linjc16/ctgov huggingface dataset:
Performance of Pulse Oximeter Sensors in Neonates

Study Overview
=================
Brief Summary
-----------------
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Detailed Description
-----------------
Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.

Official Title
-----------------
Validate Pulse Oximeter Sensors in Neonates by Comparing Sensor Readings to Blood Samples During Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Device: Pulse Oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken Consent signed by at least one legal guardian Exclusion Criteria: Presence of any skin irritation or breakdown on the foot Foot impediments which would preclude proper placement of the sensor Clinical condition precluding the use of adhesive materials

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test Subject<br>neonatal patients undergoing complex cardiac surgical procedures | Device: Pulse Oximeter<br>* Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of Pulse Oximeter Sensor in Neonates | Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013) | Data are collected anywhere from the beginning of surgery until the completion of the procedure |
Effect of THAI Traditional Massage on Bone Markers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover immediately after the massage.

Detailed Description
-----------------
Each subject received Thai traditional massage for 2 hours by a single masseuse.

Official Title
-----------------
Acute Changes in Biochemical Markers of Bone Resorption and Formation After THAI Traditional Massage

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Procedure: Thai Traditional massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Thai women aged 20 to 40 years Have been massaged by Thai Traditional massage style Exclusion Criteria: Hyperparathyroidism, Thyrotoxicosis, Diabetes Mellitus, Rheumatoid Arthritis, Cancer Antiresorptive agent, Teriparatide and Glucocorticoid Swelling Joints

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1= THAI traditional massage | Procedure: Thai Traditional massage<br>* Thai traditional massage for 2 hours by a single masseuse.<br>* Other names: Thai massagae;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical markers of bone resorption; C-terminal telopeptide of type I collagen (CTx-I) and of bone formation; total procollagen type 1 amino-terminal propeptide (P1NP)level |  | 2 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thai Traditional massage, Bone Formation, Bone Resorption
Antibiotic Prophylaxis Before Percutaneous Gastrostomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of antibiotics (i.e. Kefzol) before percutaneous gastrostomy performed in interventional radiology. Patient will be randomized to receive antibiotics or placebo before the procedure, and the rates of skin infection after the procedure will be determined between the two groups. This has never been studied in our population of patients undergoing the procedure. However, antibiotics are routinely given despite the lack of evidence. The investigators hypothesize that patient receiving prophylactic antibiotics will have a decreased number of infections compared to placebo.

Official Title
-----------------
Antibiotic Prophylaxis Before Percutaneous Gastrostomy: A Randomized, Controlled Clinical Trial

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone over the age of 18 years who is not currently on antibiotics for other reasons Exclusion Criteria: Anyone on antibiotics for the treatment of other infections. Anyone under the age of 18 years Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Those receiving antibiotics<br>Patients who received one prophylactic dose of antibiotics. | |
| Placebo<br>Patients who did not receive one prophylactic dose of antibiotics (received placebo). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of infection | Wounds surround the g-tube will be assessed at 4 points after the procedure to document the presence of infection. An assessment for redness, induration, pus, etc. will be performed and documented at 4 times points after the procedure. | Within one month of the procedure (antibiotic dose, if given) |
HOMA-IR as a Screening Test in NAFLD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the role of HOMA-IR in diagnosis of NAFLD in patients with type 2 DM.

Detailed Description
-----------------
this study is a retrospective cohort study included 100 patients with type 2 DM from the outpatient clinic of internal medicine department at Fayoum University Hospital. They were divided into two equal groups according to the presence of NAFLD by ultrasound. All patients were subjected to history taking, clinical examination and investigations which included: ALT, AST, total cholesterol, TG, FBG and fasting insulin level,HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) assessment.

Official Title
-----------------
Is HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) a Potential Screening Test for Non-alcoholic Fatty Liver Disease in Adults With Type 2 DM?

Conditions
-----------------
NAFLD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diabetes obesity Exclusion Criteria: use of alcohol

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Diabetics with NAFLD<br>Diabetics whose abdominal ultrasound showed that they have NAFLD | |
| Diabetics without NAFLD<br>Diabetics whose abdominal ultrasound showed that they do not have NAFLD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between HOMA-IF and NAFLD | Find a statistically significant correlation between HOMA IR and NAFLD in diabetics | 6 months |
EGM Analysis in Idiopathic Outflow Tract Ventricular Arrhythmia

Study Overview
=================
Brief Summary
-----------------
Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).

Detailed Description
-----------------
The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.

Official Title
-----------------
Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site During Idiopathic Outflow Tract Ventricular Arrhythmia Ablation

Conditions
-----------------
Ventricular Outflow Tract Tachycardia

Intervention / Treatment
-----------------
* Procedure: Radio-frequency Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo ablation for idiopathic OTVA Have the ability to provide informed consent for study participation. Exclusion Criteria: Be currently participating in any other investigational study Be less than 18 years of age Be pregnant Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)

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: Radio-frequency Ablation|A procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery |  | Intraoperative, an average of 2 hours |
Neutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis?

