linjc16/ctgov huggingface dataset:
Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).

Official Title
-----------------
Ultrasonic Perfusion Imaging for Monitoring Mastectomy Skin Microcirculation in Post-mastectomy Irradiated Patients Before and After Autologous Fat Transfer

Conditions
-----------------
Breast Reconstruction, Radiation Dermatitis, Radiation Fibrosis, Fat Grafting

Intervention / Treatment
-----------------
* Procedure: Fat grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy Have undergone mastectomy Exclusion Criteria: Patients who are unwilling to participate

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast reconstruction with fat grafting<br>fat grafting | Procedure: Fat grafting<br>* Fat grafting<br>|
| No Intervention: breast reconstruction without fat grafting<br>No Fat grafting | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Fibrosis | Number of subject to experience radiation fibrosis | 12 months |
Photoplethysmographic Dichrotic Notch Reflexes Systemic Hemodynamics

Study Overview
=================
Brief Summary
-----------------
Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The investigators have previously demonstrated that the shape of the pulse oximetry waveform (photoplethysmography) is closely related to the changes observed in systemic vascular resistence. The main change in pulse waveform is based to the dichrotic notch position. The present study was designed to determine if the dichrotic notch position is related to a local or a systemic change in the vascular tone.

Detailed Description
-----------------
This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform of surgical patients is related to a local or a sistemic changes in the vascular tone. The investigators will studied 15 patients undergoing regional brachial plexus anesthesia for upper limb surgeries. Photoplethysmography will be continuously recorded in the thumb of the tested hand (anesthetized hand) and in the thumb of the control, opposite hand. Duplex color and power Doppler will measure flow in the both brachial arteries and in the aorta (supraesternal view). The contour analysis of both, photoplethysmogram and arterial flow velocities will be analyzed, correlated and compared.

Official Title
-----------------
Dichrotic Notch Positioning in Finger Photoplethysmography Waveform Reflex Systemic Vascular Resistance

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Finger photoplethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Inform Consent Programmed surgery Supine position Exclusion Criteria: Emergency surgery Peripheral vascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Finger photoplethysmography|Bilateral finger photoplethysmogray, bilateral brachial artery Doppler, Aorta artery Doppler|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis in the position of the dichrotic notch between photoplethysmogram and spectral Doppler waveforms. | The position of the dichrotic notch of pulse waveform in photoplethysmogram (time arrival of diastolic wave expressed in seconds) was compared to the one observed in the spectral Doppler waveform (seconds). | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Doppler, Photoplethysmography
Can the Perception of a Treatment Influence Pain Processing - an Examination of Psychological and Neurobiological Mechanisms

Study Overview
=================
Brief Summary
-----------------
The study investigates the effect of an open (in full view of the patient) vs hidden treatment (without the patient's knowledge).

Official Title
-----------------
Can the Perception of a Treatment Influence Pain Processing - an Examination of Psychological and Neurobiological Mechanisms

Conditions
-----------------
Neuropathic Pain

Intervention / Treatment
-----------------
* Behavioral: Open-hidden


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Neuropathic pain > 3 on a 0-10 NRS. Exclusion Criteria: Psychiatric or competing neurological disorders. Known allergies to any medications, including local anesthetics.

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 |
| --- |
|Behavioral: Open-hidden|Administration of a treatment openly (in full view of the patient) vs hidden (without the patient's knowledge).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical visual analogue scale | Neuropathic pain assessed on mechanical visual analogue scale | 10 minutes after treatment administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic neuropathic pain
Time Interval for Endoscopic Variceal Ligation

Study Overview
=================
Brief Summary
-----------------
Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. Patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. However there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. We will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. Our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.

Official Title
-----------------
Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices

Conditions
-----------------
Variceal Bleeding

Intervention / Treatment
-----------------
* Device: Endoscopic Variceal Ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who presented with acute upper GI bleeding due to esophageal varices and underwent successful endoscopic variceal ligation. Patients who would normally receive repeat endoscopic ligation therapy to eradicate varices. Exclusion Criteria: Persistent bleeding despite endoscopic and medical therapy Platelet count < 40,000

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ligation: 1-week interval<br>Endoscopic variceal ligation performed at 1-week intervals | Device: Endoscopic Variceal Ligation<br>* Ligation of esophageal varices<br>* Other names: variceal banding;|
| Active Comparator: Ligation 2-week interval<br>Endoscopic variceal ligation performed at 2-week intervals | Device: Endoscopic Variceal Ligation<br>* Ligation of esophageal varices<br>* Other names: variceal banding;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Eradication of Esophageal Varices |  | At 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal hemorrhage, esophageal varices, gastrointestinal endoscopy, ligation
Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH

Study Overview
=================
Brief Summary
-----------------
This study explore AAA prevalence in OSAHS patients by ultrasound screening and try to analysis risk factors of AAA in OSAHS patients.

Detailed Description
-----------------
Abdominal aortic aneurysm (AAA) is an extremely high mortality disease, and ultrasound has been recommended for the screening of AAA, which is highly sensitive and specific. Studies have shown that screening for AAA in the population can significantly reduce deaths from ruptured abdominal aortic aneurysms. However, those study mainly focus on cardiovascular disease patients or general population, no previous study target on obstructive sleep apnea hypopnea syndrome (OSAHS) population. Retrospective studies show that the incidence of apnea syndrome in patients with abdominal aortic aneurysm is higher than that in the control group, which suggests that OSAHS may be one of the causes of abdominal aortic aneurysm. At present, there is no relevant research on the screening of AAA in OSAHS population. The main objective of this study was to screen the prevalence of AAA in OSAHS population by a cross-sectional study.

