linjc16/ctgov huggingface dataset:
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria

Study Overview
=================
Brief Summary
-----------------
This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.

Official Title
-----------------
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)

Conditions
-----------------
Chronic Inducible Urticaria

Intervention / Treatment
-----------------
* Drug: Oral EP262


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing Willing to discontinue chronic treatment with antihistamines during the study Exclusion Criteria: Urticaria with a clear underlying etiology other than symptomatic dermographism or cold urticaria Other active skin diseases that might confound the study evaluations (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis) Regularly experience wheals covering the area of the body where skin testing will be conducted (eg, more than one third of the volar surface of the forearms)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EP262 150 mg<br>Once daily | Drug: Oral EP262<br>* Once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of EP262 | Assessed by the incidence of treatment-emergent adverse events | Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Critical Friction Threshold (CFT) | Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism) | Measured from Baseline to Week 4 | 
| Change in Critical Temperature Threshold (CTT) | Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria) | Measured from Baseline to Week 4 |
Immunogenicity, Reactogenicity of Shingrix in SLE

Study Overview
=================
Brief Summary
-----------------
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.

Official Title
-----------------
Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.

Conditions
-----------------
Zoster, Systemic Lupus Erythematosus, Vaccine Reaction

Intervention / Treatment
-----------------
* Drug: Shingrix
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females ≥ 19 years of age at time of consent ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14) Clinically stable SLE Corticosteroid use: ≥ 5mg/day of prednisolone equivalent Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks Antimalarials (≤400 mg/day) Azathioprine (≤3 mg/kg/day) Mycophenolate mofetil (≤3 mg/day) Tacrolimus (≤5mg/day) Methotrexate (≤20mg/week) Cyclosphosphamide (≤1mg/BSA/month) Must understand and voluntarily sign an informed consent form including writing consent for data protection Exclusion Criteria: Pregnant or lactating females Acute infection with T >38°C at the time of vaccination Previous anaphylactic response to vaccine components or to egg History of Guillain-Barre syndrome or demyelinating syndromes Any condition including laboratory abnormality which places the subject at unacceptable risk Subjects who decline to participate

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Shingrix<br> | Drug: Shingrix<br>* Shingrix vaccination<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo vaccination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of positive humoral vaccine response at 1 month post-dose 2 | Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of positive humoral vaccine response at 6 months post-dose 2 |  | 8 months | 
| Frequency of humoral responses 12 month post-dose 2 |  | 14 month | 
| Anti-gE antibody concentration at 6 months post-dose 2 |  | 8 months | 
| Anti-gE antibody concentration at 12 months post-dose 2 |  | 14 months |
Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Detailed Description
-----------------
This study includes screening and treatment and follow-up periods.

Official Title
-----------------
A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

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

Intervention / Treatment
-----------------
* Biological: CM310


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years ≤ age ≤ 45 years. Voluntarily participate in the study and sign the ICF. Have the ability to understand the study. Exclusion Criteria: With history of chronic or serious illness. With any medication within 28 days prior to administration; Plan to undergo surgery during the research period; With any situations unsuitable to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>CM310 injection, Subcutaneous | Biological: CM310<br>* CM310 injection<br>|
| Experimental: Group B<br>CM310 injection, Subcutaneous | Biological: CM310<br>* CM310 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic: the maximum concentration (Cmax) | Concentration and exposure | up to week 6 |
Analysis of Risk Factors and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
This hospital-based retrospective study reviewed patients who underwent surgery for CHD between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway anomalies.

Official Title
-----------------
Analysis of Epidemiology, Risk Factors, and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease

Conditions
-----------------
Congenital Heart Disease, Pediatric

Intervention / Treatment
-----------------
* Other: airway anomalies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020. Exclusion Criteria: with much missing clinical data

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: airway anomalies|with or without airway anomalies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical mortality | hospital expired after operation | 1 year | 
| intermediate survival | expired during follow-up | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative ICU stay | The length of ICU stay after operation | 1 year | 
| post-operative intubated days | The length of intubated days after operation | 1 year |
Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this work is to compare validity between CT and MRI in detecting muscular invasion in Patients with bladder cancer.

Official Title
-----------------
Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: CT with contrast
* Diagnostic Test: MRI pelvis
* Procedure: TURBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with urinary bladder mass Exclusion Criteria: bleeding tendency ,patients had chemo , radiotherapy
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT group<br>this group of patient is doing CT abdomen and plevis with IV contrast then they undergo TURBT and compare the radiological staging to histopathological staging. | Diagnostic Test: CT with contrast<br>* CT abdomen and pelvis with IV contrast<br>Procedure: TURBT<br>* transurethral resection of bladder tumor<br>|
| Active Comparator: MRI group<br>this group of patient is doing MRI pelvis with contrast then they undergo TURBT and compare the radiological staging to histopathological staging. | Diagnostic Test: MRI pelvis<br>* MRI pelvis with contrast<br>Procedure: TURBT<br>* transurethral resection of bladder tumor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| which is better to detect muscular invasion in bladder cancer CT vs MRI | the radiological staging of CT and MRI compared to histopathological staging | 1 month |
Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel segmentation, semi-automatic segmentation. Correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.

