linjc16/ctgov huggingface dataset:
The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of mifepristone on the expression of three cervical EP3 receptor isoforms (EP3-2, EP3-3 and EP3-6) in pregnant women ≤63 days gestational age.

Official Title
-----------------
Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone

Conditions
-----------------
Cervical Prostaglandin EP3 Receptors, Pregnancy

Intervention / Treatment
-----------------
* Drug: Mifepristone
* Other: Non-treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good general health ≥18 years old seeking termination of a viable intrauterine pregnancy of ≤63 days, without any evidence of a threatened or spontaneous abortion Exclusion Criteria: medical problems confirmed or suspected ectopic pregnancy having taken medications in the seven days prior to enrollment that would affect PG synthesis or metabolism of mifepristone

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone<br> | Drug: Mifepristone<br>* Administration of 200 mg of mifepristone orally 48 hours prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity<br>* Other names: mifeprex;|
| Active Comparator: Non-treatment<br> | Other: Non-treatment<br>* Non-treatment prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of expression of EP3 receptor mRNA levels in cervical tissue after the administration of mifepristone |  | 48 hours after the administration of mifepristone | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of cervical dilation after the administration of mifepristone |  | 48 hours after the administration of mifepristone | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervix, EP3 receptors, Mifepristone, Prostaglandin, Receptors, Steroids
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.

Official Title
-----------------
A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6-month dry eye history Exclusion Criteria: Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid Diagnosed with keratoconjunctival chemical burns or thermal burn Eye disease other than dry eye disease which needs treatment Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation Those who need to wear contact lenses during the clinical study Those who are considered inappropriate for this study by the investigator or subinvestigators

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3% DE-089 ophthalmic solution<br> | Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution<br>* Placebo ophthalmic solution; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 2-week run-in period 3% DE-089 ophthalmic solution; ; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 4-week treatment period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal fluorescein staining score | Change in corneal fluorescein staining score at week 4/ at the time of discontinuation | Week 4 |
Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study

Study Overview
=================
Brief Summary
-----------------
ECHAS One will test the use of a smartphone app to assist patients to decide if it is necessary to call for emergency care with symptoms that could represent a heart attack or stroke.

Detailed Description
-----------------
The ECHAS One Study will be conducted in 200 patients who have already called for emergency care for a heart or stroke, and have been evaluated. The endpoint of the study will be a decision if the initial call was an appropriate call for emergency care. The sensitivity of the app for detecting appropriate calls will be assessed.

Official Title
-----------------
Assessment of a Prehospital Mobile App and Sensor Triage System to Detect Neurologic and Cardiac Emergencies: The ECHAS Assessment Study (ECHAS- One)

Conditions
-----------------
Heart Attack and Stroke

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presented to ED via emergency medical services (EMS) for Stroke alert symptoms, including: Slurred speech Asymmetric weakness or numbness Balance problems Vision changes Headache And/or MI alert symptoms including: Chest discomfort Chest pressure or pain Palpitations Shortness of breath Lightheadedness or presyncope Syncope Age ≥ 18 years Able to provide informed consent Exclusion Criteria: Non-English speaking Moderate or greater dementia Severe visual impairment Inability to use smartphone (for physical, cognitive, or other reasons) Unable to consent for study

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 |
| --- | --- |
| Patients post emergency evaluation<br>Interview of patients post notification of emergency system | Other: Interview<br>* Patients will be interviewed post an emergency call and evaluation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriate Emergency Activation | Was the right call made for a possible heart attack or stroke | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Triage, Smartphone
Systemic Metabolic Rate of Diabetic Patients Before and After Bariatric Gastric Bypass Using the Breezing® Device.

Study Overview
=================
Brief Summary
-----------------
To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Detailed Description
-----------------
Objective of the research: Primary To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device. Secondary To measure the indirect metabolic rate by quantifying O2 gas consumption (g) and CO2 gas release (g); To analyze the 'population impact', that is, to measure using statistical tools how many cases of metabolic maladjustment could be prevented if the diabetes risk factor were to be eliminated; To correlate, by means of a regression test, if there is any dependence between the metabolic rate and the diabetes risk factor; To validate the accuracy of the Breezing® device. Evaluation of the risks and benefits Risks As the patient only needs to blow on the Breezing® device using a small straw (blower), the direct risks are minimal, perhaps contamination due to failure to exchange the blower. Thus, the risks are indirect and are more associated to the malfunctioning of the device. Benefits The advantage is that the procedure is simple and can provide results with important information about the metabolic rate even just using the iPhone or iPad of patients as a strategy to monitor metabolic control.

Official Title
-----------------
Prospective Clinical Study to Evaluate the Metabolism Using the Breezing Device in the Preoperative and Postoperative Periods of Gastric Bypass in Patients With Type II Diabetes.

