linjc16/ctgov huggingface dataset:
Cardiovascular Responses to Spartathlon Running

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the cardiovascular effects of ultramarathon running and their relation to performance.

Detailed Description
-----------------
The purpose of the study is to determine the changes of cardiovascular morphology and function after an ultramarathon race. 50 entrants to the Spartathlon 2017 246-km running race will participate in the study. Cardiac and arterial morphology and function tests will be conducted one day before the race and within 20 minutes of race completion.

Official Title
-----------------
Cardiovascular Effects of Ultramarathon Running

Conditions
-----------------
Disorder Heart

Intervention / Treatment
-----------------
* Other: 246-km running


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Runners at least 18 years old, healthy and sufficiently trained. Runners being accepted to participate in the Spartathlon race according to the eligibility criteria (http://www.spartathlon.gr/en/registration-en.html) Runners who will volunteer to be examined pre- and post the race Exclusion Criteria: Runners with chronic diseases Runners receiving any medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: athletes participating in the ultra marathon running
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Athletes<br>246-km running | Other: 246-km running<br>* Spartathlon 2017<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of right ventricular function after one day ultra-marathon running | Echocardiographic study of left ventricular function | before and after 1 day running | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of left ventricular function after one day ultra-marathon running | Echocardiographic study of left ventricular function | before and after 1 day running | 
| Change of carotid artery function after one day ultra-marathon running | Echocardiographic study of carotid arteries | before and after 1 day running |
Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to study the cut-off of high sensitivity troponin T using SYSMEX HLSCL Machine in Thai population at percentile 99.

Official Title
-----------------
Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population

Conditions
-----------------
Diagnoses Disease

Intervention / Treatment
-----------------
* Device: SYSMEX HLSCL


Participation Criteria
=================
Eligibility Criteria
-----------------
For healthy group Inclusion Criteria: Group 1: Aged 18 - 40 years Group 2: Aged > 40 - 70 years A presumably healthy population will define from a health questionnaire Exclusion Criteria: Heart diseases Renal diseases (CKD or recent AKI) History of pulmonary embolism For Patient group with stable heart diseases Inclusion Criteria: Aged > 40 - 70 years Stable heart disease individuals will be evaluated by cardiologist Non hospitalized (OPD settings) Exclusion Criteria: Stable heart diseases with ACS Renal diseases (CKD or recent AKI) History of pulmonary embolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Healthy<br>Control group | Device: SYSMEX HLSCL<br>* Diagnostic device<br>|
| Active Comparator: Stable heart disease<br>Stable heart disease and non-hospitalized | Device: SYSMEX HLSCL<br>* Diagnostic device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of high sensitivity-troponin T level |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myocardial Infarction, Cardiac marker, Troponin
Music and Adherence Home Programs Post Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.

Official Title
-----------------
Music and Adherence in Upper Extremity Home Programs Post Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Preferred music playlist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 40-85 Mild to Moderate hemiparesis as determined by a score of 21 to 50 on the FM- UE At least 6 months post stroke American English as primary language Exclusion Criteria: Significant visual impairment as determined by aphasia-friendly and age appropriate screening Significant hearing impairment as determined by self-report Actively receiving occupational or physical therapy services for upper extremity motor recovery Severe auditory comprehension impairment such that they cannot understand one-step directions as indicated by a WAB-R score below 8/10 on Sequential Commands Subtest Sitting or standing blood pressure of 180/110 or HE > 100 bpm

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Preferred Music Playlist<br>All participants will have this phase twice in the protocol. See description in intervention section. | Behavioral: Preferred music playlist<br>* Client will be instructed in a home program based on repetitive task practice principles and will complete this program with and without the use of a preferred music playlist during practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions of practice |  | 4 weeks | 
| Duration of sessions of practice |  | 4 weeks | 
| Number of minutes of practice |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure | Perceived occupational performance on activities of importance to the client | Baseline and no more than one week post intervention period | 
| Motor Activity Log | Perceived amount and quality of use of the affected upper extremity | Baseline and no more than one week post intervention period | 
| Western Aphasia Battery - Revised | Measure of language impairment | Baseline | 
| Cognitive Linguistic Quick Test | Measure of cognition | Baseline |
Impact of Hyperoxia During Cardiopulmonary

Study Overview
=================
Brief Summary
-----------------
The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.

Official Title
-----------------
Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery

Conditions
-----------------
Cardiac Complications

Intervention / Treatment
-----------------
* Drug: medical oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient ≥ 18 years Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery Signed Consent Affiliation to social security Exclusion Criteria: Permanent atrial fibrillation Cordarone therapy, Pregnant woman Patient under guardianship or trusteeship or private public law Internal pacemaker Hypothermia, Patient refusal, Cardiac surgery without extracorporal circulation (ECC), Participation in another study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: normoxia<br>During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg. | Drug: medical oxygen<br> <br> |
| Active Comparator: hyperoxia<br>During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %. | Drug: medical oxygen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation) |  | 15 days after surgery |
A Non-interventional Survey on the EGFR (Epidermal Growth Factor Receptor) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology

Study Overview
=================
Brief Summary
-----------------
This is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. The patients should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation in regular medical practice.

