linjc16/ctgov huggingface dataset:
Ultrasound and Pediatric Endotracheal Tube Size

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to evaluate the ultrasonographic airway measurement in pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse airway diameter (MTAD) with tube size predicted by different age-related formulas and diameter of little finger. Previous studies already showed that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTAD. In this study measurements are performed at three predefined anatomic structures of the airway with each of These at two airway pressures. The investigators hypothesize that one of the specific measurements predicts the fitting ETT size better than age-related formulas or diameter of little finger.

Official Title
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Prediction of Uncuffed Endotracheal Tube Size in a Pediatric Population by Sonographic Measurements at Various Structures of the Airway Compared to Age-related Formulas and Little-finger Diameters

Conditions
-----------------
Intubation With Uncuffed Endotracheal Tube

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent by the legal guadian elective surgery requiring endotracheal intubation Exclusion Criteria: missing informed consent allergy to ultrasound gel

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- | --- | --- |
| Minimal transverse airway Diameter (MTAD) | In this study measurements of MTAD are performed at three predefined anatomic structures of the airway with each of these at two airway pressures in the time frame between the administration of muscle relaxant and Intubation (average time available 3min). | Between administration of muscle relaxant and intubation (3min) |
Genetic Susceptibility Factors for Candidemia.

Study Overview
=================
Brief Summary
-----------------
This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.

Official Title
-----------------
Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.

Conditions
-----------------
Invasive Candidiasis, Candidemia, Genetic Predisposition to Disease

Intervention / Treatment
-----------------
* Genetic: Analysis of genetic polymorphisms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years. Informed consent. Positive blood culture with isolation of Candida sp. Exclusion Criteria: No informed consent. Patient younger than 18. No insurance coverage.

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 |
| --- | --- |
| Candidemia patients<br>These patients are included in the study after the reception of a positive blood culture for Candida sp. | Genetic: Analysis of genetic polymorphisms<br>* An analysis of the SNPs (single nucleotide polymorphism) of 25 candidate genes will be performed. This analysis will be completed by a genome wide association study.<br>|
| Control patients<br>These patients are matched on case patients on the following criteria: Age+/-5 years length of hospitalisation type of ward type of surgery for surgical patients IGS2 for intensive care patients | Genetic: Analysis of genetic polymorphisms<br>* An analysis of the SNPs (single nucleotide polymorphism) of 25 candidate genes will be performed. This analysis will be completed by a genome wide association study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of the polymorphisms between the groups |  | In the 48-72 hours following the positive blood culture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gene Expression Profiling, Genome-Wide Association Study, Polymorphism, Single Nucleotide, Drug Resistance, Fungal
Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness

Study Overview
=================
Brief Summary
-----------------
Interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk extensors stiffness.

Detailed Description
-----------------
Single visit interventional study of the effects of a trunk extensor muscles fatigue protocol on multifidus and erector spinae muscle stiffness measured by Ultrasound based Shearwave elastography.

Official Title
-----------------
Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness

Conditions
-----------------
Muscle Tightness

Intervention / Treatment
-----------------
* Other: isometric trunk extensor muscles fatigue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physically active at least 3 hours a week Exclusion Criteria: Low back pain in the past 6 months History of chronic low back pain History of spinal or pelvic operation Hypermobility, more than 4 points on Beighton scale Cardiovascular or systemic diseases Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isometric fatigue<br>Fatiguing intermittent isometric exertions of trunk extensor muscles will be performed. | Other: isometric trunk extensor muscles fatigue<br>* Participants will perform three sets of intermittent isometric efforts between 50 and 60 percents of their maximal isometric strength. A padded force sensor will be placed approximately at the level of the 7th thoracic vertebrae. The first two sets will last six minutes each, while the third set will last three minutes. Between each set participants will rest for two minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of trunk extensors muscle stiffness | Muscle stiffness will be measured at rest and during standardised sub-maximal exertions in prone lying position. Muscle stiffness will be expressed as the shear modulus value in kilopascals. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle electromyography mean amplitude | Muscle activation of trunk extensors will be measured using superficial electromyography at rest and during two standardised sub-maximal exertions in prone lying position (single arm raise and upper body raise). Mean amplitude in six to eight second time frames will be calculated. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multifidus, erector spinae, muscle stiffness
Assessment of Suicidality in Epilepsy - Rating Tools

Study Overview
=================
Brief Summary
-----------------
This will be a cross-sectional study enrolling 200 outpatients/inpatients with treatment resistant partial epilepsy for at least two years, receiving 1-3 AEDS. The study will consist of one or two visits, each lasting 1-2 hours. All subjects will complete Visit 1. Twenty five percent of the subjects will return for Visit 2. The study will assess the prevalence of depression and suicidal thoughts and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy (PWE) who may be ineligible for future trials.

Detailed Description
-----------------
In light of the recent issues regarding antiepileptic drugs and suicidality, The Epilepsy Study Consortium is proposing a pilot study. Several scales to assess suicidality and screen for depression and anxiety disorders will be administered to a group of epilepsy patients with characteristics similar to patients who are usually enrolled in epilepsy clinical trials. The study will assess the prevalence of depression, suicidal thoughts, and behavior and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy who may be ineligible for future trials because they have had active suicidal thoughts in the last 6 months, suicidal behavior in the last 2 years or a current major depressive episode.

