linjc16/ctgov huggingface dataset:
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions.

Conditions
-----------------
Short Term Treatment of Insomnia

Intervention / Treatment
-----------------
* Drug: Zaleplon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Zaleplon or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zaleplon|Short term treatment of insomnia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  |  |
Neuromuscular Control of the Ankle With External Support

Study Overview
=================
Brief Summary
-----------------
Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the combined use of the 3D motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and to an influence on the neuromuscular control are examined. The tests will simulate situations with a higher risk of injury. In the experimental set-up, an element of surprise will be integrated in order to analyze any muscular compensation mechanisms.

Conditions
-----------------
Chronic Ankle Instability

Intervention / Treatment
-----------------
* Other: Taping the ankle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic ankle instability giving way repeated ankle sprains Exclusion Criteria: other injuries of the lower extremities surgery on the lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: taping the ankle<br> | Other: Taping the ankle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in elektromyographic signal in peroneus longus muscle (surface EMG) |  | baseline (=before) and immediately after applying the device |
Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK

Study Overview
=================
Brief Summary
-----------------
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Forceps.

Official Title
-----------------
Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK

Conditions
-----------------
Endothelial Cell Loss With Different Insertion Devices

Intervention / Treatment
-----------------
* Device: Use of the Tan Endoglide to insert the donor graft
* Device: Forceps for delivery of the donor graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation. Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma. Ability to understand the nature of the procedure and give full informed consent. Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital. Exclusion Criteria: Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty. Patients with complex anterior segment pathology precluding successful DSAEK procedure. Patients not giving full informed consent to participate in the trial

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Forceps delivery of donor graft<br>Using the forceps to insert the donor graft. | Device: Forceps for delivery of the donor graft<br>* Use of the forceps for delivery of the donor graft into the eye.<br>|
| Experimental: Tan Endoglide for insertion of the donor graft<br>Use of the Tan Endoglide for insertion of the donor graft. | Device: Use of the Tan Endoglide to insert the donor graft<br>* Using the Tan Endoglide to insert the donor graft into the eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor Graft Endothelial cell counts |  | 1 year | 
| Best corrected visual acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of surgery |  | 1 year |
Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
To apply an existing diagnostic imaging test (saline infusion sonohysterography by Hysteroscopic) to characterize the filling defect of a previous cervical cesarean delivery scar in the nonpregnant uterus

Official Title
-----------------
Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

Conditions
-----------------
Cesarean Section Scar

Intervention / Treatment
-----------------
* Procedure: Hysteroscopic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cesarean section diverticula patients in our hospital from 2016 to Dec 2018.The diagnosis was confirmed on the basis of medical history (at least one C-section), clinical symptoms (post¬menstrual spotting, no significant change of cycle before and after C-section),transvaginal ultrasonography (TVU), and mag¬netic resonance imaging (MRI) findings Exclusion Criteria: 1) irregular menstrual cycle before cesar¬ean section; 2) previous placement of an intrauterine contracep¬tive device; and 3) presence of another organic uterine pathology responsible for abnormal uterine bleeding examined by hysteroscopy, such as endome-trial hyperplasia, endometrial polyps, malignancy, or submucosal myomas

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| CSD-TVU<br>Cesarean Section Scar Evaluation by TVU | |
| CSD-MRI<br>Cesarean Section Scar Evaluation by MRI | |
| CSD-MRI with saline<br>Cesarean Section Scar Evaluation by MRI with saline | |
| CSD-Hysteroscopic<br>Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy | Procedure: Hysteroscopic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean Section Scar Evaluation by TVU and MRI |  | 2015.12-2016.7 |
Head Position on Preventing Emergence Cough

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation.

Detailed Description
-----------------
During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the head position to reduce the emergence cough followed by endotracheal extubation was not confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is thought to be acceptable more.

Official Title
-----------------
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Conditions
-----------------
Gallbladder Diseases

Intervention / Treatment
-----------------
* Procedure: Head on bed
* Procedure: Head on pillow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operation schedule of laparoscopic cholecystectomy Must be performed under general anesthesia Exclusion Criteria: BMI > 30 kg/m2 Respiratory infection Uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

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

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 |
| --- | --- |
| Placebo Comparator: Control group<br>The endotracheal extubation is performed in head on bed without pillow. | Procedure: Head on bed<br>* During emergence, head is kept on bed without pillow.<br>|
| Active Comparator: Head elevation group<br>The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) . | Procedure: Head on pillow<br>* During emergence, head is kept on pillow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of cough | 0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough | during extubation |
Reticular Pseudodrusen Progression Study

Study Overview
=================
Brief Summary
-----------------
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. Reticular pseudodrusen (RPD) have been recognized as an additional phenotypic characteristic frequently observed in patients with AMD. Several studies have proven that the prevalence of RPD is associated with AMD as well as a high risk of disease progression to geographic atrophy, the late form of dry AMD. The pathogenesis of RPD is yet still incompletely understood. Retrospective studies have demonstrated that the RPD affected retinal area increases over time. Potential factors influencing progression of RPD have not been intensely studied and potentially predictive markers are yet unknown. The primary objective of this study is to characterize RPD progression in more detail and to identify predictive markers of RPD progression and development of AMD late stages.

