linjc16/ctgov huggingface dataset:
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer RH+ HER2- patients with systemic therapy guided by Oncotype DX (ODX) Breast Recurrence Score®.

Official Title
-----------------
FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years old With invasive breast carcinoma diagnosed on biopsy or surgical sample (histological evidence) Operable breast cancer HR+ (at least ER+) /HER2- tumors With ODX assay performed Exclusion Criteria: Inoperable tumor(s) or inoperable patient (e.g., patient too frail to undergo surgery) Synchronous breast cancers with different clinico-pathological features (e.g. : HR+/HER2 negative and triple-negative or HER2-positive breast cancer Patient undergoing neoadjuvant chemotherapy or neoadjuvant hormone therapy Nodal involvement in more than 4 lymph nodes (pN2 or higher) Metastatic breast cancer at diagnosis Other malignancy diagnosed in the past 10 years (except for cutaneous malignancies other than melanoma) The patient participated in the RxPONDER study in France The patient communicated a refusal to participate in the study (via a refusal letter to the investigator) Legal incapacity or limited legal capacity

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

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

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 |
| --- | --- | --- |
| to evaluate the clinical outcomes represented by iDFS in French early breast cancer patients with Oncotype DX (ODX) Breast Recurrence Score® (RS) results-guided therapy |  | time between surgery and recurrence (local, regional, distant), contralateral breast cancer, second cancer or death (all causes), whichever occurs first, assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer-specific survival |  | time between surgery and death related to breast cancer, assessed up to 5 years | 
| Distant disease-free survival |  | time between surgery and distant recurrence or death (all causes), whichever occurs first, assessed up to 5 years | 
| Locoregional relapse-free survival |  | time between surgery and progression/recurrence (local, regional), ipsilateral DCIS or death (all causes), whichever occurs first, assessed up to 5 years | 
| Overall Survival |  | time between surgery and death, assessed up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Early breast cancer
Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula

Study Overview
=================
Brief Summary
-----------------
Comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula.

Detailed Description
-----------------
Delayed intubation after NIV / HFNC failure is associated with high mortality rate in acute respiratory failure patients. There are Many factors to predict early failure but World still searching for new factors and comparing between each ;in order to eatablish best one that achieve the least mortality rate. Little studies about effiecacy of HACOR Score as a predictor of failure in HFNC patients. Little studies about effiecacy of ROX Index as a predictor of failure in NIV ventilating patients.

Official Title
-----------------
Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula in Acute Respiratory Failure Patients : the Standardized PaO2 / FiO2 Ratio (P /F-st), ROX Index and HACOR

Conditions
-----------------
Acute Respiratory Failure Patients on NIV and HFNC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute respiratory failure patients who need ventilatory Support either NIV or HFNC due to : RR > 25 cycle / min using accessory muscles and paradoxical breath. PaO2 / FiO2 ratio < 300 Exclusion Criteria: Absolute indication for intubation like coma, haemodynamically unstable… etc Contr-indication of NIV like untreated Pneumothorax.

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 |
| --- | --- | --- |
| Determine Golden time for intubation | Determine best time for intubation according to some predictors of failure of NIV and HFNC | 1 year |
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)

Study Overview
=================
Brief Summary
-----------------
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.

Detailed Description
-----------------
This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having > 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon. The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.

Official Title
-----------------
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)

Conditions
-----------------
Arteriovenous Fistula Stenosis

Intervention / Treatment
-----------------
* Device: Angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Failing mature upper limb AVF Resistant stenosis (>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation) Patient is >= 21 years of age Ability to provide informed consent Exclusion Criteria: Thrombosed AVF Target lesion has a sharp angle (> 45 degrees) Lesions requiring cutting balloon size > 7 mm Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure Contraindication to dual antiplatelet therapy Severe allergy to contrast media that cannot be adequately managed for the procedure Breast-feeding and/or pregnant females Male patients who are planning to father children during the trial period Unable to comply with follow up protocol (for instance, limited life expectancy)

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment arm<br>Cutting and drug-coated balloon angioplasty | Device: Angioplasty<br>* Angioplasty with cutting and drug-coated balloon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion primary patency | Time from index treatment to repeat treatment of target lesion or thrombosis of circuit. | 6 months after index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arteriovenous fistula, drug-coated balloon, cutting balloon, stenosis
Preoperative Clear Liquid Diet Fasting; Survey Among Medical School Physician

Study Overview
=================
Brief Summary
-----------------
To determine knowledge and practice about liquid diet fasting among physicians in a Quaternary-care academic center study decide: questionnaire based study to ask concerning and knowledge and practice about liquid diet fasting and other diet fasting.

Official Title
-----------------
The Knowledge and Practice of Preoperative Clear Liquid Diet Fasting Among Medical Staff in a Medical School Hospital.

Conditions
-----------------
Fasting Before Operation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physician who have opportunity to order fasting for surgical patient. Exclusion Criteria: none

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

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 |
| --- | --- | --- |
| Score of multiple-choice question test about fasting before operation in physician of medical school. | Multiple-choice question for access knowledge about fasting before operation in physician of medical school. Possible score range from 0 (poor knowledge) to 8 (excellence knowledge). | 1 year |
Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar.

