linjc16/ctgov huggingface dataset:
Goal Concordant Care Learning Laboratory

Study Overview
=================
Brief Summary
-----------------
The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness.

Detailed Description
-----------------
The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness. The lab will test a variety of interventions, including triggered conversations and feedback to healthcare providers.

Official Title
-----------------
Palliative Care Learning Laboratory

Conditions
-----------------
Cancer, Heart Failure, Copd, Dementia

Intervention / Treatment
-----------------
* Behavioral: Feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duke Health patient Exclusion Criteria: None

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Several interventions will be tested, at the patient and provider levels
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Intervention<br>Feedback to provider regarding frequency and quality of communication | Behavioral: Feedback<br>* Providers will receive detailed feedback about the timing, quality, and frequency of their goals of care communication with patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of goals of care communication | Frequency of goals of care conversations in the last 6 months of life | 2 years | 
| Timing of goals of care communication | Proximity of goals of care communication to death | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palliative care
UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess UDFF performance (compared to MRI)

Official Title
-----------------
UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

Conditions
-----------------
Non Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Diagnostic Test: UDFF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who had hepatic ultrasound with available UDFF measurements and hepatic MRI (with steatosis quantification sequences) between 01/01/2022 and 31/09/2023 may be included. Exclusion Criteria: chronic liver disease with a different etiology other than NAFL/NASH or mixed (hepatitis B or C, hemochromatosis, autoimmune hepatitis, Wilson's disease, cholestasic disease, alpha 1 antitrypsin deficiency), decompensated cirrhosis (ascites, jaundice, encephalopathy, rupture of esophageal varices), hepatocellular carcinoma. opposition to the use of its data

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 |
| --- | --- |
| one group<br>Patients who had during their care UDFF ultrasound measurements and liver MRI over the study period may be included in this study | Diagnostic Test: UDFF<br>* quantification of liver fat: UDFF (lipid fraction derived from ultrasound) from one of the probes of an ultrasound system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the perfomances of the UDFF system for the quantification of hepatic steatosis in patients suspected of chronic hepatophyte. | Steatosis value measured by multiecho sequences in MR | 3 months maximum between the 2 measurements (UDFF and MRi) |
Neoadjuvant Immunochemotherapy for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at one application of PD-1 inhibitor.

Official Title
-----------------
Retrospective Research on Lung Cancer Patients Receiving Neoadjuvant Immunochemotherapy From Zhongshan Hospital Fudan University.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Neoadjuvant immunochemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan Hospital; At least one cycle of neoadjuvant treatment containing the immune drug PD-1 immunosuppressant was performed before surgery; Malignancy was present and confirmed in the pathology before treatment and after surgery; The lung lesion was the primary lesion. Exclusion Criteria: No lung surgery was performed until 2022.11; No preoperative neoadjuvant therapy was performed or recorded; Neoadjuvant therapy did not include immune drugs; Previous history of malignancy (including surgery and adjuvant therapy); Previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the investigator.

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 |
| --- | --- |
| MAICT<br>chemotherapy that included at one application of PD-1 inhibitor | Drug: Neoadjuvant immunochemotherapy<br>* Patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.<br>* Other names: surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Progression-free defined as status of recurrence of lung cancer | 2017-2023 | 
| Overall survival (OS) | Overall defined as the living status, alive or dead | 2017-2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoadjuvant therapy
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

Official Title
-----------------
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

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

Intervention / Treatment
-----------------
* Drug: Astegolimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of the 52-week treatment period in either parent GB43311 or GB44332 Exclusion Criteria: Withdrawal of consent and/or premature discontinuation from parent study Any permanent discontinuation of study drug in parent study Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Extension<br>Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study | Drug: Astegolimab<br>* Participants will receive SC astegolimab Q2W<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse events (AEs) |  | Up to 12 weeks after last dose of study treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic obstructive pulmonary disease, COPD
M-Vizion™ Macroscopic Radiographic Study

Study Overview
=================
Brief Summary
-----------------
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.

Detailed Description
-----------------
The aim of this study is to evaluate the M-Vizion modular stem performance in patients who undergo total hip replacement according to the standard practice. It is expected that subjects receiving revision hip arthroplasty with the Medacta M-Vizion™ modular hip stem will have less than 5mm of stem subsidence at 2 years.

