linjc16/ctgov huggingface dataset:
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals

Study Overview
=================
Brief Summary
-----------------
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.

Detailed Description
-----------------
The study had the following objectives: Verify that the CoVa Monitoring System does not interfere with implanted devices. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System. Verify that the CoVa Monitoring System fits on a wide variety of body types.

Official Title
-----------------
Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device

Conditions
-----------------
Heart Failure, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening. Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study. Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition. Exclusion Criteria: Subject is participating in another clinical study that may affect the results of either study. Subject is unable or not willing to wear electrode patches as required. Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches. Subject is considered by the PI to be medically unsuitable for study participation.

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 |
| --- | --- |
| Cohort 1<br>Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Interference between implanted devices and CoVa Monitoring System |  | One time for up to 15 minutes during a clinic visit for device interrogation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluids, Hypertension, Heart Failure
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Study Overview
=================
Brief Summary
-----------------
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial. IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery. The study was powered to detect 10% difference in 3 year OS.

Conditions
-----------------
Rhabdomyosarcoma, Malignant Soft Tissue

Intervention / Treatment
-----------------
* Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 6 months and < 18 years no distant metastases diagnosis within previous 8 weeks without prior treatment except surgery pathology available for central review written consent according to institutional requirement Exclusion Criteria: stage III (node positive) stage I or II non alveolar orbital tumours patients with parameningeal disease aged < 3 years

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

| Intervention/Treatment |
| --- |
|Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore survival advantage for an intensified chemotherapy strategy in a randomised trial |  |  |
Care of Critically Ill Patients Enteral Nutrition Guidelines for the Implementation of the Effectiveness of the Intervention

Study Overview
=================
Brief Summary
-----------------
This study is to find out care of critically ill patients enteral nutrition guidelines for the implementation of the effectiveness of the intervention.

Official Title
-----------------
Care of Critically Ill Patients Enteral Nutrition Guidelines for the Implementation of the Effectiveness of the Intervention

Conditions
-----------------
ICU Ill Patients, Enteral Nutrition Feeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients elder than 18 years of age (APACHE II) score > 15 Patients expected to remain in ICU for more than 2 days Exclusion Criteria: Patients that have consented to a Do-Not-Resuscitate document Patients not expected survive more than 2 days Patients that have returned to ICU due to their condition worsening after previously leaving ICU Patients that have transferred from ICU of other hospitals.

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 |
| --- | --- |
| Experimental Group<br> | |
| Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enteral nutrition feeding
Changes in Digital Phenotype During PE Therapy

Study Overview
=================
Brief Summary
-----------------
PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD. The current study is a non-interventional observational study, aimed at measuring changes in the digital phenotype of participants with PTSD during and following PE therapy. Physiological data will be collected using wearable sensors during the sessions, and participants will be assessed using questionnaires and psychiatric assessments before and after the completion of their imaginal or writing based PE therapy (10-15 sessions).

Official Title
-----------------
Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch

Conditions
-----------------
PTSD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD diagnosis Proper ability to give informed consent Exclusion Criteria: Active psychotic or suicidal symptoms Severe dissociative symptoms A traumatic brain injury (TBI) diagnosis Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Imaginal PE<br> | |
| Writing PE<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Heart Rate | Heart Rate and HRV (Heart Rate Variability) | 3 months | 
| Changes in Saturation | Changes in saturation SPO2 (oxygen saturation by pulse oximetry) | 3 months | 
| Changes in blood pressure | Changes in Continuous Blood Pressure | 3 months | 
| Changes in Pulse Pressure | Changes in Pulse Pressure | 3 months | 
| Changes in Respiratory rate | Changes in Respiratory rate | 3 months | 
| Changes in Stroke Volume | Changes in Stroke Volume | 3 months | 
| Changes in Systemic Vascular Resistance | Changes in Systemic Vascular Resistance | 3 months | 
| Changes in sweat | Changes in Sweat | 3 months | 
| Changes in Body Temperature | Changes in Body Temperature | 3 months | 
| Changes in Cardiac Output | Changes in Cardiac Output | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between changes in digital phenotype (multiple measures) | Correlation between changes in digital phenotype during the sessions and the clinical improvement according to the psychiatric evaluation and questionnaires. | 3 months |
Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair

