linjc16/ctgov huggingface dataset:
Study of the Anti-tumoral Immune Response

Study Overview
=================
Brief Summary
-----------------
This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.

Official Title
-----------------
Study of the Anti-tumoral Immune Response T Cells Cluster of Differentiation 4 (TCD4): Proof of the Concept in Breast Cancer and Glioma

Conditions
-----------------
Breast Cancer, Glioma

Intervention / Treatment
-----------------
* Other: additional blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Performance status 0,1 or 2 breast cancer or glioma Arm glioma: patients without anti-tumoral treatment Arm breast cancer: inclusion before treatment Arm breast cancer HER2: patients with current therapy Exclusion Criteria: Psychiatric disease compromising the understanding of the information or the realization of the study vulnerable People according to the law (minors, adults under protection, private persons of freedom ...) Unaffiliated People to the Social Security People being for the period of exclusion from another study Life expectancy estimated unless 3 months. For patients in Arm glioma: patients having already begun a systematic treatment. For patients with a breast cancer: patient already under current therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glioma<br>1 additional blood sample for patients with glioma and without treatment | Other: additional blood sample<br> <br> |
| Experimental: breast cancer<br>2 additional blood samples for patients with localized brest cancer, metastatic breast cancer in 1st line of treatment and breast cancer in second line of treatment. | Other: additional blood sample<br> <br> |
| Experimental: breast cancer HER2+<br>1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression | Other: additional blood sample<br> <br> |
| Experimental: Breast Cancer HER 2+ or HER2 triple -<br>1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant | Other: additional blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous immune responses of T cells CD4 specific tumor antigens |  | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cells level |  | 15 months |
Evaluation the Feasibility of the FOSTI Device

Study Overview
=================
Brief Summary
-----------------
Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue

Detailed Description
-----------------
Characterization of the optical fiber sensor's interaction with the tissue. Creating a database of tissue lesions and their 'optical signature' (lesion classifier). Optimization of the FOSTI device by minimizing the false-positive and false-negative results.

Official Title
-----------------
Evaluation the Feasibility of the FOSTI Device Accurately and in a Real Time Way to Differentiate Malignant From Benign Tissue (Performed ex Vivo) in Cancer Surgery

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of all ages. Subject is able, agree and sign the Informed Consent Form. Exclusion Criteria: Subject has any conditions, which precludes compliance with study
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer
Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.

Official Title
-----------------
A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy

Conditions
-----------------
Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available; Subject was 18 years of age or older at the time of NIPT; Subject provides signed and dated informed consent in English; Exclusion Criteria: Subjects' treating physician is not located in the United States.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple gestations<br>Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay | Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient | Subjects contacted within 3 years after pregnancy is completed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noninvasive prenatal testing
Evaluation of the American Thoracic Society Criteria for Predicting Multidrug-resistant Bacteria in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria in China.

Detailed Description
-----------------
All data concerning patient characteristics at ICU admission and during ICU stay were prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates from intubated patients and specimens from the infection location) was performed at ICU admission and discharge. Risk factors for infection or colonization with MDR bacteria were recorded, and the accuracy of the ATS criteria in predicting infection or colonization with these bacteria at ICU admission was documented. All of the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of the ATS guidelines.

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients hospitalized in the ICU were eligible for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonization, infection, multidrug-resistant bacteria, guideline
Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

Study Overview
=================
Brief Summary
-----------------
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.

Official Title
-----------------
A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis of one or both knees on stable NSAID or none due to intolerance women either post menopausal or on stable birth control no clinically significant disease or or abnormal laboratory values signed informed consent, communicate effectively, understand and comply with all study requirements Exclusion Criteria: serious or unstable medical or psychological condition known sensitivity to honeybee venom, histamine or lidocaine history of asthma any clinically significant ECG abnormalities any clinically significant laboratory values OOR history of drug or alcohol abuse history of joint injury and forms of inflammatory arthritis

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: histamine<br>histamine in saline administered ID as active control for Apitox | Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))<br>* multiple intradermal injections of 100 ug pure honeybee venom<br>* Other names: Apitoxin (Korea) Apitox (USA);|
| Experimental: Apitox pure honeybee venom<br>ID study drug | Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))<br>* multiple intradermal injections of 100 ug pure honeybee venom<br>* Other names: Apitoxin (Korea) Apitox (USA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
honeybee venom, osteoarthritis, pain, knees
Viral Dynamics of Omicron in Children

Study Overview
=================
Brief Summary
-----------------
SARS-CoV-2 transmission is dependent on multiple factors, which may be related to either host-virus interaction or the environment. While there have been several studies evaluation viral dynamics and transmission risk in adults, there is limited pediatric data available. The objective of this study is to characterize the period of communicability for children less than 19 years of age with SARS-CoV-2 infection with the Omicron variant.

