linjc16/ctgov huggingface dataset:
Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum?

Study Overview
=================
Brief Summary
-----------------
Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.

Official Title
-----------------
Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?

Conditions
-----------------
Gestational Diabetes Mellitus, Type 2 Diabetes

Intervention / Treatment
-----------------
* Procedure: Oral glucose tolerance test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dx of gestational diabetes treated with insulin To be in post-partum Delivery of a baby of at least 37 weeks of gestation Have signed the consent form Exclusion Criteria: History of glucose intolerance of diabetes before the pregnancy Obstetrical pathology during pregnancy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral glucose tolerance test<br>oral glucose tolerance test performed 48 hours post-partum and 8 weeks post-partum. | Procedure: Oral glucose tolerance test<br>* Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral glucose tolerance test | Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test | 8 weeks post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of screening test | Prefered moment to do the screening test (48 hours post partum or 8 weeks post partum) | 8 weeks post partum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Post-partum screening
Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.

Detailed Description
-----------------
It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.

Official Title
-----------------
Femoral Access Site Groin Complication Rates After 2517 Groin Punctures Undergoing Vascular Closure by Either Manual Compression or the Perclose Vascular Closure Device

Conditions
-----------------
Vascular Closure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital Patients who received vascular closure by manual compression at Tampa General Hospital Exclusion Criteria: Patients less than 18 years old

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 |
| --- | --- |
| Manual Closure<br>Patients who received vascular closure with manual compression after percutaneous coronary intervention (PCI) | |
| Perclose Device<br>Patients who received vascular closure with the Perclose VCD after percutaneous coronary intervention (PCI) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major vascular complications |  | 0-30 days (during Index hospitalization) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor vascular complications |  | 0-30 days (during index hospitalization) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perclose
A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to follow up patients, who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in the PEP005-020 study, over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.

Official Title
-----------------
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Lesion count


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures Patient achieved complete clearance of AK lesions (lesion count of 0) in the selected treatment area at the Day 57 visit in study PEP005-020 Exclusion Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study) Early termination from study PEP005-020

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> | Drug: Lesion count<br>* Lesion count in area treated by study drug in a prior study over a 12 month period No drug will be applied during this long-term follow up study. Drug was applied during the primary study.<br>* Other names: AK lesion recurrence;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarize treatment area recurrence of AK lesions in the selected treatment area |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarize long-term safety data (incidence of adverse events in the treatment area) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peplin, Actinic keratosis, PEP005
Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Geriatric patients who undergo general anesthesia experience post induction hypotension which is treated with intravenous fluids and ephedrine. The main cause of post-induction hypotension is the decrease in the sympathetic outflow causing arterial vasodilatation, a decrease in venous return and consequently the activation of the Bezold Jarish reflex (BJR) that elicits a triad of bradycardia, vasodilatation and further hypotension. BJR is elicited by activation of 5-HT3 receptors within the intracardiac vagal nerve endings. Glucocorticoids in general inhibit 5-HT3 expression and dexamethasone was found to decrease the level of 5-HT3 in the cerebral cortex and hippocampus in developing rats. So, the research team hypothesizes that dexamethasone can attenuate the postinduction hypotension in geriatric patients undergoing general anesthesia if administered preoperatively.

Official Title
-----------------
Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia: a Randomized Controlled Trial

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) Physical Status Class-I and II. Elective surgery under general anesthesia. Exclusion Criteria: Emergency surgeries. Ischemic heart disease. Peptic ulcer & active infection. Psychiatric disorder. Patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D Group (50 patients)<br> | Drug: Dexamethasone<br>* Patients will receive dexamethasone 8 mg diluted in 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.<br>|
| Placebo Comparator: C Group (50 patients)<br> | Other: Placebo<br>* Patients will receive 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg). | The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg). | intraoperative |
Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to verify the safety and accuracy of an FDA-approved device called the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the Inland Empire of Southern California, with subjects being enrolled at Loma Linda University Medical Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.

