linjc16/ctgov huggingface dataset:
Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.

Official Title
-----------------
Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Procedure: Endoscopic lung volume reduction coil treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) < 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg) Informed consent Exclusion Criteria: Therapeutic anticoagulation Anti-platelet therapy exceeding the use of acetylsalicylic acid Severe pulmonary hypertension

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 |
| --- |
|Procedure: Endoscopic lung volume reduction coil treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in PaCO2 |  | 3 months after endoscopic lung volume reduction (ELVR) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in PaCO2 |  | 6 and 12 months after ELVR | 
| Changes in FEV1 |  | 3, 6 and 12 months after ELVR | 
| Changes in vital capacity |  | 3, 6 and 12 months after ELVR | 
| Changes in residual volume |  | 3, 6 and 12 months after ELVR | 
| Changes in 6-minute walk distance |  | 3, 6 and 12 months after ELVR | 
| Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ) |  | 3, 6 and 12 months after ELVR | 
| Changes in BMI |  | 3, 6 and 12 months after ELVR |
The Effects of Ultrasonic Noise Exposure on Human Hearing

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to investigate the effects of ultrasonic noise exposure on the human auditory system (how it effects hearing). Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research. A cohort of 20 audiometrically healthy volunteers will undergo pure tone audiometry (PTA); a standard test for hearing sensitivity, at both pre and post exposure to ultrasonic noise (40kHz for 15 min at 120 dB SPL). A subgroup of 10 subjects will be used as a control group. The resulting audiograms will establish the extent of any recoverable loss in hearing sensitivity known as temporary threshold shifts (TTS).

Official Title
-----------------
An Investigation of the Effects of Ultrasonic Noise Exposure on the Human Auditory System Via Pure Tone Audiometry (PTA) on Audiometrically Healthy Volunteers.

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Other: Ultrasonic noise exposure
* Diagnostic Test: Pure Tone Audiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, audiometrically healthy Exclusion Criteria: Underlying/pre-existing hearing impairment

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Noise Exposed Group<br> | Other: Ultrasonic noise exposure<br>* Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.<br>Diagnostic Test: Pure Tone Audiometry<br>* Participants will undergo 2 (pre and post exposure) hearing tests<br>|
| Placebo Comparator: Control Group<br> | Diagnostic Test: Pure Tone Audiometry<br>* Participants will undergo 2 (pre and post exposure) hearing tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporary Threshold Shifts (TTS) | Mild and recoverable hearing loss in sensitivity due to noise exposure will be checked for statistical significance using paired and independent t-test. | Audiometry will be conducted immediately (with 2 hours) from noise exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Hearing
Insertion of Different Supraglottic Airway Devices on Manikin

Study Overview
=================
Brief Summary
-----------------
When tracheal intubation and face mask ventilation fail, and the insertion of supraglottic airway devices (SHA) can provide ventilation, protecting the patient from hypoxemia. Supraglottic airway devices have become an important part of difficult airway algorithms. The European Resuscitation Council Guidelines recommend supraglottic airway devices for airway management by non-specialized healthcare providers. Education through simulators contributes to the development of students without direct contact with patients. In this study, it was aimed to compare the success of placement of four different supraglottic airway devices on the manikin of term 5 students who participate to the Anesthesiology and Reanimation internship.

Official Title
-----------------
Placement of Four Different Supraglottic Airway Devices by Medicine Faculty Students: A Manikin Study

Conditions
-----------------
Ventilation, Airway Management, Education

Intervention / Treatment
-----------------
* Device: Proseal Laryngeal Mask
* Device: Classic Laryngeal Mask
* Device: I-gel
* Device: Suprema Laryngeal Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Studying in medical school in term 5 To have completed anesthesiology and reanimation internship Exclusion Criteria: who do not want to participate in the study Students with previous experience with four airway devices

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Proseal Laryngeal Mask<br> | Device: Proseal Laryngeal Mask<br>* insertion of Proseal Laryngeal Mask<br>|
| Other: Classic Laryngeal Mask<br> | Device: Classic Laryngeal Mask<br>* insertion of Classic Laryngeal Mask<br>|
| Other: I-gel<br> | Device: I-gel<br>* insertion of I-gel<br>|
| Other: Suprema Laryngeal Mask<br> | Device: Suprema Laryngeal Mask<br>* insertion of Suprema Laryngeal Mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difficulty of attempts | pointing the difficulty of insertion from 0 to 100 | during insertion procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of attempts | time from insertion to ventilation | during insertion procedure | 
| number of attempts | number of attempts for successfull placement | during insertion procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airway management, Supraglottic airway devices, Manikin study, education
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.