Official Title
-----------------
Assessment of Suicidality in Epilepsy - Rating Tools

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Partial epilepsy for at least two years, confirmed with EEG studies Aged 18 to 70 years-old Proficient in English Having a minimum of a 4th grade reading level Having been on stable doses and type of AEDs for the previous two months Have at least 1 observable partial seizure (simple partial with motor component, complex partial or secondarily generalized tonic clonic seizure) per month for the past 6 months Is currently receiving 1-3 AEDs Has failed at least 2 AEDs (including current therapy) Exclusion criteria: Non-epileptic seizures with or without comorbid epileptic seizures Subjects who currently carry a diagnosis of a major psychotic disorder Subjects who are currently taking an investigational medication Subjects with a known history of alcoholism, drug abuse, or drug addiction within the past 2 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy

Study Overview
=================
Brief Summary
-----------------
This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal variable(s) to represent mitochondrial function.

Official Title
-----------------
Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics of the Vastus Lateralis After Sub-maximal Exercise in Patients With Mitochondrial Myopathy

Conditions
-----------------
Mitochondrial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ≥ age 18 years old with primary mitochondrial myopathy Known alteration in electron transport chain activity (<25 % activity of ETC) or known mutations in mitochondrial gene. Exclusion Criteria: Failure based on standard clinical MRI Screening form - the form is intended to establish the safety of subjects participating in the MRI scan without divulging any confidentiality information -

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 |
| --- | --- |
| Subjects with mitochondrial disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCr recovery after submaximal exercise by 31P-MRS |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitochondria
Nutritional Requirement for the Severe Trauma Patients

Study Overview
=================
Brief Summary
-----------------
After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.

Official Title
-----------------
Nutritional Requirement for the Severe Trauma Patients

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Dietary Supplement: high caloric nutritional supplement
* Dietary Supplement: low caloric nutritional supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ISS more than 15 score older than 20 years old patient who need parenteral nutrition more than 5 days Exclusion Criteria: patients who have metabolic disease except for diabetes patients who cannot resuscitated very low body weight (< 40kg)

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low calory<br>15kcal/kg caloric supplement | Dietary Supplement: high caloric nutritional supplement<br>* high caloric nutritional supplement (25kcal/kg)<br>|
| Active Comparator: high calory<br>25kcal/kg | Dietary Supplement: low caloric nutritional supplement<br>* low caloric nutritional supplement(15kcal/kg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of antibiotics usage (days) |  | participants will be followed for the duration of hospital stay, an expected average of 2 week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | participants will be followed for the duration of hospital stay, an expected average of 2 week | 
| Number of date when is showing hyperglycemia (more than 200mg/dL) |  | participants will be followed for the duration of hospital stay, an expected average of 2 week | 
| Hospitals stays |  | participants will be followed for the duration of hospital stay, an expected average of 2 week | 
| ICU stays |  | participants will be followed for the duration of hospital stay, an expected average of 2 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, nutrition, hyperglycemia
Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

Study Overview
=================
Brief Summary
-----------------
The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.

Detailed Description
-----------------
During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Official Title
-----------------
Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Device: PSG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 60 years of age Inpatient and scheduled for surgical procedure at MGH Exclusion Criteria: Blindness, deafness or the inability to speak English Inability to provide informed consent Objective Drop Criteria Post-operative intubation greater than 24 hours

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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 |
| --- | --- |
| MGH Surgery Patients<br>PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. | Device: PSG<br>* PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association Between Sleep and POD | Duration of sleep in delirious vs non-delirious patients | Night before surgery, approximately 13 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burst Suppression Ratio | Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression. | Length of surgery (2-12 hours) |
Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213 administration in patients with iron deficiency Anemia

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: Z-213


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with iron deficiency anemia Exclusion Criteria: Patients with anemia caused by conditions other than iron deficiency Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase Patients with liver, kidney or circulatory system disease Patients with a history or present illness that is a malignant tumor or autoimmune disease Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Z-213<br> | Drug: Z-213<br>* The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Drug Reactions |  | 12 weeks | 
| Number of participants with Adverse Events |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum change in Hb value |  | 12 weeks | 
| Change in Hb value |  | 12 weeks | 
| Proportion of responders |  | 12 weeks | 
| Proportion of subjects with normalization in Hb value |  | 12 weeks | 
| Proportion of cumulative dosage |  | 12 weeks | 
| Number of doses to total dose achieved |  | 12 weeks | 
| Time to total dose achieved |  | 12 weeks |
Pemetrexed in Advanced Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).

Official Title
-----------------
Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer (NSCLC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution Patients treated with single agent pemetrexed for metastatic disease Availability of full clinical data Exclusion Criteria: Cytological diagnosis of advanced Non-small cell lung cancer Lack of tumor tissue at our institution Lack of full clinical data

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 |
| --- | --- | --- |
| Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy. |  | one year |