Official Title
-----------------
Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube After Intubation of Critically Ill Patients

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: NEMO Gauge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU) Patients who have been intubated or at high risk of being intubated, requiring confirmation of ETT position after intubation as determined by the clinical team Endotracheal tube size 7.0 mm to 8.5 mm in diameter Exclusion Criteria: Patients with active hemoptysis Patients with known tracheal or bronchial masses prior to endotracheal intubation Patients with known tracheal or bronchial abnormalities requiring surgical repair

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEMO Gauge<br>Measurement and adjustment of endotracheal tube position by stylet. | Device: NEMO Gauge<br>* Measurement and adjustment of endotracheal tube position by stylet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Correct Endotracheal Tube Position | The number of patients with correct Endotracheal tube position | Immediate, post-intervention |
A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

Study Overview
=================
Brief Summary
-----------------
Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical dysplasia without compromising the integrity of the cervix in reproductive age women.

Detailed Description
-----------------
Women age 18 to 55 years of age with Cervical Intraepithelial Neoplasia 2 or 3 on colposcopy with a negative EndoCervical Curettage are enrolled in a pilot study comparing ultrasonic surgical aspiration and traditional cervical excision procedure for the treatment of cervical dysplasia. In this pilot study, the patients serve as their own control group. Prior to receiving the traditional treatment for cervical dysplasia consisting of Cold Knife Conization with EndoCervical Curettage, each patient's cervix is treated with ultrasonic surgical aspiration. The aspirate is sent to pathology and the results compared with the findings from the cervical cone biopsy. The patients then are followed with Liquid-based Cytology pap smears every 4 to 6 months until completion of the study enrollment/treatment period.

Official Title
-----------------
A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

Conditions
-----------------
Cervical Dysplasia

Intervention / Treatment
-----------------
* Procedure: cervical conization
* Procedure: ultrasonic surgical aspiration of the cervix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical intraepithelial neoplasia II or III negative endocervical curettage not pregnant cervical conization is part of treatment plan Exclusion Criteria: positive endocervical curettage pregnant medically unable to undergo surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cervical conization|nan|
|Procedure: ultrasonic surgical aspiration of the cervix|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate treatment of cervical dysplasia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical, dysplasia
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.

Detailed Description
-----------------
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

Conditions
-----------------
Erosive Reflux Disease

Intervention / Treatment
-----------------
* Drug: Tegoprazan
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged between 19 and 75 years Subjects who have erosive reflux disease Exclusion Criteria: Unable to undergo upper GI endoscopy Symptoms of primary or secondary esophageal movement disorders Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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: Tegoprazan 50mg<br>Tegoprazan 50mg tablet, once daily, oral administration | Drug: Tegoprazan<br>* Tegoprazan 50mg tablet<br>|
| Active Comparator: Esomeprazole 40mg<br>Esomeprazole 40mg tablet, once daily, oral administration | Drug: Esomeprazole<br>* Esomeprazole 40mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first nighttime heartburn-free interval (days)) | Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials. | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of days without nighttime heartburn during the 2-week dosing period | Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100 | 2 week |
Study of T-PRED(TM) Compared to Pred Forte(R)

Study Overview
=================
Brief Summary
-----------------
Study of T-PRED(TM) compared to Pred Forte(R)

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: T-PRED
* Drug: Pred Forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Exclusion Criteria: No active or adverse disease

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T-Pred<br>Tobramycin prednisolone acetate combination | Drug: T-PRED<br>* T-PRED sterile ophthalmic solution<br>|
| Active Comparator: Pred Forte<br>Prednisolone acetate | Drug: Pred Forte<br>* Pred Forte sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Aqueous Humor Prednisolone Acetate Concentration |  | 4 hours |
Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

Detailed Description
-----------------
The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).

Official Title
-----------------
Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

Conditions
-----------------
Complication of Surgical Procedure, Leak; Blood

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly obese patients waiting for sleeve gastrectomy Exclusion Criteria: BMI<35 Kg/m2, Important comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 59 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: bleeding, leak, operative time<br> | Procedure: Bariatric surgery<br>* Staple line reinforcement during sleeve gastrectomy<br>* Other names: steaple line reinforcement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks. | a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed | six months |