Official Title
-----------------
A Non-interventional Survey on the Epidermal Growth Factor Receptor (EGFR) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosed as adenocarcinoma type of non-small cell lung cancer Have completed lung cancer operation The tumour EGFR gene mutation status test was performed as regular medical practice Exclusion Criteria: Patients who disagree to participate this study

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 |
| --- | --- |
| 1<br>Patients in this group should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type and prevalence of EGFR mutation |  | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation type and adjuvant treatment type |  | up to 3 months | 
| Disease Free Survival rate |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR mutation test, NSCLC, Non-Interventional Study, EGFR mutation status
Outcomes of Laparoscopic Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess 5 year long-term outcomes of laparoscopic sleeve gastrectomy emphasizing weight loss and modification of comorbidities such as type 2 diabetes mellitus, hypertension and gastroesophageal reflux disease from a developing country, Turkey. Prospectively-collected patient data will retrospectively reviewed. To measure the efficacy of the procedure, we will calculate the excess weight loss percentage (EWL %). Effective weight loss after LSG will accepted as more than 50%. The changes in the status of the type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease will be observed.

Official Title
-----------------
Long Term Outcomes of Laparoscopic Sleeve Gastrectomy: First Five Years' Results of a Single Center From a Developing Country

Conditions
-----------------
Bariatric Surgery Candidate, Laparoscopic Sleeve Gastrectomy, Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: Laparoscopic sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were, patients between 18 to 65 years old, initial body mass index (BMI) 40 kg/m2 or BMI of 35 kg/m2 in the presence of additional comorbidity and failure of conservative treatment for 2 years. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients who undergo laparoscopic sleeve gastrectomy | Procedure: Laparoscopic sleeve gastrectomy<br>* Each procedure will be completed with laparoscopy with five trocars. A 36F bougie will used to calibrate the volume of the remnant stomach. Linear gastrectomy will begin 2 cm proximal of the pylor and will continue until the gastroesophageal junction. According to the intraoperative decision and experience of the surgeon, endoscopic clips would be used to ensure hemostasis of the stapler line.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight loss after surgery | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remision of comorbid diseases | The pharmacological treatment status of comorbidities related to obesity of type 2 diabetes (T2DM) and hypertension and gastroesophageal reflux will be observed with questions about did it stop after surgery (improvement), did the dose or number of medications used reduce (resolution), or were there no changes? | 5 years |
Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the use of cone beam computed tomography in treating head and neck to hopefully reduce side effects

Detailed Description
-----------------
The general purpose of this study is to evaluate Kilovoltage (kv) Imaging, specifically the Cone-beam CT (CBCT) scan device, to assess the accuracy of radiation therapy treatment delivery for patients with head and neck neoplasms

Official Title
-----------------
Evaluation of Cone Beam Kilovoltage Imaging During Radiation Therapy for Tumors of the Head and Neck

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Device: PTV Reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient receiving radiation therapy for a head and neck tumor assigned to the new Elekta Synergy Linare Accelerator Exclusion Criteria: NA

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cone Beam CT<br> | Device: PTV Reduction<br>* The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Interfraction Shift of Patients Undergoing Radiotherapy | Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken. | Daily prior to radiation | 
| Average Residual Error Motion of Patients Undergoing Radiotherapy | To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms | Daily after each radiotherapy treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kilovoltage Imaging, Cone-beam CT, CBCT, radiation therapy, head and neck neoplasms
Gut Microbiota of Preterm Infants and Full-term Infants at Early Life

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome. The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.

Detailed Description
-----------------
Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .

Official Title
-----------------
Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life

Conditions
-----------------
Preterm Infant, Gut Microbiome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants gestational age <37 weeks; no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis; hospital stay > 7 days; Exclusion criteria: NICU stay less than 7 days Necrotizing enterocolitis infant Control group: Full-term healthy infants; gestational age >37 weeks; vaginally born; no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 4 Months

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 |
| --- | --- | --- |
| changes in gut microbiota over time and in relation to antibiotic treatment | Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants | 0-7 years after birth |
Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's Quality of Life Hospital Environment

Study Overview
=================
Brief Summary
-----------------
The quality of life of carriers detected infected or colonized by emerging highly resistant bacteria (BHRe) following the implementation of specific hygiene measures during the discovery of the microorganism has been little studied. To date, there have been no studies to determine the quality of life (QoL) in France of patients with hospitalized HBHRD.

Official Title
-----------------
Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Other: Quality of life questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years old Have a positive BHRe screening during the hospital stay and / or have a positive BHRe clinical sample during the hospital stay Conscious patients All types of stays in the hospital sector All pathologies Exclusion Criteria: Known patients with BHRe before hospitalization PCH immediately upon admission (history of hospitalization abroad, patients contacted during a previous hospitalization) Cognitive problem Patients not proficient in French (requiring an interpreter) Patients under guardianship

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 |
| --- | --- |
| Patients<br>Patients screened for carriers infected or colonized by emerging highly resistant bacteria. | Other: Quality of life questionnaire<br>* Quality of life questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the implementation of Complementary Hygiene Precautions following a carrier of emerging highly resistant bacteria on the quality of life of hospitalized patients | Measurement of the decrease in utility corresponding to the deterioration of the QOL of patients since the implementation of the Additional Hygiene Precautions (PCH) following the discovery of their emerging highly resistant bacteria (BHRe). | 12 months |