Official Title
-----------------
Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study

Conditions
-----------------
Revision Hip Arthroplasty

Intervention / Treatment
-----------------
* Device: revision hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF). Ability to understand and provide written authorization for use and disclosure of personal health information. Subjects who are able and willing to comply with the study protocol and follow-up visits. Patients requiring a revision total hip replacement. Subjects undergoing revision THA who will receive an M-Vizion femoral component according to the indications for use. Male and female patients ages 21 - 80 years of age at the time of surgery. Exclusion Criteria: Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. Patients with a systemic or metabolic disorder leading to progressive bone deterioration. Patients bone stock is compromised by disease or infection, which could possibly prevent adequate support and/or fixation to the prosthesis. Patients with an active or suspected latent infection in or about the hip joint. Patients that are incarcerated.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: revision hip arthroplasty|revision hip arthroplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subsidence | Occurrence of subsidence >5mm | 6 weeks post-op visit (± 2 weeks) | 
| subsidence | Occurrence of subsidence >5mm | 6 Months post-op visit (± 2 months) | 
| subsidence | Occurrence of subsidence >5mm | 1 year post-op visit (± 4 months) | 
| subsidence | Occurrence of subsidence >5mm | 2 year post-op visit (± 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
revision, hip, arthroplasty
CLUE: CLinical Utility Study of EsoGuard

Study Overview
=================
Brief Summary
-----------------
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.

Official Title
-----------------
CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)

Conditions
-----------------
Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma

Intervention / Treatment
-----------------
* Device: EsoGuard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals in whom the clinical decision has been made to screen for BE using EC/EG Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update. Exclusion Criteria: Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU) Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening Inability to provide written informed consent or participate in the required follow up

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 99 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 |
| --- | --- |
| Other: Single Arm Study<br> | Device: EsoGuard<br>* EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1)<br>* Other names: EsoGuard test on cells collected using EsoCheck;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility | Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Compliance | Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred. | Through study completion, an average of 1 year |
Trends of Cancer Incidence and Mortality in Russia

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the dynamics of incidence and mortality for all major groups of cancers for which the national data is available for the longest possible time series. The data obtained from publicly available sources are used.

Official Title
-----------------
Trends of Cancer Incidence and Mortality in Russia: the Breakpoint and Age-period-cohort Analyses of Cancer Incidence and Mortality

Conditions
-----------------
Oncology, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Non applicable

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Cancer incidence |  | 30 years | 
| Cancer mortality |  | 30 years |
What is the Experience of the Professional Nurse Advocates (PNAs) Application of the A-EQUIP Model Into Practice

Study Overview
=================
Brief Summary
-----------------
The study will utilise focus groups with trained PNAs from different Trusts spread over the Midlands region within England. This approach will help explore the experiences and views of trained PNAs in the application of the role and the foundations on which it is supported. It will also supply valuable feedback regarding the preparation, implementation, and outcome of adopting the PNA position with health care organisations, as there is a suggestion that the role could expand from England to the United Kingdom and possibly the United States of America.

Official Title
-----------------
What is the Experience of the Professional Nurse Advocates (PNAs) Application of the A-EQUIP Model Into Practice

Conditions
-----------------
Staff Attitude, Professional Role

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Qualified Professional Nurse Advocate (PNAs) all of whom would have successfully completed a PNA level 7 module provided by a Higher Education Institution within England Exclusion Criteria: • Any qualified nurse who has not successfully completed a PNA module.

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 |
| --- | --- | --- |
| To measure the experiences of PNAs in implementing the role within their clinical practice and using the A-EQUIP model | To explore the experiences of Professional Nurse Advocates and their application of the A-EQUIP model into clinical practice | 3 months |
Outcome Of Using Transfixing K Wire ln DDH With Hypoplastic Head And Severe Generalised Ligamentous Laxity

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the outcome of using transfixing hip k wire in Developmental dysplastic hip in patients with hypoplastic head and severe generalised ligamentous laxity.

Detailed Description
-----------------
The goal of treatment in developmental dysplasia of the hip (DDH) is to obtain and maintain a stable concentric reduction. Surgical treatment is done by open reduction through a medial approach or anterolateral approach with pelvic osteotomy,capsulorhaphy, femoral shortening and derotational osteotomy. Transfixing the femoral head with Kirschner wire during open reduction has long been thought to provide stability to the hip without damaging the femoral head or the acetabulum and to decrease the risk or re-dislocation. The aim of this study is to assess the effect of transfixing the hip with Kirschner wire during the operative treatment of hip dysplasia in children after the walking age on the final radiological and clinical results and to compare the risks with the benefits of adding this step.

Official Title
-----------------
Outcome Of Using Transfixing Hip K Wire ln Developmental Dysplasia Of Hip With Hypoplastic Head And Severe Generalised Ligamentous Laxity

Conditions
-----------------
Developmental Dysplasia of the Hip

Intervention / Treatment
-----------------
* Procedure: Kirschner wire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 1 year and younger than 7 Patients with hypoplastic head Patients with severe ligamentous laxity (Beighton score ≥ 4) Exclusion Criteria: Patients younger than 1 year and older than 7 years old. Beighton score < 4 Secondary hip dislocation (neuromuscular disorder) as cerebral palsy , myelodysplasia or arthrogryposis.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-wire<br>k wire transfixing hip | Procedure: Kirschner wire<br>* Transfixing femoral head Kirschner wire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified McKay's criteria | degree of Hip function score | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | pain, pin tract infection and recurrent dislocation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Developmental dysplasia of the study, Kirschner wire, Hypoplastic Head, Ligamentous laxity