linjc16/ctgov huggingface dataset:
Lysyl Oxidase, Semaphorin 7a and Semaphorin 3a in Patients With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic sclerosis. The results obtained may help us diagnose these complications of systemic sclerosis and hopefully even monitor patient treatment.

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Other: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic Sclerosis Patients Written consent to participation in study Exclusion Criteria: Serious active medical condition Other autoimmune rheumatic disease Current or past allergic/inflammatory reaction Liver disease Pregnant or breastfeeding Illegal drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Systemic sclerosis patients<br>Systemic sclerosis patients will have blood tested for fibrotic enzyme levels | Other: Blood test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrin Enzyme Levels in Blood | Patients will undergo blood tests before study and after six months to determine levels of lysyl oxidase, semaphorin 7a and 3a and thus determine severity of the disease (systemic sclerosis). | Six months |
Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the validity of perfusion index to determine the level of anesthesia in comparison with auditory evoked potential in children undergoing tonsillectomy.

Detailed Description
-----------------
The use of the perfusion index as an added monitoring tool during anesthesia provides the anesthetist with a number of benefits. It is a useful tool to forewarn the clinician of possible light planes of anesthesia, allowing for agent dose adjustment. It is a preexisting technology that is already widely available and used in most urban, regional,and rural centers, in both developed and developing countries, is noninvasive, continuous, and inexpensive. The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from the EEG-signal by using an autoregressive model with an exogenous input adaptive method

Official Title
-----------------
Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children.

Conditions
-----------------
Awareness, Anesthesia

Intervention / Treatment
-----------------
* Device: Perfusion index detected by pulse oximeter
* Device: AAI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 3-12 years Elective tonsillectomy due to recurrent or chronic tonsillitis Exclusion Criteria: Cerebral disease Cardiac disease, Renal disease, Pulmonary disease Hepatic disease.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Perfusion index detected by pulse oximeter|Perfusion index detected by pulse oximeter|
|Device: AAI|The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from the EEG-signal by using an autoregressive model with an exogenous input adaptive method.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PI | Perfusion index detected by pulse oximeter | Introperative | 
| AAI index | AAI index detected by AEP monitor | Intraoperative |
Optic Nerve Sheath Diameter in Preeclampsia

Study Overview
=================
Brief Summary
-----------------
Severe preeclampsia is associated with an elevation in intracranial pressure (ICP). Optic nerve sheath diameter is a non-invasive surrogate of invasive ICP measurement. This study targets to evaluate the ICP in patients with or without preeclampsia.

Detailed Description
-----------------
MRI studies have shown that brain edema due to an elevation in ICP develops in up to 70% of women with preeclampsia. Optic nerve sheath diameter is used to estimate the ICP and has been shown to correlate well with invasive ICP measurement. The present study aims to compare ICP using optic nerve sheath diameter in women with or without preeclampsia.

Official Title
-----------------
Evaluation of Intracranial Pressure With Optic Nerve Sheath Diameter Measurement in Women With or Without Preeclampsia

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Diagnostic Test: Optic nerve sheath diameter measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be diagnosed as preeclampsia Age must be > 18 years Exclusion Criteria: History of previous intracranial pathology or surgery Glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Preeclampsia group<br>Patients with preeclampsia will receive optic nerve sheath diameter measurement with a linear ultrasound probe carefully and gently placed on the closed upper eyelids of patients. | Diagnostic Test: Optic nerve sheath diameter measurement<br>* Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.<br>|
| Other: Pregnants without preeclampsia<br>Pregnant women without preeclampsia will receive optic nerve sheath diameter measurement with a linear ultrasound probe carefully and gently placed on the closed upper eyelids of patients. | Diagnostic Test: Optic nerve sheath diameter measurement<br>* Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICP | The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia | At 6th hour of admission |
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: AZD1236
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Have a clinical diagnosis of cystic fibrosis with an FEV1 >40% of predicted normal Be able to comply with induced sputum procedure post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy) Exclusion Criteria: Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2 Known to be infected with Burkholderia cepacia

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1236<br>* Oral tablet, 75 mg twice daily during 4 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on biomarker levels in induced sputum |  | 2 times at baseline and after 4 weeks treatment | 
| Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire) |  | At inclusion, at randomisation and after 4 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (adverse events, vital signs and laboratory safety variables) |  | throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up) | 
| Effect on biomarkers in blood |  | 2 times, at baseline and after 4 weeks treatment | 
| Effect on biomarkers in urine |  | 2 times, at baseline and after 4 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Induced sputum, cystic fibrosis, biomarker, CYBER
Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: Intrapartum polimeraze chain reaction (PCR)of group B streptoccocus (GBS) test is more accurate than Culture of GBS at 35-37 weeks gestation for GBS carriage. The investigators will compare GBS culture and PCR results taken at 35-37 weeks gestation to intrapartum PCR GBS and GBS cultures status. The larger perspective of this trial is to check the possibility of replacing the GBS culture screening program at 35-37 weeks gestation with a more accurate examination (PCR), avoiding the changing GBS carriage status from the time of culture at 35-37 weeks to delivery.

Conditions
-----------------
GBS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unknown GBS pregnant women at 35-37 weeks Exclusion Criteria: Known GBS pregnant women at 35-37 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| GBS carriage status<br> | |
| GBS status during labor<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrapartum GBS carriage staus measured by PCR and culture compared to GBS culture and PCR at 35-37 weeks gestation | Intrapartum GBS carriage status measured by culture and PCR will be compared to GBS carriage stauts measured by the same tests at 35-37 weeks gestation. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carriage status, Culture, PCR
Exploratory Study of OPC-12759 Ophthalmic Suspension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.

