linjc16/ctgov huggingface dataset:
The Effect of Antenatal Corticosteroid on Umbilical Artery Doppler Velocimetry in IUGR

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of antenatal corticosteroid administration on umbilical artery Doppler velocimetry measurements in pregnancies complicated by IUGR.

Detailed Description
-----------------
This study was conducted with pregnant women who were likely to have preterm birth and were treated with antenatal corticosteroids. Betamethasone was used as an antenatal corticosteroid. UA Doppler measurements (PI, S/D ratio, RI) before antenatal corticosteroid administration and 24 and 48 hours after the last dose of corticosteroid administration were evaluated in pregnant groups complicated with IUGR and uncomplicated with IUGR and compared with each other.

Official Title
-----------------
The Effect of Antenatal Corticosteroid Administration on Umbilical Artery Doppler Velocimetry in Pregnant Women Complicated With IUGR

Conditions
-----------------
Intrauterine Growth Restriction

Intervention / Treatment
-----------------
* Other: ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women who were likely to have preterm delivery and were treated with antenatal corticosteroids. Exclusion Criteria: Pregnant women who had complicated pregnancy with fetal anomaly, who had multiple pregnancies, who left their pregnancy follow-up unfinished, and those under 18 years of age were excluded from the study.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with IUGR<br>Pregnant women who received antenatal corticosteroid therapy and complicated with intrauterine growth retardation | Other: ultrasonography<br>* Umbilical artery Doppler evaluation by ultrasonography just before the first dose of antenatal corticosteroid, 24 hours and 48 hours after the last dose.<br>|
| without IUGR<br>Pregnant women who received antenatal corticosteroid therapy and were not complicated by intrauterine growth retardation | Other: ultrasonography<br>* Umbilical artery Doppler evaluation by ultrasonography just before the first dose of antenatal corticosteroid, 24 hours and 48 hours after the last dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic:diastolic ratio (S/D ratio) | Peak systolic velocity/end diastolic velocity | 2018-2019 | 
| pulsatility index (PI) | Pulsatility Index (PI) = (Peak systolic velocity - end diastolic velocity)/(time averaged maximum velocity) | 2018-2019 | 
| Resistive Index (RI) | Resistive Index (RI) = (Peak systolic velocity - end diastolic velocity)/(peak systolic velocity) | 2018-2019 |
Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Official Title
-----------------
Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Written informed consent History of bronchial asthma FEV1 more than or equal to 60% of predicted Stable asthma Patients who are in good health with the exception of asthma Main Exclusion Criteria: Concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ICS COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Use of ICS 4 weeks before entry into the baseline period Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception Use of other drugs not allowed Current smokers and ex-smokers with more than or equal to 10 pack-years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ciclesonide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh |  |  | 
| FVC% at PC20 AMP, SVC% at PC20 AMP |  |  | 
| regional air trapping |  |  | 
| bronchial and alveolar exhaled NO |  |  | 
| lung function variables |  |  | 
| non-cellular inflammatory markers. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Ciclesonide, Small Airways
Early Recognition of Hypoxia in Pediatric Patient Sedation

Study Overview
=================
Brief Summary
-----------------
Early recognition of hypoxia through monitoring in sedation practices in pediatric patients

Detailed Description
-----------------
In pediatric Magnetic Resonance Imaging, sedation is applied to pediatric patients of all age groups from newborn to adolescence in order to prevent the anxiety and movement of the patients during the imaging. It was aimed to compare the capnograph and pulse oximeter used for early detection of hypoxia in patient follow-up and to monitor the depth of sedation with the sedation score in the recovery room.

Official Title
-----------------
Comparison of MicroStream Capnography and Pulseoxymeter in Sedation of Pediatric Patients Undergoing Magnetic Resonance Imaging

Conditions
-----------------
Desaturation of Blood

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia Exclusion Criteria: Patients over the age of 18, Those who do not speak Turkish, Presence of deformities in the nose and forehead, Those with nail polish and henna on their nails

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum 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 |
| --- | --- | --- |
| Early recognition of hypoxia | The rapid recognition of hypoxia that may occur with the initiation of the procedure | during the procedure | 
| the changes in partial oxygen saturation | The rapid recognition of changes in partial oxygen saturation | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation score | Monitoring ramsey sedation scale. The minimum value is 1 and the maximum value is 6. Higher score means more sedatized. | during the procedure | 
| recovery time | length of stay in the recovery room | immediately after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoxia, Desaturation, MicroStream Capnography, Pulseoxymeter
Acetaminophen Biomarkers

Study Overview
=================
Brief Summary
-----------------
This study is a non-intervention, multicenter study to address biomarkers of acetaminophen toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein adducts and markers of liver injury in the blood samples of hospitalized children and adolescents who are receiving standard doses of acetaminophen, and children and adolescents who are status post acetaminophen overdose. Ultimately, the data generated from this study will be used to establish second generation biomarkers of acetaminophen toxicity, based on specific adduct proteins, which can be used in future risk assessment studies of children receiving acetaminophen.