Detailed Description
-----------------
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Official Title
-----------------
A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: PEP005 gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients at least 18 years of age. Post-menopausal female patients 4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand. Written informed consent has been obtained. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEP005 gel administration<br>0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand | Drug: PEP005 gel<br>* Two day application, 0.05%<br>* Other names: PEP005;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR) |  | 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions. |  | 57 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Topical, Actinic Keratosis, Dermatology, Hand
A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.

Official Title
-----------------
A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Ranpirnase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years ECOG less than 2 Estimated survival of greater than 12 weeks Exclusion Criteria: Prior systemic chemotherapy for locally advanced or metastatic NSCLC Use of any investigational agent within 28 days prior to registration Known hypersensitivity to any of the study drugs Brain metastases or leptomeningeal disease History of prior malignancy within the past three years

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranpirnase<br>All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase | Drug: Ranpirnase<br>* Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle<br>* Other names: Onconase;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy | 4 or more months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy | 2 years | 
| Survival | To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, NSCLC, Lung Cancer, Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
Ciprofloxacin on Burned Patients

Study Overview
=================
Brief Summary
-----------------
This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.

Official Title
-----------------
A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients

Conditions
-----------------
Burns, Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin (BAYO9867)
* Drug: Ciprofloxacin (BAYO9867)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model, Hospitalization for burning injury since at least 72h during hyper metabolic phase Active infections microbiological confirmed Signed informed consent Exclusion Criteria: Pregnant or lactating female patients Previous history of tendinopathy Knowing syndrome of QTc prolongation Impairment renal function Hepatic insufficiency Convulsion Limited life expectancy

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ciprofloxacin (BAYO9867)<br>* 400 mg iv BID<br>|
| Experimental: Arm 2<br> | Drug: Ciprofloxacin (BAYO9867)<br>* 400 mg iv TID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model |  | >72 h post injury, 48h and 120 h after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio |  | >72 h post injury, 48h and 120 h after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ciprofloxacin regimen in compromised patients, Ciprofloxacin, Burned patients
Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.

Detailed Description
-----------------
We want to compare arthrodesis of TMT 1 to temporary bridge plating of TMT 1 in acute Lisfranc injuries where at least tarsometatarsal joints 1-3 are involved. We preform arthrodesis of TMT 2 and 3 in both groups.

Official Title
-----------------
Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury

Conditions
-----------------
Lisfranc Injuries

Intervention / Treatment
-----------------
* Procedure: Temporary extraarticular plate fixation
* Procedure: Primary arthrodesis
* Procedure: Primary arthrodesis TMT 2 and 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and 3. No major fracture in relation to TMT1. Age 18-65 Exclusion Criteria: Feet with other major foot/ankle injuries Previous foot infection or foot pathology on affected side Previous surgery to the TMT joints Sequelae after previous foot injuries Diabetes mellitus, neuropathy and peripheral vascular disease

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary arthrodesis TMT 1<br>Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present | Procedure: Primary arthrodesis<br>* Primary arthrodesis<br>Procedure: Primary arthrodesis TMT 2 and 3<br>* Primary arthrodesis TMT 2 and 3 when instability is present<br>|
| Experimental: Temporary extraarticular plate fixation<br>Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present | Procedure: Temporary extraarticular plate fixation<br>* Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1<br>Procedure: Primary arthrodesis TMT 2 and 3<br>* Primary arthrodesis TMT 2 and 3 when instability is present<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS Midfoot scale | AOFAS Midfoot scale | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | SF-36 | 2 years postoperative |
Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.

Detailed Description
-----------------
The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.

Official Title
-----------------
Assessment of a New Surgical Smoke Clearing Technology, Innervision, in Laparoscopic Cholecystectomy

Conditions
-----------------
Focus: Surgical Smoke During Laparoscopic Surgery

Intervention / Treatment
-----------------
* Device: Innervision Surgical Smoke Removal System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study. Exclusion Criteria: <18 years of age Pregnant or lactating females Previous extensive abdominal surgery, which in the opinion of the Investigator presents a >5% risk of conversion to an open procedure being required Current participation in another device or drug study Unwilling or unable to provide informed consent

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: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoke clearance<br>Smoke clearance device active | Device: Innervision Surgical Smoke Removal System<br>* Smoke removal by electrostatic precipitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of a clear visual field during surgery |  | 3m | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical smoke, laparoscopic surgery, impaired vision