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 (UVAPF) Minimal Persistent Pigment - Darkening Dose (MPPD)

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(Self History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form An unambiguous MED (Minimal Erythema Dose) 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 number - SR15-61-Z15-034).<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 |
Evaluation of Heparin Rebound in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Recent work has shown that heparin rebound is common after cardiac surgery. The exact doze of protamine required to neutralize heparin at the end of CPB is unknown. Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also unknown if precise titration of protamine perioperatively in cardiac surgery can influence transfusion requirements after cardiac surgery.

Detailed Description
-----------------
This study will assess how much protamine is required to neutralize residual heparin perioperatively in cardiac surgery through measurement of functional assays of heparin (anti-Xa and anti-IIa levels). In the first phase of this study, protamine titration assays will be carried out on normal pooled plasma incubated with heparin in the laboratory. Once the correct dose of protamine required to neutralize the heparin is established in the laboratory, the second phase will begin. Herein, plasma samples from patients undergoing cardiac surgery (with anticoagulation with two different commercial preparations of heparin) will be evaluated for residual heparin (Anti-Xa and anti-IIa levels). Protamine titration assays wil then be carried out in vitro to assess neutralization of heparin.

Official Title
-----------------
Evaluation of Heparin Rebound in Cardiac Surgery

Conditions
-----------------
Coagulation Delay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Written consent Scheduled for cardiac surgery under CPB (cardiopulmonary bypass)--(elective or emergency) 10 patients undergoing cardiac surgery where CPB time is anticipated to be short (isolated primary CABG (coronary artery bypass graft);isolated mitral-valve repair or aortic-valve replacement) 10 patients undergoing cardiac surgery where CPB time is anticipated to be longer (CABG + valve surgery combined; reoperations) Exclusion Criteria: Known coagulopathies Liver dysfunction Patients receiving unfractionated or low molecular weight heparin thrombin inhibitors, warfarin, antiplatelets within the past 7 days Patients expected to undergo hypothermic CPB or circulatory arrest

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?
-----------------
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
-----------------
heparin rebound, protamine, cardiopulmonary bypass, cardiac surgery, anti-Xa, anti-IIa
Computer Aided Evaluation of Orbital Volume

Study Overview
=================
Brief Summary
-----------------
A retrospective review to assess the performance and clinical predictive value of a novel software program (Maxillo) designed to perform complex volumetric analysis with application in the field of orbital trauma.

Detailed Description
-----------------
The concept of open reduction and internal fixation of large and complex traumatic orbital deformities is well established. It is known that successful orbital reconstruction hinges upon restoration of native orbital volume in order to establish pre-morbid function and avoid long-term complications. To date, a facile, reliable, and reproducible method to measure orbital volume has not been rendered, despite numerous approaches. The objective of this study is to assess the performance and clinical predictive value of a novel software program designed to perform complex volumetric analysis with application in the field of orbital trauma.

Official Title
-----------------
Computer Aided Evaluation of Orbital Volume

Conditions
-----------------
Orbital Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chart reviews of patients at UCDMC with orbital trauma and having operative repair of the orbital fractures with post-reduction imaging included. Exclusion Criteria: Absences of post-operative imaging

Ages Eligible for Study
-----------------
Minimum Age: 3 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
-----------------
orbital fractures
Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

Study Overview
=================
Brief Summary
-----------------
This study will measure plasma concentrations of piperacillin-tazobactam and cefazolin in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to better understand the pharmacokinetics of these medications in this in vivo setting.