Official Title
-----------------
Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes: a Randomized Controlled Trial

Conditions
-----------------
Diabete Type 2

Intervention / Treatment
-----------------
* Behavioral: Food voucher


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemoglobin A1c 6.0 to 11.0 report food insecurity or financial insecurity Exclusion Criteria: live with a current study participant life expectancy < 6 months multiple life-threatening allergies to common foods require total parenteral nutrion blood dyscrasia that interferes with hemoglobin A1c interpretation hemoglobin A1c >11

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food voucher<br> | Behavioral: Food voucher<br>* A voucher of $65 (or $85 for people in larger households) that can be redeemed for food at grocery stores.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Change in hemoglobin A1c | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health (In general, how would you rate your health today?) | Self-reported health. Potential responses are: very good, good, moderate, bad, very bad and decline to respond. | 6 months | 
| Financial security (Do you have trouble making ends meet at the end of the month?) | Self-reported financial security | 6 months | 
| Food insecurity measured by 6 questions from Household Food Security Survey | Self-reported food insecurity | 6 months | 
| Fruit and vegetable consumption | Self-reported fruit and vegetable consumption | 6 months | 
| Health care utilization using administrative data | Includes hospitalizations, outpatient visits and primary care visits | 6 months | 
| Carotenoid level | Serum caortenoid level | 6 months |
Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of a CT/PET/ WSI-based deep learning signature for predicting complete pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer

Official Title
-----------------
An Integration of a Computed Tomography/Positron Emission Tomography/Whole Slide Image (CT/PET/WSI) Based Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer: A Multicenter Study

Conditions
-----------------
Non-small Cell Lung Cancer, Neoadjuvant Chemoimmunotherapy, Complete Pathological Response

Intervention / Treatment
-----------------
* Diagnostic Test: CT/PET/WSI-based Deep Learning Signature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ranging from 20-75 years; Patients who underwent curative surgery after neoadjuvant chemoimmunotherapy for NSCLC; Obtained written informed consent. Exclusion Criteria: Missing image data; Pathological N3 disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CT/PET/WSI-based Deep Learning Signature|CT/PET/WSI-based Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operating characteristic curve | The area under the receiver operating characteristic curve (ROC) of the deep learning model in predicting complete pathological response (CPR). CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy. | 2023.5.1-2023.10.31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The sensitivity of the deep learning model in predicting complete pathological response. CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy. | 2023.5.1-2023.10.31 |
Biomarkers in Concussion

Study Overview
=================
Brief Summary
-----------------
This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.

Official Title
-----------------
Biomarkers in Concussion

Conditions
-----------------
Concussion, Mild, Concussion, Intermediate, Concussion, Severe

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 12 years of age Athletes participating on a sports team willing to participate; undergo blood draws either weekly or every two weeks, depending on arm of study. Exclusion criteria: Existing active neurodegenerative disorder (ie severe TBI) Active peripheral nerve disorder (ie diabetic neuropathy)

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Concussion<br>Has an acute concussion | |
| Non-concussion<br>Does not have a concussion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of NfL levels |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of concussion symptoms |  | 12 weeks |
Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss

Study Overview
=================
Brief Summary
-----------------
In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp

Official Title
-----------------
Using Direct Non-thermal Atmospheric Pressure Plasma With Penetration Enhancement for the Treatment of Hair Loss

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Device: NTAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of mild-to moderate androgenetic alopecia ability to keep in-person follow-up appointments Exclusion Criteria: any inflammatory scalp condition starting or discontinuing any hair loss treatments within 6 months of start date allergy to any components of the carrier solution

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NTAP treatment<br>Treatment arm subjects receive the trial intervention | Device: NTAP<br>* Cold plasma is generated and applied to the scalp area, which was previously soaked with normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of detectable hair growth | Presence of hair growth as measured using the HairMetrix device | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects related to the treatment | Patients are monitored for adverse effects, including but not limited to irritation, itch, inflammation, scaling, redness, rash, peeling, blistering | throughout study completeion, 6 months |
Prognostic Markers for a Better Follow-up in Head and Neck Cancer.

Study Overview
=================
Brief Summary
-----------------
To identify tumor specific DNA mutations and aberrations and to follow these in blood over time to predict treatment response/survival and secondly to correlate presence of these markers in blood to pathological parameters (LVI, Pn, WPOI and margins), radiological findings and to tumor stage.

Official Title
-----------------
Prognostic Markers for a Better Follow-up in Head and Neck Cancer.

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Genetic: DNA exome sequencing of tumor and blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with head and neck cancer Treatment includes surgery Consent to participate Exclusion Criteria: No consent Age below 18 years No surgery No tumor material to sample

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 |
| --- | --- |
| Patient with head and neck cancer<br>Patient diagnosed with head and neck cancer | Genetic: DNA exome sequencing of tumor and blood<br>* A piece from tumor and a blood sample will be collected during surgery. DNA will be extracted and presence of tumor specific mutations/aberrations will be analysed with a DNA exome seq panel. Presence of identified markers will be followed in blood samples with the same panel and these blood samples will be collected in routine follow-up during the first two years. Presence of markers over time in blood will be correlated to outcomes 1-5.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Recurrent disease within 2 years after surgery. Is presence of these DNA changes in blood correlated to recurrence? | 2 years | 
| Survival | Alive/dead. Is presence of these DNA changes in blood correlated to survival? | 2 years | 
| Treatment response | Is presence of these DNA changes in blood correlated to treatment response? | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological parameters | Is presence of these DNA changes correlated to pathological parameters (LVI, Pn, WPOI and margins). | 6 months | 
| Radiological parameters | Is presence of these DNA markers in blood correlated to PET-findings? | 9 months | 
| Stage | If patients are stratified by stage, are there any differences in Outcome 1-5 (please see above) | 2 years |