Official Title
-----------------
Identification of New Mechanistic Biomarkers of Adverse Response to Acetaminophen

Conditions
-----------------
Acetaminophen Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group A: Children ages 1-18 inclusive Hospitalized children who are likely to receive or are receiving recommended doses of APAP Group B: Children ages 1-18 inclusive Children with no APAP use in the past 14 days Group C: Children ages 1-18 inclusive Hospitalized from an acute overdose of APAP Time of APAP overdose is known or can be estimated within a two hour window Exclusion Criteria: Group A: Acute or chronic APAP overdose within 14 days Known history of liver disease or dysfunction Group B: APAP within the last 14 days Known history of liver disease or dysfunction Group C: Chronic overdoses of APAP, defined as multiple time point ingestions of APAP History of previous APAP overdose Known pre-existing liver disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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 |
| --- | --- |
| Group A<br>Subjects receiving recommended doses of acetaminophen in the hospital. 140 Subjects | |
| Group B<br>Healthy Volunteers - No acetaminophen exposure within 14 days of enrollment 23 Subjects | |
| Group C<br>Acetaminophen Overdose Subjects - Hospitalized 90 Subjects | |

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
-----------------
Acetaminophen, APAP
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: High concentration SI-614
* Drug: Low concentration SI-614
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Have provided written informed consent Have dry eye in both eyes Exclusion Criteria: Use of contact lenses Have an uncontrolled systemic disease Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse Women who is pregnant, nursing or planning a pregnancy

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: High concentration SI-614<br> | Drug: High concentration SI-614<br>* 1 drop in each eye 4 times a day<br>|
| Experimental: Low concentration SI-614<br> | Drug: Low concentration SI-614<br>* 1 drop in each eye 4 times a day<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* 1 drop in each eye 4 times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in TFBUT |  | Day 27 | 
| Mean change from baseline in symptom score |  | Day 21 - 27 |
Microaspiration in Pulmonary Fibrosis

Study Overview
=================
Brief Summary
-----------------
Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common in patients with IPF. Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for microaspiration in patients with IPF. Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and inflammation are markers of microaspiration in IPF. Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary function. Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e. unscheduled clinic visit, emergency room visit, or hospitalization).

Official Title
-----------------
The Role of Microaspiration in Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IPF Ability ot provide informed consent Exclusion Criteria: History of fundoplication or other gastroesophageal surgery Too ill to undergo bronchoscopy in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| BAL pepsin level |  | Cross sectional |
MCA Doppler Studies in Neborns Following Exchange Transfusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study MCA Doppler before and after exchange transfusion in newborns.

Conditions
-----------------
Exchange Transfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns who need exchange transfusion by accepted criteria

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

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 |
| --- | --- |
| StudyGroup<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doppler measurement | Doppler of middle cerebral artery | one year |
Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19

Study Overview
=================
Brief Summary
-----------------
Phase I/II clinical trial to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia

Official Title
-----------------
Phase I / II Clinical Trial, Multicenter, Randomized and Controlled, to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19

Conditions
-----------------
Sars-CoV2

Intervention / Treatment
-----------------
* Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection Life expectancy > 48 hours. Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial. Exclusion Criteria: Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C). History of multiple allergies, including allergy to Penicillin or other Blactams. Pregnant and lactating women. Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe. Patients with autoimmune diseases. Chronic heart failure with ejection fraction less than 30%. Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.

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 |
| --- | --- |
| Experimental: Experimental<br> | Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS<br>* Two doses of 80 million adipose-tissue derived mesenchymal stem cells<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate |  | 12 months | 
| Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate |  | 28 days |
bIosimilar of aDalimumab, an European evAluation

Study Overview
=================
Brief Summary
-----------------
The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.

Official Title
-----------------
An International, Prospective, Observational Study of Patients With Chronic Inflammatory Diseases, to Assess 12-months Persistence Drivers After Switching to an Adalimumab Biosimilar, Idacio®, in a Real World Setting

Conditions
-----------------
Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years, male or female. Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases. Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar. Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion. Patients able to understand and complete the study questionnaires in local language during the study visits. Patients willing to sign informed consent to meet data protection requirements Exclusion Criteria: Unwillingness to provide written informed consent. Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab. Patients not expected to be available for study visits during 12 months.

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 |
| --- | --- | --- |
| TREATMENT DISCONTINUATION | A patient will be considered to have discontinued FK adalimumab (not persistent) if the investigator reports a permanent discontinuation or if the patient has been more than 90 consecutive days not covered by treatment (based on the refills reported). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adalimumab, biosimilar
Analyze Sleep Stages by Portable ECG Device

Study Overview
=================
Brief Summary
-----------------
Sleep is a fundamental need for human and is associated with the working performance and the disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more important recently. In clinical settings, the analysis of daily sleep quality depends on actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really convenient for patients. In this trial, the investigators will measure the subjects' ECG signal and movement using a portable ECG device with motion sensor. On the other hand, the sleep stages are also obtained from the current wide-established measurement- polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our algorithm of artificial neural network. Then, the investigators can obtain the preliminary analysis of sleep quality can be obtained by using ECG device with our algorithm. It is helpful for doctors to realize the patent's sleep quality quickly

Official Title
-----------------
Analyze Sleep Stages by Portable ECG Device

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: portable ECG devise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSA: OPD OSA patients; Healthy: no OSA Exclusion Criteria: heart disease arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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 |
| --- | --- |
| Healthy<br>subjects without heart disease or arrhythmia, no evidence of obstructive sleep apnea | Device: portable ECG devise<br> <br> |
| OSA<br>obstructive sleep apnea | Device: portable ECG devise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR interval changes compared to the report of polysomography | The difference of RR interval in healthy subjects and obstructive sleep apnea subjects | 8 hours |