Official Title
-----------------
Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

Conditions
-----------------
Drug Effect

Intervention / Treatment
-----------------
* Drug: piperacillin-tazobactam
* Drug: Cefazolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: supported on ECMO receive piperacillin-tazobactam or cefazolin as part of routine care or infection management Exclusion Criteria: >= 18 years No Consent provided

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Pediatric patients supported on ECMO<br> | Drug: piperacillin-tazobactam<br>* Administered for infection treatment or prophylaxis per hospital protocol<br>Drug: Cefazolin<br>* Administered for infection treatment or prophylaxis per hospital protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration: piperacillin-tazobactam | Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation. | Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks. | 
| Plasma concentration: cefazolin | Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation. | Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks. |
Colon Cancer Prevention Using Selenium

Study Overview
=================
Brief Summary
-----------------
Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The investigators will directly assess selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an accepted surrogate marker for CRC. ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases. The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether selenized yeast supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number

Conditions
-----------------
Prevention of Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Selenium, selenomethionine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All non-pregnant patients >50 years of age Exclusion Criteria: The following will be specifically looked for, and result in patients not being eligible for study enrollment: Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry. History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern). Intake of any selenium supplements within 60 days of study entry, including vitamins. Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia).

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selenium, selenomethionine<br> | Drug: Selenium, selenomethionine<br>* Patients will receive one 200 ug pill of Selenomethionine<br>|
| Active Comparator: placebo<br> | Drug: placebo<br>* Patients will be given one 200 ug placebo pill each day for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in ACF biomarkers |  | 6 months |
A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects

Study Overview
=================
Brief Summary
-----------------
This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.

Official Title
-----------------
Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: A Case Series

Conditions
-----------------
Tibia Fracture, Humerus Fracture, Femoral Fracture, Long Bone Segmental Defect

Intervention / Treatment
-----------------
* Procedure: TRUMATCH Graft Cage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Humerus, femur, or tibia segmental defects requiring surgery Evaluation and treatment at UCSD Ages 18 year and older Abiltiy to understand the content of the patient information/informed consent form Exclusion Criteria: Any not medically managed severe systemic disease Their doctor has decided that it is in the patient's best interest to receive a different method of repair Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it Prisoner Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: TRUMATCH Graft Cage|TRUMATCH Graft Cage for surgical repair of segmental long bone defect|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of the TRUMATCH Graft Cage- Long Bone |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Rates |  | 2 years | 
| Reoperation Rates |  | 2 years | 
| Complications |  | 2 years | 
| Pain Scores |  | 2 years | 
| Time to Return to Normal Activity |  | 2 years |
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in the Treatment of Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Ketotifen with a Contact Lens (no generic name)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees withing the past 24 months Successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more Exclusion Criteria: Active ocular infection Clinically significant blepharitis Follicular conjunctivitis Pterygium Narrow angle glaucoma Dry eye dyndrome Ocular surgery within past 6 months Pregnancy or lactation

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketotifen with a Contact Lens (no generic name)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival, ciliary, and episcieral redness; chemosis and mucous discharge; tearing and lid swelling |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic conjunctivitis, ophthalmology, multicenter, controlled
Motorised Probe Holder Assisting Prostate Biopsies

Study Overview
=================
Brief Summary
-----------------
Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.

Official Title
-----------------
Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Biopsies using Apollo and UroStation®
* Procedure: Biopsies using UroStation® (image fusion)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: of-age patient patient for whom a prostate biopsies session is planned patient affiliated to the social security or equivalent patient having a target identified on MRI Written informed consent Exclusion Criteria: contraindication patient wearing a mechatronic device patient concerned by the L1121-6 à 8 of the health public code

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With motorised probe handler<br>The surgeon use the motorised probe handler to do the biopsy | Device: Biopsies using Apollo and UroStation®<br>* Apollo : Motorised probe handler for prostate biopsies<br>Procedure: Biopsies using UroStation® (image fusion)<br> <br> |
| Experimental: Without motorised probe handler<br>The surgeon do the biopsy as he usually do. | Procedure: Biopsies using UroStation® (image fusion)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance between virtual and effective biopsy, in the two arms |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate |  | 8 months | 
| Probe holder positions error between virtual and effective biopsy |  | 8 months | 
| User satisfaction | biopsies session duration device manageability device unwiediness contribution of the lock of the probe set up, cleaning global satisfaction | 2 hours | 
| Safety Evaluation | number of time the device couldn't be started number of times the emergency button was pushed number of time the biopsy couldn't entirely be done using the device number of time the device protections had to be repositioned | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, cancer