linjc16/ctgov huggingface dataset:
Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics

Study Overview
=================
Brief Summary
-----------------
It is a prospective, observational cohort study of patients with dense breast tissue. The study was based on the radiomics and other clinicopathological information of patients to establish the diagnostic system for breast disease by using artificial intelligence.

Official Title
-----------------
Development of an Artificial Intelligence Precise Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics

Conditions
-----------------
Breast Diseases, Artificial Intelligence, Dense Breast Density, Predictive Cancer Model

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with dense breast density tissue Digital breast tomosynthesis was performed Breast ultrasound examination was performed Pathologic examination of breast lesions was performed Exclusion Criteria: Incomplete clinicopathologic data Female patients with fatty glands of the breast

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| the predictive model's area under curve(AUC) | To assess the predictive accuracy of the radiomic-based and clinical-based model by using operating characteristic curve (ROC) analysis and calculating the area under the curves (AUC). | follow up for 2 year for individuals |
Clinical Validation of the M5L Lung CAD

Study Overview
=================
Brief Summary
-----------------
To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading.

Detailed Description
-----------------
The main aim of this study is to compare the diagnostic performance of CAD assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. This study also aims at validating a new Web/Cloud based workflow for the use of CAD systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective CAD solution for clinical facilities.

Official Title
-----------------
Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L

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

Intervention / Treatment
-----------------
* Diagnostic Test: Computed Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed extra-thoracic neoplasm Exclusion Criteria: More than 10 nodules Severe pulmonary fibrosis Diffuse bronchiectasis Extensive inflammatory consolidation Massive pleural effusion Pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oncological patients with extra-thoracic cancer<br>Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies. | Diagnostic Test: Computed Tomography<br>* CT scans were performed on a 128 detector rows CT scanner (Somatom Definition Flash Siemens Medical Systems, Erlangen, Germany) as in routine clinical practice in the centre<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-patient detection sensitivity unassisted vs CAD assisted reading | Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis | 1 month after collection of data | 
| Per-lesion detection sensitivity unassisted vs CAD assisted reading | Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per-lesion analysis. Sub-analyses per nodule tissue, nodule dimension and nodule localization are included | 1 month after collection of data | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of reading time between unassisted vs CAD assisted reading |  | 1 month after collection of data | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Web, computer-aided diagnosis, Cloud computing, lung cancer
Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.

Official Title
-----------------
A 4 Week Randomized, Placebo-Controlled, Parallel Group, Double-Blind Pilot Study to Assess the Safety and Efficacy of Etoricoxib 90 mg Versus Placebo in the Treatment of Cancer Pain

Conditions
-----------------
Bone Neoplasms

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib / Duration of Treatment: 4 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, etoricoxib / Duration of Treatment: 4 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic efficacy over a 4 week treatment period; Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Effect of Birth on Immunological Parameters in Cord Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.

Detailed Description
-----------------
The main purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood and also whether mode and duration of delivery has an influence on immune parameters in cord blood.

Official Title
-----------------
To Investigate the Immediate Effect of Birth on Immunological Parameters in Cord Blood, and Compare With Data of CS Born Infants Collected in the JULIUS SN Study

Conditions
-----------------
Immunologic Activity Alteration

Intervention / Treatment
-----------------
* Other: This is not an interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant mothers undergoing normal vaginal delivery Exclusion Criteria: Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth Antenatal antibiotics treatment (2 weeks prior to birth) Diabetes mellitus requiring insulin treatment during pregnancy Uncontrollable Hyperthyroidism during pregnancy
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: This is not an interventional study|This is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines Profile in Cord Blood Plasma | Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa | 1 year | 
| Cord Blood Immunoglobulin Levels | Immunoglobulin levels will be measured in cord blood plasma | 1 year | 
| Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC) | Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells. | 1 year |
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter VB device) for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries).

Official Title
-----------------
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries in Thoracic, Abdominal, and Pelvic Arteries

Conditions
-----------------
Iatrogenic Vessel Injury

Intervention / Treatment
-----------------
* Device: GORE® VIABAHN® Endoprosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GORE® VIABAHN® Endoprosthesis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | A technical success is defined as is a successful device implantation and a successful hemostasis. | Day 1 to 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The safety Endpoint is the occurrence of serious adverse events and deficiencies. | Day 1 to 12 months |
Evaluation of Early Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Establishing that mucosal healing (MH) has occurred after therapy is an important treatment goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has demonstrated good correlations for clinical remission and disease severity, but its role for establishing mucosal healing after therapy has not been validated . The ability to predict mucosal healing may be different for patients in long term remission compared to assessment after obtaining clinical remission. No previous study has prospectively validated the use of PUCAI as a proxy for MH specifically during clinical remission after therapy.

Detailed Description
-----------------
All pediatric patients ≤ 19 years old and at the Wolfson Medical Center pediatric IBD center who enter clinical remission are routinely assessed by colposcopy or sigmoidoscopy assess. This is an analysis of prospectively collected data regarding PUCAI and endoscopic Mayo score at the time of assessment of mucosal healing by endoscopy. Patients could be included if they have establish ulcerative colitis, while they are on remission for at least 3 months after treatment of flare. For this study, complete clinical remission was absence of abdominal pain, and no diarrhea or bleeding (PUCAI<10). sigmoidoscopy will be performed between 12-24 weeks after remission was documented.

