linjc16/ctgov huggingface dataset:
Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.

Detailed Description
-----------------
A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.

Official Title
-----------------
Feasibility of Patient-specific Titanium Mesh Via A Transantral Approach for Repair of Orbital Floor Fractures.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unilateral orbital floor fractures indicated for surgical repair.
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 |
| --- | --- | --- |
| enophthamus | will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm | 6 months |
Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .

Official Title
-----------------
Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases

Conditions
-----------------
Case Report Form, Declaration Bias, Health Insurance Database

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: incident and prevalent cases of patients with type I or type II diabetes. arthritis: incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010). Renal failure : • incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not. Prostate cancer : • Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy). Breast cancer : • Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast). Colorectal cancer : • Incident cases of patients with colorectal cancer regardless of the stage at diagnosis (colonoscopy and polyp biopsy positive). Exclusion Criteria: - The subject participates in an experimental study of research affecting the therapeutic management of the patient. The subject is exclusion period determined by a previous study. The subject is under judicial protection, guardianship or curatorship. It is not possible to give informed about information The subject does not read French and is not autonomous filling a questionnaire. The patient has psychiatric disorders. The subject is an emergency. Monitoring between patient visits than 6 months.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of data collected in a patient diary and data stored in the database of health insurance |  | 6 month |
Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: AZD4877


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced solid tumors for which standard treatment doesn't exist or is no longer effective. Relatively good overall health other than your cancer. Exclusion Criteria: Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function.

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 |
| --- |
|Drug: AZD4877|intravenous infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment. |  | assessed at each treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment. |  | Assessed after the first course of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Solid Malignancies, Advanced solid tumors, Cancer, Phase I, Solid tumors, Solid malignancies
Neutrolin Versus Heparin for Locking Hemodialysis Catheters

Study Overview
=================
Brief Summary
-----------------
Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects. Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis. This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.

Official Title
-----------------
Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial

Conditions
-----------------
Hemodialysis Catheter Infection, Catheter Thrombosis

Intervention / Treatment
-----------------
* Drug: Heparin
* Device: Neutrolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New hemodialysis catheter Subject who will need chronic hemodialysis at least twice/week Subject likely to require for at least 120 days Subject or relative is likely to understand the nature of the study and sign the consent Age 18 years and older Exclusion Criteria: Subject with unstable malignancy Subject with liver cirrhosis with encephalopathy Subject know to have allergy to heparin, citrate or traoulidine Documented history of arterial thrombosis or known to have hypercoagulable state Subjects with active skin infections and ulcers

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: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multi-center, double-blind, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heparin group<br> | Drug: Heparin<br>* Heparin hemodialysis catheter lock solution<br>|
| Experimental: Neotrolin Group<br> | Device: Neutrolin<br>* Neutrolin hemodialysis catheter lock<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days) | Rate of hemodialysis catheter in each study arm | 18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of hemodialysis catheters with poor flow due to thrombosis | Rate of catheter dysfunction in each group | 18 month |
Preliminary Human Trial of NPI-028

Study Overview
=================
Brief Summary
-----------------
This research will determine whether the Chinese herbal medicine (NPI-028) can make a significant contribution to the management of withdrawal and to follow-up treatment aimed at preventing or managing relapse in both women and men alcoholics. The herbal preparation has been used historically in the treatment of alcohol intoxication and is still prescribed in China and Southeast Asia. Efficacy has been documented but awaits the application of current research methods to establish efficacy, safety, and probable mechanisms of action. Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and toxicological affects. The proposed human trial will develop a placebo, establish quality control, test methods of administration, and examine compliance issues. Following these preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80 subjects per treatment condition with 40 of each gender). Alcohol use, craving, health status, psychological status, and at rates will be assessed using established measures that are current in addiction research.

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: NPI-028


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to participate as an outpatient Considered of acceptable health as determined by physical examination English speaking/reading Meets DSM-IV criteria for Alcohol Dependence Have at least 10 drinking days in the past month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NPI-028|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis

Study Overview
=================
Brief Summary
-----------------
the efficacy of commercially available oregano essential oil mouthwash in the reduction of oral halitosis was compared to chlorhexidine and distilled water and the results showed significant reduction of organoleptic tongue and floss scores and BANA test scores compared to placebo

Detailed Description
-----------------
the results showed that oregawash showed a comparable effect to chx in reducing oral halitosis

Official Title
-----------------
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis :A Randomized Controlled Trial

Conditions
-----------------
Halitosis

Intervention / Treatment
-----------------
* Other: oregawash
* Other: corsodyl
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Organoleptic score was >2 at baseline. Participants between 18-23 years of age. The subjects had no systemic disease and were not taking antibiotics or receiving other antimicrobial therapy. The subjects did not receive the same time treatment for their halitosis. Exclusion Criteria: Smokers, alcoholics and drug addicts. Patients with periodontitis or pocket depth >6 mm. Patients taking drugs which induced xerostomia. Subjects consuming spicy food: garlic or onions two days before examination. Patients with orthodontic appliances or removable dentures. pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 23 Years