Official Title
-----------------
Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation

Conditions
-----------------
Low Back Pain, Degenerative Condition, Neurologic

Intervention / Treatment
-----------------
* Other: Spine surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted, for who the following parameters are available: lumbar 3D MRI with T2 weighted sequences, informed consent.

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 |
| --- | --- |
| Single cohort<br>Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted | Other: Spine surgery<br>* Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of muscle fat infiltration | Muscle fat infiltration (%) will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs | 1 year | 
| Percentage of muscle fat infiltration | Muscle fat infiltration (%) will be evaluated by 3D segmentation analysis of T2 weighted lumbar spine MRIs | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar foraminal stenosis | Lumbar foraminal stenosis will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs and expressed as a nerve/foramen surface ratio, and by the Lee et al. Classification | 1 year |
Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer. The secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67, HER2 status) and patient characteristics (age, prior chemotherapy treatment).

Official Title
-----------------
Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients

Conditions
-----------------
Early Breast Cancer

Intervention / Treatment
-----------------
* Other: None intervention (observational study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery - Age >18 years - No previous hormonal treatment - Written informed consent Exclusion Criteria: 1- Patient's inability to provide written informed consent 2 - Stage IV disease

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None intervention (observational study)|None intervention (observational study)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To record the choice, in clinical practice, of adjuvant hormone therapy. | Patients will be divided in groups according to type of adjuvant hormone therapy received: tamoxifen tamoxifen + LhRh aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test. | 21 months |
Iterative Endotracheal Tube Cuff Pressure Monitoring

Study Overview
=================
Brief Summary
-----------------
Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. There are no formal recommendations in the literature, the French Society of Anesthesia and Resuscitation (SFAR) recommends monitoring the pressure intraoperatively except after intubation. It would be interesting to see and thus make an inventory of the practices, to reiterate the importance of monitoring throughout the gesture and at the change of position to avoid either micro-inhalation linked to under pressure of the balloon or overpressure which causes a potential risk of tracheal injury.

Official Title
-----------------
Iterative Endotracheal Tube Cuff Pressure Monitoring

Conditions
-----------------
Spine Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Elderly patient ≥ 18 years old Patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023 Intubated patient with endotracheal tube under mechanical ventilation Sedation and curarization ASA 1, 2 and 3 Duration of surgery > 1 hour Subject not objecting to the reuse of their data for the purposes of this research. Exclusion criteria: Subject who expressed their opposition to participating in the study ASA 4, difficult intubation and emergency Lung pathologies (asthma, COPD, tracheomalacia) Severe heart failure Septic, cardiogenic or volume shock Morbid obesity (BMI >40)

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balloon pressure | Monitoring of balloon pressure following prone position during spine surgery | Throughout the surgical procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spine Disease, Spine surgery, Intubation Cuff Pressure, Endotracheal Intubation, Upper airways
Deep Learning Image Reconstruction for Abdominal CT of Hepatocellular Carcinoma Compared With 3-TESLA MRI

Study Overview
=================
Brief Summary
-----------------
New algorithms for processing CT acquisitions, based on artificial intelligence, have been reported to improve acquisition quality. Thats' why it's possible to imagine that new scan post-processing algorithms enable better detection and characterization of hepatocellular carcinoma lesions than with standard reconstructions. DLIR reconstructions could even match with MRI detection. The aim of the study is to compare the detection and characterization of hepatic lesions according to the LI-RADS classification in CT with DLIR artificial intelligence reconstruction, compared with ASIR-V reconstruction and the gold standard of MRI.

Official Title
-----------------
Deep Learning Image Reconstruction for Abdominal CT of Hepatocellular Carcinoma Compared With 3-TESLA MRI

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing CT and MRI scans in the same week, with protocols dedicated to the detection of HCC lesions Exclusion Criteria: imaging with radiological artefact

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion size in mm |  | Through study completion, an average of 1 year | 
| Hypervascular appearance of lesion | Qualitative measurement: presence or absence of hypervascular lesion | Through study completion an average of 1 year | 
| Hypervascular capsule | Qualitative measurement : presence or absence of hypervascular capsule | Through study completion an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infiltrative nature Classification of the hepatic lesion by LI-RADS in MRI |  | Through study completion an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma, DLIR CT, ASIR reconstruction