linjc16/ctgov huggingface dataset:
Assessment of Tele-expertise for Frozen Section Diagnosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.

Official Title
-----------------
Multidimensional Assessment of Tele-expertise for Frozen Section Diagnosis

Conditions
-----------------
Frozen Sections

Intervention / Treatment
-----------------
* Device: During Tele-expertise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| During tele-expertise<br>Remote site interpretation of frozen section | Device: During Tele-expertise<br> <br> |
| Before tele-expertise<br>Usual (on site) frozen section | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon |  | 30 minutes after the sample extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay between extraction of the sample and the diagnosis given to the surgeon |  | 24h after procedure | 
| Number of frozen section diagnosis among surgical procedures in need of frozen section diagnosis |  | Once a month | 
| Overall cost of a frozen section diagnosis | Sum of the durations of the professionals immobilization for performing a diagnosis x wages + costs of the telemedicine solution development and implementation. | 6 months after the first patient enrollment |
Eyelid Crush for Marginal Eyelid Surgery

Study Overview
=================
Brief Summary
-----------------
Surgery involves eyelid margin asscocited with intraoperative bleeding. Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results.

Detailed Description
-----------------
baseline and postoperative full ophthalmic examination was done.Procedure include all surgeries involving eyelid margin

Official Title
-----------------
Outcome of Eyelid Crush for Intraoperative Hemostasis of Eyelid Margin Surgery

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Procedure: Eyelid margin crush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All surgeries involving eyelid margin Exclusion Criteria: bleeding tendency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Study group<br>Eyelid surgery involving eyelid margin is done after eyelid margin crushing with hemostat at start of surgery | Procedure: Eyelid margin crush<br>* after marking eyelid , hemostat is used for eyelid margin incision crush . Then eyelid surgery is done<br>|
| Control group<br>Eyelid surgery involving eyelid margin is done after eyelid margin crushing without hemostat | Procedure: Eyelid margin crush<br>* after marking eyelid , hemostat is used for eyelid margin incision crush . Then eyelid surgery is done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of intraoperative bleeding | bleeding is recorded by photography | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of operation | time of surgery is recorded by stopwatch | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eyelid margin, hemostasis
High Quality Evidence of Chinese Lupus Nephritis (HELP)

Study Overview
=================
Brief Summary
-----------------
The investigators are registering LN patients at recruited hospitals and developing a LN database in China. Patients will be follow-up every year, and both baseline and follow-up information will be entered into the registration system.

Detailed Description
-----------------
The investigators are registering Lupus nephritis (LN) and developing a LN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education etc.), clinical characteristics (including systolic blood pressure, diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.), complications, drug information at the baseline will be collected. Patients will be follow-up every year, the demographic and clinical characteristics, complications; drug information of patients will be collected at each visit. We will also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage renal disease (ESRD) or serum creatinine doubling. The patient survival and renal survival will be compared using the LN database.

Official Title
-----------------
High Quality Evidence of Chinese Lupus Nephritis (HELP)

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who diagnosis as lupus nephritis Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| LN patients<br>Patients diagnosis as lupus nephritis | Other: No Intervention<br>* Registration of all LN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality and cardiovascular mortality of LN patients |  | 10years | 
| A composite renal outcome of LN patients | The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation). | 10years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus nephritis, Patient survival, Renal survival
Prognostic Values of Chest/Abdominal Wall Varices and Spider Nevi in Patients With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Chest/abdominal wall varices and spider nevi are two common presenting signs of liver cirrhosis. Their prognostic values remain unclear.

Official Title
-----------------
Prognostic Values of Chest/Abdominal Wall Varices and Spider Nevi in Patients

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Other: No relevant intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis. Consecutive admission. Permitted to physical examinations. Informed consents. Exclusion Criteria: Non-cirrhotic portal hypertension. Malignancy. Uncontrolled infection. Severe chronic diseases. Poor patient compliance.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No relevant intervention.|No relevant intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and type of chest/abdominal wall varices and spider nevi | Baseline data | 1.5 years | 
| Association between etiology of liver cirrhosis and type of chest/abdominal wall varices and spider nevi | Baseline data | 1.5 years | 
| Association between degree of liver function and type of chest/abdominal wall varices and spider nevi | Baseline data | 1.5 years | 
| Effect of chest/abdominal wall varices and spider nevi on survival | Follow-up data | 2.5 years or more | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver cirrhosis
Training and Calibration of Dental Examiners

Study Overview
=================
Brief Summary
-----------------
Training and calibration of dental examiners

Official Title
-----------------
Training and Calibration of Dental Examiners

Conditions
-----------------
Dental Plaque

Intervention / Treatment
-----------------
* Drug: Fluoride
* Drug: Triclosan
* Drug: Chlorhexidine gluconate
* Drug: Fluoride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female volunteers 18-65 years of age Good general health Must sign informed consent form Minimum of 20 natural uncrowned teeth (excluding third molars) must be present. No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. Exclusion Criteria: Subjects unable or unwilling to sign the informed consent form. Medical condition which requires pre-medication prior to dental visits/procedures Moderate or advanced periodontal disease or heavy dental tartar (calculus). 2 or more decayed untreated dental sites at screening. Other disease of the hard or soft oral tissues. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation). Use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants). Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. Pregnant or nursing women. Participation in any other clinical study within 1 week prior to enrollment into this study. Allergy to chlorhexidine Use of tobacco products Subjects who must receive dental treatment during the study dates. Current use of Antibiotics for any purpose. Presence of an orthodontic appliance. History of allergy to common dentifrice ingredients. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Fluoride<br>* Brush half mouth twice daily for four days<br>|
| Active Comparator: B<br> | Drug: Triclosan<br>* Brush half mouth daily for four days<br>Drug: Fluoride<br>* Brush half mouth daily for four days<br>|
| Active Comparator: C<br> | Drug: Chlorhexidine gluconate<br>* Mouth rinsing with 15 ml for 30 seconds twice a day for four days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental plaque |  | 6 weeks |
Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy

Study Overview
=================
Brief Summary
-----------------
To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.