Study Overview
=================
Brief Summary
-----------------
Patients with severe infection and sepsis are in high risk of hypo perfusion and therefore organ affection. Temporary or permanent kidney failure is a common complication in these patients. Today's golden standard for kidney failure detection is creatinine levels rising and / or oliguria. The investigators hypothesize that an even more sensitive biomarker; neutrophil gelatinase associated lipocalin(NGAL) in urine can predict kidney injury before creatinine levels rise. In recent studies NGAL in urine seem to be a sensitive biomarker in these patient to predict kidney injury, but the time factor for sampling optimally is not known. In this pilot study the investigators sample the urine at admission within the first hour of hospitalization to investigate if NGAL can be used as a predictor in an emergency setting.

Official Title
-----------------
Secretion of Neutrophil Gelatinase Associated Lipocalin in Septic Patients and the Development of Acute Kidney Injury

Conditions
-----------------
Severe Sepsis, Septic Shock, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe sepsis Septic shock Patients must not be able to give consent Exclusion Criteria: Underaged (18 years ) known kidney injury Fully alert patients that can give consent

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 |
| --- | --- | --- |
| Development of Acute Kidney Failure |  | During hospitalization, anticipated approximately 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of NGAL in patients with kidney failure compared to creatinine |  | During hospitalization, anticipated approximately 5 weeks |
Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren syndrome)

Official Title
-----------------
Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort

Conditions
-----------------
Primary Sjögren's Syndrome (pSS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected pSS underwent a standardised evaluation Exclusion Criteria: Opposition of patient

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 |
| --- | --- | --- |
| classification criteria | classification criteria at inclusion of patients with suspected primary Sjögren's syndrome (pSS) underwent with standardised evaluation | Inclusion (Day 0) |
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

Study Overview
=================
Brief Summary
-----------------
This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.

Official Title
-----------------
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

Conditions
-----------------
Bipolar Disorder, Bipolar Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Bipolar Disorder I or II (DSM-IV-TR) Acute depressive episode at inclusion Exclusion Criteria: Inability (in investigator´s opinion) to carry out the follow-up plan Patients participating or having participated within previous 6 months, in clinical trials Mental retardation or any other medical condition affecting cognitive performance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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<br>Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change |  | Range of Days 0-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAST score to estimate the proportion of patients that not achieve functional remission |  | Range of Days 0-3 | 
| Test Screen for Cognitive Impairment in Psychiatry (SCIP) to evaluate cognitive impairment both in the depressive phase and during clinical remission |  | Range of Days 0-3 | 
| Mood chart (self-report) |  | Range of Days 0-3 | 
| The presence of subsyndromal symptoms after the acute depressive phase using Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Diagnostic and Statistical Manual of Mental disorders (DSM-IV-TR) |  | Range of Days 0-3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar depression, subsyndromal symptoms, functioning, cognitive function
Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline.

Detailed Description
-----------------
While only about 50% of patients respond to first treatment in major depressive disorder, 30-40% did not remit after continuous 1 year treatment. However, patients must remain on their prescribed medications for at least 4 weeks without knowing whether the particular antidepressant will be effective. Studies have suggested a number of predictors of treatment response, but varying degrees of success and nearly all with poor prognostic sensitivity and specificity. The investigators investigated clinical symptoms, demographic and stress state, personality and genetic polymorphisms in patients of major depressive disorder treated with sertraline and performed multivariate analysis to extract the predicting factors. Moreover, the investigators tried to visualize weight of variables and pathway one another.

Official Title
-----------------
Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Major Depressive Disorder Must be able to swallow tablets Exclusion Criteria: pregnant breastfeeding

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 |
| --- | --- |
| Other: Sertraline, Treatment response<br>dosage, frequency and duration | Drug: Sertraline<br>* dosage,frequency and duration<br>* Other names: J Zoloft®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, treatment response, selective serotonin reuptake inhibitor
Lingual Frenum and Articulation of Phonemes

Study Overview
=================
Brief Summary
-----------------
Purpose To investigate the relationship between lingual frenum and possible alterations in the articulation of phonemes. Methods This is a quantitative observational study, the individual operative kind with transversal time reference. The population sample consisted of 16 individuals, each one with their phonological system complete. The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.

Detailed Description
-----------------
The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.

Official Title
-----------------
Lingual Frenum and Possible Alterations in the Articulation of Phonemes

Conditions
-----------------
Speech Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with the frenulum of the tongue - the presence of the central incisors and upper and lower side Exclusion Criteria: patients in speech therapy aimed at enabling oral motor or speech - without integrity orofacial motor - patients using grid palate - with changes in the temporomandibular joint - anterior open bite

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lingual frenum alterations<br>individuals each one with their phonological system complete | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between lingual frenulum altered and articulation phonetics | The quantitative assessment, we could classify the lingual frenulum as normal, values above 60%; questions to amend the frenulum-values between 50% and 60% and changed (short and / or anterior)-values below 50%. Finally, we carried out the assessment phonetics (AF) and it was applied Exam 12 Phonetic-Phonological ERT. This test, is composed of 78 pictures phonologically balanced, lexical repertoire familiar to the individual and easily recognizable pictorial. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tongue frenum, Lingual frenum, Audio Phonology, Speech disorders