Conditions
-----------------
Obesity, Diabetes Mellitus, Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years - Exclusion Criteria: obesity -
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device. | metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device. | 2 years |
Research Study in Patients With Persistent Macular Edema

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects. Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision. There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.

Official Title
-----------------
Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome

Conditions
-----------------
Diabetes, Macular Edema, Diabetic Retinopathy, Retinal Disease, Uveitis, Posterior

Intervention / Treatment
-----------------
* Drug: DEX PS DDS®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Persistent macular edema associated with diabetic retinopathy, uveitis, retinal vein occlusion, or Irvine-Gass syndrome, persisting at least 90 days after laser treatment or medical management by a physician. Exclusion: Females who are pregnant or lactating, and females of childbearing potential not using adequate birth control for the duration of the study. Any intraocular procedures or laser treatment less than 90 days before enrollment.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DEX PS DDS®|nan|

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
-----------------
Eye, Diabetes, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy, Cystoid Macular Edema, Uveitis, Vision, Retina, Retinal Vein Occlusion, Irvine-Gass Syndrome
Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer

Detailed Description
-----------------
Vimentin/Pan CK staining will be performed on tissues of patient who visited Seoul National University Hospital and were diagnosed with triple negative breast cancer and decided to perform neoadjuvant chemotherapy under clinical judgement. Histologically determined to be a metaplastic breast cancer or tested positive for vimentin/Pan CK patients decides as the metaplastic breast cancer. They evaluate the response rate of the neoadjuvant chemotherapy. Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer and this group also confirms the response rate of neoadjuvant chemotherapy. The group of metaplastic breast cancer will enroll 50 people, and the group of non-metaplastic breast cancer will enroll 100 people.

Official Title
-----------------
Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer

Conditions
-----------------
Metaplastic Breast Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Vimentin/pan CK stain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 20 years old patients with triple negative breast cancer diagnosed Seoul National University Hospital patients who decided to perform neoadjuvant chemotherapy under clinical judgement Exclusion Criteria: not applicable

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metaplastic breast cancer<br>Histologically determined to be a metaplastic breast cancer or tested positive for vimentin/Pan CK patients decides as the metaplastic breast cancer. | Diagnostic Test: Vimentin/pan CK stain<br>* Vimentin/pan CK stain positive/negative<br>|
| non-metaplastic breast cancer<br>Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate of neoadjuvant chemotherapy | response criteria for neoadjuvant chemotherapy-complete response (CR), partial response (PR), and no response (NR) | After neoadjuvant chemotherapy was finished. Average 6 month later. |
Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain Injured Patients.

Study Overview
=================
Brief Summary
-----------------
Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation. To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients

Official Title
-----------------
Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients

Conditions
-----------------
Severe Brain Injury

Intervention / Treatment
-----------------
* Other: Collection of medical data from ICU patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring ≥ 48 hours of mechanical ventilation after admission Exclusion Criteria: Pregnant women Patient consent withdrawal

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 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 |
| --- | --- |
| ICU PATIENTS<br>Patients with brain-injury | Other: Collection of medical data from ICU patients<br>* A code will be applied to each patient included. Medical data such as demography, ISS, clinical exam at time of extubation, extubation failure, tracheotomy, will be collected during ICU stay.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation failure | Extubation failure is regarded as the need of intubation in the 48 hours following extubation Establish clinial signs before extubation that can predict extubation failure Realization of a systematic clinical examination by the attending physician before performing extubation in severe brain-injured patients | In the 48 hours following extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of extubation failure | Impact of extubation failure on Duration of mechanical ventilation Length of ICU stay Mortality Describing reasons | Median 14 days after Intensive Care Unit (ICU) admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain-injury, extubation
Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Clinical Trial (Pilot Phase) to Evaluate the Efficacy of a Medical Nutrition Product, PTM202, in Children With Acute Diarrhea

Conditions
-----------------
Acute Diarrhea

Intervention / Treatment
-----------------
* Other: PTM202
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or females between 6 months and 5 years of age acute diarrhea (<48 hours) without interfering co-morbidities guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on Day 7 for a final evaluation Guardian is willing and able to report to the Investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase. Written informed consent must be obtained prior to admission to this study. The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea. Exclusion Criteria: Suspected or confirmed cholera Suspected dysentery Symptom duration >48 hours at screening Vomiting severity that is like to make administration and retention of test article impossible Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6). Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening. History of hypersensitivity or allergy to milk or egg

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 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 |
| --- | --- |
| Experimental: PTM202<br>PTM202 is a medical nutrition product | Other: PTM202<br> <br> |
| Placebo Comparator: Placebo<br>The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diarrhea duration |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| food intake |  | 7 days | 
| stool frequency |  | 7 days | 
| stool consistency |  | 7 days |