Detailed Description
-----------------
The goal of our study is to assess the viral dynamics of SARS-CoV-2 infection in children < 19 years with acute infection to inform public health practice. Specific Aims: Describe the kinetics of SARS-CoV-2 viral load in children with acute SARS-CoV-2 infection Assess the impact of various host factors on viral dynamics, including age (<1 year, 1-4 years, 5-11 years, 12-18 years), symptoms, clinical severity (hospitalization vs. outpatient), comorbidities (immunocompromised vs. not immunocompromised), vaccination (none, 1 dose, 2 doses) Estimate the time point at which children are less likely to be infectious Assess the sensitivity of self-collected rapid antigen testing (RAT) in children, compared to PCR (e.g. assess RAT test performance in children)

Official Title
-----------------
Viral Dynamics of the SARS-CoV-2 Omicron Variant in Paediatric Patients

Conditions
-----------------
SARS-CoV2 Infection, COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: Daily SARS-CoV-2 PCR Testing for 10 days


Participation Criteria
=================
Eligibility Criteria
-----------------
To be included in the study, the participant must be: Less than 19 years of age Have a positive molecular or rapid antigen test in the previous 48 hours If symptomatic, onset of any COVID-19 symptom within last 72 hours. If asymptomatic, evidence to support acute infection (e.g. negative PCR in the last 5 days, known household exposure where index case is clear) Able to collect daily samples

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Daily SARS-CoV-2 PCR Testing for 10 days|Each participant will undergo daily SARS-CoV-2 PCR testing to assess viral dynamics|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 Viral Load | We will use prospective longitudinal quantitative reverse transcription PCR testing to measure the viral RNA trajectories for individuals in the study. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid antigen test sensitivity | We will describe the RAT positivity on Days 1 to 10 and evaluate the performance of RAT compared to PCR | 10 days |
Analysis of Postoperative Bandage Use Protocols in Otoplasty

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. We hypothesize that the duration of elastic bandage use has no significant influence on the incidence of relapse of prominence of the ears and need for reoperation.

Official Title
-----------------
Analysis of the Influence of Different Protocols of Postoperative Elastic Bandage Use in the Results of Otoplasty

Conditions
-----------------
Prominent Ears

Intervention / Treatment
-----------------
* Procedure: Use of ear bandage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital bilateral ear prominence 10 years-old or older No previous attempt of surgical treatment Exclusion Criteria: Pregnant women Breastfeeding women Blod clotting disorders or current anticoagulant use Uncontrolled systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seven-day bandage use<br>Patients randomized and instructed to use of ear bandage 24h/day for seven days after otoplasty | Procedure: Use of ear bandage<br>* Elastic bandage to be used on the postoperative period of otoplasty, starting immediately after the procedure. To be used 24hours/day for the specified period.<br>|
| Active Comparator: Thirty-day bandage use<br>Patients randomized and instructed to use of ear bandage 24h/day for thirty days after otoplasty | Procedure: Use of ear bandage<br>* Elastic bandage to be used on the postoperative period of otoplasty, starting immediately after the procedure. To be used 24hours/day for the specified period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of re-operation |  | until 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from immediate postoperative period of helix-mastoid distance |  | 6 months | 
| Change from immediate postoperative period of helix-mastoid distance |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
External ear, Ear abnormalities, External ear cartilages
Psychological Context Effects

Study Overview
=================
Brief Summary
-----------------
This study explores how contextual effects in the fore of positive and negative communication can affect the effect of an osteopathic technique on pain pressure thresholds.

Official Title
-----------------
Psychological Context Effects of Participant Expectation on Pain Pressure Thresholds Following Cervicothoracic HVLA Thrust Manipulation: A Double Blind, Crossover, Randomised Controlled Trial

Conditions
-----------------
Positive Communication (Primary), Negative Communication, Control Condition

Intervention / Treatment
-----------------
* Behavioral: communication type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health volunteers with no forms of existing pain. Exclusion Criteria: Participants with existing pain.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive communication<br> | Behavioral: communication type<br>* Positive and negative communication types are the way that the practitioner communicates to the participant about the potential effectiveness of the osteopathic treatment. The control is a neutral communication condition.<br>* Other names: Control;|
| No Intervention: Control (neutral communication)<br> | |
| Experimental: Negative communication<br> | Behavioral: communication type<br>* Positive and negative communication types are the way that the practitioner communicates to the participant about the potential effectiveness of the osteopathic treatment. The control is a neutral communication condition.<br>* Other names: Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain pressure threshold | This is the degree to which the participant can tolerate pressure induced through an algometer. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contextual effects
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic human secretin) with MRCP in subjects with abnormalities of the pancreas.

Official Title
-----------------
Phase III Study to Demonstrate the Efficacy and Safety of RG1068 (Synthetic Human Secretin)- Enhanced Magnetic Resonance Cholangiopancreatography (MRCP) in the Evaluation of Subjects With a History of Acute or Acute Recurrent Pancreatitis

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Drug: RG1068 (synthetic human secretin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of pancreatitis Medically stable Able to give informed consent Exclusion Criteria: Prior history of pancreatic resection Prior history of pancreatic duct drainage procedure Presence of a pancreatic stent Unstable cardiovascular disease Any contraindication to MRI procedure Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RG1068 (synthetic human secretin)<br>* Single-dose, IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities. |  | 0 - 10 minutes post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome measure will assess safety |  | up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
secretin, RG1068, MRCP, pancreas
Bone Healing Study

Study Overview
=================
Brief Summary
-----------------
The aim of the research is to identify structural tissue changes in the early fracture hematomas.

Detailed Description
-----------------
The fracture hematomas obtained during reconstructive bone surgery from patients with bone fractures will be examined. Histological methods and ultra-thin sections for electron microscopy will be used to identify structural tissue changes in the granulation tissue in different period of time after bone fracture. Immunohistochemical analysis will be performed to estimate the dynamic of proliferation, differentiation and cell migration during granulation and reticulofibrosis bone tissues development.

Official Title
-----------------
Study of the Granulation Tissue Formation in the Early Fracture Hematoma

Conditions
-----------------
Bone Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with fractures of the upper and lower extremities Patients for whom the surgical bone reconstruction are indicated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 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 |
| --- | --- | --- |
| Granulation tissue formation |  | 23 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematoma fracture, angiogenesis, bone formation