linjc16/ctgov huggingface dataset:
Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to treat patients with on-going slow stomach emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy

Detailed Description
-----------------
This is a study on the effectiveness of domperidone, which increases movement through the digestive system for relief of symptoms, in patients who have delayed gastric solid-phase emptying

Official Title
-----------------
Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying

Conditions
-----------------
Digestive System Disease

Intervention / Treatment
-----------------
* Other: Domperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent esophagitis Heartburn Nausea Vomiting Severe dyspepsia Severe chronic constipation Exclusion Criteria: History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Other: Domperidone<br>Domperidone will be given at 10 mg before each meal and at bedtime. At completion of the study, patients will receive standard medical therapy | Other: Domperidone<br>* Domperidone dosage may be increased depending on how well the patient responds. However before increasing the dosage, patients will have follow-up EKG to evaluate any possible side effects including irregular heartbeats.<br>* Other names: Motillium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying | GERD or Delayed Gastric Emptying | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digestive System Diseases Disease
Perioperative Hypoxemia in Pediatrics

Study Overview
=================
Brief Summary
-----------------
The primary aim was to develop and validation of perioperative hypoxemia using clinical big data and deep learning technique in pediatric patients

Official Title
-----------------
Development and Validation of Perioperative Hypoxemia Using Clinical Big Data and Deep Learning Technique in Pediatric Patients

Conditions
-----------------
Hypoxemia

Intervention / Treatment
-----------------
* Other: Retrospective analysis cohort
* Other: Prospective validation cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients undergoing general or spinal anesthesia and monitored anesthesia care Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Retrospective analysis cohort|We analyze pre-existing data base and develop machine-learning-based system that predicts the risk of hypoxemia|
|Other: Prospective validation cohort|We validate our model to predict the risk of hypoxemia to prospective cohort|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoxemia | pulse oximetry desaturation below 95% | from induction of anesthesia to end of operation, about 3 hours |
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study

Study Overview
=================
Brief Summary
-----------------
This research is to determine which medication, Esmesol (PPI) or Placebo works best at reducing the chance that a patient will get an marginal ulcer after pancreaticoduodenectomy.

Official Title
-----------------
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study

Conditions
-----------------
Pancretic Dissease (Benign/Malignancy), BIle Duct Diseae(Benign/Malignancy), Ampulla of Vater Disease (Benign/Malignancy)

Intervention / Treatment
-----------------
* Drug: Arm I (Placebo),
* Drug: Arm II (ESMESOL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test Exclusion Criteria: - Subject allergic to ESMESOL Patient receiving antifungal (i.e. ketoconazole or itraconazole) Hepatic insufficiency History of Crohns disease History of Zollinger-Ellison disease Patient received an investigational drug within 30 days of enrollment Previous Gastric Surgery HX

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Interventional Model Description: Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months<br>Placebo beginning day of hospital discharge following PPPD for 6 months | Drug: Arm I (Placebo),<br>* Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months<br>|
| Experimental: Esmesol 40mg after PPPD for 6 months<br>Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months | Drug: Arm II (ESMESOL)<br>* SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal ulcer incidence | Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers | Time Frame: during first 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL | Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | Time Frame: during first 6 months after surgery |
Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination

Study Overview
=================
Brief Summary
-----------------
This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.

Detailed Description
-----------------
Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and compared to the prevalence in 2016-2017.

Official Title
-----------------
Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination

Conditions
-----------------
Human Papillomavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Aged 17 to 19 Able to complete study requirements Residing in Australia from 12 years of age Exclusion Criteria: -Males reporting sex with males in the past 12 months

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-school based vaccination program (not vaccine eligible)<br>Young (17-19 years) men who were not eligible for school based vaccination due to their age at the time of the programs roll out. | |
| Post-school based vaccination program (vaccine eligible)<br>Young men (17-19 years) who were eligible for school based vaccination due to their age at the time of the programs roll out. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Penile HPV Genotypes | Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array. Participants provided a single penile sample. | Single study visit (one time point per participant) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevalence, HPV, Human papillomavirus, Vaccination
Screening and Access to Health Care for Vascular Disease

Study Overview
=================
Brief Summary
-----------------
This is a pilot study designed to validate our methods of recruitment, screening and data collection in the community. The project will help to establish the feasibility of the study design to lay the groundwork for a potentially larger study. The final study will allow us to estimate the incidence and prevalence of abdominal aortic aneurysm (AAA), carotid artery stenosis, and peripheral artery disease (PAD) in different geographic areas in a large urban setting, as well as determine patient access to healthcare and treatment for vascular disease as related to geographic and racial differences.

Official Title
-----------------
Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations

Conditions
-----------------
Aortic Aneurysm, Abdominal, Carotid Stenosis, Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 55 or older willing/able to provide consent willing to participate in follow-up phone calls at defined intervals for up to 5 years Exclusion Criteria: unable to provide consent to participate unwilling/unable to participate in the follow-up phone call

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- | --- |
| Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geographical and racial differences in patterns of accessing healthcare prior to the screening events. |  | 1 year | 
| Differences in rates of interventions throughout the 5 year follow-up period. |  | 5 years | 
| Differences in the rates of complications related to treatment of vascular disease in the various geographic areas in which the events are held. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Aneurysm, Abdominal, Carotid Stenosis, Peripheral Arterial Disease, Health Services Accessibility
Value of Ultrasound and Computed Tomography in the Diagnosis of Acute Appendicitis With Histopathology as Gold Standard.