Official Title
-----------------
Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder

Conditions
-----------------
Keratoconjunctival Epithelial Disorder

Intervention / Treatment
-----------------
* Drug: OPC-12759 ophthalmic suspension
* Drug: Sodium hyaluronate ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect Fluorescein corneal staining score of 3 or higher Exclusion Criteria: Active ocular infection Vernal keratoconjunctivitis Recurrent corneal erosion Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period. Anticipated use of contact lens during the study. Insertion of punctal plug or fall out of punctal plug within 3 months Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease. Receipt of any investigational product within 4 months.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-12759 ophthalmic suspension<br>OPC-12759 ophthalmic suspension | Drug: OPC-12759 ophthalmic suspension<br>* OPC-12759 ophthalmic suspension 2%<br>|
| Active Comparator: Sodium hyaluronate ophthalmic solution<br>Sodium hyaluronate ophthalmic solution | Drug: Sodium hyaluronate ophthalmic solution<br>* Sodium hyaluronate ophthalmic solution 0.1%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Keratoconjunctival Staining Score From Baseline | Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test. | Basekine, 4 weeks |
Ultrasound Examination Versus Palpation to Locate the Cricothyroid Membrane

Study Overview
=================
Brief Summary
-----------------
Anesthesiologists get a course on localizing the cricothyroid membrane on a human using ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.

Detailed Description
-----------------
The ability to localize the cricothyroid membrane on patients before airway management is crucial in order to be able to follow the difficult airway algorithms. Studies have show a high failure rate when anesthesiologists rely on palpation. In this study Anesthesiologists get an e-learning course, get literature to study , and get a theoretical course and a hands-on course in using ultrasound for localizing the cricothyroid membrane. . Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.

Official Title
-----------------
Comparison of Ultrasound Examination and Palpation to Locate the Cricothyroid Membrane - a Randomized Study

Conditions
-----------------
Focus: Localizing the Cricothyroid Membrane Before Airway Management

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being an anesthesiologist attending our airway management course Exclusion Criteria: unwillingness to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Palpation<br>The group using palpation as primary attempt at localizing the cricothyroid membrane | |
| Ultrasonography<br>The group using ultrasound for their primary approach to localizing the cricothyroid membrane | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of success of localizing the cricothyroid membrane with ultrasound and palpation | the rate of success is measured | december 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to localise the cricothyroid membrane with ultrasonography and palpation | time measure for both ultrasonographic and palpation method | december 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
airway management, cricothyroid membrane
Comparison of Different Locations for Pulse Oximetry Probes in Cardiovascular (CV) Patients With Poor Peripheral Perfusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.

Detailed Description
-----------------
A comparison study design will be used to evaluate the signal quality of pulse oximetry sensors placed in two locations: forehand and finger. Each subject will serve as their own control, with measurements of signal quality evaluated at 2 second intervals over a period of one hour. The measurements will be recorded simultaneously with a computer program and laptop computer. Finger and forehand sensors will be applied according to manufacturer's guidelines. An output connection will be made from each pulse oximeter computer unit to a password protected, laptop computer for data downloading. Data will be collected for a 1 hour period at 2 second increments and stored in the hard drive of the laptop. Following completion of data collection, the study sensors will be removed.

Official Title
-----------------
Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion

Conditions
-----------------
Congestive Heart Failure, Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CICU patients with a new diagnosis or history of CHF or cardiomyopathy Patients with a medical order for pulse oximetry monitoring Age greater than or equal to 18 years of age English speaking Signs of hypoperfusion Exclusion Criteria: CICU patients with an impediment to sensor application CICU patients with excessive facial edema CICU patients with mechanical ventilation CICU patients with intra-aortic balloon pump therapy CICU patients with intravenous vasopressor drug administration

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 |
| --- | --- |
| CHF, cardomyopathy<br>Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal quality loss (dropout rate) |  | Every 2 seconds for one hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart failure, Cardiomyopathy
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects

Study Overview
=================
Brief Summary
-----------------
In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.

Detailed Description
-----------------
We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.

Official Title
-----------------
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus sakei


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20-65 years BMI equal to higher than 25 kg/m2 Exclusion Criteria: under anti-obesity medication uncontrolled diabetes uncontrolled hypertension any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics thyroid function test abnormality malignancy within 5 years immune compromised hosts or under immune suppressants antibiotics or probiotics withing 2 weeks any intervention to reduce body weight within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus sakei<br>2 packs per day | Dietary Supplement: Lactobacillus sakei<br>* 1 pack contained 5 x 109 cfu<br>|
| Placebo Comparator: Control<br>2 packs per day | Dietary Supplement: Lactobacillus sakei<br>* 1 pack contained 5 x 109 cfu<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass change in 12-week | fat mass is measured by DEXA | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight | body weight change | 12 weeks | 
| Changes in waist circumference | Waist circumference change | 12 weeks | 
| Glucose metabolism | Changes in HbA1c | 12 weeks | 
| Glucose metabolism | Changes in fasting glucose concentration | 12 weeks | 
| Glucose metabolism | Changes in insulin resistance | 12 weeks | 
| Glucose metabolism | Changes in beta-cell function | 12 weeks |