | |
| Asian<br>Must self identify as Asian with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Control | Amass a cohort of healthy controls to be used for future genotype to phenotype studies. | On-going | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Cohort
Ketamine in Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Ketamine may improve recovery from bariatric surgery.

Official Title
-----------------
Effects of Ketamine on Recovery From Bariatric Surgery

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Drug: ketamine
* Drug: fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 obesity (Body Mass Index > 30) ASA classificazion < 4 candidate to bariatric surgery Exclusion Criteria: known or presumed pregnancy previous surgery on the airway, esophagus or stomach uncontrolled psychiatric symptomatology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine<br>patients will receive ketamine at induction | Drug: ketamine<br> <br> |
| Active Comparator: fentanyl<br>patients will receive fentanyl at induction | Drug: fentanyl<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain level |  | postoperatively, up to 3 months | 
| mood level |  | postoperatively, up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dosages of analgesic and muscle relaxant drugs |  | postoperatively, up to 3 months | 
| postanesthetic recovery |  | postoperatively, up to 24 hours | 
| satisfaction of the patient and of the surgeon |  | day 1 | 
| pulse oximetry saturation |  | postoperatively, up to 24 hours | 
| lung volumes |  | postoperatively, up to 48 hours from end of surgery | 
| antihemetic drug dosage |  | postoperatively, up to 24 hours | 
| vasoactive drugs |  | intraoperatively and up to 24 hours from surgery end | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, mood, depression, respiration
Preventing Youth Soccer Injury

Study Overview
=================
Brief Summary
-----------------
A study is proposed to test whether adding additional referees to youth soccer matches may reduce the risk of injury to the children playing soccer. Publicly-open youth soccer games will be randomly assigned to have either one or three referees and videotaped. The videotaped games will then be watched to record risk-taking behavior by players, referee decisions, and other factors relevant to potential injury.

Official Title
-----------------
Preventing Youth Soccer Injury

Conditions
-----------------
Injuries, Sports Injury, Sports Injuries in Children

Intervention / Treatment
-----------------
* Behavioral: 3 referees present
* Other: 1 referee present


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unit of measurement was youth soccer teams playing in Birmingham, Alabama area league Exclusion Criteria: teams serving children under age 9 or over age 11

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 referees<br>Three referees were present on the field during these youth soccer matches. | Behavioral: 3 referees present<br>* We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.<br>|
| Active Comparator: 1 referee<br>One referee was present on the field during these youth soccer matches. | Other: 1 referee present<br>* We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Injuries During Soccer Matches | average number of injury events requiring player to leave the field or be attended by an adult, across all games in study | baseline through one hour, which is beginning of the game until the end of the game, averaged across games | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
youth soccer injury
Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients. A prospective, observational, multicenter study (ANTHICUS).

Official Title
-----------------
Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients. A Prospective, Observational, Multicenter Study (ANTHICUS)

Conditions
-----------------
Infection in ICU

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hospital-acquired infections and hospitalised in the ICU at one moment of their hospital stay Hospital-acquired infections accounting for eligibility are: nosocomial pneumonia (including ventilator-associated pneumonia) bacteremia intra-abdominal infections urosepsis

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of appropriate antibiotic therapy (defined as the use of antibiotic(s) with in vitro efficacy against the identified pathogens responsible for the infection) |  |  | 
| the frequency of the strategy of de-escalation according to the culture results |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic, ICU, hospital acquired infection.
Biofilm Correlation and Validation

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.

Official Title
-----------------
A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds

Conditions
-----------------
Wound Infection

Intervention / Treatment
-----------------
* Device: MolecuLight DX Imaging Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with acute or chronic wounds 18 years or older Willing to consent Exclusion Criteria: Treatment with an investigational drug within 1 month of enrolment Any contra-indication to regular wound care Inability or unwillingness to consent

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 |
| --- | --- |
| ARM 1<br>Patients with negative clinical suspicion of Biofilm containing wounds(CSB-). | Device: MolecuLight DX Imaging Device<br>* The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.<br>|
| ARM 2<br>Patients with positive clinical suspicion of Biofilm containing wounds(CSB+) | Device: MolecuLight DX Imaging Device<br>* The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load |  | 3 months |
COhort Study on A/H1N1 FLU During PREGnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the mother and her child and to identify the determinants in pregnant women during pandemic period in three public maternities in Paris, France.

