linjc16/ctgov huggingface dataset:
Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.

Official Title
-----------------
Determining the Efficacy of Using FEES Compared to VFSS to Diagnose Laryngeal Penetration and Aspiration in Infants in the Neonatal Intensive Care Unit (NICU)

Conditions
-----------------
Deglutition Disorders

Intervention / Treatment
-----------------
* Other: VFSS
* Other: FEES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 37 weeks or more postmenstrual age Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician Inpatient at Baylor University Medical Center NICU Exclusion Criteria: Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician Bilateral complete cleft lip and palate

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEES<br>Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing | Other: FEES<br>* Fiberoptic Endoscopic Swallow Study<br>|
| Active Comparator: VFSS<br>Swallowing evaluation with the Videofluoroscopic Swallowing Study | Other: VFSS<br>* Videofluoroscopic Swallow Study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High sensitivity and specificity values for FEES |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of laryngeal penetration or tracheal aspiration during breastfeeding |  | at time of assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deglutition Disorders, Intensive Care Units, Neonatal
Ethnopharmacological Studies in Oral Medicine

Study Overview
=================
Brief Summary
-----------------
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.

Detailed Description
-----------------
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain relief in Central and South America.

Official Title
-----------------
Ethnopharmacological Studies in Oral Medicine

Conditions
-----------------
Oral Pain, Oral Ulcers, Oral Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who use plants to relieve oral pain, inflammations, ulcers, and tumors
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
oral mucosal pain, oral inflammations, anisillo, cordonsillo, Piperaceae, oral ulcers, oral tumors, mucosal pain, mucosal inflammations, cordoncillo
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).

Official Title
-----------------
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)

Conditions
-----------------
Diabetic Macular Edema, Diabetic Retinopathy, Retinal Ischemia

Intervention / Treatment
-----------------
* Drug: Ozurdex Drug Implant Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years and Older. Diagnosis of diabetes mellitus (type 1 or type 2). At least one eye meets the study eye criteria listed. Visual Acuity 20/30 - 20/200 Snellen equivalent Have received no previous treatment for diabetic macular edema,(treatment naïve) Mild to Severe Non-proliferative Diabetic Retinopathy Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm. Able and willing to provide informed consent. Exclusion Criteria: Have had any prior ocular treatment. Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy. 4. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D >/= 0.5 with correlated NFLA thinning or IOP>25mmHg). 6. Have a contraindication to Ozurdex.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ozurdex Implant<br>Intravitreal injection of Ozurdex implant | Drug: Ozurdex Drug Implant Product<br>* Intravitreal Ozurdex injection<br>* Other names: Dexamethasone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate re perfusion following Ozurdex use. | Determined by OCT-A | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Macula Edema, Diabetic Retinopathy, Retina Ischemia
China Post-Market Clinical Follow-up of FACILLE®

Study Overview
=================
Brief Summary
-----------------
The results showed that subjects tolerated the Sodium Hyaluronate Gel for Injection (FACILLE®) well, with no systemic AEs, SAEs, and unanticipated AEs and associated with high satisfaction and self-evaluated effectiveness. Nearly half of the subjects maintained correction for 12 months and were satisfied with the product 3 years after the first injection.

Official Title
-----------------
China Post-Market Clinical Follow-up of FACILLE®

Conditions
-----------------
Dermal Filler, Hyaluronic Acid, Nasolabial Fold

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older of male or female; Have used or plan to use FACILLE® Sodium Hyaluronate Gel for Injection; Agree to participate and comply with the follow-up schedule of this study. Exclusion Criteria: With a history of hypersensitivity or allergy to hyaluronic acid or any component of the device; Other circumstances were judged to be unsuitable for participating in the study by the investigator.

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 |
| --- | --- | --- |
| Adverse events reported during the study period | The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects self-evaluating satisfaction | Patients rate their treatment satisfaction based on highly satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied. | 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection | 
| Subjects self-evaluating effectiveness | Patients rate their effectiveness based on effective and ineffective. | 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection |
Insulin Action: Role of Skeletal Muscle and Insulin-Mediated Blood Flow

Study Overview
=================
Brief Summary
-----------------
The overall objective of this proposal is to examine the contribution of changes in total body fat, enhancement in insulin-mediated vasodilatation and enhancement in endothelium-derived nitric oxide production to the improvements in metabolic insulin action. In addition, the study will track whether these improvements are related to changes in blood pressure.

Official Title
-----------------
Insulin Action: Role of Skeletal Muscle and Insulin-Mediated Blood Flow

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Age 50 - 75 years, elevated blood pressure, BMI greater than 25 but less than 40 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure, insulin sensitivity, blood flow
Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices

Study Overview
=================
Brief Summary
-----------------
This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper and/or lower endoscopy.