Official Title
-----------------
Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH

Conditions
-----------------
Sleep Apnea, Obstructive, AAA - Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who accept respiratory sleep monitoring in the department of ENT, BTCH, aged over 45 years, from 2018-01-01 to 2019-12-30 Exclusion Criteria: 1. Any previous diagnosis of AAA history; 2. Received AAA related treatment; 3. Past imaging test result suggested increased diameter of the abdominal aorta. 4. Poor compliance; refused to follow the requirements set in this study follow-up, and refused to sign informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Diameter of aorta | Diameter of aorta measured by ultrasound | 0-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABI | Ankel brachal index measured by Angiolab 2 - Phlebolab Doppler-System | 0-48 hours | 
| Carotid artery stenosis | Carotid artery stenosis measured by ultrasound | 0-48 hours |
Visual Perception After Virtual Implantation

Study Overview
=================
Brief Summary
-----------------
Evaluation of visual perception through diffractive optical lens designs by virtual implantation.

Official Title
-----------------
Evaluation of Visual Perception Through Diffractive Optical Lens Designs by Virtual Implantation.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Virtual implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between and including 18 and 50 years of age; Healthy eyes; Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia; Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent; Negative COVID19 screening test prior to every trial visit. Exclusion Criteria: Subjects of less than 18 or more than 50 years of age; Monocular CDVA of dominant eye < 1.0 decimal (> 0.0 logMAR) without cycloplegia; Subject unable to comply with the study protocol or likely to be non-cooperative during the study; Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent; Pseudophakic subjects; Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus; Pathologic miosis; Intake of drugs affecting vision; Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist; Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber; Hyperopes with more than +6 D refraction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual implantation of diffractive optical lens design A<br> | Other: Virtual implantation<br>* Temporary placement of virtual optical lens in the crystalline lens plane.<br>|
| Experimental: Virtual implantation of diffractive optical lens design B<br> | Other: Virtual implantation<br>* Temporary placement of virtual optical lens in the crystalline lens plane.<br>|
| Experimental: Virtual implantation of diffractive optical lens design C<br> | Other: Virtual implantation<br>* Temporary placement of virtual optical lens in the crystalline lens plane.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected distance visual acuity | Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs | during the intervention |
Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.

Detailed Description
-----------------
Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.

Official Title
-----------------
Comparison of Decolonization of MRSA Using Theraworx

Conditions
-----------------
Methicillin-Resistant Staphylococcus Aureus

Intervention / Treatment
-----------------
* Other: Theraworx
* Drug: mupirocin antibiotic ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive MRSA culture Exclusion Criteria: Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.) Patients with MRSA infected wounds Patients under the age of 18 years A woman currently pregnant or nursing a child Patients participating in another study within 30 days of randomization

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>No Treatment | |
| Experimental: 2<br>Theraworx intranasal | Other: Theraworx<br>* Theraworx swab intranasal BID for 5 days<br>|
| Active Comparator: 3<br>mupirocin antibiotic ointment intranasal | Drug: mupirocin antibiotic ointment<br>* mupirocin antibiotic ointment swab intranasal BID for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of decolonization confirmed by intranasal culture |  | Up to 14 days post treatment (+/- 1-2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic-Cost comparison of treatment Evidence of decolonization |  | 5 days of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methicillin resistance
I-beam and Cruciate Tibial Components Used in Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.

Conditions
-----------------
Degenerative Arthritis, Osteoarthritis, Rheumatoid Arthritis, Knee Arthritis

Intervention / Treatment
-----------------
* Device: I-beam design
* Device: Cruciate design


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved. Patients requiring correction of varus, valgus, or posttraumatic deformity Patients requiring correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Exclusion Criteria: Patients with infection, sepsis, or osteomyelitis.

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> | Device: I-beam design<br>* This group will utilize tibial components with an I-beam design for total knee replacement.<br>|
| 2<br> | Device: Cruciate design<br>* This group will utilize tibial components with cruciate designs for total knee replacement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision rate |  | 10 years |
Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

Study Overview
=================
Brief Summary
-----------------
To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in 4 weekly applications to human periorbital skin area by grating pre- and 90-days post treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded evaluators.

Official Title
-----------------
Safety and Efficacy of Non-invasive Dermatologic Procedure With XP200 Radiofrequency for the Primary Treatment of Wrinkles and Rhytids

Conditions
-----------------
Periorbital Wrinkles

Intervention / Treatment
-----------------
* Device: RF XP200
* Device: XP200 RF device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35-60 years old periorbital wrinkles Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

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

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

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: XP200 device RF treatments<br>Every subject in the study will undergo 4 treatments and will be followed up for 6 months with photoraphic 3 evaluations: before treatment, 3 and 6 months follow-up. Photographs will be scored on a Fitzpatrick scale by 3 blinded evaluators. | Device: RF XP200<br>* Four weekly non-invasive periorbital wrinkles treatment with RF XP200 device<br>Device: XP200 RF device<br>* 4 RF treatments of periorbital region on one side of the face<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in wrinkles appearance | One point or greater improvement in periorbital wrinkle score on a Fitzpatrick scale 3 months after last treatment as determined by at least 2 out of 3 blinded photographs evaluators | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wrinkles, rhytids, periorbital