Official Title
-----------------
Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women

Conditions
-----------------
Influenza, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Pregnancy between 12 and 35 weeks of gestation, going in one of the following maternity cares: Port Royal, Necker, Saint Vincent de Paul Provides written informed consent Speaks and understands French Covered by French Social Security Exclusion Criteria: Not covered by French Social Security Previous H1N1 influenza (virologically documented)

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

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

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 |
| --- | --- | --- |
| Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Flu vaccine |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pandemic, A/H1N1, pregnancy, cohort, vaccine, Influenza and Pregnancy
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The study was designed to test the hypothesis whether a standardized, time-and score-oriented treatment following a strict evidence based algorithm is equally effective to a standard treatment regimen for moderate to severe atopic dermatitis. Study Type: Mono-centre study, patients are blinded, physicians are randomized to either treat study- or controll group Eligible are patients age 2 years or older with SCORAD >= 20 Duration: 12 Months, study visits every 4 weeks. Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment. Secundary endpoints are quality of life, safety and economic burden in both treatment groups.

Official Title
-----------------
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis

Conditions
-----------------
Moderate to Severe Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Pimecrolimus
* Drug: Tacrolimus
* Drug: Prednisolone
* Drug: Ciclosporin A
* Drug: Dermatop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe atopic dermatitis (SCORAD 20 or more) fulfilling the diagnostic criteria by Raika and Hanifin Exclusion Criteria: Pregnancy Nursing Women in childbearing age without contraception Drug - and or alcohol abuse Gene defects that are associated with increased light sensibility, e.g. Xeroderma pigmentosum, Cockayne Syndrome, Bloom Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pimecrolimus|nan|
|Drug: Tacrolimus|nan|
|Drug: Prednisolone|nan|
|Drug: Ciclosporin A|nan|
|Drug: Dermatop|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
-----------------
atopic dermatitis, atopy
Hip Fracture and Patent Foramen Ovale

Study Overview
=================
Brief Summary
-----------------
Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin. A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain. The hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.

Official Title
-----------------
Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Device: Transthoracic echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hip fracture requiring a surgical procedure Exclusion Criteria: simultaneous other traumatic lesion

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: detection of a patent foramen ovale<br> | Device: Transthoracic echocardiography<br>* A transthoracic echocardiography is performed to discover a patent foramen ovale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative complications probably related to the presence of a patent foramen ovale | Complications probably related to the presence of a patent foramen ovale | First postoperative week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale | Complications probably not related to the presence of a patent foramen ovale | First postoperative week | 
| Number of days before walking without help |  | One year | 
| Number of days at home during the first postoperative year | Number of days of stay at home | one year | 
| Mortality |  | Three months and one year |
Longitudinal Pancreatic Cancer Study

Study Overview
=================
Brief Summary
-----------------
To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of pancreatic cancer.

Detailed Description
-----------------
The study objectives are described below: Obtain serum and plasma specimens longitudinally collected from approximately 140 subjects diagnosed with pancreatic cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently under development, as an aid for monitoring recurrence or progressive disease. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 19-9 assays, for monitoring the course of disease and therapy in subjects diagnosed with pancreatic cancer.

Official Title
-----------------
A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients With Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Other: CA 19-9 Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, age≥ 18 years Histologic/pathologic confirmation of exocrine pancreatic cancer Any stage of disease: Newly diagnosed, stable, disease progression Any treatment time point: Treatment naïve, currently receiving or completed therapy for pancreatic cancer including active monitoring. Individuals with a history of malignant disease other than pancreatic cancer that was resected greater than 5 years ago and are currently in remission are eligible. Life expectancy greater than 6 months Able to understand and willing to provide informed consent Exclusion Criteria: Males and females, age <18 years No histologic/pathologic confirmation of exocrine pancreatic cancer Life expectancy less than 6 months Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ cervical cancer. Unable to provide informed consent

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

| Intervention/Treatment |
| --- |
|Other: CA 19-9 Assay|Physicians use the CA 19-9 test results to manage their patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer |  | 3 years |