linjc16/ctgov huggingface dataset:
Microcirculation & ASICs

Study Overview
=================
Brief Summary
-----------------
Pressure ulcers are a common and costly problem. Advancing the understanding regarding the basic pathophysiological mechanisms mediating the development of pressure ulcers will allow for better delineation of populations at risk. Healthy skin is protected from pressure-induced ischemic damage because of the presence of pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous ischemia, which could lead to pressure ulcer formation. Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments that block ASICs.

Official Title
-----------------
Study of the Cutaneous Microcirculation: ASIC Involvement.

Conditions
-----------------
Physiological Conditions

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Drug: Amiloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males or females aged between 18 and 40 years of age Exclusion Criteria: no consent, diabetes, neuropathy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diclofenac|diclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler|
|Drug: Amiloride|amiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the difference in the cutaneous microvascular response to local pressure application between treated (amiloride and diclofenac) and untreated skin. |  | Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate difference in the cutaneous sensitivity and the cutaneous microvascular response to acetylcholine, sodium nitroprusside, electrical current and local heating between treated (amiloride and diclofenac) and untreated skin |  | Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin, microcirculation; ASIC, pressure ulcer
Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
In this study, we plan to systematically analyze the motion of organs and tissues in the abdomen, to understand the physical mechanisms of three-dimensional (3D) motion and interactions of abdominal organs and tissues. This work will allow us to learn how to mathematically model and predict abdominal organ motion.

Detailed Description
-----------------
Specifically, we plan to conduct this study in 3 steps, in an order of increasing complexity, starting with the (intra-fractional) respiratory only motion, then adding intra-fractional GI motility motion, and finally the inter-fractional anatomical variations (adding food intakes and fecal excretion). The research methods described will allow the study team to develop the ability to estimate the motion of both tumor target and critical organs given the patient's MRI, CBCT or x-ray fluoroscopy images on the day of radiation treatment.

Official Title
-----------------
Study and Modeling of Organ Motion During Abdominal Imaging

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, body habitus, claustrophobia). May have pre-existing medical conditions provided they are capable of completing the exam and their condition is not expected to affect the physical tissue properties of the organs that will be imaged. Women of child-bearing potential must verbally confirm lack of pregnancy prior to signing consent Exclusion Criteria: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteer MRI<br> | Other: MRI<br>* collection of MRI scans for mathematical model development<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal respiratory motion as measured by MRI |  | baseline | 
| gastrointestinal motility motion as measured by MRI |  | baseline | 
| inter-fractional motion as measured by MRI | inter-fractional motion is defined as the change in motion of organs and tissues between different image examinations on different days | baseline, up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging (MRI), Abdominal Cancer, Radiation Therapy Planning
Study to Determine the Pharmacokinetics of Product 0405

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects.

Detailed Description
-----------------
Treament medication will be administered topically twice daily for 28 days.

Official Title
-----------------
An Open-Label, Multi-Center Study to Determine the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Product 0405


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Atopic Dermatitis Good health with the exception of Atopic Dermatitis Percent body surface area minimums Exclusion Criteria: Subject who are nursing, pregnant or planning a pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 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: Product 0405<br>Topically Active Investigational Product 0405 | Drug: Product 0405<br>* Product 0405 will be administered topically, twice daily for 28 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phamacokinetic sampling |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory tests, vital signs, adverse events and local skin safety signs |  | 28 days |
Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

Study Overview
=================
Brief Summary
-----------------
To investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.

Official Title
-----------------
Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Salmeterol and Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must use salmeterol and fluticasone for the first time Exclusion Criteria: Patients with hypersensitivity to salmeterol and fluticasone Patients with infection which salmeterol and fluticasone is not effective Patients with deep mycosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed salmeterol and fluticasone<br>Patients with chronic obstructive pulmonary disease prescribed salmeterol and fluticasone during study period | Drug: Salmeterol and Fluticasone<br>* Administered according to the prescribing information in the locally approved label by the authorities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice. |  | 1 year |
The Role of a Private Hospital in Hong Kong Amid COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Hong Kong public healthcare system is facing tremendous pressure under the COVID-19 pandemic. As the virus spread in Hong Kong, Hong Kong Sanatorium & Hospital (HKSH) is one of the first private hospitals which immediately provide reliable and rapid COVID-19 test -- Reverse Transcription Polymerase Chain Reaction (RT-PCR). Early provision of the RT-PCR screening test for COVID-19 not only facilitates identification of COVID-19 but also contains the spread of the virus in the community and frontline medical staff. Since description of role of private hospital in Hong Kong amid COVID-19 pandemic is lacking, this study will describe COVID-19 screening algorithm and methodology. A retrospective analysis on clinical characteristics, laboratory findings as well as outcome of patients who underwent COVID-19 test in HKSH is also performed.

Official Title
-----------------
The Role of a Private Hospital in Hong Kong Amid COVID-19 Pandemic: A Descriptive Study of Patients With SARS-CoV-2 RT-PCR Performed

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Diagnostic Test: COVID 19 Diagnostic Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who underwent COVID-19 test in HKSH during the study period Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects underwent COVID-19 test<br>Subjects who underwent COVID-19 test in HKSH during the study period | Diagnostic Test: COVID 19 Diagnostic Test<br>* COVID 19 Diagnostic Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of asymptomatic subjects | Proportion of asymptomatic subjects (%) who underwent COVID 19 test | 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with recent contact history | Proportion of subjects (%) with recent contact history | 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong | 
| Proportion of subjects with recent travel history | Proportion of subjects (%) with recent travel history | 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong |
Renal Cancer Detection With Liquid Biopsy

Study Overview
=================
Brief Summary
-----------------
Glycosaminoglycans (GAGs) were significantly altered in localized as well advanced RCC compared to healthy samples. In addition, GAG scores correlated with progression-free survival and overall survival (OS) in a prospective cohort of patients with metastatic ccRCC and localized RCC. However, it is still unknown whether alterations in plasma and urine GAGs are exquisitely specific to RCC or are shared by other benign lesions in the kidney, such as angiomyolipomas, oncocytomas, or PEComa.