Official Title
-----------------
Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices While Being Passively Monitored

Conditions
-----------------
Sedation for Non-Emergent Upper and/or Lower Endoscopy

Intervention / Treatment
-----------------
* Device: Passive monitoring with pulse-oximetry, NIBP and ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:adult (>=18 years),ASA I-III, non-emergent upper and/or lower endoscopy Exclusion Criteria: Emergent indications for upper and/or lower endoscopy (i.e., acute hemorrhage, cholangitis) Baseline respiratory rate of < 6 breaths per minute Baseline hypotension (systolic blood pressure < 90 mm Hg) Baseline arterial oxygen saturation < 90% on room air Baseline bradycardia: heart rate < 50 beats per minute Baseline tachycardia: heart rate > 110 beats per minute Allergy or inability to tolerate any of the sedatives or analgesics to be administered during the procedure Inability to squeeze the Automated Responsiveness Test hand piece (last 50 subjects only) Significant hearing impairment Actively abusing alcohol, opioids, benzodiazapines or sedatives, or other drugs Are considered tolerant to opioids, benzodiazapines and/or other sedatives through prescription.

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: Passive monitoring with pulse-oximetry, NIBP and ECG|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Short Versus Long Wire ERCP Systems

Study Overview
=================
Brief Summary
-----------------
This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system.

Official Title
-----------------
Prospective Randomized Blinded Comparison of a Short-wire ERCP System to Traditional Long-wire Devices

Conditions
-----------------
Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
-----------------
* Procedure: ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing ERCP. Exclusion Criteria: Age less than 18 years, pregnant women, patients unable to provide informed concent, prior surgery causing a significant change in the anatomy of the papilla (Billroth II or Roux-en-Y)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Short-wire device<br>The Fusion Short-wire ERCP device was used | Procedure: ERCP<br>* Patients with clinical indication for ERCP were invited to participate in the Study<br>|
| Long-wire device<br>The traditional Long-wire ERCP device was used | Procedure: ERCP<br>* Patients with clinical indication for ERCP were invited to participate in the Study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for device exchange and stent insertion |  | during the ERCP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, Study focus was to compare the performance of the ERCP short-wire device versus the Long-wire device.
Chagas Disease Diagnostic - Inconclusive Serology

Study Overview
=================
Brief Summary
-----------------
T. cruzi infection affects approximately five million people in Brazil. The diagnosis of the chronic phase of infection is performed by indirect serological methods which, nevertheless, leave inconclusive results. One of the direct methods used for T. cruzi identification, blood culture in LIT (liver infusion tryptose) medium, presents low sensitivity in that phase of the disease. A negative result does not eliminate the possibility of infection, but a positive test has high absolute diagnostic value, which enables the indication of antiparasitic treatment. Molecular diagnosis (PCR) in this phase is promising and can be used as a confirmatory test, particularly when individuals present inconclusive results in conventional serological tests, such as ELISA, HAI and IFI. This study aimed at improving blood culture sensitivity in LIT medium by performing PCR in individuals with positive and inconclusive serology for chagasic infection.

Official Title
-----------------
PCR in Blood Cultures of Individuals With Positive and Inconclusive Serology for Chagas' Disease

Conditions
-----------------
Parasitemia, Protozoan Infections

Intervention / Treatment
-----------------
* Other: chagas disease diagnostic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals with positive or inconclusive results in conventional serological tests: ELISA, HAI and IFI for Chagas disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: chagas disease diagnostic|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder

Conditions
-----------------
Urinary Incontinence, Overactive Bladder

Intervention / Treatment
-----------------
* Drug: MK0594


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with predominantly urge incontinence overactive bladder episodes Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards Exclusion Criteria: History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia Lower urinary tract symptoms associated with benign prostatic hypertrophy Active or current Urinary Tract Infections (UTIs) Surgery to correct prolapsed uterus or stress incontinence

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0594|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline in average daily micturitions as recorded on patient voiding diaries. | Change in baseline in average daily micturitions as recorded on patient voiding diaries. | Duration of Trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of dry mouth. | The incidence of dry mouth. | Duration of Treatment | 
| Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. | Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. | Duration of Treatment | 
| Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms. | Global assessment of improvement in UI, perception of urgency, and bother of UI | Duration of Treatment |
Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Official Title
-----------------
Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: insulin NPH
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs HbA1c between 8.0-10.5% Body mass index (BMI) below 35.0 kg/m2 Able and willing to perform self-monitoring of blood glucose Exclusion Criteria: Total daily insulin dose of 1.80 IU/kg or more Known or suspected allergy to trial product or related products Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: insulin NPH|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 4 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8-point blood glucose profile |  |  | 
| incidence of hypoglycaemic episodes |  |  | 
| safety profiles |  |  | 
| changes in body weight and vital signs |  |  |