Study Overview
=================
Brief Summary
-----------------
The study will include 40 patients who fulfil all the points in the inclusion and exclusion criteria will be randomized into two equal groups, each consisting of 20 patients, namely group (B) and group (C). Group (B): will receive erector spinae plane block. Group (C): will not receive any block. Postoperative pain score will be assessed using the FLACC scale or Face, Legs, Activity, Cry, Consolability scale immediately after extubation and at 1, 2, 4, 6, 8, 12, 18, and 24 hours. Routine postoperative analgesia in the form of intravenous paracetamol 7.5 mg/kg/6 hours will be given to all patients (the first dose is given after skin closure). Rescue analgesia in the form of 1 ug/kg fentanyl intravenously for patients if FLACC scale > 4, and the time for the first rescue analgesic administration will be recorded.

Official Title
-----------------
Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: Nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients presented for aortic coarctation repair via left thoracotomy. Exclusion Criteria: Hypersensitivity to local anesthetic. Mental or neurologic disorders. Preoperative critically ill patients. Parents or legal guardian refusal. Infection at the site of injection. Any liver disease. Any coagulopathy.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group (B): will receive erector spinae plane block.<br>unilateral ultrasound-guided erector spinae plane block using bupivacaine 0.25% (on the left side) with total volume 0.5 ml/kg and a maximum dose of 2 mg/kg of bupivacaine in erector spinae plane block group patients | Procedure: Nerve block<br>* unilateral ultrasound-guided erector spinae plane block using bupivacaine 0.25% (on the left side) with total volume 0.5 ml/kg and a maximum dose of 2 mg/kg of bupivacaine in erector spinae plane block group patients<br>|
| No Intervention: • Group (C): will not receive any block.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of times for usage of fentanyl in postoperative period |  | in the first 12 hours. |
Postoperative Desogestrel for Endometriosis Related Pain

Study Overview
=================
Brief Summary
-----------------
Endometriosis is one of the most common disease in reproductive aged women.Surgical intervention has a significant symptoms relief. However, symptom recurrence is often after surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary outcome measurement is pain score at 6 months after surgery.

Detailed Description
-----------------
After conservative surgery, the patients are randomized to Desogestrel and placebo groups. VAS pain score are compared after complete 6 months

Official Title
-----------------
A Prospective Double Blind Randomized Controlled Trial to Study the Effectiveness of a Desogestrel for the Treatment of Pelvic Pain or Dysmenorrhea in the Patients Undergone Conservative Surgery for Pelvic Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Desogestrel
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnoses endometriosis Plan conservative surgery initial pain score at least 5 voluntary to be the participant of this study with inform consent No desired child bearing in 6 months Exclusion Criteria: residual lesion after surgery which required further treatment cannot participate complete 6 months after surgery contraindication for Desogestrel, Paracetamol or Ponstan Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desogestrel<br> | Drug: Desogestrel<br>* Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months<br>* Other names: Cerazette;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsule takes 1 capsule before bedtime for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score will be assessed by visual analog scale (0-10) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect compared between both group |  | 6 month | 
| Patients satisfaction compare between both groups |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Desogestrel, Placebo
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.