Official Title
-----------------
Reticular Pseudodrusen Progression Study

Conditions
-----------------
Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Men and women, any race, aged 60 years or older at the baseline visit Presence of RPD without any other type of drusen, hypo/hyperpigmentation, geographic atrophy, choroidal neovascularization Patient is willing to undergo ocular examinations once every 12 for up to 24 months Exclusion Criteria: Presence or history of soft drusen, hypo-/hyperpigmentation, geographic atrophy or choroidal neovascularization in the study eye Ocular disease in the study eye that may confound assessment of the retina (e.g., diabetic retinopathy, uveitis) Any condition that would make adherence to the examination schedule of once every 12 months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic alcoholism, Alzheimer's Disease or drug abuse

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

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 |
| --- | --- | --- |
| Change of reticular pseudodrusen affected retinal area to baseline |  | 24 months |
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis

Study Overview
=================
Brief Summary
-----------------
The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

Detailed Description
-----------------
F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.

Official Title
-----------------
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis

Conditions
-----------------
Cardiac Amyloidosis

Intervention / Treatment
-----------------
* Drug: F-18 florbetapir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis Patients with a ratio of affected to unaffected free light chains >5 or free light chain difference of >50 Exclusion Criteria: Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm Contraindication to florbetapir or its components Refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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: AL or TTR type amyloidosis<br>The participants will undergo F-18 florbetapir PET scan. | Drug: F-18 florbetapir<br>* Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).<br>* Other names: 18F-AV-45;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Myocardial F18-florbetapir Uptake | Number of participants with quantitative F18-florbetapir uptake above previously defined control values | at the time of the PET scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
F-18 florbetapir, Amyvid, PET scan, Early detection
Nebivolol Versus Carvedilol in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic properties may play a role in different subgroups of patients with CHF. OBJECTIVE: To compare the effects of nebivolol and carvedilol on LV function and clinical outcome in patients with chronic heart failure and reduced LV systolic function. METHODS: 160 hypertensive CHF patients, LV ejection fraction (EF) 40% and in New York Heart Association (NYHA) functional class II or III were randomly assigned to receive carvedilol or nebivolol therapy for 24 months. At baseline and after 24 months of treatment, all patients underwent clinical evaluation: echocardiogram and 6-minute walking test.

Official Title
-----------------
Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: left ventricular ejection fraction (LVEF) < 40%; symptomatic heart failure with functional New York Heart Association (NYHA) class II or III; arterial hypertension with systolic blood pressure >140 mmHg and diastolic blood pressure >85 mmHg; clinical stability without hospital admission for heart failure in the previous 3 months. Exclusion Criteria: history of asthma or severe chronic obstructive pulmonary disease; severe liver or kidney diseases; second-degree or third degree heart block without a permanent pacemaker, sick sinus syndrome, heart rate <60 beat/min, systolic blood pressure <90 mmHg.

Ages Eligible for Study
-----------------
Minimum Age: 53 Years
Maximum Age: 76 Years

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
-----------------
chronic heart failure, hypertension, beta blockers
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery.

Detailed Description
-----------------
Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration of CTCs in rectal cancer patients could play an important role in diagnosis, predicting the risk for tumor recurrence and effectiveness of neoadjuvant therapy. The investigators choose several timepoints to detect the dynamic change of CTCs,1 day before the 1st ,3rd and 5th(if the patient needs before surgery) neoadjuvant therapy course,1 day before and 7days ,3 month,6 month after surgery. Approximately 7.5-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with rectal cancer . Briefly, the number of CTCs will be count by the cellsearch system , recorded and analysed by the investigator.

Official Title
-----------------
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy

Conditions
-----------------
Rectal Neoplasms, Circulating Tumor Cells

Intervention / Treatment
-----------------
* Other: ISET system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: >18 years old. Diagnosis of stage III rectal cancer based on histology. Will receive neoadjuvant treatment using Folfox or chemoradiotherapy . Life expectancy: Greater than 3 months. Patients have no severe inflammation, such as vasculitis. Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Patients with other primary tumor except rectal cancer. History of coagulation disorders or anemia.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circulating Tumor Cells<br>Use ISET system to test the number of CTCs from patients before and during treatment. | Other: ISET system<br>* Use ISET system to test the number of CTCs from patients before and during treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of Circulating Tumor Cells (CTCs) |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating Tumor Cells, rectal Neoplasms, neoadjuvant otherapy