linjc16/ctgov huggingface dataset:
Airway IgA: Respiratory Tract IgA Levels in Critically Ill Intubated Patients

Study Overview
=================
Brief Summary
-----------------
This study will examine the impact of acute illness on sequential airway IgA levels in intensive care patients who will require prolonged intubation. Infections are the most common cause of late deaths in non-head injured trauma patients and a frequent cause of morbidity and mortality in hospitalized patients, especially intubated Intensive Care Unit (ICU) patients. Nosocomial pneumonia is the most common of these infections, and its incidence in defined populations of critically injured patients is responsive to route and type of nutrition. This study will focus on the mechanisms of specific immune mucosal defenses in intestinal and extraintestinal sites and link enteral feeding (or lack of it) with maintenance (or deterioration) of respiratory mucosal defenses.

Official Title
-----------------
Respiratory Tract IgA Levels in Critically Ill Intubated Patients

Conditions
-----------------
Intubation, Critically Ill

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be intubated, intensive care patients. Exclusion Criteria: No severe pulmonary contusions or evidence of airway bleeding

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubated patients
Heat and Moisture Exchanger and Low-flow Gas

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to measure the inspired gas temperature and humidity of the anesthetic circuit in the Dräger Primus machine and esophageal temperature with or without and heat and moisture exchanger (HME) and low-flow gas during anesthesia in patients submitted to gynecological surgeries.

Official Title
-----------------
The Effects of a Heat and Moisture Exchanger on Temperature and Humidity in Low -Flow Anesthesia Workstation

Conditions
-----------------
Gynecological Surgery, General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 to 69 years old Gynecological Exclusion Criteria: Obesity Fever Endocrine disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heat moisture exchanger (HME)<br>This group was submitted to general anesthesia with low flow gas and heat moisture exchanger | |
| Low flow gas (LFG)<br>This group was submitted to general anesthesia with only low flow gas | |
| Humidity of the respiration<br>Heat and moisture group: The first group (G1)will be submitted to low flow gas anesthesia and heat and moisture exchanger (HME) Control group: The second group(G2)Will be submitted to low flow gas anesthesia | |
| HME and LFG<br> | |

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
-----------------
low flow gas, Heat and moisture exchanger, Humidity, Temperature, Core temperature, Women
HIFU in Patients With Non-malignant Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.

Official Title
-----------------
Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

Conditions
-----------------
Non-malignant Thyroid Nodules

Intervention / Treatment
-----------------
* Device: Echopulse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient 18 years or older. Patient presenting with at least one thyroid nodule with no signs of malignancy: Non suspect clinically and at ultrasonography imaging Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the last 6 months Normal serum calcitonin No history of neck irradiation Normal thyroid-stimulating hormone (TSH). Targeted nodule accessible and eligible to HIFU Absence of abnormal vocal cord mobility at laryngoscopy. Nodule diameter ≥ 10mm measured by ultrasound. Nodule volume inferior to 10 cc Composition of the targeted nodule(s) : no more than 30% cystic Exclusion Criteria: Head and/or neck disease that prevents hyperextension of neck. Known history of thyroid cancer or other neoplasias in the neck region. History of neck irradiation. Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment Posterior position of the nodule if the thickness of the nodule is <15mm Pregnant or lactating woman Any contraindication to the assigned analgesia/anaesthesia.

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: Single arm<br> | Device: Echopulse<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US) |  | Month 6 and Month 12 | 
| Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US) |  | Month 6 and Month 12 | 
| Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US) |  | Month 6 and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events as a measure of safety and tolerability |  | Day 1, Month 1, Month 3, Month 6 and Month 12 |
Sun Protection Factor Assay (SPF Assay 207/2016)

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 Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521


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 (Subject 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987521<br>Each test site area is divided into test sub site 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: BAY987521<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 Code:Z09-067)<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 |
Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment

Study Overview
=================
Brief Summary
-----------------
Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment

Official Title
-----------------
Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation) Inclusion criteria for the control arm (treated by ACEi): Patients over 18 years of age Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) Patients, who tolerate ACEi treatment Exclusion Criteria: Cholestasis, severe hepatic insufficiency Allergy to telmisartan Gravidity or lactation Exclusion criteria for the arm of patient treated by ACEi: Cholestasis, severe hepatic insufficiency Allergy to ACEi Gravidity or lactation