Conditions
-----------------
Erosive Gastritis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: SK-MS10
* Drug: SK-MS10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment. Patients who voluntarily signed written informed consent may participate in the study. Exclusion Criteria: Pregnant or lactating female. Patients have gastric ulcer, duodenal ulcer and GERD. Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy Patients requiring corticosteroid therapy Severe neurological or psychological disease History of allergic reaction to the medications used in this study Use of other investigational drugs within 30 days prior to the study. Patients that investigators consider ineligible for this study

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dosage<br>|
| Experimental: SK-MS10 160mg t.i.d<br> | Drug: SK-MS10<br>* Dosage<br>|
| Experimental: SK-MS10 320mg t.i.d<br> | Drug: SK-MS10<br>* Dosage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rates of erosive gastritis according to the sydney classification |  | Change from Baseline in the grade of erosive gastritis at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rates of erosive gastritis according to the sydney classification |  | Change from Baseline in the grade of gastric erosions at 2 weeks | 
| Improvement rates of erosive gastritis by estimated the number of erosion |  | Change from Baseline in the number of gastric erosions at 2 weeks | 
| Healing rates of edema according to the sydney classification |  | Change from Baseline in the grade of edema at 2 weeks | 
| Improvement rates of erythema according to the sydney classification |  | Change from Baseline in the grade of erythema at 2 weeks | 
| Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement |  | Change from Baseline in the grade of hemorrhage at 2 weeks | 
| Improvement rates of symptoms using Korean NDI |  | Questionaire at baseline and then week 2 |
Optimizing the Influenza Clinical Decision Support Tool

Study Overview
=================
Brief Summary
-----------------
The proposed study aims to examine several iterations of the Influenza Best Practice Alert at NYU Langone Health. The goal is to increase ordering of the influenza vaccine through the alert.

Official Title
-----------------
Optimizing the Influenza Clinical Decision Support Tool

Conditions
-----------------
Clinical Decision Support

Intervention / Treatment
-----------------
* Other: Current Version of the Influenza Alert
* Other: Alternate Modifications of the Influenza Alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All NYU Langone Health inpatients eligible for the Influenza clinical decision support tool Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>The current version of the alert will fire for this arm of the study. | Other: Current Version of the Influenza Alert<br>* Intervention includes the current version of the Influenza Alert that fires in the electronic medical record if the patient has not received the flu vaccination, as part of usual care.<br>|
| Active Comparator: Alert Iteration<br>A modified version of the alert will fire for this arm of the study. | Other: Alternate Modifications of the Influenza Alert<br>* Intervention includes various iterations of the Influenza Alert that fires in the electronic medical record if the patient has not received the flu vaccination.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alert Cancelation Rate | Number of times alert fires in medical record within 2 Month period | 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination Rate at Discharge | Number of vaccinations recorded in EMR within 2 Month period | 2 months |
Does Body Composition Predict Running Time?

Study Overview
=================
Brief Summary
-----------------
Several studies performed in elite endurance athletes have shown that running performance may be determined by a low fat mass in the overall population. The Course de l'Escalade occurs yearly during the first week-end of December. This race takes place in the city of Geneva. The distance of this race is 7.3 km for all men and elite women, and 4.8 km for non-elite women. During this race, measurement of body composition by biolelectrical impedance analyses (BIA) were performed in volunteer, between December 1999 and 2017. Hypothesis : We hypothesize that: A low fat mass is associated with a slower running time, when adjusting for age, body weight, and habitual physical exercise. An increase in fat mass over time increases running time over the years Objectives : To evaluate whether total and regional body composition is associated with running time at the Course de l'Escalade. To determine whether changes in body composition with progressive aging lead to changes in running time.

Official Title
-----------------
Does Body Composition Predict Running Time?

Conditions
-----------------
Body Composition, Running Performance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects who underwent a measurement of body composition by tetrapolar bioelectrical impedance analyses (BIA) at the Course de l'Escalade, a fun race occurring yearly in Geneva, between December 1999 and 2017. Exclusion Criteria: Measurements of people <18 years at the time of BIA measurement. Measurements of people who did not perform or finish the race.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between total and regional body composition and running time at the Course de l'Escalade | Body composition measured by bioelectrical impedance analyses. Running time timed. | One day per year between 1999 and 2017 (i.e. the day of the Course de l'escalade) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between changes in body composition with progressive aging and changes in running time at the Course de l'Escalade | Body composition measured by bioelectrical impedance analyses. Running time timed. | One day per year between 1999 and 2017 (i.e. the day of the Course de l'escalade) |