Official Title
-----------------
The Effects of Using Heated Humidified Carbon Dioxide Gas on Post Operative Pain Scores, Nausea and Analgesic Requirements in Patients Undergoing Gynaecological Laparoscopy: a Randomised Controlled Trial.

Conditions
-----------------
Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery

Intervention / Treatment
-----------------
* Device: Standard cold carbon dioxide gas
* Device: Heated humidified carbon dioxide gas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial. Capacity to consent Exclusion Criteria: Patients unable to speak English Patients unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard cold carbon dioxide gas<br>Standard cold carbon dioxide gas | Device: Standard cold carbon dioxide gas<br>* Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.<br>|
| Active Comparator: Heated humidified carbon dioxide gas<br>Heated humidified carbon dioxide gas | Device: Heated humidified carbon dioxide gas<br>* Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder tip pain | Shoulder tip pain recorded as a visual analogue scale from 1-10, 8 hours post surgery compared to baseline | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General abdominal pain, nausea, vomiting and analgesia requirements | General abdominal pain, nausea, vomiting and analgesia requirements 8 hours post surgery compared to baseline | 8 hours | 
| Shoulder tip pain, general abdominal pain, nausea, vomiting. | Shoulder tip pain, general abdominal pain, nausea, vomiting over a 7 day period compared to baseline | 7 days |
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

Detailed Description
-----------------
To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus. To evaluate the safety and tolerability of RTA 402.

Official Title
-----------------
A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Chronic Kidney Disease, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: RTA 402


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD patients with type 2 diabetes mellitus Patients whose eGFR levels are eligible for this study Patients being treated with stable dose of ACE inhibitors and/or ARB etc. Exclusion Criteria: Patients with Type 1 diabetes Patients with known non-diabetic renal disease Patients with a history of renal transplantation Patients with mean SBP > 160 mmHg or mean DBP > 90 mmHg Patients with HbA1C > 10% Patients with cardiovascular disease specified in the study protocol etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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 |
| --- | --- |
| Experimental: RTA402<br> | Drug: RTA 402<br> <br> |
| Experimental: RTA402 Low<br> | Drug: RTA 402<br> <br> |
| Experimental: RTA402 Medium-low<br> | Drug: RTA 402<br> <br> |
| Experimental: RTA402 Medium-high<br> | Drug: RTA 402<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:Changes in eGFR | Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation. | Up to 16 weeks | 
| Adverse event collection and assessment | Adverse Event collection and assessment will be done for all treated subjects. | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | Relationship between the study drug dose and the trough concentration of study drug | Baseline, week 4, 8 and 12. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD patients with type 2 diabetes
Flow Proportional Pressure Support in Volunteers

Study Overview
=================
Brief Summary
-----------------
Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. In this study the investigators evaluate objective and subjective measured data in healthy volunteers with artificial increased resistance and FPPS breathing assistance.

Official Title
-----------------
Flow Proportional Pressure Support as a New Mode of Spontaneous Breathing Assist - Evaluation of Objective and Subjective Measured Data in Volunteers

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

Intervention / Treatment
-----------------
* Device: artificial increased resistance (flow proportional pressure support)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years ASA I and II Exclusion Criteria: refusal of written informed consent chronic respiratory or cardiac diseases

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: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volunteers<br>artificial increased respiratory resistance | Device: artificial increased resistance (flow proportional pressure support)<br>* respiratory resistance is increased by interpose of an artificial resistance tool in the in- and expiratory airways of the mechanical respirator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pressure support |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistance, flow proportional pressure support, pressure support ventilation, volunteers, assistant breathing, breathing comfort and objective breathing data
Examining the Relationship Between Hormone Therapy (HT) and Cognitive Function (The WHIMS-ECHO Study)

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational study of the cohort of older post-menopausal participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials. Annual cognitive assessments and ascertainment of cognitive impairment enable the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive vulnerability and resilience in older women.

Detailed Description
-----------------
Identification of the predictors of cognitive impairment and cognitive resilience among aging women is important because the incidence of mild cognitive impairment (MCI) and dementia increases with age and women live the longest. The Women's Health Initiative Memory Study examined the impact of randomization to hormone therapy (conjugated equine estrogen alone or in combination with medroxyprogesterone vs. placebo) in a subset of participants aged 65-79 years at enrollment into WHI and the WHI Hormone Trials. WHIMS revealed an increased risk of all-cause dementia and MCI plus poorer global cognitive function among women randomized to HT compared to those receiving placebo. WHIMS ECHO is a prospective, observational study of the remaining cohort of WHIMS participants following cessation of treatment. Annual cognitive assessments of learning, attention, memory, working memory, executive function and language are conducted by telephone by trained staff and adjudication of incident cognitive impairment (MCI and dementia) continues. This enables the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive aging and resilience in older women.

Official Title
-----------------
Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes

Conditions
-----------------
Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in the WHIMS study Exclusion Criteria Non-English speaking Hearing Impaired

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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 |
| --- | --- | --- |
| All-cause dementia and Mild Cognitive Impairment |  | Measured annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global and domain specific cognitive function |  | Measured annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognition, Memory, Hormone Therapy, HT