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective evaluation of all patients treated surgically for appendicitis over a period of 3 years at the Sint- Andries Hospital, Tielt. Belgium. The goal is to evaluate the value of ultrasound (US), computed tomography (CT) and laboratory testing in diagnosing acute appendicitis and to look for the possible impact on the treatment.

Official Title
-----------------
Value of Ultrasound and Computed Tomography in the Diagnosis of Acute Appendicitis With Histopathology as Gold Standard - Retrospective Cohort Study.

Conditions
-----------------
Appendicitis Acute

Intervention / Treatment
-----------------
* Diagnostic Test: Radiologic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of acute appendicitis Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| US<br>Ultrasound | |
| CT<br>Computed tomography | |
| US after CT<br>Ultrasound after Computed tomography | Diagnostic Test: Radiologic examination<br>* Patients underwent US, CT or CT after US<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of diagnostic test | For US and CT sensitivity and specificity for diagnosing acute appendicitis were evaluated. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, General Surgery, Ultrasound, Computed Tomography
Validation of a New Device to Measure Neuromuscular Disease Progression

Study Overview
=================
Brief Summary
-----------------
There is a great need for the development of sensitive outcomes that allow experimental drugs to be tested in human subjects more efficiently. If we could more precisely measure whether an experimental drug slows the progression of ALS or other neuromuscular diseases, this would allow more drugs to be tested quicker and at less expense. We have developed a new device that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength (ATLIS). This device was designed to be portable, quick, and easy to use, while generating accurate and reliable, interval level data. This study will enable us to test the reliability and validity of ATLIS.

Official Title
-----------------
Validation of a New Device to Measure Neuromuscular Disease Progression

Conditions
-----------------
Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must be at least 18 years old and able to provide informed consent All subjects have no health conditions that limit their ability to safely exert maximal force using the muscles in their arms and legs. Subjects with a diagnosis of laboratory supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial, as determined by their referring neurologist at MGH. All subjects must be able to speak and understand English. Exclusion Criteria: Presence of significant arthritis, orthopedic conditions, or cardio-pulmonary conditions or other medical conditions that may limit the ability to maximally exert force safely.

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>Individuals with ALS | |
| 2<br>Healthy Adults | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| isometric strength measures |  | cross sectional | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Strength testing, Disease progression, ALS, Healthy Adults
A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.

Official Title
-----------------
A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: LT3001 Drug Product
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 90 years NIHSS of 4 to 30 Diagnosis of AIS within 24 hours after stroke symptoms onset Exclusion Criteria: Treatement with approved drug during the current AIS Pre-stroke disability Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment Suspected subarachnoid hemorrhage Seizure Uncontrolled hypertension INR >1.7 and/or abnormal aPTT or platelet count <100,000/mm3 Blood glucose concentration <50 mg/dL or >400 mg/dL Lactating or pregnant subjects or those planning to become pregnant during the study Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours AIS, myocardial infarction, serious head trauma or major surgery within 90 days Bleeding event within 21 days Puncture of noncompressible vessels within 7 days Severe hepatic, renal, and/or infectious disease

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LT3001 Drug Product<br> | Drug: LT3001 Drug Product<br>* Active comparator<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subject have symptomatic intracranial hemorrhage (sICH) of a single dose LT3001 drug product in subjects with AIS. | Compare the the percentage of subject having symptomatic intracranial hemorrhage (sICH) between LT3001 drug product and Placebo. | Within 36 hours |
Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.

Official Title
-----------------
Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress

Conditions
-----------------
Heat Stress, Fatigue

Intervention / Treatment
-----------------
* Other: Hot Dry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals Regularly completes aerobic exercise at least 60 min per week Exclusion Criteria: History of cardiovascular, metabolic, respiratory, neural, or renal disease Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure > 139 mmHg, Diastolic Blood Pressure > 89 mmHg, heart rate > 100 bpm) Current tobacco or nicotine use or previous regular use within the past 2 years Current or previous musculoskeletal injury limiting physical activity Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.) A positive pregnancy test at any point during the study or currently breastfeeding Study physician discretion based on any other medical condition or medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hot Dry<br>The participant will complete four hours of work at a 45:15 work rest cycle in a 98°F (36.7°C) and 20% relative humidity environment. | Other: Hot Dry<br>* 98°F (36.7°C) and 20% relative humidity environment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fatigue | Fatigue will be measured using accelerometry, with the primary variable being jerk, the smoothness or unevenness of movement. | Hour 4 | 
| Biomarkers of acute kidney injury | Tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) are biomarkers that have the potential for early prediction of acute kidney injury. | Hour 4 |