linjc16/ctgov huggingface dataset:
Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

Study Overview
=================
Brief Summary
-----------------
Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, we will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.

Official Title
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Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

Conditions
-----------------
Inclusion Body Myositis

Intervention / Treatment
-----------------
* Device: PAMSys pendant PAMSys wrist sensors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM. Able to provide informed consent. Exclusion Criteria: Unwillingness to follow study procedures. Participation in an investigational drug research study within the past 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PAMSys pendant PAMSys wrist sensors|The PAMSysTM sensor consists of a 3-axis accelerometer, battery, and built-in memory for recording long-term data. Accelerometer data is recorded at a sampling frequency of 50 Hz|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate validity of PAMSys wrist sensor and pendant sensor as monitoring biomarker of upper and lower limb function and physical activity, including leg function, change in IBM patients. | will investigate if sensor-derived parameters measured by the PAMSys wrist sensors and pendant sensor can quantify disease severity and track subtle changes in upper and lower limb health and ambulation over time. | Baseline, Month 6, Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Biomarker
Pediatric Apple Watch Study

Study Overview
=================
Brief Summary
-----------------
Specific Aim #1 - To determine the accuracy of Apple Watch ECG tracings heart rate in children. Specific Aim #2 - To determine if extended monitoring with the Apple Watch can identify arrhythmia events that were not detected by short term clinical monitoring.

Official Title
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Leveraging Wearable Technologies for Arrhythmia Detection in Children - The PAW (Pediatric Apple Watch) Study

Conditions
-----------------
Arrhythmia in Children

Intervention / Treatment
-----------------
* Device: Apple Watch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients age 6 - 21 years undergoing clinically indicated arrhythmia monitoring Patients with developmental ability (as determined by patient and parents) to safely wear the Apple Watch and utilize the patient activated trigger buttons on both the clinical monitor and the Apple Watch. Exclusion Criteria: Age < 6 years. Those under 6 many not be able to safely use the watch and have the developmental ability (as gauged by clinician and parents) to utilize the trigger features on the watch and cardiac rhythm monitor. Inability to effectively utilize the triggered features of the monitor or watch Patients unable to utilize the Apple Watch.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple Watch<br>Participants will wear an Apple Watch for 6 months | Device: Apple Watch<br>* Wearable monitor for heart rate and arrhythmia detection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate correlation | Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor | Up to 2 weeks | 
| Arrhythmia correlation | Comparison of the number of clinically significant arrhythmia events between the Apple Watch and standard clinical rhythm monitor. Clinically significant arrhythmia events include supraventricular arrhythmias, ventricular arrhythmias, sinus pauses, and conduction abnormalities/heart block | Up to 6 months |
Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.

Study Overview
=================
Brief Summary
-----------------
The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.

Detailed Description
-----------------
The main question it aims to answer are: Patency of the semibranch Feasibility of the technique regarding cannulation and stentgrafting The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.

Official Title
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Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.

Conditions
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Stent-Graft Endoleak, Aortic Aneurysm, Endovascular Aortic Repair

Intervention / Treatment
-----------------
* Device: Semibranch CMD branched aortic stentgraft


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 18 years or older Presence of pararenal or thoracoabdominal aortic pathology Treatment planned a semibranch device branch from Artivion Availability of the patients during the follow up period Informing patients about the study and providing written informed consent Exclusion Criteria: Women of childbearing age Patients under 18 years

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 |
| --- |
|Device: Semibranch CMD branched aortic stentgraft|bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from target vessel instability | primary patency and freedom from stenosis fo the semibranch | 30 days after intervention | 
| Mortality | overall mortality rate during 30 days after intervention | 30 days after intervention | 
| technical success | Feasibility in terms of cannulation and stentgrafting of the semibranches | During intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Access site, bowel ischemia, kidney failure, paraplegia | During follow up period (up to 3 years) | 
| freedom Endoleak Type I and III | absence of endoleaks arising from the semibranch | During follow up period (up to 3 years) | 
| Long term mortality | overall mortality up to 3 years | During follow up period (up to 3 years) | 
| Branch patency | primary patency of all branches | During follow up period (up to 3 years) |
Role of 18F-FDG PET/CT in Gastric Cancer

Study Overview
=================
Brief Summary
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The objective of the study is to assess the value of PET/CT in diagnosis, staging, response evaluation, and relapse monitoring of gastric cancer.

