linjc16/ctgov huggingface dataset:
Monitoring Exhaled Propofol to Individualize General Anesthesia

Study Overview
=================
Brief Summary
-----------------
This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath, blood and drug effect in volunteers undergoing general anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model for propofol in exhaled breath.

Official Title
-----------------
Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Drug: Propofol Anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Written informed consent Ability and willingness to give written informed consent American Society of Anesthesiologists (ASA) risk score I Exclusion Criteria: Volunteers ASA physical status II - III Pregnancy Volunteers with history of neurological disease or stroke Volunteers with a history of recreational drug abuse Volunteers with a history of alcohol abuse Smokers Anesthesia within 6 months Known drug allergies History of adverse events during general anesthesia

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

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Propofol<br>Volunteers will receive propofol anesthesia on the study day. | Drug: Propofol Anesthesia<br>* Volunteers will undergo propofol anesthesia for 90 min.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled propofol (parts per billion) |  | Continuous measurement over 90 min | 
| Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia |  | continuous over 90 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breath, propofol, general anesthesia
Biochemical Marker to Predict the Recurrence of Atrial Fibrillation After Surgical Maze Procedure

Study Overview
=================
Brief Summary
-----------------
The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b, MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after surgical Maze procedure. The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with the recurrence of AF after surgical Maze procedure.

Official Title
-----------------
Plasma ANP and NT-pro-BNP, Atrial Anatomical Change May Determine the Outcome of Maze Operation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation Exclusion Criteria: Coronary heart disease Congestive heart failure

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| AF recurrence |  | year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Maze procedure
Effect of Dialysate Temperature on Haemodynamic Stability and Haemodialysis Efficiency

Study Overview
=================
Brief Summary
-----------------
Comparison between dialysate temperatures on haemodynamic stability and haemodialysis efficiency.

Detailed Description
-----------------
Comparison of 4 different dialysate temperatures for haemodialysis of patients with chronic renal failure. Comparison of 3 different dialysate temperatures for haemodialysis of patients with acute renal failure. Investigation of the efficiency of haemodialysis of patients with acute renal failure

Official Title
-----------------
Effect of Dialysate Temperature on Haemodynamic Stability and Haemodialysis Efficiency

Conditions
-----------------
Acute Renal Failure, Chronic Renal Failure

Intervention / Treatment
-----------------
* Procedure: Haemodialysis with different dialysate temperatures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic renal failure Acute renal failure Aged between 21-90 years Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hemodialysis<br> | Procedure: Haemodialysis with different dialysate temperatures<br>* Haemodialysis with different dialysate temperatures is used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic stability and tolerance |  | t0 |
Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.

Official Title
-----------------
A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: CTP-543


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial Exclusion Criteria: Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication Donation of blood at any point throughout the study and for 30 days after last dose of study medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: CTP-543<br>Patients who previously completed a qualifying CTP-543 clinical trial | Drug: CTP-543<br>* Twice daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety |  | 276 weeks | 
| Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) |  | 276 weeks |
Different PEEP Settings of COVID-19 Induced ARDS

Study Overview
=================
Brief Summary
-----------------
This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose PO2/FiO2<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Epidemiological, clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet. The study was approved by the Ethics Committee of Zhongda Hsopital, Southeast University.

Detailed Description
-----------------
After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet.

Official Title
-----------------
Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study

Conditions
-----------------
COVID-19, Mechanical Ventilation Pressure High, Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: Gas exchanges at different PEEP
* Other: lung mechanics at different PEEP
* Other: Hemodynamics changes at different PEEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 patients with mechanical ventilation PO2/FIO2<300mmHg ages>18 years Exclusion Criteria: pneumothorax pregnant hemodynamics is unstable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimizing oxygenation<br>Best oxygenation during PEEP titration | Other: Gas exchanges at different PEEP<br>* Gas exchanges measurement at different PEEP<br>|
| Experimental: Optimizing compliance<br>Best compliance during PEEP titration | Other: lung mechanics at different PEEP<br>* lung mechanics measurement at different PEEP<br>|
| Experimental: ARDSnet<br>PEEP settings according to ARDSnet table | Other: Hemodynamics changes at different PEEP<br>* Hemodynamics changes measurement at different PEEP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory system compliance improvement | the respiratory system compliance was compared among three groups | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas echanges improvement | P/Fwere compared among three groups | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, COVID-19, mechanical ventilation, PEEP
Ketorolac in Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.

Official Title
-----------------
Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.