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

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

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: oregano<br>oregawash mouthwash was used twice times daily for 7 days | Other: oregawash<br>* mouthwash containing oregano essential oil<br>|
| Placebo Comparator: placebo<br>distilled water was used twice times daily for 7 days | Other: placebo<br>* distilled water<br>* Other names: distilled water;|
| Active Comparator: chlorhexidine<br>Corsodyl with 0.2%CHX mouthwash was used twice times daily for 7 days | Other: corsodyl<br>* 0.2% chlorhexidine mouthwash<br>* Other names: chlorhexdine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| organoleptic tongue and floss scores | organoleptic measuements | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BANA test | chair side BANA test | 9 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral halitosis, oregano essential oil, mouthwash
Antibacterial Activity of Urea Against Ocular Bacteria

Study Overview
=================
Brief Summary
-----------------
Antibacterial properties of urea was tested against 35 isolates from ocular infections.

Detailed Description
-----------------
In vitro susceptibility testing was performed with commercially available antibiotic discs, homemade urea discs saturated with urea solution at a concentration of 96 mmol. The weight of urea in one drop = 0.37 mg, in one ml = 10.34 mg (5 microliter/ disc) discs and combined discs (antibiotic discs to which urea solution was added). Combined discs provided better in vitro susceptibility results than antibiotics alone. Scanning electron micrographs of bacterial isolates incubated overnight with urea solution showed marked disruption of bacterial aggregative patterns and irregularities of their cell walls. Western blotting showed marked reduction in total proteins in bacterial isolates incubated overnight with urea solution. These findings may explain the possible mechanisms for antibacterial activity of urea solution as a result of protein denaturation.

Official Title
-----------------
In Vitro Evaluation of Antibacterial Activity of Urea Solution Against Ocular Bacterial Isolates

Conditions
-----------------
Urea in Blood; High

Intervention / Treatment
-----------------
* Biological: Antibacterial Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ocular infection Exclusion Criteria: Local antibiotics treatment

Ages Eligible for Study
-----------------
Minimum Age: 5 Months
Maximum Age: 65 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 |
| --- | --- |
| Antibacterial Activity of Urea<br>Activity of Urea Solution against Ocular Bacterial Isolates | Biological: Antibacterial Activity<br>* Antibacterial Activity of Urea Solution against Ocular Bacterial Isolates<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibacterial effect of Urea Solution against Ocular Bacterial | Samples were both inoculated on Muller Agar (Sigma-Aldrich) plates and directly examined under the microscope using Gram stained smears. Inoculated plates were incubated at 37oC for 48 hrs. Gram negative isolates were sub-cultured on MacConkey's, Eosin Methelyene Blue (EMB) and Cystine Lactose Electrolyte Deficient (CLED) agar plates (Sigma-Aldrich). Gram positive isolates were sub-cultured on Mannitol Salt agar plates (Sigma-Aldrich). | 6 month |
Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.

Conditions
-----------------
Intertrochanteric Fractures of the Hip

Intervention / Treatment
-----------------
* Device: gamma nail stryker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagozied with acute intertrochantric unstable fracture a minimum minimental score of 6 ability to walk 500 meters indepedently Exclusion Criteria: pathological fracture multiple fractures neurological conditions

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gamma nail, fracture stabilization, better walking<br> | Device: gamma nail stryker<br>* for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip function score | at the last clinical visit (1 year) the patient will perform hip score testing and record. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| x-ray, surgical outcome | in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record | 1 year |
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Study Overview
=================
Brief Summary
-----------------
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

Official Title
-----------------
Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

Conditions
-----------------
Abdominal Aortic Aneurysms, Iliac Aneurysms, Aorto-iliac Aneurysms

Intervention / Treatment
-----------------
* Device: Zenith(R) Low Profile AAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size Vessels suitable for endovascular access and aneurysm repair Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Unsuitable arterial anatomy

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 |
| --- | --- |
| Other: 1<br>Treatment with Endovascular Graft | Device: Zenith(R) Low Profile AAA Endovascular Graft<br>* The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Major Adverse Events (MAE) | MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation. | 30-day | 
| Patients With Device Failures | Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm. | 12-month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Profile, Abdominal Aortic Aneurysms, Endovascular
Confocal Endomicroscopy for GI Neoplasia Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard free-hand image acquisition.

Detailed Description
-----------------
The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia.

Official Title
-----------------
Confocal Endomicroscopy for GI Neoplasia Study

Conditions
-----------------
Colorectal Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study. Exclusion Criteria: Patients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Quality of the confocal image | Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts. | 1 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polyps, inflammatory bowel disease, associated neoplasia