Detailed Description
-----------------
gastric cancer (GC) is the fifth most common malignancy and the third leading cause of cancer mortality worldwide (1) It carries a poor prognosis, with a 5-year survival of only 20%-30% (2) Clinical staging, based mainly on imaging, is critical in determining the best treatment.There is a widely accepted consensus of the usefulness of FDG PET/CT in staging and restaging of gastric cancer. According to evidence-based data, this modality can evaluate gastric cancer more accurately and is helpful for evaluation of tumor biologic characteristics, detection of lymph node and distant metastases, assessment of tumor response to therapy(9). retrospective and prospective study will conducted at Sohag oncology hospital, nuclear medicine unit& Assuit university hospital, nuclear medicine unit including 50 patients in 12 months .

Official Title
-----------------
Role of 18F-FDG PET/CT in Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
-----------------
* Device: pet -ct


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as GC on surgically resected specimens; Patients with gastric and extragastric metastasis. patients with gastric cancer either operated or not. Exclusion Criteria: Patients with second malignancy. Patient without proven pathology of cancer stomach. Severely ill patient (patient with disturbed conscious level, or couldn't lay supine during the imaging). uncontrolled diabetic patient with blood glucose level more than 200mg\dl. pregnant women

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pet -ct|assessment of added value of pet -ct in patients with gastric cancer and how patient get benefit from this finding|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of pet -ct finding with ct finding | The 18F-FDG PET/CT scan is visually estimated in the patients included in the study and quantitatively assessed by estimation of standardized uptake value(suv max). Statistical analysis of the included quantitative data. | base line |
Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.

Official Title
-----------------
Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions

Conditions
-----------------
Potentially Malignant Lesions, Oral Lichen Planus, Leukoplakia, Oral

Intervention / Treatment
-----------------
* Diagnostic Test: Real-time Polymerase Chain Reaction technique


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: participants will be divided into 3 groups: Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions. Exclusion Criteria: Subjects taking any drugs inducing any changes that could affect the salivary flow. Pregnant females. Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling. Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
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 |
| --- | --- |
| Oral Lichen Planus<br> | Diagnostic Test: Real-time Polymerase Chain Reaction technique<br>* Real-time Polymerase Chain Reaction technique<br>|
| Leukoplakia<br> | Diagnostic Test: Real-time Polymerase Chain Reaction technique<br>* Real-time Polymerase Chain Reaction technique<br>|
| Healthy control<br> | Diagnostic Test: Real-time Polymerase Chain Reaction technique<br>* Real-time Polymerase Chain Reaction technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary expression of lncDQ786243 in OLP, Leukoplakia, control |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary expression of miRNA146a in OLP, Leukoplakia, control |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lncRNA DQ786243, saliva, oral potentially malignant lesions, miRNA146a
Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Role of immunonutrition in modulating the lung microbiota of intubated TBJ patients and how this interaction may affect the infections and outcomes. For these reasons, the aims of our study are the evaluation of the impact of immunonutrition on the lung microbiota and the relationship between lung microbiota and infection in TBJ patients in ICU.

Detailed Description
-----------------
Traumatic brain injury patients, requiring mechanical ventilation admitted to ICU will be randomly divide in two groups receiving standard nutrition or specialized formula. Lower lavage (Bronco Alveolar Lavage: BAL) samples will be collected at admission in ICU and at day 7 for the microbiota analysis. Clinical follow-up at day 28 will be obtained

Official Title
-----------------
Lung Microbiota in Traumatic Brain Injury

Conditions
-----------------
Microbial Colonization

Intervention / Treatment
-----------------
* Dietary Supplement: standard enteral nutrition
* Dietary Supplement: specialized nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults (age > 18 years), paziente with traumatic brain injury Exclusion Criteria: pregnant women, patients with gastric content inhalation patients with chronic inflammatory bowel diseases patients underwent major abdominal surgery and/or organs/tissues transplant patients on corticosteroid and/or immunosuppressive therapy