Conditions
-----------------
Curative Breast Cancer Surgery, Inflammatory Positive/Negative Status, Pre Surgical Incision Administration

Intervention / Treatment
-----------------
* Drug: Ketorolac 30 mg IV
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio >4 and/or triple negative histological status and/or Positive lymph nodes Exclusion Criteria: Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketorolac 30 mg<br>Active drug to be compared with placebo | Drug: Ketorolac 30 mg IV<br>* Active drug<br>* Other names: ketorolac tromethamine;|
| Placebo Comparator: NaCl 0.9% 3mL<br>Placebo looking like the Active drug | Drug: Placebos<br>* Placebo looking like the Active drug<br>* Other names: NaCl 0.9%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free Survival | 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years) | 5 years |
Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.

Study Overview
=================
Brief Summary
-----------------
The study is experimental and aims to (a) compare the viscoelastic properties of bronchial secretions obtained in patients suffering from obstructive respiratory disease, and (b) to compare the viscoelastic properties of bronchial secretions obtained in patients before and after application of a respiratory physiotherapy or exercise as usually prescribed. After agreement, the sputum of the participants will be collected according to the method used in clinical routine.Experiments (collection and analysis of sputum) will be conducted at the Saint-Luc University Clinic.

Official Title
-----------------
VLM-2: Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.

Conditions
-----------------
Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstructive pulmonary disease 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will receive standard physiotherapy as prescribed by the physician
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Group<br>Patients with obstructive pulmonary diseases receiving standard physiotherapy treatment | Other: Physiotherapy<br>* Chest Physiotherapy, physical exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viscoelasticity | Evolution of elastic modulus, viscous modulus, phase angle and non-linear characteristics of lung secretions. | 30 minutes |
A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip

Study Overview
=================
Brief Summary
-----------------
This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip.

Conditions
-----------------
Osteoarthritis, Hip, Musculoskeletal Diseases

Intervention / Treatment
-----------------
* Device: Synvisc (hylan G-F 20)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic osteoarthritis pain of hip Exclusion Criteria: Patients with current or prior conditions or treatment that would impede measurement of efficacy and safety

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- |
|Device: Synvisc (hylan G-F 20)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis of the hip, Musculoskeletal Diseases
Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-trial access (PTA) program is to provide nipocalimab for the treatment of participants with Warm Autoimmune Hemolytic Anemia (wAIHA) who are experiencing clinical benefit after completing 28-weeks open-label extension in MOM-M281-006 (NCT04119050) study.

Official Title
-----------------
Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006

Conditions
-----------------
Warm Autoimmune Hemolytic Anemia

Intervention / Treatment
-----------------
* Drug: Nipocalimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants demonstrate clinical benefit (improvement of hemoglobin from baseline) at the Week 28 assessment in the open-label extension of the MOM-M281-006 (NCT04119050) study Participants does not have co-morbidities that would alter the risk-benefit of nipocalimab administration (determined by treating physician) Participants completed treatment in the 28-week open-label extension of the MOM-M281-006 (NCT04119050) study without receiving rescue treatment or discontinuation of the study prior to Week 28 visit Exclusion Criteria: Participants have a serious or clinically significant infection (example: pneumonia, biliary tract infection, diverticulitis, Clostridioides difficile infection) requiring parenteral anti-infectives and/or hospitalization Participants have a chronic infection (example: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or require chronic treatment with anti-infectives (example: antibiotics, antivirals)

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nipocalimab|Depending on the dose received at their last administration in the MOM-M281-006 (NCT04119050) study, participants will continue to receive either nipocalimab dose-1 every 2 weeks (Q2W) or nipocalimab dose-2 every 4 weeks (Q4W) by intravenous (IV) infusion.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of the myopic optical defocus on the Humphrey Matrix 30-2 test.

Detailed Description
-----------------
The Humphery Matrix (Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA), which is a recently developed version of FDT perimetry, showed more improved technology to detect early glaucomatous damage. The user's guide for the Humphrey Matrix (Humphrey® matrix visual field instrument user's guide. Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA; 2003) suggests that myopic refractive errors more than -3.0 D need to be corrected before the 30-2 test. However, the proper correction of the optical defocus is not always easy because of a lack of trial frame. The purpose of the present study is twofold. At first, the influence of the low-grade myopia on the Humphery Matrix 30-2 test will be evaluated and compared to the effect of moderate-grade myopia. Secondly, the influence of myopic optical defocus and the glaucomatous visual field damage on the pattern deviation plot change according to the severity of glaucomatous visual field damage will be estimated.

Official Title
-----------------
The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test

Conditions
-----------------
Myopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intra-ocular pressure 23 or higher suspicious glaucomatous optic disc change suspicious defect of retinal nerve fiber layer or eyes with various degrees of glaucoma Exclusion Criteria: a high myopic eye (SE more than -6.0 D) moderate to severe cataract evidence of diabetic or hypertensive retinopathy macular disease intra-ocular inflammation history of intraocular surgery and any other ocular lesion that could have an influence on the perimetry result

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 61 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 |
| --- | --- |
| 1<br>low myopic group | |
| 2<br>moderate myopic group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean defect |  | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myopia, Humphery Matrix 30-2 test