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 |
| --- | --- |
| Group 1<br> | Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)<br>* Patients under daily life treatment receiving Pritor according to local drug information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial Hypertension
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

Detailed Description
-----------------
This clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

Official Title
-----------------
A Prospective Randomized Multi - Center Clinical Outcomes Collection Study To Analyze The Effect Of Ebi Osteogen™ Direct Current Stimulator On The Surgical Reconstruction Of Tibia Nonunions

Conditions
-----------------
Tibia Fracture Non Union Bone

Intervention / Treatment
-----------------
* Device: OsteoGen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a tibia nonunion. Male or female between ages of 18 and 75 years old, inclusive Exclusion Criteria: Subject has open wounds or underlying osteomyelitis. Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating. Subject has an implanted unipolar pacemaker. Subject has active cancer. Subject has severe peripheral vascular disease (ABI <0.4)

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 - standard films<br>Tibia reconstruction surgery with OsteoGen™ with standard radiographs | Device: OsteoGen<br>* OsteoGen Implatable stimulator<br>|
| 2 - Standard films plus CT<br>Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks. | Device: OsteoGen<br>* OsteoGen Implatable stimulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure for this trial will be the percentage of successful tibia unions achieved |  | 8 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline) |  | 8 Months |
CLamp vs Off Clamp Kidney During Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.

Official Title
-----------------
Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy

Conditions
-----------------
Nephrectomy, Kidney Neoplasm, Glomerular Filtration Rate

Intervention / Treatment
-----------------
* Procedure: Clamp Robotic partial nephrectomy
* Procedure: Clampless Robotic partial nephrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal coagulation trim pre operative Glomerular Filtration Rate (GFR) > 60 ml/min healty contralateral kidney low (4-6) or intermediate (7-10) RENAL score availability of Da Vinci Robotic System Exclusion Criteria: altered coagulation trim pre operative Glomerular Filtration Rate (GFR) < 60 ml/min anatomic or functional solitary kidney RENAL score >10

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clamp<br>Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor | Procedure: Clamp Robotic partial nephrectomy<br>* Renal artery clamping during partial nephrectomy<br>|
| Experimental: Off clamp<br>Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor | Procedure: Clampless Robotic partial nephrectomy<br>* Robotic partial nephrectomy without renal artery clamping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate (GFR) variation | difference between pre and post operative Glomerular Filtration Rate (GFR) | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of clampless robotic partial nephrectomy | number of cases shifted from clampless to clamping procedure; time of suture of the renal parenchyma; overall operative time. | Duration of the surgical procedure | 
| Morbidity of clampless robotic partial nephrectomy | Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate | 90 days | 
| Oncological safety of clampless robotic partial nephrectomy | positive surgical margins rate | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal function, Off-clamp, Partial nephrectomy, Robotic, Hylar clamping
Treatment of PED With AMT and Autologous Serum

Study Overview
=================
Brief Summary
-----------------
Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.

Official Title
-----------------
Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects

Conditions
-----------------
Corneal Epithelial Defect

Intervention / Treatment
-----------------
* Procedure: Amniotic membrane transplantation
* Drug: Autologous serum/BSS 20%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal epithelial defect of more than 14 days that has not responded to conventional therapy Exclusion Criteria: Under age 18 Pregnant/lactating females Patients with hemoglobin levels < 12 mg/ml Patients with limbal stem cell deficiency

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Amniotic membrane transplantation|nan|
|Drug: Autologous serum/BSS 20%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal re-epithelialization (= initial success) |  |  | 
| Persistent corneal re-epithelialization (= lasting success) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Corneal transplant, Neurotrophic keratitis, Post-bacterial keratitis, Metaherpetic keratitis
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

Conditions
-----------------
Hemodialysis, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: PA21


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving stable maintenance hemodialysis 3 times a week Dialysis patients with hyperphosphatemia Exclusion Criteria: Patients having history of a pronounced brain / cardiovascular disorder Patients having severe gastrointestinal disorders Patients having severe hepatic disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 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: PA21<br> | Drug: PA21<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| TSAT at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| Hb Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| Constipation Condition |  | 12 weeks | 
| Satisfaction With Bowel Movement |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Hyperphosphatemia