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: specialized nutrition group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: microbiota and specialized nutrition<br>microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition | Dietary Supplement: specialized nutrition<br>* specialized enteral nutrition. The calories (25 kcal/kg/die) and protein (1.2 g/kg/die) target will be progressively reached in the first week of ICU stay.<br>|
| Sham Comparator: microbiota and standard nutrition<br>microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition | Dietary Supplement: standard enteral nutrition<br>* standard enteral nutrition. The calories (25 kcal/kg/die) and protein (1.2 g/kg/die) target will be progressively reached in the first week of ICU stay.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection | pulmonary infection in mechanically ventilated patients | pulmonary infection within 28 days |
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to perform a pilot study investigating the first attempt intubation success rate differing between video laryngoscope nasotracheal intubation and direct laryngoscope nasotracheal intubation. The study population will consist of 60 neonates and infants with congenital heart disease less than 1 year of age who need nasotracheal intubation during general anesthesia for cardiac procedures. Standard nasotracheal intubation will be performed using either a video laryngoscope or direct laryngoscopy. Neonates and infants will be randomly assigned (1:1) to standard video laryngoscopy (with one of the following systems: Storz C-MAC Miller Video Laryngoscope, Karl Storz, Tuttlingen, Germany or Mc Grath Video Laryngoscope, Medtronic, Boulder,USA) or to direct laryngoscopy with one of the following blades: Miller or Macintosh (Heine, Hersching, Germany).

Official Title
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Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation in Neonates and Infants With Congenital Heart Disease Less Than 1-year of Age Prior Cardiac Surgery: a Pilot Study

Conditions
-----------------
Congenital Heart Disease, Airway Complication of Anesthesia

Intervention / Treatment
-----------------
* Device: laryngoscopy


Participation Criteria
=================
Eligibility Criteria
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Inclusion criteria. Age less than 1 year Congenital heart disease Scheduled for cardiac surgery Planned postoperative ICU stay Exclusion criteria Nostrils not suitable for nasotracheal intubation Bleeding during dilation of nostrils

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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 |
| --- | --- |
| Active Comparator: Video<br>using video laryngoscopy for endotracheal intubation | Device: laryngoscopy<br>* laryngoscopy for nasotracheal intubation<br>|
| Active Comparator: Direct<br>using direct laryngoscopy | Device: laryngoscopy<br>* laryngoscopy for nasotracheal intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first attempt intubation success rate | number | study period, 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endotracheal intubation
Oral Health Related Quality of Life

Study Overview
=================
Brief Summary
-----------------
As oral health has a major impact on general health and quality of life, good oral health are essential. The aspects of oral health that are most important for each individual vary, and quality of life is subjective, and influenced by the person´s experiences, perceptions, expectations and ability to adapt to circumstances. FDI World Dental federations definition of oral health is; Oral health is multifaceted and includes the ability to speak, smile, smell, taste, touch, chew, swallow, and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and disease of the craniofacial complex.

Official Title
-----------------
Oral Health Related Quality of Life and Its Implications for Dental Health Care - a Swedish National Survey

Conditions
-----------------
Oral Health Related Quality of Life, Oral Disease

Intervention / Treatment
-----------------
* Behavioral: OHRQoL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Read and understand Swedish - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 18-85 years of age<br> | Behavioral: OHRQoL<br>* Oral health-related quality of life will be measured by the Oral Impact on Daily Performance (OIDP)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHRQoL | Questionnaire, Oral health problems in the last six months with eating, cleaning teeth, socializing. The questionnaire used will be OIDP | 2024-01-15 - 2024-12-31 |
Preoperative Anemia Frequency

Study Overview
=================
Brief Summary
-----------------
In our retrospective study, it was aimed to determine the frequency of anemia in non-emergency patients over the age of 18 who applied to the Anesthesiology and Reanimation Department of our hospital.

Official Title
-----------------
Preoperative Anemia Frequency

Conditions
-----------------
Preoperative Evaluation

Intervention / Treatment
-----------------
* Other: preoperative anemia frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -patient over 18 years old, Patients applying to the Department of Anesthesiology and Reanimation AD Exclusion Criteria: Pregnant, under 18 years old, will undergo cardiac and emergency surgery Patients with Massive Bleeding Patients who underwent multiple surgeries during the study period

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Those with anemia according to WHO definition (Group 1)<br> | Other: preoperative anemia frequency<br>* patients who applied to the outpatient clinic prospectively for 3 months<br>* Other names: blood transfusion frequency;|
| Those without anemia according to WHO definition (Group 2)<br> | Other: preoperative anemia frequency<br>* patients who applied to the outpatient clinic prospectively for 3 months<br>* Other names: blood transfusion frequency;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PREOPERATIVE ANEMIA FREQUENCY AND TREATMENT APPROACH | preoperative anemia frequency | Patients who applied to the outpatient clinic within a 3-month period after ethical approval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PREOPERATIVE ANEMIA FREQUENCY AND TREATMENT APPROACH | blood transfusion frequency | Patients who applied to the outpatient clinic within a 3-month period after ethical approval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preoperative evaluation, preoperative anemia