Official Title
-----------------
Renal Cancer Detection With Liquid Biopsy

Conditions
-----------------
Renal Cancer, Oncocytoma

Intervention / Treatment
-----------------
* Diagnostic Test: GaGnostic
* Diagnostic Test: GaGnostic
* Diagnostic Test: GaGnostic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent CT-scan with suspicion of renal tumor and the scans show no sign of renal cancer. For patient with ccRCC or oncocytoma, they should have a histological verified tumor (Biopsy or surgical specimen) Sign up information consent Can perform protocol procedure Exclusion Criteria: Non-clear cell Renal cell carcinoma RCC with pure sarcomatoid differentiation, also called sarcoma of the kidney Use of heparin for concurrent disease in need of blood dilution (e.g. ongoing deep vein thrombosis or lung emboli). Note: use of of heparin for thrombus prophylaxis in conjunction with primary surgery or postoperatively ≤4 weeks will be allowed.

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 |
| --- | --- |
| Renal Call Carcinoma<br>Patrients with renal cancer | Diagnostic Test: GaGnostic<br>* Plasma<br>* Other names: Glycosaminoglycan;Diagnostic Test: GaGnostic<br>* Serum<br>* Other names: Glycosaminoglycan;Diagnostic Test: GaGnostic<br>* Urine<br>* Other names: Glycosaminoglycan;|
| Oncocytoma<br>Patients with oncocytoma | Diagnostic Test: GaGnostic<br>* Plasma<br>* Other names: Glycosaminoglycan;Diagnostic Test: GaGnostic<br>* Serum<br>* Other names: Glycosaminoglycan;Diagnostic Test: GaGnostic<br>* Urine<br>* Other names: Glycosaminoglycan;|
| Healthy persons<br>Patients with CT scan shows no renal cancer | Diagnostic Test: GaGnostic<br>* Plasma<br>* Other names: Glycosaminoglycan;Diagnostic Test: GaGnostic<br>* Serum<br>* Other names: Glycosaminoglycan;Diagnostic Test: GaGnostic<br>* Urine<br>* Other names: Glycosaminoglycan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the optimal GAG score | To identify the optimal GAG score in RCC patients | 2 years | 
| To identify the optimal GAG score | To identify the optimal GAG score in oncocytoma | 2 years | 
| To identify the optimal GAG score | To identify the optimal GAG score in healthy individuel | 2 years |
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Randomized, single-blind trial in which one group of patients will be operated with a Mid-Vastus approach of the knee joint and the other group will undergo knee surgery with a Sub-Vastus approach.

Official Title
-----------------
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up

Conditions
-----------------
Tricompartmental Gonarthrosis

Intervention / Treatment
-----------------
* Procedure: Sub-Vastus arthrotomy
* Procedure: Mid - Vastus arthrotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with osteoarthrosis of the knee patients must be in good general health condition Exclusion Criteria: patients with morbid obesity (BMI >45) patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Experimental: Sub - Vastus arthrotomy<br>Sub-vastus arthrotomy | Procedure: Sub-Vastus arthrotomy<br>* Sub-vastus arthrotomy<br>|
| Active Comparator: Mid-Vastus arthrotomy<br>Mid-vastus arthrotomy | Procedure: Mid - Vastus arthrotomy<br>* Mid-vastus arthrotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS, KOOS and HSS scales |  | at day 1, day 2, day 3, day 4 and day 5 post-operatively | 
| Rehabilitation time; time needed for 90° flexion of the knee joint |  | post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS, HSS, KOOS questionnaires |  | at 6 weeks, 3 months and 12 months after surgery. | 
| Amount and type of analgesic drugs used. |  | pre-operatively and post-operatively |
A Mindfulness-Based Intervention to Improve CPAP

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess the effectiveness of a mindfulness-based intervention in improving CPAP use compared to online peer support

Official Title
-----------------
A Mindfulness-Based Intervention to Improve CPAP Adherence in Adolescents With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea (Moderate to Severe), Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: Mindfulness Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent age (13-18 years) Confirmed diagnosis of moderate or severe OSA Adolescent should have the capacity to consent themselves Exclusion Criteria: Known developmental delay such that they are not able to participate in the study; Neuromuscular disorders Central sleep apnea Known diagnosis of severe psychiatric illnesses (e.g. suicidal ideation) Limited knowledge and proficiency in English to complete the study as judged by the clinical team

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Program<br>Participants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program. | Other: Mindfulness Program<br>* Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum<br>|
| No Intervention: Online Peer Support Program<br>Participants will attend an online peer support program where they will engage with each other by sharing experiences while providing advice and emotional support. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of MBI for CPAP adherence. | The primary objective is to evaluate the effectiveness of a mindfulness-based intervention (MBI) in improving CPAP adherence in adolescents with OSA when compared to online peer support. Adherence to CPAP will be measured objectively as hours of usage of CPAP per night. | Week 4-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of increased adherence on mental, physical, and psychosocial statuses. | Evaluate the effects of increased CPAP adherence on daytime sleepiness, HRQOL, psychosocial functioning and mental health status (e.g. anxiety and depression). This will be measured by administering questionnaires at baseline, before intervention, after intervention and again at follow-up. | Week 4-12 |