Official Title
-----------------
Evaluation of PUCAI Score at Assessment for Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulcerative Colitis patient clinical remission (PUCAI<10) for at least 3 months. Sigmoidoscopy for assessment mucusa healing after therapy performed between 12-24 weeks after remission was documented - -

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 19 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 |
| --- | --- | --- |
| Mucusa healing according to the MAYO score | present of endoscopic disease defined by mayo score | cross sectional study, the data will be reported during 4 years |
Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men. PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.

Detailed Description
-----------------
OBJECTIVES: To determine whether the anal cytology screening outcome derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens in men who have sex with men. To determine whether the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens. OUTLINE: Dry sterile Dacron swabs and flocked nylon swabs are used to collect intra-anal cytology specimens for anal Pap testing and human papillomavirus typing. Participants undergo a digital rectal examination and high-resolution anoscopy. If lesions are identified, an anal biopsy is performed for histological examination.

Official Title
-----------------
Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy

Conditions
-----------------
Anal Cancer, Nonneoplastic Condition, Precancerous Condition

Intervention / Treatment
-----------------
* Other: Papanicolaou test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected or -uninfected adult men who have sex with men Concurrent enrollment in the Multicenter AIDS Cohort Study required Exclusion Criteria: history of anal perforation or other medical contraindications

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: swab test<br> | Other: Papanicolaou test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab |  | a day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human papilloma virus infection, anal cancer, HIV infection
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-062)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression

Detailed Description
-----------------
The duration of treatment is 8 weeks.

Official Title
-----------------
A Double-Blind, Multicenter, Placebo and Active-Controlled, Acute Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: aprepitant
* Drug: Comparator: paroxetine HCL
* Drug: Comparator: Placebo (Unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Major Depressive Disorder

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aprepitant|nan|
|Drug: Comparator: paroxetine HCL|nan|
|Drug: Comparator: Placebo (Unspecified)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD-17 total score at week 8. Tolerability. |  | at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-I Scale score at week 8 and Sheehan Disability Scale at week 8 |  | at week 8 |
Emergency Surgery During Covid Compared to Emergency Surgery During Pre-covid Period

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the trend of hospitalizations and how emergency operations have qualitatively and quantitatively changed in our Department of Medical and Surgical Sciences of the Foggia Hospital from 2019 (pre-covid era) to date.

Official Title
-----------------
Is Emergency Surgery Back to Pre-covid-19 Era? Our Cohort Study

Conditions
-----------------
Emergencies, Surgery, COVID-19

Intervention / Treatment
-----------------
* Other: Emergency surgery during covid-19 pandemic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent emergency surgery from March 2019 to May 2022 Exclusion Criteria: Patients underwent elective surgery
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Emergency surgery during covid-19 pandemic|Patients undergoing emergency surgery during the covid period and compared with emergency interventions before the pandemic|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is emergency surgery back to pre-covid-19 era? | How emergency surgery has changed during covid pandemic | From March 2019 to May 2022 |
Randomized Controlled Trial on Uptake of NHS Health Checks

Study Overview
=================
Brief Summary
-----------------
The National Health Service (NHS) Health Check is a significant part of the strategy to tackle premature mortality and promote healthy lifestyles. Public Health England aspires to an uptake rate of 75% but national uptake is less than 50%. This study aims to assess the impact of two new behaviourally informed NHS Health Check leaflets on the uptake of NHS Health Checks, by randomizing patients in Lewisham and North East Lincolnshire to the different leaflets and comparing patient-level uptake data. The study will test whether a shorter risk-framed leaflet or a shorter benefits-framed leaflet will be more effective than the current national leaflet at encouraging uptake of the NHS Health Check.

Official Title
-----------------
Randomized Controlled Trial to Compare the Effect of Two New Behaviourally Enhanced NHS Health Check Leaflets and the Current Nationally Recommended Leaflet on Uptake of NHS Health Checks

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: risk-framed leaflet
* Other: benefits-framed leaflet
* Other: current national leaflet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: due to be invited for an NHS Health Check aged 40-74 Exclusion Criteria: have an existing Cardio-Vascular Disease-related medical condition have had an NHS Health Check in the last five years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: risk-framed leaflet<br>Patients sent 2-sided risk-framed leaflet with NHS Health Check invitation | Other: risk-framed leaflet<br>* 2-sided leaflet, emphasizing health risks of not going to the NHS Health Check<br>|
| Experimental: benefits-framed leaflet<br>Patients sent 2-sided benefits-framed leaflet with NHS Health Check invitation | Other: benefits-framed leaflet<br>* 2-sided leaflet, emphasizing benefits of attending an NHS Health Check<br>|
| Active Comparator: control<br>Patients sent 4-sided current national leaflet with NHS Health Check invitation | Other: current national leaflet<br>* 4-sided leaflet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attendance at NHS Health Check | whether or not the patient attended their NHS Health Check | up to 6 months from time of invitation |